(90 days)
The TruView Light Cable is intended to provide surgical site illumination from a fiber optic light source.
The TruView Light Cable is a fiber optic surgical light designed to be compatible with a variety of fiber optic light sources.
The provided text describes the submission of a 510(k) premarket notification for a medical device called the "TruView Light Cable" and its variants. This document does not describe a study involving an AI/Machine Learning device or a diagnostic algorithm. Instead, it focuses on the substantial equivalence of a physical medical device (a fiber optic light cable) to existing predicate devices.
Therefore, many of the requested criteria related to AI/ML model performance, such as sample sizes for training/test sets, expert adjudication, MRMC studies, standalone algorithm performance, and ground truth establishment for AI models, are not applicable to this document.
However, the document does contain information about performance testing for the physical device. Here's a breakdown of the relevant information provided:
1. A table of acceptance criteria and the reported device performance:
The document states that the TruView Light Cable was subjected to three performance tests and "met the acceptance criteria for the testing performed." While specific numerical acceptance criteria and performance values are not explicitly detailed in a table, the document lists the types of tests and their purpose:
| Test Name | Purpose | Reported Performance |
|---|---|---|
| Fit Test | To show that the cable is compatible with the retractor. | Met acceptance criteria. |
| Collateral Heating Test | To show that the cable, when used with the identified light source, does not pose a risk to the surgeon or operating room users (burn/injury to user). | Met acceptance criteria. |
| Intensity Test | To show that the cable, when used with the identified light source and the worst-case retractor blade configuration, does not pose a risk to the patient (burn/patient injury). | Met acceptance criteria. |
2. Sample sizes used for the test set and the data provenance:
- Sample Size: Not specified. The document simply states "three (3) performance tests." It does not indicate the number of units tested for each performance test.
- Data Provenance: Not specified regarding "country of origin of the data" or "retrospective/prospective." This testing would typically be prospective, in-house laboratory testing of the manufactured devices.
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):
- Not Applicable. This is a physical device performance test, not a diagnostic algorithm requiring expert interpretation of medical images or data. Ground truth would be defined by engineering specifications and objective measurements (e.g., temperature, fit, light intensity).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. See point 3.
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-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For a physical device like a light cable, the "ground truth" would be established by engineering specifications, regulatory standards, and objective measurements.
- For the Fit Test: Successful mechanical coupling and operation.
- For the Collateral Heating Test: Temperature measurements staying below defined safety thresholds for burns.
- For the Intensity Test: Light intensity measurements meeting efficacy requirements while staying below defined thresholds to prevent patient injury.
8. The sample size for the training set:
- Not Applicable. This is not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established:
- Not Applicable. See point 8.
§ 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.