Search Results

The mobility scooter is intended for providing assistance to people restricted to a sitting position.

The mobility scooter mainly consists of steal frame, two front wheels, two rear wheels, a seat, a tiller console, an electric motor, an electromagnetic brake, front lights, two rechargeable Lead-acid Batteries, and a battery charger. The product is intended to be used for assisting people restricted to a sitting position. It is driven by the end users for movement. It is compact, maneuverable but not necessarily able to overcome obstacles. The maximum load is 150 kg. It is powered by rechargeable batteries with 25.3 km theoretical distance range which maximum speed up to 10.5 km/h (tested value).

This document describes the acceptance criteria and the study that proves the device meets the acceptance criteria for a Mobility Scooter (C4+) seeking 510(k) clearance.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally based on meeting the requirements of various ISO 7176 series standards for wheelchairs and motor scooters, as well as EMC and biocompatibility standards. The document explicitly states that the device met all these requirements.

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

• Performance Testing: The document does not specify the exact sample size for each performance test (e.g., number of scooters tested for static stability). It implies that the test was conducted on the device (Mobility Scooter C4+).
• Biocompatibility Testing: The document does not specify the sample size for the materials tested.
• Package Validation: The document does not specify the sample size (number of packages tested).
• Usability and Human Factor Testing: The document does not specify the sample size (number of users) for this testing.
• Data Provenance: The document does not explicitly state the country of origin of the data for these tests. However, the manufacturer is in China (YONGKANG YILE VEHICLE CO., LTD., Zhejiang, PRC) and the submission correspondent is with a consulting company in Shanghai, China, suggesting the testing was likely conducted in China or by labs recognized by the manufacturer. The nature of these tests (performance, biocompatibility, package validation, usability) generally implies they are prospective tests conducted specifically for this submission.

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

This type of information is generally not applicable to the non-clinical testing performed for a mobility scooter. "Ground truth" established by experts is more relevant for diagnostic or AI-driven devices where human interpretation is a key component. For this device, the "ground truth" is defined by the objective pass/fail criteria of the specified engineering and safety standards (e.g., whether the brake engages within a certain distance, or if a material causes a cytotoxic reaction).

4. Adjudication method for the test set:

Not applicable. The performance, biocompatibility, and package validation tests rely on objective measurements against predetermined standard thresholds, not on subjective expert consensus or adjudication. For usability testing, it's mentioned that observations and questionnaires were used, which would typically involve user feedback and possibly expert review of the results, but no formal adjudication method (like 2+1) is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or similar devices where different readers interpret cases, often with and without AI assistance. This device is a mobility scooter, which does not involve diagnostic interpretation.

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

Not applicable. This device is a physical product (mobility scooter), not an algorithm or AI system that would have a "standalone" performance.

7. The type of ground truth used:

• Performance Testing: The ground truth is defined by the objective pass/fail criteria specified in the various ISO 7176 series standards, IEC standards, and ASTM standards. These are engineering specifications and safety thresholds.
• Biocompatibility Testing: The ground truth is determined by the objective results of standard biological assays (cytotoxicity, intracutaneous reactivity, sensitization) as per ISO 10993-1, with clear pass/fail criteria.
• Package Validation: The ground truth is whether the packaging successfully protects the product under simulated shipping conditions, as defined by ASTM D4169-16.
• Usability and Human Factor Testing: The "ground truth" here is user feedback and observed user behavior aligning with safe and effective operation, and the absence of newly identified risks. This is derived from user questionnaires and observations based on FDA guidance.

8. The sample size for the training set:

Not applicable. This device is a physical product and not an AI/ML algorithm that requires a training set.

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

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

Ask a specific question about this device

The Capenergy C equipments RF System - C25, C50, C100, C200, C300, C400, C500 are intended to provide topical heating for the purpose of elevating tissue temperature for treatment of selected medical conditions such as: relief of pain, muscle spasms, increase in local circulation The massage device provided is intended to provide a temporary reduction in the appearance of cellulite.

Capenergy C equipments RF System - C25, C50, C100, C200, C300, C400, C500 are indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis.

Capenergy C equipment's RF System - C25, C50, C100, C200, C300, C400, C500, including the hand piece, is a system generating RF energy with integral temperature and impedance feedback mechanism for procedures that require elevating tissue temperature. The Capenergy System constantly monitors the temperature and impedance of the target treatment tissue, automatically adjusting energy delivery to maintain effective and safe tissue heating.

