Search Results

The Affiniti Total and Hemi-Shoulder System are indicated for:

1. A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis;
2. 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;
3. 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:

1. Ununited humeral head fractures.
2. Avascular necrosis of the humeral head.
3. 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

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."

Ask a specific question about this device