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The Porous Titanium Acetabular Augments are indicated for cemented or non-cemented use in cases of:

1. Noninflammatory 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.

The porous titanium augments are intended to provide the orthopedic surgeon with a prosthetic alternative to structural allograft in cases of segmental deficiencies.

The porous titanium acetabular augment is affixed to the mating acetabular cup using bone cement. The assembled porous titanium augment/acetabular construct is intended for cemented or uncemented use.

The porous titanium acetabular augments are intended for general use in skeletally mature individuals undergoing primary and/or secondary revision surgery.

The acetabular augments are constructed of porous titanium alloy conforming to ASTM F 1580-95. The augments range in outer diameter size from 48 mm to 58 mm in 2 mm increments. Each outer diameter will have three subsizes; small, medium, and large. The Porous Titanium Acetabular Augments incorporate screw holes that allow for the use of 6.5 mm bone screws, for adjunct fixation of the acetabular component and the native bone.

The provided text describes a 510(k) premarket notification for a medical device, the Porous Titanium Acetabular Augments. This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than proving safety and effectiveness through extensive clinical trials as seen with novel devices. Therefore, the information you've requested regarding acceptance criteria and a study proving the device meets those criteria, as typically understood for AI/diagnostic devices, is largely not applicable in this context.

Here's why and what information can be extracted based on your request:

Key Takeaway: No clinical studies with acceptance criteria, sample sizes, expert ground truth, or MRMC studies were performed or reported in this 510(k) submission. The device received clearance based on non-clinical testing demonstrating functional equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

• Not Applicable. The 510(k) summarized here does not present a table of specific acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) for its performance. Substantial equivalence is determined by comparing the new device's technological characteristics and intended use to a legally marketed predicate device.

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

• Not Applicable. No clinical "test set" and associated size or provenance information are mentioned. The clearance was based on non-clinical laboratory testing.

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

• Not Applicable. No clinical "test set" requiring expert ground truth was used for this 510(k) submission.

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

• Not Applicable. No clinical "test set" requiring adjudication was used.

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 device is a passive implant for hip arthroplasty, not an AI or diagnostic device that would involve human readers or AI assistance. Therefore, an MRMC study is not relevant.

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

• Not Applicable. This is a physical orthopedic implant, not an algorithm or AI device.

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

• Not Applicable. For this 510(k) submission, "ground truth" in the diagnostic sense is not relevant. The equivalence was established through non-clinical testing. The "truth" here relates to the mechanical and material properties meeting established standards (e.g., ASTM F 1580-95 for the material) and performing functionally as intended.

8. The sample size for the training set

• Not Applicable. This refers to a medical implant, not a machine learning model. There is no "training set" in this context.

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

• Not Applicable. As there is no training set for a machine learning model, this question is irrelevant to the provided document.

Summary of Relevant Information from the Provided Text about Device Performance and Testing:

• Acceptance Criteria (Implied): The implied acceptance criteria for a 510(k) submission are that the new device is "substantially equivalent" to a legally marketed predicate device in terms of intended use, technological characteristics, and performance.
• Study Proving Equivalence: The study performed was "Non-Clinical Testing".
• Reported Device Performance: "The results indicated that the device was functional within its intended use."
• Predicate Device: Hedrocel® Acetabular Augment (K001471).
• Basis for Equivalence: The submission states, "The technological characteristics (material modification, design, sizing, indications) of the Porous Titanium Acetabular Augments are similar to or identical to the predicate device."
• Clinical Testing: "None provided as a basis for substantial equivalence." This explicitly states that no clinical trials were conducted or reported for this submission to establish safety and effectiveness for a new device, which reinforces why the detailed clinical study data you asked for is absent.

In essence, the device was cleared because it was shown to be very similar to an already approved device through benchtop (non-clinical) testing, without requiring new clinical outcome studies.

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