(90 days)
The SBi ArtFIX is intended for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device.
The SBi ArtFIX System consists of compression screws that are used for internal fixation. ArtFIX is a cannulated, fully threaded, headless compression screw based on a conical design. The ArtFIX screw has a cutting tip and three thread configurations along its length.
This looks like an FDA 510(k) premarket notification for a medical device called "SBi ArtFIX," which is a bone fixation screw. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a clinical study as would be seen for a novel AI/software medical device.
Therefore, the provided text does not contain the information requested regarding acceptance criteria and the study that proves the device meets those criteria, as it's not a performance study report for an AI device.
Let's break down why the requested information isn't present in this document and what each point asks for:
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A table of acceptance criteria and the reported device performance: This would typically be a table outlining specific metrics (e.g., sensitivity, specificity, accuracy for an AI device, or mechanical strength thresholds for a physical device) and the study results demonstrating the device met those pre-defined thresholds. The provided 510(k) summary for SBi ArtFIX focuses on substantial equivalence based on design, materials, and intended use, not performance against acceptance criteria.
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): This refers to the characteristics of the dataset used to evaluate an AI model's performance. Since SBi ArtFIX is a physical bone screw and not an AI/software device, there is no "test set" in this context.
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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): Ground truth is crucial for evaluating AI performance. For a physical device like a screw, there isn't "ground truth" established by experts in the same way as for diagnostic imaging.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: This describes how discrepancies in expert opinions were resolved when establishing ground truth for an AI device. Not applicable here.
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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: This is specifically for evaluating the impact of AI assistance on human performance, a concept entirely unrelated to a bone fixation screw.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: This describes an AI device's performance without human interaction. Not applicable for a physical medical device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): As mentioned, "ground truth" for a physical screw isn't defined by these methods. Performance for such devices would be based on mechanical testing (e.g., fatigue, torsion, pull-out strength) and clinical outcomes in predicate device equivalency, not expert consensus on data.
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The sample size for the training set: Refers to the dataset used to train an AI model. Not applicable for a physical device.
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How the ground truth for the training set was established: Similar to point 8, not applicable for a physical device.
In summary, the provided document is a 510(k) clearance letter for a bone fixation screw, which establishes substantial equivalence to a predicate device based on design, materials, and intended use, not through a performance study that measures against specific acceptance criteria for an AI or software device.
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K07/656
510(k) Summary
AUG 2 7 2007
| Manufacturer: | Small Bone Innovations International, SAZ.A. Les BruyeresPeronnas France 01960 |
|---|---|
| Submitted By: | Small Bone Innovations1380 South Pennsylvania AvenueMorrisville, PA 19067 |
| Proprietary Name: | SBi ArtFIX |
| Classification name: | Class II, 888.3040 - Screw, Fixation, Bone |
| Common/Usual Name: | Smooth or threaded metallic bone fixation fastener |
| Product Code: | HWC |
| Substantial Equivalence: | Documentation is provided which demonstrated the SBiArtFIX to be substantially equivalent to other legallymarketed devices. |
| Device Description: | The SBi ArtFIX System consists of compression screwsthat are used for internal fixation. ArtFIX is a cannulated,fully threaded, headless compression screw based on aconical design. The ArtFIX screw has a cutting tip andthree thread configurations along its length. |
| Intended Use: | The SBi ArtFIX is intended for bone reconstruction,osteotomy, arthrodesis, joint fusion, fracture repair, andfracture fixation of bones appropriate for the size of thedevice. |
| Material: | The implants are made from Ti-6Al-4V per ISO 5832-3 |
:
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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 consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized symbol featuring three abstract human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Small Bone Innovations, Inc. % Musculoskeletal Clinical Regulatory Advisors, LLC Mr. Robert Hoehn Regulatory Associate 505 Park Avenue, 14th Floor New York, New York 10022
AUG 2 7 2007
Re: K071656 Trade/Device Name: SBi ArtFIX Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: May 23, 2007 Received: May 29, 2007
Dear Mr. Hoehn:
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
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Page 2 - Mr. Robert Hoehn
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.
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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Barbara Buchner
Mark N. Më lkerson 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:
Device Name: SBi ArtFIX
Indications For Use:
The SBi ArtFIX is indicated for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the device.
Prescription Use V (Part 21 CFR 801 Subpart D)
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)
Page 1 of 1
Barbara Bonchm
Division of General, Restorative, and Neurological Devices
510(k) Number K071686
§ 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.