ESOP S/C FEMORAL STEM by FOURNITURES HOSPITALIERES

The ESOP® S/C Femoral Stem is a device 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 exists sufficient sound bone to seat the prosthesis. This device is intended for cementless application.

Device Description

The ESOP® S/C Femoral Stem consists of a ceramic head, left and right configuration metaphysary parts in various size diameters, and diaphysary parts in various sizes. The ESOP® S/C instrumentation system is utilized for proper implantation of the device.

AI/ML Overview

The provided text describes the 510(k) summary for the ESOP® S/C Femoral Stem, a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing extensive clinical trials with specific acceptance criteria related to disease detection or diagnosis, as would be common for AI/ML-based diagnostic devices.

Therefore, the information required in your request regarding acceptance criteria for device performance, sample sizes for test/training sets, expert qualifications, ground truth establishment, MRMC studies, and standalone performance is not applicable to this particular document. This is a premarket notification for a traditional orthopedic implant, not an AI/ML-driven diagnostic tool. The "performance data" mentioned refers to engineering and materials testing, not diagnostic accuracy.

Here's a breakdown of why many of your requested fields are not present or applicable:

Acceptance Criteria and Reported Device Performance (Table): This document does not present acceptance criteria in terms of diagnostic metrics (e.g., sensitivity, specificity, AUC) or human reader performance. Its "performance" refers to the mechanical and material characteristics of the implant.
Sample Sized used for the test set and the data provenance: Not applicable. There isn't a "test set" in the context of diagnostic data for this type of device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic performance is not relevant here.
Adjudication method for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This is not a diagnostic device requiring human reader interpretation or AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical implant, not an algorithm.
The type of ground truth used: Not applicable in the diagnostic sense. The "ground truth" for an orthopedic implant's performance is established through material science testing, mechanical testing, and clinical follow-up over time (not typically part of the 510(k) summary itself, but post-market surveillance).
The sample size for the training set: Not applicable. There's no training set for an AI/ML model for this device.
How the ground truth for the training set was established: Not applicable.

However, I can extract the information that is relevant to the nature of this submission, focusing on the equivalence argument and basic device characteristics:

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

The "acceptance criteria" for a 510(k) submission like this are generally defined by demonstrating "substantial equivalence" to a predicate device in terms of:

Intended use
Technological characteristics (materials, design)
Performance (mechanical, biocompatibility, sterilization, etc.)

Since no specific numerical acceptance limits for "performance" are provided in the document (other than meeting general engineering standards), I will describe the approach.

Acceptance Criteria Category	Description (as implied/stated in 510(k))	Reported Device Performance
Intended Use	Must be the same as or very similar to predicate devices.	"The ESOP® S/C 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 exists sufficient sound bone to seat the prosthesis. This device is intended for cementless application." (Stated to have the same intended use as predicate devices).
Technological Characteristics	Design features, materials (ceramic head, metaphysary parts, diaphysary parts, hydroxylapatite coating) must be similar to or justified as equivalent to predicate devices.	"The ESOP® S/C Femoral stem design includes: 2 ceramic heads with short, medium, or long necks; 10 left and right configuration metaphysary parts in various size diameters with a 10° relief to the lateral side of the metaphys for ease of insertion into the femoral canal; and 7 diaphysary parts in various sizes which are to be screwed into the extremitv of the metaphyseal part." (Stated that predicate devices may incorporate some or all of these features).
Performance Data	Testing to characterize materials, coatings, and overall device performance under defined laboratory conditions. (Specific metrics not detailed in summary, but generally includes mechanical strength, fatigue, biocompatibility, etc.)	"Testing conducted to characterize the materials, the hydroxylapatite coating, and the performance characteristics of the device under defined laboratory conditions was provided to support a finding of substantial equivalence."
Safety and Effectiveness	Demonstrated through substantial equivalence to predicate devices, without raising new questions of safety or efficacy.	"The ESOP® S/C Femoral Stem is substantially equivalent to predicate device in terms of intended use, safety, and effectiveness."

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

Sample Size: Not applicable in the context of diagnostic data. The "testing" mentioned refers to engineering and material characterization tests. The dimensions and specifications of the various parts (2 ceramic heads, 10 metaphysary parts, 7 diaphysary parts) define the "sample space" of the product, but not a data test set.
Data Provenance: Not explicitly stated for performance testing, but the submitter is "Fournitures Hospitalieres" located in Quimper, France. The testing would have been conducted by them or a contracted lab. No mention of retrospective or prospective data in a clinical sense.

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)

Not applicable. This is not a diagnostic device requiring expert interpretation of clinical data for ground truth.

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

Not applicable.

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. This is not an AI/ML diagnostic device and does not involve human readers interpreting data enhanced by AI.

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

Not applicable. This is a physical orthopedic implant.

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

For the "performance data" referenced, the 'ground truth' would be established through scientific and engineering standards, physical measurements, and established material testing methodologies. For example, fatigue testing would have a 'ground truth' based on cycles to failure under specific load conditions, measured against established standards for implants. Biocompatibility testing results (e.g., ISO standards) would form part of this. There is no clinical outcomes data or pathology reference provided in the 510(k) summary itself to form a "ground truth" for clinical performance, as that is typically beyond the scope of a 510(k) unless specifically required for novel claims.

8. The sample size for the training set

Not applicable. No AI/ML model training is involved.

