(59 days)
The Michelangelo Bunion System is intended for the following surgical indication: To assist in the correction of hallux valgus deformities by providing reduction of the 1st intermetatarsal angle.
The Instratek Michelangelo Bunion System is intended to assist in the correction of Hallux Valgus deformities by providing reduction of the 1st. intermetatarsal angle. Like the predicate device, the Michelangelo Bunion System is intended to assist in the correction of hallux valgus deformities by providing reduction of 1st intermetatarsal angles up to and including 16 degrees. The Michelangelo Bunion System may eliminate the necessity of a traditional osteotomy in the correction of Hallux Valgus deformities within the indicated criteria. The implanted device consists of three components: Medial Plate, Lateral Plate, Suture. There are 6 accessories required to implant the device: suture lasso, kwire, cannulated drill bit, kwire guide, plate bender, suture scissor.
The provided document is a 510(k) summary for the Michelangelo Bunion System and does not contain detailed information about acceptance criteria or a comprehensive study demonstrating direct device performance against such criteria. The document states that performance tests included "knot pull testing," but no specific acceptance criteria or results from this testing are provided.
Instead of a study proving the device meets acceptance criteria, the submission concludes that the device is "substantially equivalent" to predicate devices (HAV-Lok Bunion Correction System, K082384, and Arthrex Mini-Tightrope, K061925) based on similar technological characteristics and intended use. The core of the submission relies on this substantial equivalence argument rather than presenting a standalone study with defined acceptance metrics.
Therefore, most of the requested information cannot be extracted from this specific document.
However, based on the available information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Knot pull strength (specific threshold not provided) | Knot pull testing was performed (results not provided). The technological characteristics and intended use are the same as predicate devices. The device is considered "as safe and effective as the predicate devices." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified. The document only mentions "knot pull testing" was performed, but no number of samples or tested units is provided.
- Data Provenance: Not specified. The document does not indicate the country of origin of any test data or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not applicable and not provided. The study mentioned (knot pull testing) is a mechanical performance test, not one requiring expert human interpretation or ground truth establishment in a clinical sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. Adjudication methods are typically associated with clinical studies involving human readers or expert consensus, which is not the nature of the "knot pull testing" mentioned.
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
- This is not applicable as the Michelangelo Bunion System is a surgical device, not an AI-based diagnostic or assistive technology for human readers. No MRMC study was done, and therefore, no effect size related to AI assistance is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is not applicable for this device. The device is a surgical implant and associated accessories, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the "knot pull testing," the ground truth would be the objectively measured force at which the knot failed. This is a physical measurement, not a clinical ground truth like pathology or expert consensus. No specific measurement data is provided.
8. The sample size for the training set
- Not applicable/Not provided. As this is a 510(k) submission for a physical device relying on substantial equivalence, there is no mention of a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
- Not applicable/Not provided for the same reasons as above.
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Special 510(k)
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| 510(k) Summary |
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| Submitter: | Instratek, Inc.210 Springhill DriveSuite 130Spring, TX 77386 |
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| AUG 14 2009 | |
| Contact person: | Mr. Jeff SeaveyVice President |
| Phone: | (281) 890-8020 |
| Fax: | (281) 890-8068 |
| E-mail: | jeff@instratek.com |
| Date summary prepared: | June 12, 2009 |
| Device trade name: | Michelangelo Bunion System |
| Device common name: | Button/Suture |
| Device classification name: | Washer,Bolt Nut, HTN at 21 CFR 888.3030 |
| Legally marketed devices to which the device is substantially equivalent: | HAV-Lok Bunion Correction System, K082384Arthrex Mini-Tightrope, K061925 |
| Description of the device: | The Instratek Michelangelo Bunion System is intended to assist in the correction of Hallux Valgus deformities by providing reduction of the 1st. intermetatarsal angle.Like the predicate device, the Michelangelo Bunion System is intended to assist in the correction of hallux valgus deformities by providing reduction of 1st intermetatarsal angles up to and including 16 degrees. The Michelangelo Bunion System may eliminate the necessity of a traditional osteotomy in the correction of Hallux Valgus deformities within the indicated criteria. The implanted device consists of three components Medial PlateLateral PlateSuture There are 6 accessories required to implant the device suture lassokwirecannulated drill bitkwire guideplate bendersuture scissor |
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| Intended use of thedevice: | The Michelangelo Bunion System is intended for the followingsurgical indication:• To assist in the correction of hallux valgus deformities byproviding reduction of the 1st intermetatarsal angle. |
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| Technologicalcharacteristics: | The technological characteristics between the predicate andproposed devices are the same. |
| Performance tests: | Performance tests included knot pull testing which was performedwith the predicate device submission. |
| Conclusions: | There are no significant differences between the proposed andpredicate device; therefore, the proposed device does not raiseany questions regarding safety and effectiveness.The Michelangelo Bunion System, as designed, is as safe andeffective as the predicate devices. Comparisons have been madeto a legally marketed predicate device, and the device isdetermined to be substantially equivalent to the referencedpredicate device currently on the market. |
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
AUG 1 4 2009
Instratek, Inc. % Mr. Jeff Seavey 210 Springhill Drive, Suite 130 Spring, Texas 77386
Re: K091763
Trade/Device Name: Michelangelo Bunion System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HTN Dated: July 15, 2009 Received: July 23, 2009
Dear Mr. Seavey:
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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. Jeff Seavey
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/cdrh/comp/ for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrb/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Callen Bucheld
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
- 510(k) Number:
Device Name:
Indications for Use:
K091763
Michelangelo Bunion System
The Michelangelo Bunion System is intended for the following surgical indication:
- To assist in the correction of hallux valgus deformities . by providing reduction of the 1st intermetatarsal angle.
Prescription Use X (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Yaukey I. Saye
1041765
(Division Sign-Off) Division of Surgical, Orthopedic, Co Restorative Devices
510(k) Number
§ 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.