FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The Stryker Endoscopy Q-5000 light source is used to illuminate the site of surgery during minimally invasive surgical procedures in arthroscopy (orthopedic surgery), laparoscopy (general and gynecological surgery), and endoscopy (general, gastroenterological and ENT surgery). The light is transmitted from the source through an optical cable and a scope. The light source is an integral component of a visualization system which consist of the a video camera, a video monitor, a light cable and a scope.

The Q-5000 light source is AC powered and is designed to meet international medical devices safety standards (IEC 601-1, UL, CSA) to provide safe operation and eliminates or minimizes risks of burns, fire, explosion eye damage, electromagnetic interference or electrical shock that may be associated with it.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device, specifically the Stryker Endoscopy Q-5000 light source. It's a regulatory submission, not a study report.

Therefore, the prompt's request for detailed information regarding acceptance criteria, study design, sample sizes, expert qualifications, ground truth establishment, and effect sizes cannot be fulfilled from the provided text.

Here's why and what information can be extracted:

No "acceptance criteria" in the traditional sense of AI/Algorithm performance: This document is about a manufactured physical device (a light source), not an algorithm or AI. Its "acceptance" is based on regulatory clearance for manufacturing and marketing, not on performance metrics like sensitivity, specificity, AUC, or reader improvement.
No "study" in the sense of a clinical trial proving performance: The document states "The Stryker Endoscopy Q-5000 light source is substantially equivalent to the Circon-ACMI MV9082 light source and raises no additional safety or effectiveness issues." This is a key part of 510(k) submissions. Instead of conducting new clinical trials, manufacturers demonstrate that their new device is "substantially equivalent" to a device already legally marketed (the "predicate device"). This avoids the need for extensive, new clinical studies.
No "device performance" in terms of clinical outcomes: The performance described relates to its function (illuminating the surgical site) and safety (meeting standards to prevent burns, fire, etc.).

Information that can be extracted or inferred from the text related to the prompt's categories:

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria (Implied by 510(k) process): Substantial equivalence to a predicate device and adherence to relevant safety standards.
- Reported Device Performance:
  - Function: Illuminates the site of surgery during minimally invasive surgical procedures.
  - Safety: Designed to meet international medical device safety standards (IEC 601-1, UL, CSA) to eliminate or minimize risks of burns, fire, explosion, eye damage, electromagnetic interference, or electrical shock.
  - Equivalence: Substantially equivalent to the Circon-ACMI MV9082 light source.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable. No test set or data provenance in the context of clinical performance evaluation is mentioned, as this is a substantial equivalence claim for a physical device.
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. No ground truth establishment for a test set is mentioned. The ground truth for this type of submission is the regulatory standard and the performance of the predicate device.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No test set or adjudication process for clinical performance is mentioned.
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 a light source, not an AI or diagnostic tool that assists human readers. No MRMC study was performed or is relevant here.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical light source, not an algorithm.
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Primary Ground Truth: Regulatory standards (IEC 601-1, UL, CSA) and the established safety and effectiveness of the predicate device (Circon-ACMI MV9082 light source). Historical use of light sources ("Light sources have been used in endoscopic surgical procedures for at least 15 years. They have been safe and effective...") also serves as a basis for general safety and effectiveness claims.
The sample size for the training set:
- Not applicable. No training set for an algorithm is mentioned.
How the ground truth for the training set was established:
- Not applicable. No training set is involved.

In summary, this document is a regulatory filing for a medical device that relies on the concept of "substantial equivalence" to a predicate device, rather than a clinical study evaluating novel performance through a test set and ground truth.

Summary

Regulation Number and Section

§ 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.