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The Reverse Shoulder Prosthesis is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with a grossly deficient rotator cuff shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly deficient rotator cuff shoulder joint. The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. The glenoid baseplate is intended for cementless application with the addition of screws for fixation. The humeral stems are intended for cemented or cementless use. The Glenoid Reconstruction System baseplate is intended for cementless application with the addition of polyaxial screws for primary stability. A Glenoid Reconstruction System central screw can be used to provide additional fixation.

The Reverse Shoulder Prosthesis - Short Humeral Diaphysis is indicated for primary total shoulder replacement in patients with grossly deficient rotator cuff shoulder joint with severe arthropathy. The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. The glenoid baseplate is intended for cementless application with the addition of screws for fixation. The humeral short stem is intended for cementless use. The Glenoid Reconstruction System baseplate is intended for cementless application with the addition of polyaxial screws for primary stability. A Glenoid Reconstruction System central screw can be used to provide additional fixation.

Glenoid Reconstruction System (GRS) Full Wedge baseplate is a Medacta Shoulder System line extension to provide a larger product offering.

It includes GRS Full Wedge baseplate and central screws, sterile implantable devices used to replace only the glenoid side of the gleno-humeral joint in a shoulder reverse configuration.

The GRS Full Wedge baseplate, intended for cementless application, is designed to be fixed into the glenoid bone by means of both a press-fit central post and Glenoid Polyaxial Screws. If desired, a GRS Central Screw can be used to provide additional stability.

The GRS Full Wedge baseplate is designed to provide an interface for glenosphere coupling.

The subject baseplate is available in two taper diameters (024.5 and 027) with two different lengths (20 and 30 mm) of the central post and 4 full wedge options (10°, 15°, and 20°).

It is made of Ti6Al7Nb according to ISO 5832-11 and double coated with Ti coating according to ASTM F1580-18 and HA coating according to ASTM F1185-03.

The provided text describes the 510(k) premarket notification for the "Glenoid Reconstruction System - Full Wedge Baseplate." It outlines the device, its intended use, and a comparison to predicate devices, but it does not contain information regarding acceptance criteria or a study that proves the device meets those criteria in the context of a human-AI performance study. Instead, it focuses on non-clinical performance data (e.g., fatigue testing, micromotion assessment, material characterization) to demonstrate substantial equivalence to existing devices.

Therefore, many of the requested fields cannot be filled from the provided document.

Here's a breakdown of what can and cannot be answered:

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

• Cannot be provided. The document lists non-clinical studies performed (e.g., fatigue testing, micromotion assessment, material characterization), but it does not specify quantitative acceptance criteria or the specific performance results for those criteria. It states that "performance testing was conducted to written protocols," implying that there were pre-defined criteria, but these are not detailed.

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

• Cannot be provided. The studies mentioned are non-clinical (mechanical, material, biocompatibility testing) and do not involve human patients or test sets in the typical sense of AI performance evaluation. Thus, there is no sample size of patients/cases or data provenance to report.

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. This information is relevant for studies involving human interpretation or AI performance assessment against expert ground truth, which is not present in this document.

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

• Not applicable. As above, this pertains to studies involving human interpretation and ground truth establishment.

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

• No. The document explicitly states: "No clinical studies were conducted." Therefore, no MRMC study with AI assistance was performed or reported.

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

• Not applicable. The device is a physical medical implant (glenoid reconstruction system), not a software algorithm or AI device.

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

• Not applicable. For the non-clinical studies mentioned, the "ground truth" would be established engineering specifications, material standards (e.g., ASTM, ISO), and validated testing methods. It is not related to clinical ground truth types like pathology or expert consensus.

8. The sample size for the training set

• Not applicable. This device is a physical implant, not an AI/ML algorithm. Therefore, there is no training set mentioned or relevant.

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

• Not applicable. As above, no training set for an AI/ML algorithm is involved.

Summary of available information regarding compliance:

The device's substantial equivalence to predicate devices is supported by the following non-clinical studies:

• Design Validation: Glenoid Reconstruction System Full Wedge Baseplate Design Validation.
• Performance Testing:
  • Fatigue testing on glenoid reconstruction system.
  • Micromotion assessment on Glenoid reconstruction system Full Wedge Baseplate according to ASTM F2028-17.
  • Range of Motion Assessment.
  • Characterization Report "Y367" Titanium + "Osprovit" Hydroxyapatite double coating on GRS Glenoid baseplate component.
  • Scanning electron microscopy pictures of the "Y367" Titanium + "Osprovit" HA implant surfaces of the GRS Glenoid baseplate.
  • Cross sectioned area of "Y367" Titanium + "Osprovit" HA implant surfaces of the GRS Glenoid baseplate.
  • Rationale comparison between features of the Hydroxyapatite Osprovit coating deposited on the Medacta GRS Glenoid baseplate and on planar samples made of Ti6A17Nb, based on XRD analyses.
• Pyrogenicity:
  • Bacterial endotoxin test (LAL test) according to European Pharmacopoeia §2.6.14 (equivalent to USP chapter ).
  • Pyrogen test according to USP chapter for pyrogenicity determination.
• Biocompatibility evaluation.
• Shelf-life evaluation.

