Search Results

The Shaw Scalpel System Controller (Model SG6) is a surgical instrument designed to retain the precise, clean cutting characteristics of a traditional stainless steel scalpel and to minimize blood loss by sealing blood vessels as they are cut with minimal tissue damage and virtually no muscle stimulation, using heat thermally conducted to the tissue from an elevated temperature blade.

The Shaw Scalpel System Controller (Model SG6) is a surgical instrument designed to retain the precise, clean cutting characteristics of a traditional steel scalpel and to minimize blood loss by simultaneously sealing blood vessels as they are cut with minimal tissue damage and virtually no muscle stimulation, using heat thermally conducted to the tissue from an elevated-temperature blade. The system utilizes a razor-sharp blade coated with proprietary thick-film inks which when used with the handle and controller heat the blade to precisely controlled temperature levels to achieve the desired levels of hemostasis during surgery. The temperature of the Shaw Scalpel System's blade can be adjusted from 70° C to 300° C at the touch of button on the handle or the controller. The Shaw Scalpel System is intended to provide hemostasis as the surgeon incises. The sharpness of the steel blade and scalpel pressure provides the incising action. The steel blade is covered with a black non-stick coating. Below the non-stick coating surface and a layer of insulation is temperature-controlled micro- circuitry which transfers heat uniformly to the entire blade. The Shaw Scalpel System consists of the following main components: a) Controller An electronic power supply/controller that energizes the blade and provides various automatic calibration, sensing, and control functions. It has user controls with visual and audible indications of instrument status. The controller includes software installed on a PCBA. The software monitors the resistance of the blade which it uses to calculate the amount of power needed to be applied to the blade to maintain the temperature setting on the controller. b) Disposable Handle and Blade Both the subject and the Predicate Controllers utilize a sterile disposable scalpel handle and blade, connected to the controller with a light- weight, flexible electrical cable for use with disposable blades. Handles and blades were cleared via 510 (k) K002021. c) Footswitch An optional footswitch is available for use with the Controller which allows the user to increase/decrease the blade temperature and to switch from CUT and COAG modes. The footswitch was cleared via K091107.

The provided text describes the Shaw Scalpel System Controller (Model SG6) and its comparison to a predicate device, the Hemostatix Model P8400 Thermal Scalpel System Controller. The submission focuses on demonstrating substantial equivalence rather than a new clinical study. Therefore, the information typically requested for AI/ML device studies (such as MRMC, standalone performance, training set details, and specific ground truth provenance for complex algorithms) is not directly applicable or available in this document.

However, I can extract information related to the device's performance verification and usability testing, which include acceptance criteria and study details.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Electrical Safety & Blade Temperature Tests: The sample size is not explicitly stated for these engineering tests. It would typically involve multiple units tested under various conditions to ensure compliance. Data provenance is implied to be from the manufacturer's internal testing or an independent laboratory dedicated to device performance verification.
• Human Factors Usability Testing:
  • Sample Size: 30 participants (15 in the non-sterile group, 15 in the sterile group).
  • Data Provenance: Prospective, conducted as part of the device's development and validation. The study was conducted by C2Dx, Inc.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Electrical Safety & Blade Temperature Tests: N/A. Ground truth for these engineering tests is based on predefined technical specifications and standards (e.g., IEC standards, temperature tolerances). Expert interpretation for ground truth is not applicable in the same way it would be for diagnostic AI.
• Human Factors Usability Testing:
  • Number of Participants (representing users): 30 participants.
  • Qualifications (not "experts" in ground truth, but representative users):
    • Non-sterile group: 15 circulating nurses.
    • Sterile group: 11 scrub techs and 4 surgeons.
  • These individuals acted as the "ground truth" in terms of user interaction and usability of the device for its intended purpose.

4. Adjudication Method for the Test Set

• Electrical Safety & Blade Temperature Tests: N/A. These tests involve direct measurement against established quantitative thresholds rather than expert adjudication.
• Human Factors Usability Testing: The document does not specify an "adjudication method" in the typical sense of resolving disagreements among experts for ground truth. Instead, it describes a usability study where participants' interactions and feedback are assessed against predefined usability parameters and safety criteria. The "acceptance criteria" for usability were met, implying that user performance and feedback were deemed satisfactory without requiring a separate adjudication panel.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The submission is a 510(k) for a hardware device, focusing on demonstrating substantial equivalence to a predicate device through engineering verification and usability testing, not on comparing diagnostic or treatment effectiveness of human readers with vs. without AI assistance. The device is an electrosurgical scalpel system, not an AI/ML diagnostic aid.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, in essence, the pure "standalone" performance relates to the intrinsic functioning of the device's control software and hardware.

• The Electrical Safety tests and Actual Blade Temperature vs. Controller Set-point tests demonstrate the standalone performance of the device's electrical systems and temperature control algorithms without human intervention beyond activating the device and setting parameters.
• The software within the controller is responsible for monitoring temperature sensors and controlling power to maintain the set temperature. This functionality operates autonomously in a "standalone" fashion.

7. The Type of Ground Truth Used

• Electrical Safety: Ground truth is based on engineering standards and regulatory requirements (e.g., IEC 60601-1, IEC 60601-1-2).
• Actual Blade Temperature vs. Controller Set-point: Ground truth is defined by specific quantitative temperature tolerances (+10°, -20° C) relative to the set-point. These are engineering specifications.
• Human Factors Usability Testing: Ground truth relates to "safe and effective use" as determined by established usability practices (ANSI AAMI HE75) and user performance/feedback during simulated use.

8. The Sample Size for the Training Set

N/A. This product is a hardware device with embedded control software, not a machine learning model that requires a "training set" in the conventional sense of AI/ML development. The software capabilities are determined by traditional programming and control algorithms, not by learning from large datasets.

9. How the Ground Truth for the Training Set was Established

N/A, as there is no "training set" for an AI/ML model for this device. The software logic and control parameters are designed and validated through engineering principles and testing, not learned from data.

