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The CoreHip® System is intended to replace a hip joint. The device is intended for:

· Patients suffering from severe hip pain and disability due to rheumatoid arthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fractures of the femur

• · Patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital femoral epiphysis
• · Patients suffering from disability due to previous fusion
• · Patients with acute femoral neck fractures

The CoreHip® System is available with two (2) types of femoral stem is manufactured from CoCrMo and is intended for cemented fixation and the other femoral stem is manufactured from Ti with Plasmapore® and is intended for uncemented (pressfit) fixation.

The CoreHip System includes cemented and uncemented (pressfit) stems. The CoreHip uncemented (pressfit) Stem is offered as CoreHip uncemented (pressfit) Primary and CoreHip uncemented (pressfit) Extended which are manufactured from Ti with a Ti plasma spray coating (Plasmapore®) proximally and rough-blasted distally. The Cemented Stem is offered as CoreHip Cemented Primary stem which is manufactured from CoCrMo. The CoreHip System includes stem variants of varus, neutral, valgus and dysplasia is offered in CoreHip uncemented (pressfit) Primary only), which have different medial curves in order to address different patient morphologies. The femoral stems will be offered in a 12/14 external taper in stem sizes 1 to 11 for the uncemented (pressfit) design (primary (except size 1 dysplasia) and extended) and sizes 1-11 for the cemented design.

This document is a 510(k) premarket notification for a hip implant system, not an AI/ML device study. Therefore, the requested information about acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details for AI/ML device is not present in this document.

The document discusses the substantial equivalence of the CoreHip® System to predicate devices. It focuses on the safety and effectiveness of the traditional medical device (hip implant) through:

• Indications for Use: Defining for which patient conditions the device is intended.
• Technological Characteristics Comparison: Comparing materials, fixation types, stem sizes, and geometry with predicate devices.
• Performance Data: This section details non-clinical performance testing, primarily mechanical endurance testing, to demonstrate the device's substantial equivalence to previously cleared devices.

Here's what can be extracted regarding performance, even though it's not related to AI:

Acceptance Criteria and Reported Device Performance

This document does not provide a table of acceptance criteria with specific numerical targets and reported device performance values in the way you might expect for a diagnostic or AI device. Instead, the performance claims are based on compliance with established standards and comparison to predicate devices.

Key Performance Statements:

• "Endurance properties of the CoreHip cemented and uncemented (pressfit) stem, head and neck were evaluated in accordance to Guidance for Industry and FDA Staff Non-clinical Information for Femoral Prostheses, September 17, 2007; ASTM F2068-15; ISO 7206-4 and ISO 7206-6."
• "Additional Femoral head/Taper testing was completed."
• "Range of Motion (ROM) analysis to satisfy the requirements of ISO 21535 was completed."
• "Testing demonstrated that the subject device is substantially equivalent to the Primary and reference predicate devices."
• "PYROGEN TESTING: LAL testing was completed and met the pyrogen limit of 20 E.U./device."

Essentially, the acceptance criteria are implicitly met by:

1. Adherence to recognized industry standards: ASTM F2068-15, ISO 7206-4, ISO 7206-6, and ISO 21535.
2. Demonstrating substantial equivalence to legally marketed predicate devices in terms of performance and safety.
3. Meeting specific pyrogenicity limits: LAL testing confirmed meeting the pyrogen limit of 20 E.U./device.

As this is a 510(k) for a physical implant, specific "reported device performance" in terms of accuracy, sensitivity, or specificity (relevant to AI/ML) is not applicable. The performance is assessed on mechanical integrity, fatigue life, and biocompatibility, which are demonstrated through testing against relevant standards.

The remaining points of your request are not applicable to the provided document as it describes a non-AI medical device submission.

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