The Arthronet BLACKLINE Arthroscopic Blades are indicated for minimally invasive joint surgeries, including but not limited to synovectomie, subacromial decompression, chondroplastic and ACL reconstruction.

Device Description

The Arthronet BLACKLINE Arthroscopic Blades are manufactured by Arthronet GmbH & Co. KG (formerly Imtec Medinzentechnik). The Blades are limited-use arthroscopic blade components (intended to be used three times, or until they are damaged/dull - whichever occurs first).

This product consists of either two or three components. The three-component product has an outer blade assembly, an inner blade, and an inner blade hub adapter. The two component product has an outer blade assembly and an inner blade assembly. The blade sets consist of six hub assembly configurations, and has both straight and curved blade configurations. Each configuration, except for the Arthronet 123 series, is designed to fit a specific FDA Cleared Arthroscopic Shaver System.

Arthronet BLACKLINE Arthroscopic Blades are all made from 304 Stainless Steel and the adapter hubs are made from hardened anodized aluminum and stainless steel. These materials are essentially equivalent to those of predicate devices. Configurations and sizes are typical of predicate devices and indicated in catalog labeling.

Arthronet BLACKLINE Arthroscopic Blade assemblies consist of 2 piece and 3 piece blade assemblies, depending upon the shaver system they are used with. The 3 Piece blade consists of a single outer blade/hub assembly within which a two-piece inner blade and hub assembly can be inserted. The inner blade assembly snaps into place within the inner blade hub adapter. The resulting inner blade assembly, in turn, snaps into place within the outer blade assembly. The 2 Piece blade consists of a single blade/hub outer and a single inner blade/hub that are joined together in the identical fashion as the 3 Piece. The distal cutting orifices of the inner and outer blade assemblies align precisely to allow for rotary cutting as the inner blade rotates within the fixed outer blade. These assemblies are designed to facilitate cleaning and autoclave sterilization. Autoclave sterilization parameters are equivalent to predicate products noted and directions for use, cleaning and sterilization are contained in product labeling.

Arthronet BLACKLINE Arthroscopic Blades are provided in a Non-Sterile condition. Recommended disassembly, cleaning, reassembly and sterilization instructions are identified and included in product labeling. These products are intended to be steam pressure autoclaved at cycle parameters equal to or exceeding 132 degrees C and 2bar pressure for 5 minutes. Cautionary warnings alert the user to thoroughly clean the units prior to sterilization and to remove all debris during the cleaning process. Cleaning and sterilization criteria are recommendations only and are based upon simulated use testing on file with the manufacturer. Labeling clearly indicate that hospitals should use their own validated cleaning and sterilization processes for these types of products.

Arthronet BLACKLINE Arthroscopic Blades are limited use devices. Blades are clearly labeled for use a maximum of three (3) uses. The blade assemblies can be discarded after three uses. Product usage and cautions related to potential damage to the blade assemblies as a result of handling or cleaning are clearly defined in product labeling. All product usage is based upon design data developed during product design, simulated use verification testing, and is also based upon seven years of clinical product experience in the worldwide market.

AI/ML Overview

The provided text does not contain detailed acceptance criteria for the device beyond its intended use and material similarity to predicate devices. It also states the device has been sold worldwide for eight years and meets international safety requirements, with a complete risk analysis filed. However, it does not describe a "study" in the sense of a clinical trial or performance evaluation with specific numerical metrics and results.

Here's an analysis of what information is available based on your request, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied/Stated)	Reported Device Performance
Intended Use: Minimally invasive joint surgeries (synovectomie, subacromial decompression, chondroplastic, ACL reconstruction)	The device is "indicated for" these procedures. This implies it performs them as intended, but no specific performance metrics (e.g., cutting efficiency, precision, safety in use) are provided.
Limited Use: Maximum of three (3) uses	Clearly labeled for a maximum of three uses. Product usage is based on design data, simulated use verification testing, and seven years of clinical product experience. No specific performance data (e.g., degradation after use 1, 2, 3) is given.
Material Equivalence: Made from 304 Stainless Steel and hardened anodized aluminum for hubs	Materials are "essentially equivalent" to predicate devices and conform to many other surgical instruments.
Cleaning & Sterilization: Can be disassembled, cleaned, reassembled, and steam autoclaved at 132°C and 2bar for 5 minutes.	Recommended disassembly, cleaning, reassembly, and sterilization instructions provided in labeling. Cleaning and sterilization criteria are "recommendations only" based on "simulated use testing on file with the manufacturer." Hospitals should use their own validated processes. No specific validation results are provided in this text.
Safety: No identifiable risks requiring redesign	A complete risk analysis has been performed and filed. No specific risk assessment results or details are provided in this text.
Compatibility: Fits various shaver systems (Linvatec, Friatec, Arthrex, Dyonics EP 1, Aesculap, Stryker, Storz)	Each configuration is designed to fit a specific FDA Cleared Arthroscopic Shaver System.
Global Market Acceptance: Meets international product safety requirements	Sold worldwide by Arthronet GmbH & Co. KG and their previous company for eight years and meets international product safety requirements; will bear the CE mark.