Ask a specific question about this device

The Model 9160 VitaloQUB is a whole-body plethysmograph device, when used with the Vitalograph Model 9100, is designed for lung function testing on adults and pediatrics, 6 years and older, by trained medical healthcare professionals in a variety of professional healthcare environments e.g., primary care, hospitals, and pharmaceutical research centers.

The proposed Model 9160 VitaloQUB incorporates the cleared Model 9100 (K221030) with integrated LCD display and ComPAS2 software (K213872).

The ComPAS2 software controls valves and reads unprocessed data from the sensors in the Model 9100 and from Model 9160. The ComPAS2 software then determines respiratory parameters including the 2 new parameters.

The ComPAS2 software is unchanged from K213872. The Model 9160 and Model 9100 firmware does not determine any respiratory parameters.

The Model 9160 is adding 2 additional parameters:

• TVG – Thoracic Gas Volume
• Raw Airway resistance

The provided text describes the regulatory clearance for the VitaloQUB Model 9160, a whole-body plethysmograph device. However, it does not contain specific details on the acceptance criteria or a dedicated study report that demonstrates the device explicitly meets numerical acceptance criteria. The text focuses on establishing substantial equivalence to predicate devices.

Here's an analysis based on the information available and what is missing:

The submission states that "Performance testing demonstrated that the subject device met its acceptance criteria," and then lists the types of testing performed. However, it does not provide the specific numerical acceptance criteria or the reported device performance for these criteria.

1. Table of acceptance criteria and the reported device performance:

Missing Information: For VTG and Raw, while the document states performance testing was done, the specific acceptance criteria and the results demonstrating compliance are not provided. The accuracy values listed in the table are copied directly from the "Subject Model 9160" column, indicating that these are the device's inherent specifications, and the comparison section implies they are similar to or meet expectations based on the predicate.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

This information is not provided in the document. The text mentions "Bench testing" but does not detail the sample sizes for any of the performance tests, nor does it specify if any clinical data with human subjects (and thus data provenance) was used for direct performance evaluation of VTG and Raw measurements. The comparison tables focus on technological characteristics and principle of operation similarities to predicates.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not provided in the document. The device outputs objective physiological measurements, rather than interpretations requiring expert consensus as ground truth. If clinical studies were performed for the new parameters (VTG, Raw), the method of establishing ground truth would depend on the study design. However, the document provided does not detail such clinical studies or the involvement of experts in establishing ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not provided in the document. Given the nature of the device (measuring physiological parameters rather than rendering diagnoses or classifications), an adjudication method for a test set as described is unlikely to be directly applicable in the same way as for image-based diagnostic AI. If human subject studies were conducted to compare measurements, adjudication of patient conditions might be relevant, but this is not detailed.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This is not applicable to this device. The VitaloQUB Model 9160 is a pulmonary function measurement device. It measures physiological parameters and does not involve "readers" or "AI assistance" in the diagnostic interpretation sense for which MRMC studies are typically performed. The device itself performs the measurements and calculations (via the ComPAS2 software), it does not assist human interpretation of complex data (like images) in a way that would be quantified by an MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The device is inherently a standalone measurement system in terms of calculating the parameters. The ComPAS2 software, which is part of the system, outputs the respiratory parameters. This is the "algorithm only" performance. The document states: "The ComPAS2 software controls valves and reads unprocessed data from the sensors in the Model 9100 and from Model 9160. The ComPAS2 software then determines respiratory parameters...". The performance testing mentioned ("Bench testing", "ATS / ERS (2002, 2005, 2013, 2017 and 2019) Static condition") assesses the accuracy of these measurements directly from the device/software. Specific performance for VTG and Raw measurements would have been assessed in this standalone manner, but the numerical results are not provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For physiological measurement devices, the "ground truth" is typically established by physical standards, calibration gases, and established reference methods or simulated physiological conditions that adhere to recognized industry standards (e.g., ATS/ERS standards). The document mentions compliance with various ISO and ATS/ERS standards, which dictate the methods and accuracy requirements for such measurements. For example, gas concentrations for DLCO are compared against medical-grade gas mixes, and flow/volume against calibrated instruments.

8. The sample size for the training set:

This information is not provided. As the device is a measurement instrument incorporating software (ComPAS2) for calculations based on physical readings, it's not described as an AI/ML device that requires a "training set" in the conventional sense (e.g., for pattern recognition or classification). The software implements algorithms for physiological calculations rather than learning from data in a machine learning paradigm.

9. How the ground truth for the training set was established:

This information is not provided, and likely not applicable as the device is not described as an AI/ML system requiring a training set with ground truth in the context of machine learning. The algorithms are based on established physiological principles and equations.

Ask a specific question about this device

The Model 9100 PFT/DICO is a pulmonary function testing device which uses Morgan Scientific's ComPAS2 software to measure subject respiratory parameters including FVC, SVC, MVV, CPF, RMS, SNIP, DLCO, MBN2 and SBN2.

The device is PC-based and designed for lung function testing on adults and pediatrics, 6 years and older, in a variety of professional healthcare environments e.g., primary care, hospitals, pharmaceutical research centers and physicians' offices.

The Model 9100 PFT/DICO is intended for the assessment of respiratory function through the measurement of dynamic lung volumes i.e., spirometry and other lung functions i.e., diffusing capacity.

The Model 9100 PFT/DICO is composed of various sensors and valves with associated low level firmware. The firmware interfaces with the Morgan Scientific's ComPAS2 software (K213872) that resides on an on-board computer. The Model 9100 also provides for user input and present resulting data on an integral display.

The ComPAS2 software controls valves and reads unprocessed data from the sensors in the Model 9100then determines respiratory parameters including FVC, SVC, MVV, CPF, RMS (MIP and MEP), SNIP, DLCO, MBN2 and SBN2. The Model 9100 PFT/DICO firmware does not determine any respiratory parameters.

