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The Catalyst CSR Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint where hemi- or total shoulder arthroplasty is determined by the surgeon to be the preferred method of treatment. The Catalyst CSR Shoulder System is intended for use in patients with the following conditions where the humeral head, neck and glenoid vault are of sufficient bone stock and the rotator cuff is intact or reconstructable.

• Osteoarthritis
• Avascular Necrosis
• Rheumatoid Arthritis
• Post-traumatic Arthritis
• Correction of functional deformity
  Both components of the Catalyst CSR Shoulder System are intended for cemented use only.

The Catalyst CSR Shoulder System is a bone preserving total shoulder prosthesis designed for use in patients where the humeral head, neck and glenoid vault are of sufficient bone stock and there is an intact or reconstructable rotator cuff. The design requires minimal bone resection, thus giving the patient an alternative to other total shoulder designs where more bone is removed.
This submission adds larger, standard (non-spherical) humeral components to the CSR Shoulder System. Like the previously cleared CSR humeral components, the Size H and Size I CSR standard humeral components are manufactured from cast Co-Cr-Mo alloy conforming to ASTM F75. They have a non-spherical polished surface for articulation with the glenoid component or the glenoid cavity of the scapula. The humeral components incorporate 4 pegs which assist with alignment and provide rotational stability. The four plane geometry of the back side of the humeral component matches four cut surfaces on the humeral head to recreate the geometry and thickness of the removed bone.
The CSR humeral components are compatible with previously cleared CSR 3 Peg glenoid components.

The provided text is a 510(k) premarket notification for a medical device called the "Catalyst CSR Shoulder System." This document does not describe acceptance criteria for an AI/ML powered device, nor a study proving a device meets such criteria. Instead, it details the indications for use, device description, and a summary of substantial equivalence for a physical shoulder prosthesis, with non-clinical testing performed on its components.

Therefore, I cannot provide the information requested in your prompt based on the provided text, as it pertains to an entirely different type of medical device submission.

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The Arthrex UNIVERS REVERS COATED BASEPLATE is designed to be used as the glenoid component of the existing Univers Revers Shoulder Prosthesis System.

The Arthrex UNIVERS REVERS COATED BASEPLATE is indicated for use in a grossly rotator cuff deficient glenohumeral joint with severe arthropathy failed joint replacement with a gross rotator cuff deficiency. 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 Arthrex UNIVERS REVERS COATED BASEPLATE is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

The Arthrex UNIVERS REVERS COATED BASEPLATE is coated and is intended for cementless use with the addition of screws for fixation.

The Arthrex UNIVERS REVERS COATED BASEPLATE is a coated titanium glenoid baseplate designed to be used as the glenoid component of the existing Univers Revers Shoulder Prosthesis System. The baseplate is centrally anchored by a barbed post with superior and inferior multi-directional screws to ensure optimal fixation. The baseplate comes in three sizes and is designed to be paired with the Univers Revers glenosphere.

The provided document is a 510(k) premarket notification for the "Arthrex UNIVERS REVERS COATED BASEPLATE." This document describes a medical device, specifically a shoulder prosthesis component, and not an AI/ML-driven medical device that would involve AI performance metrics.

Therefore, the requested information (acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details) related to AI/ML device performance is not applicable to this document.

The document focuses on demonstrating substantial equivalence to a predicate device through:

• Mechanical Testing: Mentioned as "Rocking Horse, Shear Force" to show equivalent performance to the predicate device.
• Coating Compliance: Non-clinical testing to demonstrate compliance with FDA Guidance for Industry on Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants.
• Bacterial Endotoxin Testing: To demonstrate the device meets pyrogen limit specifications.

These are standard engineering and biocompatibility tests for orthopedic implants, not performance studies for AI/ML algorithms.

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The Anatomical Shoulder System is intended for long-term implantation into the human shoulder joint in primary or revision, total or hemi shoulder arthroplasty. The system is intended to relieve pain and restore function in patients with adequate bone stock to support the prosthesis.

The ASHCOM Shoulder System is intended for reverse shoulder arthroplasty.