Capenergy C equipment's RF System - C25, C50, C100, C200, C300, C400, C500 consists of an AC/DC power supply unit, RF generator, controller and user interface. The RF hand piece is connected to the console via a cable and a switch activates the energy delivery to the hand piece. The hand piece is comprised of conductive and capacitive electrodes.

The provided document, a 510(k) Premarket Notification Submission for the Capenergy C Equipment RF System, does not describe the acceptance criteria and a study proving the device meets those criteria in the typical format of a clinical study assessing diagnostic accuracy or comparative effectiveness.

Instead, this document focuses on demonstrating substantial equivalence to existing predicate devices based on non-clinical performance testing and conformance to voluntary standards. The "acceptance criteria" here are primarily functional specifications and regulatory compliance rather than statistical performance metrics from a human-in-the-loop or standalone study.

Here's a breakdown of the information that can be extracted, and where the requested information is not applicable or not provided in this specific document:

1. Table of Acceptance Criteria and Reported Device Performance

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

This document primarily describes non-clinical, bench testing, and compliance with standards. There is no mention of a clinical "test set" in the context of patient data or clinical images for evaluating diagnostic performance. The "test set" implicitly refers to the physical devices themselves and their components undergoing various performance and safety assessments.

• Sample Size: Not applicable in the context of clinical data. For bench testing, typically multiple units or components are tested, but the exact count is not specified.
• Data Provenance: Not applicable in the context of clinical data. The testing is reported as "Functional laboratory testing performed in foreseeable operating conditions." This suggests internal laboratory testing rather than external clinical data.

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

This is not applicable to this type of submission. Ground truth, in the context of diagnostic or AI-based devices, refers to a definitive diagnosis or finding against which the device's performance is measured (e.g., pathology report, expert consensus on images). This submission pertains to an energy-based therapeutic device and its safety/functional performance, not a diagnostic AI system requiring expert-adjudicated ground truth.

4. Adjudication Method for the Test Set

This is not applicable for the same reasons as point 3. There is no diagnostic "test set" of cases requiring 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

This is not applicable. The Capenergy C equipment RF System is a therapeutic device intended for "topical heating for the purpose of elevating tissue temperature for treatment of selected medical conditions" and "electrocoagulation and hemostasis." It is not an AI-assisted diagnostic device, and therefore, no MRMC study or assessment of human reader improvement with AI assistance would be relevant or performed for this product.

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

This is not applicable. As a therapeutic RF energy system, the device's primary function is to deliver energy for heating and coagulation. It's not an "algorithm-only" or "standalone" diagnostic system. Its performance relates to its physical outputs (RF power, temperature control, etc.), which were evaluated through bench testing.

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

This is not applicable in the sense of clinical ground truth for diagnostic purposes. The "ground truth" for this device's performance relies on:

• Engineering specifications and standards: Conformance to electrical safety, EMC, software, and biocompatibility standards (e.g., IEC 60601 series, IEC 62304, ISO 10993-1).
• Physical measurements: The ability to achieve and maintain specific temperatures (40-45°C) and power outputs.
• Comparison to predicate devices: Establishing substantial equivalence by showing that the subject device operates safely and effectively within similar parameters as legally marketed devices.

8. The sample size for the training set

This is not applicable. This device is a hardware-based therapeutic system, not an AI/machine learning model that undergoes "training." Its "software" (evaluated to IEC 62304) controls the device's functions, but this is a traditional software development and validation process, not machine learning.

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

This is not applicable for the same reasons as point 8.

Ask a specific question about this device

The C4 Fiducial Marker is indicated to be implanted into the body in situations where the location of specific anatomy, normal or diseased, needs to be marked for a future medical procedure. The device can be visualized using MRI, CT or x-ray, and provides a reference from which other procedures can be guided.

The C4 Fiducial Marker consists of a sealed polyether ether ketone (PEEK) polymer tube containing a solution of up to 1% cobalt chloride and up to 2% N-Acetylcysteine, The ratio of cobalt chloride to N-Acetylcysteine is 1:2. Zirconium oxide is sealed within the polymer shell of the device. The length of the polymer capsule is between 5.5 mm and 10.0 mm, and the diameter is 1.0 mm (+/- 0.2 mm).

This document is a 510(k) premarket notification for a medical device, the C4 Fiducial Marker, and does not contain information about a study that measures the device's performance against specific acceptance criteria in the manner requested (e.g., diagnostic accuracy, sensitivity, specificity, or human reader improvement with AI assistance).

