(91 days)
The Arthrex Bio-Compression Screw is a bioabsorbable polylactide (PLLA) screw intended to provide fixation of small bone fragments such as apical fragments, osteochondral fragments, and cancellous fragments. Specifically; Apical Fragments: Radial Head, Patellar Rim, Navicular, Metacarpal and Metatarsal Osteochondral Fragments: Talar Vault, femoral condyle Cancellous Fragments: Talus
The Arthrex Bio-Compression Screw is manufactured using poly(L-lactide). These are offered sterile, in distinct sizes.
The provided text is a 510(k) summary for the Arthrex Bio-Compression Screw, a medical device for bone fixation. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a study proving the device meets specific acceptance criteria through performance metrics.
Therefore, many of the requested sections (acceptance criteria table, sample sizes, expert involvement, adjudication, MRMC, standalone performance, ground truth establishment) are not applicable or cannot be extracted from this type of document.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
- Not Applicable. This 510(k) summary does not define specific performance-based acceptance criteria (e.g., tensile strength, degradation rate, biocompatibility metrics) or report the device's performance against such criteria. The submission aims to prove substantial equivalence, implying that the device performs similarly to already approved predicate devices, not that it meets a new set of defined performance goals with quantified results.
2. Sample size used for the test set and the data provenance:
- Not Applicable. No specific test set or clinical study data is provided in this 510(k) summary. The submission relies on a comparison to predicate devices and the known properties of the material used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. As no specific clinical or performance test set is described, there's no mention of experts establishing ground truth for such a set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. No test set or related adjudication method is mentioned.
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:
- Not Applicable. This device is a bioabsorbable screw, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. Since no specific performance study is detailed, no ground truth types are mentioned. The "ground truth" for this 510(k) submission is effectively the established safety and effectiveness profile of the predicate devices and the well-characterized nature of the PLLA material.
8. The sample size for the training set:
- Not Applicable. This is a physical medical device, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not Applicable. See point 8.
Summary of Device Acceptance (as per 510(k) process):
The device's acceptance is based on demonstrating substantial equivalence to legally marketed predicate devices, as stated in the 510(k) summary:
"By definition, substantial equivalence means that a device has the same intended use and technical characteristics as the predicate device, or has the same intended use and different technological characteristics, but can be demonstrated to be as safe and effective as the predicate device. The difference between the Arthrex Bio-Compression Screw and the predicate devices with similar indications do not raise any questions regarding the safety and effectiveness of the implant. Furthermore, the material is well characterized and has been used in predicate devices with similar indications. The device, as designed, is as safe and effective as predicate devices."
The FDA's letter explicitly confirms this: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... You may, therefore, market the device..."
In essence, the "study" proving the device meets "acceptance criteria" is the 510(k) submission itself, which primarily relied on a comparative analysis of the device's and predicate devices' intended use, technological characteristics, and material properties, rather than new, extensive performance testing data explicitly documented in this summary.
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OCT - 7 2003
510(k) Summary
| 510(k) Number: | Arthrex, Inc. |
|---|---|
| Company: | 2885 S. Horseshoe Dr., Naples, FL 34104 |
| Address: | (239) 643-5553 |
| Telephone: | (239) 430-3494 |
| Facsimile: | Ann Waterhouse |
| Contact: | |
| Trade Name: | Arthrex Bio-Compression Screw |
| Common Name: | Fastner, Fixation, Degradable |
| Classification: | Class II |
MAI
Description:
Product Code:
The Arthrex Bio-Compression Screw is manufactured using poly(L-lactide). These are offered sterile, in distinct sizes. Further description is contained in Tab 6.
Indications for Use:
The Arthrex Bio-Compression implant is a bioabsorbable polylactide (PLLA) screw intended to provide fixation of small bone fragments such as apical fragments, osteochondral fragments, and cancellous fragments. Specifically;
Apical Fragments: Radial Head, Patellar Rim, Navicular, Metacarpal and Metatarsal Osteochondral Fragments: Talar Vault, femoral condvle Cancellous Fragments: Talus
Predicate Devices:
Please see Tab 7 for specific information concerning predicate devices.
Substantial Equivalence:
By definition, substantial equivalence means that a device has the same intended use and technical characteristics as the predicate device, or has the same intended use and different technological characteristics, but can be demonstrated to be as safe and effective as the predicate device. The difference between the Arthrex Bio-Compression Screw and the predicate devices with similar indications do not raise any questions regarding the safety and effectiveness of the implant. Furthermore, the material is well characterized and has been used in predicate devices with similar indications. The device, as designed, is as safe and effective as predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of a human figure, represented by three curved lines, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 7 2003
Ms. Ann Waterhouse Regulatory Affairs Specialist Arthrex, Inc. 2885 South Horseshoe Drive Naples, Florida 34104
Re: K032098
Trade/Device Name: Bio-Compression Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: July 7, 2003 Received: July 9, 2003
Dear Ms. Waterhouse:
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 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.
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Page 2 - Ms. Ann Waterhouse
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) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. 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.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
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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510(k) Number (if known):
Device Name:
Indications for Use:
The Arthrex Bio-Compression Screw is a bioabsorbable polylactide (PLLA) screw intended to provide fixation of small bone fragments such as apical fragments, osteochondral fragments, and cancellous fragments. Specifically;
Apical Fragments: Radial Head, Patellar Rim, Navicular, Metacarpal and Metatarsal
Talar Vault, femoral condyle Osteochondral Fragments:
Talus Cancellous Fragments:
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Option Format 3-10-98)
Mark N. Milken
Division of General, Restorative and Neurological Dey 510(k) Number
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.