The Mitek PDS/PGA Staple is an absorbable implant used in the fixation of scaffolding (for example periosteal autograft, collagen membranes or synthetic scaffolding) to articular cartilage lesions of the knee.

Device Description

The Mitek PDS/PGA Staple is a sterile, implantable device intended for single patient use only. The PDS/PGA Staple consists of an injection molded polydioxanone (PDS) U-shaped strap and two injection molded polyglycolic acid (PGA) cones. The PDS U-shaped strap is insert-molded around the two injection molded PGA cones, resulting in a single, mechanically joined, PDS/PGA Staple construct. The PDS/PGA Staple is manufactured from two absorbable polymers that are well-known and well-characterized and have been used in a multitude of commercially available medical devices.

AI/ML Overview

The provided text is a 510(k) summary for the Mitek PDS/PGA Staple. It describes the device, its intended use, and the basis for its substantial equivalence to predicate devices. However, it does not explicitly define acceptance criteria or detail a specific study with performance metrics in the way one might expect for an AI/ML device.

This document focuses on demonstrating substantial equivalence to existing, legally marketed devices. The "safety and performance" section refers to studies, but these are to show equivalence, not to meet specific, quantifiable performance targets set as acceptance criteria for a novel device.

Therefore, many of the requested categories cannot be directly answered from the provided text because it's a submission for a medical device that established substantial equivalence through in vitro and in vivo animal studies, and biocompatibility data, rather than a comparative effectiveness study with human readers or AI algorithms.

Here's a breakdown of what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Implicit Acceptance Criteria: Demonstration of substantial equivalence to predicate devices (6-0 Coated VICRYL Absorbable Suture, PDS II Suture, Mitek "H" Fix Meniscal Fastener) based on safety and performance.	Performance Studies (as evidence for equivalence): - Biocompatibility data - In vitro strength retention assessment - Simulated use evaluation - In vivo animal studies
Safety Profile	Data provided supports safety and performance.
Performance Profile	Data provided supports safety and performance to be substantially equivalent to currently marketed devices.
Materials	Manufactured from two absorbable polymers (PDS and PGA) that are well-known and well-characterized.
Operating Principle	Similar to predicate devices.
Intended Use	Fixation of scaffolding to articular cartilage lesions of the knee, similar to predicate devices.
Manufacturing Processes	Similar to predicate devices.
Sterilization Processes	Similar to predicate devices.

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

Sample Size for Test Set: Not specified. The document mentions "in vitro strength retention assessment," "simulated use evaluation," and "in vivo animal studies," but does not provide specific sample sizes for these.
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The studies are referred to generally.

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

Not applicable. This device is not an AI/ML diagnostic tool requiring expert ground truth for image interpretation. The performance is assessed through laboratory and animal studies, not human expert evaluations for a test set.

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

Not applicable for a medical device of this type. Adjudication methods are typically used in clinical studies involving interpretation of data by multiple reviewers.

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. This is not an AI/ML device, and an MRMC study is not relevant to its type of submission.

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

No. This is not an AI/ML algorithm.

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

The "ground truth" for this device's performance would be derived from the specific metrics measured in the biocompatibility data, in vitro strength retention assessment, simulated use evaluation, and in vivo animal studies. For example, in vitro strength retention might be measured against a predefined mechanical standard, and in vivo animal studies would assess biological response and tissue integration. These are objective measurements rather than expert consensus on interpretative data.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable.

Summary

{0}------------------------------------------------

510(k) Summary

K021953} page 142

June 10, 2002 Date:

Mitek Worldwide Sponsor: 249 Vanderbilt Avenue Norwood, MA 02062 Registration #1221934

Petra C. Smit Contact: (781) 251-3196 Tel: Fax: (781) 278-9578 E-mail: psmit@ethus.jnj.com

Proprietary Name: Mitek PDS/PGA Staple

Classification Name:

Fastener, Fixation, Biodegradable, Soft Tissue (21 CFR 888.3030); Class II Product Code: 87 MAI

Common Name:

Biodegradable Fastener, Soft Tissue Fixation

Predicate Device(s):

K946271 6-0 Coated VICRYL (polyglactin 910) Absorbable Suture PMA N18331 PDS II Suture K970119 Mitek "H" Fix Meniscal Fastener

DEVICE DESCRIPTION:

Product Description

The PDS/PGA Staple is manufactured from two absorbable polymers that are well-known and well-characterized and have been used in a multitude of commercially available medical devices.

{1}------------------------------------------------

K021953 page 2 of
CONFIDENTIAL

Indications for Use

Safety and Performance.

Biocompatibility data, results of an in vitro strength retention assessment, a simulated use evaluation and results of in vivo animal studies have been provided to support the safety and performance of the PDS/PGA Staple. The data provided supports that the PDS/PGA Staple is substantially equivalent to currently marketed devices.

CONCLUSION

Based on 1) safety and performance data, and 2) similarities in operating principle, intended use, materials, manufacturing processes and sterilization processes, the PDS/PGA Staple has been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act,

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized symbol featuring three abstract human profiles facing to the right, with the profiles overlapping each other.

DEC 2 0 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Petra C. Smit Sr. Project Manager, Regulatory Affairs Mitek Worldwide 249 Vanderbilt Avenue Norwood, Massachusetts 02062

Re: K021953

Trade/Device Name: Mitek PDS/PGA Staple Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple Component Metallic Bone Fixation Appliances and accessories Regulatory Class: Class II

Product Code: JDR Dated: September 24, 2002 Received: September 25, 2002

Dear Ms. Smit:

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 FDAs 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 Acts 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.

{3}------------------------------------------------

Page 2 - Ms. Petra C. Smit

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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket_ notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
lilla watt

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

{4}------------------------------------------------

Page 1 of 1

510(k) Number (if known):

K 04195(-3

Device Name:

Mitek PDS/PGA Staple

Indications for Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-the -Counter Use No

Division Sign-Offy Division of General, Restorative and Neurological Devices

510(k) Number __

Traditional 510(k) Premarket Notification June 10, 2002

Mitek Worldwide Mitek PDS/PGA Staple

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.