The Catalyst EA Convertible Stemmed Shoulder is intended for use as a replacement of shoulder joints in anatomic or reverse arthroplasty. Should the need arise for a conversion from an anatomic total shoulder to a reverse total shoulder, the humeral stem can remain in place, while the articulating surfaces are exchanged.

Device Description

The Catalyst EA Convertible Stemmed Shoulder is an anatomic designed total shoulder prosthesis that mates with the Catalyst R1 humeral stems cleared in K202611. This submission adds conversion adapters, locking screw and humeral heads to mate with the previously cleared Catalyst R1 humeral stems. The humeral head components are compatible with previously cleared CSR 3 Peg glenoid components or for articulation with the glenoid cavity of the scapula. When the humeral stem (cleared K202611), adapter and humeral head are mated together, this creates a hemiarthroplasty (product code HSD). When the humeral stem, adapter and humeral head are used in conjunction with the CSR glenoid components (cleared K191811 and K173812), this creates a total shoulder arthroplasty (product code KWS). The adapters and locking screw are manufactured from Ti-6A1-4V ELI conforming to ASTM F136. The humeral components are manufactured from Co-Cr-Mo alloy conforming to ASTM F1537.

AI/ML Overview

The provided document describes a 510(k) premarket notification for the "Catalyst EA Convertible Stemmed Shoulder" device. This is a submission to the FDA to demonstrate substantial equivalence to previously marketed devices, not a study proving the device meets explicit acceptance criteria in the context of a clinical trial or AI performance.

Therefore, many of the requested categories in your prompt are not applicable to this type of regulatory document. Specifically, there is no mention of acceptance criteria related to AI performance, sample sizes for test/training sets, ground truth establishment, expert adjudication, or MRMC studies.

However, I can extract the information that is relevant to the non-clinical testing performed for this device.

Acceptance Criteria and Device Performance (Non-Clinical)

Acceptance Criteria Category	Reported Device Performance
Construct Fatigue Testing	"met the pre-determined acceptance criterion"
Axial Disassembly Tests (pre-fatigue)	Performed; results implicitly met standards enabling substantial equivalence
Axial Disassembly Tests (post-fatigue)	Performed; results implicitly met standards enabling substantial equivalence
Range of Motion Analyses	Performed; results implicitly met standards enabling substantial equivalence
Biocompatibility Assessment	Performed; results implicitly met standards enabling substantial equivalence
Overall Equivalence to Predicate	"All testing has determined that the device is substantially equivalent to the predicate device."

Study Details (Non-Clinical)

Your prompt asks for specific details related to AI/clinical studies that are not present in this 510(k) summary. Here's a breakdown of why and what information is available:

Sample size used for the test set and the data provenance: Not applicable. This document refers to non-clinical bench testing of a medical implant, not AI or clinical data. The "test set" would refer to the physical prototypes or samples used for mechanical testing. The specific number of samples for each test (e.g., how many constructs for fatigue testing) is not detailed in this summary.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for AI or diagnostic studies is not relevant here. The "ground truth" for mechanical testing is established by engineering standards and specifications.
Adjudication method for the test set: Not applicable. There is no expert review or adjudication process described for the lab-based mechanical tests.
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. The document explicitly states: "Clinical testing was not necessary to demonstrate substantial equivalence of the Catalyst EA Convertible Stemmed Shoulder to the predicate devices." This is a mechanical implant, not a diagnostic AI device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No. This is not an algorithm or AI device.
The type of ground truth used: For the non-clinical testing, the "ground truth" would be established by engineering specifications, material standards (e.g., ASTM F136, ASTM F1537), and predetermined acceptance criteria for mechanical performance (e.g., fatigue life, disassembly forces).
The sample size for the training set: Not applicable. No AI training was performed.
How the ground truth for the training set was established: Not applicable. No AI training was performed.

Context from the Document:

The document clearly states:

"Non-Clinical Testing: Range of motions analyses, biocompatibility assessment and construct fatigue testing were all conducted. Axial disassembly tests were performed pre-fatigue and post-fatigue testing. The construct fatigue testing demonstrated that the construct of the Catalyst EA Convertible Stemmed Shoulder humeral heads with conversion adapter, met the pre-determined acceptance criterion. All testing has determined that the device is substantially equivalent to the predicate device."

