Patients disabled by either non-inflammatory or inflammatory arthritis (i.e. rheumatoid arthritis, . osteoarthritis and avascular necrosis).
Mild or moderate humeral head deformity and / or limited motion.
Post-traumatic arthritis.
Patients with an intact or reparable rotator cuff.

Device Description

The Ascension® HRA® System TPS/HA includes an anatomically designed, semi-constrained, monolithic device designed for resurfacing of the humeral head (hemi-shoulder). The system is designed for noncemented (i.e. press-fit) fixation. Each device is boxed individually and delivered sterile for single use. The system incorporates eight anatomically designed head geometries with appropriately sized stems. Head sizes are identified using width and height (in millimeters). The Ascension® HRA® device incorporates design features for replacing the damaged humeral head bearing surface and restoring normal anatomy with minimal bone resection. The stem is tapered and fluted to provide rotational as well as axial stability of the seated implant. System instrumentation, including a range of implant trials, is designed to offer precise implant preparation. The HRA device is made from Cobalt Chrome (ASTM F-1537 wrought or ASTM F-75 cast) and features a highly polished bearing surface with a CP Titanium or HA plasma spray undersurface and stem coating for osseointegration. No new materials are introduced with this device. Ascension® HRA® System components will be manufactured by contract manufacturers per Ascension Orthopedics, Inc., specifications.

AI/ML Overview

The provided document is a 510(k) summary for the Ascension® HRA® System TPS/HA, a medical device for humeral head resurfacing. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific performance acceptance criteria through clinical studies in the way a diagnostic AI device might.

Therefore, many of the requested categories related to AI device evaluation (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable to this type of submission.

However, I can extract the information that is relevant to the "acceptance criteria" (which in this context refers to the characteristics that demonstrate substantial equivalence) and the "study" (which is the comparison to predicate devices) as presented in the 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

In the context of this 510(k) submission, "acceptance criteria" are the features and characteristics that the new device must meet to be considered substantially equivalent to the predicate devices. The "reported device performance" is how the new device measures up against these criteria, often shown by direct comparison to the predicate.

Specification / Characteristic (Acceptance Criteria)	Ascension® HRA® System TPS/HA (Reported Device Performance)	Predicate Device (Example: Biomet / Copeland Humeral Resurfacing Head)
FDA 510(k) clearance	K062861 (this submission)	K010664, K010827, and K051843
Use	Single use	Single use
Implantation duration	Longer than 30 days	Longer than 30 days
Constraint	Semi-constrained	Semi-constrained
Articulating Surface Material	ASTM F-75 Co-Cr Casting Alloy or ASTM F1537 wrought Co-Cr	ASTM F-75 Co-Cr Casting Alloy
Under-Coating Material	CP Ti (ASTM F1580) HA (ASTM F 1185-03) Plasma Spray Coating	CP Ti (ASTM F1580) Plasma Spray Coating
Number of Sizes	8	8
Width Range	40mm - 56mm	42.7mm - 54.0mm
Height Range	15mm - 21mm	12.0mm - 27.0mm
Radius Range	20.5mm - 29.2mm	25mm - 27.5mm
Shell Thickness (head)	Same (compared to predicates)	Same
Under-surface Flat	No	No
Primary Fixation	Press Fit Stem	Press Fit Stem
Tapered Stem	Yes	Yes
Stem Cross-Section	Four-Fluted	Four-Fluted
Variable Stem Lengths	Yes	Yes
Cannulated Instrumentation	Yes	Yes
Minimal Bone Removal	Yes	Yes
Penetration of Intramedullary Canal	No	No
Easy Conversion to Stemmed Component	Yes	Yes
Indications for Use	Identical to predicates	Identical indications
New Materials Introduced	No new materials	(Predicate uses industry standard materials)

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

Sample size used for the test set: Not applicable. This is a 510(k) submission based on substantial equivalence, not a clinical trial with a "test set" in the context of AI or diagnostic device evaluation. The "test set" here would refer to the characteristics and materials of the device itself and its comparison to legally marketed predicate devices.
Data provenance: Not applicable in the traditional sense of patient data. The "data" here comes from a comparison of design specifications, materials, and intended use as documented for the submitted device and previously cleared predicate devices (Biomet Coneland Humeral Resurfacing Head K010664, K010827 and K051843; DePuy Global C.A.P. K031971 and K033516; Ascension® Humeral Resurfacing Arthroplasty (HRA) System K062861). The study is a retrospective comparison of existing device specifications and regulatory clearances. The origin is the specifications of the devices themselves.

