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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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1. The TITAN Modular Total Shoulder System is indicated for use as a hemi or total shoulder replacement for:
   Severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid
   arthritis.Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted,
   separated from its blood supply or where the surgeon's experience indicates that alternative methods
   of treatment are unsatisfactory.Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not
   acceptable (e.g., revision of a failed primary component).Shoulder Hemiarthroplasty is also indicated for:
   Ununited humeral head fractures.Avascular necrosis of the humeral head.Rotator cuff arthropathy.Deformity and/or limited motion.The humeral component is intended for cemented or uncemented use. The glenoid component is intended for
   cemented use only.
2. The TITAN Reverse Shoulder System is indicated for use in a grossly deficient rotator cuff joint with severe
   arthropathy or a previously failed joint replacement with a grossly deficient rotator cuff joint. The patient's joint
   must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is
   necessary to use the device. The Titan Reverse Shoulder System is indicated for primary, fractures including
   proximal humeral, 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
   screws for fixation. The humeral stem is indicated for cemented or uncemented use and the humeral body
   component is intended for cementless use.
3. The Ascension HRA System is intended for resurfacing of the humeral head due to:
   Patients disabled by either non-inflammatory or inflammatory arthritis (i.e., rheumatoid arthritis,
   osteoarthritis and avascular necrosis)Mild or moderate humeral head deformity and/or limited motionPost-traumatic arthritisMalunions of the humeral headAcute fractures of the humeral headPatients with an intact or reparable rotator cuffContraindications:
   Infection, sepsis, and osteomyelitisOsteoporosisMetabolic disorders which may impair bone formationOsteomalaciaRapid joint destruction, marked bone loss or bone resorption apparent on roentgenogramRevision procedures where other devices or treatments have failed4. The Ascension Modular Radial Head is intended for:
   Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain,
   crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with:

• joint destruction or subluxation visible on x-ray
• resistance to conservative treatmentPrimary replacement after fracture of the radial headSymptomatic sequelae after radial head resectionRevision following failed radial head arthroplasty5. The Katalyst Radial Head system is generally indicated for use in radial head replacement arthroplasty.
  Use of the implant is contraindicated in those cases where complete avascular necrosis has rendered bone
  stock inadequate.

The purpose of this submission is the addition of MR Conditional information to the labeling of the predicate devices.
There are no other changes proposed in this submission. The following aspects of the devices are not impacted by
the additional labeling and remain identical to the predicate devices as cleared in their respective 510(k)s.
• Intended Use/Indications for Use
• Contraindications
• Design and Dimensions
• Performance Specifications
• Materials
• Biocompatibility

The provided document is a 510(k) summary for the Smith & Nephew TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral Resurfacing Arthroplasty System (HRA), Modular Radial Head System (MRH), and Katalyst Bipolar Radial Head System (Katalyst).

However, the document does not contain information about an AI/ML-based medical device or any study demonstrating its performance against acceptance criteria. Instead, it focuses on the addition of MR Conditional information to the labeling of existing predicate devices. The "Non-Clinical Performance Data" section describes the testing performed to ensure MR compatibility, which is a different type of performance testing than what would be expected for an AI/ML device.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving the device meets those criteria for an AI/ML-based medical device from this document. The document describes a traditional medical device submission for orthopedic implants.

To answer your request, if this were a document about an AI/ML device, I would look for sections describing:

• Clinical Performance Study: Details about how the AI/ML model's output was evaluated, often involving a comparison to a ground truth or human expert readings.
• Performance Metrics: Specific metrics like sensitivity, specificity, AUC, F1-score, accuracy.
• Acceptance Criteria: Predetermined thresholds for these metrics that the device must meet to be considered effective.
• Test Set Description: Information on the size, source, and characteristics of the data used for testing.
• Ground Truth Establishment: How the definitive diagnosis or finding for the test data was determined (e.g., expert consensus, pathology, long-term follow-up).
• Reader Study Information: If applicable, details about human reader performance with and without AI assistance.

Since the provided document does not contain this type of information, I must state that it is not possible to fulfill the request based on the given input.

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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 INTEGRA® TITAN™ Modular Total Shoulder System Fin-Lock™ Glenoid is intended for use in Total Shoulder Arthroplasty which is indicated for:

1. Severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis.
2. Fracture dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicated that alternative methods of treatment are unsatisfactory.
3. Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. – revision of a failed primary component)
   The humeral component is intended for cemented or uncemented use.
   The glenoid component is intended for cemented use only.

The Integra TITAN™ Modular Total Shoulder System Fin-Lock™ Glenoid is a fully cemented all highly cross-linked polyethylene glenoid used in total shoulder arthroplasty for resurfacing the glenoid fossa. The glenoid component has one central peg with barbs and three peripheral pegs. The articulating surface of the glenoid device will be the same dimensions and sizes as existing Titan Modular Total Shoulder System three peg inline glenoids for consistent mismatching. The Fin-Lock™ Glenoid is intended to be a part of the TITAN™ Modular Shoulder System, 2.5 (K142413) and be used with the humeral component.