Hemi or Total Arthroplasty Application of the Anatomical Shoulder Humeral Stems and Domelock System
The Anatomical Shoulder Humeral Stems and Domelock System are indicated for
• Advanced wear and tear of the shoulder joint resulting from degenerative, posttraumatic or rheumatoid arthritis.
• Avascular necrosis.
• Conditions consequent to earlier operations.
• Omarthrosis.
• Rheumatoid arthritis.
• Revision of shoulder prosthesis.

The Humeral Stems Cemented are intended for cemented use and the Humeral Stems Uncemented are intended for uncemented use. When used in a total shoulder application, the Anatomical Shoulder Pegged and Keeled Glenoids Cemented and the Biomet all-polyethylene Keeled Glenoid are intended for cemented use only. The Biomet Modular Hybrid Glenoid is intended to be implanted with bone cement. The optional porous titanium peg may be inserted without bone cement. The optional polyethylene peg should be inserted with bone cement.

Reverse Application of the Anatomical Shoulder System and ASHCOM Shoulder System
• The Anatomical Shoulder Inverse/Reverse System and the ASHCOM Shoulder System are indicated for primary, fracture or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.
• 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 Humeral Stems Cemented are intended for cemented use and the Humeral Stems Uncemented are intended for uncemented use. When used with the Anatomical Shoulder Glenoid Fixation, it is intended for uncemented use and requires two screws for fixation.

Fracture Application of the Anatomical Shoulder Fracture System
The Anatomical Shoulder Fracture System is intended for use in prosthetic replacement of the proximal humerus and the glenoid articular surface of the scapula during total-, hemi and fracture shoulder arthroplasty in treatment of the following:
• Complex 3- and 4-part fractures of the proximal humerus with subluxation of the head fragment
• Complex 3- and 4-part fractures of the proximal humerus with loosening of the spongiosa in the head fragment
• Complex 3- and 4-part fractures of the proximal humerus with additional cross split of the head fragment
• Fracture instability after osteosynthesis of 3- and 4part fracture fragments of the proximal humerus
• Posttraumatic necrosis of the humeral head
• Posttraumatic arthrosis after humeral head fracture

The Humeral Fracture Stems are intended for either cemented or uncemented use. When used in a total shoulder application, the Anatomical Shoulder Pegged and Keeled Glenoids Cemented are intended for cemented use only.

Anatomical Shoulder Combined System
Advanced destruction of the shoulder joint resulting from:
• Omarthrosis.
• Rheumatoid arthritis
• Post-traumatic arthritis
• Avascular necrosis of the humeral head
• Cuff-tear arthropathy (Bigliani/Flatow Heads with heights of 27mm or greater)
• Conditions following earlier operations (including revision shoulder arthroplasty).

The Anatomical Shoulder Combined System is intended for cemented or cementless use.

When used with the following humeral stems the Anatomical Shoulder Combined System is intended for cemented use:
• Anatomical Shoulder Standard Cemented Humeral Stem.
• Anatomical Shoulder Revision Stem.

When used with the following humeral stem the Anatomical Shoulder Combined System is intended for cementless use:
• Anatomical Shoulder Standard Uncemented Stem.

When used with the following humeral stems the Anatomical Shoulder Combined System is intended for cemented or cementless use:
• Anatomical Shoulder Fracture Stem.
• Anatomical Shoulder Fracture Long Stem.

When used with the following glenoids the Anatomical Shoulder Combined System is intended for cemented use:
• Bigliani/Flatow Glenoid (pegged and keeled).
• Trabecular Metal™ Glenoid.

The ASHCOM Shoulder AC-Connector is a double tapered Adaptor that allows the combination of the Anatomical Shoulder Humeral Stems with the Comprehensive Trays. The male oval cone taper of the ASHCOM Shoulder AC-Connector is compatible with the cemented, uncemented and fracture humeral stems of the Anatomical Shoulder System. The female round taper is compatible with the Comprehensive Reverse Trays. In combination with compatible Zimmer Biomet reverse glenoid the implant is intended for a reverse application. The existing Anatomical Shoulder System, for which MR conditional labeling is proposed, is a modular shoulder prosthesis designed to be used in primary or revision, total or hemi shoulder arthroplasty. The existing Anatomical Shoulder Combined System, for which MR conditional labeling is proposed, allows the combination of a Bigliani/Flatow® Head with any Anatomical Shoulder Humeral Stem.

