The Surgical Dynamics Meniscal Staple is intended for the repair of vertical longitudinal full thickness tears (i.e., bucket-handle) in the red-red and red-white zones.

Device Description

The currently marketed Surgical Dynamics Meniscal Staple is an absorbable implantable staple. The staple consists of two rigid resorbable barbed legs connected by a length of resorbable, flexible braided filament. The staple is designed to facilitate meniscal repair in the vascular zone of the meniscus.

AI/ML Overview

The provided text is a 510(k) summary for the Surgical Dynamics Meniscal Staple, a medical device. It does not include information about acceptance criteria, study details, or performance metrics that would typically be found in a clinical study report or a detailed validation document for a new device.

The context of this document is a submission to the FDA requesting clearance based on "substantial equivalence" to a previously marketed device, not a de novo clearance requiring extensive clinical performance studies. Therefore, many of the requested details about performance studies, such as sample size, ground truth, and expert qualifications, are not present in this type of submission.

Here's a breakdown of why the requested information is absent and what the document does tell us:

Substantial Equivalence: The key phrase in the document is "substantially equivalent." This means the manufacturer is asserting that the modified Surgical Dynamics Meniscal Staple is as safe and effective as a legally marketed predicate device (the "currently marketed version of the device"), and therefore does not require new, extensive clinical studies to prove effectiveness.
Device Description and Indications for Use: The document clearly states the device description and its intended use, which are crucial for defining the scope of equivalence.
No New Performance Data Required for 510(k) Equivalence: For a 510(k) submission based on substantial equivalence, the FDA typically relies on the performance data of the predicate device, or bench testing / non-clinical data to show that the new device performs as safely and effectively as the predicate. Extensive clinical trials with specific acceptance criteria are usually not required unless there are significant differences in technology, indications for use, or safety/effectiveness concerns compared to the predicate.

Given this, I cannot provide the requested information in the format you asked for.

However, I can extract what is explicitly stated or can be inferred from the provided text:

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated as performance metrics. The underlying "acceptance criterion" for a 510(k) is "substantial equivalence" to a predicate device. This typically involves demonstrating that the new device has the same intended use, technological characteristics, and performs as safely and effectively as the predicate device.
- Reported Device Performance: Not explicitly reported in terms of clinical outcomes or specific quantitative metrics in this summary. The summary states, "The modified Surgical Dynamics Meniscal Staple was claimed to be substantially equivalent* to the currently marketed version of the device." This implies that its performance is considered equivalent to the predicate, but specific performance data or a comparison table is not provided.
Sample sized used for the test set and the data provenance:
- Not applicable/Not provided. There is no mention of a clinical "test set" or human subject data in this 510(k) summary for the modified device. Equivalence would likely be demonstrated through engineering specifications, material properties, and potentially non-clinical testing comparing it to the predicate.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided for the reasons above.
Adjudication method for the test set:
- Not applicable/Not provided.
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 device, nor is a MRMC study typically required for this type of 510(k) submission.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI device.
The type of ground truth used:
- Not applicable. As no clinical "test set" is described, no ground truth determination method is mentioned. The "ground truth" here is the established safety and effectiveness of the predicate device.
The sample size for the training set:
- Not applicable. No training set is mentioned as this is not an AI/machine learning device.
How the ground truth for the training set was established:
- Not applicable.

In summary, the provided document is a 510(k) summary focused on demonstrating substantial equivalence, not a detailed clinical study report. Therefore, it lacks the specific performance data and study design details (like sample sizes, ground truth establishment, expert qualifications, etc.) that would be associated with proving device performance against explicit acceptance criteria in a de novo or PMA submission.

Summary

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Attachment 4

DEC 1 1 2001

K 013890
page 1 of 1

510(k) Summary

Surgical Dynamics Meniscal Staple

United States Surgical 150 Glover Avenue Norwalk, CT 06856 USA

DEVICE DESCRIPTION

The currently marketed Surgical Dynamics Meniscal Staple is an absorbable implantable staple The ourtency martides bolymer. The staple consists of two rigid resorbable barbed legs connected by a length of resorbable, flexible braided filament. The staple is designed to facilitate meniscal repair in the vascular zone of the meniscus.

INDICATIONS FOR USE

The Surgical Dynamics Meniscal Staple is intended for the repair of vertical longitudinal full thickness tears (i.e., bucket-handle) in the red-red and red-white zones.

SUBSTANTIAL EQUIVALENCE*

The modified Surgical Dynamics Meniscal Staple was claimed to be substantially equivalent* to the currently marketed version of the device. Information pertaining to this device was provided in the submission.

Any claim of substantial equivalence is made exclusively in regard to the U.S. Food, Drug and Cosmetic Act and should not be viewed in any other light.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 1 2001

Ms. Jenny Schuck Regulatory Affairs Senior Associate United States Surgical 150 Glover Avenue Norwalk, Connecticut 06856

Re: K013890

Device Name: Surgical Dynamics Meniscal Staple Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: November 20, 2001 Received: November 23, 2001

Dear Ms. Schuck:

We have reviewed your Section 510(k) premarket notification of intent to market the device wo nove 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 for use sured in the encreated 776, the enactment date of the Medical Device Amendments, or to conniner of the 11th 2011-11-11 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 I ou may, alcrever, mains 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 If your device is elassinod (600 as controls. Existing major regulations affecting your device can may or bayer to been 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 r 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 or uny 1 sattail 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 Of It in the quality systems (21 (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. Jenny Schuck

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and my of your finding of substantial equivalence of your device to a legally premarked noutheater - 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of Compliance alease 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 Other general 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 vours,

Sincerely yours,

Mark A. Melkerson

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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Attachment 2

page lof 1

Indications for Use Statement

510(k) Number

K013890

Device Name Surgical Dynamics Meniscal Staple

Indications For Use

The Surgical Dynamics Meniscal Staple is intended for the repair of vertical longitudinal full thickness The Durglour Dyl-handle) in the red-red and red-white zones.

(Please do not write below this line - continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Labels	Values
Prescription Use:	Yes
(Per 21 CFR 801.109)
OR Over-The-Counter Use:	No

for Mark N. Melker
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices

Labels	Values
510(k) Number	K013890

Regulation Number and Section

N/A