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.

Device Description

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.

AI/ML Overview

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."

Summary

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SECTION 2. SUMMARY AND CERTIFICATION

510(k) Summary A.

Submitter:	NOV 0 2 2001SterilMed, Inc.
Contact Person:	Patrick Fleischhacker11400 73 rd Avenue NorthMinneapolis, MN 55369Ph: 888-856-4870Fax: 763-488-3350
Date Prepared:	August 6, 2001
Trade Name:	SterilMed Reprocessed Powered Arthroscopic Accessories
Classification Nameand Number:	Arthroscope, Class II, 21 CFR 888.1100
Product Code:	HRX
Predicate Device(s):	The reprocessed powered arthroscopic accessories aresubstantially equivalent to:The powered arthroscopic accessories included in the Linvatec Universal Drive System (K971059);The Smith & Nephew Dyonics Disposable Endoscopic Surgery Blades (K970511);The Smith & Nephew Dyonics Disposable Arthroscopic Blades (K953695); andTheir counterparts from the original manufacturers.
Device Description:	SterilMed's reprocessed powered arthroscopic accessoriesconsist of surgical instruments which run at variable speedsand are used for cutting soft tissue, cartilage and bone.These accessories are straight or angled, and have rotatingblades that are used with irrigation and suction. Theirdiameters range from 2.0 to 6.0 mm and come in burr,shaver, and cutter designs. These accessories are designedto run in conjunction with a control console, motor driveunit, foot or hand switch, and a suction /irrigation systemunder endoscopic/video visualization. However, thissubmission only pertains to the accessories and not theother system components, such as the control console ormotor drive unit.

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K012536

Reprocessed powered arthroscopic accessories are intended Intended Use: 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.

Representative samples of reprocessed powered Safety Testing: arthroscopic accessories underwent bench testing to demonstrate substantially equivalent functional characteristics. Process validation testing was done to validate the cleaning and sterilization procedures as well as the device packaging. In addition, the manufacturing process includes visual and functional testing of all products produced.

The powered arthroscopic accessories reprocessed by Conclusion: SterilMed are substantially equivalent to the powered arthroscopic accessories included in the Linvatec Universal Drive System (K971059), the Smith & Nephew Dyonics Disposable Endoscopic Surgery Blades (K970511), the Smith & Nephew Dyonics Disposable Arthroscopic Blades (K953695), and their counterparts from the original manufacturers. This conclusion is based upon the fact that these devices' are essentially identical to their predicate devices in terms of functional design, materials, indications for use, and principles of operation.

Functional and

Premarket Notification

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized abstract symbol resembling a person embracing another, or a bird in flight. The symbol is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all caps and is evenly spaced around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 0 2 2001

Mr. Patrick Fleischhacker Vice President Regulatory and Quality Control SterilMed, Inc. 11400 73rd Avenue North Minneapolis, Minnesota 55369

Re: K012536

K012530
Trade/Device Name: SterilMed Reprocessed Powered Arthroscopic Accessories Regulation Number: 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: HRX Dated: August 6, 2001 Received: August 7, 2001

Dear Mr. Fleischhacker:

We have reviewed your Section 510(k) premarket notification of intent to market the indication we nave reviewed your Section >10(x) premained is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regars manned to the Medical Device Amendments, or to commerce prior to May 26, 1776, the enacenture with the provisions of the Federal Food. Drug, devices that have been recuire approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval application (PM and Cosment Act (Act) that to hot require subject to the general controls provisions of the Act. The Act. The You may, therefore, market the dovice, belyer to the most
general controls provisions of the Act include requirements for annual registration, listing of general controls provisions of the 110 labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it ( If your device is classified (see above) the exist on a consequentions affecting your device can
may be subject to such additional controls. Existing major and the collected this be subject to such additional controller in the 21, Parts 800 to 898. In addition, FDA may be found in the Code of Poderal Regarities in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA s issuation of a backed complies with other requirements of the Act
that FDA has made a determination that your device complies with on anyat that I DA has made a determination administered by other Federal agencies. You must or any regeral statutes and regulations annualing, but not limited to: registration and listing (21 Comply with an the 71et 31equirements, and manufacturing practice requirements as set CFK Part 807), labeling (21 CFRT art 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Patrick Fleischhacker

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter with anow you to begin mainting of substantial equivalence of your device to a legally prematicated predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and IT you desire specific authoritor for your witto diagnostic devices), please contact the Office of additionally 21 CHT Fur 007.10 for questions on the promotion and advertising of Compination at (301) 591-1899 - 1854 - 15 - 15 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - - 1 - - - - - - - - - - - - - - - - - - - - - - - - your do roo, prodo combronding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Oiner general information on your responsional and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Walker, m

Image /page/3/Picture/5 description: The image shows a close-up of a handwritten letter. The letter is written in black ink on white paper. The handwriting is cursive and appears to be a signature. The signature is illegible.

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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NOV 0 2 2001

K012536

Indications for use Page

Device Name: Reprocessed Powered Arthroscopic Accessories

Indications for Use:

Reprocessed powered arthroscopic accessories are intended for use in operative large and Reprocessed powered antinoscopic accessors and Functional Endoscopic Sinus Surgery (FESS). small Joint arthroscopic procedures and I and Laster in
These accessories are indicated for resection of soft, osseous and cartilaginous tissue, and These accessorres are large and articular cavities and FESS.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Walker

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K012536

Premarket Notification

Regulation Number and Section

§ 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.