The ComPAS2 software uses flow and volume from the Vitalograph pneumotachograph spirometer to display the flow and volume information measured directly from patient effort. ComPAS2 also utilizes gas analyzer readings from the Model 9100 patient test benchmark to display dilution lung volume data and single / multi breath diffusion data measured directly from patient effort. This information is then provided in a report format.

The provided text describes the regulatory clearance of the Vitalograph Model 9100 PFT/DICO, a pulmonary function testing device, and its substantial equivalence to a predicate device. However, it does not contain information about a study proving the device meets acceptance criteria related to a machine learning or AI model's performance.

The document outlines performance testing conducted for the device's electrical, mechanical, and biocompatibility aspects, as well as software verification and validation. It explicitly states that the device uses "Morgan Scientific's ComPAS2 software to measure subject respiratory parameters," but there's no indication that this software includes an AI or machine learning component that would require a study with human-in-the-loop performance, expert ground truthing, or MRMC studies typically associated with AI/ML medical devices.

Therefore, many of the requested details about acceptance criteria for an AI model's performance and associated study specifics (sample size for test/training, number of experts, adjudication, MRMC, standalone performance, ground truth type) cannot be extracted from this document.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device based on similar indications for use, technological characteristics, and principles of operation, supported by standard bench testing and software validation.

Here's an attempt to answer the request based only on the provided text, highlighting the absence of AI/ML-specific details:

Device: Vitalograph Model 9100 PFT/DICO

Study Type: This document describes a 510(k) premarket notification for substantial equivalence, supported by bench testing, software verification/validation, and compliance with various standards. It is not an AI/ML performance study. The "study that proves the device meets the acceptance criteria" refers to the entire body of evidence submitted for 510(k) clearance, rather than a specific AI model's performance study.

1. A table of acceptance criteria and the reported device performance

The document defines performance specifications and states that testing supported the safety and performance, implying these specifications were met. The specific "acceptance criteria" for the overall device's performance are embedded in the compliance with standards and the "similar" comparisons to predicate/reference devices.

Note on "Acceptance Criteria" for AI: The document does not describe acceptance criteria for an AI or machine learning model. The stated accuracies (e.g., flow, volume, gas sensors) are for the physical measurement components of the device, not a predictive algorithm based on complex data interpretation.

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not specified for any performance testing, other than the implication that tests were sufficient to meet specific standards (e.g., ATS/ERS waveforms, drop tests, cleaning validations). There is no test set in the context of an AI/ML model's performance.
• Data Provenance: Not applicable in the context of typical AI/ML data provenance (e.g., country of origin, retrospective/prospective clinical data). The performance tests are largely bench-based or simulated.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. There is no mention of human experts establishing ground truth for a test set, as would be done for an AI/ML interpretation task. Ground truth for the device's measurements would be established by reference standards or highly accurate laboratory equipment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. No expert adjudication process is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No, an MRMC comparative effectiveness study was not done. The device measures physiological parameters; it does not "assist" human readers in interpreting complex medical images or data.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable in the context of an AI/ML algorithm. The device itself is the "standalone" entity that performs measurements. The software (ComPAS2) controls the device and processes the raw sensor data, but there's no indication of it being a standalone AI/ML interpreter.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• The ground truth for the device's performance relies on calibration standards, reference instruments, and established engineering/medical device testing protocols (e.g., ATS/ERS guidelines for spirometry, ISO standards for gas analysis accuracy, and various electrical/mechanical standards). There is no "expert consensus," "pathology," or "outcomes data" used for performance validation in the AI/ML sense.

8. The sample size for the training set

• Not applicable. There is no mention of an AI/ML model that would require a training set. The ComPAS2 software and device firmware are likely developed using traditional software engineering and embedded system development methods, not machine learning model training.

9. How the ground truth for the training set was established

• Not applicable, as there is no AI/ML training set.

Ask a specific question about this device

The Shengwei Biopsy needle consist of Model 121 Biopsy Needle, Model 111/112 Biopsy Needle, and Model 13 1 Disposable Coaxial Biopsy Needle. These devices are indicated for use as follows:

Model 121 Biopsy Needle is intended for obtaining percutaneous or surgical histological core samples from soft tissues such as breast, kidney, liver, lung and various soft tissue masses. The device is not intended for use in bone.

Model 111/112 Biopsy Needle is intended for obtaining core biopsy from samples soft tissues such as kidney, liver, prostate and various soft tissue masses. The device is not intended for use in bone.

Model 111/112 Biopsy Needle is also indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is designed to provide breast tissue for histologic examination with partial or complete removal of the abnormality.

Model 131 Disposable Coaxial Biopsy Needle is intended for use with biopsy needle during soft tissue core biopsy procedures. The device is not intended for use in bone.

The extent of histological abnormality cannot be reliably determined from it mammographic appearance. Therefore the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histological abnormality (e.g. malignancy). When the sampled abnormality is not histologically benign, it is essue margins be examined for completeness of removal using standard surgical procedures.

The Shengwei Biopsy needle include semi-automatic and automatic spring powered guns (disposable). Cannula accessory is provided in a variety of sizes, designed to work with the manufacturer's semi-automatic and automatic guns to obtain and deliver a soft tissue core sample, facilitate skin and tissue penetration, sample retention and / or expulsion depending on the sample sites.

The provided document describes the acceptance criteria and the study that proves the device meets the acceptance criteria for the Shengwei Biopsy Needles (Model 121, Model 111/112, and Model 131 Disposable Coaxial Biopsy Needle).

