(94 days)
The updated ACE-Fischer® External Fixation System is indicated for open and closed long bone fracture fixation to include tensioned wire fixation of periarticular fractures, arthrodesis, limb lengthening, osteotomy, reconstruction, non-unions, pseudoarthrosis, correction of bony or soft tissue defects and deformities.
The updated ACE-Fischer® External Fixation System is a highly versatile frame that can be constructed for applications ranging from simple fractures to complex reconstruction. This modular system can be configured for many different applications.
The provided text is a 510(k) summary for the DePuy ACE-Fischer External Fixation System and does not contain information about acceptance criteria, device performance, or a study proving that the device meets acceptance criteria. The submission is for a medical device (external fixation system) and typically, for such devices, "acceptance criteria" and "device performance" are mechanical or structural properties tested through bench testing, rather than an AI-based system.
Therefore, many of the requested fields cannot be answered based on the provided document.
However, I can extract what is available regarding the type of study conducted:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated (likely mechanical/structural integrity standards for external fixation systems) | Equivalence confirmed through bench testing. |
(Note: The document states "Equivalence was confirmed through bench testing," implying that the device's performance, as measured by bench tests, was found to be comparable or "substantially equivalent" to the predicate device. However, the specific acceptance criteria (e.g., tensile strength, fatigue life) or the quantitative performance results are not detailed in this summary.)
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size for Test Set: Not specified.
- Data Provenance: Not applicable. The study involved "bench testing" of the physical device, not analysis of patient data.
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):
- Not applicable. This was a physical device bench test, not an expert-driven ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable.
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. This is a medical device for bone fixation, not an AI 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):
- For "bench testing," the "ground truth" would be the established engineering and biomechanical standards or the performance of the predicate device. The document does not specify the exact nature of these standards.
8. The sample size for the training set:
- Not applicable. This is a physical medical device, not an AI model.
9. How the ground truth for the training set was established:
- Not applicable.
In summary, the provided document focuses on regulatory approval (510(k)) based on substantial equivalence for a physical medical device. It mentions "bench testing" as the method to confirm equivalence but does not delve into the specifics of the test setup, acceptance criteria, or quantitative results that would be expected for an AI system's performance evaluation.
{0}------------------------------------------------
MAR 2 3 2009
510(k) Summary
| Submitted by: | DePuy Orthopaedics, Inc.700 Orthopaedic DriveWarsaw, IN 46581Phone: (305) 269-6386(305) 269-6441Fax: | |
|---|---|---|
| Contact Person: | Suzana Otaño, Project Manager, Regulatory Affairs | |
| Date Prepared: | December 18, 2008 | |
| GeneralProvisions | The name of the device is: | |
| Proprietary Name | Common or Usual Name | |
| ACE-Fischer External Fixation | Single/multiple component metallic bone | |
| System | fixation appliances and accessories | |
| Name of PredicateDevices | The device is substantially equivalent to the currently marketed DePuy ACE-Fischer External Fixation system that consists of K801594: ACE-Fischer ExternalFixation System, K860014: Fischer Wire/Pin Clamp, K875012: ACE-FischerPercutaneous Half Pins and K955388: ACE Dupont Composite Rings. | |
| Classification | Class II, 21 CFR 888.3030 and 888.3040 | |
| PerformanceStandards | Performance standards have not been established by the FDA under section 514of the Food, Drug and Cosmetic Act for these devices. | |
| Indications forUse | The updated ACE-Fischer® External Fixation System is indicated for open andclosed long bone fracture fixation to include tensioned wire fixation of periarticularfractures, arthrodesis, limb lengthening, osteotomy, reconstruction, non-unions,pseudoarthrosis, correction of bony or soft tissue defects and deformities. | |
| DeviceDescription | The updated ACE-Fischer® External Fixation System is a highly versatileframe that can be constructed for applications ranging from simple fractures tocomplex reconstruction. This modular system can be configured for manydifferent applications. | |
| Biocompatibility | The updated ACE-Fischer® External Fixation System does not requirebiocompatibility testing. | |
| Summary ofSubstantialEquivalence | The updated ACE-Fischer® External Fixation System is substantiallyequivalent to the predicate devices. Equivalence was confirmed through benchtesting. |
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image contains the text "Public Health Service". The text is written in a simple, sans-serif font. The words are arranged horizontally, with "Public" and "Health" on the first line and "Service" on the second line. The text appears to be part of a document or sign.
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" is arranged in a circular fashion around the bird symbol.
MAR 2 3 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DePuy Orthopaedics, Inc. % Ms. Suzana Otaño Project Manager, Regulatory Affairs 700 Orthopaedic Drive Warsaw, Indiana 46581
Re: K083789
Trade/Device Name: ACE-Fischer External Fixation System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and
accessories
Regulation Class: Class II Product Code: KTT, JDW Dated: February 18, 2009 Received: February 19, 2009
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
{2}------------------------------------------------
Page 2 - Ms. Suzana Otaño
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. 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 the reporting 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 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 vours,
Samghim, m.D. for
Mark N. Melkerson Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
K083789 510(k) Number:
ACE-Fischer® External Fixation System Device Name:
Indications For Use:
The updated ACE-Fischer® External Fixation System is indicated for open and closed long bone fracture fixation to include tensioned wire fixation of periarticular fractures, arthrodesis, limb lengthening, osteotomy, reconstruction, non-unions, pseudoarthrosis, correction of bony or soft tissue defects and deformities.
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)
Sh. Arim, M.D.
storative.
Page 1 of 1
5100k)
DePuy ACE-Fischer External Fixation System Special 510(k)
Page 42 of 82
§ 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.