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The DYNASTY® BIOFOAM® Shells are intended for use in cementless total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.
Indications for Use

• non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
• inflammatory degenerative joint disease such as rheumatoid arthritis;
• correction of functional deformity; and,
• revision procedures where other treatments or devices have failed.
  The DYNASTY® BIOFOAM® Shell is intended for cementless hip arthroplasty.

Design features of the shells are summarized below:

• Shells manufactured from Titanium alloy substrate, coated with BIOFOAM® coating ● manufactured from commercially pure (CP) titanium
• Solid shell sizes: 46mm-68mm outer diameter
• Three different hole patterns:
• 10-hole shell sizes: 46mm-76mm outer diameter
• 3-hole shell sizes: 46mm-68mm outer diameter
• 5-hole shell sizes: 46mm-50mm outer diameter

The provided text is a 510(k) summary for the DYNASTY® BIOFOAM® Shell, an acetabular cup for hip arthroplasty. It focuses on demonstrating substantial equivalence to predicate devices rather than reporting the results of a primary clinical study with acceptance criteria and device performance. Therefore, the requested information about acceptance criteria and study details cannot be fully extracted from the provided text.

Specifically, the document states:

• "The subject DYNASTY® BIOFOAM® Shells were cleared in K121544 for use with metal/metal bearings. The shells are identical to shells in K082924, except that the subject device posses different screw hole patterns. Additionally, the DYNASTY® BIOFOAM® Shells were evaluated via post-impaction analysis of clearance, form and frictional torque. A review of these results concludes that the DYNASTY® BIOFOAM® Shells were cleared in K121544 and are equivalent to predicate devices."
• "The safety and effectiveness of the subject DYNASTY® BIOFOAM® Shells are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification."

This indicates that the device was evaluated through bench testing (post-impaction analysis of clearance, form, and frictional torque) and comparison to predicate devices, not through a clinical study that would establish clinical acceptance criteria and report device performance in human subjects.

Therefore, most of the requested fields related to a clinical study (sample size, data provenance, experts for ground truth, adjudication, MRMC study, standalone performance, type of ground truth, training set details) are not applicable or not provided in this type of regulatory submission.

However, based on the provided text, here's what can be inferred or stated:

Acceptance Criteria and Device Performance (Bench Test/Equivalence)

Study Details (for this 510(k) submission):

1. Sample size used for the test set and the data provenance: Not applicable for a clinical test set. The evaluation involved bench testing (post-impaction analysis) of the device components. The data provenance would be internal laboratory testing by the manufacturer.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for bench testing is typically based on engineering specifications and physical measurements, not expert clinical interpretation.
3. Adjudication method for the test set: Not applicable.
4. 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 medical device (hip implant) 510(k), not an AI diagnostic device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used: For the bench testing, the "ground truth" would be the engineering specifications and measurable physical properties of the device (clearance, form, frictional torque) compared against established design parameters or predicate device performance.
7. The sample size for the training set: Not applicable for this type of submission. There is no mention of an algorithm or training set.
8. How the ground truth for the training set was established: Not applicable.

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The DYNASTY® BIOFOAM® Shells are intended for use in cementless total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.

Indications for Use

• non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
• inflammatory degenerative joint disease such as rheumatoid arthritis;
• correction of functional deformity; and,
• revision procedures where other treatments or devices have failed.

The DYNASTY® BIOFOAM® Shell is intended for cementless hip arthroplasty.

Design features of the shells are summarized below:

• Shells manufactured from Titanium alloy substrate, coated with BIOFOAM® coating manufactured from commercially pure (CP) titanium
• Solid shell sizes: 46mm-68mm outer diameter
• Three different hole patterns:
  • 10-hole shell sizes: 46mm-76mm outer diameter
  • 3-hole shell sizes: 46mm-68mm outer diameter
  • 5-hole shell sizes: 46mm-50mm outer diameter

The DYNASTY® BIOFOAM® Shells are identical to previously cleared devices, except that the subject device posses different screw hole patterns. Additionally, the DYNASTY® BIOFOAM® Shells were evaluated via post-impaction analysis of clearance, form and frictional torque. A review of these results indicates that the DYNASTY® BIOFOAM® Shells are equivalent to predicate devices.

The provided text is related to a 510(k) summary for a medical device called the DYNASTY® BIOFOAM® Shell, an acetabular cup for hip arthroplasty. The document describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not describe any clinical study or testing with acceptance criteria and reported device performance in the way a typical AI/ML device submission would.

The core of this submission is based on substantial equivalence to previously cleared devices (DYNASTY® Acetabular System K082924). The key statement that replaces a detailed performance study is:

"The DYNASTY® BIOFOAM® Shells are identical to previously cleared devices, except that the subject device posses different screw hole patterns. Additionally, the DYNASTY® BIOFOAM® Shells were evaluated via post-impaction analysis of clearance, form and frictional torque. A review of these results indicates that the DYNASTY® BIOFOAM® Shells are equivalent to predicate devices."

And:

"The safety and effectiveness of the DYNASTY® BIOFOAM® Shells are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification."

Therefore, I cannot provide the requested information about acceptance criteria or a study proving the device meets them because such a study, with the specific details requested, is not present in this 510(k) summary. The submission relies on demonstrating equivalence through design and limited engineering analysis (post-impaction analysis).

Here's a breakdown of why this information is missing based on the document:

• No new clinical study: The document explicitly states the device is "identical to previously cleared devices, except that the subject device posses different screw hole patterns." This indicates that a comprehensive, new clinical performance study, often required for novel devices or significant changes, was not performed or deemed necessary.
• Reliance on Predicate Device Performance: The safety and effectiveness are established by the substantial equivalence to the predicate device (DYNASTY® Acetabular System, K082924). The performance of the predicate device is implicitly accepted.
• Limited "Evaluation" mentioned: The only "evaluation" mentioned is "post-impaction analysis of clearance, form and frictional torque." This is an engineering/benchtop test, not a clinical study involving patients or expert review. The document does not provide specific acceptance criteria or results for this analysis beyond stating it indicates equivalence.

In summary, the provided text does not contain the information required to answer your specific questions regarding acceptance criteria and a study proving their fulfillment, as it describes a 510(k) submission based on substantial equivalence and engineering analysis rather than a clinical performance study.

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