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The Titan™ Reverse Shoulder System is indicated for use in a grossly deficient rotator cuff joint with severe arthropathy or a previous failed joint replacement with a grossly deficient rotator cuff joint. 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 glenoid base plate is intended for cementless application with the addition of screws for fixation.
The humeral stem is indicated for cemented or uncemented use and the humeral body component is intended for cementless use.

The Integra TITAN Reverse Shoulder System is a modular shoulder prosthesis system. The humeral components consist of humeral stems, varying heights of reverse bodies, and humeral poly liners. The poly liners are available in varying thicknesses and constraints to achieve stability and offset of the glenohumeral joint. The variable length reverse bodies and proximally-filling shape are designed to accommodate the natural humeral geometry, providing stable fixation as well as proximal bone loading. The glenoid components are composed of a baseplate secured by a central compression screw and 4 peripheral screws, two of which can be locked. A glenosphere is attached to the baseplate via taper lock. Glenospheres are available in varying offsets and lateralizations.

The provided document describes the Integra TITAN Reverse Shoulder System, a medical device. The information details nonclinical testing performed to establish substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria in a clinical or AI-assisted diagnostic context.

Therefore, the following information, as requested in the prompt, is not available in the provided text:

• A table of acceptance criteria and reported device performance (in a diagnostic context)
• Sample size used for the test set and data provenance (for diagnostic performance)
• Number of experts used to establish ground truth for the test set
• Qualifications of those experts
• Adjudication method
• If a multi reader multi case (MRMC) comparative effectiveness study was done
• Effect size of human readers improving with AI vs without AI assistance
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for a diagnostic algorithm
• The sample size for the training set (for a diagnostic algorithm)
• How the ground truth for the training set was established (for a diagnostic algorithm)

However, I can extract information regarding the nonclinical performance testing that was conducted for the device. The document explicitly states: "Clinical performance data were not necessary to support substantial equivalence." This means no human clinical trials (as one might expect a diagnostic AI to undergo) were presented for this 510(k) submission.

Here's what can be extracted about the device's nonclinical performance:

Nonclinical Testing and Acceptance Criteria:

The Integra TITAN Reverse Shoulder System underwent several nonclinical performance tests to confirm its ability to perform under expected clinical conditions. The acceptance criteria for each test are implicitly met as the summary states the "System met all acceptance criteria" or "is acceptable" for each respective test.

Additional Notes:

• Sample Size (for nonclinical tests): The document does not specify the exact sample sizes (number of units tested) for each nonclinical test, but refers to "worst-case components or constructs" being tested.
• Data Provenance (for nonclinical tests): These are laboratory-based engineering tests, not clinical data from patients or a specific country.
• Ground Truth (for nonclinical tests): The ground truth for these tests is based on established engineering principles, biomechanical justification, industry standards (e.g., ASTM F2009-00(2011)), and FDA guidance documents.
• Training Set (for nonclinical tests): This concept does not apply to the nonclinical testing described. These are physical performance assessments against predefined engineering parameters.

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Smith & Nephew Shoulder Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Shoulder Systems and their cleared Indications for Use.

Indications for Shoulder Replacement:
Proximal Humeral Prosthesis

1. Complex, acute fractures or fracture-dislocations of the humeral head (e.g., trauma-three and four-part injuries in the Neer classification, or head-splitting, or head impression fractures).
2. Complex, chronic fractures or fracture-dislocations of the humeral head with malunion, nonunion of a small osteoporotic head fragment, or chronic dislocation with loss of humeral head cartilage, or large impression fractures.
3. Avascular necrosis with intact glenoid cartilage.
4. Selected patients with arthritis who do not have adequate scapular bone to support a glenoid component or who must engage in moderately heavy activities.

