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The MBT Sepsityper is a qualitative in vitro diagnostic device consisting of an MBT-CA (Sepsityper) software extension and a reagent kit (MBT Sepsityper Kit US IVD) for use in conjunction with other clinical and laboratory findings to aid in the early diagnosis of bacterial and yeast infections from positively flagged blood cultures using the MALDI Biotyper CA System.

The MBT Sepsityper Kit US IVD is a disposable blood culture processing device that includes associated reagents that are intended to concentrate and purify microbial cells from blood culture samples identified as positive by a continuous monitoring blood culture system and confirmed to demonstrate the presence of a single organism as determined by Gram stain. This sample preparation manual method is performed by laboratory health professionals in a clinical diagnostic setting. Subculturing of positive blood cultures is necessary to recover organisms for identification of organisms not identified by the MBT-CA System, for susceptibility testing and for differentiation of mixed growth.

Positive MBT Sepsityper results do not rule out co-infection with organisms that may not be detected by the MBT-CA System. Results of the MBT Sepsityper should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. Results of the MBT Sepsityper should be correlated with Gram stain results and used in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial and yeast bloodstream infections.

Organisms recovered from positive blood culture bottles that are suitable for identification using the MBT Sepsityper Kit US IVD and MBT-CA Systems are listed in the MALDI Biotyper CA System Package Insert Reference Library.

The MALDI Biotyper CA System uses MALDI (matrix-assisted laser desorption/ionization) TOF (time of flight) mass spectrometry technology for the identification of organisms isolated from clinical samples. Identification can be performed from an isolated colony or from a cell extract. The sample material is transferred to a target plate, dried and overlaid with a matrix. The MBT FAST Shuttle US IVD is an optional hardware tool that may be used for drying the samples deposited on the MALDI target plate under controlled conditions.

The MALDI process transforms the proteins and peptides from the isolated microorganisms into positively charged ions. This is achieved by irradiating the matrix-sample composite with a UV laser. The matrix absorbs laser energy and transfers protons to the intact proteins or peptides in the gas phase. These ions are electrostatically accelerated and arrive in the flight tube at a mass-dependent speed. Because different proteins/peptides have different masses, ions arrive at the detector at different times (time of flight). The MBT-CA System measures the time (in the nanosecond range) between pulsed acceleration and the corresponding detector signal of the ions, and the time is converted into an exact molecular mass.

The highly abundant microbial ribosomal proteins result in a mass spectrum with a characteristic mass and intensity distribution pattern. This pattern is species-specific for many bacteria and yeasts and can be used as a 'molecular fingerprint' to identify a test organism. The spectrum of the unknown test organism, acquired through the software MBT Compass HT CA of the MBT-CA System, is electronically transformed into a peak list. Using a biostatistical algorithm, this peak list is compared to reference peak lists of organisms in the MBT-CA Reference Library and a log(score) between 0.00 and 3.00 is calculated. The higher the log(score), the higher the degree of similarity to a given organism in the MBT-CA Reference Library. The log(score) ranges reflect the probability of organism identification.

The FDA 510(k) submission document focuses on demonstrating substantial equivalence to an existing predicate device rather than presenting a traditional acceptance criteria study for a new device. Therefore, the "acceptance criteria" discussed are largely driven by proving that the new components (MBT Compass HT CA software and MBT FAST Shuttle US IVD) maintain or improve the performance and safety established by the predicate device.

Here's an analysis of the provided text to fulfill your request:

Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" in this context isn't a single set of predefined thresholds for a novel device's performance against a clinical gold standard (e.g., sensitivity/specificity targets). Instead, it's about demonstrating that the new components do not negatively impact the established performance of the predicate device and potentially offer improvements (like accelerated drying time). The "reported device performance" is presented as evidence that these conditions are met.

Table 1: Acceptance Criteria (Implied) and Reported Device Performance

Study Details

Based on the provided text:

1. Sample sizes used for the test set and the data provenance:

   • MBT FAST Shuttle - Repeatability: 120 mass spectra (presumably from 12 bacterial/yeast strains * 10 repeats * 2 runs across DT, eDT, Ext, Sepsityper workflows as indicated in Table 3 headers, although the text says "each out of 2 runs" for "each workflow/method" - suggesting 10 per method/workflow per run).
   • MBT FAST Shuttle - Reproducibility (Site-to-Site): 2700 samples for MBT workflow (900 samples per study site * 3 sites) and 1350 samples for Sepsityper workflow (450 samples per study site * 3 sites). The document mentions "10 microorganisms" used per study site.
   • MBT FAST Shuttle - Reproducibility (Device-to-device): 1080 samples for MBT workflow (360 samples per MBT FAST Shuttle * 3 shuttles) and 540 samples for Sepsityper workflow (180 samples per MBT FAST Shuttle * 3 shuttles).
   • MBT FAST Shuttle - Reproducibility (Operator-to-operator): 900 samples for MBT workflow (450 samples per operator * 2 operators) and 450 samples for Sepsityper workflow (225 samples per operator * 2 operators).
   • MBT FAST Shuttle - Reproducibility (Day-to-day): 900 samples for MBT workflow (180 samples per day * 5 days) and 450 samples for Sepsityper workflow (90 samples per day * 5 days).
   • MBT FAST Shuttle - Method Comparison (Drying): 279 mass spectra for air-dried and 279 mass spectra for MBT FAST Shuttle dried from three study sites (93 mass spectra per site per drying method). Ten (10) microorganisms and a blood culture, each spotted in triplicates.
   • MBT Compass HT CA - Low Confidence Results: 15,270 spectra in total, with 1,670 yellow log(scores) re-analyzed.
   • MBT Compass HT CA - IDealTune: Data collected from 133 BTS-QC runs at Site 1 (over 17 months) and 76 BTS-QC runs at Site 2 (over 14 months).