Missing Information Regarding Acceptance Criteria and Performance:

The document focuses on establishing substantial equivalence to predicate devices, material descriptions, and intended use rather than presenting a performance study with detailed acceptance criteria and quantitative results. There are no specific numerical thresholds for performance metrics (e.g., cutting force, wear resistance, sharpness after sterilization cycles) that would constitute "acceptance criteria" in a typical device performance study.

Regarding the "Study" Proving Acceptance:

The document refers to "simulated use testing on file with the manufacturer" for cleaning and sterilization, and "design data developed during product design, simulated use verification testing, and ... seven years of clinical product experience in the worldwide market" for product usage and cautions. However, no details about these "studies" are provided in the text.

Here's an assessment based on the available information:

2. Sample Size Used for the Test Set and Data Provenance:

Test Set Sample Size: Not specified. The phrase "simulated use testing on file with the manufacturer" and "seven years of clinical product experience in the worldwide market" are mentioned, but no specifics on the number of devices or cases used for testing the current device for its regulatory submission are provided.
Data Provenance: "Worldwide market" and "on file with the manufacturer" (likely Germany, where Arthronet GmbH & Co. KG is located) are mentioned for clinical experience and simulated use testing, respectively. This suggests a retrospective compilation of experience and internal prospective testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

Not applicable/Not specified. The document does not describe a study involving expert assessment or ground truth establishment in the context of human interpretation or diagnostic accuracy. The device is a surgical tool, and its "performance" would relate to its mechanical function, material properties, and sterility.

4. Adjudication Method for the Test Set:

Not applicable/Not specified. Given the nature of the device (arthroscopic blade), the concept of "adjudication" for a test set (which usually applies to diagnostic interpretations) is not relevant here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No. This type of study (MRMC) is typically for diagnostic imaging devices where human readers interpret medical images, often with and without AI assistance. The Arthronet BLACKLINE Arthroscopic Blades are surgical tools, not diagnostic devices.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Not applicable. This device is a physical surgical tool and does not involve an algorithm or AI.

7. The Type of Ground Truth Used:

For Cleaning/Sterilization: The text states "simulated use testing on file with the manufacturer" was used, and that "cleaning and sterilization criteria are recommendations only" with hospitals needing to use their own validated processes. This suggests internal engineering/bench testing to establish initial parameters, but not a "ground truth" derived from patient outcomes or pathology.
For Product Usage (Limited Use): Based on "design data developed during product design, simulated use verification testing, and... seven years of clinical product experience." Again, this points to engineering/bench testing and real-world experience/outcomes surveillance rather than a specific "ground truth" established for a defined test set.

8. The Sample Size for the Training Set:

Not applicable. The device is a physical surgical instrument, not an AI or machine learning model that requires a "training set."

9. How the Ground Truth for the Training Set Was Established:

Not applicable. (As above, no training set for an algorithm).

In summary, the provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to existing predicate devices based on materials, intended use, and general design principles for a simple, non-AI surgical instrument. It references internal testing and market experience but does not detail a formal performance study with specific acceptance criteria and results as typically found for more complex or novel devices.

Summary

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DEC 1 1 2002

4. 510(k) Summary

Product Submitted by:	Arthronet Medical, Inc.8 Hammond, Suite 108Irvine, CA 92618Phone (760) 436-3766FAX (760) 632-0276
Manufactured by:	Arthronet GmbH & Co. KG.(formerly Imtec Medizintechnik)Geilenbacher Straße 31D-51399 BurscheidGermany

Introduction

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BLACKLINE Blade System

ArthronetBlackline ShaverBlade Series:	Hub Adapter Fits thefollowing Shaver System:	Materials Used:	Equivalent to:
123	Arthronet (pending reviewand FDA clearance)	304 grade Stainless Steeland anodized aluminumfor hub	Smith & Nephew Dyonics, Inc. LimitedReuse Arthroscopic Blades (K955914);Arthronet, Inc. Series 145/155 Blades(K003203)
133	Linvatec, Friatec, ArthrexShaver Systems	304 grade Stainless Steeland anodized aluminumfor hub	Smith & Nephew Dyonics, Inc. LimitedReuse Arthroscopic Blades (K955914);Arthronet, Inc. Series 145/155 Blades(K003203)
153	Dynonics EP 1	304 grade Stainless Steeland anodized aluminumfor hub	Smith & Nephew Dyonics, Inc. LimitedReuse Arthroscopic Blades (K955914);Arthronet, Inc. Series 145/155 Blades(K003203)
163	Aesculap	304 grade Stainless Steeland anodized aluminumfor hub	Smith & Nephew Dyonics, Inc. LimitedReuse Arthroscopic Blades (K955914):Arthronet, Inc. Series 145/155 Blades(K003203)
173	Stryker	304 grade Stainless Steeland anodized aluminumfor hub	Smith & Nephew Dyonics, Inc. LimitedReuse Arthroscopic Blades (K955914);Arthronet, Inc. Series 145/155 Blades(K003203)
183	Storz	304 grade Stainless Steeland anodized aluminumfor hub	Smith & Nephew Dyonics, Inc. LimitedReuse Arthroscopic Blades (K955914);Arthronet, Inc. Series 145/155 Blades(K003203)

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The Arthronet BLACKLINE Arthroscopic Blade configurations utilize materials similar to the predicate devices noted in the previous table. All predicate devices noted in this section have the same intended use.

