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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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Hemiarthoplasty/Conventional Total Application:

• · Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
• · Rheumatoid arthritis.
• · Correction of functional deformity.
• · Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
  · Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may 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.
  Reverse Application:
  Zimmer Biomet Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically suited to receive the implants and a functional deltoid muscle is necessary.
  The Zimmer Biomet Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.
  The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component or reverse components for total shoulder arthroplasty (conventional or reverse applications). The humeral components may be used cemented or uncemented (biological fixation).
  The Titanium Humeral Head and Glenosphere components are indicated for patients with suspected cobalt alloy sensitivity. The wear properties of Titanium alloys are inferior to that of cobalt alloy. A Titanium humeral head or Glenospheres not recommended for patients who lack suspected material sensitivity to cobalt alloy.

The Identity Shoulder System is a comprehensive collection of components designed with the intention of providing the modularity and adaptability necessary to facilitate individual anatomical adjustment and restoration of the glenohumeral joint during shoulder arthroplasty.
The Identity Shoulder System in the anatomic configuration is comprises of several individual components such as Humeral Stem, Fixed Angle Humeral Stem Adapter, Humeral Head Adapter, and Humeral Head. This configuration can be used as a hemiarthroplasty with the humeral head articulating against the natural glenoid bone or as an anatomic total shoulder replacement with a compatible glenoid component.
The components of the Identity Shoulder System may also be used in the reverse configuration. Individual components include a Humeral Stem, Humeral Tray and Humeral Bearing. This constructed is intended to be used with a compatible glenospheres/baseplate component.

This FDA 510(k) summary for the "Identity Shoulder System" does not contain any information about acceptance criteria or a study proving the device meets said criteria.

The document is a premarket notification for a medical device seeking substantial equivalence to previously cleared devices. It primarily focuses on:

• Indications for Use: What the device is intended for (e.g., non-inflammatory degenerative joint disease, rheumatoid arthritis, fractures).
• Device Description: A high-level overview of the components and configurations (hemiarthroplasty, total shoulder replacement, reverse configuration).
• Technological Characteristics: How the device is similar to predicate devices in terms of intended use, indications for use, materials, design features, and sterilization.
• Non-Clinical Tests/Justifications: A list of non-clinical tests performed (e.g., FEA, Axial Pull Off, Fatigue, Corrosion) to support substantial equivalence, but no results or acceptance criteria are provided for these tests in this summary document.
• Clinical Tests: Explicitly states "None provided."

Therefore, based solely on the provided text, I cannot answer the requested questions regarding acceptance criteria and studies proving the device meets them because this information is not present. This type of detail is typically found in the full 510(k) submission, not in the public summary.

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