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

Not applicable. There is no "ground truth" established by experts for a test set in the context of this 510(k) submission. The ground truth, in a sense, is the regulatory acceptance of the predicate devices and the documented specifications of all devices.

4. Adjudication method for the test set

Not applicable. No adjudication method was used, as there was no test set or expert assessment of outcomes.

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 not an AI or diagnostic imaging device, so MRMC studies are not relevant.

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

Not applicable. This is not an algorithm-based device.

7. The type of ground truth used

The "ground truth" for this 510(k) is the established regulatory acceptance and performance specifications of the predicate devices. The new device demonstrates "substantial equivalence" to these established benchmarks.

8. The sample size for the training set

Not applicable. This is not an AI or machine learning device and therefore does not have a training set.

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

Not applicable. As there is no training set, this question is not relevant.

In summary, this 510(k) submission demonstrates that the Ascension® HRA® System TPS/HA is substantially equivalent to legally marketed predicate devices by comparing its design, materials, and intended use. The "study" is a feature-by-feature comparison, and the "acceptance criteria" are derived from the characteristics of the predicate devices. It is crucial to understand that this type of submission follows a different regulatory pathway than, for instance, an AI-powered diagnostic device, and thus many of the questions are not applicable to the information provided.

Summary

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510(k) SUMMARY

K071064	(pg 1/3)
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SUBMITTER NAME:	Ascension Orthopedics, Inc.8700 Cameron Road, C-100Austin, TX 78754-3832
510(k) CONTACT:	Glen NeallyPhone: (512) 836-5001	JUN 2 2 2007
TRADE NAME:	Ascension® HRA® System TPS/HA
COMMON NAME:	Sterile Resurfacing Shoulder Joint Replacement Prosthesis
CLASSIFICATION:	21 CFR 888.3690
PRODUCT CODE:	HSD
PANEL:	Orthopedic

PREDICATE DEVICES:

Biomet Coneland Humeral Resurfacing Head (K010664, K010827 and K051843) DePuy Global C.A.P. (K031971 and K033516) Ascension® Humeral Resurfacing Arthroplasty (HRA) System (K062861)

DEVICE DESCRIPTION:

INTENDED USE:

The Ascension® HRA® System TPS/HA is intended for resurfacing of the humeral head due to:

Patients disabled by either non-inflammatory or inflammatory arthritis (i.e. rheumatoid arthritis, . osteoarthritis and avascular necrosis)
Mild or moderate humeral head deformity and / or limited motion .

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510(k) Premarket Notification Device: Ascension® Humeral Resurfacing Arthroplasty (HRA) System TPS/HA

. Post-traumatic arthritis
K071064 (pg 2/3)
. Patients with an intact or reparable rotator cuff

BASIS OF SUBSTANTIAL EQUIVALENCE:

A comparison of identical materials and nearly identical design features, demonstrates that the Ascension® HRA® device is substantially equivalent to the predicate device as indicated in the chart below:

Specification /Characteristic	AscensionOrthopedics Inc(ΑΟΙ)Humeral ResurfacingArthroplasty (HRA)Device (& TPS/HA)	Biomet / CopelandHumeralResurfacing Head	DePuy / GlobalC.A.P.
FDA 510(k) clearance	K062861(this submission)	K010664, K010827,and K051843	K031971 andK033516
Use	Single use	Single use	Single use
Implantation duration	Longer than 30 days	Longer than 30 days	Longer than 30 days
Constraint	Semi-constrained	Semi-constrained	Semi-constrained
Articulating Surface	ASTM F-75 Co-CrCasting Alloyor ASTM F1537wrought Co-Cr	ASTM F-75 Co-CrCasting Alloy	ASTM F-75 Co-CrCasting Alloy
Under-Coating	CP Ti (ASTM F1580)HA (ASTM F 1185-03)Plasma Spray Coating	CP Ti (ASTM F1580)Plasma Spray Coating	Porocoat® PorousCoating
Sizes	8	8	10
Width Range	40mm - 56mm	42.7mm - 54.0mm	40mm - 56mm
Height Range	15mm - 21mm	12.0mm - 27.0mm	15mm - 21mm
Radius Range	20.5mm - 29.2mm	25mm - 27.5mm	20.1mm - 30.8mm
Shell Thickness (head)	Same	Same	Same
Under-surface Flat	No	No	Yes
Primary Fixation	Press Fit Stem	Press Fit Stem	Press Fit Stem
Tapered Stem	Yes	Yes	Yes
Stem Cross-Section	Four-Fluted	Four-Fluted	Four-Fluted
Variable Stem Lengths	Yes	Yes	Yes
CannulatedInstrumentation	Yes	Yes	Yes
Minimal Bone	Yes	Yes	Yes

REG-04-901-001 Rev. A

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510(k) Premarket Notification Device: Ascension® Humeral Resurfacing Arthroplasty (HRA) System TPS/HA

Removal
Penetration ofIntramedullary Canal	No	No	No
Easy Conversion toStemmed Component	Yes	Yes	Yes

Similarities of the Ascension® HRA® device and the Biomet Copeland and the DePuy Global C.A.P. devices include: All devices have the same indications for use; All devices are made of the same industry standard materials; No new materials are introduced; Minimal bone removal surgical procedure for all device; Anatomic head sizes; All devices incorporate a press-fit stem as the primary fixation method; All devices are intended for surgical implantation longer than 30 days: All devices are intended for single use only.

Summary:

The Ascension® HRA® System TPS/HA is identical functionally, and had the same indications for use when compared to the predicate devices, and is fabricated from the same materials as the predicate devices. Dimensionally, the Ascension® HRA® device is nearly identical to the predicate devices. Devices for the subject and predicate systems are provided sterile in individual packages. Therefore, the Ascension HRA device is substantially equivalent to the predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three overlapping wing-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 2 2007

Ascension Orthopedics, Inc. % Mr. Glen Neally Vice President of QA/RA/CA 8700 Cameron Road, Suite 100 Austin, Texas 78754-3832

Re: K071064

Trade/Device Name: Ascension® Humeral Resurfacing Arthroplasty (HRA) System TPS/HA Regulation Number: 21 CFR 888.3690 Regulation Name: Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis Regulatory Class: II Product Code: HSD Dated: April 12, 2007 Received: April 16, 2007

Dear Mr. Neally:

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

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Page 2 - Mr. Glen Neally

systems (OS) 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 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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 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 Briem

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: K071064 (pg 1/1)

Ascension® Humeral Resurfacing Arthroplasty (HRA) System TPS/HA Device Name:

Indications for Use:

Prescription Use

The Ascension® HRA® device is intended for resurfacing of the humeral head due to:

Patients disabled by either non-inflammatory or inflammatory arthritis (i.e. rheumatoid arthritis, . osteoarthritis and avascular necrosis).
Mild or moderate humeral head deformity and / or limited motion. �

ાર

Post-traumatic arthritis. �
Patients with an intact or reparable rotator cuff. .

(Part 21 CFR 801Subpart C) (Part 21 CFR 801 Subpart B) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY) Concurrence of CDRET Stuges 96 for Stelle Off ODE Division of General, Restorative, and Neurological Devices REG-04-901-001 Rev. A 510(k) I

Over-The-Counter Use

Regulation Number and Section

§ 888.3690 Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.

(a)
Identification. A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium-molybdenum. It has an intramedullary stem and is intended to be implanted to replace the articular surface of the proximal end of the humerus and to be fixed without bone cement (§ 888.3027). This device is not intended for biological fixation.(b)
Classification. Class II.