(88 days)
Endoscopic video camera to transmit an image from an endoscope or arthroscope to a remotely located video monitor
- Power source
- Video board
- Camera head holding video chip
- Camera cable
- 628 lines resolution
- 0.9 lux minimum illumination
- ½" CCD lens
- +6 dB pre-signal conditioning
- Automatic iris 1:16000S
100 - 240V ± 10% 0 - 440H,
Here's a breakdown of the acceptance criteria and study information for the Corin Endocam & Daycam, based on the provided text.
Note: The provided document is a 510(k) summary from 1996. It details a submission for substantial equivalence, not a robust clinical trial with detailed acceptance criteria and performance metrics as understood in modern medical device submissions for AI or diagnostic devices. Therefore, much of the requested information (like sample sizes, ground truth establishment, expert qualifications, MRMC studies) is not available in this type of document for this era of device approval. The "acceptance criteria" here are essentially the technical specifications that need to be met for substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Set by Comparison Device - Dyonics Digital video camera system) | Reported Device Performance (Corin Endocam & Daycam) |
|---|---|
| Power source specifications | 100 - 240V ± 10% 0 - 440H, |
| Controls | Not explicitly detailed, but stated as "substantially equivalent" |
| Functions | Not explicitly detailed, but stated as "substantially equivalent" |
| Output | 628 lines resolution |
| Iris control | Automatic iris 1:16000S |
| Iris shutter speed | Not explicitly detailed, but stated as "substantially equivalent" |
| Light requirement (minimum illumination) | 0.9 lux minimum illumination |
| CCD lens size | ½" CCD lens |
| Pre-signal conditioning | +6 dB pre-signal conditioning |
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 for Test Set: Not applicable. This submission relies on technical specifications for substantial equivalence to a legally marketed device, not a test set of data or cases in the way a modern diagnostic or AI device would.
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set
- Adjudication Method: Not applicable.
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
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is an endoscopic video camera, and AI assistance was not relevant for its approval in 1996.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: No, a standalone performance study as described (for an algorithm) was not done. This device is a camera, and its performance is measured by its technical output specifications, not an algorithm's diagnostic accuracy.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not applicable. The "ground truth" for this substantial equivalence claim is the technical specifications and performance of the predicate device (Dyonics Digital video camera system). The Corin Endocam & Daycam needed to demonstrate that its technical specs and functionality were comparable.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This device does not use an algorithm that requires a training set.
9. How the ground truth for the training set was established
- How Ground Truth for Training Set was Established: Not applicable.
§ 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.