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The proposed device system is an orthopaedic joint intended to replace the damaged or diseased natural hip joint in total hip or hemi hip arthroplasty to provide pain relief and restore function. The hip system is modular in design, consisting of the subject monolithic, femoral stem along with previously cleared, legally marketed compatible Biomet modular heads and/or acetabular components for total hip or hemi hip arthroplasty.

Indications for use:

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
2. Rheumatoid arthritis.
3. Correction of functional deformity.
4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
5. Revision of previously failed total hip arthroplasty

Porous coated components are intended for uncemented, biological fixation.

The Echo Bi-Metric Microplasty Hip System consists of the subject Echo Bi-Metric Microplasty Hip stem component and legally marketed Biomet modular heads and/or acetabular components for total hip or hemi hip arthroplasty. The subject hip stem combines the design features of the standard length Echo Bi-Metric Press-Fit Stems but offers a shortened stem length design within the legally marketed shortened stem lengths using the same previously cleared materials.

Patient contacting, reusable implant specific instruments are manufactured from stainless steel and include an aluminum titanium nitride (AlTiN) PVD or titanium nitride (TiN) PVD coating.

The Echo Bi-Metric Microplasty Hip Stems are proximally fitting, porous coated shortened stems for uncemented, biological fixation. Stem lengths are within the range of legally marketed short stems also cleared for biological fixation. The subject femoral stem utilizes the identical manufacturing processes as the predicates. The subject stem substrate and plasma spray coating are identical to that of K070274 and K090757.

The provided text describes the regulatory clearance (510(k)) for the Echo Bi-Metric Microplasty Hip System. This document does not contain the acceptance criteria or a study proving the device meets those criteria for software or algorithms. Instead, it focuses on the substantial equivalence of a physical medical device (a hip implant).

Therefore, I cannot extract the information required for your request for the following reasons:

• No Acceptance Criteria for AI/Software: The document discusses the performance of a physical hip implant. Acceptance criteria in this context would relate to mechanical strength, fatigue, material properties, and biocompatibility, not to the performance of a software or AI device.
• No Study for AI/Software Performance: The "Performance Data" section explicitly states "No clinical testing was necessary for a determination of substantial equivalence." and lists non-clinical tests like "Range of Motion," "Femoral Stem Proximal Fatigue," "Femoral Stem Distal Fatigue," and "Biocompatibility (Implant Specific Instrument material)." These are tests for the physical characteristics of the hip implant, not for an AI or software component.
• No AI/Software Component Described: The device description is for a hip implant: "The Echo Bi-Metric Microplasty Hip System consists of the subject Echo Bi-Metric Microplasty Hip stem component and legally marketed Biomet modular heads and/or acetabular components for total hip or hemi hip arthroplasty." There is no mention of an AI or software element that would require the kind of data you're asking for (test set, ground truth, MRMC study, etc.).

In summary, the provided document is for a physical medical device (hip implant) and does not contain any information related to the acceptance criteria or performance study of an AI or software device.

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