(83 days)
The NEWDEAL® TTC Plates are intended for use in arthrodesis of the ankle joint and distal tibia, fractures, osteotomies, fusions and replantations of small bones including the foot and ankle.
The NEWDEAL® TTC Plates consists of a plate, available in different sizes, and implanted using NEWDEAL® locking system fixation screws and washers. The NEWDEAL® locking system includes as many fixation screws as there are threaded lipped sockets on the plate and as many washers as implanted screws. The NEWDEAL® locking system creates a single implant/screw unit fixed into the bone. The osteosynthesis screws must be driven into the bone through the holes in the plate. The system is locked by means of washers drilled into the threaded lipped socket at the top of each hole, thus blocking each screw head.
The provided document is a 510(k) summary for the NEWDEAL® TTC Plates, which are bone fixation devices. It details the device's description, intended use, and substantial equivalence to existing devices.
Crucially, this document describes a medical device clearance based on substantial equivalence, not a study evaluating an AI algorithm's performance. Therefore, many of the requested elements pertaining to AI studies (such as acceptance criteria for AI algorithms, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance) are not applicable and cannot be extracted from this text.
The document only states that "The results of performance tests demonstrate that the TTC Plates have mechanical properties compatible with the predicate devices and intended use." This indicates that mechanical testing was performed to demonstrate an equivalence of physical properties, not diagnostic performance.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied for Mechanical Properties) | Reported Device Performance (Implied) |
|---|---|
| Mechanical properties compatible with predicate devices | Compatible with predicate devices |
| Mechanical properties compatible with intended use | Compatible with intended use |
Explanation: The document does not provide specific numerical acceptance criteria (e.g., tensile strength, fatigue life) or exact performance values. It only states that the performance tests demonstrated compatibility.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This document does not describe a study involving an AI algorithm or a "test set" in the context of diagnostic performance evaluation. The "performance tests" mentioned are mechanical tests of the physical device. Therefore, no information on sample size for a test set or data provenance is provided.
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. There is no "ground truth" to be established by experts for a mechanical bone fixation plate in the context of this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No ground truth establishment for a diagnostic test set 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
- No. This is not an AI diagnostic device. No MRMC study was conducted or is relevant for this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. For a bone fixation plate, "ground truth" relates to its mechanical integrity and biocompatibility, which are assessed through engineering standards and material science, not clinical diagnostic ground truth. The "ground truth" for showing substantial equivalence relies on comparing the device's mechanical properties to those of the predicate devices and demonstrating that they meet the same functional requirements.
8. The sample size for the training set
- Not Applicable. This is not an AI algorithm.
9. How the ground truth for the training set was established
- Not Applicable. This is not an AI algorithm.
In summary: The provided text is a regulatory submission for a medical device (bone fixation plates) seeking clearance based on substantial equivalence. It does not involve an AI algorithm, and therefore the extensive information requested about AI study design and performance metrics is not present in this document. The "study" mentioned refers to mechanical performance tests of the physical device, not an evaluation of diagnostic accuracy.
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MAY 17 2008
510(K) SUMMARY
TTC Plates
Submitter's name and address: Newdeal SAS 10, place d'Helvétie
69006 Lyon, France Tel: +33 4 37 47 51 51 Fax: +33 4 37 47 51 52
Contact person and telephone number
Morgane Grenier Regulatory and Clinical Affairs Director Newdeal SAS 10, place d'Helvétie 69006 Lyon, France Tel: +33 4 37 47 51 51 Fax: +33 4 37 47 51 52
Alternate Contacts
Authorized Agent in the United States
Judith E. O'Grady, RN, MSN Sr. Vice President, Regulatory Affairs, Quality Assurance and Clinical Affairs Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, NJ 08536, USA Tel: (609) 936-2311 Fax: (609) 275-9445 E-mail: jogrady@integra-ls.com
Date Summary was prepared:
May 11, 2006
Name of the device:
| Proprietary Name: | TTC Plates |
|---|---|
| Common Name: | Plate, Fixation, Bone |
| Classification Name: | Single/multiple component metallic bone fixation appliances andaccessories (21CFR 888.3030) |
| Device Product Code: | HRS |
| Classification Panel: | Orthopedic |
Substantial Equivalence:
The TTC Plate is substantially equivalent to the Synthes Ankle Arthrodesis Plates, K022255 and the Synthes Modular Foot System - 2.7 mm Module, K010321.
Device Description:
The NEWDEAL® TTC Plates consists of a plate, available in different sizes, and implanted using NEWDEAL® locking system fixation screws and washers.
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The NEWDEAL® locking system includes as many fixation screws as there are threaded lipped sockets on the plate and as many washers as implanted screws.
The NEWDEAL® locking system creates a single implant/screw unit fixed into the bone. The osteosynthesis screws must be driven into the bone through the holes in the plate. The system is locked by means of washers drilled into the threaded lipped socket at the top of each hole, thus blocking each screw head.
Intended Use:
The NEWDEAL® TTC Plates are intended for use in arthrodesis of the ankle joint and distal tibia, fractures, osteotomies, fusions and replantations of small bones including the foot and ankle.
Testing and Test Results:
The results of performance tests demonstrate that the TTC Plates have mechanical properties compatible with the predicate devices and intended use.
Conclusion
The Newdeal TTC Plates are substantially equivalent to commercially marketed devices, the Synthes Ankle Arthrodesis Plate, K022255 and the Synthes Modular Foot System - 2.7 mm Module, K010321.
The Newdeal TTC Plates do not raise any new issues of scientific technology, safety or effectiveness.
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Image /page/2/Picture/1 description: The image is a seal for the Department of Health and Human Services (HHS) in the United States. The seal features the HHS logo, which is a stylized representation of three human figures. The logo is surrounded by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
TAY 17 2006
Newdeal SA c/o Ms. Judith O'Grady, R.N., M.S.N. Sr. VP. Regulatory Affairs Integra Lifesciences Corporation 311 Enterprise Drive Plainsboro, New Jersey 08536
Re: K060473
Trade/Device Name: TTC Plate Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: May 11, 2006 Received: May 12, 2006
Dear Ms. O'Grady:
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
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Page 2 - Ms. Judith O'Grady, R.N., M.S.N.
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. 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 requlation 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 vours.
Herbert Hoover hp
Mark N. Melkerson, M.S. 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): K060473
Device Name: TTC Plates
Indications For Use:
The NEWDEAL® TTC Plates are intended for arthrodesis of the ankle joint and distal tibia, fractures, osteotomies, fusions and replantations of small bones in the floor and ankle.
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)
Hubert Lemerno
Page 1 of 1
sion Sign-Division of General, Restorative, and Neurological Devices
510(k) Number K060473
§ 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.