   Data Provenance: The studies were performed at multiple sites (at least 3 for reproducibility studies), and one study explicitly mentions that microorganisms were shipped to both US study sites. This implies the data is, at least in part, prospectively collected in a multi-center setting for verification/validation. The "low confidence results" study was a retrospective non-interventional validation using data from previous clearances.

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

   • The document does not specify the number or qualifications of experts used to establish ground truth for most of these performance studies. The studies primarily focus on performance consistency and equivalence compared to established methods using what appears to be common laboratory standards (e.g., identity confirmed organisms, BTS quality checks).
   • For the "low confidence results" study, it states: "Isolates from clinical routine were used to compare the results of the MBT-CA System against a gold standard (16S sequencing)." This suggests the ground truth was established by 16S sequencing, a molecular method, rather than solely by human experts, and then potentially interpreted by experts.

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

   • No adjudication method involving multiple human readers for conflict resolution is mentioned or appears to be applicable given the nature of the device (mass spectrometry-based organism identification). The performance is assessed on the agreement with an expected identification or log(score) thresholds.

4. 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 or human-in-the-loop comparative effectiveness study with human readers assisting or being assisted by AI is described in this document. The device is a "clinical mass spectrometry microorganism identification and differentiation system," not an AI-assisted diagnostic imaging tool.

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

   • Yes, the performance validation studies of the MBT FAST Shuttle US IVD and MBT Compass HT CA software are essentially standalone performance evaluations of these components within the overall MALDI Biotyper CA System. The "outputs" (identification results, log(scores)) are generated by the system (including the hardware, software, and reference library) without direct human interpretation of the raw mass spectra. Human involvement is in sample preparation and operating the system, but the core identification is algorithmic.

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

   • For the analytical performance of organism identification, the ground truth appears to be based on:
     • Reference strains/known microorganisms: Used in repeatability and reproducibility studies.
     • 16S sequencing: Explicitly stated as the "gold standard" for comparing results in the "low confidence results" study.
     • Internal quality control standards: Like the Bacterial Test Standard (BTS) for IDealTune validation.
   • This is primarily laboratory-based "gold standard" ground truth (molecular methods, established reference cultures), rather than expert consensus on clinical cases.

7. The sample size for the training set:

   • This document describes the validation of new components for an existing system. It does not provide details about the training set size for the underlying MALDI Biotyper CA System's reference library or analytical algorithms. The "reference library" (which acts as a form of "training data" for identifying unknown spectra) is mentioned as being continually updated, but its size is not specified.

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

   • Similar to the above, the document does not detail how the ground truth was established for the training data (the reference library) of the overall MALDI Biotyper CA System. However, standard practice for building such libraries involves:
     • Well-characterized bacterial and yeast strains: Often from culture collections, with identity confirmed by a variety of methods including 16S rRNA gene sequencing, traditional biochemical tests, and possibly whole-genome sequencing.
     • Internal validation and verification: Ensuring the spectral patterns are consistent and representative for each species.

In summary, this 510(k) submission successfully demonstrates substantial equivalence by showing that the new components (MBT Compass HT CA software and MBT FAST Shuttle US IVD) maintain the safety and effectiveness of the predicate device, and in some cases, enhance usability (faster drying time, improved instrument maintenance) without introducing new risks or compromising diagnostic accuracy. The studies presented are analytical validations focusing on performance characteristics relevant to microorganism identification in a laboratory setting.

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The device is indicated for use in obtaining diagnostic images to aid the physician with diagnosis. The system can be used to perform radiographic imaging of various portions of the human body, including the skull, spinal column, extremities, chest, abdomen and other body parts. The device is not indicated for use in mammography

The DRX-Compass System is a general purpose x-ray system used for acquiring radiographic images of various portions of the human body. The system consists of a combination of components including various models of high voltage x-ray generators, control panels or workstation computers, various models of patient support tables, wall-mounted image receptors/detectors for upright imaging, various models of tube support devices, x-ray tube, and collimator (beam-limiting device). The DRX-Compass can be used with digital radiography (DR) and computed radiography (CR) receptors. Smart Features are added to the DRX-Compass system to provide remote capabilities for existing functions of the DRX-Compass system. These remote capabilities simplify exam set up and improve workflow for the operator while preparing for the patient exposure. The "smart features", described below, are designed to reduce the technologist's manual tasks and to speed up workflow for existing features of the system. These improvements are referred to as "smart features" in the product documentation. Implementation of these "smart features" does not change the intended use of the system.

The provided text does not contain detailed information about specific acceptance criteria and a study that comprehensively proves the device meets those criteria for the DRX-Compass system. The document is a 510(k) summary for the FDA, which focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive efficacy study for new features.

However, based on the information provided, I can extract the relevant details that are present and explain why some requested information is not available in this document.

Here's a breakdown of what can be inferred and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions that "Predefined acceptance criteria were met and demonstrated that the device is as safe, as effective, and performs as well as or better than the predicate device." However, the specific acceptance criteria themselves (e.g., specific thresholds for DQE/MTF, or performance metrics for the "smart features") are not explicitly detailed in this 510(k) summary. Similarly, the reported device performance values against those specific criteria are also not provided.

