SPACER-S by TECRES SPA | FDA 510(k) Summary

Interspace Shoulder is indicated for temporary use (maximum of 180 days) as a shoulder replacement (SR) in skeletally mature patients undergoing a two-stage procedure due to a septic process. The head and stem are inserted into the glenoideal cavity and the humeral medullary canal, respectively, following removal of the existing implant and radical debridement. The device is intended for use in conjunction with systemic antibiotic therapy (standard treatment approach to an infection). Interspace Shoulder is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g. resection arthroplasty, fusion etc.).

Device Description

The Interspace Shoulder devices is a temporary device composed of fully formed PMMA bone cement with gentamicin and an inner stainless steel metal core. The design mimics a hemi-shoulder prosthesis.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Tecres Interspace Shoulder Temporary Shoulder Prosthesis:

Based on the provided 510(k) summary (K112983), this submission is for a modified medical device, not a new AI/software-as-a-medical-device (SaMD) or diagnostic device. As such, the typical "acceptance criteria" and "study" questions you'd ask for an AI model's performance metrics (like sensitivity, specificity, AUC) are not directly applicable in this context.

Instead, the "acceptance criteria" here refer to production specifications and performance adequate for in vivo application under temporary conditions of use, and the "study" is a performance testing conducted to demonstrate substantial equivalence to a previously cleared device.

Here's the breakdown of the information as requested, translated into the context of this medical device submission:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implied)	Reported Device Performance
Material Properties	Mechanical properties matching predicate device and suitable for use.	Evaluated and found to support substantial equivalence.
Drug Release Profile	Gentamicin release consistent with intended therapeutic effect.	Evaluated and found to support substantial equivalence.
Stability	Device stability for temporary use (up to 180 days).	Evaluated and found to support substantial equivalence.
Manufacturing Standards	Meeting production specifications.	Evaluated and found to support substantial equivalence.
Biocompatibility	Suitable for in vivo application.	Implicitly covered by substantial equivalence to predicate.
Indications for Use	Same as predicate device (temporary shoulder replacement for septic process, up to 180 days).	Confirmed as the same, thus meeting this "performance" criterion.

Note: The document states that the performance testing was to verify that the implant performance "continues to meet the production specifications and be adequate for in vivo application under the temporary conditions of use." The primary "acceptance criteria" seem to be demonstrating that the modified device is substantially equivalent to its predicate (K060535) despite the addition of a metal reinforcing structure and a new material supplier.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not explicitly stated. The "performance testing" described is likely mechanical and chemical testing of the device itself and its components, rather than a clinical trial with patient data. Therefore, the "test set" would refer to the number of devices or material samples subjected to laboratory tests (e.g., fatigue testing, tensile strength, gentamicin elution studies). Without further documentation, the exact number cannot be determined from this summary.
Data Provenance: Not applicable in the sense of patient data. The testing would have been conducted in a laboratory setting by the manufacturer (Tecres S.p.A.).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Number of Experts: Not applicable. For material and mechanical performance testing, "ground truth" is established through standardized engineering and chemical testing methods, not expert consensus on clinical cases.
Qualifications of Experts: Not applicable. The testing would be performed by qualified engineers, chemists, and technicians following established protocols.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. This type of testing involves objective measurements against predefined specifications, not human interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of an AI diagnostic tool on human reader performance, which is not the nature of this device.
Effect Size: Not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Standalone Performance: Not applicable. This device is an implanted prosthesis, not an algorithm or a software device.

7. The Type of Ground Truth Used

Type of Ground Truth: For the performance testing, the "ground truth" would be established by:
- Engineering specifications and standards: For mechanical properties (e.g., ISO standards for implant materials, internal design specifications for strength and durability).
- Chemical analysis standards: For gentamicin release and stability (e.g., pharmacopeial methods, validated analytical chemistry techniques).
- Comparison to predicate device's established performance: To demonstrate substantial equivalence.

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable. This is not an AI/machine learning device. The device itself is the product. The term "training set" is not relevant here.

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set: Not applicable, as there is no "training set."

Summary of the 510(k) Submission's Core Argument:

The K112983 submission for the Interspace Shoulder Temporary Shoulder Prosthesis argues for substantial equivalence to its own previously cleared version (K060535). The key modifications are the introduction of a metal reinforcing structure and a new material supplier. The manufacturer conducted performance testing (mechanical properties, gentamicin release, and stability data) to demonstrate that these changes did not negatively impact the device's ability to meet its production specifications and remain adequate for its temporary in vivo application. The FDA's clearance indicates that they found this demonstration of substantial equivalence sufficient without requiring complex clinical trials or new performance metrics beyond what was presented for the predicate device.

