RIDIDFIX 2.7MM BTB CROSS PIN KIT by MITEK PRODUCTS

The device described in this 510(k) is a sterile, disposable, device designed for single patient use only. The cross pins are constructed of bioabsorbable Poly Lactic Acid (PLA).

AI/ML Overview

The provided document is a 510(k) summary for the "RigidFix™ 2.7mm BTB Cross Pin Kit," a medical device. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical studies with acceptance criteria in the way a new drug or high-risk medical device might.

Therefore, many of the requested elements (like acceptance criteria for a study, sample sizes for test/training sets of data, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth for training) are not applicable to this type of regulatory submission as they pertain to clinical or AI/algorithm performance studies, which were not conducted or required for this device.

Here's an analysis based on the information provided:

Description of Acceptance Criteria and Proving Device Meets Criteria

This submission is a 510(k) Pre-market Notification for a Class II medical device (Appliance for reconstruction of bone to soft tissue). The core purpose of a 510(k) is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device, meaning it has the same intended use and the same technological characteristics as the predicate, or, if it has different technological characteristics, that the new characteristics do not raise new questions of safety and effectiveness.

For this device, the "acceptance criteria" are predominantly related to demonstrating functional equivalence and safety through bench testing and biocompatibility testing, rather than clinical performance metrics in a study involving human subjects. The acceptance criteria for these tests would typically be defined as meeting certain material properties, mechanical strength thresholds, and biological compatibility standards that are comparable to or better than the predicate device and established industry standards.

The "study" that proves the device meets these criteria is the functional and integrity bench testing and biocompatibility testing performed.

1. Table of Acceptance Criteria and Reported Device Performance:

Since the document does not explicitly list numerical acceptance criteria or detailed results of specific tests (e.g., "tensile strength must be > X MPa, and device achieved Y MPa"), a precise table cannot be constructed. However, based on the text, the general acceptance criteria and performance can be inferred:

Acceptance Criteria (Inferred)	Reported Device Performance
Functional & Integrity Bench Testing:
a. Initial fixation strength comparable to predicate devices for bone-tendon-bone grafted ACL reconstructions.	"testing was performed to determine the initial fixation strength of the proposed RigidFix™ 2.7mm BTB Cross Pin Kit for Bone-Tendon-Bone grafted ACL Reconstructions." The conclusion states this testing, along with others, demonstrates "substantial equivalence." This implies the device met the required fixation strength characteristics to be considered equivalent.
b. Overall mechanical and structural integrity suitable for its intended use (femoral and tibial fixation of autograft or allograft ACL BTB grafts).	"Functional and integrity bench testing... were performed." The conclusion of substantial equivalence implies these tests demonstrated the device's design, technological characteristics, and safety and performance are appropriate for its indications for use.
Biocompatibility Testing:
a. Biocompatibility (e.g., non-toxic, non-irritating, non-sensitizing) in accordance with relevant standards (e.g., ISO 10993).	"Biocompatibility testing (according to FDA Memorandum #G95-1, 1995, Use of International Standard to die FDA garadies dooament, OB B Medical Devices Part 1: Evaluation and Testing" were performed." The conclusion of substantial equivalence implies these tests demonstrated the device is biocompatible and safe for implantation, meeting the standards outlined in the referenced documents.
Overall:
Demonstrates substantial equivalence to predicate devices (Mitek - RigidFix™ 2.7mm BTB Cross Pin Kit (K974291) and Linvatec BioScrew® Absorbable Interference Screw (K973758)).	The final conclusion states: "Based on the Indications for Use, design, technological characteristics and safety and performance testing, the proposed RigidFix™ 2.7mm BTB Cross Pin Kit has been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act."

Regarding the other requested information:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not Applicable. This submission details design verification and validation through bench testing and biocompatibility, not clinical data sets involving human subjects. Therefore, there's no "test set" of patient data, data provenance, or retrospective/prospective nature to describe in that context. The "sample size" for bench tests would refer to the number of devices tested, which is not specified in this summary.

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):

Not Applicable. As no clinical "test set" data from patients was used, there was no need for experts to establish ground truth in this manner. Evaluation was based on engineering and biological testing standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not Applicable. No human-based adjudication of patient data was required for this type of submission.

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:

Not Applicable. This is not an AI/algorithm-based device and no MRMC studies were conducted or relevant.

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

Not Applicable. This is a hardware implantable device, not an algorithm.

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

For the functional and integrity testing, the "ground truth" would be established engineering specifications, mechanical principles, and validated test methods.
For biocompatibility, the "ground truth" is established biological safety standards as outlined in documents like ISO 10993 (referenced as "International Standard to die FDA garadies dooament, OB B Medical Devices Part 1: Evaluation and Testing" and FDA Memorandum #G95-1).

8. The sample size for the training set:

Not Applicable. No machine learning model or "training set" was involved.

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

Not Applicable. As above, no training set was used.