And:

"Clinical Testing: Clinical testing was not necessary to demonstrate substantial equivalence of the Catalyst EA Convertible Stemmed Shoulder to the predicate devices."

This indicates that the FDA cleared this device based solely on non-clinical (i.e., lab/mechanical) testing and comparison to predicate devices, and not on AI performance, clinical trials, or human diagnostic studies.

Summary

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November 10, 2022

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the image, there is the Department of Health & Human Services logo. To the right of that, there is a blue square with the letters "FDA" in white. To the right of the blue square, there is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Catalyst OrthoScience, Inc. Dale Davison Senior VP - Product Development 14710 Tamiami Trail North Naples, Florida 34110

Re: K222317

Trade/Device Name: Catalyst EA Convertible Stemmed Shoulder Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWS, HSD, PHX Dated: September 23, 2022 Received: September 23, 2022

Dear Dale Davison:

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.

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

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Digitally signed by Farzana Farzana Sharmin -S Sharmin -S Date: 2022.11.10

For Victoria Lilling, M.D. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K222317

Device Name

Catalyst EA Convertible Stemmed Shoulder

Indications for Use (Describe)

The Catalyst EA Convertible Stemmed Shoulder is intended for use as a replacement of shoulder joints in anatomic or reverse arthroplasty. Should the need arise for a conversion from an anatomic total shoulder, the humeral stem can remain in place, while the articulating surfaces are exchanged.

Anatomic Total Shoulder or Hemi-Shoulder

The Catalyst EA Convertible Stemmed Shoulder is indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint where hemi- or total shoulder arthroplasty is determined by the surgeon to be the preferred method of treatment. The Catalyst EA Convertible Stemmed for use in patients with the following conditions where the humeral head, neck and glenoid vault are of sufficient bone stock and the rotator cuff is intact or reconstructable.

· Osteoarthritis
· Avascular Necrosis
· Rheumatoid Arthritis
· Post-traumatic Arthritis
· Correction of functional deformity

The Catalyst 3-Peg glenoid implants are intended for cemented use only.

The Catalyst R1 Reverse Shoulder humeral stems are intended for cemented or uncemented applications.

Reverse Total Shoulder

The Catalyst EA Convertible Stemmed Shoulder replacement for patients with a functional deltoid muscle and a grossly deficient rotator cuff joint suffering from pain and dysfunction due to:

· Severe arthropathy with a grossly deficient rotator cuff;

· Previously failed joint replacement with a grossly deficient rotator cuff;
Fracture of glenohumeral joint from trauma or pathologic conditions of the shoulder including humeral head fracture,

displaced 3- or 4-part fractures of proximal humerus, or reconstruction after tumor resection;

· Bone defect in proximal humerus;
• Non-inflammatory degenerative disease including osteoarthritis and avascular necrosis of the natural head and/or glenoid;
· Inflammatory arthritis including rheumatoid arthritis;
· Correction of functional deformity

The Catalyst R1 Shoulder humeral stems are intended for uncemented applications.

The glenoid baseplate is intended for uncemented use with the addition of screws for 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) Summary
Prepared Date:	November 10, 2022
Submitter:	Catalyst OrthoScience, Inc.14710 Tamiami Trail North, Suite 102Naples, FL 34110
Contact:	Dale DavisonSr. VP of Manufacturing & Product Development1-239-325-9976 ext. 102ddavison@catalystortho.com
Proprietary Name:	Catalyst EA Convertible Stemmed Shoulder
Common Name:	Shoulder Prosthesis
Classification Name:	21 CFR 888.3660: Shoulder joint metal/polymer semi-constrainedcemented prosthesis; Class II21 CFR 888.3690: Shoulder joint humeral (hemi-shoulder)metallic uncemented prosthesis; Class II
Product Code:	KWS, HSD, PHX
Primary Predicate:	Encore Medical (DJO) AltiVate Shoulder System K172351
Secondary Predicate:	Catalyst CSR Shoulder System, K182500

Device Description:

The Catalyst EA Convertible Stemmed Shoulder is an anatomic designed total shoulder prosthesis that mates with the Catalyst R1 humeral stems cleared in K202611.

