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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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This total shoulder prosthesis is intended for treatment of patients who are candidates for total shoulder arthroplasty because the natural humeral head and/or glenoid has been affected by osteoarthritis, inflammatory arthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis or proximal humeral fracture, and revision arthroplasty where bone loss is minimal. This system includes a humeral stem and head and is to be used with bone cement. These devices are intended to aid the surgeon in relieving the patient of shoulder pain and restoring shoulder motion.

The glenoid is fabricated from UHMWPE (ASTM F648). The articulating surface has a radius of curvature greater than the corresponding humeral head. This mismatch between the glenoid and humeral head to allows for translation of the head in the superior/inferior and anterior/posterior directions. The back surface of the component is spherical in geometry and has either a keel or three pegs for fixation in the glenoid. These glenoid components are 4 mm thick and available in five sizes for each component, the keeled and pegged components.

This looks like a 510(k) premarket notification for a medical device submitted to the FDA in 1996. The provided text is a "Summary of Safety and Effectiveness" which focuses on describing the device and its intended use, along with identifying predicate devices.

Disclaimer: Based on the provided text, it's highly unlikely that a medical device submission from 1996 for a glenoid component would include the detailed performance study information you're asking for, especially concerning AI/machine learning aspects. The regulatory landscape and technological capabilities were vastly different then.

However, I will extract what I can from the provided text and then make educated assumptions or state where the information isn't available from the given submission for the remaining criteria, particularly focusing on the spirit of your request (i.e., how modern device submissions address these points).

Analysis of K960906 and Response to Your Request:

The provided document (K960906) is a premarket notification for a medical device (Glenoid Component for the Foundation™Total Shoulder System) submitted in 1996. This type of submission, especially from that era, typically focuses on demonstrating substantial equivalence to a predicate device through material composition, design, and intended use, rather than extensive clinical performance studies as would be expected for novel AI/ML-driven devices today.

Therefore, much of the information you've requested regarding AI performance, expert adjudication, MRMC studies, and detailed ground truth methodology is not present and not applicable to this specific submission from 1996. The "study" proving the device meets acceptance criteria for this type of device and era would primarily involve engineering testing (e.g., mechanical strength, wear testing) and comparison to predicate devices, rather than clinical efficacy studies with human readers or AI.

Here's a breakdown of your requested information based on the provided text and general knowledge of 1996 510(k) submissions:

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

• Spherical back surface
• Keel or three pegs for fixation
• 4 mm thick
• 5 sizes | - Articulating surface has a radius of curvature greater than the corresponding humeral head.
• Back surface spherical geometry with keel or three pegs.
• 4 mm thick, 5 sizes for each component type. - Meets |
  | Intended Use | - Treatment for osteoarthritis, inflammatory arthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis, proximal humeral fracture.
• Revision arthroplasty with minimal bone less.
• Used with bone cement.
• Relieve pain, restore motion. | - Intended for these conditions and revision arthroplasty.
• To be used with bone cement.
• Intended to aid in relieving pain and restoring motion. - Meets (based on comparison to predicate) |
  | Substantial Equivalence | Comparison to predicate devices (Kirshner Neer II™ Glenoid Component, Intermedics Select™ Shoulder Glenoid Component) | Product description suggests equivalence in design principles and materials to known predicate devices. - Demonstrated (implied by 510(k) clearance) |
  | Biocompatibility | (Not specified, but standard for UHMWPE implants) | (Assumed to meet ISO 10993 or equivalent standards for the time, based on material) |
  | Mechanical Performance | (Not specified, but typically includes fatigue, wear, strength testing) | (Assumed to meet relevant ASTM or internal standards, based on predicate equivalence) |

Note: For a 1996 device like this, "performance" would primarily relate to its physical and mechanical properties, and its functional similarity to proven predicate devices. There would not be "reported device performance" in terms of diagnostic accuracy or clinical outcomes as you would see for an AI device.

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

This information is not applicable and not present in the provided 1996 510(k) document. A glenoid component is a mechanical implant; its regulatory approval primarily relies on engineering testing and comparison to predicate devices, not on a "test set" of clinical data in the way an AI diagnostic device would.

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)

This information is not applicable and not present in the provided 1996 510(k) document. "Ground truth" in this context would relate to engineering specifications and material properties, not expert clinical interpretation.

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

This information is not applicable and not present in the provided 1996 510(k) document. Adjudication methods are relevant for clinical trials or diagnostic performance studies, not for the material and design evaluation of a mechanical implant in a 1996 510(k).

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 information is not applicable and not present in the provided 1996 510(k) document. MRMC studies and AI assistance were not part of the regulatory framework for this type of device in 1996.

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

This information is not applicable and not present in the provided 1996 510(k) document. This device is a physical implant, not an algorithm.

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

For this type of device, "ground truth" during its approval process would be primarily:

• Engineering Specifications and Standards: Material properties (e.g., F648 for UHMWPE), dimensional tolerances, mechanical load capabilities defined by standards or internal testing.
• Predicate Device Equivalence: The functional and safety characteristics of the established predicate devices served as a benchmark for equivalence.
• Biocompatibility Testing: Results from in vitro or in vivo biocompatibility tests (not detailed in this summary).

8. The sample size for the training set

This information is not applicable and not present in the provided 1996 510(k) document. "Training set" is a concept for machine learning models, which is irrelevant for this mechanical orthopedic implant.

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

This information is not applicable and not present in the provided 1996 510(k) document. As there is no "training set," there is no ground truth for it.

Conclusion:

The provided K960906 document details a 1996 510(k) for a glenoid component. The information requested regarding AI performance metrics, expert adjudication, MRMC studies, and detailed data provenance is characteristic of modern AI/ML device submissions, which were not a regulatory consideration or technological reality for this type of mechanical implant in 1996. The "study" for this device mostly involved demonstrating substantial equivalence to predicate devices through design comparison, material verification, and likely mechanical testing, none of which are explicitly detailed in this summary document beyond the device description itself.

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