(128 days)
The REMA Shaver Blades are intended to provide shaving, cutting and abrading of bone and tissue during arthroscopic surgical procedures conducted by qualified surgeons.
The REMA Shaver Blades consists of an outer tube with a hub and a rotating inner tube with a connector. The inner and outer tube consists of stainless steel. The hub and connector can consist of stainless steel or Polyphenylsulfone (PPSU). The components are designed and intended to be operated exclusively as a unit.
The provided text describes a 510(k) summary for REMA Shaver Blades, which is a medical device. However, the document does not contain any information regarding acceptance criteria, performance studies, sample sizes, expert involvement, or any of the other specific details requested in your prompt.
The document primarily focuses on:
- Identification of the device and applicant.
- Classification and proprietary names.
- Identification of predicate devices.
- Description of the device's components and materials.
- Intended use/indications.
- A general statement about safety and substantial equivalence based on material selection and similarity to predicate devices.
- The FDA's decision letter regarding substantial equivalence.
Therefore, I cannot provide the requested table and study details as they are not present in the given text.
The table below reflects that the requested information is not available in the provided document.
| Information Category | Details from provided document |
|---|---|
| 1. Acceptance Criteria and Device Performance | Not provided. The document states: "Biocompatibility, function, indications and designs have been developed to ensure the safety of this device and it is substantially equivalent to commercially approved shaver systems available for sale in the USA." No specific acceptance criteria or performance metrics are reported. |
| 2. Sample Size (Test Set) & Data Provenance | Not provided. No performance study is described. |
| 3. Number & Qualifications of Experts | Not provided. No performance study involving experts for ground truth is described. |
| 4. Adjudication Method | Not provided. No ground truth adjudication process is described. |
| 5. MRMC Comparative Effectiveness Study | No. This device is a surgical tool, not an AI or imaging diagnostic device where MRMC studies are typically conducted. No such study is mentioned. |
| 6. Standalone Algorithm Performance | No. This device is a physical surgical tool, not an algorithm. No standalone performance study is described. |
| 7. Type of Ground Truth Used | Not applicable. No ground truth was established as no performance study is described. The approval is based on substantial equivalence to predicate devices and material biocompatibility. |
| 8. Sample Size for Training Set | Not applicable. This is a physical device, not an AI model requiring a training set. |
| 9. Ground Truth for Training Set | Not applicable. This is a physical device, not an AI model requiring a training set. |
§ 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.