Instead, this document describes the device, its intended use, and demonstrates substantial equivalence to previously cleared predicate devices through performance testing related to device integrity and visualization capabilities rather than clinical efficacy metrics.

Here's a breakdown of the information that can be extracted, and what is not available in the provided text:

Information Available:

• Device Name: C4 Fiducial Marker
• Intended Use: To be implanted into the body to mark the location of specific anatomy (normal or diseased) for a future medical procedure. The device can be visualized using MRI, CT, or X-ray, and provides a reference for guiding other procedures.
• Predicate Devices:
  • Mixed media marker (K102506) from Cortex Manufacturing
  • BiomarC Fiducial Marker (K063193) from Carbon Medical Technologies
• Reference Device: C4 Imaging MRI Marker NS (K171487)
• Testing Performed (categorized as "Performance Testing"):
  • Structural and functional integrity testing (negative and positive pressure, axial and lateral load testing).
  • MRI, CT, and X-ray imaging demonstrating functional performance.
  • Separate MRI, CT, and X-ray imaging tests performed in tissue equivalent phantoms.
  • Biocompatibility (ISO 10993) assessment.
  • Endotoxin tests.

Missing Information (not detailed in the provided text for this 510(k) summary):

1. Table of Acceptance Criteria and Reported Device Performance (Clinical/Diagnostic Accuracy): The document does not provide specific acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, localization accuracy in a clinical context) or reported values against such criteria. The "performance testing" described is for device integrity and basic visualization, not clinical effectiveness.
2. Sample Size used for the test set and data provenance: Not applicable in the context of clinical accuracy or a test set as described for AI evaluation. The device integrity and visualization tests would have used a sample of the manufactured markers, but specific numbers are not provided, nor is information on the provenance of "data" in a clinical sense.
3. Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable. The "ground truth" for the tests performed would be related to physical properties, not expert consensus on clinical findings.
4. Adjudication method for the test set: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: No, this type of study was not mentioned. The device is a physical marker, not an AI or imaging interpretation tool that would involve human readers.
6. Stand-alone (algorithm only without human-in-the-loop performance) study: No, this is not an AI algorithm.
7. Type of ground truth used: For the device integrity tests, the ground truth would be the physical integrity of the device (e.g., no leaks, ability to withstand loads). For visualization, the ground truth is simply the visual presence and distinctness of the marker on imaging modalities, often evaluated in phantoms. This is not clinical ground truth like pathology or outcomes data.
8. Sample size for the training set: Not applicable, as this is not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

Summary of what the document implies about "acceptance criteria" and "study":

The "acceptance criteria" for this device (as inferred from the "Performance Testing" section) relate to:

• Structural and Functional Integrity: The marker must maintain its integrity under various pressures and loads. While specific numerical acceptance criteria (e.g., "withstanding X psi pressure" or "withstanding Y N axial load") are not stated, the tests imply that the device must pass these challenges without failure (e.g., leaking, breaking).
• Visualization: The marker must be visible on MRI, CT, and X-ray in tissue-equivalent phantoms. The acceptance criterion is likely successful visualization that meets a standard for medical markers (e.g., clear, distinct signal/contrast).
• Biocompatibility: The materials of the device must be biocompatible according to ISO 10993 standards, and endotoxin levels must be acceptable. The acceptance criteria here would be passing the specified ISO tests and meeting endotoxin limits.

The "study" or "testing" proving these criteria are met consists of the aforementioned structural, functional, visualization, and biocompatibility tests. The document states these tests were performed and implies the device met the necessary standards for substantial equivalence to predicates.

Ask a specific question about this device

These products are intended to be used in displaying digital images for review and analysis by trained medical practitioners. They do not support the display of mammography images for diagnosis.

C44W+ is a 30-inch TFT color LCD monitor. It is specifically designed to display high quality, high definition images required for Ultrasound and General Radiography. With built-in multi-display modes, it facilitates convenient viewing by doctors of various images, data, and layout of information. The product is designed to be able to meet DICOM 3.14 calibration standards. With features such as brightness stability control. 14 bit image processing technology, and interfaces with external calibration software, it ensures optimal viewing conditions over the life of the display. The specially designed base supports height and tilt adjustments for erqonomic comfort.

