(224 days)
SureTek Reprocessed Arthroscopic Blades and Burs are intended for use during arthroscopic and endoscopic procedures for cutting and resection of soft tissue, cartilage and bone. Endoscopic sinus surgery is limited to small diameter instruments (2 to 3.5mm).
Arthroscopic Shavers and Burs are powered instruments designed for cutting of soft tissue, cartilage and bone during arthroscopic/endoscopic surgeries. The stainless steel instrument consist of a hollow shaft with a distal blade or bur that rotates within an open-ended cannula with outer diameters ranging from 2 to 6 mm. Devices are designed for use only with compatible driver systems with continuous irrigation and aspiration of fluids through the inner shaft during use. Depending upon the aggressiveness required for cutting, shavers are designed with different serrated and non-serrated blades and angles, and burs have varying shapes (round, barrel, tapered) and number flutes (4 to 12). Reprocessed blades and burs have identical technological characteristics as the predicate devices, i.e. device component materials, dimensions and system compatibility are unchanged during reprocessing.
The SureTek Reprocessed Arthroscopic Shavers and Burs received 510(k) clearance based on substantial equivalence to predicate devices, without specific acceptance criteria or a dedicated study explicitly detailing device performance against such criteria in the provided summary. The information focuses on a comparison to new, unused devices through bench testing and compliance with various ISO and ASTM standards.
Here's an analysis of the provided information based on your requested categories:
1. A table of acceptance criteria and the reported device performance
The submission does not specify numerical acceptance criteria for performance metrics (like cutting efficiency, blade sharpness, or bur abrasion rate) or reporting device performance against specific targets. Instead, it states that "bench testing of devices following the maximum number of use and reprocessing cycles found their performance to be substantially equivalent to new, unused devices."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Performance substantially equivalent to new, unused devices | Bench testing confirmed performance to be substantially equivalent to new, unused devices after maximum use and reprocessing cycles. |
| Effective decontamination for grossly contaminated instruments (Cleaning) | SureTek cleaning process validated to be effective under worst-case operational conditions. |
| Conformance to ISO 11607 for packaging performance | Product packaging conforms to relevant requirements of ISO 11607, with performance qualifications tested according to EN868-1 and ASTM F88-00, F2906-04, D4169-04a and F1980-02. |
| Conformance to ISO 11135 for sterility and process validation | Product sterility and process validation conform to relevant requirements of ISO 11135. |
| Conformance to ISO 10993 for biological evaluation (EO residuals, biocompatibility) | Products conform to relevant requirements of ISO 10993 for ethylene oxide residuals and biocompatibility of device materials. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample size used for the bench testing beyond "devices." It also doesn't specify the data provenance (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided. The study appears to be a bench test comparison against new devices, rather than a clinical study requiring expert assessment for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the study described is bench testing and does not involve human adjudication of results in a clinical context.
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
This is not applicable. The device is a reprocessed arthroscopic shaver/bur, not an AI-assisted diagnostic or therapeutic tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. The device is a physical medical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the performance evaluation, the "ground truth" was implicitly established by the performance characteristics of new, unused devices. For cleaning validation, the "ground truth" would be the absence of viable microorganisms and contaminants as per established standards and methods. For biocompatibility, it would be the absence of adverse biological responses as defined by ISO 10993.
8. The sample size for the training set
This is not applicable. The device is a reprocessed physical instrument and does not involve machine learning or a training set.
9. How the ground truth for the training set was established
This is not applicable. There is no training set for this type of device.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.