IMPLEX ALUMINA FEMORAL HEAD by IMPLEX CORP.

Severely disabled joints as a result of degenerative arthritis or avascular necrosis.
Secondary revision of a previously unsuccessful femoral component or total hip replacement.
Other hip problems where clinical experience has shown that alternative modes of treatment are less likely to achieve satisfactory results.
Fracture dislocation of the hip or irreducible fractures in which adequate fixation cannot be obtained.
Non-Union of femoral neck or head fractures.
Salvage of a failed primary or secondary total hip or hemi-hip arthroplasty.

Device Description

The Implex Alumina Femoral Head is a ceramic femoral head. The Implex Alumina Femoral Head is offered in a 28 mm OD with +0, +3, and +6 neck offset lengths, and is intended for use with all legally Femoral Continuum Hip System marketed Components with a 12/14 locking taper.

AI/ML Overview

The provided text does not describe acceptance criteria or a study proving that the "Implex Alumina Femoral Head" device meets specific performance criteria in the way typically seen for AI/ML-driven medical devices. Instead, it is a 510(k) summary for a mechanical medical device (a ceramic femoral head for hip replacement).

The document focuses on demonstrating substantial equivalence to existing predicate devices, primarily through:

Comparison of device characteristics, materials, intended use, and indications for use.
Mechanical test data.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set data) are not applicable to this type of submission.

Here's a breakdown based on the information provided, highlighting the differences for a mechanical device:

Acceptance Criteria and Study for Implex Alumina Femoral Head
(Based on the provided 510(k) summary for a mechanical device)

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state numerical acceptance criteria in the format of a table for performance metrics like sensitivity, specificity, or AUC, as would be expected for an AI/ML device. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to predicate devices and the successful completion of mechanical testing.

Acceptance Criteria (Implied)	Reported Device Performance
Substantial Equivalence: Device characteristics, materials, intended use, and indications for use are comparable to legally marketed ceramic femoral heads.	"A comparison of device characteristics, materials, intended use and indications for use to commercially available ceramic femoral heads provided in this premarket notification support the determination that the Implex Alumina Femoral Head is substantially equivalent to legally marketed ceramic head components."
Mechanical Performance: Device will perform as intended based on mechanical test data.	"Mechanical test data provided in this premarket notification demonstrates that the Alumina Femoral Head will perform as intended."

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

Sample Size (Test Set): Not specified. For a mechanical device, "test set" would refer to the number of devices or samples subjected to mechanical testing. The document only states "Mechanical test data provided in this premarket notification."
Data Provenance: Not applicable in the context of clinical data for AI/ML. For mechanical testing, the provenance refers to the lab conducting the tests, which is not disclosed.

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

Not applicable. Ground truth, in the AI/ML sense (e.g., expert consensus on medical images), is not relevant for this mechanical device's 510(k) submission. The "ground truth" for mechanical testing would be the physical properties and performance metrics determined by standardized tests.

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

Not applicable. Adjudication methods are typically used for establishing ground truth from multiple human reviewers in AI/ML studies. For mechanical testing, results are typically 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:

Not applicable. This type of study is specifically for evaluating the impact of AI on human reader performance, which is not relevant for a ceramic femoral head.

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

Not applicable. There is no algorithm being tested in this submission.

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

For mechanical devices, the "ground truth" is established through standardized mechanical testing procedures that measure properties like strength, fatigue resistance, wear, etc. The document generally states "Mechanical test data... demonstrates that the Alumina Femoral Head will perform as intended," implying successful completion of these tests.

8. The sample size for the training set:

Not applicable. There is no AI/ML algorithm that requires a training set for this device.

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

Not applicable. There is no AI/ML algorithm that requires a training set for this device.

Summary regarding the 510(k) for the Implex Alumina Femoral Head:

This 510(k) focuses on demonstrating substantial equivalence to existing mechanically similar devices and ensuring the device meets its design specifications through mechanical performance testing. The framework of AI/ML evaluation (e.g., test sets, ground truth experts, MRMC studies) is not applicable to this type of traditional medical device submission.

