(41 days)
The Synthes 3.5 mm Conical Screws are intended to be used with existing Synthes LCP plating systems for fixation and interfragmentary compression of various bones, such as the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia and fibula, particularly in osteopenic bone.
The 3.5 mm conical screws are self-tapping, have a stardrive or hex drive recess, and are manufactured from stainless steel and titanium. The 3.5 mm conical screws are available in various lengths ranging from 40-95 mm.
The provided text is a 510(k) summary for the Synthes 3.5mm Conical Screws. This type of regulatory document focuses on demonstrating substantial equivalence to a predicate device, primarily through comparing device characteristics and intended use. It does not contain information about acceptance criteria or specific study results that would typically be found for a device like AI software or diagnostics.
Therefore, I cannot provide the requested information. The document focuses exclusively on the administrative and regulatory aspects of device classification and equivalence rather than performance studies that would measure metrics like sensitivity, specificity, or reader improvement.
To directly answer your request based on the provided text:
- A table of acceptance criteria and the reported device performance: Not available. The document is about substantial equivalence, not performance metrics.
- Sample size used for the test set and the data provenance: Not available. No "test set" in the context of device performance is mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available. No ground truth establishment is described.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not available.
- 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 a bone fixation screw, not an AI-assisted device.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a bone fixation screw, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not available.
- The sample size for the training set: Not applicable. No training set is mentioned for a physical medical device like this.
- How the ground truth for the training set was established: Not applicable.
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Image /page/0/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a design inside. A horizontal line runs underneath the word "SYNTHES". A small "R" in a circle is located to the right of the word.
| 510(k) Summary | Page 1 of 1 |
|---|---|
| Sponsor: | Synthes (USA)1302 Wrights Lane EastWest Chester, PA 19380(610) 719-5000 |
| Device Name: | Synthes 3.5mm Conical Screws |
| Classification: | 21 CFR 888.3040: Smooth or Threaded Metallic Bone FixationFastener. |
| Predicate Devices: | Synthes 3.5 mm Locking Screws |
| Device Description: | The 3.5 mm conical screws are self-tapping, have a stardrive or hexdrive recess, and are manufactured from stainless steel andtitanium. The 3.5 mm conical screws are available in variouslengths ranging from 40-95 mm. |
| Intended Use: | The Synthes 3.5 mm Conical Screws are intended to be used withexisting Synthes LCP plating systems for fixation andinterfragmentary compression of various bones, such as theclavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia andfibula, particularly in osteopenic bone. |
| 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 & Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with healthcare, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the symbol. The caduceus is depicted with three wavy lines, and the text is in a sans-serif font.
Public Health Service
APR 2 7 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Kathy Anderson Regulatory Affairs Manager Synthes (USA) 1302 Wrights Lane East West Chester, Pennsylvania 19380
Re: K050683
Trade/Device Name: Synthes (USA) 3.5mm Conical Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: March 16, 2005 Received: March 17, 2005
Dear Ms. Anderson:
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. Kathy Anderson
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,
Miriam C. Provost, Ph.D. Acting 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):
Device Name:
Synthes (USA) 3.5 mm Conical Screws
Indications for Use:
The Synthes 3.5 mm Conical Screws are intended to be used with existing Synthes LCP plating systems for fixation and interfragmentary compression of various bones, such as the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia and fibula, particularly in osteopenic bone.
Prescription Use (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)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.