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The Paragon™ Hip System is intended for use as the femoral component of a total hip replacement or partial hip replacement. This femoral hip stem is intended for uncemented fixation and single use implantation. This prosthesis may be used for the following conditions, as appropriate:

1. Degenerative osteoarthritis of the hip.
2. Inflammatory arthritis of the hip.
3. Secondary arthritis of the hip, such as may follow trauma (e.g. fracture of the femoral neck, or fracture and/or dislocation of the hip or acetabulum), or congenital conditions (e.g. developmental dysplasia of the hip).
4. Displaced intracapsular femoral neck fractures where there is a high risk of non-union or avascular necrosis and bone collapse.
5. Avascular Necrosis of the femoral head.
6. Revision of a failed femoral component from previous hip surgery e.g. internal fixation device from previous osteotomy, fracture treatment or hemi-arthroplasty.

The Paragon™ Hip System is to be used in conjunction with a compatible femoral head and acetabular component as part of a total hip arthroplasty, or as the femoral stem in a hemiarthroplasty. The body of the Paragon™ Hip System tapers proximal to distal in the lateral and frontal planes, and lateral to medial in the sagittal plane resulting in a bi-planar wedge geometry that is conducive to axial and rotational stability. The Paragon™ Hip System is manufactured from titanium alloy (Ti6A14V ELI per ASTM F136) and Hydroxyapatite (HA) (ISO 13779-1 for the HA powder and ISO 13779-2 for the coating).

The provided document does not describe the acceptance criteria or a study that proves the device meets acceptance criteria. Instead, it is a 510(k) summary for the Paragon™ Hip System, which focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through clinical studies.

The document states that "Preclinical Testing" was performed on the Paragon™ Hip System, including "Range of Motion, Stem Fatigue Testing, Neck Fatigue Testing, Burst Strength Testing when coupled with ceramic femoral heads, and characterization of the stem's HA coating." It also states that "The results support the substantial equivalence of the Paragon™ Hip System." However, it does not provide details on the specific acceptance criteria for these tests, nor does it present the detailed results of these tests.

Therefore, I cannot provide the requested information.

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The MSA Hip System is indicated for cementless use and is intended to replace a hip joint.

The device is intended for:

• skeletally mature individuals undergoing primary surgery for total hip replacement
• patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fracture of the femur.
• patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis
• patients suffering from disability due to previous fusion
• patients with acute femoral neck fractures

The MSA Hip System is a modular hip system consisting of a short stem which mates with a modular neck. The hip stems are made of Ti-6AI-4V (ASTM F136) with a commercially pure titanium plasma spray coating (ASTM F1580) on the proximal end. The stems are available with and without a hydroxyapatite coating. The modular necks are made of CoCr alloy (ASTM F1537). The MSA Hip System can be mated with metal or ceramic femoral heads and acetabular components.

The provided text describes a Special 510(k) submission for the MSA Hip System, specifically to add ceramic femoral heads to the device. The submission focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than a clinical study evaluating human or AI performance.

Therefore, many of the requested elements (sample sizes for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone AI performance, human-in-the-loop performance, etc.) are not applicable and not present in the provided document, as it is a regulatory submission for a physical medical device (hip implant) and not a software/AI-driven diagnostic or treatment device.

Here's a breakdown of the relevant information from the provided text based on your request:

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

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Test set sample size: Not specified. The document only mentions "burst strength testing of the ceramic femoral head" but does not provide details on the number of samples tested.
• Data provenance: Not specified. The manufacturer, Global Manufacturing Technology, is located in Australia, so it is likely the testing was conducted there or at a supplier's facility. It is a technical test on the device itself, not human clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Number of experts: Not applicable. The "ground truth" here is the physical performance of the device (burst strength) against engineering specifications, not a diagnostic assessment requiring expert interpretation of medical images or clinical outcomes. The determination of whether the acceptance criteria were met would be based on objective measurements and comparison to predefined thresholds, typically validated by engineers or quality control personnel.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Adjudication method: Not applicable. See point 3.

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

• MRMC study: No. This is not applicable as the device is a physical hip implant, not an AI or diagnostic tool that involves human readers.

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

• Standalone study: No. This is not applicable as the device is a physical hip implant.

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

• Type of ground truth: Engineering specifications/pre-determined acceptance criteria for burst strength of the ceramic femoral head. This is a physical and mechanical performance metric.

8. The sample size for the training set

• Training set sample size: Not applicable. This concept applies to machine learning models, not physical medical devices undergoing mechanical testing.

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

• Ground truth for training set: Not applicable. See point 8.

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The MSA Hip System is indicated for cementless use and is intended to replace a hip joint. The device is intended for: skeletally mature individuals undergoing primary surgery for total hip replacement patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fracture of the femur. patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis patients suffering from disability due to previous fusion patients with acute femoral neck fractures

The MSA Hip System is a modular hip system consisting of a short stem which mates with a modular neck. The proximal portion of the stem has a plasma spray coating and a hydroxyapatite coating. The MSA Hip System can be mated with a number of previously cleared femoral heads and acetabular components. The hip system is intended for cementless implantation. The hip stems are made of Ti-6AI-4V (ASTM F136) with a commercially pure titanium plasma spray coating (ASTM F1580) and the modular necks are made of CoCr alloy (ASTM F1537).

The provided text describes a 510(k) submission for the "MSA Hip System" and focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria or reporting specific performance metrics against such criteria in the traditional sense of a clinical or standalone study.

Therefore, many of the requested sections about acceptance criteria, detailed study design, sample sizes, ground truth establishment, expert qualifications, and specific performance outcomes cannot be extracted from the provided text as it does not contain this type of information.

Here's what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

Explanation: The document states that "The test results demonstrate that the MSA Hip System is substantially equivalent to legally marketed predicate devices." This implies that the tests performed (neck endurance, stem fatigue, interconnection strength, and ROM testing) met the necessary internal criteria to support substantial equivalence. However, the specific numerical acceptance criteria (e.g., minimum endurance cycles, maximum fatigue crack propagation) and quantifiable performance results for each test are not provided in this summary.

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

• Sample Size for Test Set: Not specified. (The document mentions "non-clinical tests" but does not detail the number of units tested for each specific test like neck endurance or stem fatigue).
• Data Provenance: Not specified. (As these are non-clinical tests, data provenance in terms of country of origin or retrospective/prospective status typically applies to clinical data, which is not discussed here.)

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

• Not Applicable. This document describes non-clinical engineering tests (mechanical performance), not clinical studies where expert-established ground truth is typically assessed for diagnostic accuracy or similar endpoints.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not Applicable. See explanation above.

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:

• No. This document does not mention any MRMC study or AI components. It pertains to a physical orthopedic implant.

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

• Not Applicable. This document does not describe an algorithm or software device.

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

• Not Applicable. For mechanical testing, the "ground truth" would be established by the physical testing methodology and predefined engineering standards for material properties and mechanical performance rather than clinical ground truth types.

8. The sample size for the training set:

• Not Applicable. There is no mention of machine learning or an "algorithm" with a training set.

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

• Not Applicable. There is no mention of machine learning or an "algorithm" with a training set.

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