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The Compass Steerable Needle is a steerable transbronchial biopsy needle intended to 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 Needle (CSN) is sterile, single use, 22-gauge transbronchial needle with a unidirectional, steerable distal tip for the acquisition of tissue from the intrapulmonary regions. The Compass Steerable Needle include two model numbers, Model CSN1001 and Model CSN1002. Model CSN1001 includes two accessory adapters for attachment to bronchoscopes.

The subject of this 510(k) is the addition of two new adapters to Model CSN1002. Adapter SRA-1-01 connects the Model CSN1002 to the Ion™ Endoluminal System, and Adapter SRA-2-01 connects the Model CSN1002 to the Monarch™ Platform or Galaxy System™.

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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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Morgan Scientific's ComPAS2 is a software application intended to be used to compatible Morgan Scientific or thirdparty devices to acquire, analyze, view, store, export, and print the device outputs including measurements of flow, volume, pressure, and gas concentrations. The product is designed for use on adults and pediatrics 4 years and older, in a variety of healthcare environments such as, but not limited to, primary care, hospitals, and research health centers under the supervision of a healthcare provider.

ComPAS2 is a software application designed to provide a secure PC based medical device for creating, adding/recalling subjects, and performing cardio-pulmonary function testing on those subjects. ComPAS2 will interface and link to compatible Morgan Scientific and third-party devices to read, analyze, and display their output to allow the information to be retained with the subject. Current compatible approved devices: TransAir (K953990), SpiroAir (K042595), Body Plethysmograph (K022636), WristOx2 (K102350), tremoFlo (K170185), Pneumotrac (K142812), Micro (K160253), Model 9100 PFT/D1CO (K221030). Data can be reported directly to a printer or communicated with hospital information systems/electronic medical records. All data are preserved in an SQL database, with key sub-systems of ComPAS2 interacting with the database through an API (Application Program Interface).

ComPAS2 is designed to operate with compatible cardio-pulmonary function testing hardware by manufacturers offering the capability to measure key pulmonary functions including, but not limited to: static and dynamic spirometry, bronchial challenge, maximum voluntary ventilation, respiratory muscle strength, cough peak flow, lung volume sub-divisions (such as but not limited to helium dilution, nitrogen washout and plethysmography), single breath diffusion, airway resistance, distribution with lung clearance index closing volume. Other features include: a task manager to manage patient data for reporting; manual entry to input additional information; and historical data review to analyze data for trending and reporting.

The ComPAS2 device, a software application for diagnostic spirometry, was found to be substantially equivalent to its predicate device, ComPAS2 v2019.1.0 (K190568). The primary "study" proving this substantial equivalence was non-clinical performance testing of the software.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in a typical quantitative pass/fail format for each performance metric, but rather highlights that performance testing demonstrated that the subject device met its acceptance criteria. The "reported device performance" is implied to be equivalent to the predicate device's performance, as the core functionality and technical characteristics remain largely the same, and the software was validated against the predicate's results.

However, based on the comparison table and the general description, we can infer some performance aspects:

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

• Test Set Sample Size: Not explicitly stated as a number of patients or cases. The testing involved "developing test cases and test runs for the performance of end-to-end testing with both biological and mechanical controls." This suggests a series of functional tests and expected outcomes rather than a traditional patient-based clinical study with a specific sample size.
• Data Provenance: The document does not specify the country of origin for any data used in this non-clinical testing. The nature of the testing (bench testing, software validation) suggests it's primarily synthetic or controlled data generated internally, or data from mechanical/biological controls (e.g., spirometer calibration syringes, simulated lung models). The testing was against "existing results from ComPAS2 v2019.1.0," indicating a retrospective comparison to previously established performance.

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

Not applicable. The ground truth for this software validation was established by comparing the results of the ComPAS2 v2022.1.0 software to the "existing results from ComPAS2 v2019.1.0," the predicate device, and ensuring compliance with recognized standards (ATS/ERS guidelines). Expertise would have been in the form of engineers, quality assurance personnel, and potentially pulmonologists for clinical interpretation of the standards and expected outputs, but the document does not specify a panel of experts for "ground truth" establishment in the sense of a diagnostic interpretation study.

