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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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This device is intended for cemented use in treatment of the following:

• Advanced wear and tear of the shoulder joint resulting from degenerative, posttraumatic or rheumatoid arthritis.
• Omarthrosis.
• Rheumatoid arthritis.
• Revision of shoulder prosthesis.
• Traumatology: the only cone to be used in traumatological indications is the traumatology cone.

The keeled glenoid component is part of the Anatomical Shoulder System. It provides surgeons with another bone anchorage option while maintaining the system's articular surface geometry.

This document is a Summary of Safety and Effectiveness for the Zimmer Anatomical Shoulder™ System Keeled Glenoid, which is a shoulder prosthesis.

Based on the provided text, the device's acceptance criteria and the study that proves it meets those criteria are as follows:

1. Table of Acceptance Criteria and Reported Device Performance

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

• The document refers to "Testing completed as part of the design assurance process" which implies non-clinical testing.
• Sample Size: Not specified.
• Data Provenance: The data is described as "Non-Clinical Performance" and directly linked to "design assurance." This indicates in-house testing by the manufacturer (Zimmer, Inc.) rather than external or patient data. It is retrospective in the sense that it's part of the product development and verification process.

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

• This information is not provided in the document. The testing described is non-clinical performance, so it wouldn't involve expert establishment of ground truth in the same way clinical studies do. The "truth" here would be derived from engineering specifications and testing standards.

4. Adjudication Method for the Test Set

• This information is not provided. Given that the testing is non-clinical, an adjudication method for a test set (as typically seen in clinical trials with human readers/assessors) is not applicable or described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and 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 device is a shoulder prosthesis, not an AI-assisted diagnostic tool. Therefore, the concept of human readers improving with AI assistance is not relevant to this submission.

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

• No, a standalone study (in the context of an algorithm) was not done. This is a medical device (implant), not a software algorithm. The "standalone" performance here refers to the device's physical and mechanical performance, which was assessed through non-clinical testing.

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

• The ground truth for the non-clinical testing would be based on engineering specifications, mechanical testing standards, and established material properties. For example, tests for strength, wear, and fatigue would have predefined pass/fail criteria based on industry standards and the predicate device's performance.

8. The sample size for the training set

• Not applicable. This document describes a medical implant, not a device involving machine learning or AI that would require a "training set."

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

• Not applicable. As stated above, this device does not utilize AI/ML, so there is no training set or associated ground truth establishment in that context.

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The PROMOS® Shoulder is indicated for:

• Advanced wear of the shoulder joint due to degenerative, post-traumatic or rheumatoid arthritis
• Fracture or avascular necrosis of the humeral head
• Post-traumatic loss of joint configuration, especially in the case of functional impairment
• Humerus fracture
  The humeral component is intended for cemented or cementless use.
  The glenoid component is for use with bone cement only.

The PROMOS® Shoulder will help in restoring shoulder motion and eliminating pain.
The glenoid component has a spherical articulating surface with four pegs on the inferior surface for attachment to the bone. It is manufactured from ultra high molecular weight polyethylene (UHMWPe). The glenoid is available in four sizes with each size having three different spherical radii of curvature for a total of twelve glenoid components.
The humeral component is modular with a distal stem, body, inclination set and humeral head. The distal stem is rectangular in cross sectional shape and available in seven cementless sizes. It is attached to the body via a Morse type taper. Both cemented and cementless stems are fabricated from titanium alloy (Ti6Al4V) that conforms to ISO 5832-3. The body is made of titanium alloy and is available in three sizes. The body has a cavity in the proximal portion to accept the inclination set. The inclination set consists of an insert, offset module and ball screw. The ball screw inserts through the offset module and insert, and the assembly is threaded into the cavity in the body. The offset module can be set at various positions and when the ball screw is tightened into the body the offset module is locked into place. The offset module has a male Morse type taper to which the humeral head is attached. All components of the inclination set are made from titanium alloy. The offset module is available in three different heights resulting in the humeral head being placed at three heights.
The modular humeral heads are manufactured from CoCrMo alloy that conforms to ISO 5832-12. The head is available in eight different sizes.

This document is a 510(k) summary for the PROMOS® Shoulder device. It describes the device, its intended use, and compares its technological characteristics to predicate devices. However, this document does not contain any information regarding acceptance criteria, device performance metrics, study designs, sample sizes, ground truth establishment, or expert involvement as requested in your prompt.

The "Summary Non-clinical Tests" section briefly states: "The results of laboratory testing indicate that the PROMOS Shoulder will survive the expected in-vivo loading." This is a very high-level statement and does not provide quantifiable acceptance criteria or detailed results of the study.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets those criteria based on the provided input. The information you're looking for (performance metrics, study details, sample sizes, etc.) is typically found in the full 510(k) submission, not in the summary document.

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Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the gleno-humeral joint; non-union humeral head fracture; displaced 3 and 4 proximal humeral fractures; avascular necrosis of the humeral head; or other difficult management problems where arthrodesis or resectional arthroplasty are not acceptable.

