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The Apex K1™ Hip Stem is intended for use as the femoral component of a primary or revision total 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:

• . Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
• Rheumatoid arthritis; .
• Correction of functional deformity: .
• . Congenital dislocation;
• Revision procedures where other treatments or devices have failed: .
• . Femoral neck and trochanteric fractures of the proximal femur.

The Apex K1 Hip Stem consists of a rectangular tapered stem, and modular heads that connect to the tapered trunion on the neck. Four configurations are available for each size: standard and long lengths, each with standard and lateraliz ed necks. These configurations allow the user to choose a combination of stem and head components to appropriately fit the anatomy of the patient. The Apex K1 Hip Stem may be used in conjunction with the Apex Modular™ Acetabular Cup (K031110) for total hip arthroplasty.
The femoral stems are manufactured from titanium alloy, and can be used with the cobalt chromium alloy heads and the alumina ceramic heads that are part of the Apex Modular and Apex K2 hip systems.

The provided 510(k) summary for the Apex K1™ Hip Stem does not describe acceptance criteria, a study that proves the device meets specific acceptance criteria, or performance metrics in the way typically expected for AI/software-as-a-medical-device (SaMD) devices.

This document is for a medical implant (a hip stem), and the regulatory submission process for such devices focuses on demonstrating substantial equivalence to a legally marketed predicate device primarily through:

• Comparison of design and materials: Ensuring the new device has similar characteristics.
• Bench testing: Addressing mechanical properties, fatigue, and biocompatibility.
• Performance data: Often derived from established standards for orthopedic implants.

Therefore, many of the specific questions about acceptance criteria, sample sizes for test sets, expert ground truth, MRMC studies, and standalone performance for AI are not applicable to this type of device submission.

Here's an attempt to answer the questions based on the provided text, highlighting where the information is not present or relevant to this type of device:

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

The document does not provide a table of acceptance criteria or specific performance metrics (like sensitivity, specificity, accuracy) typically associated with AI/SaMD. The "performance" for a hip stem is generally implied by its design, materials, and mechanical properties, which are shown to be substantially equivalent to predicate devices.

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

Not applicable. This is a physical medical implant. There is no "test set" in the context of data for an algorithm. The "testing" involved would be mechanical and biocompatibility bench tests, not data analysis.

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)

Not applicable. This is a physical medical implant. The determination of "ground truth" (e.g., successful performance or safety) comes from engineering standards, material science, and clinical experience with similar implants, rather than expert consensus on data interpretation.

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

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

Not applicable. This is a physical medical implant, not an AI or software device that assists human readers.

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

Not applicable. This is a physical medical implant, not an algorithm.

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

The "ground truth" for this device's safety and effectiveness is established through:

• Engineering design principles.
• Material testing to industry standards (e.g., for fatigue, strength).
• Biocompatibility testing.
• Demonstration of substantial equivalence to predicate devices with a history of safe and effective use.
• No specific "ground truth" is explicitly mentioned in the document in the context of data for an algorithm.

8. The sample size for the training set

Not applicable. This is a physical medical implant, not an AI/software device that uses a training set.

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

Not applicable. See point 8.

Summary regarding the provided document:

The 510(k) summary for the Apex K1™ Hip Stem focuses on demonstrating substantial equivalence to predicate devices (SL-Plus® and SLR-Plus® hip stems, and Apex K2™ Hip System) based on:

• Intended Use: Identical or very similar.
• Design Features: Comparison of coated status, modularity (head vs. neck), surface finish, stem shape, etc.
• Materials: Comparison of titanium alloys, head materials, and coatings.

The document states: "Substantial equivalence is claimed to the SL-Plus® and SLR-Plus® hip stems distributed by Plus Orthopedics (K001942 and K021178), and the Apex K2™ Hip System (K041950)." This is the core "study" and "acceptance criteria" mechanism for this type of device – proving that it is sufficiently similar to devices already on the market that have been deemed safe and effective. The FDA's letter confirms this "substantial equivalence determination."

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