4. Adjudication Method for the Test Set

Not applicable. This was a software verification and validation study, not a clinical study requiring adjudication of diagnostic outcomes. Validation involved ensuring consistency and accuracy of the new software's outputs against the predicate and established standards.

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 or described. The device is a software application intended to acquire, analyze, view, store, export, and print device outputs, not to provide AI-assisted diagnoses that impact human reader performance.

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

Yes, the performance testing described is a standalone evaluation of the ComPAS2 software application. The "Bench" section explicitly states "software testing activities" and "system level testing to ensure that the product is capable of meeting the intended use." This indicates the algorithm's performance (i.e., the software's ability to process and display data) was tested independently. The software interfaces with hardware devices that generate the raw data, but its own function of processing and presenting that data was evaluated as described.

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

The ground truth used for the validation of ComPAS2 v2022.1.0 was primarily:

• Existing results from the predicate device (ComPAS2 v2019.1.0): The new software's outputs were compared against the established, cleared performance of the previous version.
• Current standards for Lung Function Testing: Compliance with standards issued by the American Thoracic Society (ATS) and European Respiratory Society (ERS) (e.g., Laszlo, 2006; Macintyre et al., 2005; Miller, Crapo, Hankinson, et al., 2005; Pellegrino, et al., 2005; Wanger et al., 2005; ERS/ATS 2017 & 2019 standards).

8. The Sample Size for the Training Set

Not applicable. This is a software update to an existing device, and the testing described is primarily verification and validation against established standards and the predicate's performance. There is no mention of a machine learning or AI component requiring a "training set" in the context of this submission. The software performs calculations and displays data based on established algorithms in pulmonary function testing.

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

Not applicable, as there is no mention of a training set for machine learning or AI.

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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 ComPAS2 software is intended to operate with the Screenstar pneumotachograph spirometer, Morgan Transflow test PFT system and the Morgan transfer test benchmark PFT system. ComPAS2 uses flow and volume from each of the devices to display the flow and volume information measured directly from patient effort. ComPAS2 also utilizes gas analyzer readings from the Transfer test benchmark to display helium dilution lung volume data and single breath diffusion data measured directly from patient effort. This information is for use in pulmonary function testing and reports.

ComPAS2 is designed to interface with various pieces of hardware (previously cleared pulmonary function testing devices, K142812, K042595, K022636, K953990, K013752) to capture clinical data in the performance of clinical testing. Those data can be reported directly to a printer or communicated with hospital information systems/electronic medical records. All data are preserved in an SOL database, with key sub-systems of ComPAS2 interacting with the database through an API (Application Program Interface).

ComPAS2 is designed to operate with pulmonary function testing hardware by manufacturers offering the capability to measure key pulmonary functions including: static and dynamic spirometry, bronchial challenge, maximum voluntary ventilation (MVV), respiratory muscle strength, cough peak flow, lung volume sub-divisions (by helium dilution, nitrogen washout and plethysmography), single breath diffusion, airway resistance, distribution with lung clearance index closing volume. Other features include a task manager in order to manage patient data for reporting, manual entry in order to input additional information and historical data in order to analyze data for trending and reporting.

The user performs daily quality checks/calibrations prior to performing any tests. Once the test subject enters the Pulmonary Function Testing lab, foundation biographical information (Unique ID, Name, DOB) are either entered by the user, recalled or received in and order via Health Level 7(HL7) message from the information system. The functionality of ComPAS2 software remains the same as the predicate and provides the end user with the same experience.

Encounter information is added at the time of testing such as height, weight, diagnosis and physician. Test capability depends upon the Pulmonary Function Testing device being employed. Completed test information can be printed and handed to the physician for interpretation or data can be routed to the EMR (Electronic Medical Record).

ComPAS2 software connects using USB-powered desktop pulmonary function testing devices for the purpose of creating, adding and recalling subjects and performing pulmonary function testing on those subjects to aid in the measuring of the effect of lung disease on pulmonary function.

