Exactech Novation Crown Cup TM Constrained Liners and Rings are components of the Exactech Novation® non-cemented acetabular cup system. The device is intended for use in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered. They are intended for press-fit fixation and are compatible with Exactech press-fit or cemented femoral stem components.

Device Description

The proposed Novation® Constrained Acetabular Liners are modifications of the previously cleared AcuMatch A-Series predicates. The design features of the subject devices are summarized below:

NOVATION CONSTRAINED LINERS

Sphere and taper inner diameter geometry for compatibility with the Novation . Crown Cup
Increased range-of-motion and lever-out moment by decreasing the height of the . constraining petals, increasing the constraining diameter and increasing the lead in chamfer
Addition of a 36mm ID option. .

NOVATION CONSTRAINED RINGS

The constraining ring will be made of Ti-6Al-4V per ASTM F1472 instead of Ti- 6Al-4V per ASTM F136.
Ring snaps into a locking feature on the Novation Crown Cup instead of press-. fit.
Inner and outer diameter of the constraining ring modified for compatibility with . the proposed constrained liner and Novation Crown Cup.

AI/ML Overview

The provided text describes a 510(k) submission for the Exactech® Novation Crown Cup™ Constrained Liners and Rings. This is a medical device submission, and as such, the "acceptance criteria" and "study" are not in the context of typical AI/ML performance metrics, but rather engineering evaluations and substantial equivalence to a predicate device.

Here's an interpretation based on the given information:

1. Table of Acceptance Criteria and Reported Device Performance

For medical devices like this, the "acceptance criteria" for a 510(k) submission are typically related to a demonstration of substantial equivalence to an already legally marketed (predicate) device, and the "performance" is verified through engineering evaluations to ensure it's "adequate for anticipated in vivo use."

Acceptance Criteria (Implied)	Reported Device Performance
Substantial equivalence to predicate device (K040601)	The Novation Crown Cup™ Constrained Liners and Rings were found to be substantially equivalent to the AcuMatch A-Series & MCS Constrained Liners (K040601).
Mechanical performance suitable for anticipated in vivo use	"Engineering evaluations were conducted to verify that the performance of the proposed acetabular components would be adequate for anticipated in vivo use. Based on successful results discussed in this submission, we conclude that the proposed devices are substantially equivalent to the previously cleared predicates." (Specific results are not detailed in this summary).
Compatibility with Novation Crown Cup system	Design features ensure compatibility: sphere and taper inner diameter geometry for Novation Crown Cup, inner and outer diameter of constraining ring modified for compatibility with proposed constrained liner and Novation Crown Cup.
Material specifications (for constraining rings)	Constraining ring will be made of Ti-6Al-4V per ASTM F1472, ensuring material equivalence or suitability.
Increased range-of-motion and lever-out moment	Achieved by "decreasing the height of the constraining petals, increasing the constraining diameter and increasing the lead in chamfer."
Presence of a 36mm ID option	An additional design feature.
Successful locking mechanism (for constraining ring)	Ring "snaps into a locking feature on the Novation Crown Cup instead of press-fit."

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the acceptance criteria is referred to as "Engineering evaluations."

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

Sample Size for Test Set: Not specified in the provided text. For mechanical testing of medical devices, sample sizes are typically determined by statistical methods for specific tests (e.g., fatigue, wear, pull-out strength). The summary only states "Engineering evaluations were conducted."
Data Provenance: Not specified, but generally, such engineering evaluations are conducted in a laboratory setting by the manufacturer (Exactech, Inc.) based in the USA (Gainesville, Florida). The data would be prospective, as it's generated specifically for this submission.

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

This concept (experts establishing ground truth) is primarily applicable to studies involving human interpretation (e.g., radiology for AI models). For a mechanical device 510(k) submission, "ground truth" is typically objective engineering measurements and established material science standards.

No specific number of human "experts" establishing ground truth for the test set (engineering evaluations) is mentioned. The "experts" in this context would be the engineers and scientists conducting and reviewing the tests, following established ASTM/ISO standards for medical device testing. Their qualifications would be in biomedical engineering, materials science, mechanical engineering, etc., likely with experience in orthopedic implants.

4. Adjudication Method for the Test Set

Again, "adjudication" usually refers to resolving disagreements between human readers/interpreters. For engineering evaluations, the "adjudication" is inherent in the scientific and engineering review process, ensuring test protocols are followed, data is correctly analyzed, and conclusions drawn are valid.

No explicit "adjudication method" like 2+1 or 3+1 is mentioned or applicable in the context of engineering evaluations for a mechanical device.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic tools where human readers are involved. The Novation Crown Cup™ is a mechanical orthopedic implant, not an AI diagnostic device.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

No, a standalone (algorithm only) study was not done. This concept applies to AI/ML software. The Novation Crown Cup™ is a physical medical device.

