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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.

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The Augment Off-Axis Instrument System consists of specialized instruments intended to prepare anatomy prior to implantation of Comprehensive® Reverse Shoulder System components in reverse total shoulder arthroplasty procedures or Alliance® Augmented Glenoid System components in anatomic total shoulder arthroplasty procedures in accordance with their respective cleared indications for use and contraindications.

The instruments for this system are specifically indicated for use with the Comprehensive ® Reverse Shoulder System (K193373) or the Alliance® Augmented Glenoid System (K193180).

The Augment Off-Axis Instrument System consists of specialized instruments that are designed for preparation of anatomy prior to implantation of Comprehensive® Reverse Shoulder System or Alliance® Augmented Glenoid System components. The instruments in this system are intended to provide an alternate approach in ensuring proper preparation of the glenoid bone and tissue for receipt of a glenoid implant augment in reverse and anatomic total shoulder arthroplasty procedures.

A drop-in instrument tray contains the Augment Off-Axis reusable surgical instruments for secure and ergonomic storage, sterilization, and transportation between uses.

The provided document is a 510(k) premarket notification from the FDA, specifically concerning an orthopedic surgical instrument system called the "Augment Off-Axis Instrument System." It focuses on demonstrating substantial equivalence to a predicate device for design modifications.

Crucially, this document does not contain any information about acceptance criteria or a study that proves the device meets those criteria, especially not in the context of an AI/human-in-the-loop diagnostic device performance study. The device described is a set of physical surgical instruments, not a diagnostic AI system.

Therefore, I cannot fulfill your request for information regarding AI/human-in-the-loop study criteria such as:

1. A table of acceptance criteria and reported device performance
2. Sample size used for the test set and data provenance
3. Number of experts used to establish ground truth and their qualifications
4. Adjudication method for the test set
5. MRMC comparative effectiveness study results or effect size
6. Standalone (algorithm-only) performance
7. Type of ground truth used
8. Sample size for the training set
9. How ground truth for the training set was established

The document explicitly states under "Clinical Testing": "Clinical testing was not required as a basis for substantial equivalence." This further confirms that no such performance study, as you described, was conducted or reported in this submission.

The "Performance Data - Nonclinical" section mentions that the impact of modifications was evaluated via "analysis of the worst-case device," and "no further mechanical testing was performed" because the modification "did not introduce a new worst-case scenario." This refers to biomechanical or engineering performance of the physical instruments, not diagnostic accuracy of an algorithm.

Ask a specific question about this device

The Augment Off-Axis Instrument System consists of specialized instruments intended to prepare anatomy prior to implantation of Comprehensive® Reverse Shoulder System components in reverse total shoulder arthroplasty procedures or Alliance® Augmented Glenoid System components in anatomic total shoulder arthroplasty procedures in accordance with their respective cleared indications for use and contraindications.

The instruments for this system are specifically indicated for use with the Comprehensive ® Reverse Shoulder System (K193373) or the Alliance® Augmented Glenoid System (K193180).

The Augment Off-Axis Instrument System consists of specialized instruments that are designed for preparation of anatomy prior to implantation of Comprehensive® Reverse Shoulder System or Alliance® Augmented Glenoid System components. The instruments in this system are intended to provide an alternate approach in ensuring proper preparation of the glenoid bone and tissue for receipt of a glenoid implant augment in reverse and anatomic total shoulder arthroplasty procedures.

A drop-in instrument tray contains the Augment Off-Axis reusable surgical instruments for secure and ergonomic storage, sterilization, and transportation between uses.

The provided FDA 510(k) document for the "Augment Off-Axis Instrument System" (K233148) does not describe an AI/ML device or software that requires acceptance criteria based on performance metrics such as sensitivity, specificity, or accuracy.

Instead, this submission is for a system of specialized surgical instruments intended to prepare anatomy for shoulder implant procedures. The document focuses on demonstrating substantial equivalence to existing predicate devices (K193373 and K193180) based on non-clinical performance data.

Therefore, the requested details regarding acceptance criteria, study design, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set information are not applicable to this specific device submission.

The document explicitly states:

• "Clinical testing was not required as a basis for substantial equivalence."
• "Substantial equivalence is supported by the results of verification testing to confirm features, geometry, and performance of the Augment Off-Axis instruments, which support that the subject device performs as well as the predicate system instruments."

The "acceptance criteria" here are implicitly tied to the verification testing and the demonstration that the new instruments perform as intended and are safe and effective, similar to the predicate devices. These criteria would relate to engineering specifications, material properties, sterility, and functional performance of the surgical tools themselves, not statistical performance metrics for an AI algorithm.

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