Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
Rheumatoid arthritis
Correction of functional deformity
Correction of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
Revision of previously failed total hip arthroplasty.
The Balance® Hip System Standard Femoral stems are intended for uncemented use only.

Balance® Hip System Microplasty® stems:

Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
Rheumatoid arthritis
Correction of functional deformity
Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
Revision of previously failed femoral head resurfacing components.
The Balance® Hip System Microplasty® Stems are intended for uncemented use only.

Device Description

The Balance® Hip System Femoral stems are collarless, porous coated stems available in 10mm increments of length. The proximal geometry of the Balance® Hip System Standard and Microplasty® stems provide immediate three point (anterior-proximal, inferior-medial, and distal-lateral) fixation. The top of the stems have a threaded hole to accommodate the inserter / extractor tool.

AI/ML Overview

This is a 510(k) premarket notification for the Balance® Hip System and as such describes demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria and device performance as one might see for a novel device. The document repeatedly states that the new device, the Balance® Hip System, is "substantially equivalent" to predicate devices. There is no independent study with acceptance criteria and a reported device performance. The only performance data mentioned is for "non-clinical testing," which "demonstrates that the Balance® Hip System is technically equivalent to the predicate femoral hip stems."

Therefore, for this particular document, I cannot fulfill all sections of your request as it pertains to a new device performance study with acceptance criteria.

However, I can extract the following information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

There is no formal table of "acceptance criteria" or "reported device performance" against such criteria in the context of a new efficacy study. The submission asserts substantial equivalence to predicate devices. The "performance" is implicitly that the device performs equivalently to the listed predicates in a non-clinical setting.

Acceptance Criteria (Implied)	Reported Device Performance
Substantially equivalent to predicate devices (Mallory-Head® Total Hip System, Mayo Conservative Hip Prosthesis, Bi-Metric® Total Hip System) in terms of materials, design, and indications for use.	Non-clinical testing determined that the stems are substantially equivalent to the predicate stems and technically equivalent to predicate femoral hip stems.

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

Sample Size for Test Set: Not applicable. The document refers to "non-clinical testing" rather than a clinical trial with a defined test set of patients. The testing details (e.g., number of components tested) are not provided.
Data Provenance: The testing is "non-clinical" and likely conducted in a laboratory setting. No country of origin for such data is specified, but the applicant is based in Warsaw, Indiana, USA. The testing is not described as retrospective or prospective clinical data.

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

Not applicable. This is not a study involving expert assessment of clinical outcomes or images where ground truth would be established by experts. The "ground truth" for substantial equivalence would be based on engineering principles and comparisons to existing devices.

4. Adjudication method for the test set:

Not applicable, as there is no clinical test set requiring adjudication in the context of this submission.

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 submission is for an orthopedic implant (hip stem), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to AI assistance is irrelevant.

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

Not applicable, as this submission is for an orthopedic implant, not an algorithm or software device.

7. The type of ground truth used:

The "ground truth" for this 510(k) submission is the established performance and safety of the predicate devices (Mallory-Head® Total Hip System, Mayo Conservative Hip Prosthesis, Bi-Metric® Total Hip System). The new device is deemed "substantially equivalent" based on comparison to these known devices, using material properties, design specifications, and non-clinical performance data (e.g., mechanical testing).

8. The sample size for the training set:

Not applicable. There is no concept of a "training set" in this 510(k) submission for an orthopedic implant.

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

Not applicable.

Summary

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MAY 27 2005 K050251 P 1/2

510(k) Summary

Applicant/Sponsor:	Biomet Manufacturing Corp.56 East Bell DriveP.O. Box 587Warsaw, Indiana 46581-0587
Contact Person:	Gary BakerRegulatory SpecialistBiomet Manufacturing Corp.P.O. Box 587Warsaw, Indiana 46581-0587Phone: (574) 267-6639FAX: (574) 372-1683
Proprietary Name:	Balance ® Hip System
Common Name:	Femoral Hip Stems
Classification Name:	The Balance ® Hip System femoral stems and compatible shells, heads, andliners included in this submission have the following classifications:

Hip joint metal/polymer constrained cemented or uncemented prosthesis (21 CFR §888.3310)
Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis (21

CFR §888.3320) 3. Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis (21 CFR §888.3330)
(21 CFR 9886.3530)
Hip joint metal/polymer semi-constrained cemented prosthesis (21 CFR §888.3350) 4.
Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis 5. (21 CFR §888.3353)
(21 CFR 9666.3333)
Hip joint metal/polymer/metal semi-constrained, porous-coated, uncemented prosthesis (21 CFR 6. 888.3358)

176

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KOSOGI 1 2/2

Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

Mallory - Head® Total Hip System - Biomet Inc. (K921181, K030055) Mayo Conservative Hip Prosthesis - Zimmer Inc. (K943230) Bi-Metric® Total Hip System - Biomet Inc. (K921224, K030055)

Device Description: The Balance® Hip System Femoral stems are collarless, porous coated stems available Device Description: The Dalance "The Bygths. The proximal geometry of the Balance" Hip System IN 00th Standard and Micropiasy - Stein Teligaal Tilling of the metaphysis and provide immediate three point (anterior-proximal, inferior-medial, and distal-lateral) fixation.

The top of the stems have a threaded hole to accommodate the inserter / extractor tool.

Indications for Use: Balance® Hip System Standard Femoral stems

Non-inflammatory degenerative joint disease including osteoarthritis and avascular 1 . necrosis.
Rheumatoid arthritis 2.
Correction of functional deformity 3.
Correction of ranchenal developed neck fracture, and trochanteric fractures of the 4. proximal femur with head involvement, unmanageable using other techniques.
Revision of previously failed total hip arthroplasty. న్.