Summary

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510(k) Summary

Christine L. Brauer, Ph.D. Official correspondent: US AGENT Manufacturer/Submitter: Tecres S.p.A. Via A. Doria 6 37066 Sommacampagna Verona - Italy FDA Owner/Operator ID: 9033624 December 9, 2011 Date: 510(k) Number: K112983 Trade/Proprietary model names: Interspace Shoulder Temporary Shoulder Prosthesis with Gentamicin Common name: Semi-constrained Cemented Prosthesis Prosthesis, Shoulder, Device classification name: Hemi-, Humeral, Metallic, Cemented or Uncemented 21 CFR § 888.3690 Classification regulation Class II Regulatory class: Orthopedic Classification panel: HSD - Prosthesis, Shoulder, Hemi-, Humeral, Metallic Classification product code: Uncemented Semi-Constrained, Shoulder. Prosthesis, K WS — Metal/Polymer, Cemented The Interspace Shoulder devices is a temporary device Device description: composed of fully formed PMMA bone cement with gentamicin and an inner stainless steel metal core. The design mimics a hemi-shoulder prosthesis. Indication for Use and IntendedInterspace Shoulder is indicated for temporary use (maximum of 180 days) as a shoulder replacement (SR) in skeletally Use: mature patients undergoing a two-stage procedure due to a septic process. The head and stem are inserted into the glenoideal cavity and the humeral medullary canal, respectively, following removal of the existing implant and radical debridement. The device is

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DEC 1 2 2011

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Substantial Equivalence:	intended for use in conjunction with systemic antimicrobiaantibiotic therapy (standard treatment approach to aninfection).Interspace Shoulder is not intended for use for more than 180days, at which time it must be explanted and a permanentdevice implanted or another appropriate treatment performed(e.g. resection arthroplasty, fusion etc.).
	The Interspace Shoulder Spacer has the same intended use asthe predicate device, the Interspace Shoulder Spacer clearedvia K060535. Both devices are intended for use as atemporary shoulder implant for patients undergoing a two-stage revision procedure due to an infection.
	The Tecres Interspace Shoulder Spacer device is substantiallyequivalent to itself. The device has previously been cleared:K060535. The intended use and conditions of use remain thesame. This 510(k) application was submitted for theintroduction of a metal reinforcing structure into the deviceand to add a new material supplier.
	Performance testing was conducted to verify that implantperformance continues to meet the productions specificationsand be adequate for in vivo application under the temporaryconditions of use. Mechanical properties, gentamicin releaseand stability data were evaluated and found to support thesubstantially equivalence of the devices.
	Based on the same fundamental scientific technology and onthe results of the verification activities, it is concluded that themodified Tecres Interspace Shoulder Spacer device issubstantially equivalent to legally marketed Tecres spacerdevice.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized caduceus-like symbol with three lines representing the human form. The emblem is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". The text is arranged in a circular fashion around the emblem.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

DEC 1 2 2011

Tecres S.p.A. % Brauer Device Consultants, LLC Christine L. Brauer. Ph.D. Regulatory Affairs Consultant 7 Trailhouse Court Rockville, Maryland 20850

Re: K112983

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: November 18, 2011 Received: November 18, 2011

Dear Dr. Brauer:

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. Ilsting 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.

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Page 2 - Christine L. Brauer, Ph.D.

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fdagov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm 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/cdrh/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,

Mark N. Melk Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number: K112983

Device Names: Interspace Shoulder

INDICATIONS FOR USE STATEMENT

Interspace Shoulder

Interspace Shoulder is indicated for temporary use (maximum of 180 days) as a shoulder replacement (SR) in skeletally mature patients undergoing a two-stage procedure due to a septic process.

The head and stem are inserted into the glenoideal cavity and the humeral medullary canal, respectively, following removal of the existing implant and radical debridement. The device is intended for use in conjunction with systemic antibiotic therapy (standard treatment approach to an infection). Interspace Shoulder is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g. resection arthroplasty, fusion etc.).

Signature of

(Division Sign-Off) (Division Sign-On), Orthopedic, Divisionative Devices

510(k) Number __

Please do not write below this line - use another page if needed.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Part 21 CFR 801 Subpart D) and/or Over the Counter Use (21 CFR 801 Subpart C)

Regulation Number and Section

§ 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.