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The hip prosthesis AMIStem-C is designed for cemented use in total or partial hip arthroplasty in primary or revision surgery. Hip replacement is indicated in the following cases:
• Severely painful and/or disabled joint as a result of arthritis, rheumatoid polyarthritis or congenital hip dysplasia
· Avascular necrosis of the femoral head
· Acute traumatic fracture of the femoral head or neck
· Failure of previous hip surgery: joint reconstruction, arthrodesis, partial hip arthroplasty, hip resurfacing replacement or total hip arthroplasty

AMIStem-C is a straight triple tapered cemented femoral stem of rectangular cross-section, for use in total or partial hip arthroplasty for primary or revision surgery. The material is High Nitrogen Stainless steel in accordance with ISO 5832-9. Its superficial feature is a mirror polishing on the neck and the body: the whole body is mirror polished in order to minimize the wear due to the occasional contact between neck and cup, particularly in case of double-mobility cups, and to optimize the load transfer from stem to cement avoiding the stress shielding. The AMIStem-C femoral stem size 00 is a line extension to the stems to the currently marketed Amistem-C product line.

This document is a 510(k) premarket notification for a medical device, specifically a femoral stem for hip replacement. It generally focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with defined acceptance criteria and detailed performance metrics as one might find in an AI/ML device submission.

Therefore, many of the requested elements (e.g., sample sizes for training/test sets, ground truth establishment methods, expert qualifications, MRMC studies, effect sizes of AI assistance) are not applicable as this submission is for a physical orthopedic implant, not an AI/ML-based diagnostic or treatment device.

However, I can extract the relevant information regarding performance testing that was leveraged from the predicate device to support the substantial equivalence claim.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical "acceptance criteria" and "reported device performance" in the format typically used for AI/ML device evaluations (e.g., sensitivity, specificity, AUC). Instead, it states that the performance testing from the predicate device was leveraged because the new size does not create a new worst-case scenario. The acceptance is implicitly that the device performs equivalently to the predicate and passes the specified ISO standards.

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

These concepts (test set, data provenance, country of origin, retrospective/prospective) are mostly associated with clinical studies or AI/ML evaluations. For this submission, which relies on engineering performance testing of a physical implant and leveraging predicate data:

• Sample Size: Not explicitly stated for each test (e.g., how many stems were tested for fatigue). The "test set" here refers to the physical samples used for the engineering tests.
• Data Provenance: The data is from engineering performance testing based on predicate device data, conducted to international standards (ISO). The specific country of origin for the testing or whether it's retrospective/prospective in a clinical sense is not directly relevant or stated, as it's mechanical testing data leveraged from an already cleared device.

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

Not Applicable. This is an orthopedic implant being cleared based on mechanical performance and substantial equivalence to a predicate, not an AI/ML diagnostic requiring expert interpretation for ground truth.

4. Adjudication method for the test set

Not Applicable. Adjudication methods (e.g., 2+1, 3+1) are used for expert consensus on ground truth in clinical or image-based studies. This submission relies on objective engineering measurements against ISO standards.

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/ML device.

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

Not Applicable. This is not an AI/ML device.

7. The type of ground truth used

The "ground truth" for this device's performance is objective compliance with international engineering standards (ISO 7206-4:2010, ISO 7206-6:2013) and established biocompatibility/sterility standards (LAL test, USP ). The performance of the new design (size 00) is considered equivalent if it does not create a "new worst case" compared to the predicate device that has already demonstrated compliance with these standards.

8. The sample size for the training set

Not Applicable. This is not an AI/ML device.

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

Not Applicable. This is not an AI/ML device.

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The Medacta Total Hip Prosthesis System – Quadra C Femoral Stems are intended for cemented use in total or partial hip arthroplasty and in primary or revision surgery. Hip replacement is indicated in the following cases: Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid polyarthritis, or congenital hip dysplasia; Avascular necrosis of the femoral head; Acute traumatic fracture of the femoral head or neck; Failure of previous hip surgery, joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement. Size 0 implants should not be implanted in patients with a mass of 65 kg or greater.

