(294 days)
The reprocessed arthroscopic shapers are accessories intended for use in arthroscopic procedures.
The devices that are the subject of this submission are used as accessories for shaping bone and soft tissue during arthroscopic procedures. They have a variety of names, such as shavers, burs, or trimmers, are made of a variety of materials, and come in many shapes and sizes. They come from several different original equipment manufacturers as single use devices. Reprocessing includes cleaning, refurbishing, testing, packaging, and sterilization. It allows the shapers to be used several times rather than just once.
The provided K012667 510(k) summary for "Reprocessed Arthroscopic Shapers" explicitly states that "Comparative performance testing and clinical evaluations were not included as part of this 510(k)." This means that a study proving the device meets acceptance criteria, as typically understood in a performance study with quantitative metrics, was not conducted or submitted for this particular clearance.
The basis for clearance was a demonstration of substantial equivalence to existing legally marketed predicate devices (the original single-use arthroscopic shapers) based on shared technological characteristics and intended use.
Therefore, many of the requested details about acceptance criteria, device performance, sample sizes, ground truth, and expert involvement are not available in the provided documents because a traditional performance study was not performed.
Here's a breakdown of the information that can be extracted from the provided text, and where gaps exist:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly defined in terms of quantitative performance metrics for the reprocessed device versus the original. The implicit acceptance criterion for this 510(k) pathway was that the reprocessed device would be "substantially equivalent" to the predicate device. This equivalence was based on technological characteristics and intended use, rather than a direct comparative performance study.
- Reported Device Performance: No specific quantitative performance metrics comparing the reprocessed device to the new device are reported. The submission states that the reprocessed device has identical materials, dimensions, geometry, method of use, and compatibility with arthroscopic systems as the original single-use shaper.
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. A specific performance "test set" as part of a comparative performance study was not conducted.
- Data Provenance: Not applicable.
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)
- Number of Experts/Qualifications: Not applicable. Ground truth for a comparative performance study was not established, as such a study was not conducted.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. No test set requiring expert adjudication was described.
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 surgical instrument, not an AI-powered diagnostic tool, so an MRMC study is not relevant or applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance: Not applicable. This is a surgical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not applicable. No performance study requiring ground truth was conducted. The "ground truth" for substantial equivalence was the design specifications and declared functionality of the original, single-use predicate devices.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This is a reprocessed medical device, not a machine learning algorithm.
9. How the ground truth for the training set was established
- Ground Truth Establishment for Training Set: Not applicable.
§ 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.