(35 days)
Operative and Diagnostic Cystoscopy for visual imaging and light transmission.
Cystoscopes
The provided 510(k) submission for the Medifix Inc. Cystoscopes is very brief and lacks detailed information regarding specific performance testing and acceptance criteria. It primarily focuses on demonstrating substantial equivalence to older predicate devices through design comparisons.
Here's an attempt to answer your questions based only on the provided text, highlighting where information is absent:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance | Comments |
|---|---|---|
| Safety and Effectiveness | "as safe and effective as all other devices earlier and currently on the market" | This is a general claim of equivalence, not a specific, quantifiable criterion. No performance metrics are provided. |
| Mechanical Stress Testing | "extense mechanical...stress testing to assure safe and long term use." | No specific thresholds (e.g., force, cycles) or measured outcomes are provided. |
| Thermic Stress Testing | "extense...thermic stress testing to assure safe and long term use." | No specific temperature ranges, durations, or measured outcomes are provided. |
| No Adverse Health Effects | "We are not able to determine any adverse health effects compared to the already marketed devices and can not imagine any possibility of this kind." | This is a declarative statement, not a result of a specific test with predefined acceptance. |
| Material/Component Equivalence | "designs, lens-systems, materials, glues and epoxies are commonly used by the endoscope industry." | This implies an acceptance criterion of using established components, but no performance data for these components in the prototype is reported. |
| Substantial Equivalence to Predicate | "found substantial equivalence in all significant details" compared to R. Wolf devices. | This is a conclusion of the comparison, not a performance metric of the device itself. Specific details of the comparison that constituted "significant details" are not provided. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The document mentions "Cystoscope prototypes" but does not indicate how many prototypes were tested or how many individual test units were subjected to "extensive mechanical and thermic stress testing."
- Data Provenance: Not specified. The data would be prospective, as it involves testing their own prototypes. However, the location or specific conditions of the testing are not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The document only states "We compared our Cystoscope prototypes in detail to much older equipment..." implying internal assessment, but no details on who performed this assessment or their qualifications.
4. Adjudication method for the test set
- Adjudication Method: Not specified. It appears that the assessment was internal ("We compared..."), implying no formal external adjudication process.
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. This device is a passive optical instrument (cystoscope), not an AI-powered diagnostic tool. Such a study would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: The "ground truth" for the performance testing appears to be comparison to established, predicate devices. The submission states they compared their prototypes to "much older equipment, manufactured by R.Wolf and other Manufacturers" and concluded they are "as safe and effective." For the design comparison, the "ground truth" was the "manufacturing drawings with corresponding devices from R.Wolf." There is no mention of expert consensus, pathology, or outcomes data.
8. The sample size for the training set
- Sample Size for 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
- Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.
§ 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.