Search Results

Anatomic Total Shoulder Applications:

· Osteoarthritis

• The patient must be anatomically and structurally suited, as evident by scapula and proximal humerus closure, to receive the implants.

OsseoFit™ Stemless Shoulder humeral components have a porous surface and are indicated for uncemented biological fixation applications.

Compatible Glenoid components are intended to be implanted with bone cement. The porous posts may be inserted without bone cement.

Compatible Convertible Glenoid Baseplate components are intended for cementless applications with the addition of screw fixation.

The OsseoFit™ Stemless Shoulder System consists of a stemless humeral head adapter for anatomic total shoulder applications. The OsseoFit humeral implant is an anatomical (left/right specific), asymmetric humeral anchor with six fins whose location, length, and height vary. The OsseoFit humeral implants are available in Onlay and Inlay variants. The Onlay implants sit on top of the prepared bone while the Inlay implants have a dished superior portion with a shorter fin length to sit within the bone. The OsseoFit Humeral Implant also includes anterior suture holes for soft tissue attachment.

The humeral implants are manufactured through additive manufacturing which includes areas of OsseoTi porous technology to allow biological fixation.

The OsseoFit Stemless Shoulder System is intended for cementless applications and is designed to be used with a compatible Identity Shoulder System (K213856) humeral head. The Identity Humeral Head is assembled to the OsseoFit Humeral Head Adapter via a locking taper by a disposable impactor that is packaged together with the head adapter. The Identity heads can be used with a compatible Alliance Glenoid Implant (K191814 and K193180) or Comprehensive Convertible Baseplate liner (K211729).

The provided text describes the regulatory filing for the OsseoFit Stemless Shoulder System, a medical device. It focuses on demonstrating substantial equivalence to existing predicate devices, primarily through non-clinical testing.

However, the document does not contain any information about a study that assesses the device's performance against specific acceptance criteria in terms of algorithm or diagnostic accuracy, or human reader improvement with AI assistance. The "Non-Clinical and/or Clinical Tests Summary & Conclusions" section explicitly states "Clinical Tests: None Provided." The non-clinical tests listed are related to the mechanical and material properties of the device (e.g., fatigue testing, micromotion testing, MRI compatibility, porous coating characterization, manufacturing validation), not to an AI component or a diagnostic performance study.

Therefore, I cannot provide details on:

1. A table of acceptance criteria and the reported device performance: This information is not present as there's no mention of a performance study in the context of diagnostic accuracy or AI.
2. Sample size used for the test set and the data provenance: No such test set or data are mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
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: The document clearly states "Clinical Tests: None Provided." There is no mention of an AI component or human reader study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No algorithm or standalone performance is discussed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in this context.
8. The sample size for the training set: Not applicable as there's no mention of an AI model or training.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) summary for a medical implant, focusing on its mechanical, material, and design characteristics relative to predicate devices. It does not contain information about studies measuring diagnostic performance, AI performance, or human reader effectiveness with AI assistance.

Ask a specific question about this device

• 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
• 2. Rheumatoid arthritis.
• 3. Correction of functional deformity.
• 4. Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
• 5. Difficult clinical management problems, where other methods of treatment may not be inadequate.

Optional use in revision: in some medical conditions (e.g. revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure.

The Alliance Monoblock glenoid components are indicated for cemented application only. The Alliance Modular Glenoid components are intended to be implanted with bone cement. The TM and porous posts may be inserted without bone cement.

The Alliance Glenoid system is a series of glenoid components which includes previously cleared (K191814) monoblock glenoids with 2 or 3 pegs and modular glenoids with 3 or 4 pegs. In addition to the predicate neutral (flat) modular 4-pegged design, an augmented configuration for correction of glenoid bone defects is being added to the product line. All glenoid types are available in various sizes. The posts of the modular glenoids are made of either a Tivanium® substrate with Trabecular Metal (TM) sleeve or the Tivanium® substrate with Porous Plasma Spray (PPS) coating.

The Alliance Glenoids are intended to be used with existing humeral stem and head components to complete a total shoulder replacement construct.

The provided FDA 510(k) document for the Alliance Augmented Glenoid focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that a device meets specific acceptance criteria for performance in an AI/software context.

The document discusses a medical device (an augmented glenoid component for shoulder replacement), not an AI/software device. Therefore, the questions related to AI/software performance metrics, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, and standalone performance are not applicable to this document.

The "Summary of Performance Data" explicitly states "Non-Clinical Tests: o Glenoid Loosening (Rocking Horse) (ASTM F2028)" and "Clinical Tests: o None provided." This indicates that the performance evaluation was based on mechanical testing, a common approach for physical medical implants, not a clinical study involving human patients or an evaluation of an AI algorithm's diagnostic capabilities.

Here's a breakdown of the relevant information provided in the document based on your request, along with explanations of why certain points are not applicable:

1. A table of acceptance criteria and the reported device performance:

The document doesn't define specific "acceptance criteria" in terms of numerical performance thresholds for diagnostic accuracy, sensitivity, or specificity, as would be expected for an AI/software device. Instead, it relies on demonstrating that the Alliance Augmented Glenoid is substantially equivalent to a legally marketed predicate device (Alliance Glenoid K191814) through design similarities and non-clinical mechanical testing.

The primary performance data reported is for Glenoid Loosening (Rocking Horse) (ASTM F2028). The document implies that the results of this test demonstrated comparable performance to the predicate device, thereby supporting the claim of substantial equivalence. However, the specific metrics or acceptance values from this test are not explicitly detailed in the provided text.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

• Not Applicable. This is a physical medical device (implant), not an AI/software device evaluated on patient data. The "test set" would refer to the physical components subjected to mechanical testing. The document does not specify the number of physical samples tested under ASTM F2028.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

• Not Applicable. Ground truth, in the context of diagnostic performance, is not relevant here as this is a physical implant. The evaluation is based on engineering and materials science principles, typically involving qualified engineers and technicians performing the ASTM F2028 mechanical test.

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

• Not Applicable. Adjudication methods are used to establish ground truth in diagnostic studies, which is not relevant for this physical device.

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. MRMC studies are for evaluating diagnostic performance (often with AI assistance), which is not the subject of this 510(k). The document explicitly states "Clinical Tests: o None provided."

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

• Not Applicable. This is not an algorithm or AI device.

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

• Not Applicable. Ground truth in the diagnostic sense is not relevant here. The "ground truth" for the device's mechanical integrity would be derived from the objective results of the ASTM F2028 mechanical stress test.

8. The sample size for the training set:

• Not Applicable. There is no "training set" as this is not an AI/machine learning device.

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

• Not Applicable. As there is no training set.

Ask a specific question about this device