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The Shoulder Innovation's InSet Total Shoulder System, when used with the Inset Stem, is intended for use as an orthopedic implant for partial or total shoulder arthroplasty to treat the following:

1. Significant disability in degenerative, rheumatic disease of the glenohumeral joint;
2. Fractures of the humeral head
3. Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
4. Avascular necrosis of the humeral head
5. Revision where other devices or treatments have failed.

The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component for total shoulder arthroplasty.

The InSet 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 that articulate with a glenoid component. The humeral stems are collarless and manufactured from Titanium Alloy (Ti6-4) with fins to provide rotational stability. The collarless stems allow the humeral head to prevent stem subsidence. The stems have a female Morse-type taper to interface with the modular humeral heads. The proximal body and fins are coated with a rough, porous coating for un-cemented fixation or for use with bone cement.

The humeral heads are manufactured from CoCr and are available in standard and offset configurations. The heads have a male Morse-type taper to interface with the humeral stems.

The glenoid components of the Total Shoulder System are manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE). The glenoid implant is a peqged design intended for cemented fixation only.

This document concerns the 510(k) premarket notification for the "InSet Total Shoulder System" and specifically a product line extension to add the "InSet 95 Humeral Stem." This is a medical device approval and not an AI/ML software approval.

Therefore, the information requested about acceptance criteria and studies proving the device meets those criteria, particularly aspects related to AI/ML such as ground truth, expert adjudication, MRMC studies, and training/test set sample sizes, are not applicable to this document.

The document states under "Clinical Testing Summary": "Clinical testing was not necessary to demonstrate substantial equivalence of the InSet Total Shoulder System InSet 95 Humeral Stem to the predicate device." This indicates that the approval was based on non-clinical testing and comparison to predicate devices, rather than a clinical study with human subjects or an AI/ML model's performance evaluation.

Here's a breakdown of what is relevant from the document in relation to the device's acceptance:

Acceptance Criteria and Device Performance (Based on information provided, specifically for this medical device approval):

Study Details (as per the document):

1. Sample size used for the test set and the data provenance: Not applicable. This was not a data-driven AI/ML study but a medical device submission based on substantial equivalence and non-clinical engineering tests. No "test set" in the context of an AI/ML model's performance on patient data was used.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for patient data is not established for this type of device approval. The "ground truth" relates to engineering specifications and performance against those specifications, which were assessed via non-clinical testing and comparison to predicates.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
4. 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: Not applicable. This is not an AI-assisted diagnostic device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical orthopedic implant, not an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device approval would be established engineering standards, material properties, and performance benchmarks derived from predicate devices and regulatory requirements. For example, mechanical strength is evaluated against established limits or performance of predicate devices.
7. The sample size for the training set: Not applicable. This is not an AI/ML device that requires training data.
8. How the ground truth for the training set was established: Not applicable.

In summary, the provided document details the FDA's clearance of a physical medical device (shoulder implant) based on its substantial equivalence to previously cleared devices and non-clinical engineering testing, not on the performance of an AI/ML algorithm or clinical studies involving human patient data.

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The Shoulder Innovations Total Shoulder System with Humeral Stemless is intended for use as an orthopedic implant for total shoulder arthroplasty to treat severely painful and/or disabled joint resulting from osteoarthritis or traumatic arthritis.

The Shoulder Innovations Total Shoulder System components are intended for single use only.

The Humeral Stemless components are indicated for press-fit, un-cemented use. The glenoid component is intended for cemented fixation only.

The Shoulder Innovations Total Shoulder System consists of modular humeral stems and heads that articulate with a glenoid component. The humeral stems are collarless, as the humeral head acts as the collar, and manufactured from Titanium Alloy (Ti-GAL-4V) conforming to ASTM F136 with fins to provide rotational stability and are coated with a rough, porous coating. The stems have a female 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 male Morse-type taper to interface with the humeral stems.

The glenoid components of the Total Shoulder System are manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE) with a pegged design intended for cemented fixation.