The closest information related to performance is:

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

This information is not provided in the 510(k) summary. The document states "Non-clinical testing such as standards testing are the same as that of the predicate. The verification and validation testing of the modified device demonstrates that the modified device performs as well as the predicate and is substantially equivalent." without detailing the specific sample sizes or data provenance for these tests. For imaging performance, it mentions DQE/MTF data for detectors, but not the sample size of images or patients used for performance evaluation of the overall system or its new "smart features."

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the 510(k) summary. The document focuses on technical verification and validation, and comparison to a predicate device, rather than a clinical study requiring expert consensus on ground truth.

4. Adjudication Method for the Test Set

This information is not provided in the 510(k) summary. Given the absence of specific clinical study details or expert ground truth establishment, no adjudication method would be mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study is not mentioned in this document. The submission's focus is on demonstrating substantial equivalence through technical testing and compliance with recognized standards, particularly for the "smart features" which are described as workflow enhancements rather than diagnostic AI tools requiring reader performance studies. There is no mention of AI assistance for human readers or associated effect sizes.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study of an algorithm without human-in-the-loop is not explicitly mentioned in this document. The "smart features" are described as functionalities to assist the operator, implying human-in-the-loop operation, rather than a standalone diagnostic algorithm. The document mentions "Flat panel detector DQE/MTF data shows that the additional detectors supported by the modified device (DRX-Compass) are equivalent in image quality to that of the DRX Plus detectors cleared with the predicate," which is a technical performance metric for the detector component, not an algorithm's diagnostic performance.

7. Type of Ground Truth Used

The type of ground truth used for any performance evaluation is not explicitly stated. For the detector performance, DQE/MTF data refers to physical image quality metrics rather than a diagnostic ground truth (like pathology or clinical outcomes). For the "smart features," their evaluation appears to be based on functional verification and validation of their workflow enhancement capabilities, rather than comparison to a ground truth for diagnostic accuracy.

8. Sample Size for the Training Set

This information is not provided in the 510(k) summary. The document does not describe the use of machine learning algorithms that would typically require a training set. The "smart features" appear to be rule-based or real-time processing functionalities rather than learning algorithms.

9. How Ground Truth for the Training Set Was Established

Since there is no mention of a training set or machine learning, details on establishing its ground truth are not provided.

In summary, the 510(k) submission for the DRX-Compass focuses on demonstrating substantial equivalence to a predicate device by:

• Ensuring the modified device's indications for use are identical.
• Confirming compliance with recognized electrical safety and performance standards (AAMI ES60601-1, IEC 60601-1-6, IEC 60601-1-3, IEC 60601-2-54, IEC 62366).
• Applying risk management (ISO 14971) to ensure no new risks are introduced.
• Showing that new components (e.g., additional detectors) maintain equivalent image quality (e.g., DQE/MTF data).
• Asserting that new "smart features" improve workflow without changing the device's intended use or safety profile.

The document does not provide the kind of detailed clinical study data often found for AI/ML-based diagnostic devices, including specific acceptance criteria values, sample sizes for test or training sets, expert qualifications, or adjudication methods, as these may not be typically required for modifications to a stationary X-ray system primarily focused on workflow enhancements and component upgrades.

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The Compass Steerable Needle is a steerable biopsy needle intended be used through a compatible working channel bronchoscope or Medtronic Extended Working Channel (EWC) for the collection of tissue from the intrapulmonary regions.

The Compass Steerable Needles (CSN) are sterile, single use, 22-gauge needles with a unidirectional, steerable distal tip for the acquisition of tissue from the intrapulmonary regions. The Steerable Needle consists of a handle, shaft, and needle. The handle provides the user with control of device rotation, extension, retraction, distal tip articulation of 70°±10° unidirectionally within a plane and a sampling mechanism to extend and retract the needle out of the shaft to obtain tissue samples. A Luer connector on the proximal end of the device provides the connection for the stylet or a syringe for aspiration during sampling. There are two models of the Compass Steerable Needle. Model CSN1001 can be coupled to Olympus® 190 or Pentax® bronchoscopes with a 2.0 working channel and 600 mm working length. It is packaged with a stylet, and adapters. Model CSN1002 can be coupled to the Medtronic Illumisite™ Extended Working Channel (EWC) with a 2.0 mm working channel. It is packaged with a stylet. The Compass Steerable Needles with stylet are inserted and coupled to either a bronchoscope or a Medtronic Illumisite EWC. The translation arm advances the device into the lung. Depressing the plunger articulates the distal end of the shaft. The sampling mechanism is depressed extending the needle to obtain a sample.

The provided text is a 510(k) summary for the Serpex Medical, Inc. Compass Steerable Needle. It outlines the device's characteristics, intended use, and comparison to predicate devices, along with performance data. However, it does not describe a study that proves the device meets specific acceptance criteria in terms of AI model performance, diagnostic accuracy, or clinical effectiveness as typically seen for AI/ML-enabled devices.

Instead, the "acceptance criteria" and "study" described in the document refer to standard medical device verification and validation activities for a new physical medical device (a steerable biopsy needle), focusing on its engineering performance, safety, and functionality. This includes:

• Bench Testing: Mechanical and functional performance of the device.
• Validation Testing: Simulated use conditions, including human cadaver testing for clinical performance.
• Human Factors Usability: Assessment of user interface and potential use errors.
• Biocompatibility: Evaluation of material safety in contact with human tissue.
• Sterilization: Validation of the sterilization process.

Therefore, I cannot extract the information required for an AI/ML-driven device's acceptance criteria and study proving it meets them. The prompt's request for "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI (e.g., sample size for test set, data provenance, number of experts, MRMC studies, standalone performance, ground truth) is not applicable to the content of this 510(k) summary.

