(253 days)
The RIWO Drive Generator with motor handle serves to drive Wolf Power Cutters and Burrs to remove tissue during endoscopic procedures.
Indication and field of application:
For therapy with endoscopic accessories:
- in arthroscopy, e.g., for resection of meniscus, for removal of soft tissue, as well as for intra-articular severing or abrading of bone tissue, e.g., ACL or shoulder procedures
- in sinus surgery, e.g. for removal of polyps
- in spine surgery (arthroscopic mirco disectomy (AMD), spinal endsoscopy)
The power Cutters and Burrs consist of a hollow, fenestrated tube, containing a rotating twoedged cylindrical blade (cutter) or an abrader (burr) that spins within the hollow tube. They are driven by a motor handle.
This document is a 510(k) summary for the "Power Cutters and Burrs for RIWO Drive System" and outlines the device's substantial equivalence to previously marketed devices rather than detailing specific acceptance criteria and a study to prove they are met.
Therefore, the requested information regarding acceptance criteria and a study proving the device meets them cannot be fully extracted as presented in this document. The document explicitly states:
- "No known performance standard exists."
- "No clinical tests were performed."
However, I can extract information related to the general claims of safety and effectiveness and the basis for substantial equivalence.
Here's an analysis of the provided text in relation to your request:
1. A table of acceptance criteria and the reported device performance
Based on the provided text, there are no specific quantitative acceptance criteria or reported device performance metrics in the format of a clinical study or performance testing with defined thresholds.
The document claims:
- "The submitted devices pose the same type of questions about safety or effectiveness as the compared devices. The new technological characteristics have not diminished safety or effectiveness."
- "These devices are designed and tested to guarantee the safety and effectiveness, when used according to the instructions manual."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for the test set: Not applicable (N/A) – No clinical tests were performed, and no performance data from a test set is presented.
- Data provenance: N/A – No clinical or performance data is presented.
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)
- N/A – No test set or ground truth establishment by experts is mentioned as part of device performance evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A – No test set or adjudication method is mentioned.
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
- N/A – No MRMC study or AI component is mentioned. This device is a mechanical instrument (cutters and burrs), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- N/A – This device is a mechanical surgical instrument, not an algorithm. Standalone performance as an algorithm is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- N/A – There is no mention of ground truth in the context of device performance evaluation tests. The primary basis for approval is substantial equivalence to predicate devices, which implies the predicate devices' established safety and effectiveness serve as an indirect "ground truth."
8. The sample size for the training set
- N/A – There is no mention of a training set as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- N/A – Not applicable.
Summary of what the document DOES state regarding "performance":
The approval is based on "substantial equivalence" to existing devices, meaning:
- "The submitted devices pose the same type of questions about safety or effectiveness as the compared devices."
- "The new technological characteristics have not diminished safety or effectiveness."
- The devices are "designed and tested to guarantee the safety and effectiveness, when used according to the instructions manual." (However, the specific "tests" are not detailed or quantified in this summary, and it's stated "No clinical tests were performed.")
The predicate device for substantial equivalence is:
- 510(k) Number: K970088
- Trade or proprietary or model name: RIWO Drive Generator w/ Footswitch, Motor Handles & Single Use Rotary Blades & Abraders
- Manufacturer: Richard Wolf GmbH
In conclusion, this 510(k) summary focuses on establishing substantial equivalence based on technological characteristics and intended use, rather than presenting a detailed study with acceptance criteria and measured performance outcomes for the device itself.
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.