(61 days)
The Fiber Optic Endoillumination Probe is indicated for intraocular illumination in vitreoretinal surgery.
The Fiber Optic Endoillumination Probe is provides intraocular illumination. The light is transmitted from the source to the inside of the eye through a flexible optical fiber, which has been threaded through an illumination probe.
The provided text is a 510(k) summary for the MicroVision, Inc. Fiber Optic Endoillumination Probe. It does not describe an "acceptance criteria and the study that proves the device meets the acceptance criteria" in the typical sense of a clinical or performance study with defined metrics. Instead, this document focuses on demonstrating substantial equivalence to a predicate device.
Therefore, many of the requested elements for a study that "proves the device meets acceptance criteria" are not applicable or cannot be extracted from this document, as it's not a report of such a study.
Here's an analysis based on the provided text:
1. Table of acceptance criteria and the reported device performance
The document doesn't define quantitative acceptance criteria for performance; instead, it establishes equivalence based on descriptive characteristics.
| Comparison Criteria | Acceptance Criteria (Implicit for Equivalence) | Reported Device Performance (MicroVision Fiber Optic Endoillumination Probe) |
|---|---|---|
| Device Type: Fiber Optic Probe | Must be a Fiber Optic Probe | Yes |
| Indication: Intraocular illumination in vitreoretinal surgery | Must be indicated for intraocular illumination in vitreoretinal surgery | Yes |
| Patient Contact Materials | Must use PMMA, fluoropolymer fiber, and medical grade Surgical stainless steel | Yes (PMMA and fluoropolymer fiber and medical grade Surgical stainless steel) |
| Sterilization Method | Must have a validated sterilization method | Validated ETO |
| Packaging | Must have validated packaging | Validated Heat Sealed Tyvek |
Study Details (Not Applicable/Cannot be Extracted from a 510(k) Summary for Substantial Equivalence):
The 510(k) summary is a premarket notification to demonstrate substantial equivalence, not a detailed report of a performance study with specific acceptance criteria in the sense of clinical trial outcomes or detailed engineering specifications. It relies on comparing descriptive and technological characteristics to a legally marketed predicate device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. This document describes the device itself and its comparison to a predicate, not a performance study on a test set. There is no mention of a "test set" of patients or data.
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. Ground truth establishment for a test set is not relevant to a 510(k) substantial equivalence submission for this type of device. The "ground truth" here is essentially the characteristics of the predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set or adjudication process is described.
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 device is a fiber optic endoillumination probe, a physical medical device for illumination during surgery, not an AI or diagnostic imaging device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical surgical tool, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the purpose of substantial equivalence: The "ground truth" is the established characteristics and performance of the predicate device (Infinitech, Inc. Fiber Optic Probe, K870942). The claim is that the new device is functionally identical or very similar.
8. The sample size for the training set
- Not applicable. There is no training set mentioned, as this is not a machine learning or AI device.
9. How the ground truth for the training set was established
- Not applicable. No training set is involved.
§ 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.