Tendon repairs, transfers, or transplants, such as in the treatment of paralytic conditions, tendon avulsions or ruptures, in which the tendon is fixed to the bone.
Ligament repairs, reconstruction, or replacement in which the ligament is fixed to the bone.

Device Description

The Intrinsic Therapeutics Fixation Staple is made from 6Al 4V ELI Titanium conforming to ASTM F136. The legs of the staple have barbs and are curved to provide strength in bone fixation. The staple is provided sterile. A reusable insertion tool is provided to facilitate insertion of the staple.

AI/ML Overview

The provided text describes a medical device, the Intrinsic Therapeutics Fixation Staple, and its submission for 510(k) clearance by the FDA. The submission focuses on demonstrating "substantial equivalence" to predicate devices rather than proving the device meets specific acceptance criteria through clinical studies or extensive performance testing as might be required for new technologies or higher-risk devices.

Therefore, many of the requested categories for acceptance criteria and study details are not directly applicable or available in this specific document. The document highlights benchtop testing as the primary performance data provided.

Here's a breakdown based directly on the provided text, indicating where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Functioned as intended	The Intrinsic Therapeutics Fixation Staple functioned as intended.
Met test criteria	The Intrinsic Therapeutics Fixation Staple met the test criteria.
Supported listed shelf life	Package integrity tests were performed to support the listed shelf life.
Safe and effective as predicate devices	Performance data demonstrate that the Intrinsic Therapeutics Fixation Staple is as safe and effective as the predicates.

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

Sample Size: Not specified. The document only mentions "Benchtop testing."
Data Provenance: Not specified, but generally, benchtop testing is conducted in a lab setting, not typically described by country of origin or as retrospective/prospective in the same way clinical data would be.

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 available. Benchtop testing typically relies on predefined engineering or material science standards, not expert human assessment to establish "ground truth."

4. Adjudication method for the test set

This information is not applicable and not available, as there was no human expert assessment or adjudication described.

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 MRMC study was done. This device is a physical fixation staple, not an AI-powered diagnostic or assistive technology for human readers.

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

No standalone algorithm performance study was done. This device is a physical fixation staple, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the benchtop testing, the "ground truth" would be the engineering specifications and performance standards established for fixation staples and potentially derived from the predicate devices. This is not explicitly detailed but implied by the nature of benchtop testing.

8. The sample size for the training set

Not applicable/available. This device is a physical product, not an AI model that requires a training set.

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

Not applicable/available, as there was no training set for a machine learning model.

Summary

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K071637 Page lot 2

510(k) SUMMARY

Intrinsic Therapeutics Fixation Staple

AUG -- 3 2007

Applicant:

Intrinsic Therapeutics, Inc. 30 Commerce Way Woburn, MA 01801 USA

Phone: (781) 932-0222 Facsimile: (781) 932-0252

Krishna Uppugonduri Contact Person: June 14, 2007 Date Prepared:

Trade Name of Device

Intrinsic Therapeutics Fixation Staple

Common or Usual Name

Fixation Staple

Classification Name

Staple, Fixation, Bone 21 CFR 888.3030, Product Code: JDR

Predicate Devices

(1) Conmed Linvatec Fixation Staple (2) Smith & Nephew Fixation Staple

Intended Use / Indications for Use

The Intrinsic Therapeutics Fixation Staple is intended for providing soft tissue fixation to bone in orthopedic procedures such as:

1. Tendon repairs, transfers, or transplants, such as in the treatment of paralytic conditions, tendon avulsions or ruptures, in which the tendon is fixed to the bone.
1. Ligament repairs, reconstruction, or replacement in which the ligament is fixed to the bone.

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c71637 Page a.t2

Device Description/Technological Characteristics

Performance Data

Benchtop testing was performed on the Intrinsic Therapeutics Fixation staple and the predicate devices. The Intrinsic Therapeutics Fixation Staple functioned as intended and met the test criteria. Package integrity tests were performed to support the listed shelf life.

Substantial Equivalence

The Intrinsic Therapeutics Fixation Staple is as safe and effective as the predicate devices. The Intrinsic Therapeutics Fixation Staple has the same intended use, technological characteristics, and principles of operation as its predicate devices. The minor technological differences between the Intrinsic Therapeutics Fixation Staple and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the Intrinsic Therapeutics Fixation Staple is as safe and effective as the predicates. Thus, the Intrinsic Therapeutics Fixation Staple is substantially equivalent.

Conclusions:

Based upon the proposed device's design and technological characteristics, indications for use, and results of comparative testing against predicate devices, the Intrinsic Therapeutics Fixation Staple is considered to be substantially equivalent to the cited legally marketed predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the bird.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Intrinsic Therapeutics, Inc. % Mr. Krishna Uppugonduri 30 Commerce Way Woburn, MA 01801

AUG - 3 2007

Re: K071637

Trade/Device Name: Intrinsic Therapeutics Fixation Staple Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories. Regulatory Class: II

Product Code: JDR Dated: June 14, 2007 Received: June 15, 2007

Dear Mr. Uppugonduri:

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 - Mr. Krishna Uppugonduri

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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Mark A. Mcllheran

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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Indications for Use Statement

510(k) Number (if known):_K071637

Device Name: Intrinsic Therapeutics Fixation Staple

Indications for Use:

The Intrinsic Therapeutics Fixation Staple is intended for providing soft tissue fixation to bone in orthopedic procedures such as:

Tendon repairs, transfers, or transplants, such as in the treatment of paralytic conditions, tendon avulsions or ruptures, in which the tendon is fixed to the bone.
Ligament repairs, reconstruction, or replacement in which the ligament is fixed to the bone.

Prescription Use _X (Part 21 C.F.R. 801 Subpart D)

AND/OR

Over-The-Counter Use (21 C.F.R. 807 Subpart C)

(QLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

510(k) Number	K071637
Page	of

Intrinsic Therapeutics Fixation Staple 510(k) Page 13

Regulation Number and Section

§ 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.