The DYNASTY™ Acetabular System is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

non-inflammatory degenerative joint disease such as ostecarthritis, avascular necrosis, 1. ankylosis, protrusio acetabuli, and painful hip dysplasia;
inflammatory degenerative joint disease such as rheumatoid arthritis; 2.
1. correction of functional deformity; and,
1. revision procedures where other treatments or devices have failed.

Device Description

The design features of the DYNASTY™ Acetabular Shell and DYNASTY™ A-CLASS™ Poly Acetabular Liner are summarized below:

Shells manufactured from cast titanium (Ti) alloy .
Shells porous coated with Ti alloy sintered beads .
Shell sizes: 50mm-58mm outer diameter .
. Shells provide 3 screw holes in a single quadrant for additional fixation
Liners manufactured from UHMWPE .
Liner sizes: 32mm-42mm inner diameter

AI/ML Overview

Here's an analysis of the provided text regarding the DYNASTY™ Acetabular System, focusing on the absence of specific testing data for AI/ML device criteria:

The provided document is a 510(k) Premarket Notification for the DYNASTY™ Acetabular System, a medical device for total hip arthroplasty. This type of submission aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving novel performance against detailed acceptance criteria through a clinical study for AI/ML.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be found in this document because the approval pathway (510(k) for a physical implant) does not typically require or present this type of data, especially not for an AI/ML device as it pre-dates widespread AI/ML medical device submissions.

The document states:
"The safety and effectiveness of the DYNASTY™ Acetabular System are adequately supported by the substantial equivalence information, materials information, and analysis :lata provided within this Premarket Notification."

This indicates that the primary method of demonstrating safety and effectiveness was by showing similarity to existing, approved devices, along with materials testing and engineering analysis, not by clinical performance metrics based on expert-derived ground truth or AI/ML model output.

Despite the lack of the specifically requested AI/ML-related information, here's an attempt to structure the answer based on the provided text, highlighting what can be inferred and what is explicitly missing:

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

The provided 510(k) Premarket Notification for the DYNASTY™ Acetabular System focuses on demonstrating substantial equivalence to predicate devices rather than meeting specific performance acceptance criteria through the kind of study described for AI/ML devices. Therefore, the document does not contain information on detailed performance metrics, sample sizes for AI/ML testing, ground truth establishment, or expert reviews in the context of an AI/ML algorithm's output.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a mechanical implant seeking 510(k) clearance based on substantial equivalence, there are no "acceptance criteria" in the sense of predictive performance metrics (like sensitivity, specificity, AUC) for an AI/ML device. The "acceptance criteria" for a 510(k) are met by demonstrating that the device is as safe and effective as a legally marketed predicate device.

Acceptance Criteria (Implied for 510(k) Substantial Equivalence)	Reported Device Performance (Summary from Submission)
Intended Use: Identical to predicate device.	"The indications for use of the DYNASTY™ Acetabular System are identical to the previously cleared predicate devices."
Design Features: Substantially equivalent to predicate device.	"The design features and materials of the subject devices are substantially equivalent to those of the predicate devices."
Materials: Substantially equivalent to predicate device.	"The design features and materials of the subject devices are substantially equivalent to those of the predicate devices."
Fundamental Scientific Technology: Unchanged relative to predicate device.	"The fundamental scientific technology of the modified device has not changed relative to the predicate devices."
Safety and Effectiveness: Adequately supported by equivalence, materials, and analysis data.	"The safety and effectiveness of the DYNASTY™ Acetabular System are adequately supported by the substantial equivalence information, materials information, and analysis :lata provided within this Premarket Notification."

Note: The "reported device performance" here refers to the claims made in the 510(k) about its equivalence and safety/effectiveness, not quantitative performance metrics from a dedicated clinical study for distinguishing AI/ML output.

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/Not provided within this 510(k) submission. The document does not describe a "test set" for evaluating an AI/ML algorithm. The evidence presented is for a physical orthopedic implant.

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/Not provided within this 510(k) submission. Ground truth establishment for an AI/ML test set is not relevant to this submission for a physical implant.

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

Not applicable/Not provided within this 510(k) submission. Adjudication methods for AI/ML test sets are not relevant here.

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/Not provided within this 510(k) submission. This device is an orthopedic implant, not an AI/ML diagnostic tool meant to assist human readers.

