FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The Univers Revers Shoulder Prosthesis is indicated for use in a grossly rotator cuff deficient glenohumeral joint with severe arthropathy or a previous failed joint replacement with gross rotator cuff deficiency. The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.

The glenoid baseplate is CaP coated and is intended for cementless use with the addition of screws for fixation.

The uncoated cup and stem are intended for cemented use, all other components are for cementless use only.

Device Description

The Arthrex Univers Revers Shoulder Prosthesis System has an articular design that is inverted compared to traditional total shoulder prosthesis. The system is comprised of two main components; the Arthrex Univers Revers Shoulder Prosthesis and the Universal Glenoid Shoulder Prosthesis. The Arthrex Univers Revers Shoulder Prosthesis is a titanium humeral stem and epiphysis or humeral cup, a titanium spacer, and an UHMWPE humeral cup liner. The humeral stem and epiphysis are available uncoated or with CaP coating. The Universal Glenoid Shoulder Prosthesis consists of a TPS/CaP coated titanium glenoid baseplate, a cobalt chrome glenosphere, and titanium screws.

AI/ML Overview

The provided document is a 510(k) summary for the Arthrex Univers Revers Shoulder Prosthesis System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through clinical studies in the same way a novel AI algorithm might. Therefore, many of the requested details about acceptance criteria, specific study design for device performance, ground truth establishment, expert involvement, and reader studies (MRMC, standalone AI) are not applicable to a 510(k) for a medical device like a shoulder prosthesis.

The core of a 510(k) submission is to show that the new device is as safe and effective as a predicate device and does not raise new questions of safety or effectiveness. This is typically done through a comparison of technological characteristics, materials, design, and often, mechanical testing.

Here's the information that can be extracted or deduced from the document, organized according to your request, with explanations for why certain aspects are not present in this context:

Acceptance Criteria and Device Performance for Arthrex Univers Revers Shoulder Prosthesis System (K130129)

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Demonstrated Equivalence)	Reported Device Performance (Summary of Equivalence)
Intended Use Equivalence: The device must have the same or substantially similar intended use as the predicate devices.	The Univers Revers Shoulder Prosthesis System is indicated for use in a grossly rotator cuff deficient glenohumeral joint with severe arthropathy or a previous failed joint replacement with gross rotator cuff deficiency, requiring the patient's joint to be anatomically and structurally suited and a functional deltoid muscle. This intended use is stated to be substantially equivalent to the predicate devices.
Technological Characteristics Equivalence: The device's design, size ranges, materials, and components must be substantially equivalent to the predicate devices. Differences must not raise new questions of safety or effectiveness.	The device is comprised of a titanium humeral stem and epiphysis/humeral cup, a titanium spacer, and a UHMWPE humeral cup liner. The humeral stem and epiphysis are available uncoated or with CaP coating. The Universal Glenoid Shoulder Prosthesis consists of a TPS/CaP coated titanium glenoid baseplate, a cobalt chrome glenosphere, and titanium screws.
These characteristics are compared to predicate devices (K053274: Zimmer Anatomical Shoulder System; K100142: Torneir Aequalis Revers Shoulder Prosthesis) and deemed "substantially equivalent ... in regards to its intended use, design, size ranges, and materials." Differences are considered minor and do not raise questions concerning safety and effectiveness.
Biocompatibility Equivalence: Materials used must be biocompatible (implicitly, materials similar to predicate devices are accepted).	The materials (Titanium, UHMWPE, Cobalt Chrome) are standard for such devices and implicitly accepted as biocompatible given their use in predicate devices.
Mechanical Performance Equivalence: The device's mechanical strength (e.g., fatigue strength) must be substantially equivalent to the predicate devices. This is typically demonstrated through mechanical testing. Implicit acceptance criteria: Meet or exceed the mechanical performance characteristics of the predicate device for relevant load cases.	"The submitted mechanical testing data demonstrated that the fatigue strength of the proposed devices is substantially equivalent to the fatigue strength of the predicate devices. The mechanical data indicate that the Univers Revers Shoulder Prosthesis System is adequate for their intended use." (Specific quantitative performance metrics or thresholds are not provided in this summary but would be in the full submission).
Sterilization Equivalence: The device must be able to be sterilized effectively (implicitly, methods and validation similar to predicate devices are accepted).	(Not explicitly detailed in the provided summary, but implied that sterilization methods are equivalent or validated according to standards).

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not applicable in the context of a 510(k) submission for a shoulder prosthesis. The "test set" here refers to the mechanical tests conducted on the device itself, not clinical data from patients. The number of samples for mechanical testing would be based on engineering standards and statistical requirements for device strength and durability specific to the tests performed (e.g., fatigue, static strength testing), but these numbers are not given in this summary.
Data Provenance: Not applicable in the context of clinical data. For mechanical testing, the data originates from laboratory testing of the manufactured device components.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. "Ground truth" in this context would refer to the true state of a patient, which is not evaluated in a 510(k) for a medical implant like this. The "truth" for mechanical testing is derived from controlled laboratory environments. The experts involved would be engineers and material scientists conducting the tests, but their specific numbers and qualifications are not part of this summary.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1 for clinical interpretations) are not relevant for mechanical testing of a medical implant.

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 a medical device (shoulder prosthesis), not an AI diagnostic or interpretive tool. Therefore, MRMC studies and AI-driven performance improvements are irrelevant.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

For Mechanical Performance: The "ground truth" is established through objective engineering measurements and standards for material properties, fatigue life, and static strength of the device components. This involves direct physical testing of the device under simulated physiological conditions.
For Substantial Equivalence: The "ground truth" is a comparison against the characteristics and performance of the predicate devices, which have already been deemed safe and effective by the FDA.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not a machine learning algorithm. There is no concept of a "training set" in this context.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" for this type of device submission.

Summary of 510(k) Approach:

The key to this 510(k) submission is establishing "Substantial Equivalence" to predicate devices (K053274: Zimmer Anatomical Shoulder System; K100142: Torneir Aequalis Revers Shoulder Prosthesis). The manufacturer (Arthrex) demonstrated this through:

Comparison of Intended Use.
Comparison of Technological Characteristics (design, size ranges, materials, components).
Submitted mechanical testing data to show equivalent fatigue strength, ensuring the device is adequate for its intended use.

The document explicitly states: "Clinical data and conclusions are not needed for this device." This confirms that no clinical patient studies involving "test sets," "ground truth" derived from patient outcomes, or expert adjudication of clinical data were part of this submission for market clearance.

Summary

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.”