a.) Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
b.) Rheumatoid arthritis.
c.) Correction of functional deformity.
d.) Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
e.) Revision of previously failed total hip arthroplasty due to recurrent dislocations.

The PLR Splined Revision Stem is intended for press-fit application for general use in skeletally mature individuals undergoing surgery for rehabilitating hip joints. This device is a single use implant

Device Description

The PLR Splined Revision Stem is a one-piece, press-fit revision stem machined from wrought Titanium (Ti-6Al-4V). The region above the resection level has a machine finish and the remainder of the stem is a grit blast finished.

The distal portion of the stem has splines. The neck-shaft angle is 135 degrees. The lateral offset for a standard 28mm head is 42mm on all sizes. The stem is 270 mm in length measured from the medial resection level to the distal end. Sizes range from 14mm to 24mm in 1mm increments.

The stem has the standard Biomet, Inc. Type I taper to fit all sizes and types of modular femoral heads. Neck flats are present for stem removal if necessary. The proximal region of the stem has a lateral flare with three holes to use with CoCr cables/wires for attachment of the greater trochanter.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "PLR Splined Revision Stem." It is a request for clearance from the FDA to market a new device by demonstrating its substantial equivalence to a legally marketed predicate device.

Here's an analysis of the provided text with respect to your questions:

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

The provided text does not contain a table of acceptance criteria or reported device performance in the manner you'd expect for clinical studies. This document is a premarket notification (510(k)), which primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical performance data with specific acceptance criteria.

The substantial equivalence argument is the "performance" demonstrated for a 510(k):

Acceptance Criteria (Implied by 510(k) Process)	Reported Device "Performance" (Demonstrated in 510(k))
Device is as safe and effective as predicate.	The PLR Splined Revision Stem is substantially equivalent to two predicate devices: - Wagner Revion Stem (K960588) - Wagner Revisional Femoral Hip Prosthesis (K871347) This substantial equivalence is based on the device's design, materials (wrought Titanium (Ti-6Al-4V) with machine finish and grit blast finish), intended use, and general characteristics being similar to the predicates.
Risks are the same as with any joint replacement.	Potential risks are listed and are considered "the same as with any joint replacement device." This implies that no new, unanticipated risks are introduced by the device compared to similar predicate devices.
Meets indicated uses.	The device's intended use matches the established applications for hip reconstruction, implying its design supports these uses in a similar manner to predicate devices.

Regarding the remaining questions, the provided 510(k) document is a regulatory submission for premarket clearance and does not include detailed study data or methodologies typically found in clinical trial reports or academic papers. Therefore, most of the specific information requested about sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies is not present in this type of document.

Here's why and what information can be inferred:

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

Not Applicable: A 510(k) submission generally does not require new clinical studies for mechanical orthopedic implants if substantial equivalence can be demonstrated through design, material, and performance testing (e.g., mechanical bench testing), or by referencing clinical data of predicate devices. This document does not mention any specific test set of patients for a clinical study of the PLR Splined Revision Stem itself. The "test set" here would implicitly be the body of evidence (including predicate device history and any non-clinical testing) used to support the substantial equivalence claim.

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: As there's no mention of a clinical test set requiring ground truth establishment, this information is not provided.

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

Not Applicable: No clinical test set details are 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

Not Applicable: This device is a mechanical orthopedic implant (hip stem), not an AI/software as a medical device (SaMD). Therefore, MRMC studies or AI assistance metrics are not relevant or discussed.

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

Not Applicable: As stated above, this is a mechanical orthopedic implant, not an algorithm.

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

Not Applicable: No specific patient-level ground truth data is presented. The "ground truth" for a 510(k) is the established safety and effectiveness of the legally marketed predicate devices.

8. The sample size for the training set

Not Applicable: There is no mention of a "training set" in the context of this device. The development process for such a device would involve engineering design, finite element analysis, and mechanical testing, not machine learning training on data.

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

Not Applicable: As there is no training set mentioned, this information is not provided.

Summary

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SUMMARY OF SAFETY AND EFFECTIVENESS

×994184

SPONSOR:

Biomet, Inc. P.O. Box 587 Airport Industrial Park Warsaw, Indiana 46581-0587

CONTACT PERSON: Tracy J. Bickel

DEVICE NAME: PLR Splined Revision Stem

CLASSIFICATION NAME: Prosthesis, hip, semi-constrained metal/ceramic/polymer, cemented or non-porous uncemented (21 CFR 888.3350)

INTENDED USE:

The PLR Splined Revision Stem is indicated for use in patients requiring total reconstruction of the hip joint due to the following:

a.) Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
b.) Rheumatoid arthritis.
c.) Correction of functional deformity.
d.) Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
e.) Revision of previously failed total hip arthroplasty due to recurrent dislocations.

The PLR Splined Revision Stem is intended for press-fit application for general use in skeletally mature individuals undergoing surgery for rehabilitating hip joints.

DEVICE DESCRIPTION:

The stem has the standard Biomet, Inc. Type I taper to fit all sizes and types of modular femoral heads. Neck flats are present for stem removal if necessary. The P.1/2

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

proximal region of the stem has a lateral flare with three holes to use with CoCr cables/wires for attachment of the greater trochanter.

POTENTIAL RISKS:

The potential risks associated with this device are the same as with any joint replacement device. These include, but are not limited to:

Fracture of the component Cardiovascular disorders Implant loosening/migration Soft tissue imbalance Deformity of the joint Tissue growth failure Delayed wound healing Metal sensitivity
Bone fracture Hematoma Blood vessel damage Nerve damage Excessive wear Infection Dislocation Breakdown of the porous surface >

SUBSTANTIAL EQUIVALENCE:

Direct comparison was made with the following predicates:

1. Wagner Revion Stem: K960588 Manufactured by Intermedics (Austin, TX)
1. Wagner Revisional Femoral Hip Prosthesis: K871347 Manufactured by Protek (Indianapolis, IN)

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, which is a common symbol associated with HHS.

Public Health Service

FEB 1 5 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Tracy J. Bickel Regulatory Specialist Biomet, Inc. Airport Industrial Park P.O. Box 587 Warsaw. Indiana 46581-0587

Re: K994184 Trade Name: PLR Splined Revision Stem Regulatory Class: II Product Code: LZO & JDI Dated: December 7, 1999 Received: December 10, 1999

Dear Ms. Bickel:

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 Regulations. Title 21, Parts 800 to 895. A 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 regulation may result in regulatory action. 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.

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Page 2 - Ms. Tracy J. Bickel

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 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, blease 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,

/iucil/c-/

James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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Page _ of _

510(k) Number (if known): K99 4184 Device Name: PLR Splined Revision Stem Indications for Use:

The PLR Splined Revision Stems is indicated for use in patients requiring total reconstruction of the hip joint due to the following:

a.) Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
b.) Rheumatoid arthritis.
c.) Correction of functional deformity.
d.) Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
e.) Revision of previously failed total hip arthroplasty due to recurrent dislocations.

(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
§10(k) Number	KC994184

Prescription Use	OR	Over-The-Counter Use
(Per 21 CFR 801.109)		(Optional Format 1-2-96) ______

00004

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.