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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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