(57 days)
The 5th Metatarsal Fracture Screw is indicated for fixation of bone fractures or for bone reconstruction of the 5th Metatarsal. Examples include:
- Fixation of malunions and nonunions
- Acute fractures
- Avulsion fractures
- Repetitive stress fractures
- Jones Fractures
- Malleolar Fractures
- Talus Fractures
- Greater Tuberosity Fractures
The design features of the 5th Metatarsal Fracture Screw are summarized below:
- Manufactured from Stainless Steel .
- Offered in three diameters: 4.5mm, 5.5mm, and 6.5mm .
- Offered in lengths ranging from 40mm-70mm .
This document is a 510(k) Summary for the 5th Metatarsal Fracture Screw. It outlines the device's intended use, description, and claims of substantial equivalence to a previously cleared predicate device (Multi-Use Compression Screw). The FDA's letter states that the device is substantially equivalent for the indications of use described.
Here's an analysis of the provided text in relation to your request for acceptance criteria and study information:
Acceptance Criteria and Device Performance:
The document does not report specific quantitative acceptance criteria or device performance data in the format you requested for a medical device that might typically undergo clinical trials or performance testing with measurable outcomes (like sensitivity, specificity, accuracy for an AI device).
Instead, this 510(k) summary focuses on establishing substantial equivalence to a previously cleared predicate device. This means the primary "acceptance criterion" is that the new device is as safe and effective as a legally marketed device.
Table of Acceptance Criteria and Reported Device Performance (as inferred from the document):
| Acceptance Criteria (Inferred from 510(k) Process) | Reported Device Performance (as per document) |
|---|---|
| Safety: | |
| - Manufactured from Stainless Steel. | The 5th Metatarsal Fracture Screw is manufactured from Stainless Steel, matching a common material for bone fixation devices. |
| - Adherence to relevant material standards. | Implied by "materials information" provided in the Premarket Notification. |
| Effectiveness: | |
| - Indicated for fixation of bone fractures or bone reconstruction of the 5th Metatarsal. | The device is intended for the specified indications, which are considered to be substantially equivalent to the predicate device. |
| - Similar design features to predicate device. | The design features (e.g., diameters, lengths) are comparable to the predicate device. |
| - Similar intended use to predicate device. | The intended use for bone fixation and reconstruction, specifically for the 5th Metatarsal, is consistent with the predicate. |
| Substantial Equivalence: | The 5th Metatarsal Fracture Screw is "substantially equivalent to the previously cleared Multi-Use Compression Screw" in design features, material, and indications for use. |
Study Information:
Based on the provided text, there is no detailed study described that measures performance against specific acceptance criteria in the way you might expect for an AI/algorithm-based device. This 510(k) is for a physical medical device (a screw for bone fixation), and the submission focuses on demonstrating substantial equivalence rather than explicit performance metrics from a comparative study.
Here's a breakdown of why many of your requested points are not applicable or cannot be answered from this document:
- Sample size used for the test set and the data provenance: Not applicable. This is not an AI/algorithm device that uses a "test set" in the computational sense. The "test set" for a physical device like this might involve mechanical testing, but such details are not provided here.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth and expert consensus are not relevant for demonstrating substantial equivalence of a physical bone screw based on design, material, and intended use.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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 not an AI assistant to human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of an AI device. For this physical device, "ground truth" would relate to mechanical properties, biocompatibility, and clinical outcomes for the intended use, which are typically established through existing standards, mechanical testing, and clinical experience of similar devices. The document states "analysis data" was provided, which likely refers to engineering and material testing.
- The sample size for the training set: Not applicable. This is not an AI/algorithm device that uses a "training set."
- How the ground truth for the training set was established: Not applicable.
In summary:
This 510(k) filing for a 5th Metatarsal Fracture Screw demonstrates substantial equivalence to a predicate device. It does not contain the detailed performance metrics or study information typically found for AI-driven clinical devices, as it is a physical implant. The "acceptance criterion" here is primarily regulatory: that the device is shown to be as safe and effective as a device already on the market. The "study" proving this involves comparing its design, materials, and intended use to the predicate device, along with "materials information" and "analysis data" (likely mechanical and biocompatibility testing results, not presented in this summary).
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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CRF 807, this information serves as a Summary of Safety and Effectiveness for the use of the 5th Metatarsal Fracture Screw.
| Submitted By: | Wright Medical Technology, Inc. |
|---|---|
| Date: | November 5, 2005 |
| Contact Person: | Wesley L. Reed |
| Regulatory Affairs Specialist | |
| Proprietary Name: | 5 th Metatarsal Fracture Screw |
| Common Name: | Bone Fixation Screw |
| Classification Name and Reference: | 21 CFR 888.3040 Smooth or threaded metallic bonefixation fastener - Class II |
| Device Product Code and Panel Code: | Orthopedics/87/HWC |
DEVICE INFORMATION
A. INTENDED USE
The 5th Metatarsal Fracture Screw is indicated for fixation of bone fractures or for bone reconstruction of the 5th Metatarsal. Examples include:
- Fixation of malunions and nonunions
- · Acute fractures
- · Avulsion fractures
- · Repetitive stress fractures
- · Jones Fractures
- · Malleolar Fractures
- · Talus Fractures
- · Greater Tuberosity Fractures
B. DEVICE DESCRIPTION
The design features of the 5th Metatarsal Fracture Screw are summarized below:
- Manufactured from Stainless Steel .
- Offered in three diameters: 4.5mm, 5.5mm, and 6.5mm .
- Offered in lengths ranging from 40mm-70mm .
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C. SUBSTANTIAL EQUIVALENCE INFORMATION
The design features, material, and indications for use of the 5" Metatarsal Fracture Screw are substantially equivalent to the previously cleared Multi-Use Compression Screw. The safety and effectiveness of the 5th Metatarsal Fracture Screw is adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.
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2006 JAN 5
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Wesley L. Reed Regulatory Affairs Specialist Wright Medical Technology, Inc 5677 Airline Road Arlington, Tennessee 38002
Re: K053136
Trade/Device Name: 5th Metatarsal Fracture Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: November 4, 2005 Received: November 9, 2005
Dear Mr. Reed:
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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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 (240) 276-0120. 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 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/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
105 3136 510(k) Number (if known):
Device Name: 5th Metatarsal Fracture Screw
Indications For Use:
The 5th Metatarsal Fracture Screw is indicated for fixation of bone fractures or for bone reconstruction of the 5th Metatarsal. Examples include:
- Fixation of malunions and nonunions
- · Acute fractures
- · Avulsion fractures
- · Repetitive stress fractures
- · Jones Fractures
- Malleolar Fractures
- · Talus Fractures
- · Greater Tuberosity Fractures
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General, Restorative, and Neurological Devices |
| 510(k) Number | K053136 |
|---|---|
| --------------- | --------- |
§ 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.