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

Not applicable.

Summary

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K96 48 78

510(k) SUMMARY - ESOP® S/C FEMORAL STEM

MAR - 5 1998

Submitter Name:	Fournitures HospitalieresOffice Medico Chirurgical International
Submitter Address:	6 Rue Nobel, Z.I de KernevezQuimper, France 29000
Contact Person:	Christine Quendez
Phone Number:	(+33) 98.55.68.95
Fax Number:	(+33) 98.53.42.13
Date Prepared:	December 5, 1996
Device Trade Name:	ESOP® S/C Femoral Stem
Device Common Name:	Hip Stem
Classification Name:	Prosthesis, Hip, Femoral Component (Metal Stem -Ceramic Head)
Predicate Devices:	Primaloc® Cementless Hip System (K953977),Ortho Development Corporation;Intrinsic® Cementless Total Hip System (K923911),Ortho Max, Inc.
Device Description:	The ESOP® S/C Femoral Stem consists of a ceramic head,left and right configuration metaphysary parts in varioussize diameters, and diaphysary parts in various sizes. TheESOP® S/C instrumentation system is utilized for properimplantation of the device.
Intended Use:	The ESOP® S/C Femoral Stem is intended for use indegenerative and inflammatory arthritis of the hip joint,trauma, non-acute femoral neck fracture, revision ofpreviously failed hip arthroplasties, and idiopathicavascular (osteo) necrosis where radiographic evidenceshows there exists sufficient sound bone to seat theprosthesis. This device is intended for cementlessapplication.

Continued . . .

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510(k) Summary (continued)

Device TechnologicalCharacteristics andComparison toPredicate Devices:	The ESOP® S/C Femoral stem design includes: 2 ceramicheads with short, medium, or long necks; 10 left and rightconfiguration metaphysary parts in various size diameterswith a 10° relief to the lateral side of the metaphys for easeof insertion into the femoral canal; and 7 diaphysary partsin various sizes which are to be screwed into the extremitvof the metaphyseal part. Identified predicate devices havethe same intended use and may incorporate some of or allof the above described design features either alone or incombination.
Performance Data:	Testing conducted to characterize the materials, thehydroxylapatite coating, and the performancecharacteristics of the device under defined laboratoryconditions was provided to support a finding of substantialequivalence.
Conclusion:	The ESOP® S/C Femoral Stem is substantially equivalentto predicate device in terms of intended use, safety, andeffectiveness.

Device TechnologicalCharacteristics andComparison toPredicate Devices:

The ESOP® S/C Femoral stem design includes: 2 ceramicheads with short, medium, or long necks; 10 left and rightconfiguration metaphysary parts in various size diameterswith a 10° relief to the lateral side of the metaphys for easeof insertion into the femoral canal; and 7 diaphysary partsin various sizes which are to be screwed into the extremitvof the metaphyseal part. Identified predicate devices havethe same intended use and may incorporate some of or allof the above described design features either alone or incombination.

Performance Data:

Testing conducted to characterize the materials, thehydroxylapatite coating, and the performancecharacteristics of the device under defined laboratoryconditions was provided to support a finding of substantialequivalence.

Conclusion:

The ESOP® S/C Femoral Stem is substantially equivalentto predicate device in terms of intended use, safety, andeffectiveness.

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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 consists of a stylized eagle or bird-like figure with three curved lines representing its wings or body. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 5 1998

Mr. Ben Van der Kooij Director, Europe/USA Pro-Active International Requlatory Agent for Fournitures Hospitalieres c/o Advanced Bioresearch Associates 1700 Rockville Pike, Suite 450 Rockville, Maryland 20852

Re : K964878 ESOP® S/C Femoral Stem Requlatory Class: II Product Codes: MEH and LZO Dated: December 5, 1997 Received: December 5, 1997

Dear Mr. Van der Kooij:

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). This decision is based on consideration of the specific design of stem and coating composition detailed in this application. You may, therefore, market the device, subject to the general controls provisions of the Act and the following limitations:

1. The package insert must reflect that the ESOP® Femoral Ceramic Heads are to be used only with the titanium alloy cone of the ESOP® S/C Femoral Stem.
1. You may not label or in any way promote these devices for "biological attachment, enhanced clinical or radiographic performance, enhanced fixation and/or long-term stable fixation." The data presented support equivalence with no additional claims over a conventional press-fit hip prosthesis (i.e., mechanical interlock, only).

Additional limitations for more specific claims of safety and effectiveness may be forthcoming. Should additional limitations be applied you will be contacted in writing to inform you of the additional labeling limitations.

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Page 2 - Mr. Ben Van der Kooij

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.

You may market your device under the above limitations as class II devices. These devices would be considered not substantially equivalent to a legally marketed predicate device if labeled with other intended uses and/or claims of safety or effectiveness. Any other intended uses or claims may cause the device to be classified into Class III under Section 513 (f) of the Act. Class III devices are required to have an approved premarket approval (PMA) application prior to marketing.

Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to A substantially equivalent determination assumes 895. 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 Druq Administration (FDA) will verify such assumptions. 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.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic 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

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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,

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):

Device Name:

K964878

ESOP® S/C 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)

Signature

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number	2964878

Prescription Use (Per 21 CFR 801.109)	X	OR...	Over-The-Counter Use
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(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.