The ComPAS2 software is intended to interface with existing pulmonary function testing hardware to capture and display clinical data related to static and dynamic spirometry, bronchial challenge, maximum voluntary ventilation, respiratory muscle strength, cough peak flow, lung volume sub-divisions, single breath diffusion, airway resistance, and distribution with lung clearance index closing volume, for use in pulmonary function testing and reports.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly list "acceptance criteria" in a typical quantitative format for device performance. Instead, it details that the ComPAS2 device has identical functionality and indications for use as its predicate device, ComPAS (K021200). The comparison table highlights that key functional performance parameters are the same between ComPAS and ComPAS2. Since ComPAS was already cleared by the FDA, the demonstration of identical functionality and adherence to the same established standards (ATS/ERS) serves as the basis for substantial equivalence.

Note: The key "acceptance criterion" implicitly demonstrated is that ComPAS2 functions identically and adheres to the same established performance standards as the predicate device (ComPAS K021200), which was already cleared. The minor changes (updated operating system compatibility and localization support) are considered not to introduce new risks or alter the fundamental performance.

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

The document states that ComPAS2 software testing involved "developing test cases and test runs for the performance of end to end testing with both biological and mechanical controls." It specifically mentions "results from ComPAS2 testing of the American Thoracic Society's 26 waveform loops for flow/volume validation (Hankinson & Crapo, 1995)".

Sample Size:

• For flow/volume validation, 26 waveform loops from the American Thoracic Society were used.
• The document does not specify a distinct 'test set' sample size in terms of patient data but rather focuses on testing the software's ability to process and display data in congruence with existing hardware and standards.

Data Provenance:

• The 26 waveform loops are derived from a standard set (American Thoracic Society). The original provenance (country of origin, retrospective/prospective) of these standardized waveforms is not detailed in this document, but they represent a recognized benchmark for spirometry validation.

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

The document does not mention the use of human experts to establish "ground truth" for the test set in the context of this software clearance. The validation relies on standardized waveforms and comparison with the predicate device's existing results. The "ground truth" for the performance metrics (e.g., flow accuracy, volume accuracy) is inherently established by the widely accepted ATS/ERS standards and the performance of the predicate device.

4. Adjudication Method for the Test Set

Not applicable. There was no mention of an adjudication process by multiple experts for establishing ground truth for the software's performance, as the validation relied on standardized waveforms and comparison to predicate device performance.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This type of study typically assesses how AI assistance impacts human reader performance (e.g., radiologists interpreting images). The ComPAS2 software is a data acquisition and display system for pulmonary function tests, not an AI-driven interpretive aid for human readers. Its validation focuses on accurate data processing and display, matching the predicate device.

6. Standalone Performance Study

Yes, a standalone performance study was implicitly conducted, focused on the software's ability to accurately process and display data. The "ComPAS2 software testing activities consisted of developing test cases and test runs for the performance of end to end testing with both biological and mechanical controls." The results were "validated against existing results from ComPAS, the aforenamed predicate device." This indicates the software was tested independently to ensure its calculations and outputs matched expected results based on the predicate and established standards.

7. Type of Ground Truth Used

The ground truth used for validating ComPAS2's performance appears to be a combination of:

• Established industry standards: Specifically, the American Thoracic Society and European Respiratory Society's Standardization for Lung Function Testing (ATS/ERS 2005, and later updates from 2017). These standards define acceptable accuracy and performance for spirometry.
• Standardized mechanical and biological controls/waveforms: The mention of "26 waveform loops for flow/volume validation (Hankinson & Crapo, 1995)" points to using standardized, known input data against which the software's outputs are compared.
• Predicate device results: The software's output was validated against "existing results from ComPAS," implying that the previously cleared and validated performance of the predicate serves as a benchmark for equivalence.

8. Sample Size for the Training Set

The document does not mention a "training set" because ComPAS2 is not described as a machine learning or AI algorithm in the context of typical AI device development that requires a training set. It is a software redesign of an existing pulmonary function testing application. Its development involves standard software engineering practices rather than algorithmic training on a dataset.

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

Not applicable, as there was no mention of a training set or machine learning 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.

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

For the safety tests (sterilization, EO residuals, BET, EMC/Wireless), specific sample sizes are mentioned:

• EO Residuals: "Three samples were processed through two routine (Cycle 20) sterilization cycles".
• Other tests: Sample sizes are not explicitly stated for EMC/Wireless, Sterilization validation, or BET, beyond stating that testing was performed.
• Pressure performance: No specific test set sample size is described for evaluating the pressure accuracy of the Compass Cast itself, as its performance is stated to be "identical" to the predicate. Therefore, any data provenance for such a study would refer to the predicate device development.