Here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Sample Size: For performance testing (Depth Projection, Penetration Force, Activation Force, Mechanical Durability, Extraction), "Samples of each device product family (subject device) were selected at the extremes of device design for needle length and gauge sizes." For Depth Projection, Activation Force, and Extraction, testing was performed "over 50 shots per use." For Penetration Force, "Each tested subject and predicate device was activated 50 times." For Shelf-life, "Three lots of aged and non-aged subject devices were tested in triplicate."
• Data Provenance: The document does not explicitly state the country of origin of the data for these performance tests. It also does not explicitly state whether the tests were retrospective or prospective, but given they are laboratory performance tests, they are inherently prospective for the purpose of this submission.
• Clinical Data: No clinical data was included in this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• This information is not applicable as the studies described are laboratory performance tests focusing on mechanical and biological properties of the device, not clinical performance requiring expert interpretation or ground truth establishment in a medical context.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• This information is not applicable as the studies described are laboratory performance tests measuring quantifiable physical properties of the device, not clinical studies involving interpretation or adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No MRMC study was done. This document is for a medical device (biopsy needle), not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• No standalone (algorithm only) performance study was done. This document is for a physical medical device (biopsy needle), not a diagnostic algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• For biocompatibility, the ground truth is established by recognized international standards (ISO 10993 series and USP tests) which define acceptable biological responses.
• For performance testing, the ground truth is established by specific criteria outlined in the testing protocols (e.g., "Needle Advancement > 20 mm," "Breakage Force (SHENGWEI) > FPredicate") and comparison to legally marketed predicate devices. Quantitative measurements are taken against these predefined standards or predicates.

8. The sample size for the training set

• This information is not applicable as the document describes laboratory performance and biocompatibility testing for a physical medical device, not a machine learning model that would require a training set.

9. How the ground truth for the training set was established

• This information is not applicable for the same reason as point 8.

Ask a specific question about this device

The 1D Water Phantom WP-3840 and WP-3040 is used to position various radiation detectors in water or air. It consists of a cubic acrylic tank and a precision one-dimensional hand crank. By design it is suitable to act as a phantom according to various protocols such as the AAPM's TG-51protocol.

The Water Phantom WP-3840 and WP-3040 comprises of a one-dimensional precision mechanism attached to an Acrylic water tank. Various radiation detectors can be positioned along a vertical guide rail in different depths according to the application needs. The WP-3840 and WP-3040 consist of the basic acrylic water tank phantom, equipped with a hand crank to move the detector. That hand crank is coupled to a mechanical counter, reset-able position indicator that displays the depth.

This document, a 510(k) Premarket Notification Summary (K173848) for the CNMC Model WP-3840 and WP-3040, primarily focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study or performance evaluation with a dedicated test set and ground truth.

Therefore, many of the requested details about acceptance criteria, study design, expert involvement, and ground truth establishment are not present in this type of regulatory submission.

However, based on the provided text, we can infer the "acceptance criteria" through the comparison made to the predicate device and the "study" by the comparison table and conclusion.

Here's how we can address the questions based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The "acceptance criteria" for equivalency are implicitly defined by the characteristics of the predicate device (Medtec, Inc. - K943199, Model MT-150). The "reported device performance" is a statement of the CNMC Model WP-3840/WP-3040's characteristics.

Note: The "acceptance criteria" here are not numerical thresholds for performance metrics but rather a qualitative comparison to the established characteristics of the predicate device for demonstrating substantial equivalence.

2. Sample size used for the test set and the data provenance:

This document describes a comparison of device specifications and intended use, not a study involving a "test set" of data or patient samples. Therefore, there is no information about sample size or data provenance (country of origin, retrospective/prospective). The "test" is a comparison of product specifications against a predicate.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This is not a study requiring expert-established ground truth on a test set. The "ground truth" for the comparison is the published specifications of the predicate device and the design specifications of the new device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. There is no test set or adjudication process described as this is a comparison of technical specifications.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a water phantom used for radiation dosimetry, not an AI-assisted diagnostic device for human readers. No MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a physical medical device (water phantom), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The "ground truth" in this context is the technical specifications and intended use of the legally marketed predicate device (Medtec, Inc. - K943199, Model MT-150), along with the design and manufacturing specifications of the new device (CNMC WP-3840/WP-3040). There's no biological or clinical ground truth involved.

8. The sample size for the training set:

Not applicable. This document does not describe a machine learning or AI device that requires a training set.

9. How the ground truth for the training set was established:

Not applicable. No training set is described.

In summary:

This 510(k) notification demonstrates substantial equivalence to a predicate device based on comparison of engineering specifications and intended use, rather than a clinical performance study with defined acceptance criteria and a test set like those typically used for diagnostic or AI-based medical devices. The "study" is the comparative analysis presented in the "Similarities/Differences" table.

Ask a specific question about this device

The ZOLL® Model 330 Multifunction Aspirator is a self-contained suction device designed for removing debris from a patient's airway or respiratory system, secretions, blood, vomitus, tissue (including bone), bodily fluids and infectious materials during surgery. Programmable intermittent gastrointestinal and abdominal wound drainage can also be performed with the device. It is suitable for use in pre-hospital, mass casualty and transport environments, including aeromedical. The Model 330 is only for use by or on the order of a physician.

The ZOLL Model 330 Multifunction Aspirator is a product based on the currently marketed Model 326/326M Aspirator (acquired by ZOLL Medical Corporation through an asset acquisition of Impact Instrumentation, Inc., reviewed and cleared under K951423). Similar to the currently marketed 326 Aspirator, the ZOLL 330 Aspirator is a small, durable, full-featured portable aspirator designed to operate in the hospital, prehospital, field hospital, mass casualty and during ground or air transport settings.

Like the predicate 326 Aspirator, the proposed 330 Aspirator is an electrically powered suction pump intended to remove debris from a patient's airway or respiratory system, secretions, blood, yomitus, surgical fluids, tissue (including bone), bodily fluids and infectious materials during surgery. Both the devices can also be used to perform programmable intermittent gastrointestinal and abdominal wound drainage.