In summary, the provided document details the regulatory clearance process for a physical medical device (a steerable biopsy needle), not an AI/ML diagnostic or assistive device. Consequently, it does not contain the information requested regarding AI model performance, expert adjudication, or MRMC studies.

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Endoscopic biliary stent placement for biliary drainage of obstructed ducts that could be caused by common bile duct stones, malignant biliary obstruction, benign or malignant strictures or other obstructed biliary conditions requiring drainage.

The Compass BDS® Biliary Stent includes double pigtails with double radiopaque marker bands. Compass BDS® Biliary Stents are recommended for use with Cook stent introducers (PC-7, PC-7E, and FS-PC-7). The product code for Compass BDS® Biliary Stent is CBBSO-X-Y (CBBSO-7-5, CBBSO-7-10, CBBSO-7-15), where X denotes French size (Fr) and Y denotes the length in centimeters (cm). This product contains a stent and a pigtail straightener. The stent design allows the stent to be introduced on either side and the double-pigtails minimize migration, while side holes enhance biliary fluid drainage. It also has a tapered tip at both ends to facilitate smooth cannulation. The stent has two radiopaque bands on both ends for fluoroscopic visibility.

This application is for a medical device (Compass BDS Biliary Stent), not an AI/ML powered device. Therefore, the requested information regarding AI/ML powered device acceptance criteria and study details are not applicable here.

However, based on the provided document, here's what can be extracted about the device's performance data and substantial equivalence to a predicate device:

The acceptance criteria for the Compass BDS Biliary Stent are implicitly met through a comparison to a predicate device and a series of non-clinical performance tests. The study's conclusion is that the device is substantially equivalent to the predicate device and meets its design input requirements.

1. Table of Acceptance Criteria and Reported Device Performance

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

This document does not specify sample sizes for the performance tests. The data provenance is Cook Ireland Ltd.'s internal design control system. It does not mention country of origin or whether the studies were retrospective or prospective, but given it's a premarket notification for a device, the tests are primarily non-clinical and conducted by the manufacturer.

3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts

This information is not applicable as the studies described are non-clinical (biocompatibility and performance testing) of a physical device, not an AI/ML algorithm requiring expert interpretation for ground truth.

4. Adjudication Method for the Test Set

This is not applicable for the non-clinical testing described.

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

This is not applicable as the application is for a physical medical device, not an AI/ML system, and no human reader studies are mentioned.

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

This is not applicable as the application is for a physical medical device, not an AI/ML algorithm.

7. The Type of Ground Truth Used

For biocompatibility, the ground truth is established by adherence to recognized international standards (ISO 10993-1:2018) and FDA guidance for biological evaluation. For device performance testing, the ground truth is established by the predefined design input requirements for the device.

8. The Sample Size for the Training Set

This is not applicable as there is no mention of a training set for an AI/ML algorithm.

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

This is not applicable as there is no mention of a training set for an AI/ML algorithm.

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The device is indicated for use in obtaining diagnostic images to aid the physician with diagnosis. The system can be used to perform radiographic imaging of various portions of the human body, including the skull, spinal column, extremities, chest, abdomen and other body parts. The device is not indicated for use in mammography.

The DRX-Compass System is a general purpose x-ray system used for acquiring radiographic images of various portions of the human body. The system consists of a combination of components including various models of high voltage x-ray generators, control panels or workstation computers, various models of patient support tables, wallmounted image receptors/detectors for upright imaging, a ceiling mounted tube support, x-ray tube, and collimator (beam-limiting device).

The DRX-Compass can be used with digital radiography (DR) and computed radiography (CR) receptors. Systems equipped with DR or CR receptors can also be configured to include a workstation computer that is fully integrated with the x-ray generator.

The modified (subject) device, DRX-Compass, is the previously cleared Q-Rad System stationary x-ray system which has been modified as follows:

• New marketing names DRX-Compass and DR-Fit will be used depending upon regional marketing strategies.
• Implementation of a new wall stand that provides options for automated vertical motion and vertical to horizontal manual tilt (90 degrees).
• Implementation of a different Overhead Tube Crane (OTC): This OTC is ceiling suspended and provides x-y movement capability for the tube head with respect to the detector. The tube head is capable of three options for alignment with the image acquisition device (detector) as follows: 1) manual alignment by moving the x-ray tube support, 2) manual alignment using the "tube-up/tube-down" switch on the tube support, or 3) automatic alignment using the "Auto Position" switch to activate motors on the tube support in x, y, z, and alpha directions
• Focus 35C and Focus 43C Detectors are added as additional optional detector selections for customers ordering a DRX-Compass system.
• X-Ray Generator: Several Carestream designed generators are available with the system depending on power requirements and regional configurations. These generators are functionally identical to the generators currently offered for sale with the Q-Rad System.

This looks like a 510(k) summary for a medical device called DRX-Compass, an X-ray system. The document does not contain the acceptance criteria or results of a study (like an AI model performance study) that would typically involve statistical metrics, ground truth establishment, or expert reviews.