Summary

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ATTACHMENT H

K013781

FEB 0 6 2002

SUMMARY OF SAFETY & EFFECTIVENESS

Pursuant to §513(i)(3)(A) of the Food, Drug, and Cosmetic Act, Mitek Products is requires assets and r ulsulant to 915(1)(3)(1) or the Food, 27th, adequate summary of any information respecting safety and this Frenarket Northeaton will be made available upon request of any person." Mitek Products choose to submit a summary of information respecting safety and effectiveness. According to $13(i)(3)(B), "Any summary under subparagraph (A) respecting a device shall contain detailed information regarding data concerning adverse health effects ... "

The summary regarding the adverse health effects of the proposed RigidFix™ 2.7mm BTB Cross Pin Kit is as follows:

Trade Name:	RigidFix™ 2.7mm BTB Cross Pin Kit
Sponsor:	Mitek Products249 Vanderbilt AvenueNorwood, MA 02062Registration: 1221934
Device Generic Name:	Appliance for reconstruction of bone to soft tissue
Classification:	According to Section 13 of the Federal Food, Drug and Cosmetic Act, thedevice classification is Class II, Performance Standards.
Predicate Devices:	Mitek - RigidFix™ 2.7mm BTB Cross Pin Kit (K974291)Linvatec BioScrew® Absorbable Interference Screw (K973758)

All of the devices mentioned above have been determined substantially equivalent by FDA.

Device Description: The device described in this 510(k) is a sterile, disposable, device designed for single patient use only. The cross pins are constructed of bioabsorbable Poly Lactic Acid (PLA).

Indications for Use: The RigidFix™ 2.7mm BTB Cross Pin Kit is indicated for femoral and tibial fixation of autograft or allograft ACL bone-tendon-bone (BTB) grafts.

Safety and Performance: Functional and integrity bench testing and Biocompatibility testing (according Sately and I criormance. I antenoid and ante and Memoradum #G95-1, 1995, Use of International Standard to die FDA garadies dooament, OB B Medical Devices Part 1: Evaluation and Testing" were performed, 100-10035, "brooked the substantial equivalence of the proposed RigidFix™ 2.7mm BTB Cross Pin Kit. Specifically, testing was performed to determine the initial fixation strength of the proposed RigidFix™ Diporneany, tosting was for Bone-Tendon-Bone grafted ACL Reconstructions.

Conclusion: Based on the Indications for Use, design, technological characteristics and safety and performance testing, the proposed RigidFix™ 2.7mm BTB Cross Pin Kit has been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act.

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three wavy lines, resembling a bird or a symbol representing health and human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 0 6 2002

Ms. Jennifer Johnson Regulatory Affairs Associate Mitek Products Ethicon, Inc., a Johnson & Johnson Company 249 Vanderbilt Avenue Norwood, Massachusetts 02062

Re: K013781

Trade Name: Rigidfix ™ 2.7mm BTB Cross Pin Kit Regulation Number: 888.3030 Regulation Number. 866:5050
Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HTY, MAI Dated: November 13, 2001 Received: November 14, 2001

Dear Ms. Johnson:

We have reviewed your Section 510(k) notification of intent to market the device referenced we have reviewed your Section > roke its substantially equivalent (for the indications for use stated in the enclosure) to 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 Your may enactment uate of the Medical Dories Finesal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general therefore, market the device, basyev to equirements for annual registration, listing of devices, Controls provisions of the receively, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III If your device is classified (see acc re) and additional controls. Existing major regulations (Fremarks) Approval), it they of Sale of Federal Regulations, Title 21, Parts 800 to 895. arrecting your do rios bant determination assumes compliance with the current Good A substantially cquiralent determination as set forth in the Quality System Regulation (QS) for Manufacturing Fractice requirements, as 3 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure 10 Inspections, the rood and Drug Nammonation of Collection. In addition, FDA may publish comply with the GMT regaration may readine in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might response to your premation stations of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) prematet notification. The FDA finding of substantial equivalence of your device to a legally marketed noutheation. The I Driving of cassion for your device and thus, permits your device to proceed to the market.

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Page 2 – Ms. Jennifer Johnson

If you desire specific advice for your device on our labeling regulation (21 CFF Part 801 and IT you desire specific days. I four astic devices), please contact the Office of Compliance at additionally 607.10 for in This dagliestions on the promotion and advertising of your device, (201) 594-4037. Additionally, for quest at (301) 594-4639. Also, please note the regulation prease connect the Orifice or Compilance an (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small
information on your responsibilities under the Act may be obtained from 112012 1 miorination on your responsibilities and in and in at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

lo Mark N Wilkerson

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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RigidFix 2.7mm BTB Tibial Cross Pin Kit

November 13, 2001

FEB 0 6 2002

Page of 1 1

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Rigidfix(tm) 2.7mm BTB Cross Pin Kit

Indications for Use: The Mitek RigidFix 2.7mm BTB Cross Pin Kit is indicated for femoral and tibial fixations for 050. "The Ingraft ACL bone-tendon-bone grafts.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

X Prescription Use (Per 21 CFR 801.109) Over-the -Counter Use ________________________________________________________________________________________________________________________________________________________

Mark N. Milliken

'estorative

K013781

510(k) Number

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.