(16 days)
Synthes 6.5mm Midfoot Fusion Bolt is indicated for fracture fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Synthes 6.5mm Midfoot Fusion Bolt is a solid metallic fixation bolt which is intended to be used in procedures involving the foot and ankle. The 6.5mm Midfoot Fusion Bolt is partially threaded on both ends and will be available in versions composed of implant quality stainless steel and titanium alloy.
The provided text is a 510(k) summary for the Synthes 6.5mm Midfoot Fusion Bolt. This document focuses on demonstrating substantial equivalence to a predicate device for regulatory approval, primarily through mechanical testing and comparison of design, materials, and intended use. It does not contain information about acceptance criteria or a study proving device performance in a clinical or AI-assisted context.
Therefore, I cannot populate the requested table or answer the questions related to clinical study design, AI performance, ground truth, or expert involvement. The information provided is for a traditional medical device (implantable screw/bolt) and not an AI/ML-driven diagnostic or therapeutic device.
Here's a breakdown of what can be extracted from the document based on the request, and why other parts cannot be answered:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document does not describe acceptance criteria for clinical performance (e.g., sensitivity, specificity, accuracy) nor does it report clinical device performance data. The "performance" discussed implicitly within a 510(k) for an implantable device like this typically refers to mechanical and material properties (e.g., fatigue strength, tensile strength, biocompatibility), which are usually compared against the predicate device or established standards. These specific performance metrics and their acceptance criteria are not detailed in this summary.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. This question refers to a test set for assessing clinical performance, likely for AI/ML. The document does not describe any clinical test sets or performance studies.
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)
- Cannot be provided. This question pertains to establishing ground truth for evaluating a diagnostic or AI system. The document does not mention any such expert panel or ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided. This refers to a method used to resolve discrepancies in ground truth establishment, typically in clinical studies of diagnostic tools. Not applicable to this document.
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
- Cannot be provided. This document is silent on any MRMC studies or AI assistance. The device is a surgical implant, not a diagnostic or AI tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be provided. Not applicable. The device is a physical implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be provided. No ground truth for clinical performance is discussed. For an implant like this, "ground truth" might refer to successful implantation, fracture healing, or lack of adverse events, but no such data is presented here.
8. The sample size for the training set
- Cannot be provided. Not applicable to a physical implant. This refers to training data for AI/ML models.
9. How the ground truth for the training set was established
- Cannot be provided. Not applicable for the same reasons as above.
In summary, the provided content for the Synthes 6.5mm Midfoot Fusion Bolt is a regulatory submission for a traditional Class II medical device. It focuses on physical equivalence and safety through design, material comparison, and potentially mechanical testing (though not detailed here), rather than clinical performance studies that would involve acceptance criteria for diagnostic accuracy, AI performance, or human reader effectiveness.
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3.0 510(k) Summary
Page ________ of ____ of __1
| Sponsor: | Synthes (USA)Karl J. Nittinger1301 Goshen ParkwayWest Chester, PA 19380(610) 719-6941 |
|---|---|
| Device Name: | Synthes 6.5mm Midfoot Fusion Bolt |
| Classification: | Class II, §888.3040 - Smooth or threaded metallic bone fixationfastener |
| Predicate Device: | Synthes 6.5mm Cannulated Screw |
| Device Description: | Synthes 6.5mm Midfoot Fusion Bolt is a solid metallic fixation boltwhich is intended to be used in procedures involving the foot andankle. The 6.5mm Midfoot Fusion Bolt is partially threaded on bothends and will be available in versions composed of implant qualitystainless steel and titanium alloy. |
| Intended Use: | Synthes 6.5mm Midfoot Fusion Bolt is indicated for fracturefixation, osteotomies, nonunions, and fusions of large bones in thefoot and ankle. |
| Substantial | Information presented supports substantial equivalence. |
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a double helix-like design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 1 2008
Synthes (USA) % Mr. Karl Nittinger 1301 Goshen Parkway West Chester, PA 19380
MAY - 1 2008
Re: K081071 Trade/Device Name: Synthes 6.5mm Midfoot Fusion Bolt Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: April 14, 2008 Received: April 15, 2008
Dear Mr. Nittinger:
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 – Mr. Karl Nittinger
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 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 the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M. 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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Image /page/3/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 is located underneath the word "SYNTHES" and the logo. The registered trademark symbol is located to the right of the word.
Indications for Use
510(k) Number (if known):
(08107
Device Name:
2.0
Synthes 6.5mm Midfoot Fusion Bolt
Indications for Use:
Synthes 6.5mm Midfoot Fusion Bolt is indicated for fracture fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
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)
Nel Re Ol (or mtn
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
510(k) Number K081071
§ 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.