The provided text does not contain detailed acceptance criteria for a medical device or a comprehensive study demonstrating that the device meets these criteria. The document is primarily a 510(k) premarket notification for shoulder prosthetic systems (ASHCOM™ Shoulder System, Anatomical Shoulder™ System, Anatomical Shoulder™ Combined System), aiming to establish substantial equivalence to previously cleared predicate devices.

Instead, the document focuses on:

• Indications for Use: What conditions the devices are intended to treat.
• Device Description: The components and general design of the prosthetic systems.
• Comparison to Predicate Device: How the new devices are similar to existing, legally marketed devices.
• Performance Data (Nonclinical): A list of non-clinical tests performed to support safety and effectiveness, particularly for the ASHCOM Shoulder System and the MRI compatibility of the Anatomical Shoulder systems.

Here's an analysis based on the information provided, highlighting what's present and what's explicitly absent:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a formal table of acceptance criteria with specific quantitative targets and corresponding device performance data to demonstrate compliance.

Instead, it lists the types of non-clinical tests performed to show safety and equivalence:

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

For the non-clinical tests listed, the document does not specify sample sizes (e.g., number of prostheses tested) or data provenance (e.g., country of origin, retrospective/prospective). These details would typically be found within the full test reports, which are not included in this summary.

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

This section is not applicable as the document describes non-clinical performance testing of physical devices (implants), not a study involving evaluation by medical experts to establish ground truth for a diagnostic or AI-driven system.

4. Adjudication method for the test set

This section is not applicable for the same reasons as point 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 section is not applicable. The device is an orthopedic implant, not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study involving human readers and AI assistance was conducted or mentioned.

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

This section is not applicable. The device is an orthopedic implant and does not involve an algorithm.

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

For the non-clinical performance tests, "ground truth" would not be established by expert consensus, pathology, or outcomes data in the traditional sense. Instead, the "ground truth" or reference state is defined by engineering specifications, material properties, and regulatory standards (e.g., ASTM F2009 for taper connection testing). The tests aim to demonstrate that the physical properties and performance of the device meet these predefined engineering and safety criteria.

8. The sample size for the training set

This section is not applicable. The device is an orthopedic implant, and there is no mention of an algorithm or AI model that would require a training set.

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

This section is not applicable for the same reasons as point 8.

Summary of what the document does indicate regarding device performance and acceptance:

The submission relies on non-clinical performance testing and analysis to demonstrate the safety and effectiveness of the ASHCOM Shoulder System and the existing Anatomical Shoulder systems (for MRI compatibility labeling) and establish their substantial equivalence to predicate devices. The listed tests (FEA, cyclic fatigue, corrosion fatigue, static taper connection) are standard for orthopedic implants to assess mechanical integrity, durability, and material performance. For MRI compatibility, the evaluation followed FDA guidance, suggesting a series of tests to confirm the "MR Conditional" status.

The statement "Results of non-clinical performance testing and analyses demonstrate that the ASHCOM Shoulder System is safe and effective and substantially equivalent to the predicate devices" serves as the overall conclusion regarding acceptance based on the conducted studies, without detailing the specific quantitative acceptance criteria or results in this summary. The FDA's clearance (K170711) indicates that they found the provided non-clinical data sufficient to establish substantial equivalence.

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The Humelock II Reversible Shoulder System is indicated for primary, fracture or revision total shoulder arthroplasty for the relief of pain and to improve function in patients with a massive and non-repairable rotator cuff tear.

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 humeral stems are intended for cemented or cementless use. The metaglene baseplate is intended for cementless use with the addition of screws for fixation.

