The Apex Modular™ Acetabular Cup is intended for use in combination with the Apex Modular Hip Stem in total hip replacement procedures. This acetabular cup is intended to articulate with a metal (cobalt chromium) or ceramic (alumina) femoral head. This prosthesis is intended for single use implantation, and may be used for the following conditions, as appropriate:

Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
Rheumatoid arthritis;
Correction of functional deformity;
Congenital dislocation;
Revision procedures where other treatments or devices have failed;
Femoral neck and trochanteric fractures of the proximal femur.

Device Description

The Apex Modular™ Acetabular Cups are manufactured of titanium alloy, with a sintered bead porous coating (commercially pure titanium, irregular bead geometry). The liners are manufactured of ram extruded ultrahigh molecular weight polyethylene, sterilized using ethylene oxide. The articular geometry of the liners are compatible with existing Apex Modular femoral heads, manufactured from cobalt chrome or ceramic, 28 or 32 mm diameter, with various offsets.

AI/ML Overview

The provided text is a 510(k) summary for the Apex Modular™ Acetabular Cup, a medical device. This document is a premarket notification to the FDA to demonstrate substantial equivalence to legally marketed predicate devices. It does not describe acceptance criteria for a performance study or a study that proves the device meets specific acceptance criteria in the way typically required for AI/ML medical devices.

Instead, the provided document focuses on demonstrating substantial equivalence to existing predicate devices (DePuy Pinnacle™ Acetabular Cup and Wright Medical Lineage™ Acetabular Cup) based on design, materials, and intended use. The "study" mentioned is "Liner retention studies were performed on the Apex Modular liners as per the relevant FDA guidance documents," but no specific acceptance criteria, results, or details of the study itself are provided beyond this general statement.

Therefore, for many of your points, the information is not present in the provided text.

Here's a breakdown of what can and cannot be answered from the provided text:

Acceptance Criteria and Device Performance

The document does not explicitly state "acceptance criteria" and "reported device performance" in the context of a detailed performance study with quantitative metrics, as one would expect for an AI/ML device. The assessment is primarily a comparison to predicate devices, asserting "substantial equivalence."

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category (as per your request)	Specific Criteria (Not explicitly stated as performance criteria)	Reported Device Performance / Justification
Intended Use	Primary and revision total hip replacement, cementless	Yes, cementless (Matches predicates)
Design: Liner Engagement	19° taper with PE locking ring	19° taper with PE locking ring (Matches Wright, similar to DePuy)
Design: Minimum PE Thickness	6 mm	6 mm (Matches DePuy, >4 mm of Wright)
Design: Liner Options	Neutral, and 15° hooded	Neutral, and 15° hooded (Similar to predicates)
Design: Shell Options	No hole and three hole (plus apical hole)	No hole and three hole (plus apical hole) (Similar to predicates)
Design: Head Diameters	28 and 32 mm	28 and 32 mm (Similar to predicates)
Design: Shell Profile	Full profile, 14° rim flare	Full profile, 14° rim flare (Matches Wright, similar to DePuy)
Materials: Liner	UHMWPE (ram extruded, ETO sterilized)	UHMWPE (ram extruded, ETO sterilized) (Matches Wright, similar to DePuy)
Materials: Shell	Titanium alloy	Titanium alloy (Matches predicates)
Materials: Porous Coating	CP titanium sintered beads	CP titanium sintered beads (Matches predicates)
Biomechanical Performance	Liner retention as per relevant FDA guidance documents	"Liner retention studies were performed" (Implied success, no specific results given)

Explanation: The "acceptance criteria" here are inferred from the features compared against the predicate devices to establish substantial equivalence. The "reported device performance" is the statement that the Apex Modular Acetabular Cup meets or is similar to these features. The liner retention study is the only specific "study" mentioned, with the implied "acceptance criteria" being compliance with FDA guidance and "performance" being that such studies were conducted.

Additional Information (Based on the Provided Text):

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 / Not Provided. The document describes a comparison to predicate devices and mentions "liner retention studies," but does not detail sample sizes, data provenance, or whether test sets were used in the way one would for an AI/ML algorithm's performance evaluation.

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

Not Applicable / Not Provided. This type of evaluation (expert-established ground truth) is not described in the document for the Apex Modular Acetabular Cup.

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

Not Applicable / Not Provided.

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. An MRMC study is not mentioned as this device is a physical implant, not an AI diagnostic tool for human readers.

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

Not Applicable / No. This refers to AI/ML algorithm performance, which is not relevant for this physical medical device.

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

Not Applicable / Not Provided (for performance evaluation). The "truth" for this device's regulatory clearance is its substantial equivalence in design, materials, and intended use to existing legally marketed devices, and compliance with relevant guidance for mechanical testing (like liner retention).

8. The sample size for the training set:

Not Applicable / Not Provided. This concept is not relevant to the clearance of this physical implant.

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

Not Applicable / Not Provided. This concept is not relevant to the clearance of this physical implant.

