The Prevision Hip System is intended for cementless revision hip arthroplasty in patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck, or portions of the proximal femur. The Prevision Hip System is intended for revision only.

The Recon Ring is intended to bridge the areas of acetabular bone loss in patients with acetabular bone deficiency. In addition, the Recon Ring is intended to provide support for an all polyethylene acetabular implant in a cemented application.

Diagnostic indications for use of this device include acetabular dysplasia, osteoporosis, protrusion acetabuli, cystic acetabular roof, reconstruction in cases of defects after fracture, acetabular loosening, tumors or revision surgery.

The general indications associated with the use of the Recon Ring in total hip arthroplasty include:

Advanced joint destruction resulting from degenerative, posttraumatic or rheumatoid arthritis.
Fracture or avascular necrosis of the femoral head,
Failed previous surgery, e.g. osteosynthesis, joint reconstruction, arthrodesis, hemi-arthroplasty and total hip replacement.

Device Description

The Prevision Hip System is a modular system which consists of a proximal body, distal stem and a tension nut. The three individual components utilize a modular junction. The individual components may be assembled by the surgeon in the operating room or in situ to allow independent sizing of the proximal body and distal stem. All proximal components are able to mate with all distal components providing a comprehensive range of combinations offering optimal flexibility. It is designed for use with currently available Aesculap Implant Systems femoral heads, acetabular components and Bipolar cups.

The Prevision Hip System is manufactured from Titanium Alloy and intended for cementless use. The proximal body is plasma sprayed (Plasmapore®) with a secondary coating of Calcium Phosphate (u-CaP®).

The Recon Ring will be offered in three sizes with left and right configurations. The Recon Ring is manufactured from Titanium. It is designed to be used with the PE acetabular cup cleared in BiContact (K040191).

AI/ML Overview

The provided text describes a medical device submission (K102424) for the "Prevision Hip System with Recon Ring." However, it does not contain the detailed information requested regarding clinical study findings, acceptance criteria, or performance metrics in a format that would allow for a direct numerical comparison of acceptance criteria vs. device performance.

Instead, the document states:

"Testing of the Aesculap Implant Systems Prevision Hip System was performed in accordance with ISO 7206 and ASTM F 2068 and the results were found to be similar to other legally marketed predicate devices."

This indicates that the device's performance was evaluated against established industry standards for hip implants and compared to predicate devices, but no specific numerical acceptance criteria or performance data for the device itself are provided. The FDA's letter of clearance confirms substantial equivalence based on this information but does not elaborate on specific performance metrics.

Therefore, an exhaustive answer to your request is not possible with the provided document. I can, however, extract the relevant information that is present:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated in numerical terms within the document. The general acceptance criterion appears to be "similarity to other legally marketed predicate devices" and compliance with ISO 7206 and ASTM F 2068 standards.
Reported Device Performance: "the results [of testing per ISO 7206 and ASTM F 2068] were found to be similar to other legally marketed predicate devices." No specific numerical performance values are given.

2. Sample Size Used for the Test Set and Data Provenance:

The document implies that the testing was pre-clinical/bench testing rather than a clinical study with human subjects. Thus, terms like "test set" in the context of clinical data provenance are not directly applicable.
Sample Size for Test Set: Not specified.
Data Provenance: Not applicable in the context of human data. The testing was conducted in accordance with referenced ISO and ASTM standards, which are international/US standards for medical device testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:

This information is not applicable. The testing described is mechanical and material testing, not a study involving expert assessment of images or clinical outcomes.

4. Adjudication Method for the Test Set:

Not applicable, as it's not a clinical study involving human assessment.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size:

No, a MRMC comparative effectiveness study was not done. The document describes pre-clinical testing, not a clinical study.

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

Not applicable. This is a physical medical device (hip implant), not a software algorithm.

7. The Type of Ground Truth Used:

For the pre-clinical performance testing, the "ground truth" would be established by the specified test methods and acceptance limits defined in ISO 7206 and ASTM F 2068 standards. These standards typically define how performance (e.g., fatigue strength, wear resistance) is measured and what constitutes acceptable results.

8. The Sample Size for the Training Set:

Not applicable. As this is a physical medical device and the described testing is pre-clinical, there is no "training set" in the context of machine learning or algorithms.

9. How the Ground Truth for the Training Set was Established:

Not applicable for the same reasons as above.

