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A Delta Total shoulder prosthesis is indicated for use in: Grossly rotator cuff deficient joint with severe arthropathy or a previous failed joint replacement with a grossly rotator cuff deficient joint.

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 metaglene component is HA coated and is intended for cementless application with the addition of screws for fixation. All other components are intended for cemented use only.

The Delta Shoulder prosthesis is a modular total shoulder prosthesis that was designed specifically for use in patients with non-functional rotator cuffs. The articulation of this design is "inverted" compared to traditional total shoulder prosthesis. Unlike traditional total shoulder prosthesis, the Delta Shoulder is designed such that the "ball" of the articulation is incorporated into the glenoid prosthesis, and the "cup" of the articulation is incorporated in the humeral prosthesis. The distal surface of the metaglene components are coated with a hydroxyapatite coating (HA) and are intended to be used with 4 metaglene screws for fixation.

This 510(k) submission does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the manner typically associated with AI/ML-based medical devices.

Instead, this document pertains to a traditional medical device (a shoulder prosthesis) and focuses on demonstrating substantial equivalence to legally marketed predicate devices, as required for 510(k) clearance by the FDA. This regulatory pathway does not typically involve the kind of performance metrics, clinical studies, or AI/ML-specific validation often seen in submissions for software-as-a-medical-device (SaMD) or AI-enabled devices.

Here's why the requested information cannot be fully provided based on the given text:

• Device Type: The "Delta Shoulder" is a physical medical implant (a shoulder prosthesis), not an AI/ML diagnostic or prognostic tool. Therefore, the concept of "device performance" in terms of accuracy, sensitivity, or specificity against ground truth, as would be relevant for AI, does not apply in the same way.
• Regulatory Pathway: The 510(k) pathway for traditional devices primarily involves demonstrating that the new device is "substantially equivalent" to a legally marketed predicate device. This typically involves comparing indications for use, design, materials, sterilization, packaging, and often includes bench testing (e.g., mechanical strength, wear) and sometimes animal studies, but generally not human clinical trials with performance metrics against a defined ground truth as would be done for an AI algorithm.
• Content of the Document: The provided text is a 510(k) summary and the FDA clearance letter. It describes the device, its indications for use, identifies predicate devices, and states that substantial equivalence was determined based on "detailed device description, design rationale, product testing, literature and conformance with voluntary performance standards." However, it does not detail the specific "product testing" or "voluntary performance standards" in a way that allows for the extraction of acceptance criteria and reported performance metrics in the format requested for AI/ML devices.

Therefore, many of the requested fields are not applicable or cannot be extracted from this document.

However, I can extract the relevant information regarding the basis for clearance and what's available:

1. Table of acceptance criteria and the reported device performance:

• Similarity in Indications for Use: The device is intended for "Grossly rotator cuff deficient joint with severe arthropathy or a previous failed joint replacement with a grossly rotator cuff deficient joint," requiring an anatomically and structurally suited joint and a functional Deltoid muscle.
• Similarity in Design: Modular total shoulder prosthesis, "inverted" articulation (ball on glenoid, cup on humeral), HA-coated metaglene component for cementless application with screws, other components for cemented use.
• Similarity in Sterilization and Packaging.
• Product Testing: Not detailed, but typically involves mechanical and biocompatibility testing for implants.
• Literature and conformance with voluntary performance standards: Specific standards are not listed but are implied to have been met. |
  | Biocompatibility: | Implied to have been demonstrated through material selection and potentially testing, consistent with predicate devices and voluntary standards. |
  | Mechanical Performance: | Implied to have been demonstrated through "product testing" and "conformance with voluntary performance standards," ensuring the device can withstand physiological loads and wear over its intended lifespan, comparable to predicate devices. This typically includes fatigue, static strength, and wear testing, but specific results or acceptance criteria are not provided in this summary. |

The following points cannot be addressed from the provided text as they are not relevant to a 510(k) submission for a physical implant device in this context:

2. Sample sizes used for the test set and data provenance: No "test set" in the context of AI/ML performance evaluation is discussed. The validation is primarily against predicate devices and design verification.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for AI is not established here.
4. Adjudication method for the test set: Not applicable.
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-enabled device that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the AI/ML sense. The "ground truth" for a physical implant is typically its ability to function safely and effectively within the human body, assessed through engineering principles, preclinical testing, and post-market surveillance.
8. The sample size for the training set: Not applicable. No AI model is being trained.
9. How the ground truth for the training set was established: Not applicable.

