(93 days)
Transmission of light energy from the light source to an optical instrument.
The light-guide cable is used to transmit light during endoscopic procedures or for other medical illumination application when the properties and operating instructions are complied with.
The light-guide cable is designed for use with halogen, xenon or LED based light which are utilized in medical applications that involve endoscopes, medical instruments or microscopes.
The Olympus Light-Guide Cables that are subject to this submission are intended to transmit light from the light source to an optical instrument. For that purpose the Light-Guide Cable includes a bundle of optical fibers as transmission medium. The light guide adapters are intended for the mechanical connection of the Light-Guide Cables to light sources or to endoscopes.
There are two variants of Light-Guide Cables which differ according to the shaft diameter of the connected endoscope. Cable WA03300A (2.8 mm, 3 m, CF type) can be combined with endoscopes, which have a diameter ≤ 4.1mm. Endoscopes with a diameter > 4.1mm are combined with WA03310A (4.25 mm, 3 m, CF type). Otherwise the Light-Guide Cables are identical.
This document describes the FDA's 510(k) clearance for Olympus Light-Guide Cables. The core of this submission is to demonstrate substantial equivalence to a predicate device, not necessarily to provide full performance study details typical of a de novo device. Therefore, the specific information requested in the prompt, such as detailed acceptance criteria, sample sizes for test/training sets, expert qualifications, and effect sizes for human-in-the-loop studies, is largely not present in this type of regulatory document.
Here's an analysis of the provided text based on your request:
Acceptance Criteria and Reported Device Performance
The document states, "The Light-Guide Cables comply with all applicable requirements/standards as listed in Appendix IIIc of this submission." However, Appendix IIIc is not provided, so the specific acceptance criteria and their corresponding reported device performance values are not detailed in this text.
The document also mentions that "the design of the subject device Light-Guide Cables is identical to that of the predicate devices" with "minor design modifications." It asserts that these differences "do not negatively impact safety or effectiveness" and "do not raise different questions of safety or effectiveness."
Based on the provided text, a table of acceptance criteria and reported device performance cannot be fully constructed. The document primarily relies on the substantial equivalence to a predicate device that has been "used safely and effectively for years," and compliance with general safety standards.
The closest we get to "reported performance" is the mention of electrical safety testing and reprocessing validation.
| Acceptance Criteria Category | Reported Device Performance (Summary from text) | Specific Criteria Values |
|---|---|---|
| Electrical Safety | Complies with ANSI AAMI ES60601-1:2005/(R)2012 and IEC 60601-2-18: Edition 3.0 2009-08 | Not specified in document |
| Reprocessing Effectiveness | Validated Sterilization methods: Hydrogen peroxide plasma sterilization (Sterrad 100S, Sterrad NX, Sterrad 100NX), Steam Sterilization (Autoclave, prevacuum) and Vaporized hydrogen peroxide (Steris V-PRO maX, Steris V-PRO maX 2, Steris V-PRO s2 and Steris V-PRO 60). Expected service lifetime of 400 reprocessing cycles. | Specific validation criteria (e.g., sterility assurance level, material degradation limits) not specified in document |
| Material Compatibility (Outer tube) | Same materials as predicate: Silicone | Specific material properties/pass/fail criteria not specified in document |
| Material Compatibility (Connector) | Same materials as predicate: Stainless steel | Specific material properties/pass/fail criteria not specified in document |
| Non-Patient Contact | Both devices are not in patient contact and have no patient contacting materials. | Implicitly met by design |
| Light Transmission Effectiveness | "The light-guide cable includes a bundle of optical fibers as transmission medium...The ends are polished to transmit light." | Specific light output, attenuation, or efficiency metrics not specified, assumed equivalent to predicate. |
| Mechanical Protection | Subject device has "additional inner stainless steel wire for better mechanical protection". | Specific mechanical robustness criteria not specified, implied improvement over predicate. |
Study Information (Based on provided text)
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a separate "test set" in the context of a new performance study. The document states that because the devices are substantially equivalent and the predicate has been used for years, "it was not considered necessary to re-test the performance of the Light-Guide Cables concerned." However, "complete evidence of the performance test records is included in this submission" (referenced in Appendix 12a-e, which is not provided).
- Data Provenance: Not specified. Given the reliance on predicate device history and general standards compliance, no specific new clinical data is presented here.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No new "ground truth" was established for a new clinical test set as the submission relies on substantial equivalence and existing predicate safety/effectiveness.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no new clinical test set requiring adjudication for ground truth was conducted.
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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 passive light-guide cable, not an AI-assisted diagnostic or therapeutic device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-based device. Physical bench testing was likely done for electrical safety and reprocessing validation, but not a "standalone algorithm" performance.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the aspects that were tested (Electrical Safety, Reprocessing), the "ground truth" would be the established international and national standards (e.g., ANSI AAMI ES60601-1, IEC 60601-2-18) against which the device's electrical performance was measured, and validated sterilization protocols for reprocessing.
- For the overall device, the "ground truth" for safety and effectiveness is largely based on the predicate device's established use history and compliance with general device regulations.
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The sample size for the training set: Not applicable. This is a physical medical device, not an AI model requiring a training set.
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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.