The Aequalis Universal Shoulder Glenoid is intended for cemented use as the glenoid component in total shoulder arthroplasty, completed using humeral components of the Tornier Aequalis Total Shoulder System. The Aequalis Universal Shoulder Glenoid is manufactured in four sizes from Ultra High Molecular Weight Polyethylene (UHMWPE). The component's articulating (or lateral) surface is concave and is designed to articulate with the head of an existing, commercially available Tornier Aequalis Shoulder humeral prosthesis. The Aequalis Universal Shoulder Glenoid aticulating surface has a radius of curvature greater than the corresponding humeral head. This mismatch between the glenoid and the humeral head is intended to allow the translation of the head in the superior/inferior and anterior/posterior directions.

The back surface of the Aequalis Universal Shoulder Glenoid is spherical in geometry, in order to conform to the geometry of the glenoid fossa. It is grooved in order to increase the interface glenoid implant / bone cement.

The back (or medial) surface of the component has either a keel or four pegs for fixation in the glenoid. These glenoid components are 4 mm thick and available in four sizes (small, medium, large and X-large) for each component, the keeled and pegged components.

• The Aequalis Universal pegged Glenoid features one centrally located peg and three t peripheral pegs placed in a triangular configuration. The peripheral pegs are fitted with transversal grooves that provide enhanced cement fixation. The three peripheral pegs provide resistance to rocking and rotational motion caused by translation of the prosthetic humeral head. The central peg features an X-ray marking wire in Cobalt-Chromium alloy.
• -The Aequalis Universal keeled Glenoid features a centrally located keel to provide translational and rotational stability of the implant. A groove around the middle of the keel provides enhanced cement fixation. The keel features an X-ray marking wire in Cobalt-Chromium alloy.

Materials. The Aequalis Universal Shoulder Glenoid is manufactured from implant grade ultrahigh molecular weight polyethylene (UHMWPE) according to ISO5834-2, with a small Cobalt-Chromium wire included as an opaque radiographic marker.

The provided text describes the 510(k) summary for the Aequalis Universal Shoulder Glenoid, a Class III medical device. However, it does not include information about specific acceptance criteria or a study designed to prove the device's performance against such criteria in the manner typically expected for AI/software-based medical devices (e.g., sensitivity, specificity, or reader performance metrics). Instead, the submission focuses on demonstrating "substantial equivalence" to predicate devices.

The document primarily discusses:

• Device Description: What the Aequalis Universal Shoulder Glenoid is made of (UHMWPE), its design (concave articulating surface, spherical back surface with grooves, keel or pegs for fixation), and its intended use (cemented glenoid component in total shoulder arthroplasty).
• Voluntary Standards: Tornier, S.A. Standard Operating Procedures (SOP), vendor certifications and qualification procedures, Quality System Regulations (QSR), ISO9001 & EN46001, and EN552 for sterilization.
• Premarket Notification (K994393): The process of seeking FDA clearance based on substantial equivalence.
• Comparison to Predicate Devices (Table 1): A table comparing features of the Aequalis Universal Shoulder Glenoid to other commercially available shoulder glenoid components (e.g., materials, method of fixation, presence of keel/pegs, indications for use, and an UHMWPE standard).
• Summary of Safety and Effectiveness: This section outlines potential risks (procedure-related like infection, nerve injury; device-related like component disassociation, wear debris, loosening) and argues that the Aequalis Universal Shoulder Glenoid's design (all-polyethylene, similar fixation methods) makes its expected failure modes and frequencies comparable to existing devices.

Missing Information related to your specific questions:

The document does not contain the following:

1. A table of acceptance criteria and reported device performance (in the context of quantitative functional performance like accuracy, precision, or reader study results). The "reported device performance" is essentially a qualitative comparison to predicate devices and an assessment of expected failure modes based on material and design.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish the ground truth for the test set and their qualifications.
4. Adjudication method.
5. Multi-reader multi-case (MRMC) comparative effectiveness study, nor effect sizes.
6. Standalone (algorithm-only) performance study.
7. Type of ground truth used (e.g., pathology, outcomes data).
8. Sample size for the training set.
9. How the ground truth for the training set was established.

Conclusion based on the provided text:

This submission is for a physical orthopedic implant (Aequalis Universal Shoulder Glenoid) seeking clearance based on substantial equivalence to existing legally marketed devices, rather than a new AI/software medical device that would typically undergo rigorous performance studies with specific acceptance criteria related to diagnostic accuracy, sensitivity, or specificity. Therefore, the questions regarding AI performance criteria, ground truth, expert adjudication, and training/test set details are not applicable or addressed in this type of 510(k) submission.

The "study" that proves the device meets "acceptance criteria" here is primarily the comparison to predicate devices (Table 1) and a qualitative risk assessment detailed in the "Class III Summary," arguing that the Aequalis Universal Shoulder Glenoid's design and materials are comparable to existing devices, and thus its safety and effectiveness can be expected to be similar. The "acceptance criteria" are implied by the features and performance of the predicate devices.

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