C82W+ is a 31.5-inch TFT color LCD monitor. It is specifically designed to display high quality, high definition images required for diagnostic, interventional radiology and other medical applications. With built-in multi-display modes, it facilitates convenient viewing by doctors of various images, data, and layout of information. The product is designed to be able to meet DICOM 3.14 calibration standards. With features such as brightness stability control, 14 bit image processing technology, and interfaces with external calibration software, it ensures optimal viewing conditions over the life of the display. The specially designed base supports height and tilt adjustments for ergonomic comfort.

C83W+ and C85W+ are 27-inch TFT color LCD monitors. They are specifically designed to provide the high definition images output for general Radiography. The products have been strictly calibrated so they meet DICOM Part 3.14 and other standards. They use the latest generation of LED backlight panel, supporting resolution 3840 x 2160. With built-in brightness stabilization control circuit, make sure the brightness of this monitors are stable in their life, and the products meet the demand of high precision medical imaging.

For C44W+, C82W+, C83W+, C85W+, the only difference is the screen. C83W+ and C85W+ have the same screen, but their customers are different, which results in the two models.

The provided document describes the 510(k) premarket notification for Shenzhen Beacon Display Technology Co., Ltd.'s 4MP/8MP Color LCD Monitors (C44W+/C82W+, C83W+, C85W+). These monitors are intended for displaying digital images for review and analysis by trained medical practitioners, excluding mammography images for diagnosis.

The study presented is a bench test comparison to a legally marketed predicate device, the Eizo Nanao Corporation RadiForce RX440 (K130070). The purpose of the study is to demonstrate substantial equivalence to the predicate device, not necessarily to establish the device's absolute performance against a set of clinical acceptance criteria for diagnosis.

Here is an analysis based on your requested information, referencing the provided document:

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

The document does not explicitly state "acceptance criteria" in the traditional sense of a clinical study targeting specific diagnostic performance metrics (e.g., sensitivity, specificity). Instead, it focuses on demonstrating equivalence to a predicate device based on technical display characteristics and conformance to relevant industry guidelines (AAPM Task Group 18 (TG18 guideline)).

The "reported device performance" are the results of the bench tests on the proposed devices (C44W+, C82W+, C83W+, C85W+) showing their technical specifications and how they align with or differ from the predicate device. The document generally concludes that the devices are equivalent to the predicate.

Here's a summary of key performance tests conducted, which serve as the basis for their claim of equivalence:

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

The study involves bench testing of the devices themselves (C44W+, C82W+, C83W+, C85W+). It's not a study involving patient data or human interpretation. Therefore, "sample size" and "data provenance" in the context of clinical images or patient data are not applicable. The "test set" consists of the physical display units being evaluated.

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

This is a technical performance study of a device (monitor), not a diagnostic accuracy study using medical images interpreted by experts. Therefore, "ground truth" in the context of expert consensus on medical images is not applicable. The ground truth is adherence to technical specifications and industry standards like AAPM TG18. The "experts" involved would be the technical personnel performing the bench testing and evaluating the results against established standards, but their specific number and qualifications are not mentioned in this document.

4. Adjudication method for the test set

"Adjudication method" is not applicable as this is a technical performance study of display monitors, not an evaluation of diagnostic interpretations where consensus among readers would be required.

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. This submission is for medical display monitors, not an AI-powered diagnostic tool. The document focuses on the technical characteristics and equivalence of the monitors to a predicate device.

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

This question refers to AI algorithm performance. Since the device is a medical display monitor and not an AI algorithm, a standalone performance study in that context was not done. The study performed was a technical assessment of the monitor's display capabilities.

7. The type of ground truth used

The "ground truth" for this technical assessment is adherence to technical specifications, industry standards (e.g., DICOM 3.14, AAPM TG18 guidelines), and comparison with the predicate device's established performance. It's not based on pathology, expert consensus on medical images, or patient outcomes data.

8. The sample size for the training set

This question refers to the training of an algorithm. Since the device is a medical display monitor and not an AI algorithm, a "training set" is not applicable.

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

This question refers to the training of an algorithm. Since the device is a medical display monitor and not an AI algorithm, the concept of establishing ground truth for a training set is not applicable.

Ask a specific question about this device

The CAPENERGY C Devices - C100, C200, C300, C400, C50 are intended to provide topical heating for the purpose of elevating tissue temperature for treatment of selected medical conditions such as: relief of pain, muscle spasms, increase in local circulation. The massage device provided is intended to provide a temporary reduction in the appearance of cellulite.

