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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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