(78 days)
The Synthes 3.5 mm Cortex Screws are intended for fixation of fractures, osteotomies and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, calaneous, femur and fibula.
The 3.5 mm cortex screws are self-tapping, have a stardrive recess, and are manufactured from stainless steel and titanium. The self-tapping screws are available in various lengths ranging from 10-150 mm.
This document is a 510(k) Summary for Synthes 3.5mm Cortex Screws, which are a physical medical device (bone fixation fastener). It is not an AI/ML-driven device but rather a traditional medical device. Therefore, the specific information requested in the prompt regarding acceptance criteria for AI models, study types (MRMC, standalone), ground truth details, sample sizes for test and training sets, and expert qualifications for AI model validation is not applicable to this document.
The document mainly describes the device, its intended use, classification, and its substantial equivalence to a predicate device, which is the basis for its clearance by the FDA.
Here's the relevant information that can be extracted, framed within the context of a traditional device clearance:
1. A table of acceptance criteria and the reported device performance
For traditional devices like this, explicit "acceptance criteria" against quantifiable performance metrics in the same way an AI model would have them are not typically stated in a 510(k) summary. Instead, the "acceptance" is implicitly based on demonstrating substantial equivalence to a legally marketed predicate device. This usually involves:
| Acceptance Criteria (Implied for Traditional Devices) | Reported Device Performance (from document) |
|---|---|
| Similar Intended Use | The Synthes 3.5 mm Cortex Screws are intended for fixation of fractures, osteotomies and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, calaneous, femur and fibula. (This is identical to the assumed intended use of the legally marketed predicate device, Synthes 3.5 mm Cortex Screws (which already exists, hence the name similarity implying it's an updated version or specific iteration of an existing product)). This is a crucial aspect of substantial equivalency. |
| Similar Technological Characteristics (Material) | Manufactured from stainless steel and titanium. (This would be compared to the predicate device's materials.) |
| Similar Technological Characteristics (Design) | Self-tapping, stardrive recess, available in various lengths ranging from 10-150 mm. (This would be compared to the predicate device's design features.) |
| Safety and Effectiveness (Implied Equivalence) | "Information presented supports substantial equivalence." This statement is the reported performance in the context of a 510(k) – it means the device is considered as safe and effective as the predicate device. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable and not provided in a 510(k) summary for a mechanical device. There isn't typically a "test set" of data in the sense of a data set used to evaluate an algorithm. The "testing" for such devices often involves mechanical and biocompatibility testing, but specifics are not in this summary.
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" establishment by experts in the context of an algorithm for this type of device. The clearance is based on engineering specifications, material properties, and comparison to a predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) 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, as this is a mechanical device, not an AI/ML-driven diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. For a mechanical device, "ground truth" would relate to its physical properties meeting design specifications and clinical performance in terms of fracture fixation, which is generally established through mechanical testing, biocompatibility studies, and clinical experience with similar predicate devices, rather than expert consensus on a data set.
8. The sample size for the training set
Not applicable. There is no "training set" for physical medical devices of this nature.
9. How the ground truth for the training set was established
Not applicable.
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3.0
K 04/3/85
| 510(k) Summary | Page 1 of 1 |
|---|---|
| Sponsor: | Synthes (USA)1690 Russell RoadPaoli, PA 19301(610) 647-9700 |
| Device Name: | Synthes 3.5mm Cortex Screws |
| Classification: | 21 CFR 888.3040: Smooth or Threaded Metallic Bone FixationFastener. |
| Predicate Devices: | Synthes 3.5 mm Cortex Screws |
| Device Description: | The 3.5 mm cortex screws are self-tapping, have a stardrive recess,and are manufactured from stainless steel and titanium. The self-tapping screws are available in various lengths ranging from 10-150 mm. |
| Intended Use: | The Synthes 3.5 mm Cortex Screws are intended for fixation offractures, osteotomies and non-unions of the clavicle, scapula,olecranon, humerus, radius, ulna, pelvis, tibia, calaneous, femurand fibula. |
| SubstantialEquivalence: | Information presented supports substantial equivalence. |
:
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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FEB - 3 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Lisa M. Boyle Regulatory Specialist Synthes (USA) 1690 Russel Road Paoli, Pennsylvania 19301
Re: K043185
Trade/Device Name: Synthes (USA) 3.5mm Cortex Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: November 16, 2004 Received: November 17, 2004
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 clectronic 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 (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,
Mark McMillan
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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Page 1 of
Indications for Use
510(k) Number (if known):
Device Name:
2.0
Synthes (USA) 3.5 mm Cortex Screws
Indications for Use:
The Synthes 3.5 mm Cortex Screws are intended for fixation of fractures, osteotomies and nonunions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, calcaneous, femur and fibula.
X 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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number K043185
§ 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.