Elbow joint destruction which significantly compromises the activities of daily living
Non-Inflammatory degenerative joint disease including osteoarthritis, and avascular necrosis with hemophilia.
Rheumatoid arthritis or degenerative arthritis with incapacitating pain
Revision where other devices or treatments have failed.
Correction of severe functional deformity.
Treatment of acute or chronic fractures with distal humerus epicondyle involvement.
Post-traumatic lesions or bone loss contributing to elbow instability or loss of motion

The unlinked, semi-constrained version is for use in cases where there are functioning medial and lateral elbow ligaments of good quality that provide immediate stability, resisting any tendency of disengagement between ulnar and humeral components, when intraoperative manual testing is performed.

Device Description

TEMA Elbow System is a cemented total elbow prosthesis. The system provides both linked (constrained) and unlinked (semi-constrained) configurations.

TEMA Elbow System consists of modular humeral and ulnar assemblies. The humeral assembly consists of a metallic humeral stem and a metallic humeral body component with pre-assembled polyethylene bushings. The ulnar assembly is composed of a metallic ulnar stem, a metallic ulnar body and a polyethylene ulnar liner. Screws are used to secure the taper couplings between the stems and bodies of the humeral and ulnar assemblies.

The constrained (linked) version of the elbow consists of the modular humeral assembly and the modular ulnar assembly with an axle component that is inserted across the joint to connect the humeral assembly to the ulnar assembly.

The semi-constrained (unlinked) version consists of the same components without the use of the axle to link the humeral and ulnar assemblies.

TEMA Elbow system - Line extension introduces two new sizes of Ulnar stems to the ulnar stem range already cleared; moreover, a design change is introduced for the axle component, ulnar body component and for the humeral body compared to the original cleared version.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study information for the TEMA Elbow system - Line extension.

It's important to note that the provided FDA 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, not on proving that a new medical device meets specific acceptance criteria in a clinical study. The document primarily discusses non-clinical (bench) testing. Therefore, several requested categories (like ground truth, expert qualifications, adjudication, MRMC studies, training set size) are not applicable or cannot be extracted from this type of FDA submission.

Acceptance Criteria and Device Performance

The core of this submission is to demonstrate that the "TEMA Elbow system - Line extension" is substantially equivalent to the previously cleared "TEMA Elbow system (K181362)". The acceptance criteria, in this context, are not explicit pass/fail thresholds for clinical performance metrics (like sensitivity, specificity, accuracy) but rather the demonstration that the new device's performance, particularly mechanical, is comparable or superior to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance	Comments / Context from Document
Mechanical Equivalence	Demonstrated	"Mechanical evaluations (both bench tests and rationales) demonstrated the device's ability to perform in a substantially equivalent manner to the predicate devices."
- Range of Motion	Comparable / Adequately demonstrated	Explicitly tested to show equivalence.
- Stability	Demonstrated post-fatigue	Tested across modular connections.
- Fatigue	Demonstrated post-fatigue	Tested across modular connections.
- Fretting-Corrosion	Demonstrated post-fatigue	Tested across modular connections.
- Wear Evaluation	Demonstrated	Explicitly tested.
Technological Characteristics	"Extensive and significant similarities"	To the predicate device, including materials and principles of operation.
Intended Use & Indications	Identical	To the predicate device.
Safety and Effectiveness	Implied by substantial equivalence	The 510(k) process aims to ensure the new device is as safe and effective as a legally marketed predicate device.

Note: The document uses terms like "demonstrated" and "substantially equivalent" rather than specific numerical performance metrics typical for software or diagnostic devices.

Study Details (Based on available information)

2. Sample size used for the test set and the data provenance

Sample Size (Test Set): Not applicable in the context of a clinical test set from this document. The "test set" here refers to the physical samples used in bench tests. The document does not specify the number of physical components or prototypes tested for "Range of Motion," "Stability," "Fatigue," "Fretting-Corrosion," or "Wear Evaluation."
Data Provenance: Not applicable. The document describes non-clinical (bench) testing, not human or animal data. The manufacturing company is LimaCorporate S.p.A. based in Italy.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This was a non-clinical (bench) study. Ground truth in this context would likely be engineering specifications or established test standards, not expert clinical consensus.

4. Adjudication method for the test set

Not applicable. As a non-clinical (bench) study, there is no mention or need for a clinical adjudication method.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a physical elbow prosthesis, not an AI-powered diagnostic or assistive tool.

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

No, a standalone algorithm performance study was not done. This device is a physical implant.

7. The type of ground truth used

For the non-clinical (bench) tests, the "ground truth" would be established engineering standards, material properties, and performance benchmarks for orthopedic implants, typically defined in ASTM or ISO standards. The document doesn't specify these exact standards but refers to "mechanical evaluations (both bench tests and rationales)."

