(29 days)
The Zimmer Periarticular Locking Plate System is indicated for temporary internal fixation and stabilization of osteotomies and fractures, including comminuted fractures, supracondylar fractures, intra-articular and extra-articular condylar fractures, fractures in osteopenic bone, nonunions and malunions.
The Zimmer Periarticular Locking Plates and Screws are intended for internal fracture fixation. The low-profile periarticular locking plate is anatomically-contoured and has threaded holes which accept locking screws to create a stable, fixed-angle construct.
This document is a 510(k) premarket notification for the Zimmer® Periarticular Locking Plate System. It describes the device, its intended use, and a comparison to a predicate device. However, it does not contain specific acceptance criteria or details of a study proving the device meets acceptance criteria in the way that would typically be presented for an AI/algorithm-based medical device.
Key points from the document regarding performance:
- Performance Data: "Non-Clinical Performance and Conclusions: The results of non-clinical (laboratory) performance testing and analysis confirm that the proposed device is safe and effective."
This statement is very high-level and does not provide quantitative acceptance criteria or detailed study specifics. It simply states that non-clinical (laboratory) testing was performed and deemed sufficient.
Given the information provided in the input, I cannot fill out the requested table or answer most of the specific questions about acceptance criteria and studies as they would apply to an AI device. The document is for a physical medical device (bone plates and screws), not an AI/algorithm. Therefore, many of the questions (e.g., about ground truth, training set, multi-reader multi-case studies, effect size of AI assistance) are not applicable to this type of submission.
Here's how I would answer based on the provided text, highlighting what is missing or not applicable:
Acceptance Criteria and Device Performance (Based on provided text)
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria (if available) | Reported Device Performance (if available) | Notes |
|---|---|---|---|
| Safety | Not explicitly stated | Confirmed safe through non-clinical (laboratory) testing and analysis. | The document provides a high-level statement without specific metrics or thresholds. |
| Effectiveness | Not explicitly stated | Confirmed effective through non-clinical (laboratory) testing and analysis. | The document provides a high-level statement without specific metrics or thresholds. |
| Performance (Mechanical) | Not explicitly stated (e.g., strength, fatigue, fixation stability) | Non-clinical (laboratory) performance testing and analysis confirms safety and effectiveness. | For a physical orthopedic implant, mechanical testing (e.g., bending strength, fatigue life, pull-out strength of screws) would be critical. However, specific values or pass/fail criteria are not detailed in this summary. |
| Biocompatibility | Not explicitly stated | Implied by "manufactured from the same materials using similar processes" as predicate. | The materials (titanium or stainless steel) are standard for implants and generally considered biocompatible. Specific biocompatibility test results are not detailed. |
| Design Equivalence | "Same intended use, operates with the same fundamental scientific technology, is manufactured from the same materials using similar processes and is similar in design" as predicate devices. | The device is deemed substantially equivalent to predicate devices. | This is a regulatory acceptance criterion for 510(k) cleared devices. |
2. Sample sized used for the test set and the data provenance
- Sample Size: Not specified. The document only mentions "non-clinical (laboratory) performance testing and analysis." This implies a sample size of physical devices tested in a lab, but the number is not provided.
- Data Provenance: Not applicable in the context of clinical data for an AI/algorithm. This refers to laboratory testing of physical devices. No patient data (retrospective or prospective) is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This is a physical medical device; there is no "ground truth" in the diagnostic or an AI/algorithm sense. Performance is based on engineering and material science testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is a physical medical device. Adjudication methods are typically used for establishing ground truth in clinical imaging or diagnostic studies.
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 is a physical medical device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable in the context of an AI/algorithm. For this device, "ground truth" would relate to fundamental physical properties and performance under mechanical load, established by engineering standards and testing protocols (e.g., what constitutes failure under a given load).
8. The sample size for the training set
- Not applicable. This is a physical medical device. There is no concept of a "training set" in the machine learning sense.
9. How the ground truth for the training set was established
- Not applicable. This is a physical medical device.
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Image /page/0/Picture/0 description: The image shows the logo for Zimmer Biomet. The logo consists of a large, bold letter "Z" inside of a circle, followed by the word "zimmer" in a smaller, sans-serif font. The logo is simple and modern, and the use of the letter "Z" makes it easily recognizable.
MAY - I 2007
Summary of Safety and Effectiveness
Submitter:
Contact Person:
Date:
Trade Name:
Common Name:
Classification Name and Reference:
Predicate Device:
Device Description:
Intended Use:
Zimmer, Inc. P.O. Box 708 Warsaw, IN 46581-0708
Mason W. Robbins Specialist, Regulatory Affairs Telephone: (574) 371-8065 Fax: (574) 372-4605
March 30, 2007
Zimmer® Periarticular Locking Plate System
Plate, Fixation, Bone Screw, Fixation, Bone
Plate, Fixation, Bone 21 CFR § 888.3030 Screw, Fixation, Bone 21 CFR § 888.3040
Plates
Zimmer Periarticular Plates, manufactured by Zimmer Inc., K050121, cleared January 31, 2005 Screws . 2.7mm Locking Screw, K050121, cleared January
31, 2005, Zimmer, Inc.
The Zimmer Periarticular Locking Plates and Screws are intended for internal fracture fixation. The low-profile periarticular locking plate is anatomically-contoured and has threaded holes which accept locking screws to create a stable, fixed-angle construct.
The Zimmer Periarticular Locking Plate System is indicated for temporary internal fixation and stabilization of osteotomies and fractures, including comminuted fractures, supracondylar fractures, intra-articular and extra-articular condylar fractures, fractures in osteopenic bone, nonunions and malunions.
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Image /page/1/Picture/0 description: The image shows the logo for Zimmer. The logo consists of a large, bold letter "Z" inside of a circle, followed by the word "zimmer" in a smaller, sans-serif font. The logo is black and white.
Comparison to Predicate Device:
The Zimmer Periarticular Locking Plate System has the same intended use, operates with the same fundamental scientific technology, is manufactured from the same materials using similar processes and is similar in design to the predicate devices.
Performance Data:
Non-Clinical Performance and Conclusions:
The results of non-clinical (laboratory) performance testing and analysis confirm that the proposed device is safe and effective.
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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 consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or other bird with its wings spread, formed by a series of curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 1 2007
Zimmer, Inc. % Mr. Mason W. Robbins Specialist, Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708
Re: K070906 Trade/Device Name: Zimmer® Periarticular Locking Plate System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HWC Dated: March 30, 2007 Received: April 3, 2007
Dear Mr. Robbins:
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 – Mr. Mason W. Robbins
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Barbara Buehrig
ter.
Mark N. Melkerson 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
510(k) Number (if known):
Device Name:
Zimmer® Periarticular Locking Plate System - Distal Lateral Fibular Locking Plates and Screws
Indications for Use:
The Periarticular Locking Plate System is indicated for temporary internal fixation and stabilization of osteotomies and fracture, including:
- Comminuted fractures .
- Supracondylar fractures .
- Intra-articular and extra-articular condylar fractures .
- Fractures in osteopenic bone .
- Nonunions .
- Malunions .
Prescription Use X (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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara Buchm
Division of General, Restorative, and Neurological Devices
Page 1 of 1
510(k) Number
KO
§ 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.