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The Shoulder Innovations Total Shoulder System is intended for use as an orthopedic implant for partial or total shoulder arthroplasty to treat the following:

• significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint;
• united humeral head fractures of long duration: .
• . irreducible 3- and 4-part proximal humeral fractures:
• avascular necrosis of the humeral head. .
  The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component for total shoulder arthroplasty.
  The Total Shoulder System components are intended for single use only. The glenoid components are intended for cemented fixation only; the humeral stem mav be implanted by press-fit or cement fixation.

The Shoulder Innovations Total Shoulder System consists of modular humeral stems and heads, and a glenoid component. The humeral stems are manufactured from Cobalt Chrome (CoCr) and have fins to provide rotational stability. The fins have suture holes for the attachment of soft tissue and bone in the case of proximal humeral fracture. A collar is present to resist stem subsidence. The stems have a male Morse-type taper to interface with the modular humeral heads.
The humeral heads are manufactured from CoCr and are available in standard and offset configurations. The heads have a female Morsetype taper to interface with the humeral stems.
The glenoid components are manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE). The glenoid implants are available in a multi-pegged and keeled design and are intended for cemented fixation only.

The provided document focuses on a 510(k) premarket notification for a modification to the Shoulder Innovations Total Shoulder System. It describes the device, its intended use, and the proposed modification (geometry of the articular surface of the glenoid component). The document explicitly states: "No clinical testing was performed." Therefore, there is no study described that proves the device meets specific acceptance criteria based on clinical performance.

Instead, the document refers to non-clinical performance testing to demonstrate equivalence to predicate devices, specifically for glenoid loosening, and an engineering study for minimum poly thickness and range of motion.

Here's the breakdown of what can be extracted based on the provided text, and where information is missing or not applicable:

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

The document does not provide a table with specific quantitative acceptance criteria or reported performance metrics for the non-clinical tests mentioned. It only states that "Performance testing was performed to evaluate glenoid loosening" and "An engineering study was performed to evaluate the minimum poly thickness and range of motion," and that these demonstrated substantial equivalence.

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

• Test Set Sample Size: Not specified. The document mentions "performance testing" and an "engineering study" but does not give sample sizes for these non-clinical tests.
• Data Provenance: Not applicable, as no clinical data or human-derived data is mentioned. The studies are described as "engineering studies" and "performance testing," typically implying laboratory or bench testing.

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, as no clinical data or ground truth established by human experts is mentioned. The testing was non-clinical.

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

Not applicable, as no clinical data or human expert adjudication is mentioned.

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 MRMC study was done. The device described is a physical orthopedic implant, not an AI or imaging device with human-in-the-loop performance.

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, as no clinical ground truth was established. The "ground truth" for the non-clinical tests would be the physical properties and performance measured in a laboratory setting against established engineering standards or benchmarks for glenoid loosening, poly thickness, and range of motion.

8. The sample size for the training set

Not applicable. No training set is mentioned as no AI/machine learning component is described.

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

Not applicable. No training set is mentioned.

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The Shoulder Innovations Total Shoulder System is intended for use as an orthopedic implant for partial or total shoulder arthroplasty to treat the following:

• significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint;
• united humeral head fractures of long duration;
• irreducible 3- and 4-part proximal humeral fractures;
• avascular necrosis of the humeral head.
  The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component for total shoulder arthroplasty.
  The Total Shoulder System components are intended for single use only. The glenoid component is intended for cemented fixation only; the humeral stem may be implanted by press-fit or cement fixation.

The Shoulder Innovations Total Shoulder System consists of modular humeral stems and heads, and a glenoid component. The humeral stems are manufactured from Cobalt Chrome (CoCr) and have fins to provide rotational stability. The fins have suture holes for the attachment of soft tissue and bone in the case of proximal humeral fracture. A collar is present to resist stem subsidence. The stems have a male Morse-type taper to interface with the modular humeral heads.
The humeral heads are manufactured from CoCr and are available in standard and offset configurations. The heads have a female Morsetype taper to interface with the humeral stems.
The glenoid components are manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE). The glenoid implants are available in a multi-peqged and keeled design and are intended for cemented fixation only.

