The Shoulder Innovations Total Shoulder System is intended for use as an orthopedic implant for partial or total shoulder arthroplasty to treat the following:

significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint;
avascular necrosis of the humeral head.
The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component for total shoulder arthroplasty.
The Total Shoulder System components are intended for single use only. The glenoid component is intended for cemented fixation only; the humeral stem may be implanted by press-fit or cement fixation.

Device Description

The Shoulder Innovations Humeral Short Stem consists of modular humeral stems and heads and articulates with the Shoulder Innovations glenoid component (K111596). The humeral stems are collarless and manufactured from Titanium Alloy (Ti6-4) with fins to provide rotational stability. The collarless stems allow the humeral head to prevent stem subsidence. The stems have a female Morse-type taper to interface with the modular humeral heads. The proximal body and fins are coated with a rough, porous coating for un-cemented fixation or for use with bone cement.
The humeral heads are manufactured from CoCr and are available in standard and offset configurations. The heads have a male Morse-type taper to interface with the humeral stems.

AI/ML Overview

This document describes the 510(k) premarket notification for the Humeral Short Stem System by Shoulder Innovations Inc. It is a submission for a shoulder prosthesis, not an AI/ML powered device, therefore, the requested information on acceptance criteria for an AI/ML powered device, specifically points related to AI/ML model performance, ground truth establishment, expert adjudication, and MRMC studies, is not applicable to this document.

However, I can provide information about the acceptance criteria and the study proving the device meets the acceptance criteria within the context of non-clinical testing for a medical device like this shoulder prosthesis, as described in the document.

Here's an analysis of the provided text, focusing on the available information regarding device testing and acceptance:

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

The document describes non-clinical performance testing. It doesn't present a table with specific acceptance criteria values and reported performance values for each criterion. Instead, it states that tests were performed "per ASTM F2009 Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses" and that "Fatigue testing was also performed on the humeral components."

The conclusion in the "Summary of Substantial Equivalence" states: "The results of non-clinical testing and comparative analysis demonstrate that the design, function, intended use, and indications for use of the Shoulder Innovations Humeral Short Stem System is substantially equivalent to the predicate device." This implies that the device met the acceptance criteria defined by the specified ASTM standard and fatigue testing, although the specific numerical results and thresholds are not disclosed in this summary document.

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

The document does not specify the sample sizes (number of devices or test articles) used for the ASTM F2009 or fatigue testing.
For data provenance, it's non-clinical (laboratory) testing of the physical device components, not patient data.

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

Not applicable. This is for a mechanical device; "ground truth" in the context of human interpretation or clinical outcomes is not relevant here. The ground truth for mechanical testing is established by the specified ASTM standard and general engineering principles for mechanical integrity.

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

Not applicable. This refers to consensus among human readers for image interpretation or diagnosis, which is not relevant for mechanical testing.

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/ML powered device.

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

Not applicable. This is not an AI/ML powered device.

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

For this mechanical device, the "ground truth" for performance is based on established engineering standards and specifications. The document mentions:

ASTM F2009 Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses: This standard defines how to conduct the test and likely sets performance benchmarks or provides a methodology for comparison.
Fatigue testing: This evaluates the device's ability to withstand repeated stress cycles, with acceptance criteria typically based on material properties, design life, and industry standards for implant durability.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device, so there is no "training set."

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

Not applicable. As above, there is no training set for a mechanical device.

Summary of Device Performance Study (Non-Clinical):

The document indicates that Shoulder Innovations Inc. performed non-clinical testing to demonstrate the substantial equivalence of their Humeral Short Stem System to a predicate device (Biomet Comprehensive® Primary Shoulder Stems, K060692).

Key Tests Conducted:

Axial Disassembly Force of Taper Connections: Tested per ASTM F2009. This standard evaluates the strength of the connection between modular components, ensuring they do not inadvertently separate during use. The implicit "acceptance criteria" here would be meeting or exceeding the performance of the predicate device, or a specified minimum force, as per the standard's requirements for secure modular junctions.
Fatigue Testing: Performed on the humeral components. This test assesses the device's durability under cyclic loading, simulating the stresses it would experience in the body over time. The "acceptance criteria" for fatigue testing would typically involve demonstrating that the device can withstand a specified number of cycles at a certain load without failure, often compared to the predicate device's known performance or established industry benchmarks for implant longevity.

The document states that "Clinical testing was not necessary to demonstrate substantial equivalence," relying entirely on the non-clinical tests and a detailed predicate device comparison (pages 4-5) across various features (distal stem diameters, lengths, geometry, collar, modular system, bone integration, neck angle, fixation, material, sterility for both stem and head components). This comparative analysis serves as a form of "proof" that the device meets implied acceptance criteria by being "substantially equivalent" to a legally marketed predicate device.

Summary

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Shoulder Innovations Inc Don Running VP R&D 13827 Port Sheldon Street Holland, Michigan 49424

October 23, 2018

Re: K173824

Trade/Device Name: Humeral Short Stem System Regulation Number: 21 CFR 888.3670 Regulation Name: Shoulder joint metal/polymer/metal nonconstrained or semi-constrained porouscoated uncemented prosthesis Regulatory Class: Class II Product Code: MBF, KWT, KWS, HSD Dated: September 12, 2018 Received: September 14, 2018

Dear Don Running:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Daniel S. Ramsey -S 2018.10.23 16:48:03 -04'00'

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

Enclosure

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Indications for Use

510(k) Number (if known) K173824

Device Name Humeral Short Stem System

Indications for Use (Describe)

The Shoulder Innovations Total Shoulder System is intended for use as an orthopedic implant for partial or total shoulder arthroplasty to treat the following:

significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint;
avascular necrosis of the humeral head.

