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

IN ANATOMIC:
The Tornier HRS is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility and stability and to relieve pain. The Tomier HRS is indicated for use as a replacement of shoulder joints disabled by:

· Rheumatoid arthritis with pain
· Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
· Correction of functional deformity
· Fractures of the humeral head
· Traumatic arthritis
· Revision of other devices if sufficient bone stock remains

IN REVERSE:
The Tornier HRS is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle with pain disabled by:

· Rheumatoid arthritis
· Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
· Correction of functional deformity
· Fractures of the humeral head
· Traumatic arthritis
· Massive and non-repairable rotator cuff tear
· Revision of other devices if sufficient bone stock remains

The reversed tray and polyethyiene inset are in the conversion from an anatomic to reversed shoulder arthroplasty without the removal of the humeral assembly during revision surgery for patients with a functional deltoid muscle.

Notes:

· All components are single use.
· The coated humeral stem is intended for cemented or cementless use.
· The all-poly glenoid components are intended for cemented use only
· The glenoid sphere implant is anchored to the bone with screws and is for non-cemented fixation.
· Titanium humeral heads are intended for patients with suspected cobalt alloy material sensitivity.
The wear properties of Titanium and Titanium alloys are inferior to that of cobalt alloy. A Titanium humeral head is not recommended for patients who lack a suspected material sensitivity to cobalt alloy.

Tornier Perform Humeral System - Stem (Tornier PHS-Stem)

In Anatomic:
The humeral stem, humeral head coupler and humeral head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with a glenoid implant, as a total replacement.

The PERFORM™ Humeral System – Stem is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility, and to relieve pain. The PERFORM Humeral System - Stem is indicated for use as a replacement of shoulder joints disabled by:
· Non-inflammatory degenerative joint disease (i.e. osteoarthritis) and avascular necrosis

· Proximal humeral malunions
· Post-traumatic arthritis
· Revisions or fractures of the humeral head where adequate fixation can be achieved and adequate bone stock remains

Titanium humeral heads are intents with suspected cobalt alloy material sensitivity. The wear properties of titanium and titanium alloys are inferior to that of cobalt alloy. A titanium humeral head is recommended for patients with a suspected material sensitivity to cobalt alloy.

All components are single use. The humeral stems are intended for cementless use.

The PERFORM Humeral System – Stem is intended to be used with cemented components, in a total shoulder arthroplasty.

In Reverse:
The PERFORM™ Humeral System – Stem is indicated for use as a replacement of a shoulder joint for patients with a functional deltoid muscle, grossly deficient rotator cuff, and pain disabled by one or more of the following:
· Non-inflammatory degenerative joint disease (i.e. osteoarthritis) and avascular necrosis

· Pseudoparalysis or anterior superior escape
· Rotator cuff tear arthropathy
· Proximal humeral malunions
· Post-traumatic arthritis
· Revisions or fractures of the humere adequate fixation can be achieved and adequate bone stock remains

The reversed insert is indicated for use for the conversion from an anatomic to reverse shoulder prosthesis without the removal of a well fixed humeral stem for patients with a functional deltoid muscle.

All components are single use. The humeral stems are intended for cementless use. The PERFORM Humeral System – Stem is intended to be used with glenoid implants that are anchored to the bone with screws for non-cemented fixation.

Device Description

Tornier HRS (formerly branded Aequalis Flex Revive Shoulder System) is a fully convertible anatomic and reversed shoulder arthroplasty system that is designed to be used with existing Tornier implant systems. It is a non-constrained system intended for total or partial replacement of the glenohumeral articulation.

The Tornier Humeral Reconstruction System (Tornier HRS) is a line existing Aequalis™ Flex Revive™ Shoulder System (AFR) (K191318, cleared June 14, 2019) that builds upon the AFR system with additional sized distal stems, proximal bodies, and reversed insert trays, new monoblock stems, humeral head couplers and MR Conditional labeling for Tornier HRS line extension components.

The Tornier Perform Humeral System (Tornier PHS-Stem) (K2013 15) is also being expanded to include additional sized Vitamin E UHMWPE reversed inserts and a renaming of these inserts for clarity.

AI/ML Overview

This is a 510(k) Premarket Notification from the FDA for a medical device called the Tornier Humeral Reconstruction System (Tornier HRS) and the Tornier Perform Humeral System - Stem (Tornier PHS-Stem). This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing new acceptance criteria and proving performance against them through a clinical study.

Therefore, the sections of your request regarding acceptance criteria, study details, expert consensus, and effects size are not applicable (N/A) in this context. The primary evidence presented here is non-clinical testing to show that the modified device and its extensions are as safe and effective as the predicate devices.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (N/A - Not a de novo device, relies on substantial equivalence)	Reported Device Performance (Non-Clinical Testing)
N/A	Demonstrated substantial equivalence to predicate devices.
N/A	Passed Fatigue testing with corrosion evaluation.
N/A	Passed Locking mechanism fatigue testing.
N/A	Passed Pull-out and torque-out testing.
N/A	Passed Wear and range of motion testing.
N/A	Passed Material characterization testing.
N/A	Passed Biocompatibility evaluation.
N/A	Passed Packaging and shelf-life evaluations.
N/A	Passed Distribution testing.
N/A	Passed Sterilization evaluation.
N/A	Passed Endotoxin testing.
N/A	Passed MRI compatibility evaluation.
N/A	Passed System Compatibility Testing.

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

Test Set Sample Size: Not applicable. The document refers to "non-clinical testing," which typically involves bench testing of components and assemblies, not human subjects.
Data Provenance: Not applicable. The testing is described as non-clinical performance testing, likely conducted in a laboratory setting by the manufacturer.

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

Number of Experts: Not applicable. This type of non-clinical testing does not involve establishing ground truth from expert consensus in the way a diagnostic AI would. The "ground truth" is determined by established engineering and material science standards and test methods.
Qualifications of Experts: N/A.

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

Adjudication Method: Not applicable. Adjudication methods like 2+1 or 3+1 are used for human expert review in clinical studies or for establishing ground truth in diagnostic performance evaluations, which is not what occurred here.

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:

MRMC Study: No. The document explicitly states: "No clinical studies were performed."
Effect Size: Not applicable.

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

Standalone Performance: Not applicable. This is a physical orthopedic implant system, not a software algorithm or AI device.

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

Type of Ground Truth: Not applicable. For non-clinical performance testing of medical devices, "ground truth" in the diagnostic sense is not typically generated. Instead, performance is measured against established engineering specifications, material properties, and mechanical limits as defined by relevant standards (e.g., ISO, ASTM).

8. The sample size for the training set:

Training Set Sample Size: Not applicable. This is not a machine learning or AI device that requires a training set.

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

Ground Truth for Training Set: Not applicable. This is not a machine learning or AI device.

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.”