(266 days)
The SBi Forefoot Set is indicated for bone fixation of the hand and foot following trauma or osteotomy.
The SBi Forefoot Set consists of screws and washers that provide internal fixation of bones. The devices are supplied non-sterile and are available in various sizes and configurations.
I am sorry, but the provided text is a 510(k) summary for a medical device (SBi Forefoot Set), which is a regulatory document submitted to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. This type of document does not typically contain information about specific acceptance criteria and the detailed study results you've requested regarding device performance, sample sizes, ground truth establishment, or clinical comparative effectiveness studies.
The document primarily focuses on:
- Identifying the manufacturer and device.
- Classifying the device and its product code.
- Stating its intended use and materials.
- Asserting its substantial equivalence to other legally marketed devices.
Therefore, I cannot extract the following information from the provided text:
- A table of acceptance criteria and the reported device performance: This information is not present. The document declares substantial equivalence, implying the device meets performance standards similar to predicates, but doesn't detail those standards or specific performance metrics.
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not mentioned.
- If a standalone performance study was done: Not mentioned.
- The type of ground truth used: Not mentioned.
- The sample size for the training set: Not applicable, as this is a physical medical device (screws and washers for bone fixation), not an AI/software device that would have a "training set."
- How the ground truth for the training set was established: Not applicable for the same reason as above.
The 510(k) process for devices like the SBi Forefoot Set typically relies on mechanical testing, material specifications, and comparison to predicate devices, rather than clinical efficacy studies involving "test sets" with "ground truth" established by experts in the context of an AI/software device.
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K063635 of I PA
510(k) Summary
AUG 2 9 2007
| Manufacturer: | Small Bone Innovations1711 S. Pennsylvania AvenueMorrisville, PA 19067 |
|---|---|
| Submitted By: | Small Bone InnovationsJames O' Connor1711 South Pennsylvania AvenueMorrisville, PA 19067Phone (215) 428-1791 ext 254Fax (215) 428-1795 |
| Proprietary Name: | SBI Forefoot Set |
| Classification name: | Class II, 888.3040- Screw, Fixation, Bone |
| Product Code: | HWC |
| Common/Usual Name: | Smooth or threaded metallic bone fixation fastener |
| Substantial Equivalence: | Documentation is provided which demonstrated the SBIForefoot set to be substantially equivalent to other legallymarketed devices. |
| Device Description: | The SBi Forefoot Set consists of screws and washers thatprovide internal fixation of bones. The devices aresupplied non-sterile and are available in various sizes andconfigurations. |
| Indications for Use: | The SBi Forefoot Set is indicated for bone fixation of thehand and foot following trauma or osteotomy. |
| Material: | The implants are made from implant grade 316LSstainless steel (ASTM F138) or Ti6AL4V implantableTitanium (ASTM F136). |
:
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Image /page/1/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol on the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Small Bone Innovations, Inc. % Musculoskeletal Clinical Regulatory Advisers, LLC Mr. Robert Hoehn Regulatory Associate 505 Park Avenue, 14th Floor New York, New York 10022
AUG 2 9 2007
Re: K063635
Trade/Device Name: SBi Forefoot Set Regulation Number: 21 CFR 888,3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: July 16, 2007 Received: July 17, 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, JFDA 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 legal]y marketed predicate device results in a classification for your device and thus, perroits 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/industry/support/index.http://
Sincerely yours,
Barbara Buchner
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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Indications for Use
510(k) Number: 长巴6 3 635
Device Name: SBi Forefoot Set
Indications for Use:
The SBi Forefoot Set is indicated for bone fixation of the hand and foot following trauma or osteotomy.
Prescription Use √ (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
Alvarez Buchelin
(Divis Division of General, Restorative, and Neurological Devices
510(k) Number K063635
§ 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.