The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component for total shoulder arthroplasty.

The Total Shoulder System components are intended for single use only. The glenoid component is intended for cemented fixation only; the humeral stem may be implanted by press-fit or cement fixation.

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary Pursuant to 21 CFR 807.92c

Date Prepared:	September 12, 2018
Submitted By:	Shoulder Innovations, LLC13827 Port Sheldon St.Holland, MI 49424
Contact:	Don RunningVP-R&D574-253-1133don@genesisinnovationgroup.com
Proprietary Name:	Humeral Short Stem System
Common Name:	Shoulder Prosthesis
Classification:	21 CFR Section 888.3670 – Shoulder joint metal/polymer/metal nonconstrained or semi-constrainedporous-coated uncemented prosthesisProduct Code: MBF21 CFR Section 888.3650 – Shoulder jointmetal/polymer non-constrained cementedprosthesis.Product Code: KWT21 CFR Section 888.3660 – Shoulder jointmetal/polymer semi-constrained cementedprosthesis.Product Code: KWS21 CFR Section 888.3690 – Shoulder joint humeral(hemi-shoulder) metallic uncemented prosthesis.Product Code: HSD
SubstantiallyEquivalent Device:	K060692, Biomet Comprehensive® Primary ShoulderStems

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Device Description:

The humeral heads are manufactured from CoCr and are available in standard and offset configurations. The heads have a male Morse-type taper to interface with the humeral stems.

Intended Use / Indications:

The Shoulder Innovations Total Shoulder System is intended for use as an orthopedic implant for partial or total shoulder arthroplasty to treat the following:

1. significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint;
1. avascular necrosis of the humeral head.

The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component for total shoulder arthroplasty.

The Total Shoulder System components are intended for single use only. The glenoid component is intended for cemented fixation only; the humeral stem may be implanted by press-fit or cement fixation.

Predicate Device Comparison:

Humeral Stem Component

Feature	BiometComprehensivePrimary ShoulderStems (K060692)	Proposed DeviceShoulderInnovationsHumeral ShortStem System	SE?
Distal StemDiameters	5.75 mm(Labeled 4mm)	5.75 mm	Yes
StemLengths	72 mm	70 mm	Yes
Stem Geometry	Tapered circular	Tapered circular	Yes
Collar	Collarless	Collarless	Yes

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Feature	BiometComprehensivePrimary ShoulderStems (K060692)	Proposed DeviceShoulderInnovationsHumeral ShortStem System	SE?
Modular system	Female Morse-typetaper	Female Morse-typetaper	Yes
Bone Integration	Porous Coating	Porous Coating	Yes
Neck Angle	135°	132.5°	Yes
Fixation	Press-fit orCemented	Press-fit orCemented	Yes
Material	Titanium Alloy	Titanium Alloy	Yes
Sterility	Gamma Irradiated	Gamma Irradiated	Yes

Humeral Head Component

Feature	BiometComprehensivePrimary ShoulderStems (K060692)	Proposed DeviceShoulderInnovationsHumeralShort StemSystem	SE?
HeadDiameters	38, 42, 46, 50, 54, 58mm	40mm, 44mm, 48mm, 52mm, and 56mm	Yes
Head Heights	18mm - 27mm	15mm - 24mm	Yes
Configurations	Standard and Offset	Standard and Offset	Yes
Geometry	Solid semi-sphere	Solid semi-sphere	Yes
Modular system	Male Morse-typetaper	Male Morse-typetaper	Yes
Material	CoCr	CoCr	Yes
Sterility	Gamma Irradiated	Gamma Irradiated	Yes

Non-Clinical Testing:

Performance testing was performed on the Shoulder Innovations Humeral Stem System. The modular humeral components were tested per ASTM F2009 Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses. Fatigue testing was also performed on the humeral components.

Clinical Testing:

Clinical testing was not necessary to demonstrate substantial equivalence of the Shoulder Innovations Humeral Short Stem System to the predicate device.

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Summary of Substantial Equivalence:

The results of non-clinical testing and comparative analysis demonstrate that the design, function, intended use, and indications for use of the Shoulder Innovations Humeral Short Stem System is substantially equivalent to the predicate device.

Regulation Number and Section

§ 888.3670 Shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis.

(a)
Identification. A shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits movement in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral component made of alloys such as cobalt-chromium-molybdenum (Co-Cr-Mo) and titanium-aluminum-vanadium (Ti-6Al-4V) alloys, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, or a combination of an articulating ultra-high molecular weight bearing surface fixed in a metal shell made of alloys such as Co-Cr-Mo and Ti-6Al-4V. The humeral component and glenoid backing have a porous coating made of, in the case of Co-Cr-Mo components, beads of the same alloy or commercially pure titanium powder, and in the case of Ti-6Al-4V components, beads or fibers of commercially pure titanium or Ti-6Al-4V alloy, or commercially pure titanium powder. 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. This generic type of device is designed to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance: Shoulder Joint Metal/Polymer/Metal Nonconstrained or Semi-Constrained Porous-Coated Uncemented Prosthesis.”