(23 days)
The SBi Carpal Fusion Plate is designed for fusion of the carpal bones of the hand including; capitate, hamate, lunate, and triquetrum. The fusion plate is intended for use in patients suffering from pain and/or loss of function due to osteoarthritis, post-traumatic arthritis, fractures, revision of failed partial wrist fusions, carpal instability, or rheumatoid arthritis. The fusion plate is used in conjunction with screws that fix the plate to the carpal bones of the hand.
The SBI Carpal Fusion Plate is a low profile single piece construct designed to fit over the dorsal aspect of the carpal bones in the hand. The plate has spherical holes or slots that accommodate screws for fixation. The plate and screws are fabricated from implantable grade stainless steel.
The provided text is a 510(k) summary for a medical device called the "SBI Carpal Fusion Plate." This document type primarily focuses on establishing substantial equivalence to a legally marketed predicate device rather than presenting a detailed study with acceptance criteria and device performance metrics in the way an AI/ML clinical study would.
Therefore, the information typically requested for a clinical study of an AI/ML device (such as sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types) is not applicable to this 510(k) summary for a physical orthopedic implant.
Here's a breakdown based on the content available:
1. A table of acceptance criteria and the reported device performance
- Not applicable. This 510(k) summary does not define specific performance acceptance criteria (e.g., accuracy, sensitivity, specificity) for the SBI Carpal Fusion Plate in the clinical study context. Instead, it demonstrates substantial equivalence to existing devices. Performance is implied to be similar to 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)
- Not applicable. No clinical test set data is presented in this 510(k) summary. The submission relies on material safety, biocompatibility, and mechanical testing to demonstrate substantial equivalence, rather than a clinical performance study with a test set of patient data.
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. No clinical test set with ground truth established by experts is discussed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set requiring adjudication is discussed.
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. This is a medical device (plate and screws), not an AI/ML-driven diagnostic tool. Therefore, MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. Clinical performance ground truth is not typically established for this type of device through clinical studies described in 510(k) summaries in the same way it is for diagnostic algorithms. For an implant, "ground truth" might pertain to established biomechanical properties, material compatibility, or surgical outcomes observed over time, which are implicitly covered by its substantial equivalence to predicate devices and adherence to relevant standards.
8. The sample size for the training set
- Not applicable. No training set for an algorithm is relevant here.
9. How the ground truth for the training set was established
- Not applicable. No training set for an algorithm is relevant here.
Summary of the K062903 510(k) based on the provided text:
This 510(k) submission establishes the substantial equivalence of the SBI Carpal Fusion Plate to other legally marketed devices.
- Manufacturing: rms Company, Minneapolis, MN.
- Submission By: Small Bone Innovations, New York, NY.
- Device Name: SBI Carpal Fusion Plate.
- Classification: Class II, 21 CFR 888.3030 - Plate, Fixation, Bone.
- Predicate Device: Documentation provided demonstrates substantial equivalence to other legally marketed devices (specific predicate not named in this excerpt but usually required in the full submission).
- Device Description: Low profile, single-piece construct designed for dorsal aspect of carpal bones, with spherical holes/slots for screws. Fabricated from implantable grade stainless steel.
- Intended Use: Fusion of carpal bones (capitate, hamate, lunate, triquetrum) to address pain/loss of function due to osteoarthritis, post-traumatic arthritis, fractures, failed partial wrist fusions, carpal instability, or rheumatoid arthritis. Used with screws.
- Material: Implantable grade stainless steel.
The FDA's review concluded that the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market under general controls. This type of submission relies on demonstrating that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness compared to a legally marketed predicate device. It does not typically involve clinical performance studies with the types of acceptance criteria and data metrics requested for AI/ML devices.
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510(k) Summary
| Manufacturer: | rms Company8600 Evergreen BoulevardMinneapolis, MN 55433763-786-1520 - Office763-783-5073 | OCT 20 2006 |
|---|---|---|
| Submitted By: | Small Bone InnovationsJames O' Connor505 Park Avenue, 14th FloorNew York, NY 10022joconnor@totalsmallbone.com215-428-1791 - Office212-750-2112 - Fax | |
| Proprietary Name: | SBI Carpal Fusion Plate | |
| Classification name: | Class II, 888.3030 - Plate, Fixation, Bone | |
| Common/Usual Name: | Carpal Fusion Plate | |
| Substantial Equivalence: | Documentation is provided which demonstrated the SBICarpal Fusion Plate to be substantially equivalent to otherlegally marketed devices. | |
| Device Description: | The SBI Carpal Fusion Plate is a low profile single piececonstruct designed to fit over the dorsal aspect of the carpalbones in the hand. The plate has spherical holes or slotsthat accommodate screws for fixation. The plate andscrews are fabricated from implantable grade stainlesssteel. | |
| Intended Use: | The SBi Carpal Fusion Plate is designed for fusion of thecarpal bones of the hand including; capitate, hamate,lunate, and triquetrum. The fusion plate is intended for usein patients suffering from pain and/or loss of function dueto osteoarthritis, post-traumatic arthritis, fractures, revisionof failed partial wrist fusions, carpal instability, orrheumatoid arthritis. The fusion plate is used inconjunction with screws that fix the plate to the carpalbones of the hand. | |
| Material: | The SBI Carpal Fusion plate is made from implantablegrade stainless steel. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with outstretched wings, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The seal is simple and monochromatic.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Small Bone Innovations Inc. % Mr. Robert Hoehn 505 Park Avenue, 14th Floor New York, New York 10022
OC1 2 0 2006
Re: K062903
Trade/Device Name: SBI Carpal Fusion Plate Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: September 15, 2006 Received: September 27, 2006
Dear Ms. 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. Iisting 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. Robert Hoehn
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 H. Milliken
Mark N. Melkerson 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 Carpal Fusion Plate
Indications For Use:
The SBi Carpal Fusion Plate is designed for fusion of the carpal bones of the hand including; capitate, hamate, and triquetrum. The fusion plate is intendentifor use in patients suffering from pain and/or loss of function due to osteoarthritis, post-traumatic arthritis, fractures, revision of failed partial wrist fusions, carpal instability, or rheumatoid arthritis. The fusion plate is used in conjunction with screws that fix the plate the carpal bones of the hand.
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
Mark N. Mekean
(Division Sign-Off) Division of General, Restorative. and Neurological Devices
510(k) Number K062903
§ 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.