The provenance for the safety tests is internal company testing ("Centurion Protocol# 17205-16"). No country of origin is specified for these tests. The nature of these tests is prospective for this device modification.

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

This information is not provided in the document. The regulatory submission relies on adherence to established consensus standards (e.g., ANSI/AAMI BP22, ISO 11135, IEC 60601-1-2), rather than a new study requiring expert ground truth for diagnostic accuracy.

4. Adjudication method for the test set

Not applicable, as no diagnostic accuracy study requiring expert adjudication is described in the provided text for the modified device. The compliance is against engineering and safety standards.

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. The device is a pressure transducer system, not an AI-assisted diagnostic tool.

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

A standalone performance evaluation would be the stated compliance to standards like ANSI/AAMI BP22 for pressure accuracy, and the safety/EMC standards. There is no algorithm in the AI sense for a standalone "algorithm only" performance. The device itself is the "standalone" component measuring pressure.

7. The type of ground truth used

For pressure accuracy and functional performance, the ground truth is based on established metrology reference standards and methods outlined in ANSI/AAMI BP22:1994(R)2006.
For sterilization, EO residuals, BET, and EMC, the ground truth is defined by the specific requirements and test methods detailed in the respective international and national standards (e.g., ANSI/AAMI/ISO 11135, ISO 10993-7, AAMI ANSI ST72, IEC 60601-1-2).

8. The sample size for the training set

Not applicable. This is not a machine learning/AI device, so there is no training set mentioned.

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

Not applicable. There is no training set involved.

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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 Compass devices 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 Compass devices are designed to attach distally to an inserted needle or catheter, 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.

1. Table of Acceptance Criteria and Reported Device Performance:

   The document does not explicitly present a table of acceptance criteria with corresponding performance results. However, it indicates that "Pressure accuracy testing was completed per ANSVAAMI BP22:1994(R)2006." The study concludes that "The results from this in vitro testing demonstrate that the technological and performance characteristics of the Compass devices 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 met the accuracy requirements specified in the ANSVAAMI BP22:1994(R)2006 standard, which served as the acceptance criteria for pressure accuracy. Specific numerical values for the acceptance criteria and the device's performance against them are not provided in this summary.

2. Sample Size for Test Set and Data Provenance:

   The document describes "in vitro testing" without specifying a particular sample size for a test set in the context of a dataset of medical images or patient records. The testing performed focused on physical device performance, specifically pressure accuracy, rather than evaluating an algorithm on a clinical dataset. The data provenance is related to the physical testing of the device.

3. Number of Experts and Qualifications for Ground Truth:

   Not applicable. The study is a device performance test (pressure accuracy) and does not involve establishing ground truth by medical experts for a diagnostic or AI-driven task.

4. Adjudication Method for Test Set:

   Not applicable. The study is a device performance test and does not involve adjudication of expert interpretations for a test set.

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

   No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is a disposable pressure transducer with an integrated digital display, not an AI system designed to assist human readers in interpreting medical images or data.

6. Standalone (Algorithm Only) Performance Study:

   The device itself (Compass™) is the standalone device. The testing described is of the device's performance, specifically its pressure accuracy and software functionality. It's not an algorithm in the sense of a software-only diagnostic tool that would typically undergo a standalone performance study in the context of AI. The performance of the integrated pre-programmed diagnostic computer is assessed as part of the overall device.

7. Type of Ground Truth Used:

   For the pressure accuracy testing, the "ground truth" would have been established by a reference standard pressure measurement device or system, as per the ANSVAAMI BP22:1994(R)2006 standard. This is a technical (metrological) ground truth rather than clinical ground truth (e.g., pathology, outcomes data, or expert consensus on a diagnosis).

8. Sample Size for Training Set:

   Not applicable. The device is a physical pressure transducer with integrated software, not an AI system requiring a training set in the machine learning sense. The software is described as "integrated pre-programmed diagnostic computer" and "new software," suggesting it was developed through traditional software engineering processes, not by training on a dataset.

9. How Ground Truth for Training Set Was Established:

   Not applicable, as there is no "training set" in the context of this device's development. The software was likely developed and verified against functional and performance requirements through established software development lifecycles and testing protocols.

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