7. Type of Ground Truth Used

For the engineering evaluations, the "ground truth" would be objective physical measurements and adherence to established engineering standards (e.g., ASTM F1472 for material, other ASTM/ISO standards for mechanical properties like fatigue, wear, range-of-motion, lever-out moment testing). The "truth" is whether the device meets predefined mechanical performance thresholds or demonstrates equivalent performance to the predicate device under specific test conditions.

8. Sample Size for the Training Set

This concept is not directly applicable. In the context of mechanical device design, there isn't a "training set" in the machine learning sense. Instead, design iterations and simulations might be performed, but these are not referred to as training data for an algorithm. The 510(k) process focuses on validating the final product, not on the data used to "train" its design.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" in the AI/ML sense for this mechanical device. The design evolution and verification are based on engineering principles, materials science, clinical experience with previous devices, and established standards, rather than machine learning "ground truth."

Summary

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K071676

Exactech® Novation Crown Cup TM Constrained Liners and Rings Special 510(k) - 510(k) Summary

Trade or proprietary or model name(s): Novation Crown Cup TM Constrained Liners and Rings

JUL 1 9 2007

Common Name Constrained Liners and Rings

Classification name

Hip joint metal/polymer constrained cemented or uncemented prosthesis (21 CFR Section 888.3310)

Information on devices to which substantial equivalence is claimed:

510(k)Number	Trade or Proprietary or Model Name	Manufacturer
#K040601	AcuMatch A-Series & MCS Constrained Liners	Exactech. Inc.

Indications for Use:

Novation Crown Cup ™ Constrained Liners and Rings are components of the Exactech Novation® non-cemented acetabular cup system. The device is intended for use in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered. They are intended for press-fit fixation and are compatible with Exactech press-fit or cemented femoral stem components.

Device Description:

The proposed Novation® Constrained Acetabular Liners are modifications of the previously cleared AcuMatch A-Series predicates. The design features of the subject devices are summarized below:

NOVATION CONSTRAINED LINERS

Sphere and taper inner diameter geometry for compatibility with the Novation . Crown Cup
Increased range-of-motion and lever-out moment by decreasing the height of the . constraining petals, increasing the constraining diameter and increasing the lead in chamfer
Addition of a 36mm ID option. .

NOVATION CONSTRAINED RINGS

The constraining ring will be made of Ti-6Al-4V per ASTM F1472 instead of Ti-� 6Al-4V per ASTM F136.

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KO71676 Exactech® Novation Crown Cup ™ Constrained Liners and Rings Special 510(k) - 510(k) Summary

(89 2 of 2

Ring snaps into a locking feature on the Novation Crown Cup instead of press-. fit.
Inner and outer diameter of the constraining ring modified for compatibility with . the proposed constrained liner and Novation Crown Cup.

Substantial Equivalency Conclusion:

Engineering evaluations were conducted to verify that the performance of the proposed acetabular components would be adequate for anticipated in vivo use. Based on successful results discussed in this submission, we conclude that the proposed devices are substantially equivalent to the previously cleared predicates.

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Image /page/2/Picture/12 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 what appears to be an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Exactech, Inc. % Mr. Graham Cuthbert Regulatory Affairs Specialist 2320 NW 66th Court Gainesville, Florida 32653

JUL 1 9 2007

Re: K071676

Trade/Device Name: Novation Crown Cup™ Constrained Liners and Rings Regulation Number: 21 CFR 888.3310 Regulation Name: Hip joint metal/polymer constrained cemented or uncemented prosthesis Regulatory Class: Class II Product Code: KWZ Dated: June 15, 2007 Received: June 19, 2007

Dear Mr. Cuthbert:

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 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 - Graham Cuthbert

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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours.

Barbara Buehrig

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

Enclosure

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Exactech® Novation Crown Cup ™ Constrained Liners and Rings Special 510(k) - Indications for Use

510(k) Number:	K071676
Device Name:	Exactech Novation Crown Cup TM Constrained Liners and Rings
Intended Use:	Exactech Novation Crown Cup TM Constrained Liners and Rings are components of the Exactech Novation® non-cemented acetabular cup system. The device is intended for use in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered. They are intended for press-fit fixation and are compatible with Exactech press-fit or cemented femoral stem components.
Prescription Use(Part 21 CFR 801 Subpart D)	X and/or Over-The-Counter Use(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Charlane Bovehir

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K071671

Section 5 Page 1 of 1

Regulation Number and Section

§ 888.3310 Hip joint metal/polymer constrained cemented or uncemented prosthesis.

(a)
Identification. A hip joint metal/polymer constrained cemented or uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device prevents dislocation in more than one anatomic plane and has components that are linked together. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular component made of ultra-high-molecular-weight polyethylene with or without a metal shell, made of alloys, such as cobalt-chromium-molybdenum and titanium alloys. This generic type of device is intended for use with or without bone cement (§ 888.3027).(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis.”