All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion.

Device Description

The AcuMatch L-Series Bipolar is a modular two piece device consisting of a spherical cobalt chrome shell (ASTM 1537 or ASTM F75) and interchangeable polyethylene liner inserts (ASTM F638). The metal head components come in 24 sizes (38mm through 61mm). The liner options include 22, 26, 28 and 32 mm inside diameter (1.D.) offerings. The implants are supplied sterile to an assurance level (SAL) of 10°.

AI/ML Overview

The provided text describes the Exactech® AcuMatch™ Integrated Hip System L-Series Bipolar Endoprosthesis. However, it does not contain specific acceptance criteria or a detailed study proving the device meets those criteria in the way requested (e.g., using metrics like sensitivity, specificity, or inter-rater reliability with statistical significance).

Instead, the document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing a detailed performance study with quantitative acceptance criteria as might be expected for an AI/software as a medical device (SaMD).

Here's an analysis based on the provided text, addressing the requested points where information is available or inferring what's typical for this type of submission:

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

Based on the provided text for a physical medical device (hip endoprosthesis), the "acceptance criteria" are implied to be related to mechanical integrity and functional performance rather than diagnostic accuracy metrics. The "reported device performance" is a general statement about testing.

Acceptance Criterion (Implied for this Device Type)	Reported Device Performance
Adequate for anticipated in vivo load applications	Functional testing and engineering analysis were conducted to verify that the implant performance would be adequate for anticipated in vivo load applications.
Resistance to "cam-out"	Cam-out testing was conducted.
Secure assembly	Assembly testing was conducted.
Sufficient range of motion	A range of motion evaluation was conducted.

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

Sample Size for Test Set: Not specified. For a physical device like this, the "test set" would refer to the number of components or assemblies tested in the engineering evaluations. This information is typically found in the detailed test reports that are part of the full 510(k) submission, but not in the summary.
Data Provenance: Not specified. Given it's a product from Exactech, Inc. based in Gainesville, Florida, the testing would likely have occurred in the US or under conditions compliant with US regulations, but no explicit origin is stated.
Retrospective or Prospective: Not applicable in this context, as this refers to clinical study design, and the performance data mentioned refers to engineering testing.

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. The performance data described ("functional testing and engineering analysis") does not involve human interpretation or expert ground truth establishment in the way an AI/SaMD study would. The ground truth for mechanical testing is typically based on established engineering standards and physical measurements.

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

Not applicable. This is a concept used for establishing ground truth in human-centric evaluations (like image interpretation studies), not for mechanical product testing.

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 physical hip endoprosthesis, not an AI or software system intended to assist human readers (e.g., radiologists). Therefore, an MRMC study is not relevant.

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

Not applicable. This device is a physical product, not an algorithm.

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

The "ground truth" for the performance data mentioned would be based on engineering standards and physical measurements. For example:

"Cam-out testing" would have defined failure points or thresholds based on force, displacement, or number of cycles.
"Assembly testing" would verify fit, security, and integrity against design specifications.
"Range of motion evaluation" would measure the achievable motion against design targets.

8. The sample size for the training set

Not applicable. This device is a physical product, not an AI model that requires a training set. The design of the device is based on engineering principles and material science, not machine learning from a data set.

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

Not applicable, as there is no "training set" for this physical device. The "ground truth" for its design and manufacturing would stem from engineering specifications, material properties, biomechanical analyses, and clinical experience with predicate devices.

Summary of the Document's Information Relevant to Performance:

The document is a 510(k) summary for a physical medical device. It states that:

Performance Data: "Functional testing and engineering analysis were conducted to verify that the implant performance would be adequate for anticipated in vivo load applications."
Specific Tests Mentioned: "This performance data includes cam-out testing, assembly testing, and a range of motion evaluation."

The purpose of this 510(k) submission is to demonstrate substantial equivalence to existing legally marketed devices, rather than to present a novel performance study against specific, quantified acceptance criteria in the manner of an AI/SaMD. The "acceptance" by the FDA (as indicated by the clearance letter) is based on the determination of this substantial equivalence, which implies the device meets safety and effectiveness considerations akin to its predicates.