In summary: The provided document is a 510(k) summary for a physical medical device (an acetabular cup), which focuses on demonstrating substantial equivalence to existing predicate devices through comparison of design features, materials, and intended use, along with general statements about compliance with FDA guidance for certain mechanical tests. It does not contain the kind of detailed performance study information, acceptance criteria, or ground truth establishment typically associated with the evaluation of AI/ML software as a medical device.

Summary

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MAY 222003

510(K) Summary

K031110

Apex Modular™ Acetabular Cup

May 12, 2003

1. Submitter:	Apex Surgical, LLC12 Harding StreetSuite 202Lakeville, MA 02347
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Contact: Edward J. Cheal, Ph.D. Managing Director (508) 947-6500 (voice) (208) 248-8227 (fax)

2. Device Name

Proprietary Name:	Apex Modular™ Acetabular Cup
Common Name:	Acetabular cup, uncemented
Classification Name:	Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis
Regulatory Class:	Class II per 21 CFR §888.3358

3. Intended Use

The Apex Modular™ Acetabular Cup is intended for use in combination with the Apex Modular Hip Stem in total hip replacement procedures. This acetabular cup is intended to articulate with a metal (cobait chromium) or ceramic (alumina) femoral head. This prosthesis is intended for single use implantation, and may be used for the following conditions, as appropriate:

. Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
. Rheumatoid arthritis;
. Correction of functional deformity;
Congenital dislocation; .
Revision procedures where other treatments or devices have failed; ●
Femoral neck and trochanteric fractures of the proximal femur. .

4. Device Description

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Image /page/1/Picture/0 description: The image shows the logo for Apex Surgical. The logo consists of a stylized letter A on the left, followed by the words "Apex Surgical" in a serif font. The letters are all black, and the word "Surgical" is slightly smaller than the word "Apex". There is a trademark symbol to the upper right of the word "Surgical".

5. Predicate Device Comparison

Substantial equivalence is claimed to the DePuy Pinnacle™ Acetabular Cup and the Wright Medical Lineage™ Acetabular cup. The table below compares the features and characteristics of the Apex Modular Acetabular Cup to these predicate devices.

	Apex ModularAcetabular Cup	DePuyPinnacleTMAcetabular Cup(K000306 andK001534)	Wright MedicalLineageAcetabular Cup(K002149)
INTENDED USE
Primary and revisiontotal hip replacement	Yes, cementless	Yes, cementless	Yes, cementless
DESIGN
Liner engagement	19° taper withPE locking ring	"VIP Taper" withPE locking ring	19° taper with PElocking ring
Minimum PEthickness	6 mm	6 mm	>4 mm
Liner options	Neutral, and 15°hooded	Neutral, 4 mmlateralized, 10°angled, and 15°hooded	Neutral, 4 mmlateralized, and15° hooded
Shell options	No hole andthree hole (plusapical hole)	No hole, threehole, spiked, andmultihole (8-12holes), plusapical hole (all)	No hole and threehole (plus apicalhole)
Head diameters	28 and 32 mm	28, 32, and 36mm	22.25, 28 and 32mm
Shell profile	Full profile, 14°rim flare	Full profile,hemispherical	Full profile, 14°rim flare
MATERIALS
Liner	UHMWPE (ramextruded, ETOsterilized)	UHMWPE (ramextruded,radiation cross-linked, gasplasmasterilized)	UHMWPE (ramextruded, ETOsterilized)
Shell	Titanium alloy	Ti alloy	Ti alloy
Porous coating	CP titaniumsintered beads	CP titaniumsintered beads	CP titaniumsintered beads

These cups use similar materials, porous coatings, design options, and liner locking mechanisms. Liner retention studies were performed on the Apex Modular liners as per the relevant FDA guidance documents.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, with three stylized lines representing the wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 22 2003

Edward J. Cheal, Ph.D. Managing Director Apex Surgical, LLC 12 Harding Street, Suite 202 Lakeville, MA 02347

Re: K031110

Trade/Device Name: Apex Modular™ Acetabular Cup Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint/metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: II Product Code: LPH Dated: April 4, 2003 Received: April 8, 2003

Dear Dr. Cheal:

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 FDA's 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 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

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Page 2 - Edward J. Cheal, Ph.D.

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.

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,

sincerely yours,

Mark N. Milliken

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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Indications For Use Device Name: Apex Modular™ Acetabular Cup

Non-inflammatory degenerative joint disease, including osteoarthritis and . avascular necrosis;
Rheumatoid arthritis; .
Correction of functional deformity; .
Congenital dislocation; .
Revision procedures where other treatments or devices have failed; ●
Femoral neck and trochanteric fractures of the proximal femur. .

(Please do not write below this line - Continue on another page if necessary) Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Milham

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

510(k) Number K031110

Prescription Use X (Per 21 CFR §801.109)

Over-the-Counter Use

(Optional Format 1-2-96)

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.