Instead, this document describes:

• Device Name: DRX-Compass
• Regulatory Information: Product Code, Regulation Number, Class, etc.
• Predicate Device: Q-Rad System (K193574)
• Device Description: Components of the DRX-Compass system, including generator models, patient support tables, wall-mounted receptors, ceiling-mounted tube support, X-ray tube, and collimator. It also mentions the new additions/modifications compared to the predicate device (new marketing names, new wall stand, different Overhead Tube Crane (OTC), added detectors, and available generators).
• Indications for Use: Obtaining diagnostic images for various body parts.
• Substantial Equivalence: The primary claim is that the DRX-Compass is substantially equivalent to the predicate Q-Rad System, stating that modifications do not raise new issues of safety and effectiveness.
• Discussion of Testing: It briefly mentions "non-clinical (bench) testing" to evaluate performance, workflow, function, verification, and validation, and that "Predefined acceptance criteria were met." However, it does not specify what those acceptance criteria were or how they were met in terms of specific performance metrics. It's focused on demonstrating equivalence to the predicate device, not on proving performance against a detailed set of criteria that would typically be described for an AI/CAD device.

Therefore, based only on the provided text, I cannot extract the detailed information requested in the prompt. The document is a regulatory submission summary, not a clinical or performance study report.

If this were a submission for an AI/CAD device, the "Discussion of Testing" section would typically elaborate on a clinical study including:

1. A table of acceptance criteria and the reported device performance: This would list metrics like sensitivity, specificity, AUC, etc., and the target performance values.
2. Sample size used for the test set and the data provenance: Details on number of cases, patient demographics, and origin of data.
3. Number of experts used to establish the ground truth for the test set and their qualifications: Information about the radiologists/pathologists.
4. Adjudication method: How disagreements among experts were resolved.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: If conducted, the effect size (e.g., improvement in reader performance with AI).
6. Standalone performance: The algorithmic performance without human intervention.
7. Type of ground truth used: e.g., pathology, clinical follow-up.
8. Sample size for the training set: Number of cases used for model development.
9. How the ground truth for the training set was established: Similar to the test set, but for the training data.

In summary, the provided document does not contain the information requested because it pertains to a traditional X-ray system's substantial equivalence claim, not the performance evaluation of an AI/CAD (Computer-Aided Detection/Diagnosis) algorithm.

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The Compass Cast and MAP disposable pressure transducer system with integrated digital display and wireless transmission capability is intended for direct measurement and monitoring of physiologic pressure, including during the infusion of fluids and therapeutic and diagnostic agents.

The Compass Cast and MAP disposable pressure transducer system with integrated digital display and wireless transmission capability is intended for direct measurement and monitoring of physiologic pressure, including during the infusion of fluids and therapeutic and diagnostic agents.

The Compass CT and Compass CT Port are disposable, point-of-use pressure measurement and monitoring devices that incorporate a pressure transducer and an integrated pre-programmed diagnostic computer with liquid crystal display (LCD). The devices have a distal male luer fitting to connect to a needle or catheter, and a proximal female luer fitting that can be connected to accessory devices (e.g. syringes, caps, or infusion tubing). The devices measure the pressure via an embedded pressure sensor, internally convert changes in pressure into electrical currents, and then display the resulting pressure via the integrated LCD. The Compass CT Port has an additional, sealed proximal port through which commercially available guidewires can be inserted during pressure measurement.

The Compass CT Port device is being modified to add wireless Bluetooth capability to the point-of-use Compass Cast device, in order to allow for optional display of acquired pressure data and information to a separate display monitor. The modified product will consist of two components that are packaged separately, the compass Cast (Subject Device) and MAP (Monitor Accessory Plug - Accessory).

The Compass Cast (Subject Device) is a single-use, sterile pressure transducer that is physically identical to the predicate device Compass CT Port (510(k) K133624) with the exception of a slight modification to the main CT Port circuit board to accommodate the secondary Bluetooth radio board. All components and functionality of the main circuit board remain identical.

The MAP (Accessory) is a non-sterile, reusable monitor accessory plug that receives a digital pressure signal from the Compass Cast and converts the digital pressure signal to an analog output that is identical to the analog output of a traditional wired pressure transducer. There are two versions of the MAP device:

1. Wireless Pressure Receiver - GE Monitor (CWMG001-5)
2. Wireless Pressure Receiver Philips Monitor (CWMP001-5)

The provided text describes information about the submission of the "Compass Cast and MAP System" for FDA clearance. However, it does not contain explicit acceptance criteria and device performance data in a tabular format, nor does it detail a study that proves the device meets specific performance criteria related to its core function of physiological pressure measurement beyond stating adherence to existing standards.

The document focuses heavily on demonstrating substantial equivalence to a predicate device (Compass CT Port) by highlighting the technological characteristics and the modifications made (addition of Bluetooth capability and a reusable Monitor Accessory Plug - MAP). Performance data mentioned primarily concerns safety aspects due to these modifications, such as sterility, EO residuals, and electromagnetic compatibility.

Therefore, many of the requested items cannot be fully answered from the provided text.

Based on the available information:

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

The document does not explicitly state a table of new acceptance criteria established for the Compass Cast and MAP system itself in terms of pressure measurement performance. Instead, it states that the device's fundamental pressure accuracy and functional performance are "identical" to the predicate device and "Meet or exceed ANSI/AAMI BP22:1994(R)2006".

The only "acceptance criteria" and "reported performance" directly stated are for safety and compatibility tests related to the new wireless functionality and sterilization.

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The implantable device Elite SPK is intended for the attachment of soft tissue to bone during arthroscopic or open treatment of rotator cuff tears. It is intended to be implanted using the Compasso surgical instruments.

Compasso is a series of surgical instruments intended for use for the implantation of the Elite SPK or the Sharc-FT bone anchor.