Based on the provided K110905 510(k) summary for the Shoulder Innovations Total Shoulder System, here's an analysis of the acceptance criteria and study information:

This submission is a Special 510(k) for a device modification, specifically the addition of a keeled design glenoid implant. The primary goal is to demonstrate equivalence to predicate devices, not necessarily to establish de novo performance against acceptance criteria for a new device type. Therefore, many of the typical AI/ML study questions about ground truth and reader studies are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not specified in terms of number of physical units or test replicates. The performance data section refers to an "engineering study," which typically involves bench testing.
• Data Provenance: The study is an "engineering study," which implies it was conducted by Shoulder Innovations, LLC, likely in a laboratory setting. There is no mention of country of origin of data or retrospective/prospective clinical data for this specific modification.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Not Applicable. This submission does not involve an AI/ML device or a diagnostic requiring expert-established ground truth. The evaluation is based on engineering principles and comparative analysis with predicate devices.

4. Adjudication Method for the Test Set

• Not Applicable. As there are no human readers or diagnostic interpretations, no adjudication method is relevant.

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. An MRMC comparative effectiveness study was not done. This is a modification to an orthopedic implant, not an AI/ML diagnostic or assistive device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not Applicable. This is an orthopedic implant, not an algorithm.

7. The Type of Ground Truth Used

• For the engineering study, the "ground truth" would be the established performance characteristics or specifications of the predicate device, against which the modified device's engineering test results (e.g., measurements, mechanical properties, cement contact area) are compared. The goal is to show that the modified design performs equivalently.

8. The Sample Size for the Training Set

• Not Applicable. This is an orthopedic implant, not an AI/ML device requiring a training set.

9. How the Ground Truth for the Training Set Was Established

• Not Applicable. As above, no training set is relevant for this type of device.

Ask a specific question about this device

The Shoulder Innovations Total Shoulder System is intended for use as an orthopedic implant for partial or total shoulder arthroplasty to treat the following:

• significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint;
• united humeral head fractures of long duration;
• irreducible 3- and 4-part proximal humeral fractures;
• avascular necrosis of the humeral head.
  The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component for total shoulder arthroplasty.
  The Total Shoulder System components are intended for single use only. The glenoid component is intended for cemented fixation only; the humeral stem may be implanted by press-fit or cement fixation.

The Shoulder Innovations Total Shoulder System consists of modular humeral stems and heads, and a glenoid component. The humeral stems are manufactured from Cobalt Chrome (CoCr) and have fins to provide rotational stability. The fins have suture holes for the attachment of soft tissue and bone in the case of proximal humeral fracture. A collar is present to resist stem subsidence. The stems have a male Morse-type taper to interface with the modular humeral heads.
The humeral heads are manufactured from CoCr and are available in standard and offset configurations. The heads have a female Morsetype taper to interface with the humeral stems.
The glenoid component is manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE). The glenoid is a multi-pegged design and intended for cemented fixation only.

The provided text describes a 510(k) premarket notification for the Shoulder Innovations Total Shoulder System, which is an orthopedic implant. This document focuses on the substantial equivalence of the device to a predicate device based on non-clinical performance testing. It does not describe an AI/ML-driven device or study results that would typically include the requested information about acceptance criteria, sample sizes, ground truth establishment, expert involvement, or MRMC studies.

Therefore, most of the requested information regarding AI/ML device performance, human reader improvement, and ground truth types is not applicable to this document. The document refers to the following:

1. Acceptance Criteria and Device Performance (Based on Non-Clinical Testing):

2. Sample size used for the test set and the data provenance:

• This information is not provided in the document as no clinical testing was performed. The testing was non-clinical (mechanical).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This information is not applicable as ground truth related to clinical diagnosis or interpretation by experts is not relevant for the described non-clinical mechanical performance testing.

4. Adjudication method for the test set:

• This information is not applicable as there was no adjudication process for clinical data. The study involved non-clinical mechanical testing.

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, an MRMC comparative effectiveness study was not done. This document describes an orthopedic implant, not an AI-driven diagnostic or interpretative device.

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

• Not applicable. This document describes a physical orthopedic implant, not a standalone AI algorithm.

7. The type of ground truth used:

• For the non-clinical performance testing, the "ground truth" would be the physical properties and mechanical behavior of the device components as measured against the ASTM standards. This is not "expert consensus, pathology, or outcomes data."

8. The sample size for the training set:

• Not applicable. This device is a physical implant, not an AI/ML algorithm that requires a training set.

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

• Not applicable. As there is no training set for a physical implant.

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