(56 days)
The Synthes Spherical Washers are intended to prevent a screw head from breaking through the cortex of the bone by distributing the forces/ load over a large area when used for fracture fixation of large (long) bone and bone fragments.
In addition, the Spherical Washers are intended to prevent the projection of the screw head, when the screw must be inserted at an acute angle (e.g., in ankle arthrodesis).
The Spherical Washers are round or oval in design with a slotted center hole which allows for screw angulation up to 70 degrees. They are used with 4.5 - 7.3 mm diameter screws and manufactured from Stainless Steel and Titanium.
This 510(k) summary describes a medical device, the Synthes Spherical Washers, and its intended use. However, it does not contain any information about acceptance criteria, device performance testing, or study details such as sample sizes, ground truth establishment, or expert involvement.
The document is a premarket notification for a Class II medical device, which typically involves demonstrating substantial equivalence to a predicate device rather than conducting extensive clinical efficacy studies with specific performance metrics and acceptance criteria in the same way a PMA device might.
Therefore, for almost all of your requested information, the answer is that the document does not provide it.
Here's a breakdown of what can be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Response: Not provided in the document. The document focuses on demonstrating substantial equivalence to a predicate device, not on presenting specific performance data against pre-defined acceptance criteria.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Response: Not provided in the document. This type of information is not typically part of a 510(k) summary for a mechanical device like a washer, which relies on design specifications and material properties rather than clinical imaging data sets.
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)
- Response: Not applicable/Not provided. The regulatory submission for a spherical washer does not typically involve expert review of a "test set" in the context of diagnostic performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Response: Not applicable/Not provided.
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
- Response: Not applicable. This device is a mechanical implant (spherical washer), not an AI-powered diagnostic or assistive tool. MRMC studies are irrelevant to this product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Response: Not applicable. This device is a mechanical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Response: Not applicable. For this type of device, "ground truth" would relate to its mechanical properties and biocompatibility, which are assessed through engineering tests and material specifications, not through clinical diagnostic "ground truths."
8. The sample size for the training set
- Response: Not applicable/Not provided. This device is not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
- Response: Not applicable/Not provided.
Summary of what the document does provide:
- Device Name: Synthes Spherical Washers
- Intended Use: To prevent a screw head from breaking through the cortex of the bone by distributing forces/load over a large area during fracture fixation of large (long) bones and bone fragments. Also, to prevent screw head projection when inserted at an acute angle (e.g., in ankle arthrodesis).
- Predicate Device: Synthes 13.0 mm Washer
- Classification: Class II
- Regulatory Basis: Substantial Equivalence to a predicate device. This means the device met the requirements by demonstrating it is as safe and effective as a legally marketed device that does not require PMA. This typically involves performance bench testing, material characterization, and comparison of design to the predicate, rather than clinical trials with specific performance metrics like sensitivity/specificity.
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A SYNTHES.
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'K052483p.4
| NOV | 4 2005 |
|---|---|
| ----- | -------- |
| 3.0 | 510(k) Summary | Page 1 of 1 |
|---|---|---|
| Sponsor: | Synthes (USA)1302 Wrights Lane EastWest Chester, PA 19380(610) 719-5000 | |
| Device Name: | Synthes Spherical Washers | |
| Classification: | 21 CFR 888.3030: Washer, bolt, nut, non-spinal, metallic (NDG)21CFR 888.3040: Screw, Fixation, bone, non-spinal (HWC) | |
| Predicate Devices: | Synthes 13.0 mm Washer | |
| Device Description: | The Spherical Washers are round or oval in design with a slottedcenter hole which allows for screw angulation up to 70 degrees.They are used with 4.5 - 7.3 mm diameter screws andmanufactured from Stainless Steel and Titanium. | |
| Intended Use: | The Synthes Spherical Washers are intended to prevent a screwhead from breaking through the cortex of the bone by distributingthe forces/ load over a large area when used for fracture fixation oflarge (long) bone and bone fragments.In addition, the Spherical Washers are intended to prevent theprojection of the screw head, when the screw must be inserted at anacute angle (e.g., in ankle arthrodesis). | |
| SubstantialEquivalence: | Information presented supports substantial equivalence. |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings and a circular border. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged around the border of the circle.
NOV - 4 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Lisa M. Boyle Regulatory Specialist Synthes (USA) 1302 Wrights Lane East West Chester, Pennsylvania 19380
Re: K052483 Trade/Device Name: Synthes (USA) Spherical Washers Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: NDG, HWC Dated: October 19, 2005 Received: October 24, 2005
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 - 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 (240) 276-0120. 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/industry/support/index.html.
Sincerely yours,
C. M. Malik
Mark N. Metkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
2.0
Indications for Use
510(k) Number (if known):
KC52483
Device Name:
Synthes (USA) Spherical Washers
Indications for Use:
The Synthes Spherical Washers are intended to prevent a screw head from breaking through the cortex of the bone by distributing the forces/ load over a large area when used for fracture fixation of large (long) bone and bone fragments.
In addition, the Spherical Washers are intended to prevent the projection of the screw head, when the screw must be inserted at an acute angle (e.g., in ankle arthrodesis).
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)
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
510/k) Number_KOS 2483
§ 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.