This submission adds conversion adapters, locking screw and humeral heads to mate with the previously cleared Catalyst R1 humeral stems. The humeral head components are compatible with previously cleared CSR 3 Peg glenoid components or for articulation with the glenoid cavity of the scapula. When the humeral stem (cleared K202611), adapter and humeral head are mated together, this creates a hemiarthroplasty (product code HSD). When the humeral stem, adapter and humeral head are used in conjunction with the CSR glenoid components (cleared K191811 and K173812), this creates a total shoulder arthroplasty (product code KWS). The adapters and locking screw are manufactured from Ti-6A1-4V ELI conforming to ASTM F136. The humeral components are manufactured from Co-Cr-Mo alloy conforming to ASTM F1537.

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The Anatomic system consists of a humeral stem, adapter, locking screw and articulating head. The adapters are secured to the stem using a locking screw. The articulating humeral heads are secured to the adapter by a taper lock. The articulating head components have a polished surface for articulation with the compatible Catalyst 3-Peg Glenoid component or the glenoid cavity of the scapula.

The Reverse system consists of a humeral stem, articulating insert, central baseplate, fixation elements and locking components. The central baseplate is a circular disc that rests against the glenoid bone and is secured to the bone using up to four 4.5mm peripheral screws and either a central 6.5mm screw or post. The glenosphere is secured to the central baseplate by a taper lock, with the additional fixation of a locking or compression screw.

Intended Use / Indications:

Anatomic Total Shoulder or Hemi-Shoulder

The Catalyst EA Convertible Stemmed Shoulder is indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint where hemi- or total shoulder arthroplasty is determined by the surgeon to be the preferred method of treatment. The Catalyst EA Shoulder System is intended for use in patients with the following conditions where the humeral head, neck and glenoid vault are of sufficient bone stock and the rotator cuff is intact or reconstructable.

Osteoarthritis
Avascular Necrosis ●
Rheumatoid Arthritis
Post-traumatic Arthritis
Correction of functional deformity ●

The Catalyst 3-Peg glenoid implants are intended for cemented use only.

The Catalyst R1 Shoulder humeral stems are intended for uncemented applications.

Reverse Total Shoulder

The Catalyst EA Convertible Stemmed Shoulder is a reverse total shoulder replacement for patients with a functional deltoid muscle and a grossly deficient rotator cuff joint suffering from pain and dysfunction due to:

Severe arthropathy with a grossly deficient rotator cuff; ●
Previously failed joint replacement with a grossly deficient rotator cuff; ●
o Fracture of glenohumeral joint from trauma or pathologic conditions of the shoulder including humeral head fracture, displaced 3- or 4-part fractures of proximal humerus, or reconstruction after tumor resection:
Bone defect in proximal humerus;
Non-inflammatory degenerative disease including osteoarthritis and avascular necrosis of o the natural humeral head and/or glenoid;
Inflammatory arthritis including rheumatoid arthritis; ●
Correction of functional deformity

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The Catalyst R1 Shoulder humeral stems are intended for uncemented applications. The glenoid baseplate is intended for uncemented use with the addition of screws for fixation.

Comparison of Technologies/Substantial Equivalence:

The Catalyst EA Convertible Stemmed Shoulder is substantially equivalent to the predicate devices in regard to intended use and indications, materials, size ranges, and design intent. Any noted differences do not raise new types of safety and effectiveness questions, nor are there new technological issues.

Non-Clinical Testing:

Range of motions analyses, biocompatibility assessment and construct fatigue testing were all conducted. Axial disassembly tests were performed pre-fatigue and post-fatigue testing. The construct fatigue testing demonstrated that the construct of the Catalyst EA Convertible Stemmed Shoulder humeral heads with conversion adapter, met the pre-determined acceptance criterion. All testing has determined that the device is substantially equivalent to the predicate device.

Clinical Testing:

Clinical testing was not necessary to demonstrate substantial equivalence of the Catalyst EA Convertible Stemmed Shoulder to the predicate devices.

Conclusions:

The conclusions drawn from the nonclinical and clinical tests demonstrate that the device is substantially equivalent to the legally marketed device predicate. The intended use, indications, materials, size ranges and design intent are all equivalent and any noted differences do not raise different questions of safety and effectiveness.

Regulation Number and Section

§ 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder 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 includes prostheses that have a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” and
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,”
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-aluminum 4-vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-chromium-molybdenum casting alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-chromium-molybdenum alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” and
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(v) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal,”
(vii) F 1378-97 “Standard Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”