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The EcoFit® hip stems are intended to be used in total hip arthroplasty for the following indications:

• Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
• Rheumatoid arthritis;
• Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable by other techniques; and
• Revision of previously failed total hip arthroplasty.
  The EcoFit® hip stems are intended for uncemented, press-fit fixation.

The EcoFit® hip stems are intended to be used in partial (hemi) hip arthroplasty in conjunction with the ic-Bipolar Head System for the following indications:

• Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
• Rheumatoid arthritis
• Correction of functional deformity
• Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.

The purpose of this Traditional 510(k) is to expand the EcoFit® Hip System with a line extension to the existing EcoFit® short stems cementless cpTi. The new EcoFit® short stems cementless cpTi are available in two different sizes 16.25 mm and in both standard and lateralized offset versions. The new EcoFit® short stems cementless cpTi included in the subject 510(k) are intermediate sizes, as compared to the EcoFit® short stems cementless cpTi predicate devices

This FDA 510(k) summary is for a medical device, specifically hip stems, and therefore does not involve AI/ML performance testing with acceptance criteria in the same way an AI/ML software would. The "acceptance criteria" here refer to meeting established and recognized standards for mechanical and material performance of an implantable device to demonstrate substantial equivalence to a predicate device.

Here's an interpretation based on the provided document and the typical requirements for non-software medical devices:

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

Note: The document doesn't provide specific numerical results or thresholds for "acceptance criteria" within these tests. Instead, it indicates that the device met the requirements of the cited standards, which inherently defines the acceptance criteria for each test.

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

• Sample Size: The document mentions "test units representative of the finished device" but does not specify the exact number of samples used for each test. In mechanical testing of medical devices, sample sizes are typically determined by relevant standards (e.g., ISO, ASTM) and statistical considerations to ensure sufficient power to detect failures or demonstrate compliance.
• Data Provenance: The testing was performed on physical devices (EcoFit® short stem cementless cpTi). The document does not specify the country of origin of the data beyond the manufacturer being implantcast GmbH, located in Germany. These are likely prospective tests conducted specifically for this 510(k) submission.

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

This information is typically not relevant or included in a 510(k) summary for a mechanical device like a hip stem. "Ground truth" in this context refers to the physical properties and performance measured by standardized tests, rather than expert interpretation of clinical data. The "experts" would be the engineers and technicians conducting the tests and interpreting the results against the established standards. Their qualifications would include expertise in mechanical testing, biomaterials, and relevant ISO/ASTM standards.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or image interpretation where human expert disagreement needs to be resolved to establish ground truth. For physical device testing, the results are objective measurements from laboratory equipment, and interpretation is against predefined engineering 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. MRMC studies are used for evaluating diagnostic software or AI systems, particularly for image interpretation. This submission is for a physical orthopedic implant.

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

Not applicable. This is not an algorithm or software device.

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

The "ground truth" for this device's performance is based on established engineering and material science standards (e.g., ISO 7206, ASTM F2582, ASTM F2009). The tests measure objective physical properties and responses of the hip stem under defined conditions. Compliance with these standards indicates the device possesses the necessary mechanical and material properties for its intended use.

8. The sample size for the training set:

Not applicable. "Training set" refers to data used to train AI/ML algorithms. This is a physical medical device.

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

Not applicable, as there is no training set for an AI/ML algorithm.

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