The Arthronet BLACKLINE Arthroscopic Blades have been sold worldwide by Arthronet GmbH & Co. KG and their previous company for eight years and meet international product safety requirements. Submitted product intended for sale in the USA will also bear the CE mark and registration number of the Arthronet GmbH & Co. KG Notified Body and will also meet FDA product labeling requirements. Blades are identified with etched labeling noting the manufacturer and the country of manufacture.

The Arthronet BLACKLINE Arthroscopic Blades are essentially equivalent to the Arthronet Limited Use Arthroscopic Blades (such as the series 145/155 Blades, K003203) and the Smith & Nephew Dyonics Disposable Arthroscopic Blades (K953695) and the Smith & Nephew Dyonics Limited Use Arthroscopic Blades (K955914). Materials used are essentially equivalent and conform to many other surgical instruments.

Arthronet BLACKLINE Arthroscopic Blades are provided in a Non-Sterile condition. Recommended disassembly, cleaning, reassembly and sterilization instructions are identified and included in product labeling. These products are intended to be steam pressure autoclaved at cycle parameters equal to or exceeding 132°C and 2bar pressure for 5 minutes. Cautionary warnings alert the user to thoroughly clean the units prior to sterilization and to remove all debris during the cleaning process. Cleaning and sterilization criteria are recommendations only and are based upon simulated use testing on file with the manufacturer. Labeling clearly indicate that hospitals should use their own validated cleaning and sterilization processes for these types of products.

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A complete risk analysis has been performed for these products and has been filed with the products' 510(k) submission. There were no identifiable risks associated with the use of this device that can be alleviated by product redesign.

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ronet Medical, Inc.

The following table demonstrates the substantial equivalence of the Arthroscopic Blades to the following to

Company:	Device:	BladeMaterial	Hub AdapterMaterial	ProvidedSterile?	RecommendedSterilization:	Intended Use:	Reusable?	Design:	510(k)
ArthronetGmbH &CO. KG	Limited UseArthroscopicBlades and HubAdapter	SurgicalGradeStainlessSteel	Surgical Gradeanodized aluminum	NO	SteamAutoclave	Joint Surgery(used withArthronet,Dyonics EP1,Aesculap, Strkyer,Storz, Linvatec,Friatec andArthrex externalShaver systems)	Blades areLimited Use(3 times).	Inner andouter tubewith distalcutting	Pending
Arthronet, Inc.	Limited UseArthroscopicBlades and HubAdapter	SurgicalGradeStainlessSteel	Surgical GradeStainless Steel	NO	SteamAutoclave	Joint Surgery(used with DyonicsPS 3500/EP1,Linvatec, Conceptand Arthrexexternal Shaversystems)	Blades areLimited Use(3 times);Hubs arereusable.	Inner andouter tubewith distalcutting	K003203
Smith &NephewDyonics, Inc.	Limited UseArthroscopicBlades	SurgicalGradeStainlessSteel	Surgical GradeStainless Steel	NO	SteamAutoclave	Joint Surgery(used with DyonicsPS 3500 Shaversystem, orequivalent)	Limited Use	Inner andouter tubewith distalcutting	K955914
Smith &NephewDyonics, Inc.	DisposableArthroscopicBlades	SurgicalGradeStainlessSteel	Surgical GradeStainless Steel andNon-AutoclavablePlastic	YesETOsterilized byManufacturer	Notintended toberesterilized	Joint Surgery	Single Use	Inner andouter tubewith distalcutting	K953695
Micro-AireSurgicalInstruments,Inc.	ArthroscopicSurgical Blades(severalmodels)	SurgicalGradeStainlessSteel	Surgical GradeStainless Steel andaluminum	NO	SteamAutoclave	Joint Surgery	Limited Use	Inner andouter tubewith distalcutting	K901735

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract symbol that resembles a stylized caduceus or a family of three figures.

Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Arthronet Medical, Inc. Carolina Schaber 8 Hammond, Suite 108 Irvine, California 92618

Re: K023777

Trade/Device Name: Arthronet Blackline Arthroscopic Blades Regulation Number: 888.1100 Regulation Name: Arthroscope accessories Regulatory Class: Class II Product Code: HRX Dated: November 5, 2002 Received: November 12, 2002

Dear Ms. Schaber:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, 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 may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in

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Page 2 – Ms. Carolina Schaber

the quality systems (QS) regulation (21 CFR Part 820); and if applicable; the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

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

Enclosure

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Special 510(k) Submission Arthronet Medical, Inc Limited-Use Arthronet BLACKLINE Arthroscopic Blade Assemblies

3. Indications for Use

Miriam C. Provoost

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

210(k) Number K023777

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.