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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.

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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 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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