Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head. and nonunion of previous fractures of the femur.
Patients with congenital hip displasia, protrusio acetabuli, or slipped capital femoral epiphysis.
Patients suffering from disability due to previous fusion.
Patients with acute femoral neck fractures.

Device Description

The Epoch Hip Prosthesis is a femoral stem manufactured from cobalt-chromiummolybdenum alloy, polyaryletherketone (PAEK), and commercially pure (c.p.) titanium fiber metal pads. This design is intended to permit biological fixation over the entire length of the stem.

The femoral stem is anteverted proximally and is straight distally. The device is designed to fit the proximal femur and provide an interference fit with intimate contact between the porous titanium pads and the surrounding trabecular bone. The proximal one-third is wedge-shaped with a broad medial face for optimal stress distribution. The stem is available in left and right configurations in sizes ranging from 14 to 18 mm. The design includes progressive offsets that increase in proportion with stem size for optimal restoration of joint anatomy.

The head/neck junction features a Morse-type 12/14 taper designed to mate with the corresponding 12/14 bore of a variety of femoral head components.

AI/ML Overview

The provided text describes a medical device, the Epoch® Hip Prosthesis, and its clinical evaluation. However, it does not include detailed acceptance criteria for device performance in a quantitative sense, nor does it present a study design focused on proving a device meets specific, pre-defined numerical performance targets regarding metrics like accuracy, sensitivity, or specificity.

Instead, the document summarizes a clinical trial that assessed the clinical and radiographic performance of the device, focusing on patient outcomes and complications. This is common for predicate-based 510(k) submissions, where substantial equivalence to a legally marketed device is the primary regulatory pathway, rather than proving performance against pre-defined, quantitative acceptance criteria for an AI/CADe device.

Therefore, many of the requested sections about acceptance criteria, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, and standalone performance for an AI/CADe device cannot be fully extracted or are not applicable to this document.

Here's the information that can be extracted or inferred based on the provided text, with explanations where information is missing or not applicable:

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

Acceptance Criteria (Quantitative)	Reported Device Performance	Comments
Not specified (for quantitative metrics like accuracy, sensitivity, specificity, etc. typical of AI/CADe devices)	- Functional Clinical Assessment (Harris Hip Analysis): "excellent" outcomes for the device	The document does not define specific pre-clinical or clinical quantitative acceptance criteria against which the device's numerical performance (e.g., in terms of diagnostic accuracy) was measured. The reported performance is qualitative and comparative.
Not specified (for complication rates)	- Complication rates: "low and comparable to literature reports for uncemented total hip arthroplasty."	Comparative assertion, not a specific numerical target.
Not specified (for revision rates)	- Revisions: "To date, no stems have been revised."	Positive outcome, but not presented as a pre-defined acceptance criterion.
Not specified (for thigh pain reduction)	- Thigh pain: Reduced from 78.9% of patients pre-operatively to 4.3% at 24 months.	Represents a significant improvement, but not an explicit acceptance criterion.
Not specified (for periprosthetic bone loss)	- DEXA analysis on subset: Suggests "periprosthetic bone loss attributable to stress shielding is less with the Epoch Hip Prosthesis than that observed in longitudinal studies of most other all-metallic femoral prostheses."	Comparative assertion, not a specific numerical target.

2. Sample size used for the test set and the data provenance

Sample Size (Test Set): A "six-year, multicenter clinical trial" was conducted. All subjects were "followed for two years." The exact total number of subjects is not explicitly stated, although it implies a cohort followed over time. A "subset of patients" underwent DEXA analysis.
Data Provenance: The study was a "multicenter clinical trial," implying data from multiple medical centers. It was a prospective study, as subjects were followed over time for functional, radiographic, and quality of life evaluations. The country of origin is not specified but is implicitly within the scope of the FDA's jurisdiction, likely the USA, given the submission to the FDA.

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

Number of Experts: Not specified.
Qualifications of Experts: Not specified.
- Note: For this type of device (hip prosthesis), "ground truth" would not typically be established by radiologists reviewing images in the same way it would for an AI/CADe diagnostic device. Instead, "ground truth" or clinical outcomes are derived from patient follow-ups, physical examinations (Harris Hip Analysis), symptom reporting (thigh pain), and objective measures like DEXA scans and complication tracking.

4. Adjudication method for the test set

Adjudication Method: Not specified. This aspect (e.g., 2+1, 3+1 consensus) is generally relevant for studies where human expert interpretation is being used to establish a definitive "ground truth" for a diagnostic task, which is not the primary focus here. Clinical outcomes were assessed using standardized scales and objective measurements.

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

MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is specifically designed to evaluate how AI assistance impacts human reader performance (e.g., radiologists interpreting images). The Epoch® Hip Prosthesis is a physical implant, not an AI/CADe diagnostic tool.
Effect Size: Not applicable.

