(196 days)
The Schott Light Guide Cable is indicated for use in transmitting light for illumination purposes from an illuminator to various instruments such as headlights, microscopes and endoscopes, providing illumination in body cavities during examinations or surgical procedures.
The Light guide cable consists of glass fibers which are glued or fused into ferrules on both ends. The ends are polished to effectively transmit light and are equipped with standard endoscope connectors to transmit visible light from the light source to the intended instrument. The fibers are covered by Silicone sheathing for ease of handling and protecting the fibers from damage. The device is intended to be Ethylene Oxide (EtO) sterilized by the user. Sterilization information is contained in section 14.
This looks like a 510(k) premarket notification for a Light Guide Cable, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria for a new, innovative device. Therefore, much of the requested information (like efficacy studies, sample sizes for test and training sets, number of experts for ground truth, MRMC studies, etc.) is not typically included in such a submission.
Here's a breakdown of what can be extracted and what cannot:
1. Table of acceptance criteria and reported device performance:
This document does not provide a table with specific quantitative acceptance criteria (e.g., minimum light transmission efficiency, specific durability metrics) and corresponding reported performance values. The performance testing is described at a high level.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Electrical safety | Conforms to appropriate FDA Recognized Consensus Standards |
| Sterilization validation | Conforms to appropriate FDA Recognized Consensus Standards |
| Substantial Equivalence to Predicate Device (Isolux America K991208) in: | Demonstrated based on intended use, typical clinical use, and operational and fundamental technological characteristics. Any differences do not affect safety or effectiveness. |
| Function: Transmit light for illumination | Successfully transmits visible light from light source to intended instrument. |
| Design: Glass fibers, ferrules, polished ends, silicone sheathing | Meets design specifications. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document states "performance testing includes electrical safety testing and sterilization validation." This typically involves a defined number of units for testing, but the specific sample size, especially for comparing performance metrics against a predicate, is not detailed.
- Data Provenance: Not applicable in the context of device performance data for a 510(k) of this type. Performance testing is done in a lab setting by the manufacturer, not from clinical patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This device is a light guide cable, not a diagnostic or AI-driven device requiring expert-established ground truth for its performance assessment in a clinical context. Its performance is evaluated through engineering and sterilization tests.
4. Adjudication method for the test set:
Not applicable. There's no adjudication needed as it's not a diagnostic or classification task.
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 a physical medical device (a cable), not an algorithm.
7. The type of ground truth used:
- Technical Specifications/Standards: The "ground truth" for electrical safety and sterilization validation would be the relevant FDA Recognized Consensus Standards (e.g., IEC standards for electrical safety, ISO standards for sterilization).
- Predicate Device Characteristics: For substantial equivalence, the characteristics of the Isolux America K991208 Endoscopic Fiber Optic Cable serve as the de facto "ground truth" for comparison.
8. The sample size for the training set:
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable.
§ 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.