The Elite SPK is an implantable bone anchor device designed to ensure the fixation of soft tissues (especially tendons) to bone, during the repair of injuries to the shoulder performed with open or arthroscopic technique. The implantable anchor is made of polyether ether ketone (PEEK), and allows the surgeon to attach the injured tendon to the humerus using a transosseous "double row" technique. The ELITE SPK anchor is suitable for a 3 mm in diameter hole, and is provided sterile for single use.

The Compasso is a series of manual surgical instruments to implant the Elite SPK. Instruments in contact with human body are made of Stainless Steel in conformity with ISO 5832-1, while other components not in contact with the patient are made of stainless steel, aluminum and laser sintering polyamide.

The Elite SPK may be provided in a kit form with sutures for physician convenience. The sutures are provided in their final, sterile form in the original packaging from the manufacturer. FDA has previously cleared the provided sutures in 510(k) application K100006; specifically, the kit includes the HS Fiber Sutures.

This document is a 510(k) Pre-market Notification for the Elite SPK, Compasso, and Elite SPK Kit, seeking clearance from the U.S. Food and Drug Administration (FDA). This notification declares the substantial equivalence of the new device to previously cleared predicate devices.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

   Acceptance Criteria	Reported Device Performance
   Sterilization	The sterilization cycles have been validated following international standards. (Implied acceptance: device is terminally sterilized and meets sterility assurance level standards).
   Shelf Life	The shelf life of the devices has been established through stability studies. (Implied acceptance: device maintains its properties and safety over its declared shelf life).
   Biocompatibility	Biocompatibility evaluation has been performed to show the device materials are safe, biocompatible and suitable for their intended use. Both ISO 10993 and FDA Draft Guidance "Use of International Standard ISO 10993. Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" have been taken into account. (Implied acceptance: materials are non-toxic, non-irritating, non-sensitizing, etc., as per ISO 10993 standards for medical devices in contact with tissue).
   Fixation Strength (Elite SPK)	Performance testing was performed to evaluate the fixation strength of the Elite SPK compared to the predicate device. These tests showed that the Elite SPK has adequate fixation strength and is comparable to the predicate devices. (Implied acceptance: fixation strength is non-inferior to or demonstrably equivalent to the predicate device, meeting clinically relevant biomechanical requirements for soft tissue to bone attachment).
   Functional Equivalence (Compasso instruments)	Implied (but not explicitly stated as a quantified acceptance criterion): The Compasso instruments are intended for use with the Elite SPK or Sharc-FT bone anchor, suggesting functionality and usability for their intended purpose. The substantial equivalence argument relies on their ability to implant the Elite SPK similar to how instruments implant the predicate.

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

   The document does not specify the sample size used for any of the performance tests (sterilization, shelf life, biocompatibility, or fixation strength). The data provenance (e.g., country of origin, retrospective/prospective) is also not mentioned. These details would typically be found in the technical reports for each test, which are summarized here.

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

   This type of information is not applicable to the performance tests described for this device. The tests are primarily engineering, materials science, and biological safety evaluations, not diagnostic accuracy studies that require expert-established ground truth.

4. Adjudication Method for the Test Set

   Not applicable for the engineering and biological safety tests performed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

   No, a MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices or AI algorithms where human interpretation is involved. The Elite SPK and Compasso are surgical implants and instruments, respectively, and thus do not involve human readers interpreting cases.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

   Not applicable. This device is not an algorithm or AI-driven system. Its performance is related to its physical and material properties and its function in a surgical context, with a human surgeon always in the loop.

7. Type of Ground Truth Used

   The "ground truth" for the tests mentioned would be based on:

   • Sterilization: Established international standards (e.g., ISO 11137 series for radiation sterilization, ISO 17665 series for moist heat sterilization).
   • Shelf Life: Real-time or accelerated aging studies with defined acceptance criteria for physical, chemical, and functional properties over time.
   • Biocompatibility: In vitro and in vivo testing endpoints defined by ISO 10993 standards (e.g., cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, implantation effects).
   • Fixation Strength: Biomechanical testing protocols (e.g., cyclic loading, pull-out strength, stiffness) with acceptance criteria often established relative to predicate devices or clinically accepted performance benchmarks.

8. 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 mentioned above, this is not an AI/ML device.

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The CenterVue COMPASS is intended for taking digital images of a human retina without the use of a mydriatic agent and for measuring retinal sensitivity, fixation stability and the locus of fixation. It contains a reference database that is a quantitative tool for the comparison of retinal sensitivity to a database of known normal subjects.

The CenterVue COMPASS is a scanning ophthalmoscope combined with an automatic perimeter that allows the acquisition of images of the retina, as well as the measurement of retinal threshold sensitivity and the analysis of fixation. The device works with a dedicated software application, operates as a standalone unit, integrates a dedicated tablet, a joystick, a push-button and is provided with an external power supply. COMPASS operates in non-mydriatic conditions, i.e. without the need of pharmacological dilation and is intended for prescription use only.

The Centervue COMPASS device operates on the following principles:

• An anterior segment alignment system is included, which uses two infrared LEDs with a centroid wavelength of 940 nm and two cameras, whereas the former illuminate the external eye by diffusion and the latter allow a stereoscopic reconstruction of the pupil's position, used for automated alignment purposes via pupil tracking;
• An infrared imaging system captures live monochromatic images of the central retina over a circular field of view of 60° in diameter, by an horizontal line from an infrared LED with a centroid wavelength of 850 nm and by an oscillating mirror which scans the line to uniformly illuminate the retina; such images are in turn used for auto-focusing purposes and to track eye movements, providing a measure of a patient's fixation characteristics and allowing active compensation of the position of perimetric stimuli;
• A concurrent color imaging system allows the capture of color images of the central retina over a circular field of view of 60° in diameter, using a white LED and a blue LED combined to obtain a white light illuminating the retina by the same scan mechanism;
• A fixation target projecting onto the retina a fixation target obtained from a green LED;
• A stimuli projector, projecting onto the retina white light Goldmann stimuli at variable intensity and allowing measurements of threshold sensitivity at multiple locations, according to a patient's subjective response to the light stimulus projected at a certain location.

