(28 days)
The Affiniti Total and Hemi-Shoulder System are indicated for:
- A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis;
- Fracture/dislocations of the proximal humerus; where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory;
- Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g., revision of a failed primary component).
The Affiniti Hemi-Shoulder System is also indicated for:
- Ununited humeral head fractures.
- Avascular necrosis of the humeral head.
- Rotator cuff tear arthropathy.
Notes:
Glenoid components are labeled "for cemented use only" and are indicated only for use with bone cement.
Humeral stems are indicated for press-fit un-cemented use or for use with bone cement.
This is a single use device.
The sterile Affiniti Total and Hemi-Shoulder System is comprised of a :
Humeral stem, .
Humeral heads in two styles (standard and eccentric) .
Glenoids in two styles (pegged or keeled). .
The humeral heads mate on the stems through a locking taper. The humeral heads are highly polished and articulate with the glenoids.
The humeral stems are offered in two versions Non-coated humeral stems and Porous coated humeral stems :
Non-Porous coated humeral stems and Porous coated humeral stems are offered . . I in two lengths:
o Standard
o long
The humeral heads are available in:
15 standard sizes .
. 10 eccentric sizes
8 extended head sizes (Product line addition to K060988 via K073331) .
The Glenoid is available in multiple sizes in 2 different configurations(pegged or keeled).
This submission corresponds to a change made to the Affiniti Total and Hemi-. Shoulder System (previously cleared in 510(k) K060988), The change correspond to the addition of a porous coated to Humeral stems of the Affiniti Shoulder System.
The provided document describes a 510(k) premarket notification for a medical device, the Tornier Inc. Affiniti Total and Hemi-Shoulder System. This is a submission for a modification to an already cleared device, specifically the addition of a porous coating to humeral stems. The "study" conducted for this submission is focused on demonstrating substantial equivalence to the predicate device by verifying and validating the changes through a series of bench tests.
Here's an analysis of the requested information based on the provided text:
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance (Implicitly Met) |
|---|---|---|
| Bench Tests: | Performance equivalent to or better than the predicate device without introducing new or higher risks. | "The results of those evaluations allow us to conclude that the proposed Tornier Inc. Affiniti Total and Hemi-Shoulder described in this submission does not induce any new or higher risk compared to the predicate device and therefore both device (proposed and predicate) are substantially equivalent." |
| - Fatigue testing | Performance equivalent to the predicate device. | (Details not provided, but implicitly met statement above) |
| Porous coating Characterization and evaluation: | ||
| - Static Tensile Test | Performance equivalent to the predicate device. | (Details not provided, but implicitly met statement above) |
| - Static Shear Test | Performance equivalent to the predicate device. | (Details not provided, but implicitly met statement above) |
| - Shear Fatigue Test | Performance equivalent to the predicate device. | (Details not provided, but implicitly met statement above) |
| - Bending Fatigue Test | Performance equivalent to the predicate device. | (Details not provided, but implicitly met statement above) |
| - Abrasion Resistance Test | Performance equivalent to the predicate device. | (Details not provided, but implicitly met statement above) |
Note: For 510(k) submissions involving modifications, the primary acceptance criterion is typically "substantial equivalence" to a predicate device, meaning the new device is as safe and effective as the legally marketed predicate. The specific quantitative acceptance criteria for each bench test are not detailed in this summary, but the general conclusion statement suggests they were met.
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated for each test. Bench tests usually involve a specific number of samples tested for each condition (e.g., n=3 or n=6 for mechanical tests), but these numbers are not present in the provided summary.
- Data Provenance: The document does not specify the country of origin of the data. It's a submission by Tornier Inc., a US-based company with a specific address in Massachusetts. The testing would have been conducted to support this US FDA submission. The data is from prospective bench testing performed on the modified device. It is not patient data (retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is a bench testing study for a physical implant, not a diagnostic device or a study involving interpretation of medical images. Therefore, the concept of "ground truth established by experts" in the way it applies to image analysis or clinical diagnosis is not relevant here. The "ground truth" for these tests would be defined by engineering standards, test protocols, and material specifications, with the evaluation performed by engineers and technicians.
4. Adjudication method for the test set
- Not applicable as this is a bench testing study, not a study requiring reader adjudication (e.g., for clinical interpretations). The results of the mechanical tests are quantitative and objective.
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 submission for a physical orthopedic implant (shoulder system), not an AI-powered diagnostic tool, and therefore no MRMC study was performed or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical orthopedic implant, not an algorithm or AI-powered device.
7. The type of ground truth used
- The "ground truth" for this engineering evaluation is based on established engineering standards, material properties, and performance requirements for orthopedic implants, specifically shoulder systems. The performance of the modified device (porous-coated humeral stem) is compared against these standards and implicitly to the performance of the predicate device.
8. The sample size for the training set
- Not applicable. There is no "training set" as this is not a machine learning or AI algorithm.
9. How the ground truth for the training set was established
- Not applicable. There is no "training set."
§ 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.”