Both Aspirators can be operated from an AC or DC external power source, or from an internal rechargeable battery system, and supports both aspiration modes: Continuous and Intermittent. The Continuous mode in the proposed 330 Aspirator is sub-divided into four procedure types: Surgical, Pharyngeal, Tracheal, and CASS (Continuous Aspiration of Subglottic Secretions). Each procedure has a pre-set pressure range under which the device can be operated. Additionally with the proposed device we have introduced the following functionality:

• . Start Menu Functionality: Start Menu functionality is developed that allows the user to select from a series of preconfigured options that are appropriate for different patient groups: adult, pediatric, the last device settings and a custom start configuration established by the user or their organization.
• SMART FLOW Functionality: The feature detects a drop in the measured vacuum level when the ● therapy is not being applied and in response allows the aspirator to reduce the applied vacuum thereby allowing quieter operation of the device in the continuous mode.
• . ALARMS: The 330 Aspirator offers a suite of visual alarm indicators by illuminating red, yellow and green LED lights, and audible alarm indicators, to alert the user about issues relating to external power or battery, environmental conditions that could affect device performance, and device selfcheck failures.

The provided document describes a 510(k) premarket notification for the ZOLL Model 330 Multifunction Aspirator. This device is a powered suction pump and the submission focuses on demonstrating its substantial equivalence to a predicate device (Model 326/326M Aspirator).

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

Key Takeaway: This submission primarily relies on non-clinical performance testing to demonstrate substantial equivalence, rather than clinical studies or extensive statistical evaluations of diagnostic performance. The device is a physical medical device, not an AI or imaging diagnostic tool, so the typical AI/ML-specific criteria requested in the prompt (like multi-reader studies, ground truth for training data, etc.) are not applicable to this document.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantified, pass/fail manner for the device's overall performance. Instead, it demonstrates compliance with recognized standards and verifies specific performance parameters through testing. The "reported device performance" is largely described by meeting these standards and verifying functional requirements.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: Not explicitly stated in terms of a "test set" for performance evaluation, as this is not a diagnostic device involving patient data samples. The testing described (software V&V, safety, EMC, usability) refers to engineering and functional tests on the device hardware and software. There is no information about a "test set" in the context of patient data.
• Data Provenance: Not applicable. The "data" here refers to test results from engineering and functional evaluations of the device, not patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

• Number of Experts & Qualifications: Not applicable. Ground truth, in the context of diagnostic AI/ML, refers to a definitive diagnosis or outcome. For a physical medical device like an aspirator, "ground truth" is established by engineering specifications, safety standards, and functional requirements. Expert review likely occurred in the design, testing, and regulatory submission process by engineers and regulatory specialists, but not in the sense of physicians establishing ground truth for a diagnostic test.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. No "test set" of cases requiring adjudication for diagnostic accuracy is present.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• MRMC Study: No. This is not an AI/ML diagnostic device, so a MRMC study is not relevant.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Standalone Performance: Not applicable. This is a physical aspirator device, not an algorithm. Its performance is inherent to its mechanical and electrical function.

7. The Type of Ground Truth Used

• Type of Ground Truth: For a physical medical device like the Model 330 Multifunction Aspirator, the "ground truth" for demonstrating performance and safety is derived from:
  • Engineering Specifications: The device must perform according to its design specifications (e.g., free flow rate, suction pressure range).
  • International Consensus Standards: Compliance with established safety (e.g., IEC 60601-1) and performance (e.g., ISO 10079-1 for suction equipment) standards serves as the ground truth for safety and baseline functionality.
  • Predicate Device Performance: The device's ability to operate with similar, or improved, functional characteristics compared to its legally marketed predicate device (Model 326/326M Aspirator) is a key "ground truth" for substantial equivalence.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This device does not employ machine learning or AI that requires a "training set" of data.

9. How the Ground Truth for the Training Set was Established

• Ground Truth for Training Set: Not applicable, as there is no training set for an AI/ML algorithm.

Ask a specific question about this device

Model X-100C
Nonin's Model X-100C CO-Met™ Oximetry System is indicated for noninvasive measuring of functional oxygen saturation of arterial hemoglobin (%SpO2), carboxyhemoglobin saturation (%COHb), methemoglobin saturation (%MetHb), and pulse rate of adult and pediatric patients (>66 lbs / 30 kg) using the Model 8300AA sensor. The measurements may be multiple spot-checks to observe change and/or continuous monitoring. The X-100C system is indicated for use by trained personnel in clinical settings, including Emergency Medical Service (EMS). hospitals, medical facilities, and mobile environments. This device is not meant for sole use in clinical decision making; it must be used in conjunction with additional methods of assessing clinical signs and symptoms.

Model 8300AA
The Model 8300AA reusable finger clip sensor is intended for noninvasive measuring of function of arterial hemoglobin (%SpO2), carboxyhemoglobin saturation (%COHb), methemoglobin saturation (%MetHb), and pulse rate of adult and pediatric patients (> 66 lbs / 30 kg). The measurements may be multiple spot-checks to observe change and/or continuous monitoring. It is intended for use in Emergency Medical Service (EMS), hospitals, medical facilities, and mobile environments. This device is not meant for sole use in clinical decision making: it must be used in conjunction with additional methods of assessing clinical signs and symptoms.

The Model X-100C CO-Met Oximetry System displays (COHb), methemoglobin (MetHb), pulse oxygen saturation (SpO2), and pulse rate (PR) data transmitted from one channel of data through a direct connection of the signal processor to the monitor. The monitor receives, displays, provide alarm management, and storage of COHb, MetHb, SpO2, and PR. The device is capable of running on battery power or on AC power via an external power supply. The device is equipped with patient alarms to alert the user to abnormal conditions and shall provide real time data output of COHb, MetHb, SpO2, and PR.

The provided document describes the acceptance criteria and the study conducted for the Nonin Medical, Inc. Model X-100C CO-Met™ Oximetry System (K160231).

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document references ISO 80601-2-61 for accuracy calculations (root-mean-squared, Arms value). While specific numerical acceptance criteria (e.g., maximum Arms value for each parameter) are not explicitly stated in a consolidated table, the performance is reported against these implicit criteria derived from the standard.