The document states that "performance testing was conducted to written protocols," implying that these tests were designed to confirm the device's performance against predetermined specifications derived from industry standards and predicate device characteristics, thereby demonstrating substantial equivalence. However, the specific quantitative acceptance criteria and results are not detailed in this FDA summary letter.

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The Reverse Shoulder Prosthesis is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with a grossly deficient rotator cuff shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly deficient rotator cuff shoulder joint. The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. The glenoid baseplate is intended for cementless application with the addition of screws for fixation. The humeral stems are intended for cemented or cementless use.

The Glenoid Reconstruction System baseplate is intended for cementless application with the addition of polyaxial screws for primary stability. A Glenoid Reconstruction System can be used to provide additional fixation.

The Reverse Shoulder Prosthesis - Short Humeral Diaphysis is indicated for primary total shoulder replacement in patients with grossly deficient rotator cuff shoulder joint with severe arthropathy.

The patient's joint must be anatomically suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.

The glenoid baseplate is intended for cementless application with the addition of screws for fixation.

The humeral short stem is intended for cementless use.

The Glenoid Reconstruction System baseplate is intended for cementless application with the addition of polyaxial screws for primary stability. A Glenoid Reconstruction System central screw can be used to provide additional fixation.

The Glenoid Reconstruction System is a Medacta Shoulder System line extension to provide a larger product offering. It includes GRS baseplates and central screws, sterile implantable devices used to replace only the glenoid side of the gleno-humeral joint in a shoulder reverse configuration.

The GRS baseplate, intended for cementless application, is designed to be fixed into the glenoid bone by means of both a press-fit central post and Glenoid Polyaxial Screws. If desired, a GRS Central Screw can be used to provide additional stability. The GRS baseplate is designed to provide an interface for glenosphere coupling.

The subject baseplate is available in two taper diameters (024.5 and 027) with two different lengths (20 and 30 mm) of the central post and 3 lateralization options (0 mm, +3 mm and +6 mm). It is made of Ti6A17Nb according to ISO 5832-11 and double coated with Ti coating according to ASTM F1580-18 and HA coating according to ASTM F1185-03.

The GRS central screw is available in 4 different lengths, from 15 to 30 mm and it is made of Ti6Al4V according to ISO 5832-3.

The provided text describes a 510(k) premarket notification for the Glenoid Reconstruction System, specifically for new GRS baseplates and central screws. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the safety and effectiveness of a novel device through extensive clinical trials with acceptance criteria based on patient outcomes.

Therefore, the input document does not contain the information requested in your prompt regarding acceptance criteria and a study proving a device meets them in the context of an AI/ML medical device.

Here's why and what can be extracted from the document in relation to device performance and testing:

Why the requested information is not present:

• Device Type: The Glenoid Reconstruction System is a medical implant (shoulder prosthesis components), not an AI/ML-powered diagnostic or therapeutic device. The types of evaluations, acceptance criteria, and studies are fundamentally different.
• Regulatory Pathway (510(k)): A 510(k) submission primarily relies on demonstrating that a new device is "substantially equivalent" to an existing legally marketed device (the predicate). This often involves comparing technological characteristics and performing bench testing (non-clinical studies) to ensure it performs as intended and is as safe and effective as the predicate. Clinical studies are often not required for 510(k)s, especially for incremental changes or extensions of existing product lines, which is the case here.
• Focus on Performance Data: The "Performance Data" section lists non-clinical studies (design validation, fatigue testing, micromotion assessment, static tests, material characterization, biocompatibility, shelf-life). These are engineering and material science tests, not AI/ML performance metrics like sensitivity, specificity, or AUC.

What information can be extracted/inferred related to the device's performance, but not in the AI/ML context you've asked for:

• No Acceptance Criteria for AI/ML performance: As it's not an AI/ML device, there are no acceptance criteria related to metrics like sensitivity, specificity, accuracy, etc.
• No Reported Device Performance (as AI/ML metrics): The document doesn't report performance in terms of AI/ML metrics.
• Sample Size (for an AI/ML test set): Not applicable. The "test set" here refers to physical components undergoing engineering tests.
• Data Provenance (for an AI/ML test set): Not applicable.
• Number of experts / Adjudication Method: Not applicable. These relate to establishing ground truth for AI/ML studies. The "experts" involved here would be materials scientists or mechanical engineers for the non-clinical tests.
• Multi-reader Multi-case (MRMC) study: Not applicable. This is specific to diagnostic imaging interpretation, often with human interpretation.
• Standalone (algorithm-only) performance: Not applicable.
• Type of Ground Truth (for AI/ML): Not applicable. The "ground truth" for the a glenoid reconstruction system is established through engineering principles, material standards, and biomechanical testing. For example, for fatigue testing, the ground truth is whether the component withstands a specified number of cycles at a certain load without failure, according to a standard. For material characterization, the ground truth is the chemical composition and microstructure matching specifications.
• Training Set Sample Size & Ground Truth (for AI/ML): Not applicable.

In summary, the provided document describes the regulatory approval of a physical medical implant, not an AI/ML-powered device. Therefore, it does not contain the specific information you've requested regarding AI/ML acceptance criteria and performance studies.

Ask a specific question about this device