The COMPASS device interacts with the patient by directing infrared, white, blue and green wavelength illumination into the patient's eye and by recording a patient's confirmation that a certain light stimulus has been perceived or not.

Here's an analysis of the acceptance criteria and the supporting study for the CenterVue COMPASS device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA clearance letter (K150320) primarily focuses on establishing "substantial equivalence" to predicate devices, rather than explicit numerical acceptance criteria for clinical performance that might be found in a performance goal document for a novel device. However, the clinical study serves to demonstrate this equivalence. The key performance comparison is between the CenterVue COMPASS and the Humphrey HFA-II.

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

• Test Set Sample Size:
  • 200 normal subjects
  • 120 subjects with pathology affecting the visual field (specifically glaucoma)
  • Total: 320 subjects
• Data Provenance: The document does not explicitly state the country of origin. It indicates the manufacturer is in Padova, Italy, and the study was conducted to support FDA clearance in the USA, suggesting the study likely occurred in conjunction with the manufacturer's operations or clinical sites. The study is presented as prospective clinical testing ("Measurements have been obtained...").

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

The document does not specify the number of experts or their qualifications for establishing the "ground truth" for the test set (i.e., whether subjects were truly "normal" or had "glaucoma"). It only states that subjects were categorized as "normal" or with "pathology affecting the visual field (in particular glaucoma)." This implies a clinical diagnosis was used, but the specific process or number of experts for this diagnosis is not detailed.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set in terms of expert review or consensus. The study compares the performance of the COMPASS directly to the predicate device (Humphrey HFA-II) on the same subjects, rather than assessing the COMPASS's ability to classify against a pre-established ground truth determined by multiple experts.

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 device is primarily a diagnostic instrument for measuring retinal sensitivity and imaging, not an AI-assisted diagnostic aid for interpretation by human readers. The clinical study compares the device's measurements to another device, not human performance.

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

Yes, the clinical study presents data on the standalone performance of the CenterVue COMPASS device in measuring retinal threshold sensitivity. It directly compares the measurements obtained by the COMPASS to those obtained by the Humphrey HFA-II. The device operates as a standalone unit for acquiring images and measuring retinal sensitivity.

7. The Type of Ground Truth Used

The "ground truth" in this context is the measurement of retinal threshold sensitivity as determined by the accepted standard, the Humphrey HFA-II. The study aims to demonstrate that the COMPASS's measurements are "equivalent" to those of the HFA-II, specifically that the mean differences in thresholds are comparable to known differences within the HFA-II platform (SITA Standard vs. full threshold). The classification of subjects as "normal" or with "glaucoma" would have been based on clinical diagnosis, implicitly serving as a form of "expert consensus" or "clinical diagnosis" ground truth for subject selection, but not for the specific performance metric being evaluated (threshold sensitivity differences).

8. The Sample Size for the Training Set

The document describes a "reference database" that was developed to serve as a quantitative tool for comparison of retinal sensitivity to known normal subjects.

• Reference Database Sample Size: 200 eyes of 200 normal subjects.
• The age range of this population was 20 - 86 years (50.6 ± 15.2).

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

The ground truth for the "training set" (referred to as the "reference database" in the document) was established by obtaining threshold sensitivity data from 200 subjects confirmed to be "normal." The specific criteria or expert qualifications for determining "normalcy" are not detailed in this summary, but it implies a clinical assessment of individuals free from visual field pathology. The perimetric settings used to gather this data are listed (24-2 grid, 4-2 strategy, Goldmann III stimulus, etc.).

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The Compass™ CT disposable pressure transducer with integrated digital display is intended for direct measurement and monitoring of physiological pressure, including during the infusion of fluids and therapeutic and diagnostic agents.

The Compass™ CT Port disposable pressure transducer with integrated digital display is intended for direct measurement and monitoring of physiological pressure, including during the infusion of fluids and therapeutic and diagnostic agents.

The Compass CT and Compass CT Port are disposable, point-of-use pressure measurement and monitoring devices that incorporate a pressure transducer and an integrated pre-programmed diagnostic computer with liquid crystal display (LCD). The devices have a distal male luer fitting to connect to a needle or catheter, and a proximal female luer fitting that can be connected to accessory devices (e.g. syringes, caps, or infusion tubing). The devices measure the pressure via an embedded pressure sensor, internally convert changes in pressure into electrical currents, and then display the resulting pressure via the integrated LCD. The Compass CT Port has an additional, sealed proximal port through which commercially available guidewires can be inserted during pressure measurement.

The Mirador Compass™ CT and CT Port are disposable pressure measurement and monitoring devices with an integrated digital display. The devices are intended for direct measurement and monitoring of physiological pressure, including during the infusion of fluids and therapeutic and diagnostic agents.

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

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

The provided document does not explicitly present a table of acceptance criteria with corresponding performance metrics like "Accuracy: X mmHg". Instead, it states that "The subject Compass CT and CT Port incorporate new software that allows for an extended pressure range. Therefore, all verification tests related to the software and pressure accuracy that were completed to support the substantial equivalence of the predicate Compass devices were re-executed for the subject Compass CT and CT Port. Pressure accuracy testing was completed per ANSI/AAMI BP22:1994(R)2006 and ISO 60601-2-34 310 Ed."

