(97 days)
IN ANATOMIC:
The proximal body, stem, assembly screw, locking cap, optional spacer(s), and humeral head may be used together, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement.
The Tornier HRS Shoulder System 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 Tornier HRS Shoulder System 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 Shoulder System 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 the devices if sufficient bone stock remains
The reversed tray and polyethylene insert are indicated for use 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 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 system intended for total or partial replacement of the glenohumeral articulation. Tornier HRS includes a proximal body (metaphysis), a stem, assembly screw, and locking cap. The proximal body has a female taper that is compatible with Tornier Flex (formerly branded Ascend Flex) Humeral Heads and Tornier Flex (formerly branded Ascend Flex) reversed trays and poly inserts.
Tornier HRS is implanted by a surgeon and is designed to select the components to size the shoulder system for the patient. It allows the shoulder to be constructed in an anatomical or reversed configuration using cleared Tornier Flex (formerly branded Ascend Flex) Humeral Heads and Tornier Flex (formerly branded Ascend Flex) reversed trays and inserts. In addition, Tornier HRS can be transformed from anatomic to reverse shoulder prosthesis without the humeral implant assembly during revision surgery.
The humeral length is measured to determine the overall humeral implant construct length is assembled from 120 mm (using the short proximal body and stem) to 300 mm (using the standard proximal body, spacers, and stem) in 10 mm increments with the spacers as needed and either of the two available lengths of the proximal body for patient specificity.
The proximal body, stem, and spacers are made from Ti6A4V per ASTM F-136. The proximal body and stem have a Titanium plasma spray coating. The assembly screw and locking cap are made of CoCr per ISO 5832-12. All implant parts are single use and packaged sterile, using gamma radiation at a minimum dose of 25 kGy to an SAL of 1x10-6.
The provided text is a 510(k) Premarket Notification from the FDA for a medical device called the "Tornier Humeral Reconstruction System (Tornier HRS)." This document primarily focuses on demonstrating substantial equivalence to already legally marketed predicate devices, rather than presenting a study to prove the device meets specific acceptance criteria for a novel AI or diagnostic system.
The "study" described is a non-clinical testing in a Magnetic Resonance (MR) Environment to characterize the compatibility of the Tornier HRS. This is a safety assessment for an implantable device, not a performance study for, for example, a diagnostic AI.
Therefore, many of the requested elements (acceptance criteria for device performance, sample sizes for test/training sets, expert ground truth, MRMC studies, standalone AI performance, etc.) are not applicable in the context of this specific regulatory document.
However, I can extract the relevant information regarding the non-clinical testing performed:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implicit for MR compatibility) | Reported Device Performance |
|---|---|
| Compatibility in Magnetic Resonance (MR) Environment | The Tornier HRS system has been evaluated through non-clinical testing as outlined in the FDA guidance document "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment – Guidance for Industry and FDA Staff." This testing was conducted to characterize the compatibility of Tornier HRS in the MR environment. |
Note: The document states "The Tornier HRS system does not raise different questions of safety or effectiveness," which implies the device met the safety requirements for MR compatibility.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified (refers to the devices evaluated in MR environment, not typically "sample size" in the context of clinical or AI studies).
- Data Provenance: Not applicable in the traditional sense; this is non-clinical lab testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The "ground truth" here is the physical interaction of the device with an MR field, evaluated against established safety standards.
4. Adjudication method for the test set:
- Not applicable. This was based on non-clinical testing against FDA guidance.
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, an MRMC comparative effectiveness study was not done. This device is not an AI diagnostic tool that human readers would use.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not a software algorithm or AI device.
7. The type of ground truth used:
- The ground truth for this non-clinical testing is compliance with established safety standards and guidance for medical devices in an MR environment (as outlined in "FDA guidance document 'Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment – Guidance for Industry and FDA Staff'").
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable.
In summary: The provided document is for a traditional medical implantable device, not an AI or diagnostic system. The "study" mentioned is non-clinical testing for MR compatibility to ensure safety, not a performance study in the context of AI or diagnostic accuracy.
§ 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.”