The Balance® Hip System Standard Femoral stems are intended for uncemented use only.

Indications for Use: Balance® Hip System Microplasty® stems

Non-inflammatory degenerative joint disease including osteoarthritis and avascular 1. necrosis.
Rheumatoid arthritis 2.
Correction of functional deformity 3.
Corroon of non-union, femoral neck fracture, and trochanteric fractures of the 4. Proximal femur with head involvement, unmanageable using other techniques.
Revision of previously failed femoral head resurfacing component. ર.

The Balance® Hip System Microplasty® stems are intended for uncemented use only.

Summary of Technologies: The Balance® Hip System stems are materials and utilize the Summal y of Technologics. The Datanoo Trip 55000 ses as the predicates. Testing determined that the stems are substantially equivalent to the predicate stems.

Reference literature and performance data demonstrate that the Balance® Hip Non-Clinical Testing: Nor Chilleur Technically equivalent to the predicate femoral hip stems.

All trademarks are property of Biomet, Inc.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which features three abstract human figures connected by flowing lines. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 27 2003

Mr. Gary Baker Regulatory Specialist Biomet Incorporated P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K050251

Trade/Device Name: Balance® Hip System Microplasty® Stems Regulation Number: 21 CFR 888.3310, 888.3320, 888.3330, 888.3350, 888.3358 Regulation Name: Hip joint metal/polymer constrained cemented or uncemented prosthesis; Hip joint metal/metal semi constrained, with a cemented acetabular component, prosthesis; Hip joint metal/ polymer semi-constrained cemented prosthesis; Hip joint metal/polymer/metal semi-constrained porous-coated, uncemented prosthesis Regulatory Class: III Product Code: KWZ, JDL, KWA, JDI, LZO, MEH, LPH, LZY, KWY Dated: May 6, 2005 Received: May 9, 2005

Dear Mr. Baker:

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.

{3}------------------------------------------------

Page 2 - Mr. Gary Baker

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.

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), please contact the Office of Compliance at (240) 276-0210. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely yours.

A. Stephen Purdy

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications For Use

510(k) Number (IF KNOWN): K05025

Device Name: Balance Hip System Standard Femoral Stems

Indications for Use:

ations for Use.

Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.

1. Rheumatoid arthritis
1. Correction of functional deformity
1. Correction of non-union. femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
1. Revision of previously failed total hip arthroplasty.

Balance® Hip System Femoral Stems are intended for uncemented use only.

Specific indications for compatible components that can be used with the above femoral stems include:

Constrained Liners (K030047)

Constrained liners are intended for general use in skeletally mature individuals undergrand in the bone loss, soft Constrained liners are mielided for general use in skelcians valistocation, joint or bose loss, soft revision surgery at high risk of intra-operative instability and for whom all other options to constrained acetabular components have been considered.

Total Femur (K974558. K002757. K021380. K033871)

Salvage/Oncology Hip and Total Femur components are also indicated for cases of ligament deficiency, Salvage Oncology Trip and Total Pennal Virginian of unsuccessful osteotomy or arthrodesis.

Interlocking Stems (K990830, K042774)

Interlocking hip stens are indicated for non-cemented application in cases of revision, tracture, Interlocking mp siems are moreated for non econential.
oncology or other situations where severe proximal bone loss may compromise the fixation and stability of a standard type hip replacement prosthesis.

X Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801 Subpart D) AND OR

Over-the-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH. Office of Device Evaluation (ODE

tion (ODE)
Hypt Rurla

Image /page/4/Picture/25 description: The image shows handwritten text. The text on the right side of the image reads 'K050251'. The text on the left side of the image is partially visible and blurry, but it appears to be a word.

{5}------------------------------------------------

Indications For Use

510(k) Number (IF KNOWN): K050251

Device Name: Balance® Hip System Microplasty® Stems

Indications for Use:

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
Rheumatoid arthritis 2.
Correction of functional deformity 3.
Correction of functional deformily
Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur ব with head involvement, unmanageable using other techniques.
while it not on of previously failed femoral head resurfacing components. న్న

Balance & Hip System Microplasty Stems are intended for uncemented use only.

Specific indications for compatible components that can be used with the above femoral stems include:

Constrained Liners (K030047)

Constrained liners are intended for general use in skeletally mature individuals undergoung port on home loss, soft Constrained liners are mielided for general use in skercars non or brinn of bone loss, soft revision surgers at lightifisk of life distance date instability and for whom all other options to constrained acetabular components have been considered.

OSS / Salvage Systems / Total Femur (K974558, K002757, K021380, K033871)

Salvage/Oncology Hip and Total Femur components are also indicated for cases of ligament deficiency, Salvage Oneology Trip and Total ions insuccessful osteotomy or arthrodesis.

Interlocking Stems (K990830, K042774)

Interlocking hip stems are indicated for non-cemented application in cases of revision, tracture, Interlocking hip stems are indicated for non-centence approamer the fixation and stability of a standard type hip replacement prosthesis.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801 Subpart D)

AND/OR

Over-the-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH. Office of Device Evaluation (ODE)

(Division Sign-Off)

and Neurological Devices

510(k) Number kos0251

Regulation Number and Section

§ 888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.

(a)
Identification. A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two-part 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 includes prostheses that consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027).(b)
Classification. Class III.(c)
Date PMA or notice of completion of PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 18, 2016, for any hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976, or that has, on or before May 18, 2016, been found to be substantially equivalent to a hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976. Any other hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.