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The Duocentric® Reversed shoulder prosthesis is indicated for use in case of gross rotator cuff deficiency including when it is associated with osteoarthritis, revision of previous arthroplasty or complex fracture of the humerus (3 fragments or more) in an older population (e.g. 65 years of age or older).

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 humeral stem is intended for use with cement when polished or without cement when coated with Hydroxyapatite. All other components are intended for cementless use only. The glenoid baseplate is intended for cementless application with the addition of three screws for fixation. It is coated with a double layer of pure Titanium and Hydroxyapatite on its posterior side.

The additional component bail out head is intended when, during primary surgery for the Duocentric® Reversed shoulder prosthesis 1) the glenoid bone stock appears to be insufficient to bear the implant of the glenoid components, or 2) the glenoid bone fractures intra-operatively.

The Duocentric® Reversed shoulder prosthesis is a prosthesis that uses the biomechanical concepts of reverse shoulder arthroplasty as originally described by Paul Grammont.

The Duocentric® Reversed shoulder prosthesis is composed of a humeral stem, a humeral baseplate, a humeral insert, a gleonosphere (Duoglene), and a glenoid baseplate already cleared under K103251. It also includes a "bail out head" for use during rare occasions during surgery to salvage the procedure.

The humeral insert is made of ultra-high-molecular-weight polyethylene (UHMWPE), while all other components are made of wrought high nitrogen stainless steel M30NW. The humeral stem is intended for cemented use unless coated with hydroxyapatite (HA). The glenoid baseplate is coated with a double coating of pure titanium and hydroxyapatite (Ti/HA), is intended for cementless use, and is fixated with wrought high nitrogen stainless steel screws. The device is provided sterile.

The HA and Ti/HA coatings conform to ASTM standards ASTM F1185, ASTM F1609, and ASTM F1580 and are performed by Medical Coating'(Vault-en-Velin, FR) according to their Master File MAF-1633.

This submission includes an additional component, a bail out head. This additional component is included to provide a solution to the surgeon 1) when during the primary surgery, the glenoid bone stock appears to be insufficient to bear the implant of the glenoid components or 2) glenoid bone fracture occurs intra-operatively.

This document does not contain information about acceptance criteria or a study that proves a device meets them, as it is a 510(k) premarket notification for a medical implant (a shoulder prosthesis).

Here's a breakdown of why this type of document doesn't fit the request and what information it does provide:

Key Takeaway: The provided text is a 510(k) summary for a medical device (a shoulder prosthesis). The purpose of a 510(k) is to demonstrate substantial equivalence to an already legally marketed predicate device, not necessarily to prove adherence to specific performance acceptance criteria for a novel device through a standalone study with defined accuracy metrics. Therefore, most of the requested information regarding acceptance criteria, study design, ground truth, and sample sizes for performance evaluation of a device (in the context of AI or diagnostic systems) is not present.

However, I can extract information related to the device and its regulatory submission:

Device Information:

• Trade/Device Name: Duocentric® Reversed Shoulder Prosthesis
• Regulation Number: 21 CFR 888.3660
• Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis
• Regulatory Class: Class II
• Product Code: PHX, KWS, HSD
• Indications for Use: Gross rotator cuff deficiency (including with osteoarthritis), revision of previous arthroplasty, or complex fracture of the humerus (3 fragments or more) in an older population (e.g., 65 years or older). Requires anatomically and structurally suited joint and a functional deltoid muscle.
• Components: Humeral stem, humeral baseplate, humeral insert, gleonosphere (Duoglene), glenoid baseplate, and an additional "bail out head."
• Materials: Humeral insert (UHMWPE), other components (wrought high nitrogen stainless steel M30NW). Glenoid baseplate coated with double layer of pure Titanium and Hydroxyapatite (Ti/HA). Humeral stem either polished (cemented) or HA coated.
• Sterilization: Provided sterile.

