(64 days)
Synthes 4.0mm Ti. Locking screws are intended to be used with existing Synthes LCP® plating systems for the fixation of various long bones, such as the humerus, femur and tibia.
The Synthes 4.0mm Ti. Locking Screws feature a self-tapping tip, stardrive mechanishm, and have a flat head profile with rounded edges. They are available in lengths ranging from 14mm to 90mm. The threads below the head of each locking screw are designed to engage with the threaded holes of currently marketed Synthes LCP® plating systems.
The provided text describes a 510(k) premarket notification for Synthes 4.0mm Titanium Locking Screws. It focuses on establishing substantial equivalence to a predicate device rather than detailing extensive performance studies against specific acceptance criteria. Therefore, several of the requested sections regarding AI device performance studies (MRMC, standalone, training set, ground truth for training set) are not applicable or cannot be extracted from this document.
Here's the information that can be extracted:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or detailed performance metrics against those criteria. The primary "performance" discussed is the device's substantial equivalence to a predicate device, implying that its mechanical and material properties are comparable and acceptable for its intended use.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as pass/fail criteria. The overarching "acceptance criterion" is demonstrating substantial equivalence to the predicate device. | The FDA reviewed the 510(k) and determined the device is substantially equivalent to legally marketed predicate devices for its intended use. |
2. Sample size used for the test set and the data provenance
The document does not describe a "test set" in the context of an AI/algorithm performance study. The 510(k) process for this type of medical device (bone fixation fastener) typically relies on engineering and material testing, and comparison to a predicate device, rather than performance against a clinical test set with ground truth.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is not an AI/diagnostic algorithm that relies on expert interpretation for ground truth establishment.
4. Adjudication method 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
Not applicable. This is not an AI diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI diagnostic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for this device's safety and effectiveness would be established through material testing (e.g., strength, biocompatibility), design verification, and comparison to the predicate device's established performance and safety record, rather than clinical ground truth like pathology or outcomes data in the context of an AI study.
8. The sample size for the training set
Not applicable. This is not an AI diagnostic device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI diagnostic device.
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OCT 22 2003
3.0 Summary of Safety and Effectiveness Information [510(k) Summary]
| SPONSOR: | Synthes (USA)1690 Russell RoadPaoli, PA 19301(610) 647-9700Contact: Lisa M. Boyle |
|---|---|
| DEVICE NAME: | Synthes 4.0mm Titanium (Ti.) Locking Screws |
| CLASSIFICATION: | Class II § 21 CFR 888.3040: Smooth or Threaded Metallic Bone FixationFastener. |
| PREDICATE DEVICE: | Synthes 4.0 mm Stainless Steel Locking Screws |
| DEVICE DESCRIPTION: | The Synthes 4.0mm Ti. Locking Screws feature a self-tapping tip, stardrivemechanishm, and have a flat head profile with rounded edges. They areavailable in lengths ranging from 14mm to 90mm. The threads below thehead of each locking screw are designed to engage with the threaded holesof currently marketed Synthes LCP® plating systems. |
| INTENDED USE: | Synthes 4.0mm Ti. Locking screws are intended to be used with existingSynthes LCP® plating systems for the fixation of various long bones, suchas the humerus, femur and tibia. |
| SUBSTANTIALEQUIVALENCE: | Comparative information presented supports substantial equivalence. |
| MATERIAL | Titanium Alloy |
Confidential
·
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle.
Public Health Service
OCT 2 2 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Lisa M. Boyle Regulatory Associate Synthes (USA) 1690 Russell Road Post Office Box 1766 Paoli, PA 19301
Re: K032559
Trade/Device Name: Synthes (USA) 4.0mm Titanium Locking Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HRS Dated: August 18, 2003 Received: August 19, 2003
Dear Ms. Boyle:
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. Lisa M. Boyle
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 (301) 594-4659. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark N. Mikkelson
Celia M. Witten, Ph.D., M.D. 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 Statement 2.0
Page 1 of 1
| 510(k) Number (if known): | K032559 |
|---|---|
| Device Name: | Synthes (USA) 4.0mm Titanium Locking Screws |
Indications: Synthes 4.0mm Titanium Locking Screws are intended to be used with existing Synthes LCP® plating systems for the fixation of various long bones, such as the humerus, femur and tibia.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use_
Monk N. Miller
Division Sign-Off) Division of General. Restorative and Neurological Devices
Confidential
§ 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.