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The Stryker Endoscopy Medical Video Camera System is intended for endoscopic camera use in a variety of endoscopic surgical procedures including orthopedic, laparoscopic, urologic, sinuscopic, plastic and as an accessory for microscopic surgery. Sterilization of the camera head and cable is required before use. The new Stryker camera will be capable of interfacing with the Hermes Operating Room Control Center (K973700) voice-activated system, with no impact on normal camera system operation.

The Stryker Endoscopy 3-Chip Medical Video Camera System is indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery where-ever a laparoscope/endoscope/arthroscope is indicated for use. A few examples of the more common endoscopic surgeries are laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic pelvic lymph node dissection, laparoscopically assisted hysterectorny, laparoscopic & thorascopic anterior spinal fusion. anterior cruciate ligament reconstruction, knee arthroscopy, shoulder arthroscopy, small joint arthroscopy, decompression fixation, wedge resection, lung biopsy, pleural biopsy, dorsal sympathectomy, pleurodesis. internal mammary ariery dissection for coronary artery bypass, coronary artery bypass grafting where endoscopic visualization is indicated and examination of the evacuated cardiac chamber during performance of valve replacement.

The Stryker Medical Video Camera System consists of a camera control unit (CCU) and a camera head with an integral cable that connects to the CCU.

The System is AC powered and is designed to meet international medical device standards (IEC 601-1, UL 2601, & CSA 22.2) to provide safe operation and eliminate or minimize the risk of fire, electrical shock, and electromagnetic interference that may be associated with it.

The provided text is a 510(k) premarket notification for the Stryker Endoscopy Model 888 Video Camera. It focuses on establishing substantial equivalence to a predicate device based on intended use and technical characteristics, rather than presenting a formal study with acceptance criteria and performance metrics in the way a clinical study for a drug or a novel AI diagnostic would.

Therefore, many of the requested categories are not applicable or not explicitly stated in this type of submission.

Here's a breakdown based on the information available:

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

Important Note: This 510(k) summary focuses on demonstrating substantial equivalence to a legally marketed predicate device. This process typically relies on comparing intended use, technological characteristics, and performance data if available, to show that the new device is as safe and effective as the predicate. It does not usually involve setting new, independent acceptance criteria and then conducting a novel study against those criteria in the same way a new drug or a novel AI algorithm might. The "performance" here is largely inferred from the equivalence claim and compliance with relevant standards.

Regarding the specific study questions:

• 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
  • Not applicable / Not explicitly stated. This document does not describe a clinical performance study with a test set of data. The "study" mentioned is the comparison for substantial equivalence.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
  • Not applicable / Not explicitly stated. No ground truth establishment by experts for a test set is described.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
  • Not applicable / Not explicitly stated. No test set requiring annotation or adjudication is mentioned.
• 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. This is a hardware device (video camera), not an AI-powered diagnostic. An MRMC study is not relevant to this submission.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
  • No. This is a hardware device; standalone algorithm performance is not applicable.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
  • Not applicable / Not explicitly stated. For a medical video camera, ground truth typically relates to image quality and functionality, which would be assessed through technical specifications and usability evaluations, rather than a clinical ground truth like pathology for a diagnostic device.
• 8. The sample size for the training set
  • Not applicable / Not explicitly stated. No training set for an algorithm is relevant to this submission.
• 9. How the ground truth for the training set was established
  • Not applicable / Not explicitly stated. No training set is relevant.

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