For the reconstruction of painful and/or severely disabled shoulder joints resulting from post-traumatic degenerative disease or avascular necrosis. The humeral head and neck should be of sufficient bone stock to support loading. The rotator cuff should be intact or reconstructable. The device is a single use implant intended to be used with bone cement.

Device Description

The HemiCAP® Humeral Head XL (HHXL) Articular Resurfacing System incorporates an articular resurfacing component and a taper post fixation component that mate together via a taper interlock to provide stable and immobile fixation of the implant and stress bearing contact at the bone/prosthetic interface.

AI/ML Overview

This document, K142942 for the HemiCAP® Humeral Head XL (HHXL) Articular Resurfacing System, is a 510(k) premarket notification. This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than providing detailed clinical study results in the same way a PMA (Pre-Market Approval) would.

Therefore, the document does not contain the kind of detailed information about acceptance criteria for device performance in a clinical setting, sample sizes for test sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance that you are requesting. It's a regulatory submission affirming the device's similarity to existing devices the FDA has already cleared.

Instead, this submission concentrates on non-clinical (bench) testing to demonstrate that the modified device performs similarly to its predicate.

Here's what information can be extracted or inferred from the provided text, and what cannot:

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

Acceptance Criteria Category	Reported Device Performance (Summary)
Material	"Is manufactured using the same material" as the predicate device (K023096). This implies the material (e.g., medical-grade alloys) met prior established standards for the predicate.
Shelf Life	"Has the same shelf life" as the predicate device (K023096). This implies the shelf life was validated to be comparable to the predicate.
Packaging & Sterilization	"Is packaged and sterilized using the same materials and processes" as the predicate device (K023096). This implies these processes meet established standards for sterility and package integrity.
Mechanical Performance (Non-Clinical Testing)	The document states:Static Compression TestingCyclic Fatigue TestingAxial Disassembly TestingTorsional Testing"The results have demonstrated the safety and effectiveness of the HemiCAP® Humeral Head XL (HHXL) Articular Resurfacing System Implants along with substantial equivalence to the predicate device (K023096)."

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

Sample Size: Not specified. The document references non-clinical (bench) testing, not clinical studies. The "test set" in this context refers to the number of physical device samples subjected to mechanical testing.
Data Provenance: Not applicable. This is not clinical data. The testing would have been performed in a laboratory setting, presumably by the manufacturer.

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. "Ground truth" usually refers to clinical diagnoses or outcomes established by medical professionals. The testing described is mechanical (bench) testing. The "truth" is whether the device meets engineering specifications and replicates the performance of the predicate device, typically evaluated by engineers and quality control personnel.

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

Not applicable. Adjudication methods are used in clinical studies when multiple human observers interpret data. For mechanical testing, the results are typically quantitative measurements against predefined specifications.

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 mechanical orthopedic implant, not an AI or imaging device. MRMC studies are not relevant here.

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

No. This is a mechanical orthopedic implant. "Standalone algorithm performance" is not relevant.

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

Not applicable in the clinical sense. For the non-clinical testing, the "ground truth" would be the engineering specifications and performance characteristics of the predicate device, against which the new device's mechanical test results were compared to establish "substantial equivalence."

8. The sample size for the training set:

Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

Not applicable. There is no training set or clinical "ground truth" establishment in this document.

In summary, this 510(k) submission primarily relies on comparing the modified device's non-clinical performance (mechanical testing) and design characteristics to a legally marketed predicate device to demonstrate substantial equivalence, rather than providing new clinical study data with acceptance criteria for a new clinical performance claim.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: a circular text element and a symbolic graphic. The text element reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion. The graphic element features a stylized depiction of what appears to be an abstract human figure or a bird-like shape, composed of three curved lines.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 19, 2014

Arthrosurface Incorporated Ms. Dawn J. Wilson Vice President of Quality and Regulatory 28 Forge Parkway Franklin, Massachusetts 02038

Re: K142942

Trade/Device Name: HemiCAP Humeral Head XL (HHXL) Articular Resurfacing System Regulation Number: 21 CFR 888.3690 Regulation Name: Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis Regulatory Class: Class II Product Code: HSD Dated: November 18, 2014 Received: November 20, 2014

Dear Ms. Wilson:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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): medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section 4 Indications for Use Statement

510(k) Number (if known):

HemiCAP® Humeral Head XL (HHXL) Device Name: Articular Resurfacing System

Indications For Use:

Prescription Use(Part 21 CFR 801 Subpart D)	AND/OR	Over-The-Counter Use(21 CFR 801 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Section 5 510(k) Summary

HemiCAP® Humeral Head XL (HHXL) Articular Resurfacing System

Special 510(k): Device Modification

510(k) Owner:	Arthrosurface, Inc.28 Forge ParkwayFranklin, MA 02038Tel:508.520.3003508.528.4604Fax:
Contact:	Dawn WilsonVP, Quality & Regulatory508.520.3003Tel:508.528.4604Fax:dwilson@arthrosurface.com
Establishment RegistrationNumber:	3004154314
Date of Preparation:	October 9th, 2013
Confidentiality:	Reference Section 3
Proprietary Name:	HemiCAP® Humeral Head XL (HHXL)Articular Resurfacing System
Common Name:	Hemi-Shoulder Resurfacing Prosthesis
Device:	Prosthesis, Shoulder, Hemi-, Humeral, MetallicUncemented
Regulation Description:	Shoulder joint humeral (hemi-shoulder) metallicuncemented prosthesis
Requlation Number:	888.3690
Device Class:	Class II
Review Panel:	Orthopedic
Product Code:	HSD

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Intended Use

Device Description

Substantial Equivalence Information

Arthrosurface, Inc. demonstrated that, for the purposes of FDA's regulation of medical devices, the HemiCAP® Humeral Head XL Articular Resurfacing System is substantially equivalent in indications and design principles to the following predicate devices, which have been previously cleared by the FDA:

. The sponsor's previously cleared Contoured Articular Prosthetic (CAP) Humeral Head Resurfacing System (K023096, Cleared on 04/10/2003)
Biomet Inc.'s Copeland Resurfacing Heads (K003044, Cleared on 12/13/2000 and K010664, Cleared on 04/05/2001)
DePuy Orthopaedics Inc.'s Global CAP Resurfacing Replacement Shoulder ● (K031971, Cleared on 09/24/2003)

The fundamental scientific technology of the proposed device has not changed relative to the predicate device (K023096).

Has the same Indications for Use,
o Has the same operating principle,
Is manufactured using the same material,
Has the same shelf life,
ls packaged and sterilized using the same materials and processes. ●

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In support of this submission, the following non-clinical tests and analyses have been performed on the Subject Device:

o Static Compression Testing
Cyclic Fatigue Testing ●
. Axial Disassembly Testing
Torsional Testing .

The results have demonstrated the safety and effectiveness of the HemiCAP® Humeral Head XL (HHXL) Articular Resurfacing System Implants along with substantial equivalence to the predicate device (K023096).

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.