2. Sample size used for the test set and the data provenance

• Sample Size: Not explicitly stated as a number of subjects. The clinical accuracy testing sections mention "healthy, male and female, non-smoking, light to dark-skinned subjects that were 18 years of age and older." They refer to "all subjects" in the accuracy calculation but do not provide a specific count.
• Data Provenance: Retrospective or prospective is not explicitly stated. However, the description of "COHb accuracy testing was conducted at an independent research laboratory," "MetHb accuracy testing was conducted at an independent research laboratory," and "induced hypoxia studies" suggests a prospective study design where subjects were enrolled and data collected for the purpose of the study. The location is an "independent research laboratory." The country of origin is not specified but is implicitly within the scope of a U.S. FDA submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable for this type of medical device. The ground truth for oximetry is established through a co-oximeter analyzing arterial blood samples, not through expert consensus on images or clinical assessments in this context.

4. Adjudication method for the test set

Not applicable. The ground truth is objective measurement from a co-oximeter analysing blood samples.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a standalone oximetry system and does not involve human readers interpreting images with or without AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, the primary performance evaluation described is for the standalone device (Model X-100C CO-Met™ Oximetry System with 8300AA sensors) without an explicit human-in-the-loop component for interpreting the raw measurements; the device generates direct readings. The accuracy studies directly compare the device's measurements to the co-oximeter's measurements of arterial blood.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for COHb, MetHb, and SpO2 measurements was established using laboratory co-oximetry analysis of simultaneous arterial blood samples.

8. The sample size for the training set

Not applicable. This refers to a medical device for direct measurement, not an AI/machine learning algorithm that requires a training set. The device's performance is based on its sensor technology and signal processing.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this type of device.

Ask a specific question about this device

Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors: Nonin's Model 6100C Series single-patient use, disposable pulse oximeter sensors are indicated for non-invasive spotchecking and/or continuous monitoring of patients (6100CA: adults > 30 kg / 66 Ib; 6100CP: pediatrics > 10 kg / 22 1b ; 6100CI: infants > 2 kg / 4 1b; and 6100CN: neonates < 2 kg / 4 1b and adults > 30 kg / 66 lb), who are well or poorly perfused, during both motion and non-motion conditions. It is intended for use hospitals, medical facilities, Emergency Medical Service (EMS) environments, home healtheare environments, and mobile environments.

Model 6101C Series Single-Patient Use, Disposable Pulse Oximeter Sensors: Nonin's Model 6101C Series single-patient use, disposable pulse oximeter sensors are indicated for non-invasive spotchecking and/or continuous monitoring of patients (6101CA: adults > 30 kg / 66 lb; 6101CP: pediatrics > 10 kg / 22 1b ; 6101CI: infants > 2 kg / 4 1b; and 6101CN: neonates < 2 kg / 4 lb and adults > 30 kg / 66 lb), who are well or poorly perfused, during both motion and non-motion conditions. It is intended for use hospitals, medical facilities, Emergency Medical Service (EMS) environments, home healthcare environments, and mobile environments.

Model 6102C Series Single-Patient Use, Disposable Pulse Oximeter Sensors: Nonin's Model 6102C Series single-patient use, disposable pulse oximeter sensors are indicated for non-invasive spotchecking and/or continuous monitoring of patients (6102CA: adults > 30 kg / 66 Ib; 6102CP: pediatrics > 10 kg / 22 1b ; 6102C1: infants > 2 kg / 4 1b; and 6102CN: neonates < 2 kg / 4 1b and adults > 30 kg / 66 lb), who are well or poorly perfused, during both motion and non-motion conditions. It is intended for use hospitals, medical facilities, Emergency Medical Service (EMS) environments, home healtheare environments, and mobile environments.

Model 8100AA/8100AP Reusable, Finger Clip Pulse Oximeter Sensor: The Model 8100AA reusable, finger clip sensor is intended for non-invasive spot-checking and/or continuous monitoring of adult and pediatric patients (> 30 kg / 66 lb) who are well or poorly perfused, during both motion and non-motion conditions. The Model 8100AP reusable, finger clip sensor is intended for non-invasive spot-checking and/or continuous monitoring of pediatric patients (8 – 60 kg / 18 – 132 lb) who are well or poorly perfused, during both motion and non-motion conditions. It is intended for use in hospitals, medical facilities, Emergency Medical Service (EMS) environments, home healthcare environments, and mobile environments.

Model 8101AA/8101AP Reusable, Finger Clip Pulse Oximeter Sensor: The Model 8101AA reusable, finger clip sensor is intended for non-invasive spot-checking and/or continuous monitoring of adult and pediatric patients (> 30 kg / 66 lb) who are well or poorly perfused, during both motion and non-motion conditions. The Model 8101AP reusable, finger clip sensor is intended for non-invasive spot-checking and/or continuous monitoring of pediatric patients (8 – 60 kg / 18 – 132 lb) who are well or poorly perfused, during both motion and non-motion conditions. It is intended for use in hospitals, medical facilities, Emergency Medical Service (EMS) environments, home healtheare environments, and mobile environments.

Model 8102AA/8102AP Reusable, Finger Clip Pulse Oximeter Sensor: The Model 8102AA reusable, finger clip sensor is intended for non-invasive spot-checking and/or continuous monitoring of adult and pediatric patients (> 30 kg / 66 lb) who are well or poorly perfused, during both motion and non-motion conditions. The Model 8102AP reusable, finger clip sensor is intended for non-invasive spot-checking and/or continuous monitoring of pediatric patients (8 - 60 kg / 18 - 132 lb) who are well or poorly perfused. during both motion and non-motion conditions. It is intended for use in hospitals, medical facilities. Emergency Medical Service (EMS) environments, home healthcare environments, and mobile environments.

Model 8100Q2 Reusable, Ear Clip Pulse Oximeter Sensor: The Model 8100Q2 reusable, ear clip sensor is indicated for non-invasive, spot-checking and/or continuous monitoring of adult and pediatric patients (> 40 kg / 88 1b) who are well or poorly perfused, during non-motion conditions. It is intended for use in hospitals, medical facilities, Emergency Medical Service (EMS) environments, and mobile environments. The recommended application site is the earlobe.