This modification to the original Medacta Total Hip Prosthesis System -Quadra C femoral stems is a line extension to include the AMIStem C femoral stems and Quadra C Short Neck (SN) femoral stems. AMIStem C femoral stems are based on the design of the Quadra C femoral stems in the original submission. The AMIStem C femoral stems differ from the Quadra C femoral stems by a decreased length of 15% and a reduced shoulder. The Quadra C short neck femoral stems are the same design femoral stems as the Quadra C femoral stems in the original submission but the length of the neck that is 5 mm shorter. Like the Quadra C femoral stems, the AMIStem C femoral stems and the Quadra C SN femoral stems are highly polished, collarless femoral components manufactured from forged stainless steel according to ISO 5832-9. The AMIStem C femoral stems and the Quadra C SN femoral stems are straight quadratic stems with a triple taper shape. The proximal portion of the stem has a standard 12/14 taper for mechanical attachment to cleared Medacta International metallic or ceramic femoral heads. Like the Quadra C femoral stems, two different caput-collum-diaphyseal angles (CCD) are available for the AMIStem C femoral stems and the Quadra C Short neck femoral stems: 135° for the standard offset and 127° for the lateralized offset. The Quadra C short neck femoral stems come in eight sizes with a standard offset and seven sizes with a lateral offset. The AMIStem C femoral stems come in eight sizes with a standard offset and seven sizes with a lateral offset. There are no short neck versions for the AMIStem C femoral stems. The AMIStem C femoral stems and the Quadra C short neck femoral stems provide additional femoral stem options to the surgeon for use with the Medacta Total Hip Prosthesis System.

This document describes the Medacta Total Hip Prosthesis System - AMIStem C and Quadra C SN femoral stems. As a 510(k) summary, the focus is on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with detailed performance metrics against specific acceptance criteria.

The information provided does not include:

• A specific table of acceptance criteria and reported device performance.
• Details on sample sizes used for test sets, training sets, or data provenance.
• Information on the number or qualifications of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance.
• The type of ground truth used or how it was established for training sets.

Instead, the document states that performance testing was conducted according to various standards and FDA guidance documents, with predefined acceptance criteria based on these standards. The conclusion is that all acceptance criteria were met, verifying the performance and supporting substantial equivalence.

Here's a summary of the available information and a structured table for acceptance criteria, acknowledging the lack of specific numerical performance data within this summary:

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable. This document describes bench testing for a medical device rather than a clinical study involving human data. The testing was conducted on "worst case based on engineering analysis."

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

Not applicable. Ground truth, in the context of this device, refers to meeting established engineering and material standards for the implant, not to expert interpretation of medical images or patient outcomes.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are typically relevant for clinical studies or studies involving human judgment (e.g., image interpretation), which is not the nature of this submission. The "adjudication" here would be the verification against predefined engineering acceptance criteria.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No. This is a 510(k) submission for a hip prosthesis, focusing on substantial equivalence through bench testing, not a clinical effectiveness study involving human readers or AI.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Yes, in a sense. The "performance testing" described is for the device itself (the femoral stem), without human interaction in its functional evaluation. The testing verifies the physical and mechanical properties of the implant.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance testing is adherence to established engineering standards and FDA guidance documents for hip prostheses, covering aspects like material properties, mechanical strength, endurance, and design specifications. This ensures the device is mechanically sound and safe for its intended use.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device; therefore, there is no "training set" in that context. The "training" for such a device would involve its design and manufacturing processes, which are guided by established engineering principles and standards.

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

Not applicable, as there is no "training set" in the AI/ML sense. The design and manufacturing of the device are based on long-standing medical device engineering principles, material science, biomechanics, and ISO standards (e.g., ISO 5832-9 mentioned for stainless steel). The "ground truth" here is derived from scientific and engineering knowledge accumulated over time regarding safe and effective hip prostheses.

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