The proposed SynPlug™ cement restrictor is identical in intended use and fundamental scientific technology to the parent Shuttle Stop® cement restrictor that was cleared for marketing by FDA on May 4, 2000 (K000587). Design changes were made to prevent cement leakage and migration, increase pressure resistance, and improve the ease of handling of the cement restrictor. These design modifications are limited to the following:

Adoption of a cylindrical shape for the proposed SynPlug
Elimination of sidewall slots and addition of five flanges
Increase in the rigidity of the proposed device
Expansion of the number of available sizes for the proposed device to 13, designed to fit intramedullary canal diameters of 9 to 21 mm
This submission also contains a description of instrumentation sets that have been developed to facilitate the selection of cement restrictor size by assessment of the intramedullary canal diameter and provide correct insertion of the cement restrictor. The SynPlug Instrumentation Set consists of 14 measuring probes for the measurement of canal diameters from 9 to 21 mm, two insertion rods, and a sterilization tray for holding the instruments during sterilization. The Shuttle Stop Instrumentation Set is identical to the SynPlug Instrumentation Set with the exception that only five measuring probes are provided to correspond with the four sizes of Shuttle Stop and a probe measuring the maximum intramedullary canal diameter for which the largest size Shuttle Stop can be used, 8 to 20 mm.

AI/ML Overview

I am sorry, but the provided text does not contain the information required to populate the requested table and answer the questions. The document is a 510(k) summary for a medical device called SynPlug™, which is a cement restrictor. It describes the device, its intended use, and states that it is substantially equivalent to a predicate device.

However, it explicitly states:

"The differences between the proposed and parent devices are minor and do not raise new issues of safety or effectiveness."
"These design modifications were validated according to IsoTis' Design Control Procedures, in compliance with the design control procedure requirements of the Quality Systems Regulations as specified in 21 CFR 820.30."

This indicates that the submission relies on design control validation and substantial equivalence claims rather than reporting on a specific study that tested the device against explicit acceptance criteria with performance metrics, ground truth, or expert involvement as described in your prompt.

Therefore, I cannot provide:

A table of acceptance criteria and the reported device performance: No specific acceptance criteria or performance metrics for the SynPlug™ are listed.
Sample size used for the test set and the data provenance: No test set data is described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment is mentioned.
Adjudication method: Not applicable as no test set or ground truth is described.
MRMC comparative effectiveness study results: No such study is mentioned.
Standalone performance results: No standalone performance metrics are provided.
Type of ground truth used: Not applicable.
Sample size for the training set: No training set is mentioned for an AI/algorithm.
How the ground truth for the training set was established: Not applicable.

Summary

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KOI0846

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510(k) Summary Special 510(k): Device Modification SynPlug™

1. SPONSOR

IsoTis NV Prof. Bronkhorstlaan 10-D 3723 MB Bilthoven The Netherlands

Contact Person: F.J.C. van Strien, Ph.D. +31 (0) 30 2295125 Telephone:

Date Prepared: March 20, 2001

2. DEVICE NAME

Proprietary Name: SynPlug™ Common/Usual Name: Cement restrictor Classification Name: Cement obturator

3. PREDICATE DEVICE

Shuttle Stop® (K000587)

4. DEVICE DESCRIPTION

Adoption of a cylindrical shape for the proposed SynPlug ●
Elimination of sidewall slots and addition of five flanges .

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K010846 p²/2

Increase in the rigidity of the proposed device .
Expansion of the number of available sizes for the proposed device to 13, . designed to fit intramedullary canal diameters of 9 to 21 mm

This submission also contains a description of instrumentation sets that have been developed to facilitate the selection of cement restrictor size by assessment of the intramedullary canal diameter and provide correct insertion of the cement restrictor. The SynPlug Instrumentation Set consists of 14 measuring probes for the measurement of canal diameters from 9 to 21 mm, two insertion rods, and a sterilization tray for holding the instruments during sterilization. The Shuttle Stop Instrumentation Set is identical to the SynPlug Instrumentation Set with the exception that only five measuring probes are provided to correspond with the four sizes of Shuttle Stop and a probe measuring the maximum intramedullary canal diameter for which the largest size Shuttle Stop can be used, 8 to 20 mm.

INTENDED USE ട്.

The SynPlug is a cylindrical plug intended for intramedullary occlusion during cemented hip and shoulder arthroplasty.

6. BASIS OF DETERMINATION OF SUBSTANTIAL EQUIVALENCE

The proposed SynPlug is a modification of the Shuttle Stop and is therefore substantially equivalent to the Shuttle Stop cement restrictor. The intended use and technological characteristics of the proposed and parent devices are identical. Differences are limited to the design modifications listed in Section 4. These design modifications were validated according to IsoTis' Design Control Procedures, in compliance with the design control procedure requirements of the Quality Systems Regulations as specified in 21 CFR 820.30. The differences between the proposed and parent devices are minor and do not raise new issues of safety or effectiveness.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract caduceus or a representation of human figures, with three flowing lines above two wavy lines.

APR 2 0 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

IsoTis NV c/o Cynthia J. M. Nolte, Ph.D. Medical Device Consultants, Inc. 49 Plain Street North Attleboro, Massachusetts 02760

Re: K010840

Trade Name: SynPlug™ Regulation Number: Unclassified Product Code: LZN Dated: March 20, 2001 Received: March 21, 2001

Dear Dr. Nolte:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is 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 accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Costical Fee (110). I 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Cynthia J. M. Nolte, Ph.D.

This letter will allow you to begin marketing your device as described in your 510(k) I mis letter will and in Journey of substantial equivalence of your device to a premaired predicated. - The vice 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 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 your device, please contact the Office of Compliance at (301) 594-4639. also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Miriam C. Provost

tol Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

KO10840

SynPlug™ Device Name:

Indications for Use:

SynPlug™ is a cylindrical plug intended for intramedullary occlusion during cemented hip and shoulder arthroplasty.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Muriam l. Provost

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

510(k) Number K010846

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

IsoTis Special 510(k) SynPlug™

March 20, 2001

Regulation Number and Section

§ 878.3300 Surgical mesh.

(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.