(87 days)
The Synthes 3.5 mm LCP Distal Tibia T Plates are indicated for fractures, osteotomies, and non-unions of the distal tibia, especially in osteopenic bone.
Synthes 3.5 mm LCP Distal Tibia T Plates are contoured to match the anatomy of the distal tibia. The plates have both combination and locking screw holes which accept various Synthes screws. They are available in stainless steel and titanium, in a variety of lengths.
This 510(k) summary is for the Synthes 3.5 mm LCP Distal Tibia T Plates, a bone fixation device. This type of device falls under the category of traditional medical hardware and therefore does not typically involve the kinds of studies (e.g., AI algorithms, MRMC studies, ground truth establishment) that would be relevant to software-as-a-medical-device (SaMD) or AI/ML-powered devices.
As such, many of the requested elements for describing acceptance criteria and study details are not applicable to this specific device. The approval for this device is based on substantial equivalence to predicate devices. The "performance" in this context refers to meeting design specifications and mechanical testing standards, not clinical performance derived from AI predictions or human reader performance.
Here's an attempt to address the request based on the provided document, highlighting what is (and isn't) present:
1. Table of acceptance criteria and the reported device performance:
The provided document (K080522) does not explicitly state specific quantitative acceptance criteria or detailed device performance metrics in the way one would see for an AI/ML device (e.g., sensitivity, specificity, AUC). For traditional orthopedic implants like this, acceptance criteria would typically relate to:
- Design Specifications: Conformance to material standards (e.g., stainless steel, titanium), dimensions, screw hole configurations (combination and locking).
- Mechanical Testing: Bench testing for strength, fatigue life, and torsional rigidity, often compared to the predicate device or established standards for such implants.
- Biocompatibility: Confirmation that the materials meet biocompatibility standards for implantable devices.
The document implicitly states that the device "conforms to the appropriate Synthes (USA) standards and has demonstrated substantial equivalence to currently marketed predicate devices." This implies that the device met internal design and testing standards, which serve as its acceptance criteria.
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Conformance to design specifications (materials, dimensions, hole types) | Device is available in stainless steel and titanium, with combination and locking screw holes, and contoured to match distal tibia anatomy (as described). |
| Mechanical integrity (strength, fatigue, rigidity) | Demonstrated substantial equivalence to identified predicate devices (Synthes One Third Tubular LCP Plate, Synthes 3.5 mm LCP Straight Plate) through testing performed (not detailed in this summary). |
| Biocompatibility | Materials are standard implant-grade stainless steel and titanium, meeting established biocompatibility requirements for these materials. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable in the context of an "AI/ML test set." For mechanical testing of medical hardware, "samples" would refer to the number of physical plates tested. This information is not provided in the 510(k) summary.
- Data Provenance: Not applicable in the context of an "AI/ML test set." The testing would be conducted in a laboratory environment, not on patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The "ground truth" for a bone fixation plate is its mechanical performance and proper surgical application, not a diagnosis or classification by an expert. Clinical experts (surgeons) would validate the design and usability, but not establish "ground truth" in the AI sense.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are relevant for subjective interpretations, typically in imaging or clinical diagnosis, not for the objective mechanical testing of a medical device.
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 device is not an AI algorithm assisting human readers. It is a physical orthopedic implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable in the context of AI/ML. For this device, the "ground truth" for its performance would be derived from engineering standards, mechanical testing results, and established clinical performance of predicate devices that demonstrate safe and effective bone fracture fixation.
8. The sample size for the training set:
- Not applicable. This device does not involve a "training set" as it's not an AI/ML algorithm.
9. How the ground truth for the training set was established:
- Not applicable.
Summary regarding K080522:
The provided 510(k) summary for the Synthes 3.5 mm LCP Distal Tibia T Plates is for a traditional, physical medical device (an orthopedic implant), not a software or AI/ML-based device. Therefore, the questions related to acceptance criteria, test sets, ground truth establishment, expert involvement, and AI performance metrics are generally not relevant or applicable to this submission. The device received 510(k) clearance based on its substantial equivalence to existing predicate devices, meaning it was determined to be as safe and effective as devices already on the market through conformance to design specifications and mechanical testing results (which are not detailed in this summary document but would have been part of the full submission).
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MAY 2 3 2008 2008 2008
| 3.0 | 510(k) Summary | Page 1 of 1 |
|---|---|---|
| Sponsor: | Synthes (USA)1301 Goshen ParkwayWest Chester, PA 19380(610) 719-6940 | |
| Contact: | Sheri L. MusgnungSynthes (USA)1301 Goshen ParkwayWest Chester, PA 19380(610) 719-6940FAX (610) 484-356-9682 | |
| Device Name: | Synthes 3.5 mm LCP Distal Tibia T Plates | |
| Classification: | Class II, §888.3030 - Single/multiple component metallic bonefixation appliances and accessories | |
| Predicate Device: | Synthes One Third Tubular LCP PlateSynthes 3.5 mm LCP Straight Plate | |
| Device Description: | Synthes 3.5 mm LCP Distal Tibia T Plates are contoured to matchthe anatomy of the distal tibia. The plates have both combinationand locking screw holes which accept various Synthes screws.They are available in stainless steel and titanium, in a variety oflengths. | |
| Intended Use: | The Synthes LCP Distal Tibia T Plates are indicated for fractures,osteotomies, and non-unions of the distal tibia, especially inosteopenic bone. | |
| SubstantialEquivalence: | Information presented supports substantial equivalence. |
® SYNTHES®
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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 forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 3 - 2008
Synthes (USA) % Ms. Sheri L. Musgung Regulatory Affairs Managcr 1301 Goshen Parkway West Chester, Pennsylvania 19380
Re: K080522 Trade/Device Name: Synthes 3.5 mm LCP Distal Tibia T Plates Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: February 25, 2008 Received: February 26, 2008
Dear Ms. Musgung:
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. Sheri L. Musgung
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 toll-free number (800) 638-2041 or (240) 276-3150 or Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark H. Millman
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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2.0
Indications for Use
· 510(k) Number (if known):
Device Name:
Synthes 3.5 mm LCP Distal Tibia T Plates
Indications for Use:
The Synthes 3.5 mm LCP Distal Tibia T Plates are indicated for fractures, osteotomies, and non-unions of the distal tibia, especially in osteopenic bone.
Prescription Use X (Per 21 CFR 801.109)
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)
Neil R.P. Orde forman
(Division Sign-Of Division of General, Restorative and Neurological Devices
510(k) Number K080522
§ 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.