The Humelock II Reversible Shoulder is a total shoulder prosthesis designed for use in patients with a non-functional rotator cuff. The components of the system include a glenoid baseplate, standard and locking bone screws, optional baseplate post extensions, centered and eccentric glenospheres with and without a stabilization screw, 135/145° humeral cups, standard humeral cups and a 135/145° adaptor. These components are intended for use with the previously cleared Humelock II Cemented Humeral Stems and the Humelock II Cementless Humeral Stems. The design of the Humelock II Reversible Shoulder allows conversion from an anatomic shoulder configuration to a reverse shoulder configuration either intraoperatively or during revision of an anatomic shoulder with a well fixed humeral stem.

The glenoid baseplate, standard and locking screws, baseplate post extensions, glenosphere screws and 135/145° reverse adapters are manufactured from Ti-6Al-4V alloy conforming to ISO 5832-3. The backside of the baseplate and the post extensions are coated with a plasma sprayed CP Titanium and Hydroxylapatite coating. The glenospheres are manufactured from Co-Cr-Mo conforming to ISO 5832-12. The 135/145° Humeral Cups and standard Humeral Cups are manufactured from Ti-6Al-4V alloy conforming to ISO 5832-3 and UHMWPE conforming to ISO 5834-1 and ISO 5834-2.

Based on the provided text, the device described is the Humelock II Reversible Shoulder System, which is a medical implant, not an AI/software device. Therefore, the questions related to acceptance criteria, study design for AI devices, and performance metrics for AI models are not applicable to this document.

The document is a 510(k) premarket notification summary for a medical device (a shoulder prosthesis), which aims to demonstrate "substantial equivalence" to legally marketed predicate devices, rather than proving performance against specific acceptance criteria for an AI system.

However, I can extract information related to the physical device's "performance" as described in the "Non-Clinical Testing" section, which might be interpreted as "acceptance criteria" for a medical implant, and then address why other points are not applicable.

Here's a breakdown of the requested information based on the provided text, indicating where it's not applicable to this medical implant:

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the AI/Software specific questions:

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

• Not Applicable. This is a physical medical implant device, not an AI/software product, so there is no "test set" in the context of AI model evaluation. The "tests" mentioned are non-clinical biomechanical and material tests.

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 is a physical medical implant device. Ground truth, in the AI context of expert consensus, is not relevant here. The "ground truth" for the non-clinical tests would be the established engineering standards and biomechanical principles.

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

• Not Applicable. As there's no "test set" for an AI model, adjudication methods are irrelevant.

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 a physical medical implant device. MRMC studies are for evaluating diagnostic performance with or without AI assistance, which doesn't apply to a shoulder prosthesis.

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

• Not Applicable. This is a physical medical implant device. There is no algorithm or standalone AI performance to evaluate.

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

• Not Applicable in the AI context. For the non-clinical tests, the "ground truth" would be engineering specifications, material properties, and biomechanical stability benchmarks typically verified through laboratory testing against established standards.

8. The sample size for the training set

• Not Applicable. This is a physical medical implant device. There is no AI training set.

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

• Not Applicable. This is a physical medical implant device. There is no AI training set.

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The Univers Revers Shoulder Prosthesis is indicated for use in a grossly rotator cuff deficient glenohumeral joint with severe arthropathy or a previous failed joint replacement with gross rotator cuff deficiency. 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 CaP coated and is intended for cementless use with the addition of screws for fixation.

The uncoated cup and stem are intended for cemented use, all other components are for cementless use only.

The Arthrex Univers Revers Shoulder Prosthesis System has an articular design that is inverted compared to traditional total shoulder prosthesis. The system is comprised of two main components; the Arthrex Univers Revers Shoulder Prosthesis and the Universal Glenoid Shoulder Prosthesis. The Arthrex Univers Revers Shoulder Prosthesis is a titanium humeral stem and epiphysis or humeral cup, a titanium spacer, and an UHMWPE humeral cup liner. The humeral stem and epiphysis are available uncoated or with CaP coating. The Universal Glenoid Shoulder Prosthesis consists of a TPS/CaP coated titanium glenoid baseplate, a cobalt chrome glenosphere, and titanium screws.

