(27 days)
The Designs for Vision Fiberoptic Light is indicated for use in surgery and medical applications where high intensity illumination is required.
The Designs for Vision Fiberoptic Light is composed of a high intensity light source, fiberoptic cables, and fiberoptic headsets. The Designs for Vision headsets have been marketed since the early 1970s with a long history of safe use in the surgical suite. The headsets are coaxial, bifurcated, or focusable designs.
The light source includes a chuck for fiberoptic cable attachment. The Light source provides a 150-watt power output and contains a continuous illumination level adjustment, which provides 3200 K color temperature light.
The provided text is a 510(k) summary for the Designs for Vision Fiberoptic Light. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain the detailed information required to describe acceptance criteria and a study proving those criteria are met in the format requested.
Specifically, the document states: "Testing has been performed which demonstrates the electrical safety and electromagnetic compatibility characteristics of the Designs for Vision Fiberoptic Light." but it does not provide any specifics about this testing, performance outcomes, or acceptance criteria.
Therefore, I cannot populate the requested table and answer the study-specific questions based on the provided text.
Here is what I can extract based on the available information, noting the significant gaps:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Electrical Safety | (Not specified in document) | "demonstrates the electrical safety" |
| Electromagnetic Compatibility (EMC) | (Not specified in document) | "demonstrates the electromagnetic compatibility characteristics" |
| Intended Use | High intensity illumination required for surgery and medical applications | Device is indicated for this use and has "similar technological characteristics" to predicate devices. |
Missing Information for Table:
- Specific quantitative or qualitative acceptance criteria for electrical safety and EMC.
- Detailed performance results for each criterion.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size (Test Set): Not specified.
- Data Provenance: Not specified.
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 as the document does not describe a study involving expert-established ground truth for a test set. The validation seems to be primarily through regulatory compliance and substantial equivalence to existing devices.
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
- No MRMC or AI-assisted study is mentioned. This device is a fiberoptic light, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable (see point 5).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. The "ground truth" for this device appears to be functional safety (electrical, EMC) and meeting its intended purpose as a light source, likely assessed through engineering tests and comparison to predicate devices, rather than a diagnostic performance ground truth.
8. The sample size for the training set
- Not applicable. This device is not an AI/machine learning model that would require a training set.
9. How the ground truth for the training set was established
- Not applicable (see point 8).
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.