This submission adds Humeral Stemless Implants to the Shoulder Innovations Total Shoulder System. The Humeral Stemless Implants are similar to the previously cleared humeral short stems (K173824), except that the Humeral Stemless Implants do not include the stem. The Humeral Stemless Implants have fins to provide rotational stability and a female Morse-type taper to interface with modular humeral heads, identical to the humeral short stems (K173824). The Humeral Stemless Implants are manufactured from Titanium Alloy (Ti-6Al-4V) conforming to ASTM F136 with a proximal porous coating of commercially pure titanium according to ASTM F67.

The Humeral Stemless Implants are for press-fit, uncemented use. All Humeral Stemless Implants are compatible with the previously cleared Total Shoulder System humeral heads (K173824) and previously cleared Total Shoulder System glenoid components (K111596 and K192365).

The provided text is a 510(k) premarket notification for a medical device (Shoulder Innovations Total Shoulder System with Humeral Stemless). It outlines the device description, indications for use, and a summary of non-clinical testing and substantial equivalence to predicate and reference devices.

Crucially, it clearly states that "Clinical testing was not necessary to demonstrate substantial equivalence" for this device. This implies that the device's acceptance was based on non-clinical testing and a comparison to already cleared devices, rather than a clinical study evaluating its performance against specific clinical acceptance criteria.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving the device meets those criteria, as the document explicitly states no clinical study was performed for this specific submission to demonstrate substantial equivalence.

The provided text does not contain the information requested regarding acceptance criteria related to a clinical study proving device performance. There is no information about:

1. A table of acceptance criteria and reported device performance: No clinical performance metrics or predefined acceptance thresholds are mentioned.
2. Sample size used for the test set and data provenance: No clinical test set.
3. Number of experts used to establish ground truth and their qualifications: Not applicable, as no clinical ground truth was established from expert readings.
4. Adjudication method: Not applicable.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study: No such study was conducted.
6. Standalone (algorithm only) performance: Not applicable, as this is a physical medical device, not an AI algorithm.
7. Type of ground truth used: No clinical ground truth was used.
8. Sample size for the training set: Not applicable, as this is not an AI/ML device requiring a training set.
9. How ground truth for the training set was established: Not applicable.

The document focuses on non-clinical testing (lever out, pull out, torque out, and fatigue testing) to demonstrate substantial equivalence based on mechanical properties and design similarity to predicate devices, rather than clinical efficacy or diagnostic performance.

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The Inset Reverse Total Shoulder System should be used 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 and structurally suited to receive the implants and a functional deltoid muscle is necessary.

The Inset Reverse Total Shoulder System is indicated for primary or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

The Glenoid Baseplate is intended for cementless application with the addition of screw fixation. The Humeral Stem may be implanted by press-fit or cement fixation.

The Inset Reverse Total Shoulder System is intended for total shoulder replacement in a reverse shoulder configuration. Unlike traditional total shoulder replacement, a reverse shoulder employs a ball for articulation on the glenoid side of the joint and a polyethylene bearing surface on the humeral side of the joint.

For the Inset Reverse Total Shoulder System, a Glenosphere Baseplate is attached to natural bone on the glenoid side of the joint with a Central Compression Screw and Peripheral Screws. The baseplate includes a female taper to mate with the chosen Glenosphere. Glenoid baseplate components are indicated for a press-fit cement-less application with the addition of screw fixation. The chosen Humeral Bearing is attached to the Humeral Tray and the assembly is attached to the Humeral Stem (K173824) to complete the humeral side of the joint. Humeral stems are indicated for press-fit uncemented use or for use with bone cement.

The material used in the manufacture of the humeral stem, glenoid baseplate, modular tray, compression screw, and supplementary screws are titanium alloy according to ASTM F136.

The humeral stem and the glenoid baseplate have a proximal porous coating of commercially pure titanium according to ASTM F67. The glenosphere is available in cobalt-chromium (CoCr) alloy, per ASTM F1537. The humeral bearing is manufactured from ultrahigh molecular weight polyethylene (UHMWPE) according to ASTM F648. The instruments are manufactured from stainless steel and acetal copolymer.

This document is a 510(k) Premarket Notification from the FDA regarding the "Inset Reverse Total Shoulder System". The key takeaway is that this document does not describe any acceptance criteria or studies proving device performance from an AI/algorithm perspective. Instead, it focuses on the substantial equivalence of a physical medical device (shoulder implant) to previously marketed predicate devices.

Therefore, I cannot fulfill the request as it pertains to AI/algorithm performance. The provided text is solely about the regulatory clearance of a physical orthopedic implant.