The provided document is a 510(k) summary for the Arthrex Univers Revers Shoulder Prosthesis System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through clinical studies in the same way a novel AI algorithm might. Therefore, many of the requested details about acceptance criteria, specific study design for device performance, ground truth establishment, expert involvement, and reader studies (MRMC, standalone AI) are not applicable to a 510(k) for a medical device like a shoulder prosthesis.

The core of a 510(k) submission is to show that the new device is as safe and effective as a predicate device and does not raise new questions of safety or effectiveness. This is typically done through a comparison of technological characteristics, materials, design, and often, mechanical testing.

Here's the information that can be extracted or deduced from the document, organized according to your request, with explanations for why certain aspects are not present in this context:

Acceptance Criteria and Device Performance for Arthrex Univers Revers Shoulder Prosthesis System (K130129)

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not applicable in the context of a 510(k) submission for a shoulder prosthesis. The "test set" here refers to the mechanical tests conducted on the device itself, not clinical data from patients. The number of samples for mechanical testing would be based on engineering standards and statistical requirements for device strength and durability specific to the tests performed (e.g., fatigue, static strength testing), but these numbers are not given in this summary.
• Data Provenance: Not applicable in the context of clinical data. For mechanical testing, the data originates from laboratory testing of the manufactured device components.

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

• Not applicable. "Ground truth" in this context would refer to the true state of a patient, which is not evaluated in a 510(k) for a medical implant like this. The "truth" for mechanical testing is derived from controlled laboratory environments. The experts involved would be engineers and material scientists conducting the tests, but their specific numbers and qualifications are not part of this summary.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication methods (like 2+1, 3+1 for clinical interpretations) are not relevant for mechanical testing of a medical implant.

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 a medical device (shoulder prosthesis), not an AI diagnostic or interpretive tool. Therefore, MRMC studies and AI-driven performance improvements are irrelevant.

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

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

7. The Type of Ground Truth Used

• For Mechanical Performance: The "ground truth" is established through objective engineering measurements and standards for material properties, fatigue life, and static strength of the device components. This involves direct physical testing of the device under simulated physiological conditions.
• For Substantial Equivalence: The "ground truth" is a comparison against the characteristics and performance of the predicate devices, which have already been deemed safe and effective by the FDA.

8. The Sample Size for the Training Set

• Not applicable. This is a physical medical device, not a machine learning algorithm. There is no concept of a "training set" in this context.

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

• Not applicable, as there is no "training set" for this type of device submission.

Summary of 510(k) Approach:

The key to this 510(k) submission is establishing "Substantial Equivalence" to predicate devices (K053274: Zimmer Anatomical Shoulder System; K100142: Torneir Aequalis Revers Shoulder Prosthesis). The manufacturer (Arthrex) demonstrated this through:

• Comparison of Intended Use.
• Comparison of Technological Characteristics (design, size ranges, materials, components).
• Submitted mechanical testing data to show equivalent fatigue strength, ensuring the device is adequate for its intended use.

The document explicitly states: "Clinical data and conclusions are not needed for this device." This confirms that no clinical patient studies involving "test sets," "ground truth" derived from patient outcomes, or expert adjudication of clinical data were part of this submission for market clearance.

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The Anatomical Shoulder™ Fracture System is intended for use in prosthetic replacement of the proximal humerus and the glenoid articular surface of the scapula during total-, hemi- and fracture shoulder arthroplasty in treatment of the following:

• Complex 3 and 4 part fractures of the proximal humerus with subluxation of the head fragment;
• Complex 3 and 4 part fractures of the proximal humerus with loosening of the spongiosa in the head fragment;
• Complex 3 and 4 part fractures of the proximal humerus with additional cross split of the head fragment;
• Fracture instability after osteosynthesis of 3 and 4 fragments of the proximal humerus;
• Posttraumatic necrosis of the humeral head;
• Posttraumatic arthrosis after humeral head fracture.
  The Anatomical Shoulder Fracture stem is intended for cemented or cementless use.

