(84 days)
The SBi SR MTP Toe Implant is intended for use as a hemi-arthroplasty implant for the metatarsophalangeal joint, for the treatment of degenerative and posttraumatic arthritis, hallux valgus, hallux rigidus, and an unstable or painful metatarsophalangeal (MTP) joint. The SBi SR MTP Toe Implant is intended for implantation with and without bone cement.
The SBi SR MTP Toe Implant is a one-piece, stemmed device intended to replace the articulating surface of the metatarsal at the MTP joint. The implant is available in a range of sizes to match the geometry of the metatarsal head. Design features include an articulating surface which extends posteriorly on the superior side of the implant and a gently barbed stem to improve fixation in the metatarsal. The implants are made from wrought CoCrMo alloy (ASTM F1587) with a plasma coating comprised of commercially pure titanium (ASTM F1580).
This device is a SBi SR MTP Toe Implant, a medical device, not an AI/ML device. Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of AI/ML performance metrics (such as sensitivity, specificity, F1-score, sample sizes for test/training sets, expert consensus for ground truth, MRMC studies) are not applicable.
Instead, for a medical device like this implant, the "acceptance criteria" and "proof" involve demonstrating substantial equivalence to a predicate device already legally marketed. This typically involves comparing characteristics such as:
- Intended Use: The purpose for which the device is used.
- Technological Characteristics: The materials, design, and other technical aspects of the device.
- Performance Data: This might include mechanical testing (e.g., strength, wear) to show the new device performs similarly or better than the predicate, or sometimes clinical data if there are significant differences in technological characteristics or intended use that raise new safety or effectiveness questions.
The provided document, a 510(k) summary and FDA clearance letter, explicitly states how this "acceptance" was met:
Substantial Equivalence:
- The document states: "Documentation was provided which demonstrated the SBi SR MTP Toe Implant is substantially equivalent to other legally marketed devices."
- The FDA's letter confirms: "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..."
Therefore, the "study" proving the device met "acceptance criteria" was a demonstration of substantial equivalence based on a comparison to a predicate device, as required for 510(k) clearance by the FDA. The document does not contain the specific performance data (e.g., mechanical testing results) that would have been submitted to demonstrate this equivalence, but rather the conclusion of the FDA's review.
Given this context, I cannot fill in the table or answer the subsequent questions as they pertain to AI/ML device evaluations, which are not relevant here.
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MAR 1 9 2008
K073 635
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2. 510(k) Summary
| Manufacturer: | Small Bone Innovations, Inc.1380 South Pennsylvania AvenueMorrisville, PA 19067 |
|---|---|
| Submitted By: | Small Bone Innovations, Inc.1380 South Pennsylvania AvenueMorrisville, PA 19067 |
| Contact: | Jeff ZiglerMusculoskeletal Clinical Regulatory Advisers, LLC(MCRA)1331 H Street NW, 12th FloorWashington, DC 20005202.552.5800 |
| Proprietary Name: | SBi SR MTP Toe Implant |
| Classification name: | Class II, 21 CFR 888.3730 - Toe joint phalangeal (hemi-toe) polymer prosthesis |
| Common/Usual Name: | Toe joint, phalangeal (hemi-toe) prosthesis |
| Product Code: | KWD |
| Substantial Equivalence: | Documentation was provided which demonstrated the SBiSR MTP Toe Implant is substantially equivalent to otherlegally marketed devices. |
| Device Description: | The SBi SR MTP Toe Implant is a one-piece, stemmeddevice intended to replace the articulating surface of themetatarsal at the MTP joint. The implant is available in arange of sizes to match the geometry of the metatarsalhead. Design features include an articulating surface whichextends posteriorly on the superior side of the implant and agently barbed stem to improve fixation in the metatarsal. |
| Intended Use: | The SBi SR MTP Toe Implant is intended for use as ahemi-arthroplasty implant for the metatarsophalangealjoint, for the treatment of degenerative and post-traumaticarthritis, hallux valgus, hallux rigidus, and an unstable orpainful metatarsophalangeal (MTP) joint. |
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K073635 pg 2 of 2
The SBi SR MTP Toe Implant is intended for implantation with and without bonc cement.
The implants are made from wrought CoCrMo alloy Materials: (ASTM F1587) with a plasma coating comprised of commercially pure titanium (ASTM F1580).
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The eagle is composed of three curved lines that form the shape of the bird. The text is in all capital letters and is evenly spaced around the circle.
Public Health Service
MAR 1 9 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Small Bone Innovations, Inc % Mr. Jeffrey Zigler Musculoskeletal Clinical Regulatory Advisors, LLC 1331 H Street, NW, 12th Floor Washington, DC 20005
Re: K073635 Trade/Device Name: SBi SR MTP Toe Implant Regulation Number: 21 CFR 888.3730 Regulation Name: Toe joint phalangeal (hemi-toe) polymer prosthesis Regulatory Class: II Product Code: KWD Dated: December 21, 2007 Received: December 26, 2007
Dear Mr. Zigler:
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. Jeffrey Zigler
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 its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M. Milkus
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 (if known): K073635
Device Name: SBi SR MTP Toe Implant
The SBi SR MTP Toe Implant is intended for use as a hemi-arthroplasty implant for the metatarsophalangeal joint, for the treatment of degenerative and posttraumatic arthritis, hallux valgus, hallux rigidus, and an unstable or painful metatarsophalangeal (MTP) joint.
The SBi SR MTP Toe Implant is intended for implantation with and without bone cement.
Prescription Use N (Part 21 CFR 801 Subpart D)
AND/OR
... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ..
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sutte
(Division Sign-Off)
Division of General, Restorative, and Networkigheal Devices
510(k) Number K073635
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§ 888.3730 Toe joint phalangeal (hemi-toe) polymer prosthesis.
(a)
Identification. A toe joint phalangeal (hemi-toe) polymer prosthesis is a device made of silicone elastomer intended to be implanted to replace the base of the proximal phalanx of the toe.(b)
Classification. Class II.