(64 days)
The Stryker Spine LITe® Decompression System - Light Cable is intended to provide surgical site illumination from a high intensity light source when Stryker decompression tubes are in use.
The Stryker Spine LITe® Decompression System - Light Cable is a single use, sterile and disposable component. The Stryker Spine LITe® Decompression System - Light Cable consists of fiber optic cables contained within silicone tubing which can be connected to a light generator on one end and the tube of the Stryker Spine LITe® Decompression System on the other end.
This 510(k) summary is for the Stryker Spine LITe® Decompression System - Light Cable, which is a fiber optic light cable intended to provide surgical site illumination. The document focuses on establishing substantial equivalence to predicate devices and does not describe a study involving performance metrics for AI or machine learning algorithms. Therefore, many of the requested details about acceptance criteria, study design, and ground truth establishment are not applicable.
Here's an analysis based on the provided text, indicating where information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not contain specific acceptance criteria and detailed performance metrics in the way one would expect for an AI/ML device. Instead, it relies on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use. The "performance" described is in comparison to the predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Technological Characteristics: | The LITe® Decompression System - Light Cable shares the same technological characteristics as the predicate devices: similar design, technical requirements. |
| Intended Use: | The LITe® Decompression System - Light Cable is intended to provide surgical site illumination from a high intensity light source when Stryker decompression tubes are in use. This matches the function implied by similar predicate devices (NuVasive MaXcess Light Guide, Zimmer MIS Light). |
| Material & Safety (Implicit in Substantial Equivalence): | The device is a "single use, sterile and disposable component." Safety and biocompatibility are implicitly addressed through comparison to legally marketed predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not applicable. The device is a physical medical device (fiber optic light cable), not an AI/ML algorithm that processes data. Therefore, there is no "test set" of data in the context of AI/ML evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable, as there is no "ground truth" establishment in the context of an AI/ML test set. The evaluation is focused on the device's physical design, materials, and intended function compared to existing legally marketed devices.
4. Adjudication Method for the Test Set
This information is not applicable. There is no "adjudication method" for a test set as would be used for AI/ML performance evaluation. The substantial equivalence determination is made by the FDA based on the provided comparisons to predicate devices.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size of human readers' improvement with AI vs without AI assistance
This information is not applicable. The device is a surgical light cable, not an AI system. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed or is relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) study was done
This information is not applicable. The device is a physical light cable, not an algorithm.
7. The Type of Ground Truth Used
This information is not applicable. As stated, there is no "ground truth" in the context of AI/ML evaluation for this device. The evaluation relies on comparing the device's technical specifications and intended use against predicate devices.
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical product, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. As there is no training set for an AI/ML algorithm, there is no ground truth to establish for it.
§ 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.