AcuMatch L-Series Cemented Femoral Stem Components are indicated for use in skeletally mature individuals undergoing primary surgery for total hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, ankylosing spondylitis, congenital hip dysplasia, 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 revision of failed previous reconstructions where sufficient bone stock is present and to restore mobility resulting from previous fusion.

AcuMatch L-Series Cemented Femoral Stem Components are intended to be used with bone cement.

Device Description

L-Series Femoral Stem Components are made from cast Cobalt Chromium Molybdenum alloy conforming to ASTM F 75-98. Mechanical properties for ultimate strength, ductility, and grain structure are controlled by this specification. The L-Series components have a satin finish and are intended for cemented applications only.

AI/ML Overview

This document is a 510(k) Summary of Safety and Effectiveness for the Exactech AcuMatch L-Series Cemented Femoral Stem Component, which is a medical device. This type of regulatory submission in the U.S. demonstrates substantial equivalence to a legally marketed predicate device, rather than proving that the device meets specific acceptance criteria through a study in the way a new drug or novel medical device might.

Therefore, the information you've requested about acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training data is not typically part of a 510(k) submission for a device like this femoral stem component.

Here's why and what information is provided:

Device Type: This is a Class II medical device (femoral stem prosthesis). For these types of devices, the regulatory pathway focuses on demonstrating substantial equivalence to a predicate device already on the market, rather than extensive clinical studies with specified performance acceptance criteria like those for diagnostic AI software or novel treatments.
Substantial Equivalence: The primary "proof" is that the device is as safe and effective as existing legally marketed devices. This is established through comparisons of:
- Indications for Use: The L-Series has similar indications and contraindications to other legally marketed femoral components.
- Technological Features: The L-Series originated from design modifications to Exactech's AuRA femoral component and shares similarities with other predicate devices (e.g., "Conquest FX," "Spectron," "PFC") in terms of material (cast cobalt chrome), surface treatment (satin finish), and geometry (proximal to distal taper).
- Performance Data (Mechanical Testing): The document explicitly states: "Three-Point fatigue testing of the Exactech L-Series device places the strength of the stem in the range of other legally marketed devices." This is the core "study" mentioned for demonstrating performance for this type of device.

Therefore, an "acceptance criteria table" and studies as you typically describe for software or AI models are not directly applicable here.

However, I can extract the relevant information that is present in relation to performance and comparison:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, there isn't a formal "acceptance criteria" table in the sense of a diagnostic sensitivity/specificity. Instead, the performance is evaluated against predicate device characteristics and mechanical standards.

Characteristic	Acceptance Criteria (Implied)	Reported Device Performance (Exactech® AcuMatch L-Series)
Indications for Use	Similar to legally marketed femoral components.	Met: Indicated for primary hip replacement (osteoarthritis, rheumatoid arthritis, osteonecrosis, ankylosing spondylitis, congenital hip dysplasia, post-traumatic degenerative problems, proximal femoral fractures) and revision surgery, similar to predicates.
Contraindications	Similar to legally marketed femoral components.	Met: Contraindicated in active infection, insufficient bone stock, neuromuscular disorders, inappropriate weight/age/activity level, similar to predicates.
Material	Conformity to ASTM F 75-98 for cast Cobalt Chromium Molybdenum alloy.	Met: Made from cast Cobalt Chromium Molybdenum alloy conforming to ASTM F 75-98.
Surface Treatment	Similar to predicate devices (e.g., satin finish).	Met: Has a satin finish, similar to predicate devices.
Geometry	Similar to predicate devices (e.g., proximal to distal taper).	Met: Exhibits a proximal to distal taper, similar to predicate devices.
Sterilization	Sterility Assurance Level (SAL) of 10-6.	Met: Gamma radiation (Cobalt 60, 25-37 kGy) achieving SAL of 10-6.
Mechanical Strength	"In the range of other legally marketed devices."	Met: Three-Point fatigue testing places the strength of the stem "in the range of other legally marketed devices."

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

Sample Size for Mechanical Testing: Not specified in the provided text. Mechanical testing typically involves a set number of devices to demonstrate statistically significant strength, but the exact number isn't included here.
Data Provenance: Not applicable in the context of a clinical test set. The data arises from engineering and material testing of the device itself.

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

Not applicable. This submission relies on engineering specifications and mechanical testing against recognized standards and predicate devices, not on expert-adjudicated clinical ground truth from patient data.

4. Adjudication method for the test set

Not applicable. See point 3.

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

No. This is a physical orthopedic implant, not a diagnostic imaging or AI system. Therefore, an MRMC study or AI-assisted improvement metrics are not relevant.

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

No. This is a physical orthopedic implant.

7. The type of ground truth used

The "ground truth" for this device's performance is based on mechanical testing standards (e.g., ASTM F 75-98) and comparative engineering specifications against legally marketed predicate devices.

