(28 days)
The Small Bone Locking Plating System Line Extension is intended for stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions of small bones of the hand, foot, wrist, ankle, humerus, scapula, finger, toe, pelvis and craniomaxillofacial skeleton, particularly in osteopenic bone.
The Small Bone Locking Plating System Line Extension combines the attributes of a traditional compressive plating system with the enhanced benefits of locking screw and multidirectional locking screw technology.
The provided text appears to be a 510(k) summary for a medical device called the "DePuy Small Bone Locking Plating System Line Extension." It primarily focuses on demonstrating substantial equivalence to a predicate device through bench testing.
Based on the provided information, I can extract the following:
1. A table of acceptance criteria and the reported device performance:
The document states: "Equivalence was confirmed through bench testing." However, it does not provide specific acceptance criteria or detailed results of the bench testing. It only indicates that the testing confirmed equivalence to the predicate device (DePuy Small Bone Locking Plating System, K081546).
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document. The summary only states that "Equivalence was confirmed through bench testing." | Not specified in the document. The summary only states that the bench testing confirmed equivalence to the predicate device (K081546). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not provide details about sample size, data provenance, or whether the study was retrospective or prospective. It only mentions "bench testing."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not applicable. This is a medical device for bone fixation, and the evaluation was based on "bench testing" (mechanical or physical testing), not an assessment requiring expert interpretation of medical images or patient data to establish ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable, as the study was bench testing of a physical device, not an evaluation of a system requiring human interpretation or adjudication.
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:
No, an MRMC comparative effectiveness study was not done. This device is a bone plating system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This information is not applicable. This is a physical medical device (bone plating system), not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for the bench testing would be established by engineering specifications, material properties, and mechanical performance standards, compared against the predicate device. The document does not explicitly state what these specific ground truths were, beyond the general statement of "equivalence."
8. The sample size for the training set:
This information is not applicable. This is a physical medical device (bone plating system), not a machine learning model that requires a training set.
9. How the ground truth for the training set was established:
This information is not applicable, as there is no training set for this type of device.
In summary, the provided document is a 510(k) summary for a bone plating system, which relies on a demonstration of substantial equivalence through bench testing. It does not contain the detailed information requested regarding acceptance criteria, specific performance metrics, sample sizes, expert involvement, or AI-related study design elements, as those are generally not relevant for this type of medical device submission.
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V083364
DEC 1 1 2008
510(k) Summary
| Submitted by: | DePuy Orthopaedics, Inc.700 Orthopaedic DriveWarsaw, IN 46581Phone: (305) 269-6386Fax: (305) 269-6441 | |
|---|---|---|
| Contact Person: | Suzana Otaño, Project Manager, Regulatory Affairs | |
| Date Prepared: | November 12, 2008 | |
| GeneralProvisions | The name of the device is: | |
| Proprietary Name | Common or Usual Name | |
| Small Bone Locking PlatingSystem | Plate, Fixation, Bone | |
| Name ofPredicateDevices | The device is substantially equivalent to the currently marketed DePuySmall Bone Locking Plating System, K081546. | |
| Classification | Class II, 21 CFR 888.3030 | |
| PerformanceStandards | Performance standards have not be en established by the FDA undersection 514 of the Food, Drug and Cosmetic Act for these devices. | |
| Indications forUse | The Small Bone Locking Plating System Line Extension is intended forstabilization and fixation of small bone fragments in fresh fractures,revision procedures, joint fusion and reconstructions of small bones of thehand, foot, wrist, ankle, humerus, scapula, finger, toe, pelvis andcraniomaxillofacial skeleton, particularly in osteopenic bone. | |
| DeviceDescription | The Small Bone Locking Plating System Line Extension combines theattributes of a traditional compressive plating system with the enhancedbenefits of locking screw and multidirectional locking screw technology. | |
| Biocompatibility | The Small Bone Locking Plating System Line Extension does not requirebiocompatibility testing. | |
| Summary ofSubstantialEquivalence | The Small Bone Locking Plating System Line Extension is substantiallyequivalent to the predicate devi ce. Equivalence was confirmed throughbench testing. |
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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 eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Public Health Service
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DePuy Orthopaedics, Inc. % Ms. Suzana Otaño 700 Orthopaedic Drive Warsaw, IN 46581-0988
DEC 1 1 2008
Re: K083364
Trade/Device Name: DePuy Small Bone Locking Plating System Line Extension Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS. HWC Dated: November 12, 2008 Received: November 13, 2008
Dear Ms. Otaño:
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. Suzana Otaño
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark M. Millican
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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510(k) Number:
Device Name:
DePuy Small Bone Locking Plating System Line Extension
Indications For Use:
The DePuy Small Bone Locking Plating System Line Extension is intended for stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions of small bones of the hand, foot, wrist, ankle, humerus, scapula, finger, toe, pelvis and craniomaxillofacial skeleton, particularly in osteopenic bone.
Prescription Use_ (Per 21 CFR 801 Subpart D)
AND/OR
Over-the-Counter (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nikroghde Lofmxm
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K083364
Page 1 of 1
DePuy Small Bone Locking Plating System Line Extension Special 510(k)
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.