(10 days)
The Zimmer MIS Light is intended to provide surgical site illumination from a high intensity light source.
The Zimmer MiS Light consists of fiber optic cables contained within silicone tubing which can be connected on one end to a hospital provided light source and to a Zimmer surgical access instrument on the other end. Light is transmitted from the hospital light source through the cable directly to the surgical site. the Zimmer MIS Light is provided sterile for single-use only. The Light was tested for compatibility with different types of light sources ranging from 150 Watts to 300 Watts.
This document describes the 510(k) submission for the Zimmer® MIS Light. This device is a fiber optic cable intended to provide surgical site illumination. The submission focuses on demonstrating substantial equivalence to a predicate device, the NuVasive MaXcess Light Guide (K042034), rather than establishing new performance criteria through extensive clinical studies.
Therefore, many of the typical sections related to device performance, such as a detailed table of acceptance criteria, sample sizes for test sets, expert consensus, and MRMC studies, are not directly applicable or explicitly stated in this type of submission.
Here's an analysis based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table with specific quantitative acceptance criteria or detailed performance results in the way one might expect for a diagnostic or AI-driven device. Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to a legally marketed predicate device.
The reported device "performance" is described in terms of its technological characteristics, which are stated to be the same as the predicate device:
| Acceptance Criteria (Implicit from Substantial Equivalence to Predicate) | Reported Zimmer® MIS Light Performance |
|---|---|
| Similar design to predicate device | Shares "similar design" with predicate device. |
| Similar technical requirements to predicate device | Shares "similar technical requirements" with predicate device. |
| Similar materials to predicate device | Shares "similar materials" with predicate device. |
| Similar intended use to predicate device | "Intended Use: The Zimmer MIS Light is intended to provide surgical site illumination from a high intensity light source." This is consistent with the predicate's intended use. |
| Compatibility with common light sources | "The Light was tested for compatibility with different types of light sources ranging from 150 Watts to 300 Watts." (This is a specific functional test mentioned.) |
| Provided sterile for single-use | The Zimmer MIS Light is "provided sterile for single-use only." |
2. Sample size used for the test set and the data provenance
The document does not describe a "test set" in the context of a clinical performance study with human data. The "testing" mentioned is likely engineering verification and validation (V&V) related to compatibility and functionality. No human data or specific sample sizes for such tests are provided in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This type of submission for a surgical light guide does not involve establishing ground truth from experts on clinical interpretations or diagnoses.
4. Adjudication method for the test set
Not applicable. There is no mention of a test set requiring adjudication.
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. The Zimmer® MIS Light is a passive surgical illumination device, not an AI-assisted diagnostic tool or an imaging device requiring human reader interpretation. Therefore, 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
Not applicable. This device does not involve an algorithm.
7. The type of ground truth used
Not applicable in the context of clinical outcomes or expert consensus for diagnosis. The "ground truth" for this device would be its ability to physically transmit light effectively and safely, which is assessed through engineering testing and comparison to the predicate's established performance.
8. The sample size for the training set
Not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. There is no training set.
§ 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.