The proposed device is an equipment for diathermy by energy transfer using radio frequency alternating electrical currents applied to the patient by using electrodes or plates. The RF current is coupled to the human body by means of an insulated or non-insulated electrode -the active accessory-, which together with the body and the return electrode -the passive plate- forms an electric circuit, which allows the passage of RF current through the body areas situated between the two electrodes. The number of available channels on the different models of the CAPENERGY product range varies from one to four. When a model has several channels, these operate independently. Each channel has a keyboard that lets you manage the parameters of frequency and channel power. It also has two light columns that report the selected power level and a qualitative indication of the power delivered by the channel. The user interface has a screen and a keyboard that allows you to manage several functions: timer, connected accessories management, state management, energy and temperature measurements and alarms. The user interface is organized in a menu system that makes it possible to choose between the different features available on the equipment.

The provided text is a 510(k) Premarket Notification for the CAPENERGY C Devices (C100, C200, C300, C400, C50). This document is primarily focused on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed clinical study for the device itself. Therefore, much of the requested information regarding acceptance criteria and a study proving the device meets them, particularly in the context of AI/ML performance, is not present in this document.

However, based on the non-clinical data section, we can infer some information about performance testing.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified. The document states "bench testing" and "functional laboratory testing," which typically refers to testing of the device itself rather than human or image data. No patient or image test set is mentioned.
• Data Provenance: Not applicable, as no human or image data test set is described. The testing appears to be primarily laboratory-based device performance testing.

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

• Number of Experts: Not applicable. No ground truth based on expert review of patient data is mentioned.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

• Adjudication Method: Not applicable. No test set requiring adjudication (e.g., image review) 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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. The device description and intended use (diathermy device) do not involve human readers interpreting images or data with or without AI assistance.
• Effect Size of AI Improvement: Not applicable.

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

• Standalone Performance: Not applicable. This document describes a physical medical device (diathermy) and its performance, not an AI algorithm. The software validation mentioned is for the device's operational software, not an AI component making diagnostic or treatment recommendations.

7. The type of ground truth used

• Type of Ground Truth: For the performance tests mentioned (temperature maintenance, electrical safety, EMC, software validation, biocompatibility), the "ground truth" would be established by engineering specifications, relevant international standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 62304, ISO 10993-1), and internal performance targets.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This document does not describe the development or testing of an AI/ML algorithm that would require a training set.

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

• How Ground Truth was Established: Not applicable, as no training set for an AI/ML algorithm is mentioned.

Ask a specific question about this device

The indication for FLOW-i Anesthesia System is administering inhalation Anesthesia while controlling the entire ventilation of patients with no ability to breathe, as well as in supporting with a limited ability to breathe. The system is intended for use on neonatal to adult patient populations. The system is intended for use in hospital environments, except MRI environment, by healthcare professionals trained in inhalation Anesthesia administration.

FLOW-i Anesthesia System is a Anesthesia system designed to meet the many ventilatory challenges within Anesthesia, as well as to provide inhalation Anesthesia. It is intended to serve a wide range of patients from neonatal to adult.

FLOW-i Anesthesia System is a software-controlled semi-closed system for inhalation Anesthesia (Sevoflurane, Desflurane, Isoflurane and/or nitrous oxide).

The most important performance features of the FLOW-i Anesthesia System are:

• a ventilator whose functionality is based on ICU-ventilator technology, o
• the volume reflector technology. O
• the electronically controlled injector vaporizers and o
• the ergonomic design. O

This 510(k) submission for the FLOW-i Anesthesia System is based on the following modifications:

• Updates of the product for compliance with 3td edition of the 60601 standard package .
  • IEC 60601-1:2005 O
  • ISO 80601-2-13:2011 o
  • ISO 80601-2-55:2011 O
• Implementation of a new function that provides recommended ventilation values (PBW)
• Possibility to set a lower alarm limit for the Airway pressure alarm: High
• Display of Airway resistance measurement following an Inspiratory and/or Expiratory Hold

This document describes the marketing application for changes to the Maquet FLOW-i Anesthesia System, specifically versions C20, C30, and C40. The primary purpose of the document is to demonstrate "substantial equivalence" to a previously cleared predicate device (FLOW-i Anesthesia System version 3.0, K133958), allowing the manufacturer to market the updated device without a new premarket approval application (PMA).

