(87 days)
The Stryker Knifelight is a manual surgical instrument used for the release of the carpal tunnel ligament. It features an integrated light source to illuminate the surgical site which 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 device 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 device has integral protective retractors which provide for additional protection of the surrounding tissue during surgery. The Knifelight consists of two integrated components: a handpiece that acts as a power source that is connected to a blade assembly. They are sold as one device.
The provided text is for a K100884 510(k) submission for the Stryker Knifelight, which is a medical device (a lighted surgical knife), not an AI algorithm or a diagnostic tool that would typically involve acceptance criteria and a study to prove its performance in the way described in the prompt.
Therefore, much of the requested information (like performance metrics, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for training sets) is not applicable to this type of device and submission.
The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific quantitative acceptance criteria through a clinical study for a new AI algorithm.
However, I can extract the relevant information from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
This submission is for a labeling change and a legal manufacturer location change for an existing device. The primary method of demonstrating safety and effectiveness for a 510(k) for such changes is substantial equivalence to a predicate device, not through specific performance metrics against pre-defined acceptance criteria in the way an AI algorithm would be evaluated.
Therefore, there are no specific numerical acceptance criteria or reported device performance metrics in the provided text. The "performance" is implicitly deemed equivalent to the predicate device.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not applicable (device is a surgical instrument, not an AI/diagnostic tool evaluated against specific performance metrics). The focus is on substantial equivalence to a predicate device for minor changes. | Not applicable (no new performance data is presented for this type of submission). The device is considered substantially equivalent to the predicate. |
Regarding the study that proves the device meets acceptance criteria:
Based on the provided text, there is no study in the sense of a clinical trial or performance evaluation with specific data points to prove the device meets acceptance criteria. The submission is a 510(k) premarket notification focused on substantial equivalence for a labeling change and legal manufacturer location change.
The entire submission implicitly "proves" that the device still meets regulatory requirements (which are the implicit "acceptance criteria" here) because:
- It is substantially equivalent to a legally marketed predicate device (Stryker Knifelight, K961122).
- The proposed modifications (manufacturer location, disposal info, warnings, contraindications) do not alter the fundamental safety or effectiveness of the device that was previously cleared.
Breakdown of other requested information:
- 2. Sample size used for the test set and the data provenance: Not applicable. This is not a study involving a test set of data.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for a test set is mentioned.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No adjudication method for a test set 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: Not applicable. This is not an AI device, and no MRMC study is mentioned.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical surgical instrument, not an algorithm.
- 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. No ground truth established for a study.
- 8. The sample size for the training set: Not applicable. No training set is mentioned as this is not an AI/machine learning device.
- 9. How the ground truth for the training set was established: Not applicable. No training set or ground truth for it is mentioned.
§ 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.