AcuMatch Integrated Hip System - M-Series Femoral Components are indicated for use in skeletally mature individuals undergoing primary surgery for total hip replacement due to osteoarthritis, osteonecrosis, congenital hip dysplasia, rheumatoid arthritis, ankylosing spondylitis, and/or post-traumatic degenerative problems. M-Series components are also potentially indicated for revision of failed previous reconstructions where sufficient bone stock is present.

AcuMatch M-Series components are intended to be used in press-fit and cemented applications.

Device Description

The Exactech Modular Stem is a four-piece system consisting of a proximal neck segment, metaphyseal segment, diaphyseal segment and a locking screw. All of the components are interchangeable, therefore allowing for many sizing combinations to meet varying anatomical situations. The components are composed of titanium alloy.

The neck segment is available in four heights and has a male taper for attachment to the metaphyseal segment. The anteversion/retroversion adjustment of the neck is completely independent of the rest of the construction.

There are 24 sizes of plasma-coated metaphyseal segments. The bone is prepared to receive the implant using a series of milling instruments specifically designed to match the system. The proximal cross-section of this segment is trapezoidal in order to contribute torsional stability to the device. The metaphyseal segments are available in small, medium and large flare designs. A calcar version is also available.

The distal stems have parabolic distal tips, biting flutes and coronal slots. The end of the stem is polished. The stems are available in various diameters in both straight and curved designs. Each stem is interchangeable with any metaphyseal segment.

AI/ML Overview

The provided document (K993736) is a 510(k) Pre-Market Notification for a medical device: an Exactech® AcuMatch™ Integrated Hip System M-Series Femoral Stem Component. This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than providing a new, comprehensive study proving safety and effectiveness from scratch.

Therefore, the document does not contain information about specific acceptance criteria for device performance in an AI/Software as a Medical Device (SaMD) context, nor does it describe a study in the format of an AI model's performance evaluation as requested. The "acceptance criteria" discussed in this document relate to the FDA's regulatory process for demonstrating substantial equivalence for a medical implant, primarily through design comparisons, material comparisons, and general performance testing (e.g., endurance, rotational stability) against established standards and predicate devices.

Here's an attempt to answer your questions based on the available information, noting where the requested details are not present for this type of submission:

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

For a traditional medical device like a hip implant, the "acceptance criteria" are implied by the demonstration of substantial equivalence to predicate devices and adherence to relevant standards. The "reported device performance" is largely based on material properties, design features, and specific mechanical tests.

Acceptance Criteria (Implied from Substantial Equivalence and Standards)	Reported Device Performance
Primary Goal: Substantial Equivalence to Legally Marketed Predicates	The M-Series is stated to be "equivalent in materials and design" to the "S-ROM" by Joint Medical Products Corporation and "similar" to Biomet's "Impact", Biomet's "Mallory-Head", and the "Link MP" by Link America.
Material Compatibility/Equivalence	All components are composed of titanium alloy, similar to predicate stems. Predicate stems also use Titanium Alloy.
Design Features (for function and stability)	Similar to predicate devices in:Use of tapered junctions for intra-operative flexibility.Accommodation of proximal/distal mismatch.Use of a screw (like Mallory-Head and Impact) for positive lock between stem components. (Link uses a toothed sleeve)Distal flutes for rotational stability.Coronal slot to reduce distal stem stiffness (like S-ROM, Mallory Head, Impact).
Mechanical Endurance (e.g., fatigue life)	In-house endurance testing (ISO 7206-4) along with fatigue analysis by a contract testing facility shows the M-Series to be "comparable to current clinically successful implants."
Rotational Stability	Rotational stability testing revealed that the M-Series was "able to consistently withstand the torsional loads expected in vivo."
Proximal Fixation Mechanism	Uses plasma-coated metaphyseal segments (24 sizes). Similar to Mallory-Head and Impact using proximal plasma coating, and S-ROM using sintered titanium beads.

Since this is not an AI/SaMD study, the following questions are largely not applicable or the information is not present within this 510(k) summary. I will state if the information is unavailable or not relevant to this type of device.

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

Not Applicable/Information Not Provided for this Device Type: This document does not describe a clinical study with a test set of patient data, as would be relevant for an AI/SaMD product. The "testing" mentioned is mechanical testing of the physical implant components (e.g., "In-house endurance testing," "rotational stability testing").
For Mechanical Tests: The sample sizes for these mechanical tests are not specified in this summary. Data provenance would be from the Exactech facility and/or a contract testing facility.

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: There is no "ground truth for a test set" in the context of an AI/SaMD evaluation described here. The "experts" involved would be the engineers performing the mechanical testing and potentially hip surgeons providing input on design, but this is not framed as an "expert consensus" for ground truth in a diagnostic sense.

