(85 days)
Spacer-S is intended for use as a temporary (maximum 180 days) shoulder replacement in patients undergoing a two-stage procedure due to a septic process.
The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection) as defined by physician and/or surgeon.
Spacer-S is indicated for temporary use (maximum 180 days) as an adjunct to total shoulder replacement and hemi shoulder replacement procedures in skeletally mature patients undergoing a two-stage revision procedure due to a septic process. Spacer-S is only indicated for an implantation period of 180 days or less.
Spacer-S is composed of fully formed gentamicin/polymethylmethacrylate (PMMA) bone cement. The one piece design mimics a hemi-shoulder prosthesis.
The K060535 filing describes the Tecres Spacer-S, a temporary shoulder prosthesis. The information provided primarily focuses on its device description, intended use, and a demonstration of substantial equivalence to a predicate device through performance testing, rather than an AI/ML device and its associated acceptance criteria and study data.
Therefore, many of the requested categories (e.g., sample size for test/training sets, experts for ground truth, MRMC studies, standalone performance, etc.) are not applicable or cannot be extracted from the provided text, as this is a medical device approval for a physical implant, not a software or AI/ML diagnostic tool.
However, I can extract the relevant performance data that was used to establish substantial equivalence.
Here's the information that can be extracted or inferred from the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Fatigue strength | Evaluated and found adequate for anticipated in vivo load applications under temporary conditions of use. |
| Static strength | Evaluated and found adequate for anticipated in vivo load applications under temporary conditions of use. |
| Antibiotic release | Evaluated and found to support substantial equivalence. |
| Overall Goal: | Substantial equivalence to the predicate Equinoxe Shoulder System device (#K042021). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The performance testing refers to mechanical and material evaluations, not clinical trials with human subjects in the typical sense of test sets for AI/ML.
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)
This information is not applicable/provided. Ground truth, in the context of this traditional medical device, is established through engineering and laboratory testing (e.g., measuring physical properties like strength and antibiotic release), not through expert consensus on diagnostic images or clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided. Adjudication methods are relevant for studies involving human interpretation or clinical endpoints, which is not the focus of the performance testing described for this device.
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 information is not applicable. This is a physical medical implant, not an AI or imaging diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is a physical medical implant, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the performance data, the "ground truth" would be established through engineering standards and laboratory measurements of the device's mechanical properties (fatigue strength, static strength) and its antibiotic release characteristics. There is no mention of clinical pathology or outcomes data being used to define the "ground truth" for these specific performance tests.
8. The sample size for the training set
This information is not applicable. There is no "training set" in the context of this traditional medical device approval based on performance testing of the device itself.
9. How the ground truth for the training set was established
This information is not applicable. As there is no "training set," there is no ground truth to establish for it.
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MAY 2 4 2006
Tecres Spacer-S
Traditional 510(k)
Summary of Safety and Effectiveness
May 24, 2006 Date:
Exactech® Inc. Applicant/Consultant: 2320 N.W. 66th Court Gainesville, Florida 32653 (352) - 377 - 1140 Phone: Fax: (352) - 378 - 2617 Contact: Gary J. Miller, PH.D. Exec. V.P. of R&D
Manufacturer: Tecres S.p.A FDA Owner/Operator ID# 9033624
Classifications / Proprietary Names:
| Trade / Proprietary Model Names: | Spacer-STemporary Shoulder Prosthesis |
|---|---|
| Common name: | Shoulder spacer |
| Classification Name: | Prosthesis, Shoulder, Hemi-, Humeral,Metallic, Cemented or Uncemented |
| Device Class: | II |
| Classification Panel: | Orthopedic |
| Product Code: | HSD |
| C.F.R. Section: | 888.3690 |
Device Description
Spacer-S is composed of fully formed gentamicin/polymethylmethacrylate (PMMA) bone cement. The one piece design mimics a hemi-shoulder prosthesis.
Intended Use
Spacer-S is intended for use as a temporary (maximum 180 days) shoulder replacement in patients undergoing a two-stage procedure due to a septic process.
The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection) as defined by physician and/or surgeon.
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Substantial Equivalence:
Based on a comparison of design features and the results of performance testing, it is concluded that the Spacer-S device is substantially equivalent functionally to the predicate Equinoxe Shoulder System device (#K042021). Whereas the Spacer-S device differs technologically from the predicate, the differences do not raise new questions of safety and effectiveness. In conclusion, the Spacer-S as a temporary shoulder prosthesis raises no new issues of safety and effectiveness considering the recommended duration of implantation for the Spacer-S.
Performance data
Performance testing was conducted to verify that the implant performance would be adequate for anticipated in vivo load applications under the temporary conditions of use. The fatigue strength, static strength, and antibiotic release were evaluated and found to support the substantial equivalence of the device.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its wings. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" in a sans-serif font. The text is arranged around the top and left side of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 4 2006
Exactech, Inc. c/o Ms. Diana Taylor Manager, Regulatory Affairs 2320 NW 66th Court Gainesville, Florida 32653
Re: K060535
Trade/Device Name: Tecres Spacer-S Regulation Number: 21 CFR 888.3690 Regulation Name: Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis Regulatory Class: Class II Product Code: HSD, KWS Dated: February 27, 2006 Received: February 28, 2006
Dear Ms. Taylor:
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
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Page 2 - Ms. Diana Taylor
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. 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 vours.
Herbert Lemmons
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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Tecres-Spacer-S
Traditional 510(k)
Indications for Use
510(k) Number:
Device Name:
Tecres Spacer-S
Indication for Use
Spacer-S is indicated for temporary use (maximum 180 days) as an adjunct to total shoulder replacement and hemi shoulder replacement procedures in skeletally mature patients undergoing a two-stage revision procedure due to a septic process. Spacer-S is only indicated for an implantation period of 180 days or less.
Please do not write below this line - use another page if needed.
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | X |
|---|---|
| ------------------ | --- |
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
| Over the Counter Use | No |
|---|---|
| ---------------------- | ---- |
- Number K060535
§ 888.3690 Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.
(a)
Identification. A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium-molybdenum. It has an intramedullary stem and is intended to be implanted to replace the articular surface of the proximal end of the humerus and to be fixed without bone cement (§ 888.3027). This device is not intended for biological fixation.(b)
Classification. Class II.