Here's why the supplied text doesn't contain the requested information about an algorithm's performance:

• Product Type: The device is a "Shoulder joint metal/polymer semi-constrained cemented prosthesis" – a physical implant, not a software algorithm or AI.
• Study Types: The "Non-Clinical Testing" section lists mechanical tests (e.g., fatigue, torque, strength) and a cadaver study, which are typical for orthopedic implants. There is no mention of algorithm performance metrics like sensitivity, specificity, AUC, etc.
• "Clinical Testing" section: Explicitly states, "Clinical testing was not necessary to demonstrate substantial equivalence of the Inset Reverse Total Shoulder System to the predicate device." This reinforces that no human-in-the-loop or standalone AI performance study was conducted.
• Ground Truth: The concept of "ground truth" for an AI system (e.g., expert consensus on image findings, pathology reports) is irrelevant for the mechanical testing of a physical implant.

To answer your request, if this were an AI algorithm, the information would typically be in a section describing the validation study for the software, often detailing metrics like:

• Acceptance Criteria for AI: Often include thresholds for sensitivity, specificity, positive predictive value, negative predictive value, or F1-score.
• Study Design: Details on the dataset (size, origin, retrospective/prospective), reader study design (MRMC, standalone), expert qualifications, and truth establishment.

Since the provided text is about a physical medical device, not an AI, it does not contain the information needed to answer the specific questions about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/algorithm.

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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:

1. significant disability in degenerative, rheumatic disease of the glenohumeral joint;
2. 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 that articulate with a glenoid component. The humeral stems are collarless and manufactured from Titanium Alloy (Ti6-4) with fins to provide rotational stability. The collarless stems allow the humeral head to prevent stem subsidence. The stems have a female Morse-type taper to interface with the modular humeral heads. The proximal body and fins are coated with a rough, porous coating for un-cemented fixation or for use with bone cement.

The humeral heads are manufactured from CoCr and are available in standard and offset configurations. The heads have a male Morse-type taper to interface with the humeral stems.

The glenoid components of the Total Shoulder System are manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE). The glenoid implant is a multi-pegged design intended for cemented fixation only.

The provided text describes a 510(k) premarket notification for a medical device, the Shoulder Innovations Total Shoulder System, and specifically a line extension to add "Augmented Glenoids." This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study proving a device meets specific acceptance criteria based on performance data.

Therefore, many of the requested categories for acceptance criteria and study details are not applicable or cannot be extracted from this type of regulatory submission. The document relies on non-clinical testing and comparison to predicate devices to demonstrate substantial equivalence, not a clinical study with detailed performance metrics against predefined acceptance criteria.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document in the format of a typical acceptance criteria table with performance results. The document explains that non-clinical testing was performed according to ASTM F2028-17 and cadaver testing, and these tests "demonstrated that the Augmented Glenoids are adequate for their intended use." However, specific numerical acceptance criteria and performance values are not reported.

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

• Test Set Sample Size: Not explicitly stated for the non-clinical tests. For cadaver testing, a sample size is typically provided, but it's absent here.
• Data Provenance: The cadaver testing is generally considered prospective in its data collection for the specific purpose of the study. The location of testing or origin of cadavers is not mentioned.

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

This is not applicable as the document describes non-clinical and cadaveric testing, not a study evaluating human interpretation or diagnosis where expert ground truth would be established.

4. Adjudication method for the test set

This is not applicable for the same reasons as #3.

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

This is not applicable. The device is an orthopedic implant, not an AI-assisted diagnostic tool.

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

This is not applicable. The device is an orthopedic implant, not an algorithm.

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

For the non-clinical tests (ASTM F2028-17 and cadaver testing), the "ground truth" would be the physical measurements and observations from the tests themselves, demonstrating mechanical properties or performance under simulated conditions. This is not "expert consensus, pathology, or outcomes data" in the typical sense for a clinical study.

8. The sample size for the training set

This is not applicable. The document describes a physical medical device, not an AI algorithm that requires a training set.

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

This is not applicable for the same reasons as #8.