Summary

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JUN 11 1999

K990183 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Implex Alumina Femoral Head

Submitter Name:	Implex Corp.
Submitter Address:	80 Commerce DriveAllendale, New Jersey 07401-1600
Contact Person:	John Schalago or Robert Poggie
Phone Number:	(201) 818-1800
Fax Number:	(201) 818-0567
Date Prepared:	January 11, 1999
Device Trade Name:	Implex Alumina Femoral Head
Device CommonName:	Ceramic femoral head
Classification Numberand Name:	21 CFR § 888.3353

Substantial Equivalence:

The term "substantial equivalence" as used in this 510(k) notification is limited to the definition of substantial equivalence found in the Federal Food, Drug and Cosmetic Act, as amended and as applied under 21 CFR 807, Subpart E under which a device can be marketed without premarket approval or reclassification. A determination of substantial equivalency under this notification is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statements related to, or in support of equivalence herein shall substantial be construed as an admission against interest under the US Patent Laws or their application by the courts.

Device Description: The Implex Alumina Femoral Head is a ceramic femoral head. The Implex Alumina Femoral Head is offered in a 28 mm OD with +0, +3, and +6 neck offset lengths, and is intended for use with all legally Femoral Continuum Hip System marketed Components with a 12/14 locking taper.

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Indications for Use:

The Implex Alumina Femoral Head is intended to provide articulation in total hip procedures in cases of:

disabled joints as a result of 1. Severely degenerative arthritis or avascular necrosis.
1. Secondary revision of a previously unsuccessful femoral component or total hip replacement.
1. Other hip problems where clinical experience has shown that alternative modes of treatment are less likely to achieve satisfactory results.
1. Fracture dislocation of the hip or irreducible fractures in which adequate fixation cannot be obtained.
1. Non-Union of femoral neck or head fractures.
1. Salvage of a failed primary or secondary total hip or hemi-hip arthroplasty.

A comparison of device characteristics, materials, intended use and indications for use to commercially available ceramic femoral heads provided in this premarket notification support the determination that the Implex Alumina Femoral Head is substantially equivalent to legally marketed ceramic head components.

Mechanical test data provided in this premarket notification demonstrates that the Alumina Femoral Head will perform as intended.

The Implex Alumina Femoral Head is substantially equivalent to the identified predicate devices.

Device Technological Characteristics and Comparison to Predicate Device:

Performance Data:

Conclusion:

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 11 1999

Robert A. Poggie, Ph.D. Director of Applied Research Implex Corporation 80 Commerce Drive Allendale, New Jersey 07401-1600

K990183 Re : Implex Alumina Femoral Head Trade Name: Regulatory Class: II Product Code: LZO Dated: April 23, 1999 Received: April 26, 1999

Dear Dr. Pogqie:

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 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 (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. ಕ substantially equivalent determination assumes 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 Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. 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.

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Page 2 - Robert A. Poggie, Ph.D.

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 leqally 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,

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) :

K990183

Device Name:

Implex Alumina Femoral Head

Indications For Use:

The Implex Alumina Femoral Head is intended to provide articulation in total hip procedures in cases of:

1. Severely disabled joints as a result of degenerative arthritis or avascular necrosis.
1. Secondary revision of a previously unsuccessful femoral component or total hip replacement.
1. Other hip problems where clinical experience has shown that alternative modes of treatment are less likely to achieve satisfactory results.
1. Fracture dislocation of the hip or irreducible fractures in which adequate fixation cannot be obtained.
1. Non-Union of femoral neck or head fractures.
1. Salvage of a failed primary or secondary total hip or hemi-hip arthroplasty.

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

Concurrence of CDRH; Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number	K990183

Prescription Use(Per 21 CFR 801.109)	Yes
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OR...

Over-The-Counter Use	No
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(Optional Format 1-2-96)

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January 11, 1999

Regulation Number and Section

N/A