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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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The Recon Steerable Sheath is an extended working channel intended to be used with a compatible bronchoscope to guide endotherapy accessories to the target area within the respiratory system.

The Recon Steerable Sheath is a sterile, single use transbronchial sheath with a unidirectional, steerable distal tip that provides access to the intrapulmonary regions. It is designed to guide endotherapy tools with an outer diameter of up to 1.9 mm and minimum length of 1100 mm to the target tissue. The Recon Steerable Sheath (Model RSS1000) includes the Steerable Sheath, Stylet, Bronchoscope Adapter and Pentax Adapter. The Recon Steerable Sheath is compatible with Olympus® 190 or Pentax® bronchoscopes that have a 2.8mm working channel and 600 mm working length. It is coupled to the selected bronchoscope using an adapter(s). The handle provides the user with control of device rotation, extension, retraction, and distal tip articulation of 90° minimum within a plane with the stylet inserted. A Luer connector on the proximal end of the device provides the connection for the stylet. The Recon Steerable Sheath with stylet is inserted and coupled to a bronchoscope via a clip on the handle. The telescope advances the device beyond the bronchoscope into the lung. Depressing the plunger articulates the distal end of the sheath by tensioning an internal pull wire. Once in the desired location, the Stylet is removed from the Steerable Sheath and the tool of choice can be inserted for access.

The provided text is a 510(k) summary for the Recon Steerable Sheath. While it mentions performance data, it primarily focuses on bench testing, packaging, validation, usability, biocompatibility, and sterilization to demonstrate substantial equivalence to a predicate device. It does not contain information about a study proving the device meets acceptance criteria related to diagnostic performance, such as sensitivity, specificity, or accuracy. Therefore, I cannot generate the table and answer the requested questions in the format initially outlined.

The document indicates that "All tests met the predefined acceptance criteria" for bench testing and packaging, and that "The Recon Steerable Sheath met the performance requirements and was found to be clinically acceptable by all evaluators" during validation testing. However, the exact quantitative acceptance criteria and the numerical results for these specific tests are not detailed in this public summary.

If a study involving diagnostic performance (e.g., how well the device guides tools to a target) was conducted with metrics like accuracy or success rates, that information is not present here.

Therefore, I will provide the available information regarding "acceptance criteria" and "study" based on the provided text, but it will not fully match the structure you requested for a device with measurable diagnostic performance metrics.

Available Information from the Document:

The document describes various tests performed to demonstrate the safety and effectiveness of the Recon Steerable Sheath, primarily focusing on its physical and functional integrity, biocompatibility, and sterilization, rather than a diagnostic performance study.

Here's an overview of the "acceptance criteria" and "studies" mentioned, as much as can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance (Based on available information for engineering performance):

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

• Test Set Sample Size: Not explicitly stated for any of the individual tests. The document refers to "evaluators" for validation and "intended user groups" for usability studies, but no numbers are provided.
• Data Provenance: The studies were conducted by Serpex Medical, Inc. (the device manufacturer) in accordance with various FDA guidances and international standards. This is prospective testing performed for regulatory submission. Country of origin for data is not specified beyond being generated by the submitting company.

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

This information is not applicable in the context of the studies described. The "ground truth" here relates to engineering specifications, safety standards, and user-reported clinical acceptability, rather than expert-established diagnostic ground truth on a dataset. For "Validation testing", it states the device "was found to be clinically acceptable by all evaluators," but the number and qualifications of these evaluators are not specified. For "Usability," "intended user groups" were involved, but details are not provided.

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

Not applicable. The tests described are primarily objective engineering and biological tests, or user evaluations, not diagnostic performance assessments requiring adjudication of interpretations.

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 document does not describe an MRMC study or any AI component. The device is a physical medical instrument (steerable sheath), not a diagnostic algorithm.

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

Not applicable. This is a physical device, not an algorithm.

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

The "ground truth" for the various tests described refers to:

• Predefined engineering specifications and performance benchmarks (for bench testing).
• Compliance with international standards (for packaging, biocompatibility, sterilization).
• User satisfaction and ability to perform intended tasks without (new) errors (for validation and usability).

8. The sample size for the training set:

Not applicable. This is a physical device, not an AI algorithm requiring a training set.

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

Not applicable. This is a physical device, not an AI algorithm.

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