Based on the provided text, the acceptance criteria and the study results for the INTEGRA® TITAN™ Modular Total Shoulder System Fin-Lock™ Glenoid are described in the "807.92(b)(1-2) – Nonclinical Tests Submitted" section.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "The results of these performance tests met their respective acceptance criteria." However, it does not explicitly list the quantitative acceptance criteria for each test. It only mentions that the device met them.

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

The document does not specify the sample sizes used for the test sets in the performance tests. It also does not mention the data provenance (e.g., country of origin, retrospective or prospective nature). The tests are described as "nonclinical," implying they were conducted in a laboratory setting rather than using patient data.

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

This information is not applicable and not provided. The tests described are "nonclinical" performance tests (e.g., mechanical testing, material characterization), which typically do not involve human experts establishing ground truth in the way clinical studies or diagnostic AI algorithms do.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. As mentioned above, these are nonclinical performance tests, not clinical studies requiring adjudication of outcomes by experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The document describes nonclinical performance tests, not studies involving human readers or AI assistance.

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

This is not applicable. The device is a physical medical implant (shoulder prosthesis), not an algorithm or AI. The tests performed are for the physical properties and performance of the implant itself.

7. The Type of Ground Truth Used

The ground truth for these nonclinical tests would be based on engineering specifications, material science standards, and mechanical testing protocols. For example, for a "Glenoid Pull-out Fixation Test," the ground truth would be a defined force threshold or displacement limit that the device must withstand according to established engineering principles for such implants. The document implies these standards were used by stating "met their respective acceptance criteria."

8. The Sample Size for the Training Set

This is not applicable. The device is a physical medical device. There is no "training set" in the context of an AI/algorithm. The development and testing of a physical implant involve design iterations, material selection, and extensive pre-clinical testing, but not an AI-style training set.

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

This is not applicable as there is no training set for a physical medical device. The "ground truth" for the device's design and manufacturing would be based on biomaterial science, biomechanical engineering principles, clinical needs, existing standards for orthopedic implants, and the performance characteristics of predicate devices.

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The INTEGRA® TITAN™ Modular Total Shoulder System is a Total Shoulder Arthroplasty which is indicated for: Severely painful and/or disabled joint resulting from osteoarthritis or rheumatoid arthritis. Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicated that alternative methods of treatment are unsatisfactory. Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. - revision of a failed primary component) Shoulder Hemiathroplasty is also indicated for: Ununited humeral head factures, Avascular necrosis of the humeral head, Rotator cuff arthropathy, Deformity and/or limited motion. The humeral component is intended for cemented or uncemented use. The glenoid component is intended for cemented use only.

The TITAN™ Modular Total Shoulder System consists of a line of metaphyseal bodies, humeral stems, humeral heads and all polyethylene glenoid components. The body, stem and humeral head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement. The metaphyseal bodies and humeral stems are shaped to provide proximal fixation and optimal fixation area. Their variable length and proximally-filling shape are designed to accommodate the natural humeral geometry and provide stable fixation. proximal bone loading and proper head placement. The humeral heads are offered with both concentric and eccentric articulating surfaces. The humeral head may articulate against the natural glenoid bone, if it is of sufficient quality, or against the all polyethylene cemented glenoid. The glenoid has multiple options: keeled or standard pegged (3 pegs). All glenoid options are designed to function with both the concentric and eccentric heads. The humeral components are intended for cemented or uncemented use, while the glenoid component is for use with cement only.

The provided document is a 510(k) Premarket Notification summary for the INTEGRA® TITAN™ Modular Total Shoulder System. This document outlines the device description, intended use, and a comparison to a predicate device, focusing on demonstrating substantial equivalence rather than a detailed study proving the device meets specific acceptance criteria in the manner of an AI/ML device or a clinical trial.

The "acceptance criteria" and "device performance" described are related to non-clinical mechanical testing of the orthopedic implant, not to diagnostic accuracy or clinical outcomes in the way one would assess an AI/ML device. Therefore, many of the requested categories in your prompt are not applicable or cannot be extracted from this type of regulatory submission.

Here's a breakdown of the available information:

1. Table of acceptance criteria and reported device performance:

Study Proving Acceptance Criteria:

The study that proves the device meets the acceptance criteria consists of the non-clinical tests listed above. The document states: "Testing to verify the performance of the INTEGRA® TITAN™ Modular Total Shoulder System included the following: Taper Axial Disassembly Test, Fatigue Test, Maximum Static Load Test, Impact Assembly Test, Suture Verification Report. The results of these performance tests met their respective acceptance criteria and demonstrate that the INTEGRA® TITAN™ Modular Total Shoulder System is safe for the intended use, and is substantially equivalent to the predicate device identified."