8. The sample size for the training set

Not applicable. There is no training set mentioned, as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

Not applicable. No training set.

Summary

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October 26, 2022

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

LimaCorporate S.p.A. % Kenneth Newman Regulatory Affairs Associate Lima USA Inc. 2001 NE Green Oaks Blvd. Ste. 100 Arlington. Texas 76006

Re: K222807

Trade/Device Name: TEMA Elbow system - Line extension Regulation Number: 21 CFR 888.3160 Regulation Name: Elbow joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JDB, JDC Dated: August 30, 2022 Received: September 16, 2022

Dear Kenneth Newman:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpm/pmn.cfm identifies.combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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801): medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic provisions (Sections (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Victoria Lilling, M.D. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K222807

Device Name TEMA Elbow system - Line extension

Indications for Use (Describe)

TEMA Elbow system is intended for use in cemented applications for patients suffering from disability due to:

1. Elbow joint destruction which significantly compromises the activities of daily living
1. Non-Inflammatory degenerative joint disease including osteoarthritis, and avascular necrosis with hemophilia.
1. Rheumatoid arthritis or degenerative arthritis with incapacitating pain
1. Revision where other devices or treatments have failed.
1. Correction of severe functional deformity.
1. Treatment of acute or chronic fractures with distal humerus epicondyle involvement.
1. Post-traumatic lesions or bone loss contributing to elbow instability or loss of motion

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Date: October 21, 2022

Manufacturer: Limacorporate S.p.A. Via Nazionale, 52 33038 - Villanova di San Daniele Udine - Italy

U.S. Contact Person: Kenneth Newman Regulatory Affairs Associate kenneth.newman@limacorporate.comLima USA Inc. 2001 NE Green Oaks Blvd. Ste.100 Arlington, Texas 76006, USA www.limacorporate.com Cell Phone: 682.597.3381 Office Phone: 817.385.0777 FAX: 817.385.0377

Product	ProductCode	Regulation and Classification Name
TEMA Elbow System– Line extension	JDC	21 CFR 888.3150 Elbow joint metal/polymerconstrained cemented prosthesis
	JDB	21 CFR 888.3160 Elbow joint metal/polymersemi-constrained cemented prosthesis

Description:

TEMA Elbow System is a cemented total elbow prosthesis. The system provides both linked (constrained) and unlinked (semi-constrained) configurations.

The semi-constrained (unlinked) version consists of the same components without the use of the axle to link the humeral and ulnar assemblies.

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Indication for Use:

TEMA Elbow system is intended for use in cemented applications for patients suffering from disability due to:

1. Elbow joint destruction which significantly compromises the activities of daily living
1. Non-Inflammatory degenerative joint disease including osteoarthritis, and avascular necrosis with hemophilia.
1. Rheumatoid arthritis or degenerative arthritis with incapacitating pain
1. Revision where other devices or treatments have failed.
1. Correction of severe functional deformity.
Treatment of acute or chronic fractures with distal humerus epicondyle 6. involvement.
1. Post-traumatic lesions or bone loss contributing to elbow instability or loss of motion

The unlinked, semi-constrained version is for use in cases where there are functioning medial and lateral elbow ligaments of good quality that provide immediate stability, resisting any tendency of dislocation or disengagement between ulnar and humeral components, when intraoperative manual testing is performed.

Predicate Devices:

Company	Device name	Cleared via
LIMACORPORATE	TEMA Elbow system	K181362

Summarv of technology comparison:

TEMA Elbow system - line extension and TEMA Elbow system (predicate device) have extensive and significant similarities in terms of intended use, indications, technological characteristics, materials, and principles of operation. The differences between these two systems are related to a design improvement of axle, humeral body and ulnar body components aimed to improve the overall mechanical performance and laxity of the system plus the addition of two new sizes of Ulnar stems.

A comparison of technological characteristics and performance testing demonstrate that the TEMA Elbow system-line extension is substantially equivalent to the predicate devices.

Non-clinical testing

Mechanical evaluations (both bench tests and rationales) demonstrated the device's ability to perform in a substantially equivalent manner to the predicate devices in terms of:

Range of motion:
Stability, fatigue and fretting-corrosion evaluation post-fatigue of modular ● connections;
Wear evaluation. ●

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Clinical testing

Clinical testing was not necessary to demonstrate substantial equivalence of the TEMA Elbow system – Line extension components to the predicate device.

Conclusion

Based upon a comparison of intended use, materials, summary of technological characteristics, and preclinical testing, the TEMA Elbow system - Line extension components are substantially equivalent to the predicate device components identified in this premarket notification.

Regulation Number and Section

§ 888.3160 Elbow joint metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. An elbow joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an elbow joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that consist of a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a radial resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.