8. The sample size for the training set

Not applicable. This is not an AI model requiring a training set. The "design modifications" from the AuRA model might be seen as iterative design, but not a data-driven training set.

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

Not applicable. See point 8.

In summary, this 510(k) submission demonstrates substantial equivalence for a physical implant by comparing its design, materials, indications, and mechanical properties to existing, legally marketed devices, rather than through extensive clinical studies with specific performance metrics and ground truth as might be expected for an AI or diagnostic device.

Summary

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Koo1335

510(k) Summary of Safety and Effectiveness

Trade Name:	Exactech® AcuMatch L-SeriesCemented Femoral Stem Component
Common Name:	Femoral Stem
Classification Name:	Prosthesis, Hip, Semi-Constrained, Metal/Polymer,Cemented, (Femoral Component)

Legally Marketed Devices for Substantial Equivalence Comparison:

Model	Manufacturer
AuRA	Exactech (#K961304)
Conquest FX	Smith & Nephew
Spectron	Smith & Nephew
PFC	Depuy

Substantial Equivalence Information:

The Exactech AcuMatch L-Series Cemented Femoral component has similar indications and contraindications as other femoral components legally marketed in the United States. In addition the L-Series has similar technological features to other devices, most notably Exactech's AuRA femoral component. The L-Series originated from design modifications made to the Exactech's AuRA design (ref. #K961304). In addition, the proposed L-Series component is similar to femoral components currently marketed by other manufacturers. These include the "Conquest FX" and "Spectron" by Smith & Nephew and the "PFC" by Depuy. The Conquest FX model like the L-Series is manufactured from cast cobalt chrome. Other similarities between the predicate stems and the proposed L-Series design include a satin surface treatment and a proximal to distal taper. All of the components are supplied sterile. Three-Point fatigue testing of the Exactech L-Series device places the strength of the stem in the range of other legally marketed devices.

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510(k) Summary of Safety and Effectiveness

Indications for Use:

AcuMatch L-Series Cemented Femoral Stem Components are intended to be used with bone cement.

Contraindications:

AcuMatch L-Series Cemented Femoral Stem Components 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.

Device Description:

Packaging. Labeling and Sterilization:

L-Series components are first packaged at Exactech in a certified Class 100,000 Cleanroom. The products are then shipped to an ISO/EN certified Irradiation Facility and returned to Exactech where they are quarantined pending a final product inspection. Qualifying implants are then released for distribution. Packaging materials are outlined in the following table.

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510(k) Summary of Safety and Effectiveness

Material	Composition
Inner / Outer Trays	PETG – 0.040" thickness
Tray Lids	Spun-Bonded Olefin - Tyvek®
Inserts	Medium grade LD45 Foam
Box	Heavy weight cardboard
Outer Shrink-Wrap	Clear, Light-Weight Plastic
Shipping Cartons	Heavy-weight Corrugated Cardboard

Utilization and implantation instructions are included in the package insert provided with each product. The name, size, dimension, material, lot, serial number and sterility status are indicated on the labeling.

Sterilization Specifications:

Method: Gamma radiation (Cobalt 60 source) Dose: 25 – 37 kGy Sterility Assurance Level (SAL): 10-6

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 8 2000

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

Re: K001335

Trade Name: Exactech® AcuMatch™ Integrated Hip System L-series Cemented Femoral Stem Component Regulatory Class: II Product Code: JDI Dated: April 26, 2000 Received: April 27,2000

Dear Ms. Simpson:

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 control 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.

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.

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Page 2 - Ms. Lisa Simpson

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) 594-4659. 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" (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 at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Neil RPEyden

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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Indications for Use

510(k) Number:

Kool335

Device Name:

Exactech® AcuMatch™ Integrated Hip System L-Series Cemented Femoral Stem Component

Indications for Use:

AcuMatch L-Series Cemented Femoral Stem Components are indicated for use in skeletally mature individuals undergoing primary surgery for total hip replacement due to SKeloary mature marriad arthritis, osteonecrosis, ankylosing spondylitis, congenital hip Osteourinitie, Includio degenerative problems of the hip, and for treatment of proximal as the fentoral fractures whice pponents of Exactech Hip Systems are also potentially indicated presenta a softailed previous reconstructions where sufficient bone stock is present and to restore mobility resulting from previous fusion.

AcuMatch L-Series Cemented Femoral Stem Components are intended to be used with bone cement.

Contraindications:

Please do not write below this line - use another page if needed.
Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)	NRO for cmw
Division of General Restorative Devices
510(k) Number	K001335

Prescription Use	Yes	or	Over the Counter Use	No
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Section 3 Page 1 of 1

Regulation Number and Section

§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a 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 have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.