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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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The Promos Modular Shoulder System is indicated for:

• Advanced degeneration of the shoulder joint as a result of degenerative, post-traumatic or . inflammatory arthritis '
• Avascular necrosis of the humeral head o
• Complex fractures of the proximal humerus
• Complex freetarse of the precially in the case of post-traumatic loss of the joint configuration .

The humeral component is intended for cemented or cementless use. The glenoid component is for use with bone cement only

The Promos Modular Shoulder System, as cleared via premarket notification K063578, consists of two primary components: the glenoid component and the modular humeral component. The modular humeral component consists of a distal stem, body, inclination set, and humeral head. Subject of this premarket notification is a review of changes to the Promos inclination set. No changes will be made to the glenoid, humeral head, body, or distal stem as a result of this premarket notification. Modifications to the inclination set components are intended to increase the overall strength and stability of the construct. The design concept remains the same, and the inclination set continues to mate with the humeral head and proximal body in the same way.

The modified devices consist of three components: internal cone, sleeve, and set screw. The subject inclination sets are manufactured from Ti-6Al-4V material conforming to ISO 5832-3 and are available in four sizes.

The provided document describes a 510(k) premarket notification for the Promos Modular Shoulder System. This notification focuses on modifications to the inclination set components of an already cleared device, intended to increase overall strength and stability. The submission highlights mechanical testing as the basis for demonstrating safety and effectiveness, and no clinical data or studies comparing AI to human performance were conducted as this is a device modification submission.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that "A review of this testing has demonstrated that there are no new issues related to the safety and effectiveness of the subject devices." Specific quantitative acceptance criteria or threshold values for the mechanical tests are not detailed in this summary.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not specify the exact sample size (number of units tested) for each mechanical test. It generally refers to "mechanical data" and "mechanical testing."
• Data Provenance: The data is generated from retrospective mechanical testing performed on the modified Promos Modular Shoulder System components. The country of origin for the testing data is not explicitly stated but is implicitly within the scope of Smith & Nephew's internal development and testing processes, likely in the US or where their manufacturing/R&D facilities are located.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• Not Applicable. This submission is for a medical device modification based on mechanical performance, not a diagnostic or AI-driven system requiring expert assessment of a test set for ground truth. The "ground truth" here is the physical performance of the device against engineering standards.

4. Adjudication Method for the Test Set

• Not Applicable. As per point 3, there is no expert-adjudicated test set in the context of this 510(k) submission. Mechanical test results are interpreted against established engineering principles and standards.

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

• No. A MRMC comparative effectiveness study was not conducted. This is a submission for a mechanical device modification, not a diagnostic or AI-assisted system. No human readers or AI assistance are involved in the performance evaluation described.

6. Standalone (Algorithm Only) Performance Study

• No. A standalone performance study of an algorithm was not conducted. This submission pertains to a physical medical device.

7. Type of Ground Truth Used

• Engineering Standards and Mechanical Properties. The ground truth for evaluating the device's performance is based on established engineering principles, material properties, and mechanical test standards (e.g., ISO 5832-3 for Ti-6Al-4V material). The "review of mechanical data" against expected in vivo loading conditions serves as the basis for determining safety and effectiveness.

8. Sample Size for the Training Set

• Not Applicable. This is a mechanical device submission. There is no "training set" in the context of algorithm development. The design and manufacturing processes are iterative but do not involve machine learning training sets.

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

• Not Applicable. As per point 8, there is no training set for which ground truth would need to be established.

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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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