In summary: The provided document is a 510(k) submission for a traditional, physical shoulder prosthesis. The "acceptance criteria" and "study" are framed around demonstrating substantial equivalence to existing devices through design comparison, product testing (not detailed here), and adherence to standards, rather than through performance metrics of an AI/ML algorithm against a ground truth.

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Total or hemi-shoulder replacement is indicated for:

1. A 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).
4. Rotator cuff tear arthropathy.

Hemi-shoulder replacement is also indicated for:

1. Ununited humeral head fractures;
2. Avascular necrosis of the humeral head.

The Global Fx porous-coated humeral stem is intended for cemented or cementless use with fixation provided by biological tissue in-growth into the porous coating.

Porocoat® Porous-Coated Components
Porocoat® Porous-coated humeral stem prostheses are indicated for cementless use with fixation provided by biological tissue in-growth into the porous coating.

Cemented Components
Humeral stem and Glenoid components labeled "For cemented use only" are indicated only for use with bone cement.

The Porous-coated Global Fx humeral stem is a modified Global Fx humeral stem. Porocoat® porous coating has been added to the proximal portion of the stem. The stem is manufactured from cobalt-chromium --molybdenum alloy conforming to ASTM F-75. The stem mates with humeral heads previously cleared as Global Advantage Head (K984541), Global Advantage CTA Heads (K000575) and the Global Advantage Eccentric Humeral Head (K992065).

This 510(k) summary is for a medical device called the "Global™ Fx Porous-Coated Humeral Stem." This document does not describe any acceptance criteria or studies proving the device meets performance criteria, but rather focuses on demonstrating substantial equivalence to a predicate device for marketing clearance.

Therefore, most of the requested information regarding acceptance criteria, device performance, and study details like sample size, ground truth, and expert involvement is not available within the provided text.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not Applicable. The document does not describe performance acceptance criteria for the device itself or report any performance metrics against such criteria. The focus is on demonstrating substantial equivalence to a predicate device, meaning it is considered safe and effective because it is very similar to an already legally marketed device.

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

• Not available. There is no test set described for evaluating the device's performance. The review is based on a comparison to a predicate device.

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 available. No ground truth establishment for a test set is mentioned.

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

• Not available. No test set or adjudication method 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 device is a physical shoulder implant and not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human reader improvement with AI is irrelevant.

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 and not an algorithm.

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

• Not available. No ground truth is described as there are no performance studies outlined here. The "ground truth" for regulatory clearance in this context is the predicate device's existing clearance, implying its safety and effectiveness.

8. The sample size for the training set:

• Not applicable/Not available. There is no "training set" in the context of this device, which is a physical implant. The substantial equivalence argument relies on engineering analysis and comparison to an existing device, not machine learning model training.

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

• Not applicable/Not available. As above, no training set is relevant here.

Summary of Device Comparison for Substantial Equivalence (the main "study" in this document):

• Predicate Device: Global Fx Humeral Stem (K984541)
• Key Similarity: Both humeral stems have identical locking tapers, are tapered in design, come in similar sizes, and are manufactured from the same materials (cobalt-chromium-molybdenum alloy conforming to ASTM F-75).
• Key Difference (and reason for this 510(k)): The addition of Porocoat® porous coating to the proximal portion of the new Global™ Fx Porous-Coated Humeral Stem.
• Outcome: The FDA found the device "substantially equivalent" to the predicate device, allowing it to be marketed. This decision is based on the similarities described and the understanding that the addition of porous coating for biological tissue in-growth (rather than cementless use) is well-understood and fits within the regulatory framework for similar devices.

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