The ESOP® HA Femoral Stem is intended for use in degenerative and inflammatory arthritis of the hip joint, trauma, non-acute femoral neck fracture, revision of previously failed hip arthroplasties, and idiopathic avascular (osteo) necrosis where radiographic evidence shows there is sufficient sound bone to seat the prosthesis. This device is intended for cementless application.

Device Description

The ESOP® HA Femoral Stem consists of left and right configuration metaphysis parts in various size diameters, and diaphysis parts in various sizes. The ESOP® HA Femoral Stem instrument system is used for proper implantation of the device. The ESOP® HA Femoral Stem design includes: 10 left and right configuration metaphysis parts in various sizes diameters and cone angles, and 7 diaphysis parts of various sizes which are to be screwed into the extremity of the metaphysis part.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the ESOP® HA Femoral Stem, a medical device. This type of regulatory submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than presenting a detailed study proving the device meets specific acceptance criteria in the way an AI/ML device would.

Therefore, the requested information about acceptance criteria, study details, sample sizes, expert qualifications, and ground truth establishment is not present in this document. This is because the regulatory pathway for this device (a femoral stem, a physical implant) relies on demonstrating similarity to existing products, rather than efficacy through clinical trials with specific performance metrics akin to those required for a diagnostic algorithm.

Here's why each of your requested points cannot be answered from the provided text:

1. A table of acceptance criteria and the reported device performance: Not provided. The submission focuses on demonstrating substantial equivalence, not specific performance metrics.
2. Sample sized used for the test set and the data provenance: Not applicable/not provided. There isn't a "test set" in the context of an algorithm or diagnostic 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. No ground truth establishment for a test set is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/not provided. No adjudication method is relevant here.
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: Not applicable/not provided. This is a physical implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable/not provided. This is a physical implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable/not provided.
8. The sample size for the training set: Not applicable/not provided. There is no concept of a training set for this type of device.
9. How the ground truth for the training set was established: Not applicable/not provided.

Summary of available information regarding compliance:

The submission states: "Verification/validation and design control activities Performance Data: demonstrate the safety and effectiveness of the ESOP® HA Femoral Stem." and "Conclusion: The ESOP® HA Femoral Stem is substantially equivalent to the claimed predicate devices and other currently marketed femoral stems."

This indicates that the device met the regulatory requirements for a 510(k) by demonstrating substantial equivalence to predicate devices (FHI ESOP® S/C Femoral Stem, K964878 and Landos CORAIL Femoral Stem, K953111) through verification, validation, and design control activities, which would typically involve engineering tests, material compatibility tests, and possibly simulated use, but not clinical studies in the way you've outlined for AI/ML performance. The acceptance criteria for such a device would relate to engineering specifications, material properties, and manufacturing quality, all aligned with the predicate devices. These specific acceptance criteria and the data supporting them are not detailed in the provided summary.

Summary

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Sponsor: Pro-Active

MAY 0-3 2002

ESOP® HA Femoral Stem Special 510(k) Premarket Notification

K021108
page 1 of 2

510(k) SUMMARY – ESOP® HA Femoral Stem

Submitter Name:	Fournitures Hospitalieres Industrie
Submitter Address:	6 rue Nobel, Z.I. de KernevezQuimper, France 29000
Contact Person:	Christine Quendez
Phone Number:	+ 33 2 98 55 68 95
Fax Number:	+33 2 98 53 42 13
Date Prepared:	22 March 2002
Device Trade Name:	ESOP® HA Femoral Stem
Device Common Name:	Femoral Stem
Classification Name:	Prosthesis, Hip, Femoral Component
Predicate Devices:	● FHI ESOP® S/C Femoral Stem, K964878● Landos CORAIL Femoral Stem, K953111
Device Description:	The ESOP® HA Femoral Stem consists of left and rightconfiguration metaphysis parts in various size diameters,and diaphysis parts in various sizes. The ESOP® HAFemoral Stem instrument system is used for properimplantation of the device. The ESOP® HA FemoralStem design includes: 10 left and right configurationmetaphysis parts in various sizes diameters and coneangles, and 7 diaphysis parts of various sizes which areto be screwed into the extremity of the metaphysis part.
Device TechnologicalCharacteristics andComparison toPredicate Device(s):	The ESOP® HA Femoral Stem is made of similarmaterials, is available in similar diameters and lengths, hasa similar design, and the same indications for use as thepredicate devices and other currently marketed femoralstems.

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Verification/validation and design control activities Performance Data: demonstrate the safety and effectiveness of the ESOP® HA Femoral Stem.

Sponsor:

Pro-Active

Conclusion: The ESOP® HA Femoral Stem is substantially equivalent to the claimed predicate devices and other currently marketed femoral stems.

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Image /page/2/Picture/0 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three heads, representing the department's focus on health, human services, and science. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 0 3 2002

Fournitures Hospitalieres Industrie c/o Dr. Andre Weith Director, Pro-Active Healthcare c/o PharmaNet, Inc. 815 Connecticut Avenue NW, Suite 800 Washington, D.C. 20006

Re: K021108

Trade/Device Name: ESOP® HA Femoral Stem Regulation Number: 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis

Regulatory Class: II Product Code: MEH Dated: April 5, 2002 Received: April 5, 2002

Dear Dr. Weith:

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

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Page 2 - Dr. Andre Weith

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.

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 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 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 vours,

L. Mark N. Millburn

Celia 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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Sponsor: Pro-Active

ESOP® HA Femoral Stem Special 510(k) Premarket Notification

510(k) Number (if known):

K021108

page 1 of 1

Device Name:

ESOP® HA Femoral Stem

Indications for Use:

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

Concurrence of CDRH; Office of Device Evaluation (ODE)	for Mark N Melhuish (Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number	K021108
Prescription Use(Per 21 CFR 801.109)	OR Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.

(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.