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

Standalone Performance Study: No, a standalone performance study in the context of an AI/CADe device was not done. The device is a physical hip prosthesis and its performance is evaluated in vivo, in patients, as an implant, not as a standalone algorithm.

7. The type of ground truth used

Type of Ground Truth: The "ground truth" in this context refers to clinical outcomes data and radiographic evaluations. This includes:
- Functional clinical assessment (Harris Hip Analysis).
- Patient-reported outcomes (e.g., reduction in thigh pain).
- Complication rates (e.g., revisions).
- Radiographic evidence related to bone loss (DEXA analysis).
- The absence of revisions.

8. The sample size for the training set

Sample Size (Training Set): Not applicable. This document describes a clinical trial for a physical implant, not the development or training of an AI algorithm. Therefore, there is no "training set" in the AI sense.

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

Ground Truth Establishment (Training Set): Not applicable, as there is no training set for an AI algorithm.

Summary

{0}------------------------------------------------

K014070 p1/3

JUL 3 0 2002

Summary of Safety and Effectiveness

Submitted By: .

Zimmer, Inc. P.O. Box 708 Warsaw, Indiana 46581-0708 574-267-6131

Contact Person: ●

Karen Cain Manager, Regulatory Affairs Telephone: 574/372-4219 Fax: 574/372-4605

Date: �

July 22, 2002

. Trade Name:

Epoch® Hip Prosthesis

Common Name: 0

Femoral Hip Prosthesis

Classification Name: �

Prosthesis, hip, semi-constrained, composite/polymer

Predicate Devices: .

AML Total Hip System with Porocoat, manufactured by DePuy, P820024, . approved for use without bone cement August 19, 1983 (formerly called the Porocoat Modified Austin-Moore Total Hip Prosthesis); Porocoat Porous Coating, K931641, cleared for use without bone cement March 21, 1994

{1}------------------------------------------------

|C014070

BIAS® Total Hip System, manufactured by Zimmer, K842906, cleared for use ● with bone cement August 24, 1984; P850061, approved for use without bone cement January 31, 1989, subsequently downclassified to Class II on February 21, 1992
BIAS Fiber Metal Total Hip Stem (TFB), manufactured by Zimmer, K934515, . cleared August 24, 1995

Device Description �

The head/neck junction features a Morse-type 12/14 taper designed to mate with the corresponding 12/14 bore of a variety of femoral head components.

Intended Use .

The Epoch Hip Prosthesis is indicated for:

Patients suffering from severe hip pain and disability due to rheumatoid 1. arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head. and nonunion of previous fractures of the femur.
Patients with congenital hip displasia, protrusio acetabuli, or slipped capital 2. femoral epiphysis.
Patients suffering from disability due to previous fusion. 3.
Patients with acute femoral neck fractures. 4.

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Comparison to Predicate Devices .

All hip systems listed above are substantially equivalent to each other and the Epoch Hip Prosthesis in that each is intended for cementless fixation into the intramedullary canal for pathological or generative conditions involving the femur and/or acetabulum.

. Clinical Data

Clinical and radiographic performance of the Epoch Hip Prosthesis was evaluated in a six-year, multicenter clinical trial. All subjects were followed for two years and functional, radiographic and health-related quality of life evaluations were performed. Complication rates were low and comparable to literature reports for uncemented total hip arthroplasty. To date, no stems have been revised.

Functional clinical assessment by the Harris Hip Analysis indicated "excellent" outcomes for the device. Thigh pain was reduced from 78.9% of patients preoperatively, to 4.3% at 24 months.

DEXA analysis was completed on a subset of patients and suggests that periprosthetic bone loss attributable to stress shielding is less with the Epoch Hip Prosthesis than that observed in longitudinal studies of most other all-metallic femoral prostheses.

RA07251K.510

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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract symbol that resembles three stylized human profiles facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 3 0 2002

Ms. Karen Cain Manager, Regulatory Affairs Zimmer. Inc. P.O. Box 708 Warsaw, Indiana 46581-0708

Re: K014070

Trade/Device Name: Epoch® Hip Prosthesis, Model 4075 Series Regulatory 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: May 3, 2002 Received: May 7, 2002

Dear Ms. Cain:

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 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.

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· Page 2 - Ms. Karen Cain

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 yours,

Mark N. Milken

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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Exhibit K
-----------	--

Page | of |

510(k) Number (if known_KO14070

Device Name: Epoin Hip Stuitles

Indications for Use:

The Epoch® Hip Prosthesis is indicated for:

ﺎ . Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur.
1. Patients with congenital hip displasia, protrusio acetabuli, or slipped capital femoral epiphysis.
1. Patients suffering from disability due to previous fusion.
Patients with acute femoral neck fractures. 4.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use (Optional Format 1-2-96)

RA03601K.510

Mark A. Wilkerson

vision Sign-Off) Division of General, Restorative and Neurological Devices 510(k) Number -

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.