The Anatomical Shoulder Fracture System is designed specifically to treat complex 3 or 4 part proximal humerus fractures requiring hemi- or total shoulder arthroplasty. The Anatomical Shoulder Fracture System may be used with or without bone cement. The Anatomical Shoulder Fracture System consists of four components, a stem, baseplate, screw and head. The Anatomical Shoulder Fracture System baseplate offers right and left side-specific versions in order to appropriately match the original shoulder anatomy with respect to right and left humeral anatomy. The Anatomical Shoulder Fracture System head is also designed to articulate with the glenoid components of the Anatomical Shoulder System (K030259). The Anatomical Shoulder Fracture System stem is also designed to accept the Anatomical Shoulder Inverse/Reverse humeral cup (K053274) for conversion from hemi- or total shoulder arthroplasty to an inverse/reverse shoulder arthroplasty in situations when the rotator cuff is irreparable and the patient is experiencing severe instability of the shoulder joint. The Anatomical Shoulder Fracture System stem is comparable in shape and size to stems traditionally used for hemi- and total shoulder arthroplasty. The Anatomical Shoulder Fracture System stem, however, has two features which distinguish it as a stem designed for treatment of proximal humeral fractures. The proximal surface of the humeral stem and much of the surface of the baseplate offer spikes which assist in the stable anchoring of the humeral tuberosities to the stem and allow for primary stability of the tuberosities. The Anatomical Shoulder Fracture System stem and baseplate also offer several suture holes to allow initial stable fixation of the humeral tuberosities with sutures.

The provided text is a 510(k) summary for the Zimmer Anatomical Shoulder™ Fracture System, a medical device. This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

Key takeaways regarding acceptance criteria and studies:

The document states: "Performance testing indicates that all components meet or exceed predetermined performance criteria for their intended use." However, it does not provide specific numerical acceptance criteria for the device's performance, nor does it detail the specific study designs, methodologies, or results that prove these criteria were met.

Instead, the submission relies on demonstrating substantial equivalence to previously cleared predicate devices, an approach common for 510(k) submissions. This means that the device is considered safe and effective because it is similar in intended use, design, materials, and manufacturing methods to devices already on the market.

Therefore, many of the requested details about specific acceptance criteria and detailed study information are not available in the provided text because it's a summary focused on substantial equivalence rather than a full study report with performance metrics.

Here's a breakdown of what can be inferred or stated as "not applicable/provided" based on the input:

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

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

• Sample size for the test set: Not provided.
• Data provenance: Not provided. The document mentions "Performance testing" but does not specify if this involved patient data, laboratory tests, or simulation, nor does it give origin or nature (retrospective/prospective). Given it's a 510(k) for an implant, the "performance testing" likely refers to non-clinical bench testing rather than clinical patient studies.

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

• Number of experts: Not applicable/Not provided. As no clinical "test set" in the context of expert review (e.g., for image interpretation) is described, expert ground truth establishment for such a test set is not relevant here.
• Qualifications of experts: Not applicable/Not provided.

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

• Adjudication method: Not applicable/Not provided. No clinical test set requiring adjudication by experts 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

• MRMC comparative effectiveness study: No. This device is an orthopedic implant, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant or described.
• Effect size of human readers with/without AI: Not applicable.

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

• Standalone performance: Not applicable. This device is a physical shoulder implant, not a software algorithm. Therefore, "standalone (algorithm only)" performance is not a relevant concept.

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

• Type of ground truth: Performance testing for an orthopedic device typically involves biomechanical testing or material testing against engineering standards or established performance benchmarks for similar devices. The "ground truth" would be the measurable physical properties and performance under specific simulated conditions (e.g., fatigue life, strength, range of motion, wear characteristics). The document simply states "Performance testing indicates that all components meet or exceed predetermined performance criteria," implying such testing was conducted but not detailing the 'ground truth' benchmarks.

8. The sample size for the training set

• Sample size for the training set: Not applicable/Not provided. This device is not an AI/ML algorithm that requires a "training set" in the computational sense. If "training set" refers to design and testing iterations, these details are not in the summary.

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

• How ground truth for the training set was established: Not applicable/Not provided. As this is not an AI/ML device, the concept of a training set with established ground truth is not relevant here.

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