Summary

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Exactech® AcuMatch™ Integrated Hip System L-Series Bipolar Endoprosthesis

DEC 0 5 2001

2 Series Biros Bigotal Enaoprossioness K Ol 32-1 (

510(k) Summary of Safety and Effectiveness K Ol 32-1 (
Special 510(k)

Classifications / Proprietary Names:

Classification Name:	Prosthesis, Hip, Hemi-, Femoral,Metal/Polymer, Cemented or Uncemented
Product Code:	KWY
C.F.R. Section:	888.3390
Device Class:	II
Classification Panel:	Orthopedic
Trade / Proprietary Model Names:	AcuMatch L-Series Bipolar Endoprosthesis

Legally Marketed Devices for Substantial Equivalence Comparison:

Model	Manufacturer	510(k) Number
Exactech Bipolar	Exactech, Inc.	#K905370
Giliberty	Zimmer
Bi-articular	Zimmer
Centrax	Howmedica
Conversion	Richards
Self-Centering	Depuy

Device Description:

INDICATIONS

Section 4 Page 2 of 3

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Exactech® AcuMatch™ Integrated Hip System L-Series Bipolar Endoprosthesis

510(k) Summary of Safety and Effectiveness Special 510(k)

CONTRAINDICATIONS

Exactech Hip Systems are contraindicated in patients with active infection, patients without sufficient bone stock to allow appropriate insertion and fixation of the prosthesis, in neuromuscular disorders that do not allow control of the hip joint, and in patients whose weight, age, or activity level would cause the surgeon to expect early failure of the system. The L-Series unipolar and bipolar endoprostheses are also contraindicated for use in patients with evidence of degenerative changes in the acetabulum and/or pelvic fractures.

DESIGN

PERFORMANCE DATA

Functional testing and engineering analysis were conducted to verify that the implant performance would be adequate for anticipated in vivo load applications. This performance data includes cam-out testing, assembly testing, and a range of motion evaluation.

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Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 0 5 2001

Ms. Lisa Simpson Regulatory Representative Exactech, Inc. 2320 NW 66th Court Gainesville, Florida 32653

Re: K013211

Trade Name: AcuMatch L-Series Bipolar Endoprosthesis Regulation Number: 21 CFR 888.3390 Regulation Name: Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis Regulatory Class: Class II Product Code: KWY Dated: October 26, 2001 Received: November 6, 2001

Dear Ms. Simpson:

We have reviewed your Section 510(k) premarket 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) 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.

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.

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Page 2 - Ms. Lisa Simpson

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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincerely yours,

to Mark A. Mullane

Celia M. Witten. Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Exactech®, Inc.

Indications for Use

KO13211_______________________________________________________________________________________________________________________________________________________________________ 510(k) Number:

Device Name:

AcuMatch L-Series Bipolar Endoprosthesis

INDICATIONS

INDICATIONS
All Exactech Hip Systems are indicated for use in skeletally mature individuals r in Exaction inpost surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also the bargeon addicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion.

CONTRAINDICATIONS

Exactech Hip Systems are contraindicated in patients with active infection, patients without sufficient bone stock to allow appropriate insertion and fixation of the prosthesis, in neuromuscular disorders that do not allow control of the hip joint, and in patients whose weight, age, or activity level would cause the surgeon to expect early failure of the witters The L-Series unipolar and bipolar endoprostheses are also contraindicated for use in patients with evidence of degenerative changes in the acetabulum and/or pelvic fractures.

Please do not write below this line - use another page if needed.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X Over the Counter Use __

Mark N Millkum
(Division Sign-Off)
Div. General, Restorative
and Neurological Devices

K013211

Section 3
Page 1 of 1

Regulation Number and Section

§ 888.3390 Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.

(a)
Identification. A hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis is a two-part device intended to be implanted to replace the head and neck of the femur. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular component made of an alloy, such as cobalt-chromium-molybdenum, and ultra-high molecular weight polyethylene. This generic type of device may be fixed to the bone with bone cement (§ 888.3027) or implanted by impaction.(b)
Classification. Class II.