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

• Sample Size: Not specified for these non-clinical mechanical tests. Typically, mechanical testing involves a certain number of test articles (e.g., usually 3, 5, or more per test condition as per ISO or ASTM standards) rather than "patients" or "data sets." Specific quantities are not disclosed in this summary document.
• Data Provenance: N/A. These are laboratory-based mechanical tests performed on device components, not based on human data from a geographic origin.

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

• N/A. For mechanical testing, the "ground truth" is typically defined by engineering specifications, material properties, and established test standards (e.g., ASTM, ISO standards for orthopedic implants). It does not involve human expert interpretation in the way clinical diagnostic data would.

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

• N/A. This concept is for clinical data adjudication, not mechanical engineering tests.

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:

• N/A. This is a non-clinical 510(k) submission for a physical orthopedic implant, not an AI/ML diagnostic device.

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

• N/A. Not an AI/ML device.

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

• For these mechanical tests, the "ground truth" is based on engineering specifications, material science principles, and established international or national standards for orthopedic implant mechanical performance (e.g., ASTM F2028-14 for humeral prostheses, or similar standards for fatigue, static loading, and taper connections). The "acceptance criteria" are derived from these standards and the predicate device's performance.

8. The sample size for the training set:

• N/A. There is no concept of a "training set" for physical mechanical device testing as there would be for an AI/ML algorithm. The design of the device is based on engineering principles and comparison to the predicate.

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

• N/A. Not applicable to this type of device and testing.

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The Ascension TITAN Total Shoulder System is indicated for use as a hemi or total shoulder replacement for:

• Severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis.
• Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicated that alternative methods of treatment are unsatisfactory.
• Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. - revision of a failed primary component).

Shoulder Hemiarthroplasty is also indicated for:

• Ununited humeral head fractures.
• Avascular necrosis of the humeral head.
• Rotator cuff arthropathy.
• Deformity and/or limited motion.

The humeral component is intended for cemented or uncemented use. The glenoid component is intended for cemented use only.

The TITAN Modular Total Shoulder System consists of a line of metaphyseal bodies, humeral stems, humeral heads and all polyethylene glenoid components. The body, stem and humeral head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement. The metaphyseal bodies and humeral stems are shaped to provide proximal fixation and optimal fixation area. Their variable length and proximally-filling shape are designed to accommodate the natural humeral geometry and provide stable fixation, proximal bone loading and proper head placement. The humeral heads are offered with both concentric and eccentric articulating surfaces. The humeral head may articulate against the natural glenoid bone, if it is of sufficient quality, or against the all polyethylene cemented glenoid. The glenoid has two options: keeled or standard pegged (3 pegs). All glenoid options are designed to function with both the concentric and eccentric heads.
The humeral components are intended for cemented or uncemented use, while the glenoid component is for use with cement only.

The provided text is a 510(k) Summary for the Ascension® TITAN™ Total Shoulder System. This document is a premarket notification for a medical device and, as such, primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria for a new device's efficacy or diagnostic accuracy.

Therefore, the information required to answer most of your questions (acceptance criteria, device performance, sample sizes, ground truth, experts, adjudication methods, MRMC studies, standalone performance, training set details) is not present in the provided text.

Here is what can be extracted based on the document:

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

The document does not specify quantitative acceptance criteria or report device performance in terms of clinical outcomes or diagnostic accuracy. Its primary claim is substantial equivalence to a predicate device (K100448).

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

• Sample size for test set: Not applicable. No clinical test set data is presented.
• Data provenance: Not applicable. No clinical data is presented.

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. No clinical test set or ground truth establishment is described.

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

• Not applicable. No clinical test set or adjudication is described.

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-powered device, and no MRMC studies are mentioned.

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

• Not applicable. This device is a physical shoulder implant, not an algorithm.

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

• Not applicable. No clinical ground truth is described.

8. The sample size for the training set

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

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

• Not applicable.

What the document does state regarding testing:

• Non-clinical Performance Data: "Testing to support the material change and additional lengths for the humeral stems has been completed. The testing conforms to ASTM F1378." (This is a standard for testing metallic implant materials, specifically for implantable materials for surgical implants). This non-clinical data is the basis for proving substantial equivalence for these specific changes.
• Clinical Performance Data: "Clinical performance data are not required for the minor changes that are the subject of this Special 510(k)." This explicitly states that clinical data (which would involve patients, outcomes, and likely the other questions you posed) was not deemed necessary for this particular submission, implying previous clinical data for the predicate device might have satisfied regulatory requirements, or the changes were minor enough not to warrant new clinical trials.

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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.

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