Without the specific results from the re-executed pressure accuracy testing, a direct table of acceptance criteria vs. reported performance cannot be created from the given text. However, the implicit acceptance criterion is adherence to the performance standards specified in ANSI/AAMI BP22:1994(R)2006 and ISO 60601-2-34 310 Ed for pressure accuracy.

The text states: "The results from this in vitro testing demonstrate that the technological and performance characteristics of the subject Compass CT and CT Port meet defined design requirements and that they can perform in a manner equivalent to devices currently on the market used for measuring physiological pressure." This implies that the device did meet the internal design requirements and the standards cited.

Implicit Acceptance Criteria & Reported Performance:

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

The document states "Pressure accuracy testing was completed per ANSI/AAMI BP22:1994(R)2006 and ISO 60601-2-34 310 Ed." These are in vitro testing standards.

• Sample size: The specific number of devices or measurements used in the pressure accuracy testing is not provided in the given text.
• Data provenance: The testing was in vitro (laboratory-based), rather than from a clinical setting. The country of origin of the data is not explicitly stated, but the manufacturer is Mirador Biomedical, Inc. in Seattle, Washington, USA, suggesting the testing likely occurred in the US or at a certified lab. The study is prospective in the sense that these specific tests were re-executed for the new software version.

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

This type of information (experts, ground truth establishment) is typically not applicable or reported for in vitro device performance testing where the ground truth is established by a calibrated reference standard (e.g., a highly accurate pressure calibrator). The performance is assessed against these known, precise values, not expert interpretation.

4. Adjudication method for the test set

Not applicable for in vitro performance testing against a calibrated reference standard.

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 device is a direct pressure measurement device, not an AI-assisted diagnostic tool that would involve human readers interpreting images or data with and without AI.
• No AI component requiring human-in-the-loop performance measurement is described. The device incorporates an "integrated pre-programmed diagnostic computer" but this refers to its internal processing and display of pressure, not an AI for interpretation or assistance to a human reader.

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

Yes, the pressure accuracy testing conducted ("re-executed for the subject Compass CT and CT Port") is a form of standalone performance assessment. The performance of the device's internal pressure measurement and display system was evaluated independently (without human intervention in the measurement process itself, beyond operating the test equipment). The "algorithm" here refers to the software that processes the pressure sensor's input and drives the display.

7. The type of ground truth used

The ground truth for the pressure accuracy testing would be established by calibrated reference standards. This typically involves highly accurate, independently verified pressure transducers or calibrators against which the device's measurements are compared.

8. The sample size for the training set

The concept of a "training set" is not relevant here as this is not an AI/machine learning device that learns from data. It's a measurement device with a pre-programmed diagnostic computer.

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

Not applicable as there is no training set mentioned or implied for this type of device.

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The NCS Fish-Fit MD System is intended for the attachment of soft tissue to bone during arthroscopic or open treatment of rotator cuff tendons lesions with the purpose of repairing the rotator cuff (supraspinatus, infraspinatus and subscapularis).

NCS Fish-Fit MD System is an implantable anchor made from Titanium grade 4. Sutures are not pre-assembled with bone anchor. The system includes an instrumentation package, Compass MD. The instrument package is intended to facilitate implantation of the anchor.

The provided 510(k) summary for the NCS Fish-Fit MD System is for a medical device (an implantable suture anchor) and not for a software or AI/ML-based device. Therefore, the questions related to clinical studies, ground truth, expert adjudication, MRMC studies, and training sets are not applicable to this submission.

The acceptance criteria and supporting study described are for the mechanical performance of the device, comparing it to predicate devices.

Here's the information that can be extracted from the provided text, adapted for the nature of this device:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set: The document refers to "non-clinical testing" and "data have been provided," but does not explicitly state the sample size (e.g., number of anchors tested) or the provenance (e.g., in vitro, ex vivo). It implies laboratory-based mechanical testing.
• Data Provenance: Non-clinical (likely in-vitro mechanical testing).

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

• Not applicable. This is a mechanical device, and the "ground truth" is measured physical properties like strength, not a diagnostic interpretation. The testing likely conformed to engineering standards.

4. Adjudication method for the test set

• Not applicable. This is a non-clinical, mechanical testing study, not a study involving human 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

• Not applicable. This is not an AI/ML device or a diagnostic imaging device.

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

• Not applicable. This is a hardware medical device.

7. The type of ground truth used

• The "ground truth" for this device's performance measurement would be quantitative mechanical measurements (e.g., force in Newtons, displacement in millimeters) obtained from standardized engineering tests (e.g., universal testing machine results).

8. The sample size for the training set

• Not applicable. This is a hardware medical device; there is no "training set."

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

• Not applicable. There is no training set for this device.

Summary of the Study Proving Acceptance Criteria:

The study was a non-clinical testing program conducted to assess the mechanical properties of the NCS Fish-Fit MD System, specifically its fixation strength and pull-out strength. The testing was performed in accordance with the FDA guidance document "Guidance Document for Testing Bone Anchor Devices" dated April 20, 1996. The purpose was to demonstrate that the device performs as well as (i.e., is substantially equivalent to) the identified predicate devices in these critical mechanical parameters. While specific numerical results or sample sizes are not provided in this summary, the conclusion states that the testing verified adequate performance, demonstrating substantial equivalence.

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