(87 days)
Reprocessed powered arthroscopic accessories are intended for use in operative large and small Joint arthroscopic procedures and Functional Endoscopic Sinus Surgery (FESS). These accessories are indicated for resection of soft, osseous and cartilaginous tissue, and bone in large and small articular cavities and FESS.
SterilMed's reprocessed powered arthroscopic accessories consist of surgical instruments which run at variable speeds and are used for cutting soft tissue, cartilage and bone. These accessories are straight or angled, and have rotating blades that are used with irrigation and suction. Their diameters range from 2.0 to 6.0 mm and come in burr, shaver, and cutter designs. These accessories are designed to run in conjunction with a control console, motor drive unit, foot or hand switch, and a suction /irrigation system under endoscopic/video visualization. However, this submission only pertains to the accessories and not the other system components, such as the control console or motor drive unit.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the SterilMed Reprocessed Powered Arthroscopic Accessories:
Please note that the provided text is a 510(k) summary for a reprocessed medical device. These summaries typically focus on demonstrating substantial equivalence to predicate devices rather than providing detailed clinical study results with specific performance metrics and ground truth methods as you might find for a novel AI device. Therefore, some of the information you requested, particularly regarding "AI" specific metrics, will not be present.
Acceptance Criteria and Device Performance Study for SterilMed Reprocessed Powered Arthroscopic Accessories
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Functional Equivalence | Functional characteristics "substantially equivalent" to predicate devices. | Representative samples underwent bench testing to demonstrate "substantially equivalent functional characteristics." |
| Cleaning and Sterilization | Cleaning and sterilization procedures are validated. | Process validation testing was done to validate the cleaning and sterilization procedures. |
| Device Packaging | Device packaging is validated. | Process validation testing was done to validate the device packaging. |
| Manufacturing Quality Control | Products undergo visual and functional testing during manufacturing. | The manufacturing process includes visual and functional testing of all products produced. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): The filing mentions "Representative samples." No specific number is provided.
- Data Provenance: The data is generated from "bench testing" and "process validation testing" performed by SterilMed, Inc. This is internal testing, not clinical data. It is prospective for the reprocessed device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable in this context. The "ground truth" here is the functional and safety performance of the reprocessed device compared to the original manufacturers' specifications and the predicate devices. This is established through engineering and quality control testing, not expert clinical assessment of images or patient outcomes.
4. Adjudication Method for the Test Set
- Not applicable. Adjudication refers to methods used to resolve discrepancies in expert interpretation, typically in diagnostic studies. Here, the assessment is based on objective measurements and validation protocols.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging AI devices, where human readers interact with AI. This 510(k) is for a reprocessed surgical instrument.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No, a standalone algorithm performance study was not done. This is not an AI device. The "performance" being evaluated is the physical function and safety of a reprocessed surgical tool.
7. The Type of Ground Truth Used
- The "ground truth" in this context is the established functional characteristics, safety profiles, and validated manufacturing processes of the original predicate devices and the reprocessed device's ability to meet those standards. This is based on:
- Engineering Specifications: Performance metrics (e.g., speed, cutting ability) inherent to the original devices.
- Sterilization and Cleaning Standards: Industry and regulatory standards for device reprocessing.
- Visual and Functional Test Outcomes: Objective assessments during manufacturing to confirm device integrity and operation.
8. The Sample Size for the Training Set
- Not applicable. There is no "training set" as this is not an AI/machine learning device. The "training" for this product would be the development and refinement of reprocessing protocols and manufacturing processes.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there's no training set in the AI sense. The "ground truth" for developing the reprocessing procedures and manufacturing controls would have been established through:
- Regulatory Requirements: Adherence to FDA guidelines for reprocessing.
- Scientific Principles: Understanding of material science, microbiology, and sterilization science.
- Predicate Device Specifications: Ensuring the reprocessed device performs comparably to new devices.
- Internal Validation: Rigorous testing by SterilMed to prove the effectiveness of their cleaning, sterilization, and functional restoration processes.
Summary of the Study:
The study described is not a clinical trial in the traditional sense, nor is it an AI performance study. It is a bench testing and process validation study designed to demonstrate "substantial equivalence" of SterilMed's reprocessed powered arthroscopic accessories to legally marketed predicate devices (new, original devices).
The study aimed to prove that the reprocessed devices are as safe and effective as their original counterparts by focusing on:
- Functional Equivalence: Bench testing was conducted on "representative samples" of the reprocessed devices to show that their functional characteristics (e.g., cutting ability, speed range, compatibility with control systems) were "substantially equivalent" to the predicate devices.
- Process Validation: Validation studies were performed to ensure the effectiveness and consistency of the cleaning and sterilization procedures used for reprocessing. This also included validating the device packaging to maintain sterility.
- Manufacturing Quality Control: The 510(k) states that the ongoing manufacturing process includes visual and functional testing of all produced products to ensure they meet quality and performance standards.
The conclusion of the study, based on these tests, was that the reprocessed devices are substantially equivalent to the predicate devices in terms of "functional design, materials, indications for use, and principles of operation."
§ 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.