(154 days)
The Stryker Knifelight is a manual surgical instrument used for the release of ligaments or other tissue including, but not limited to, the carpal tunnel ligament. It features an integrated light source to illuminate the surgical site. The Stryker Knifelight allows for a minimally open technique with minimal disturbance of surrounding tissue.
The Stryker Knifelight is a sterile, single use, completely disposable ligament and tissue release knife with an integrated light source. The light source is intended to provide improved visualization of tissues and ligaments inside areas with restricted view due to small incisions. During minimally open carpal ligament surgical release, this device will improve visualization of the carpal ligament, median nerve and functional ligaments and tendons. Additionally, the surgical blade has integral protective retractors which provide for additional protection of the surrounding tissue during surgery. A standard elevator may be available with the device to facilitate ligament or tissue division.
The provided text describes a surgical knife with an integrated light source, not an AI-powered device or a study involving acceptance criteria and performance metrics typically associated with AI. Therefore, most of the requested information regarding acceptance criteria, study details, ground truth, and AI-specific metrics cannot be extracted from the given document.
The document is a 510K Summary for the Stryker Knifelight, which focuses on demonstrating substantial equivalence to existing legally marketed devices.
Here's a breakdown of what can be inferred and what cannot, based on your request:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document does not describe specific acceptance criteria or performance metrics in a quantitative manner as would be done for an AI device (e.g., sensitivity, specificity, AUC). It focuses on substantial equivalence in terms of intended use, function, and safety risks.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. The document does not describe any specific "test set" or clinical study data in the context of device performance evaluation. It's a regulatory submission demonstrating equivalence, not a clinical trial report.
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)
- Cannot be provided. There is no mention of a "test set" or "ground truth" establishment by experts in the context of performance evaluation in this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided. No test set or adjudication method is described.
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
- Cannot be provided. This device is a manual surgical instrument, not an AI-powered system, so MRMC studies and AI assistance are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Cannot be provided. This is not an algorithm-only device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Cannot be provided. No clinical ground truth is established or discussed in this context. The "ground truth" for a 510K submission is typically that the device is demonstrably equivalent to a predicate device.
8. The sample size for the training set
- Cannot be provided. This device does not involve a training set as it's not an AI/machine learning product.
9. How the ground truth for the training set was established
- Cannot be provided. Not applicable.
Summary of the provided document:
The document is a 510K Summary for the Stryker Knifelight.
- Device Name: Stryker Knifelight
- Classification: Surgical Knife (Class I), Surgical Instrument Light (Class II)
- Intended Use: Manual surgical instrument for the release of ligaments or other tissue (e.g., carpal tunnel ligament), featuring an integrated light source for improved visualization and protective retractors for surrounding tissue.
- Regulatory Mechanism: Demonstrates substantial equivalence to existing marketed products (e.g., from Biomet and Medtronic) based on intended use, function, and safety risks.
- Conclusion: The device "does not raise any new safety and efficacy concerns when compared to similar legally marketed devices," thus establishing substantial equivalence.
§ 878.4580 Surgical lamp.
(a)
Identification. A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.(b)
Classification. Class II (special controls). The device, when it is an operating room lamp, a surgical instrument light, a surgical floor standing light, an endoscopic surgical light, a surgical light connector, a ceiling mounted surgical light, a surgical light carrier, surgical light accessories, a surgical lamp, a remote illuminator, or an incandescent surgical lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.