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

Not Applicable: No adjudication method for a test set is described, as there is no diagnostic or classification performance being evaluated in 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 is a physical hip implant, not an AI-assisted diagnostic or decision support tool. Therefore, no MRMC study or AI assistance evaluation was performed.

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

Not Applicable: This is a physical hip implant. There is no algorithm.

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

For Mechanical Testing: For the mechanical tests (endurance, rotational stability), the "ground truth" would be established by engineering standards (e.g., ISO 7206-4 for endurance) and the physical properties and performance characteristics of the predicate devices. There is no pathology or outcomes data discussed for the performance evaluation in this 510(k) summary, though clinical outcomes are the ultimate measure of success for such implants.

8. The sample size for the training set

Not Applicable: There is no AI model or "training set" for this physical device.

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

Not Applicable: As there is no AI model, there is no training set or ground truth for it.

Summary

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Exactech®

K. 993736

2320 NW 66TH COURI GAINESVILLE, FL 3265':

352-377-1140 FAX 352-378-2617

Exactech® AcuMatch™ Integrated Hip System JAN 20 2000 M-Series Femoral Stem Component

510(k) Summary of Safety and Effectiveness

Exactech® Inc. Sponsor: 2320 N.W. 66th Court Gainesville, Florida 32653

Phone: (352) - 377 - 1140 (352) - 378 - 2617 Fax:

FDA Establishment Number 1038671

Gary J. Miller, Ph.D. Contact: V.P. of Research and Development

November 2, 1999 Date:

Section 4 Page 1 of 4

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510(k) Summary of Safety and Effectiveness

Trade Name:	Exactech® AcuMatch M-SeriesFemoral Stem Component
Common Name:	Total Hip Prosthesis Femoral Component
Classification Name:	Prothesis, Hip, Semi-Constrained, Metal/Polymer,Porous, Uncemented (Femoral Component)

Legally Marketed Devices for Substantial Equivalence Comparison:

The AcuMatch M-Series Femoral System (referred to as M-Series from this point forward) is made of similar materials and is of a similar design to other legally marketed modular femoral components. Most notably, the M-Series is equivalent in materials and design to the "S-ROM" by Joint Medical Products Corporation. The M-Series is also similar to Biomet's "Impact", Biomet's "Mallory-Head" and the "Link MP" by Link America.

Description:

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510(k) Summary of Safety and Effectiveness

Intended Use:

M-Series 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 the M-Series are also potentially indicated for revision of failed previous reconstructions where sufficient bone stock is present and to restore mobility resulting from previous fusion.

The M-Series components are indicated for press-fit and cemented applications.

Contraindications:

M-Series 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.

Substantial Equivalence Information:

The M-Series has similar intended uses and technological features to the predicate devices. The M-Series, S-ROM, Impact, Malloy Head and Link are all used in primary and revision hip replacement surgeries.

The M-Series stem is technologically similar to the predicate stems in the use of tapered junctions in order to increase surgeon intra-operative flexibility. All of the predicate modular stems have a variation of a design which allows the surgeons to accommodate proximal / distal mismatch in the femur.

The AcuMatch M-Series stem is similar to the Biomet Mallory-Head and Impact femoral stem prosthesis in that it also uses a screw to ensure a positive lock between the stem components. The Link modular prosthesis uses the same concept except that it uses a toothed sleeve instead of a tapered junction.

All of the stems use distal flutes to further increase the rotational stability of the stem. The S-ROM, the Mallory Head, and the Impact also use a coronal slot in order to reduce distal stem stiffness.

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510(k) Summary of Safety and Effectiveness

All stems are made of a Titanium Alloy. The Mallory-Head and Impact stems use proximal plasma coating to aid in proximal fixation. The S-ROM uses sintered titanium beads for the same purpose.

In-house endurance testing (ISO 7206-4) along with fatigue analysis by a contract testing facility shows the M-Series to be comparable to current clinically successful implants. In addition, rotational stability testing revealed that the M-Series was able to consistently withstand the torsional loads expected in vivo.

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Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with three curved lines above them that resemble wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 20 2000

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

Re: K993736 Trade Name: Exactech Integrated Hip System M-Series Femoral Stem Component Regulatory Class: II Product Code: LPH/JDI Dated: November 2, 1999 Received: November 4, 1999

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 controls provisions of the Act. The general control 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,

Timmerman

James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number:

K993736

Device Name:

Exactech Integrated Hip System AcuMatch M-Series Femoral Stem Component

Indications for use:

AcuMatch M-Series components are intended to be used in press-fit and cemented applications.

Contraindications:

AcuMatch M-Series 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.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use		or	Over the Counter Use
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Signature
(Division Sign-Off)

Division of General Restorative Devices

510(k) Number	K113736
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Section 3

Page 1 of 1

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Regulation Number and Section

§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.

(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.