Information Related to Substantial Equivalence and Performance (as described in the document):

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

   • This document does not present acceptance criteria in terms of specific performance metrics (like sensitivity, specificity, or accuracy) derived from a clinical study for a diagnostic or AI device. Instead, the "performance" demonstrated is substantial equivalence to predicate devices based on design, materials, manufacturing, and preclinical testing results.
   • The closest to "performance" stated is: "Pre-clinical performance testing concluded that the Duocentric® Reversed shoulder finished product with its bail-out head met all predetermined specifications and are adequate for their intended use." However, the document does not list these specific predetermined specifications or the exact results.

2. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not applicable. This is not a study assessing the performance of a diagnostic algorithm or AI system on a test set of data. The assessment is primarily mechanical and material.
   • Data Provenance: Not applicable in the context of a "test set" for diagnostic performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. There is no "ground truth" derived from expert consensus in the context of assessing the performance of this orthopedic implant.

4. Adjudication method (e.g., 2+1, 3+1, none) 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-assisted diagnostic device.

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

   • Not applicable.

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

   • Not applicable. For this type of device, ground truth relates to mechanical integrity, biocompatibility, and manufacturing quality standards, not diagnostic outcomes. The "ground truth" for showing safety and effectiveness in a 510(k) is typically demonstrated by meeting recognized standards (e.g., ASTM standards for materials and coatings) and showing equivalence to devices with a known safety and effectiveness profile.

8. The sample size for the training set:

   • Not applicable. This is not an AI-based device that requires a training set.

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

   • Not applicable.

What the document does say about "performance testing":

• "An engineering analysis analyze the requirements for pre-clinical testing associated with the inclusion of the additional component."
• "Testing results from K103251 remained applicable." (Referring to the predicate device)
• "Pre-clinical performance testing concluded that the Duocentric® Reversed shoulder finished product with its bail-out head met all predetermined specifications and are adequate for their intended use."
• Clinical data were not required for this device. This is a crucial point, indicating that substantial equivalence was demonstrated through non-clinical means (engineering analysis, material testing, comparison to predicates) rather than a clinical trial directly assessing patient outcomes or diagnostic accuracy.
• Material and Coating Standards: The HA and Ti/HA coatings conform to ASTM standards ASTM F1185, ASTM F1609, and ASTM F1580. This is a form of "acceptance criteria" for raw materials and processes, confirmed by Medical Coating's Master File MAF-1633.

In summary, for a medical implant like the Duocentric® Reversed Shoulder Prosthesis seeking 510(k) clearance, the "study" is primarily a demonstration of substantial equivalence through engineering analysis, adherence to material standards, and leveraging existing data from predicate devices, rather than a clinical performance study with statistical metrics typically associated with AI or diagnostic device evaluation.

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Implantation of a joint prosthesis is to be considered only when all other surgical options have been carefully examined and found less appropriate.

The Duocentric® Reversed shoulder prosthesis is indicated for use in case of gross rotator cuff deficiency including when it is associated with osteoarthritis, revision of previous arthroplasty or complex fracture of the humerus (3 fragments or more) in an older population (e.g. 65 years of age or older).

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 humeral stem is intended for use with cement when polished or without cement when coated with Hydroxyapatite. All other components are intended for cementless use only. The glenoid baseplate is intended for cementless application with the addition of three screws for fixation. It is coated with a double layer of pure Titanium and Hydroxyapatite on its posterior side.

The Duocentric® Reversed shoulder prosthesis is a prosthesis that uses the biomechanical concepts of reverse shoulder arthroplasty as originally described by Paul Grammont.

