The T2 Proximal Humeral Nail is intended to provide temporary stabilization of various types of proximal and/or diaphyseal fractures of the humerus. Types of fractures include, but are not limited to, non-unions, malunions, malalignments, pathological fractures, and impending pathological fractures. Examples of specific indications according to AO classification include Type A-Fractures, dislocated, Type B Fractures, dislocated, Type C-Fractures, with intact calotte, or Humeral Fractures according to Neer-Classification.

Device Description

This 510(k) submission is a line extension to the T2 Nailing System to add new types of Proximal Humeral Nails. The nails are inserted using an opened or closed technique and can be statically or dynamically locked. The T2 Proximal Humeral Nails are intended for single use only.

AI/ML Overview

The provided 510(k) summary (K042396) for the T2 Proximal Humeral Nail Line Extension is for a medical device (intramedullary nail) and not a diagnostic or AI-driven device. As such, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of diagnostic performance (e.g., sensitivity, specificity, AUC) is not applicable here.

Instead, for a medical device like an intramedullary nail, "acceptance criteria" would typically relate to mechanical performance (e.g., strength, fatigue resistance), biocompatibility, manufacturing quality, and substantial equivalence to a predicate device. The "study" proving these criteria would be mechanical testing, biocompatibility testing, and comparison to a predicate device.

Based on the provided document, here's an attempt to extract the relevant information, aligning it as much as possible with your requested categories, even though they are largely designed for diagnostic devices:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance (or how it was met)
Substantial Equivalence	Similar design concepts to predicate devices.	"The T2 Proximal Humeral Nail also has the same basic design concepts as the predicate devices."
Mechanical Properties	Comparable mechanical properties to predicate device.	"FEA Analysis demonstrated comparable mechanical properties to the predicate device."
Indications for Use	Alignment with the intended use of predicate devices.	The stated Indications for Use are consistent with those typically found for intramedullary nails for humeral fractures, implying alignment with predicate devices.
Biocompatibility	(Not explicitly stated in the provided text, but implied for all implantable devices)	(Not explicitly stated in the provided text, but would have been demonstrated as part of the overall submission for the T2 Nailing System).
Sterility	(Not explicitly stated, but implied for single-use surgical implants)	(Not explicitly stated, but would have been demonstrated as part of the overall submission for the T2 Nailing System).

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

This is not applicable for a mechanical device submission. There is no "test set" in the context of patient data or readings for diagnostic accuracy. The "test set" would be physical nails subjected to mechanical testing. The document does not specify the number of nails tested in the FEA analysis. Data provenance relates to patient data, which is not relevant here.

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

Not applicable. "Ground truth" for a mechanical device is established through engineering specifications, material science, and mechanical testing standards. There are no "experts" establishing a "ground truth" in the diagnostic sense for this device.

4. Adjudication Method for the Test Set

Not applicable. There is no "adjudication method" as this is not a diagnostic interpretation task.

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

No, an MRMC study was not done. This type of study is relevant for diagnostic devices where human readers interpret images or data, and its goal is to assess the impact of AI assistance on reading performance. This device is a surgical implant.

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

Not applicable. This is not an algorithm. The "standalone" performance for a mechanical device would be its direct mechanical properties, which were assessed via FEA.

7. The Type of Ground Truth Used

For this device, the "ground truth" for mechanical properties would be:

Engineering standards: e.g., ASTM standards for mechanical testing of orthopedic implants.
Predicate device performance data: The mechanical performance of the legally marketed predicate device (to which the T2 Proximal Humeral Nail is claiming substantial equivalence) serves as the benchmark or "ground truth" for comparison.
Material properties: Established properties of the implant materials.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a "training set" of data. The "training" for such a device is its design, manufacturing processes, and material selection based on established engineering principles.

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

Not applicable, as there is no training set in the AI/ML sense. The analogous "ground truth" for the development of such a device is based on long-standing biomechanical principles, clinical experience with similar devices, and engineering design specifications.

In summary, the 510(k) for the T2 Proximal Humeral Nail Line Extension relies on demonstrating "substantial equivalence" to a predicate device, primarily through comparable design concepts and mechanical properties (verified by FEA Analysis), rather than through diagnostic performance metrics.

Summary

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OCT 8 - 2004

510(k) Summary of Safety and Effectiveness: T2 Proximal Humeral Nail Line Extension

Submission Information

Name and Address of the Sponsor of the 510(k) Submission:

For Information contact:

Howmedica Osteonics Corp 325 Corporate Drive Mahwah, NJ 07430

Vivian Kelly, Regulatory Affairs Specialist Howmedica Osteonics Corp. 325 Corporate Drive Mahwah. NJ 07430 Phone: (201) 831-5581 Fax: (201) 831-6038

Date Summary Prepared:

September 1, 2004

Device Identification

Proprietary Name: Common Name: Classification Name and Reference: T2 Proximal Humeral Nail Intramedullary Nail Intramedullary Fixation Rod and Accessories, 21 CFR §888.3020 87 HSB

Device Product Code:

Description:

Intended Use:

The T2 Proximal Humeral Nail is intended to provide temporary stabilization of various types of proximal and/or diaphyseal fractures of the humerus. Types of fractures include, but are not limited to, non-unions, malalignments, pathological fractures, and impending pathological fractures. Examples of specific indications according to AO classification include Type A-Fractures, dislocated, Type B Fractures, dislocated, Type C-Fractures, with intact calotte, or Humeral Fractures according to Neer-Classification.

Substantial Equivalence:

The T2 Proximal Humeral Nail also has the same basic design concepts as the predicate devices. FEA Analysis demonstrated comparable mechanical properties to the predicate device.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 8 - 2004

Ms. Vivian Kelly Regulatory Affairs Specialist Howmedica Osteonics Corporation 325 Corporate Drive Mahwah, New Jersey 07430

Re: K042396

Trade/Device Name: T2Proximal Humeral Nail Regulation Number: 21CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: September 1, 2004 Received: September 2, 2004

Dear Ms. Montemurro:

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 - Ms. Vivian Kelly

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/dsma/dsmamain.html

Sincerely yours,

Mark A. Millerm

Celia M. Witten, Ph.D., M.D. 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):

Device Name: T2 Proximal Humeral Nail

Indications for Use:

Prescription Use

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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)

Division of General, Restorative. and Neurological Devices

Page 1 of 1

510(k) Number K042396

Regulation Number and Section

§ 888.3020 Intramedullary fixation rod.

(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.