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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:

1. significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint;
2. 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 Humeral Short Stem consists of modular humeral stems and heads and articulates with the Shoulder Innovations glenoid component (K111596). The humeral stems are collarless and manufactured from Titanium Alloy (Ti6-4) with fins to provide rotational stability. The collarless stems allow the humeral head to prevent stem subsidence. The stems have a female Morse-type taper to interface with the modular humeral heads. The proximal body and fins are coated with a rough, porous coating for un-cemented fixation or for use with bone cement.
The humeral heads are manufactured from CoCr and are available in standard and offset configurations. The heads have a male Morse-type taper to interface with the humeral stems.

This document describes the 510(k) premarket notification for the Humeral Short Stem System by Shoulder Innovations Inc. It is a submission for a shoulder prosthesis, not an AI/ML powered device, therefore, the requested information on acceptance criteria for an AI/ML powered device, specifically points related to AI/ML model performance, ground truth establishment, expert adjudication, and MRMC studies, is not applicable to this document.

However, I can provide information about the acceptance criteria and the study proving the device meets the acceptance criteria within the context of non-clinical testing for a medical device like this shoulder prosthesis, as described in the document.

Here's an analysis of the provided text, focusing on the available information regarding device testing and acceptance:

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

The document describes non-clinical performance testing. It doesn't present a table with specific acceptance criteria values and reported performance values for each criterion. Instead, it states that tests were performed "per ASTM F2009 Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses" and that "Fatigue testing was also performed on the humeral components."

The conclusion in the "Summary of Substantial Equivalence" states: "The results of non-clinical testing and comparative analysis demonstrate that the design, function, intended use, and indications for use of the Shoulder Innovations Humeral Short Stem System is substantially equivalent to the predicate device." This implies that the device met the acceptance criteria defined by the specified ASTM standard and fatigue testing, although the specific numerical results and thresholds are not disclosed in this summary document.

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

The document does not specify the sample sizes (number of devices or test articles) used for the ASTM F2009 or fatigue testing.
For data provenance, it's non-clinical (laboratory) testing of the physical device components, not patient data.

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

Not applicable. This is for a mechanical device; "ground truth" in the context of human interpretation or clinical outcomes is not relevant here. The ground truth for mechanical testing is established by the specified ASTM standard and general engineering principles for mechanical integrity.

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

Not applicable. This refers to consensus among human readers for image interpretation or diagnosis, which is not relevant for 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:

Not applicable. This is not an AI/ML powered device.

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

Not applicable. This is not an AI/ML powered device.

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

For this mechanical device, the "ground truth" for performance is based on established engineering standards and specifications. The document mentions:

• ASTM F2009 Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses: This standard defines how to conduct the test and likely sets performance benchmarks or provides a methodology for comparison.
• Fatigue testing: This evaluates the device's ability to withstand repeated stress cycles, with acceptance criteria typically based on material properties, design life, and industry standards for implant durability.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device, so there is no "training set."

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

Not applicable. As above, there is no training set for a mechanical device.

Summary of Device Performance Study (Non-Clinical):

The document indicates that Shoulder Innovations Inc. performed non-clinical testing to demonstrate the substantial equivalence of their Humeral Short Stem System to a predicate device (Biomet Comprehensive® Primary Shoulder Stems, K060692).

Key Tests Conducted:

• Axial Disassembly Force of Taper Connections: Tested per ASTM F2009. This standard evaluates the strength of the connection between modular components, ensuring they do not inadvertently separate during use. The implicit "acceptance criteria" here would be meeting or exceeding the performance of the predicate device, or a specified minimum force, as per the standard's requirements for secure modular junctions.
• Fatigue Testing: Performed on the humeral components. This test assesses the device's durability under cyclic loading, simulating the stresses it would experience in the body over time. The "acceptance criteria" for fatigue testing would typically involve demonstrating that the device can withstand a specified number of cycles at a certain load without failure, often compared to the predicate device's known performance or established industry benchmarks for implant longevity.

The document states that "Clinical testing was not necessary to demonstrate substantial equivalence," relying entirely on the non-clinical tests and a detailed predicate device comparison (pages 4-5) across various features (distal stem diameters, lengths, geometry, collar, modular system, bone integration, neck angle, fixation, material, sterility for both stem and head components). This comparative analysis serves as a form of "proof" that the device meets implied acceptance criteria by being "substantially equivalent" to a legally marketed predicate device.

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