Model 8101Q2 Reusable, Ear Clip Pulse Oximeter Sensor: The Model 8101Q2 reusable, ear clip sensor is indicated for non-invasive, spot-checking and/or continuous monitoring of adult and pediatric patients (> 40 kg / 88 lb) who are well or poorly perfused, during non-motion conditions. It is intended for use in hospitals, medical facilities, Emergency Medical Service (EMS) environments, home healthcare environments, and mobile environments. The recommended application site is the earlobe.

Model 8102Q2 Reusable, Ear Clip Pulse Oximeter Sensor: The Model 8102Q2 reusable, ear clip sensor is indicated for non-invasive, spot-checking and/or ing of adult and pediatric patients (> 40 kg / 88 1b) who are well or poorly perfused, during non-motion conditions. It is intended for use in hospitals, medical facilities, Emergency Medical Service (EMS) environments, and mobile environments. The recommended application site is the earlobe.

The Model 6100C Series, Model 6101C Series and Model 6102C Series Pulse Oximeter Sensors are single-patient use. non-sterile disposable pulse sensors intended for use with the Nonin Medical Model X-100 SenSmart Universal Oximetry System (Model X-100). The Model 8100AA/8100AP, Model 8101AA/8101AP, Model 8102AA/8102AP, Model 8100Q2, Model 8101Q2 and Model 8102Q2 Pulse Oximeter Sensors are reusable, non-sterile pulse sensors intended for use with the Nonin Medical Model X-100 SenSmart Universal Oximetry System (Model X-100).

Acceptance Criteria and Device Performance for Nonin Pulse Oximeter Sensors

The provided document describes the acceptance criteria and study results for Nonin Medical, Inc.'s pulse oximeter sensors, specifically the Model 6100C Series, 6101C Series, 6102C Series, 8100AA/8100AP, 8101AA/8101AP, 8102AA/8102AP, 8100Q2, 8101Q2, and 8102Q2.

1. Table of Acceptance Criteria and Reported Device Performance

The document indicates that the acceptance criteria for these pulse oximeter sensors are based on various functional, safety, and clinical standards. The reported device performance uniformly passes all these criteria, demonstrating substantial equivalence to predicate devices. The specific performance metrics for SpO2 accuracy are given in terms of ARMS values (Root-Mean-Squared) but the exact numerical values for these ARMS values are not explicitly stated in the provided text, only that they were calculated for all subjects.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: The document states that clinical SpO2 accuracy testing was conducted on "healthy, male and female, non-smoking, light to dark-skinned subjects that were 18 years of age and older" for adult/pediatric models. For neonatal models (6100CN, 6101CN, 6102CN), testing was conducted on "male and female, light to dark-skinned subjects up to 30 days of age." The specific number of subjects (the sample size) for each sensor type or a combined number is not explicitly stated in the provided text.
• Data Provenance: Clinical testing was conducted at an "independent research laboratory" for adult/pediatric and finger/ear clip sensors, and at a "Children's Hospital" for neonatal sensors. This indicates prospective data collection for the specific purpose of this study. The country of origin for the data is not explicitly stated, but the submission is to the U.S. FDA, suggesting U.S. or internationally recognized standards-compliant data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The ground truth for the clinical SpO2 accuracy testing was established using co-oximetry from simultaneous arterial blood samples. This is an objective measurement from a medical device (co-oximeter) and does not typically involve expert consensus in the same way as, for example, image interpretation. Therefore, the concept of "number of experts" and their "qualifications" for establishing this specific ground truth data is not applicable in the traditional sense. The accuracy of the co-oximeter itself would be subject to its own validation.

4. Adjudication Method for the Test Set

Since the ground truth for SpO2 accuracy was established through direct biomedical measurement (co-oximetry of arterial blood samples), an adjudication method (like 2+1 or 3+1 consensus) for subjective expert interpretation is not applicable. The comparison was directly between the device's SpO2 reading and the co-oximeter's SaO2 reading.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done, and the concept of "human readers improve with AI vs without AI assistance" is not applicable to this device. This submission concerns pulse oximeter sensors, which are hardware devices for physiological measurement, not AI-powered diagnostic software that assists human interpreters. The testing focused on the device's inherent accuracy against a physiological gold standard.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

The clinical testing described is effectively a "standalone" performance study for the pulse oximeter sensors, as it evaluates the device's output (SpO2 reading) against a medical gold standard (co-oximetry) without human intervention in interpreting the sensor's measurement. The accuracy data was calculated from the device's measurements directly.

7. The Type of Ground Truth Used

The ground truth used for SpO2 accuracy testing was co-oximetry of simultaneous arterial blood samples (SaO2). This is a highly objective and recognized medical gold standard for determining actual arterial oxygen saturation.

8. The Sample Size for the Training Set

The document describes clinical and non-clinical testing for the purpose of demonstrating substantial equivalence to predicate devices and does not refer to a machine learning or AI model that requires a distinct "training set." Therefore, a sample size for a training set is not applicable in the context of this device submission. The device's "training" would be its design, calibration, and manufacturing processes.

9. How the Ground Truth for the Training Set Was Established

As there is no "training set" in the context of an AI/ML model for this device, the question of how its ground truth was established is not applicable. The device's intrinsic accuracy is validated against established medical standards.

Ask a specific question about this device

The Tristan Technologies Model 621/624 Biomagnetometer is intended for use as a tool that noninvasively measures and displays the magnetic signals produced by the electric currents in the heart of human beings of any age or in the heart of a fetus in utero.

The Tristan Technologies Model 621/624 Biomagnetometer (hereinafter referred to as the "Model 621/624") utilizes superconducting signal pickup coils and Superconducting Quantum Interference Devices (SQUIDs) to detect and amplify magnetic fields produced by electrical activity in the heart. The Model 621/624 consists of a sensor unit, an electronics subsystem for preliminary amplification, filtering, and analog to digital conversion of the signals from each SQUID, an electronics rack containing power supplies to power the electronics subsystem, a computer to control the operation of the electronic subsystem and the SQUIDs and to acquire and store the signal values collected by the system.

