(90 days)
Richard Wolf endoscopes for use in plastic surgery, are designed to visualize anatomy through natural and recenture well and socked for ass ar processors) may be used to visualize subcuraneous tissue when the indicated application is endoscopic plastic/reconstructive surgery.
The Richard Wolf Endoscopes have 4mm, 7mm, and 10mm diameters with working lengths ranging from 190mm to 300 mm. They have a viewing direction of 0°, 25°, and 50°. The eyepieces are fixed or detachable, depending upon the specific model.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Panoview Telescopes:
Based on the provided 510(k) summary, there is no specific acceptance criteria or study that proves the device meets such criteria in the traditional sense of a performance study with quantitative results.
The document states: "These devices are designed and tested to guarantee the safety and effectiveness, when used according to the instruction manual." However, it explicitly states "6.0 Clinical Tests None" and provides no performance data or detailed study information.
Instead, the submission relies on the concept of substantial equivalence to predicate devices. This means that Richard Wolf Medical Instruments Corp. is claiming their Panoview Telescopes are as safe and effective as devices already on the market (the predicate devices).
Therefore, I cannot populate most of the requested table and study-related information as it is not present in the provided text.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
No specific quantitative acceptance criteria or reported device performance metrics (e.g., sensitivity, specificity, accuracy, precision, recall) are provided in this submission. The basis for clearance is substantial equivalence, not a direct performance study against defined criteria.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| None explicitly stated as quantitative targets. The implied "acceptance" is that the device is substantially equivalent in terms of safety and effectiveness to predicate devices. | None explicitly stated as quantitative results. The submission relies on the assertion that the device design and testing, in conjunction with substantial equivalence to legally marketed devices, ensures safety and effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. No performance study with a test set was conducted or reported.
- Data Provenance: Not applicable. No performance data was generated from a test set.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. No performance study with a test set requiring ground truth was conducted or reported.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. No performance study with a test set requiring adjudication was conducted or reported.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The document explicitly states "6.0 Clinical Tests None."
- Effect Size of Human Reader Improvement: Not applicable, as no MRMC study was conducted.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study
- Standalone Study: Not applicable. The device is an optical endoscope, not an AI algorithm. Its performance is inherent in its optical and mechanical design, which is assessed through substantial equivalence to existing devices, not through an "algorithm-only" study.
7. Type of Ground Truth Used
- Type of Ground Truth: Not applicable. No performance study was conducted that would require a ground truth. The "ground truth" for this 510(k) submission is the established safety and effectiveness of the predicate devices based on their prior clearance and market history.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. The device is an optical instrument, not a learning algorithm or AI. There is no concept of a "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth Was Established: Not applicable, as there is no training set for this type of device.
Summary of Basis for Clearance (Based on Provided Text):
The Richard Wolf Panoview Telescopes received 510(k) clearance based on Substantial Equivalence to legally marketed predicate devices. The submission asserts that the devices are "designed and tested to guarantee the safety and effectiveness" but does not provide specific performance data or clinical test results to support this beyond the claim of equivalence to already-cleared devices. The key elements cited for substantial equivalence are:
- The devices have the same intended use.
- Similar technological characteristics (though not deeply detailed or compared quantitatively).
- No clinical tests were deemed necessary for this submission.
§ 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.