Based on the provided text, there is no information about a study that proves the device meets specific acceptance criteria in the way a clinical AI/ML device would be evaluated for accuracy or performance on a test set of data.

This document is a 510(k) summary, which focuses on device modifications and demonstration of substantial equivalence through non-clinical testing and comparison to a predicate device, rather than a clinical performance study with predefined acceptance criteria for diagnostic/therapeutic efficacy.

Therefore, it is not possible to fill out the requested table and details regarding acceptance criteria, test set sample size, expert ground truth establishment, MRMC studies, or standalone performance, as these concepts are not applicable to the information provided in this 510(k) submission.

The acceptance criteria here pertain to meeting regulatory standards, ensuring safety, and demonstrating that the modifications do not introduce new questions of safety and effectiveness, meaning its performance is equivalent to the predicate device.

However, I can extract the following relevant information regarding the changes and how the manufacturer demonstrated the device's continued performance and safety:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not present acceptance criteria as quantitative performance metrics for a diagnostic or therapeutic function. Instead, it details that the modifications introduce new functionalities and updates for regulatory compliance, and that the device "performs within its specifications and within the limits of the applied performance standards."

The "acceptance criteria" can be inferred as successful completion of the listed non-clinical tests and demonstration that the modified device remains substantially equivalent to the predicate. The "performance" is the successful outcome of these tests and the comparison to the predicate.

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

• Sample Size: Not applicable in the context of a "test set" for a diagnostic/therapeutic AI/ML algorithm. This submission focuses on engineering validation and verification.
• Data Provenance: Not applicable. The tests performed are laboratory/bench testing and engineering evaluations against design requirements and safety standards. There is no patient data involved in the "test set."

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

• Not applicable. Ground truth in this context refers to engineering specifications and regulatory compliance, not expert clinical labels on patient data. Performance was verified against technical specifications and standard requirements.

4. Adjudication Method (e.g. 2+1, 3+1, none) for the Test Set:

• Not applicable. This is not a clinical study involving human readers or interpretation of results that require 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 comparative effectiveness study was done. This 510(k) is for modifications to a medical device (anesthesia system), not a diagnostic AI/ML algorithm that assists human readers.

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

• Not applicable. The device is a physical anesthesia system with integrated software, not a standalone algorithm. Its "performance" is its ability to deliver and monitor anesthesia according to specifications and safety standards.

7. The Type of Ground Truth Used:

• Ground Truth Type: Engineering specifications, industry standards (e.g., IEC 60601, ISO 80601), and the performance characteristics of the predicate device.
• Examples: Accuracy range for gas concentrations (e.g., Sevoflurane conc: Accuracy: ±0.15 vol% @ (0-1%)), pressure ranges, alarm thresholds, volume measurement accuracy.

8. The Sample Size for the Training Set:

• Not applicable. This is not an AI/ML algorithm trained on a dataset. The software changes are programming implementations, not machine learning model training.

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

• Not applicable. There is no concept of a "training set" in the context of this device's modifications. The software and hardware changes are based on design requirements, safety standards, and user needs, which were then verified and validated through non-clinical testing.

Ask a specific question about this device

JUSHA-C43 LCD Monitor is intended to be used in displaying digital images for review and analysis by trained medical practitioners. It does not support the display of mammography images for diagnosis.

JUSHA-C43 LCD Monitoris the display system with the high resolution(2560 x 1600), high luminance(350cd/m²) and 1024 simultaneous shades of gray out of a palette of 4096, 4 DICOM look up table inside, the product is consisted of the following components:

• 30inch, Color Active Matrix Liquid Crystal Display
• FR4-v0.4
• JUSHA-C43 LCD Monitor software
• Power Adapter
• Data Cable.

The LCD Monitoris designed, tested, and will be manufactured in accordance with both mandatory and voluntary standards:

1. IEC 60601-1Medical equipment medical electrical equipment - Part 1: General requirements for basic safety and essential performance 2005 + CORR. 1 (2006) +CORR. 2 (2007)
2. IEC 60601-1-2 Edition 3:2007, medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.

The provided document describes the JUSHA-C43 LCD Monitor, a display system for medical imaging review and analysis. The submission focuses on demonstrating substantial equivalence to a predicate device (RADIFORCE RX440; K130070) through bench testing for display performance and adherence to electrical safety and electromagnetic compatibility (EMC) standards.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The document does not explicitly present a table of acceptance criteria with corresponding pass/fail results or reported device performance against specific numerical targets. Instead, it lists the types of measurements performed in bench testing and states that the device "meets all performance standards" without providing the specific standards or numerical outcomes.

