Noninflammatory 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 total hip arthroplasty.
The Biomet® Modular Revision Femoral System hip components are single-use implants, intended for uncemented applications.

Device Description

The Blomet® Modular Revision Femoral System is a comprehensive, press-fit revision stem design that provides the surgeon with multiple styles of modular proximal and distal bodies for reconstruction of various defects commonly seen in femoral revision surgery. The proximal bodies will consist of broached, calcarreplacing, and cone-style implants. The system also includes auxiliary implants to aid in fixation. A single set of instrumentation is provided for all styles. The system is intended for uncemented applications

AI/ML Overview

The provided document K090757 is a 510(k) summary for the Biomet® Modular Femoral Revision System. It describes a medical device, specifically a hip implant system, and its substantial equivalence to previously marketed devices.

Based on the content of K090757, I cannot provide details on "acceptance criteria" for software performance or "study that proves the device meets the acceptance criteria" in the context of AI/ML-driven medical devices. This document pertains to a traditional orthopedic implant, and the regulatory submission relies on non-clinical testing and substantial equivalence to predicate devices, rather than clinical efficacy studies or performance metrics for an AI algorithm.

Here's why and what information can be extracted:

Why the requested information cannot be fully provided:

No AI/ML Component: The device is a physical femoral revision system (hip implant). There is no indication of any AI or machine learning component.
Focus on Substantial Equivalence: The 510(k) process for this type of device focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is primarily done through technological characteristics comparison and non-clinical (e.g., mechanical, material) testing, not clinical studies with performance metrics like sensitivity, specificity, or reader improvement.
No Clinical Testing: The document explicitly states under "Clinical Testing": "None provided as a basis for substantial equivalence." This means no human clinical trials were conducted to assess the device's performance against specific clinical acceptance criteria.

Information that can be extracted from the document related to the study (in a general sense of "evaluation"):

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Implicitly, the acceptance criterion for a 510(k) submission not requiring clinical data is that the device demonstrates substantial equivalence to predicate devices through technological characteristics and non-clinical testing, ensuring it is as safe and effective. The document states, "The results indicated that the device was functional within its intended use."
- Reported Device Performance: The document doesn't provide specific performance metrics in a table format. It generally states that "Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use."
Sample size used for the test set and the data provenance:
- Not applicable. No "test set" in the context of an AI/ML algorithm was used. Non-clinical laboratory testing would involve mechanical or material samples, but specific numbers and provenance are not detailed in this summary.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No "ground truth" for a test set was established by human experts in the context of an AI/ML device.
Adjudication method for the test set:
- Not applicable. No "adjudication method" for interpreting results from a test set of data was performed for an AI/ML device.
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. No clinical studies, especially MRMC studies comparing human performance with and without AI assistance, were performed or described.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. No algorithm is involved.
The type of ground truth used:
- Not applicable in the AI/ML sense. For this orthopedic device, the "ground truth" for safety and effectiveness is largely established by adherence to engineering standards, material properties, and comparison to the known performance of predicate devices through non-clinical testing.
The sample size for the training set:
- Not applicable. There is no AI/ML algorithm that would require a "training set."
How the ground truth for the training set was established:
- Not applicable.

Summary

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K090757

Image /page/0/Picture/1 description: The image shows the word "GIOMET" in a stylized, blocky font. The letters are outlined and filled with a pattern of small squares or dots, giving them a textured appearance. The overall design is simple and geometric, with a focus on the shape and form of the letters.

MANUFACTURING CORP.

SEP 2 5 2009

510(k) Summary

Preparation Date:

March 20, 2009

Applicant/Sponsor:

Biomet Manufacturing Corp.

56 East Bell Drive P.O. Box 587 Warsaw, IN 46581-0587 Establishment Registration Number: 1825034

Contact Person:

Becky Earl Regulatory Specialist

Proprietary Name:

Common Name:

Classification Name:

Biomet® Modular Femoral Revision System

Femoral Hip Revision System

LPH- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porqus Uncemented (21 CFR 888.3358)

KWA-Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) (21 CFR 888.3330)

JDL- Prosthesis, Hip, Semi-Constralned (Metal Cemented Acetabular Component) (21 CFR 888.3320)

LZO-Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented (21 CFR 888,3353)

KWZ-Prosthesis, Hip, Constrained, Cemented or Uncemented, Metal/Polymer (21 CFR 888.3310)

JDI- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented (21 CFR 888.3350)

KWY-Prosthesis, Hip, Hemi-Femoral, Metal/Polymer, Cemented or Uncemented (21 CFR 888.3390)

MAY-Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous Cemented, Osteophilic Finish (21 CFR 888.3353)

MEH-Prosthesis, Hip, Semi-constrained, Uncemented, Metal/Polymer, Non-Porous, Calcium-Phosphate (21 CFR 888.3353)

Meiling Address: నిల్, విశ్ల క్యక్రిక Wargan 8 48 381-0587 To Frate (200 Manders) 0180 541 267 165 1488 Fax: 574 20208137 ານປະຈິນ.Eວັນຕ່ອງໂດຍນາງ:

Shipping Address: 险会到到10月份 Warst July 46582

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K090757

Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

K031693	Mallory-Head® Modular Calcar with and without HA—Biomet
K042774	Mallory-Head® Modular Calcar Stems with Interlocking Slots-Blomet
K013106, K022549	Restoration™ Modular System—Stryker
K994038	Modular Reach® Hip--Biomet

Device Description:

Intended Use:

Indications for the Biomet® Modular Revision Femoral System Include:

1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
1. Rheumatoid arthritis.
1. Correction of functional deformity.
1. Treatment 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.

The Blomet® Modular Revision Femoral System hip components are single-use implants, intended for uncemented applications.

Summary of Technologies:

The Biomet® Modular Revision Femoral System has the same technological haracteristics as the predicates listed above.

Non-Clinical Testing:

Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use.

Clinical Testing:

None provided as a basis for substantial equivalence.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Biomet Manufacturing Corp. % Ms. Becky Earl Regulatory Affairs Specialist P.O. Box 587 Warsaw, Indiana 46581-0587

SEP 2 5 2009

Re: K090757

Trade/Device Name: Biomet® Modular Femoral Revision System Regulation Number: 21 CFR 888.3330 Regulation Name: Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis Regulatory Class: III Product Code: KWA, LPH, JDL, LZO, KWZ, JDI, KWY, MAY and MEH Dated: September 19, 2009 Received: September 21, 2009

Dear Ms. Earl:

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. Becky Earl

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Hamil Clary

FOR

Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K090757

Device Name: Biomet® Modular Femoral Revision System

Indications For Use:

1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
1. Rheumatoid arthritis.
1. Correction of functional deformity.
1. Treatment 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.

The Biomet® Modular Revision Femoral System hip components are single-use implants, intended for uncemented applications.

Prescription Use __ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use NO (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)

Jonita for MKN
This sign off

(Division Sign-Off)

Division of Surgical, Orthopedic,
and Restorative Devices

510(k) Number K090757

Page 1 of 1

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.