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

Not applicable/Not provided within this 510(k) submission. This document describes a physical medical device (hip implant), not an algorithm.

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

Not applicable/Not provided within this 510(k) submission. Ground truth for an AI/ML algorithm is not applicable to this submission. The "truth" for this device's safety and effectiveness is established through engineering principles, material science, and prior clinical use of substantially equivalent predicate devices.

8. The sample size for the training set

Not applicable/Not provided within this 510(k) submission. There is no "training set" for an AI/ML algorithm described.

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

Not applicable/Not provided within this 510(k) submission. Ground truth establishment for an AI/ML training set is not applicable here.

Summary

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Kobl547 pge 192

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

JUL - 3 2006

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807, this information serves as a Summary of Safety and Effectiveness for the DYNASTY™ Acetabular System.

Submitted By:	Wright Medical Technology, Inc.
Date:	June 2, 2006
Contact Person:	Matt PaulRegulatory Affairs Specialist
Proprietary Name:	DYNASTY™ Acetabular System
Common Name:	Acetabular ShellAcetabular Liner
Classification Name and Reference:	21 CFR 888.3350 Prosthesis, hip, semi-constrained,metal/polymer, cemented - Class II21 CFR 888.3358 Prosthesis, hip, semi-constrained,metal/polymer, porous uncemented - Class II
Device Product Code and Panel Code:	Orthopedics/87/JDI, MBL, LPH

DEVICE INFORMATION

A. Intended Use

non-inflammatory degenerative joint disease such as ostecarthritis, avascular necrosis, 1. ankylosis, protrusio acetabuli, and painful hip dysplasia;
inflammatory degenerative joint disease such as rheumatoid arthritis; 2.
1. correction of functional deformity; and,
1. revision procedures where other treatments or devices have failed.

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Page 2 of 2

B. Device Description

The design features of the DYNASTY™ Acetabular Shell and DYNASTY™ A-CLASS™ Poly Acetabular Liner are summarized below:

Shells manufactured from cast titanium (Ti) alloy .
Shells porous coated with Ti alloy sintered beads .
Shell sizes: 50mm-58mm outer diameter .
. Shells provide 3 screw holes in a single quadrant for additional fixation
Liners manufactured from UHMWPE .
Liner sizes: 32mm-42mm inner diameter �

C. Substantial Equivalence Information

The indications for use of the DYNASTY™ Acetabular System are identical to the previously cleared predicate devices. The design features and materials of the subject devices are substantially equivalent to those of the predicate devices. The fundamental scientific technology of the modified device has not changed relative to the predicate devices. The safety and effectiveness of the DYNASTY™ Acetabular System are adequately supported by the substantial equivalence information, materials information, and analysis :lata provided within this Premarket Notification.

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Image /page/2/Picture/1 description: The image shows a logo with a stylized bird symbol inside a circle. The bird is composed of three curved lines that suggest movement or flight. The circle surrounding the bird contains text, although the specific words are not clear due to the image's resolution. The logo appears to be a symbol for an organization or agency, possibly related to health or human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 3 2006

Wright Medical Technology, Inc. % Mr. Matt Paul Regulatory Affairs Specialist 5677 Airline Road Arlington, Tennessee 38002

Re: K061547

Trade/Device Name: DYNASTYTM Acetabular System Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulation Class: II Product Code: LPH, JDI, MBL Dated: June 2, 2006 Received: June 5. 2006

Dear Mr. Paul:

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

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Page 2 - Mr. Matt Paul

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. 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 of 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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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 the Division of Sinall
240, 276, 2150, and its International and Consumer Assistance at its tollall or 240-276-3150 or at its Internet address http://www.fds.gov/cdrh/industry/support/index.html.

Sincerely yours,

Surbare Buchma
for
M. N. Meller

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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Indications for Use

510(k) Number (if known):

Device Name: DYNASTY™ Acetabular System

Indications For Use:

1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dy splasia;
1. inflammatory degenerative joint disease such as rheumatoid arthritis;
correction of functional deformity; and, 3.
1. revision procedures where other treatments or devices have failed

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF
NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

babauk buelum formxi-

Page 1 of 1 =

Division of General, Restorativ and Neurological Devices

510(k) Number K101547

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.