However, based on the Discussion of Differences in the comparison table, we can infer some implied performance expectations and how the JUSHA-C43 LCD Monitor performs relative to its predicate.

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

The document describes bench testing only. There is no mention of a test set involving medical images or patient data, nor is there any information about sample size for such a test set, country of origin, or whether it was retrospective or prospective. The testing was performed on the device itself.

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. Since there was no test set involving medical images or human interpretation, there were no experts used to establish ground truth for a test set.

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

Not applicable. No test set involving human interpretation was performed.

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 an LCD monitor, not an AI-powered diagnostic tool. No MRMC study was conducted, and the concept of "human readers improve with AI vs without AI assistance" does not apply here.

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

Not applicable. This device is a display monitor, not an algorithm.

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

The "ground truth" for the device's performance relies on engineering specifications and established international standards. For example, luminance and chromaticity non-uniformity were measured against TG18 guidelines, and electrical safety and EMC were evaluated against IEC 60601-1 and IEC 60601-1-2 standards.

8. The sample size for the training set

Not applicable. This device is a hardware display monitor; it does not involve machine learning or a training set.

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

Not applicable. No training set was used.

Ask a specific question about this device

The indication for FLOW-i Anesthesia System is administering inhalation Anesthesia while controlling the entire ventilation of patients with no ability to breathe, as well as in supporting patients with a limited ability to breathe. The system is intended for use on neonatal to adult patient populations. The system is intended for use in hospital environments, except MRI environment, by healthcare professionals trained in inhalation Anesthesia administration.

The modified FLOW-i Anesthesia System version 3.0 is an Anesthesia System designed to meet the many ventilatory challenges within Anesthesia, as well as to provide inhalation Anesthesia. It is intended to serve a wide range of patients from neonatal to adult. FLOW-i Anesthesia System is a software-controlled semi-closed system for inhalation Anesthesia (Sevoffurane, Desflurane, Isofturane and/or nitrous oxide). The most important performance features of the FLOW-i Anesthesia System are: - a ventilator whose functionality is based on ICU-ventilator technology, o - the volume reflector technology, o - the electronically controlled injector vaporizers and o - the ergonomic design. o

The provided 510(k) summary describes modifications to an Anesthesia System and claims substantial equivalence to a predicate device. It specifically states that no clinical investigation was needed or performed to validate the changes. Therefore, the device does not have a study with acceptance criteria in the traditional sense, as it relies on non-clinical testing and substantial equivalence.

However, the document does list technical specifications for various parameters, which can be interpreted as the performance criteria that the device (and its modifications) must continue to meet. The "study" that proves the device meets these criteria is the non-clinical testing and performance activities.

Here's an attempt to structure the information based on the request, interpreting the provided text accordingly:

1. Table of Acceptance Criteria and Reported Device Performance

Since no specific "acceptance criteria" for a study are explicitly stated, the technical specifications from the "Specifications from FLOW-i User's Manual, section 14 Technical Specifications" are used as the inherent performance criteria the device is expected to meet. The document states that "Design verification and validation has demonstrated that the FLOW-i Anesthesia System performs within its specifications."

Ask a specific question about this device

The indication for FLOW-i Anaesthesia System is administering inhalation Anaesthesia while controlling the entire ventilation of patients with no ability to breathe, as well as in supporting patients with a limited ability to breathe. The system is intended for use on neonatal to adult patient populations. The system is intended for use in hospital environments, except MRI environment, by healthcare professionals trained in inhalation Anaesthesia administration.

FLOW-i (K102182 SE5/9/2011) is a high-performance Anaesthesia system designed to meet the many ventilatory challenges within Anaesthesia, as well as to provide inhalation Anaesthesia. It is intended to serve a wide range of patients from neonatal to adult.

FLOW-i is a software-controlled semi-closed system for inhalation Anaesthesia (Sevoflurane, Desflurane, Isoflurane and/or nitrous oxide).

The most important performance features of the FLOW-i Anaesthesia system are:

• o a ventilator whose functionality is based on ICU-ventilator technology,
• o the volume reflector technology,
• o the electronically controlled injector vaporizers and
• o the ergonomic design.

