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The Ascension Modular Total Shoulder System is indicated for use as a hemi or total shoulder replacement 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 indicates 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).
   Shoulder Hemiarthroplasty is also indicated for:
4. Ununited humeral head fractures.
5. Avascular necrosis of the humeral head.
6. Rotator cuff arthropathy.
7. Deformity and/or limited motion.
   The humeral component is intended for cemented or un-cemented use. The glenoid component is intended for cemented use only.

The Modular Total Shoulder System consists of a line of proximal 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 numeral nead may befficient bearing surface, or in conjunction with the glenoid, as a gronold proximal bodies and humeral stems are manufactured from total replacemont: "The and connect together via a Morse type taper. The humeral theads are manufactured from cobalt-chrome-molybdenum (CoCrMo) alloy and are offered in both concentric and eccentric configurations. The humeral head may onered in both contral glenoid bone if it is of sufficient quality, or against the all antionate against the naturanid. The glenoid is manufactured from ultra high polycthylone oomonton gronone (UHMVPE) and is offered in a keeled and pegged molecular weight porychylons (Ornaare designed to function with both the concentric and eccentric heads.

The provided document is a 510(k) summary for a medical device (Ascension® Modular Total Shoulder System) and primarily focuses on establishing substantial equivalence to predicate devices through design, function, and laboratory testing. It does not describe a study involving a comparison of device performance against pre-defined acceptance criteria related to a specific diagnostic or clinical efficacy outcome that would typically apply to AI/ML or imaging devices.

Instead, the "acceptance criteria" and "study" in this context refer to the engineering and biocompatibility tests conducted to demonstrate that the new device is as safe and effective as the predicate devices. The "performance" being reported is the outcome of these engineering tests, not a clinical diagnostic performance.

Therefore, many of the requested categories in your prompt related to diagnostic studies (sample size for test set, data provenance, number of experts, adjudication, MRMC, standalone performance, type of ground truth, training set size, how training ground truth was established) are not applicable to this type of device submission.

Here's an adaptation of your requested table and information based on the content available:

1. Table of Acceptance Criteria and Reported Device Performance

Study Description:

The study conducted to demonstrate the device meets the acceptance criteria was primarily a series of benchtop engineering tests and a geometrical comparison to establish substantial equivalence with legally marketed predicate devices.

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

• Test Set Sample Size: Not applicable in the context of human subjects or imaging data. The "sample size" refers to the number of device components or assemblies tested for each engineering test. Specific numbers were not provided in the summary, but standard engineering practices would dictate sufficient samples for valid statistical analysis for each test type.
• Data Provenance: The data originates from laboratory testing performed by or for Ascension Orthopedics, Inc. The location of the testing facility is not specified, but it's internal to the device development and regulatory submission process. It is prospective in the sense that these tests were specifically designed and executed for the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in this context is determined by engineering specifications, material properties, and established test standards (e.g., ASTM or ISO standards for orthopedic implants), not by clinical experts interpreting data.

4. Adjudication method for the test set: Not applicable. The "adjudication" is based on objective measurements and comparison against predefined engineering performance limits or performance of predicate devices, not on expert consensus.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, an MRMC study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of images or other data, which is not the case for an orthopedic implant's substantial equivalence submission based on mechanical testing.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, a standalone performance study was not done. This concept is specific to AI/ML algorithms, not to mechanical orthopedic implants.

7. The type of ground truth used:

• Engineering Specifications: Performance standards derived from industry norms (e.g., ISO, ASTM for orthopedic implants) and the known performance characteristics of the predicate devices.
• Predicate Device Performance: The primary "ground truth" for showing substantial equivalence is the established safety and effectiveness profile of the predicate devices (Smith & Nephew/PLUS PROMOS Modular Shoulder System and Osteonics' All Polyethylene Glenoid Shoulder Keeled Components). The new device's performance in mechanical tests is compared against that of these predicates.

8. The sample size for the training set: Not applicable. There is no "training set" in the context of an AI/ML algorithm for this type of device submission. The design and manufacturing process are analogous to "training" in the sense of refinement and optimization, but not in the data-driven AI sense.

9. How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) submission is for an orthopedic implant, where substantial equivalence is demonstrated through engineering characterization and comparison to predicate devices, rather than through clinical diagnostic performance studies typically associated with AI/ML or imaging devices. Therefore, many of your specific questions are not relevant to the type of data presented in this 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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Prosthetic replacement with this device may be indicated for the treatment of severe pain or significant disability in degenerative, theumatoid, or traumatic disease of the glenohumeral joint; ununited humeral head fractures of long duration; irreducible 3- and 4-part proximal humeral fractures; avascular necrosis of the humeral head; or other difficult clinical management problems where arthrodesis or resectional arthroplasty is not acceptable. The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component for total shoulder arthroplasty. Humeral heads with heights greater than 27 mm may be used for difficult clinical management problems involving rotator cuff deficiency where arthrodesis or conventional nonconstrained arthroplasty is not acceptable.

The New Zimmer Shoulder features modular and monoblock cobalt-chrome alloy humeral stems intended for use with or without cement in total shoulder arthroplasty. The cobaltchrome alloy humeral heads feature female Morse-type tapers which facilitate assembly with the modular humeral stems. The keeled glenoid component is manufactured from UHMWPE. It is intended for cemented use only.

The provided text describes a 510(k) submission for the "New Zimmer Shoulder System." This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to legally marketed predicate devices.

Here's an analysis based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria or specific numerical performance metrics for the New Zimmer Shoulder System. Instead, it states:

2. Sample Size for the Test Set and Data Provenance

The document does not provide details on the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective). The "Performance Testing" section states that "Testing performed on the taper and the glenoid component demonstrated that the New Zimmer Shoulder System is safe and effective and substantially equivalent to predicate devices," but it does not specify what type of testing or how many samples were involved.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not mention the use of experts to establish ground truth or their qualifications. The testing described appears to be device-specific mechanical or functional testing rather than clinical evaluation requiring expert consensus on patient data.

4. Adjudication Method for the Test Set

No adjudication method is mentioned, as there is no indication of human-reviewed test sets or expert evaluations requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned. The document focuses on demonstrating substantial equivalence through component testing, not direct comparison of human reader performance with and without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This is not applicable as the device is a physical shoulder joint prosthesis, not an AI algorithm.

7. Type of Ground Truth Used

The "ground truth" for this device would be based on engineering specifications, material science standards, and biomechanical parameters that define the safety and effectiveness of the components (taper and glenoid). The summary indicates that the testing demonstrated "safe and effective and substantially equivalent to predicate devices," implying that the performance was measured against established standards for shoulder prostheses.

8. Sample Size for the Training Set

This is not applicable as the device is a physical shoulder prosthesis, not an AI algorithm requiring a training set.

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

This is not applicable as the device is a physical shoulder prosthesis, not an AI algorithm.

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