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The SPY Laparoscope is intended to be used for gynecological and general procedures that clinicians deem appropriate for the adult or pediatric patient aged one month or older, when the dimensions of the SPY Laparoscope are appropriate for the patient size and anatomy.

The SPY Laparoscope is part of Stryker's rigid endoscope product portfolio. The SPY Laparoscope is an optical instrument used to visualize or image a patient's anatomy during minimally invasive, endoscopic procedures for examination, diagnosis or therapy. The SPY Laparoscope transmits light in both the visible and near-infrared spectrum to illuminate the anatomy, then forms and relays the image of the surgical site to a camera system for image processing and display.

The provided FDA 510(k) clearance letter for the SPY Laparoscope primarily details bench testing and compliance with various recognized standards to demonstrate substantial equivalence to a predicate device. It explicitly states that "The subject device does not require clinical studies to support the determination of substantial equivalence."

Therefore, the information you've requested regarding acceptance criteria and study proving performance, particularly related to human-in-the-loop performance, multi-reader multi-case studies, and the specifics of clinical ground truth establishment, is not available in this document. The clearance is based on a demonstration of equivalent technical performance and safety through non-clinical testing.

Here's how we can address your request based on the provided text, focusing on the available information:

Acceptance Criteria and Device Performance (Based on Non-Clinical Testing)

Since no clinical study data is presented, the "acceptance criteria" here refers to meeting the performance specifications and standards compared to the predicate device, primarily through bench testing.

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)

Information Not Available (Due to Reliance on Non-Clinical Testing)

The following points cannot be addressed from the provided document because the 510(k) clearance was based on non-clinical testing for substantial equivalence, not on clinical performance studies involving human subjects or AI:

2. Sample size used for the test set and the data provenance: Not applicable in the context of clinical data. The "test set" here refers to the physical units of the SPY Laparoscope and reference devices used in the various bench tests. Data provenance is internal lab testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for bench testing is derived from metrology and engineering standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is an endoscope, not an AI-driven image analysis tool. The document explicitly states "The subject device does not require clinical studies to support the determination of substantial equivalence."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a hardware device; no AI algorithm is mentioned or evaluated in this context.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For non-clinical tests, "ground truth" is defined by established engineering and optical standards, and measurements. For example, FOV measurements are compared against an acceptable range, not a clinical diagnosis.
8. The sample size for the training set: Not applicable. This is not an AI or machine learning device requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary: The FDA clearance for the SPY Laparoscope, as described in this 510(k) summary, is based entirely on a demonstration of non-clinical substantial equivalence to a predicate device. This includes demonstrating equivalent optical performance, electrical safety, biocompatibility, reprocessing efficacy, and overall risk management. Clinical studies or studies involving human-in-the-loop performance, AI, or advanced diagnostic accuracy metrics were not part of this clearance process.

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The SPY Laparoscope is intended to be used for gynecological and general procedures that clinicians deem appropriate for the adult or pediatric patient aged one month or older, when the dimensions of the SPY Laparoscope are appropriate for the patient size and anatomy.

Stryker's SPY Laparoscope is part of Stryker's rigid endoscope product portfolio. Stryker's SPY Laparoscopes are tubular optical instruments used to visualize or image a patient's anatomy during minimally invasive, endoscopic procedures for examination, diagnosis or therapy. The SPY Laparoscope transmits light in both the visible and near infrared spectrum to illuminate and image the anatomy, then forms and relays the image of the surgical site to a camera system for processing and display.

The provided text describes the regulatory clearance of the SPY Laparoscope by the FDA, but it does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria related to its clinical effectiveness or diagnostic accuracy. The "Performance Testing" section details various engineering and biological tests (electrical safety, packaging, biocompatibility, cleaning & disinfection, sterilization, and bench performance related to optical and mechanical verification), but these are primarily for safety and functional verification, not clinical performance or diagnostic accuracy.

Therefore, I cannot provide the requested information regarding:

• A table of acceptance criteria and reported device performance for clinical effectiveness or diagnostic accuracy.
• Sample size used for the test set and data provenance for clinical performance studies.
• Number of experts and their qualifications for establishing ground truth for clinical performance.
• Adjudication method for clinical performance.
• Multi-reader multi-case (MRMC) comparative effectiveness study details or effect size.
• Standalone (algorithm only) performance details.
• Type of ground truth used for clinical performance (e.g., pathology, outcomes data).
• Sample size for the training set for clinical performance.
• How ground truth for the training set was established for clinical performance.

The document focuses on demonstrating substantial equivalence to a predicate device (Stryker AIM System, K210088) through comparisons of design, intended use, principles of operation, and a battery of standard safety and functional tests. This is typical for a 510(k) submission, where the focus is on showing similarity to an already legally marketed device rather than proving novel clinical efficacy or diagnostic accuracy.

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