The proposed modification (K112114) includes two additional ventilation modes and a backup function:

• o PRVC, Pressure Regulated Volume Control
• O SIMV (VC and PC), Synchronized Intermittent Mandatory Ventilation
• o Pressure Support with Backup

In addition to the new ventilation modes the proposed modification includes a number of minor changes.

PRVC is a controlled mode of ventilation which combines the advantages of volume controlled and pressure controlled ventilation. FLOW-i assures that the preset tidal volume is delivered at the lowest possible pressure in order to protect the lungs. The flow during inspiration is decelerating and patient can trigger extra breaths.

SIMV is designed to improve synchronization of breaths which can decrease patient's tendency to fight against the Anaesthesia ventilator.

Backup functionality has been added to Pressure Support to add safety for the patient and improve the work flow for the users by minimizing apnea alarms.

The provided text describes modifications to the MAQUET FLOW-i Anaesthesia System (K112114) and claims substantial equivalence to a previously cleared version of the FLOW-i (K102182) and the GE Datex-Ohmeda, Aisys Anaesthesia System (K090233). Rather than outlining specific acceptance criteria and a detailed study proving performance against them, the document focuses on demonstrating that the updated device performs within its specifications and applied performance standards through various non-clinical tests.

Here's a breakdown of the requested information based on the provided text, highlighting what is available and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics. Instead, it lists areas where performance testing was conducted to ensure the device performs "within its specifications and within the limits of the applied performance standards."

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

The document does not specify a "test set" in terms of a patient cohort or a dataset with a defined sample size for clinical evaluation. The testing described is non-clinical, focusing on device performance characteristics. Therefore, information on data provenance (country of origin, retrospective/prospective) is not applicable or provided.

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

This information is not applicable as the study described is a non-clinical device performance and verification study, not a clinical study involving expert assessment of medical data.

4. Adjudication Method for the Test Set

This is not applicable for the same reasons as point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No MRMC comparative effectiveness study is mentioned. The study is a non-clinical verification and validation of device performance against specifications and standards, not a comparison of human reader performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device is an anaesthesia system, which is inherently a human-in-the-loop system controlled by healthcare professionals. The concept of "standalone algorithm performance" as typically applied to AI/ML software is not relevant here. The performance testing focuses on the system's ability to deliver ventilation and anaesthesia as specified.

7. The Type of Ground Truth Used

For the non-clinical performance and verification testing, the "ground truth" would be established by the engineering and design specifications for the device, and compliance with recognized standards (e.g., electrical safety, EMC). It relies on objective measurements against these predefined acceptable ranges and behaviors. There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for this type of non-clinical evaluation.

8. The Sample Size for the Training Set

No training set is mentioned as this device is not an AI/ML algorithm that undergoes a "training" phase. The system is software-controlled, but the "validation" described is for the software's functionality and performance against design requirements, not statistical learning from a dataset.

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

Not applicable, as no training set is mentioned.

Ask a specific question about this device

The ATMOS C361/C451 Suction Pump™ device is intended for aspiration and collection of secretions, body fluids and tissue from wounds during surgery or at the patient's bedside.

The ATMOS C361/C451 device is an AC/DC-powered surgical suction unit. With a direct docking and direct docking disposable system, hose connection errors are not possible. There is only one connection for the hose to the patient. The connection from the jar to the pump is integrated in the container lid.

The ATMOS C361/C451 is centered on a silent diaphragm-type pump which generates a vacuum inside the collection jar, allowing secretions to be withdrawn and collected. Using a vacuum regulator and the vacuum-gauge, the target vacuum and airflow rate can be adjusted.

The provided 510(k) summary for the ATMOS C361/C451 Suction Pump™ is for a medical device and therefore does not include information pertaining to algorithm performance, acceptance criteria, ground truth, or study details typically found in AI/ML device submissions. This document is a traditional 510(k) for a hardware device and evaluates substantial equivalence to a predicate device based on technological characteristics and intended use, not on AI-driven performance metrics.

Therefore, I cannot provide the requested information. The document explicitly states:

• "The C361/C451 Suction Pump does not raise any new issues of safety, efficacy, or performance of the product."
• "The 510(k) for the ATMOS C361/C451 Suction Pump™ device contains adequate information and data to enable FDA to determine substantial equivalence to the predicate device."

These statements indicate that the device was evaluated against existing standards and a predicate device (NOUVAG AG - VACUSON 40 AND VACUSON 60) based on its physical and functional characteristics, not on data-driven performance metrics for an algorithm.

Ask a specific question about this device