The INTERSEAL® Acetabular Cup is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
inflammatory degenerative joint disease such as rheumatoid arthritis;
correction of functional deformity;
revision procedures where other treatments or devices have failed; and,
treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

Device Description

The INTERSEAL® Acetabular Screw Hole Plug provides an optional filler for INTERSEAL® acetabular shell screw holes to prevent a pathway for wear debris through unused screw holes holes during placement of the acetabular shell without screws. The INTERSEAL® Acetabular Screw Hole Plug is machined from ultra high molecular weight polyethylene (UHMWPE) conforming to ASTM F 648. The one-piece, snap-in design will be offered sterile in a pack of up to four plugs for insertion into the screw holes of the INTERSEAL® Acetabular Cup by the surgeon during implantation.

AI/ML Overview

The provided text focuses on the 510(k) summary for a medical device called the INTERSEAL® Acetabular Screw Hole Plug. It describes the device, its indications for use, and a brief summary of a single test. However, it does not contain the detailed information necessary to fully address all aspects of your request regarding acceptance criteria and a comprehensive study proving the device meets those criteria.

Here's a breakdown of what can be extracted and what is missing:

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

Acceptance Criteria	Reported Device Performance
Tensile Properties: Met or exceeded minimum requirements of ASTM F 648.	EtO-sterilized components and control unsterilized UHMWPE bar stock meet or exceed the minimum requirements of ASTM F 648.

Missing Information: The specific quantitative "minimum requirements" of ASTM F 648 are not detailed in this document. Only a qualitative statement of compliance is given.

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

Missing Information: The document does not specify the sample size used for the tensile properties testing, nor does it provide any information on data provenance (country of origin, retrospective/prospective).

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)

This question is not applicable to the type of testing described. The "ground truth" for tensile properties is established by the ASTM F 648 standard, which defines the physical and mechanical properties of UHMWPE. It doesn't involve expert interpretation in the way, for example, a diagnostic imaging study would.

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

This question is not applicable. Adjudication is typically used in studies involving subjective assessment or multiple expert opinions to establish a ground truth. For materials testing like tensile properties, the results are objectively measured against a standard.

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

This question is not applicable. The device is a physical implant (an acetabular screw hole plug), not an AI-assisted diagnostic tool or an imaging device.

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

This question is not applicable, as the device is a physical implant.

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

The "ground truth" for the device's performance in terms of tensile properties is defined by the ASTM F 648 standard for Ultra-High-Molecular-Weight Polyethylene (UHMWPE) for surgical implants.

8. The sample size for the training set

This question is not applicable. The device is a physical implant, not a machine learning model that requires a training set.

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

This question is not applicable, as there is no training set for a physical implant.

In summary:

The provided text details the regulatory submission for a physical medical device. The "acceptance criteria" discussed are related to the material properties of the device, specifically its tensile properties, which are shown to meet an existing industry standard (ASTM F 648). The document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than providing a comprehensive, detailed study report with all the specifics of experimental design, sample sizes, and expert panel configurations that would be present in a clinical trial or AI performance study.

Summary

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Image /page/0/Picture/0 description: The image shows a stylized letter "W" logo. The "W" is formed by three thick, black, diagonal lines against a white background. The lines are arranged to create the shape of a "W", with the middle line slightly offset to the right. A registered trademark symbol is located at the bottom right corner of the logo.

Image /page/0/Picture/1 description: The image shows the logo for Wright Medical Technology, Inc. The logo features the company name in bold, uppercase letters, with the words "MEDICAL TECHNOLOGY, INC." appearing in a smaller font size below. The address "5677 AIRLINE ROAD ARLINGTON, TN 38002" and phone number "901-867-9971" are printed below the company name.

K97.1429

510(k) Summary

JUL - 9 1997 Contact Person: Cristie Manuel Date Prepared: April 17, 1997

Trade/Common Name:	INTERSEAL® Acetabular Screw Hole Plug
Classification Name:	Hip joint, metal/polymer/metal semi-constrained, porous-coateduncemented prosthesis
Predicate Devices:	INTERSEAL® Apical Hole Plug manufactured by Wright MedicalTechnology, Inc.; and Opti-Fix Cement Spacer Pod manufacturedby Smith and Nephew.

This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.

Description

Indications

This device is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1) noninflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia: 2) inflammatory degenerative joint disease such as rheumatoid arthritis: 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; and, 5) treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

Testing Summary

Tensile properties of the EtO-sterilized components and control unsterilized UHMWPE bar stock meet or exceed the minimum requirements of ASTM F 648.

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Image /page/1/Picture/1 description: The image is a black and white circular logo for the Department of Health & Human Services USA. The logo features the department's emblem, which is a stylized representation of a human figure embracing a bird. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged around the emblem in a circular fashion.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Christie Manuel Requlatory Affairs Associate Wright Medical Technology, Inc. 5677 Airline Road 38002 Arlington, Tennessee

JUL - 9 1997

... ..

K971429 Re : INTERSEAL® Acetabular Screw Hole Plug Regulatory Class: II Product Code: LPH Dated: April 17, 1997 Received: April 18, 1997

Dear Ms. Manuel:

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 provisions The general controls provisions of the Act of the Act. include requirements for annual reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 Requlations, 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 Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Druq 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 Reqister. 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 requlations.

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Fage 2 - Ms. Christie Manuel

This letter will allow you to begin marketing your device as described in your 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 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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

fo colly

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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C.	Indications for Use of the Device
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510(k) Number (if known):	9711429
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Device Name: INTERSEAL® Acetabular Screw Hole Plugs, Product Line Addition to the INTERSEAL® Acetabular Cup

Indications for Use:

The INTERSEAL® Acetabular Cup is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
1. inflammatory degenerative joint disease such as rheumatoid arthritis;
correction of functional deformity; 3)
revision procedures where other treatments or devices have failed; 4) and,
ર) treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

f. colles

(Division Sign-Off) Division of General Restorative Devices 510(k) Number.

Prescription Use_X (Per 21 CFR 801.109) Or

Over-the-Counter Use

(Optional Format 1-2-96)

0000009

Regulation Number and Section

§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.

(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.