This document is a 510(k) premarket notification for the Tristan Technologies Model 621/624 Biomagnetometer. The notification primarily focuses on establishing substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a comprehensive study against them. Therefore, many of the requested sections regarding the study and ground truth will not be directly derivable from this document.

Here's an analysis based on the provided text, highlighting what is available and what is not:

1. A table of acceptance criteria and the reported device performance

This document does not present a table of specific, quantifiable acceptance criteria or a direct comparison of the Model 621/624's performance against such criteria. The "performance" assessment is based on demonstrating technological equivalence to a predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not explicitly stated in terms of patient numbers. The "non-clinical test measurements" were conducted at the University of Wisconsin Department of Medical Physics.
• Data Provenance: The tests were "non-clinical" and involved "test measurements" at a university in the US (University of Wisconsin). It is unclear if these were on human subjects or phantoms, but given the context of biomagnetic signals from the heart, it implies human data. The document does not specify if the data was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The "ground truth" here is the measurement of magnetic signals, not a diagnostic interpretation that would require expert consensus. The study focused on comparing the device's ability to measure these signals against a predicate device's published measurements.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There was no diagnostic adjudication process involved. The comparison was based on the output signals themselves.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This is not an AI-based device, and no MRMC study was conducted or mentioned. The device is a "Biomagnetometer" that measures and displays magnetic signals from the heart.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Essentially, yes, in the sense that the "non-clinical test measurements" focused on the device's ability to generate signals. However, this is not an "algorithm-only" device in the AI sense. It's a measurement device. Its performance is its standalone capability to measure. The study aimed to show its measurements were comparable to the predicate device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" was the expected magnetic signals produced by electrical activity in the heart, as measured by a legally marketed predicate device. The comparison was made based on published data from the predicate device. In essence, the predicate device's measurements served as the reference for technological equivalence.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

9. How the ground truth for the training set was established

Not applicable, as there is no training set.

Ask a specific question about this device

The CNMC Model 206 is a medical dosimeter, or medical electrometer that is capable of performing measurements of diagnostic and therapeutic amounts of ionizing radiation when an appropriate ionization chamber or diode dosimeter is connected. These instruments are used exclusively by qualified personnel, typically medical physicists, for the calibration and quality control of medical equipment that produces ionizing radiation.

The CNMC Model 206 is a dosimetry electrometer intended for measuring the output charge of an Ionization chamber or dosimetry diode that is used in a radiotherapy beam.

The CNMC Model 206 is a medical dosimeter, or medical electrometer that is capable of performing measurements of diagnostic and therapeutic amounts of ionizing radiation when an appropriate ionization chamber or diode dosimeter is connected. These instruments are used exclusively by qualified personnel, typically medical physicists, for the calibration and quality control of medical equipment that produces ionizing radiation.

Here's an analysis of the provided text regarding the acceptance criteria and study for the CNMC Model 206 Electrometer/Dosimeter:

General Note: The provided document is a 510(k) Premarket Notification Summary from the FDA. This document primarily focuses on establishing "substantial equivalence" to a predicate device, rather than providing a detailed report of a new clinical study with specific acceptance criteria and performance data for a novel device. Therefore, many of the requested items (e.g., sample sizes, ground truth establishment, expert qualifications, MRMC studies) are not typically found in this type of regulatory submission because the device is not a complex AI/ML system requiring extensive clinical validation. Instead, the focus is on demonstrating that the new device performs comparably to an already approved device.

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

Summary: The CNMC Model 206 Electrometer/Dosimeter is primarily evaluated for "substantial equivalence" to a predicate device (Sun Nuclear Model 1010/206 – K002444). The acceptance criteria are implicitly defined by the specifications of the predicate device and the new device's ability to meet those specifications. The "study" demonstrating this involves comparing the technical specifications and intended use of the CNMC Model 206 to the predicate device.

1. A table of acceptance criteria and the reported device performance

Since this is a substantial equivalence submission, the "acceptance criteria" are the performance specifications of the predicate device, and the "reported device performance" is how the CNMC Model 206 matches or is equivalent to those specifications.

Conclusion from document: The Model 206 is substantially equivalent to the predicate device because:

1. The indication for use of the Model 206 is exactly the same as the predicate device.
2. The units are of identical design.
3. The Model 206 and the predicate device are tested to the same specifications.
4. The Model 206 and the predicate device use the same vendors for purchasing of material for manufacturing.
5. CNMC considers the Model 206 equivalent in all areas to the predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. For a substantial equivalence claim for a comparatively simple electrometer, detailed "test set" data in the context of clinical populations or image datasets is typically not required. The "test" here refers to whether the device's technical specifications match those of the predicate. Data provenance, if any, would be from internal engineering testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable/provided in the document as there isn't a "ground truth" established by experts in the context of diagnostic interpretation (like in AI/ML products). The "ground truth" for an electrometer is its physical measurement accuracy, which is verified against calibrated standards, not human expert consensus.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable/provided. Adjudication methods are relevant for subjective assessments, particularly in medical imaging or clinical diagnosis. This device measures physical quantities and its performance is assessed against known standards, not through human adjudication of results.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable/provided. The device is an electrometer/dosimeter, not an AI-assisted diagnostic tool. Therefore, MRMC studies and "human readers improving with AI" are entirely outside the scope of this device and its 510(k) submission.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This information is not applicable/provided. This device is a measurement instrument, not an algorithm. Its performance is always "standalone" in that it produces a measurement. The "human-in-the-loop" is the qualified personnel (medical physicists) who interpret and utilize the measurements for calibration and quality control.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for an electrometer's performance is typically established by traceable physical standards and calibrated reference instruments. The document doesn't explicitly state the methodology for this, but it implies that the device is "tested to the same specifications" as the predicate, which would involve comparison to these physical standards.

8. The sample size for the training set

This information is not applicable/provided. This device is a hardware measurement instrument and does not use a "training set" in the context of machine learning or AI.

9. How the ground truth for the training set was established

This information is not applicable/provided for the same reasons as item 8.

Ask a specific question about this device