The Duocentric® Reversed shoulder prosthesis is composed of a humeral stem, a humeral baseplate, a humeral insert, a gleonosphere (Duoglene), and a glenoid baseplate. The humeral insert is made of ultra-high-molecular-weight polyethylene (UHMWPE), while all other components are made of wrought high nitrogen stainless steel M30NW. The humeral stem is intended for cemented use unless coated with hydroxyapatite (HA). The glenoid baseplate is coated with a double coating of pure titanium and hydroxyapatite (Ti/HA), is intended for cementless use, and is fixated with wrought high nitrogen stainless steel screws. The device is provided sterile.

The HA and Ti/HA coatings conform to ASTM standards ASTM F1185, ASTM F1609, and ASTM F1580 and are performed by Medical Coating (Vault-en-Velin, FR) according to their Master File MAF-1633.

This document is a 510(k) premarket notification for the Duocentric® Reversed Shoulder Prosthesis. It does not contain information about acceptance criteria or a study proving device performance in the way typically seen for AI/ML-based medical devices, as it is a traditional medical device (implant). Therefore, I will extract relevant information from the document that is analogous to the requested criteria for traditional medical devices.

Here's the breakdown based on the provided text, interpreting the request for a traditional medical device:

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

   • Acceptance Criteria (Implicit Standard): The device (Duocentric® Reversed shoulder prosthesis) must meet predetermined specifications and be adequate for its intended use. This is common for traditional medical devices, where "specifications" often relate to mechanical properties, material integrity, and design functionality.
   • Reported Device Performance: "Pre-clinical performance testing concluded that the Duocentric® Reversed shoulder finished product and its components met all pre-determined specifications and are adequate for their intended use."

   Acceptance Criteria (Implicit)	Reported Device Performance
   Device meets all pre-determined specifications.	Pre-clinical performance testing concluded the device and its components met all pre-determined specifications.
   Device is adequate for its intended use.	Pre-clinical performance testing concluded the device and its components are adequate for their intended use.
   Materials conform to ASTM standards.	HA and Ti/HA coatings conform to ASTM standards ASTM F1185, ASTM F1609, and ASTM F1580.
   Does not raise new issues of safety and effectiveness.	The subject device does not raise any new issues of safety and effectiveness (as compared to predicate devices).
   Comparable to predicate devices in specific aspects.	Substantially equivalent to predicate devices based on similarities in indications for use, materials, dimensions, design, packaging and sterilization.

2. Sample size used for the test set and the data provenance

   • Sample Size: Not specified in terms of a "test set" for performance evaluation in the context of clinical data. The performance mentioned refers to "pre-clinical performance testing," which typically involves bench testing of components and assemblies. The number of physical units tested is not provided.
   • Data Provenance: The pre-clinical testing data would be generated in a lab setting, likely in France (where Aston Medical is located). The document also mentions "post-market data" from Europe starting in 2003, indicating real-world usage data, but this is not the primary basis for the pre-market submission's performance claim.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

   • This is not applicable to this type of device submission. The "ground truth" for a mechanical implant is established through engineering and material science standards and testing, not expert clinical interpretation of data in the same way an AI diagnostic tool would.

4. Adjudication method for the test set

   • Not applicable. Adjudication methods like 2+1 or 3+1 are used for human expert review in diagnostic studies, which is not relevant here. Determining if mechanical specifications are met is typically done through measurement and comparison to predefined tolerances.

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 a mechanical implant, not an AI-assisted diagnostic tool involving human readers.

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

   • Not applicable. This is a mechanical implant, not an algorithm.

7. The type of ground truth used

   • For the pre-clinical performance testing, the "ground truth" is defined by engineering specifications, material standards (e.g., ASTM F1185, ASTM F1609, ASTM F1580), and functional requirements for the device and its components. These are objective, measurable criteria.
   • The submission also references post-market data from Europe (since 2003) which "has shown to be safe and effective," indicating real-world clinical outcomes as a type of ground truth, but this wasn't the main pre-market evidence.

8. The sample size for the training set

   • Not applicable. This is a traditional medical device, not an AI/ML model that requires a training set.

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

   • Not applicable. As above, this device does not use a training set.

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