Summary

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K102424 (pg 1/2)

Page 1 of 2

B. 510(k) SUMMARY (as required by 21 CFR 807.92)

DEC - 9 2010

Prevision Hip System with Recon Ring December 3, 2010

COMPANY:	Aesculap Implant Systems, LLC3773 Corporate ParkwayCenter Valley, PA 18034Establishment Registration Number: 3005673311
----------	-------------------------------------------------------------------------------------------------------------------------------------

CONTACT: Kathy A. Racosky 610-984-9291 (phone) 610-791-6882 (fax) Kathy.racosky@aesculap.com

TRADE NAME: Prevision Hip System

COMMON NAME: Femoral Hip Prosthesis

CLASSIFICATION NAME: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calcium-Phosphate Prosthesis, Hip, Semi-constrained, Metal/Polymer, Cemented Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented or Uncemented

888.3353, 888.3350, 888.3360, 888.3353, 888.3390, REGULATION NUMBER:

PRODUCT CODE: MEH, JDI, LWJ, LZO, KWY

SUBSTANTIAL EQUIVALENCE

Aesculap Implant Systems, LLC believes that the Prevision Hip System with Recon Ring is substantially equivalent to:

Zimmer, Inc. ZMR Hip System (K992667 & K994286) ●
Intermedics Orthopedics Inc., Burch/Schneider Reinforcement Cage (K960678) .
Aesculap Implant Systems Metha Hip System (K071916) .
Aesculap Implant Systems Bicontact (K040191) .

DEVICE DESCRIPTION

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Page 2 of 2

PURPOSE FOR PREMARKET NOTIFICATION

The purpose for this submission is to gain marketing clearance for the Aesculao Implant Systems Prevision Hip System with Recon Ring.

INDICATIONS FOR USE

Diagnostic indications for use of this device include acetabular dysplasia, osteoporosis, protrusion acetabuli, cvstic acetabular roof, reconstruction in cases of defects after fracture, acetabular loosening, tumors or revision surgery.

The general indications associated with the use of the Recon Ring in total hip arthroplasty include:

Advanced joint destruction resulting from degenerative, posttraumatic or rheumatoid . arthritis.
. Fracture or avascular necrosis of the femoral head,
Failed previous surgery, e.g. osteosynthesis, joint reconstruction, arthrodesis, hemi-● arthroplasty and total hip replacement.

TECHNOLIGICAL CHARACTERISTICS(compared to Predicate(s)}

The components of the Aesculap Implant Systems Prevision Hip System with Recon Ring are offered in a similar range of shapes and sizes as the predicate devices. The material used for the Aesculap Implant Systems device is the same as that used to manufacture the predicate devices.

PERFORMANCE DATA

Testing of the Aesculap Implant Systems Prevision Hip System was performed in accordance with ISO 7206 and ASTM F 2068 and the results were found to be similar to other legally marketed predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an abstract image of an eagle.

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

Aesculap Implant Systems LLC % Ms. Kathy A. Racosky 3773 Corporate Parkway Center Valley, PA 18034

DEC - 9 2010

Re: K102424

Trade/Device Name: Prevision Hip System with Recon Ring Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: II Product Code: MEH, JDI, LWJ, LZO, KWY Dated: December 3, 2010 Received: December 6, 2010

Dear Ms. Racosky:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section 910(x) premained is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regarly manatinent date of the Medical Device Amendments, or to commerce province to May 26, 1976, the enasting with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval app and Cosment Act (Act) that to not require approvinces of the general controls provisions of the Act. The You may, merelore, market the device, subject to the genirements for annual registration, listing of general controls provisions of the rict liveling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability adulteration. Prease note: CDICT does not over be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it
es an be If your device is classified (Scc above) fine viar regulations affecting your device can be
may be subject to additional controls. Existing major regulations addition, EDA m may be subject to additions: Existing mays. Existing mays found in the Code of I cucral Rogarations) This Levice in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s Issualitat equr device of a success at
that FDA has made a determination that your device complies with other requirements of the Act

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Page 2 - Ms. Kathy A. Racosky

I uge 2 - Ms. Ratily in Not regulations administered by other Federal agencies. You must or any I 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.

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.htm1.

Sincerely yours,

{}

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 STATEMENT A.

DEC - 9 2010

510(k) Number: K102424(pg 1/1)

Device Name: Prevision Hip System with Recon Ring

Indications for Use:

The general indications associated with the use of the Recon Ring in total hip arthroplasty include:

Advanced joint destruction resulting from degenerative, posttraumatic or rheumatoid ● arthritis.
Fracture or avascular necrosis of the femoral head, �
Failed previous surgery, e.g. osteosynthesis, joint reconstruction, arthrodesis, hemi-. arthroplasty and total hip replacement.

Prescription Use	X
and/or Over-the-Counter Use

(per 21 CFR 801.109)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Apr M. Wilkerson

(Division Sign-Off (Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K102424

Regulation Number and Section

N/A