Total Shoulder Arthroplasty:
Severe destruction of the glenohumeral articular surfaces with intractable chronic pain in rheumatoid arthritis, osteoarthritis, traumatic arthritis, cuff tear arthroplasty, ancient septic arthritis, avascular necrosis with secondary glenoid changes, radiation necrosis, and other failed reconstructive procedures

Indications for the PROMOS Modular Shoulder System (Standard):

• Advanced wear of the shoulder joint due to degenerative, post-traumatic or inflammatory arthritis
• Avascular necrosis of the humeral head
• Complex fractures of the proximal humerus
• Functional impairment especially in the case of post-traumatic loss of the joint configuration

Indications for the PROMOS Modular Shoulder System (Reverse):

• The PROMOS Reverse Shoulder is indicated for use in a grossly deficient rotator cuff joint with severe arthropathy or a previous failed joint replacement with a grossly deficient rotator cuff joint
• 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.

Subject of this Traditional 510(k) Premarket Notification are the Smith & Nephew, Inc. Shoulder System Instruments. The subject devices are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Shoulder Systems and their cleared Indications for Use. Smith & Nephew Shoulder System Instruments can be organized into instrument families which are categorized as follows: Trials, Guides, Insertion, Holding, Impactors, and Cutting Instruments.

This 510(k) summary for the Smith & Nephew Shoulder System Instruments does not contain information regarding acceptance criteria or a study proving the device meets those criteria. The document is a premarket notification for surgical instruments, and its primary purpose is to establish substantial equivalence to predicate devices, not clinical performance for the instruments themselves.

Therefore, I cannot fulfill your request for the specific details about acceptance criteria and studies as they are not present in the provided text.

Based on the content analysis, here's what can be inferred about why this information is missing and what the document does address:

• Device Type: The "Smith & Nephew Shoulder System Instruments" are described as "accessory devices" intended to "assist in the implantation" of other cleared Smith & Nephew Shoulder Systems. They are not the implantable devices themselves, but rather the tools used during surgery.
• Regulatory Pathway: This is a Traditional 510(k) Premarket Notification. For accessory devices or instruments that are largely mechanical and support the use of already cleared implantable devices, the FDA typically focuses on demonstrating "substantial equivalence" to existing, legally marketed predicate devices.
• Substantial Equivalence Justification: The document explicitly states the basis for substantial equivalence (Page 3):
  • Share the same raw materials.
  • Are manufactured through the same processes.
  • Utilize the same sterilization procedures.
  • Have similar nature of body contact.
    It further asserts that "The Smith and Nephew Shoulder System Instruments are similar in design and function to competing shoulder surgical instrumentation on the market."

Missing Information:

Since this document is a 510(k) for surgical instruments demonstrating substantial equivalence, it does not typically include:

1. Acceptance Criteria Table & Performance Results: These are usually for implantable devices or diagnostics where clinical performance metrics (e.g., accuracy, sensitivity, specificity, mechanical strength against specific standards) are directly relevant. For instruments, the "performance" is inherently linked to their ability to facilitate the implantation of the main device, and this is typically assumed if they are substantially equivalent to existing instruments.
2. Sample Size for Test Set, Data Provenance, Expert Ground Truth, Adjudication Methods: These details are specific to clinical studies or performance testing, which are generally not required for basic surgical instruments under a substantial equivalence pathway.
3. MRMC Comparative Effectiveness Study: This is for evaluating changes in human reader performance with AI assistance, which is entirely irrelevant to surgical tools.
4. Standalone (Algorithm Only) Performance: Also irrelevant, as these are physical instruments, not an algorithm.
5. Type of Ground Truth: Not applicable, as there's no diagnostic output or measurement being made by the instruments themselves that would require a ground truth.
6. Training Set Sample Size & Ground Truth: These are related to machine learning models, which are not involved here.

In summary, the provided document focuses on demonstrating that the manufacturing process, materials, and intended function of these new surgical instruments are similar enough to existing, legally marketed instruments that they do not raise new questions of safety and effectiveness. Clinical performance studies with explicit acceptance criteria are not typically part of this specific regulatory submission type for this class of device.

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