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Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.

Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.

The Reflection 3 Acetabular System is for single use only and is intended for cementless use.

Subject of this Traditional 510(k) premarket notification is a modification to the R3 22-36mm XLPE Acetabular Liners. The liners were originally cleared under K070756. Four vents have been added to the locking detail of the subject liners. The vents have been added to allow for improved fluid egress from behind the locking beads in an effort to minimize the potential for difficulty seating the liners during aggressive impaction.

K113848 is a 510(k) premarket notification for a modification to an existing device, the R3 XLPE Acetabular Liners, not a study involving AI or human readers. The provided text describes mechanical testing performed to demonstrate that the modified device is substantially equivalent to predicate devices, and thus does not include the typical elements of an AI-based regulatory submission.

Therefore, many of the requested categories are not applicable to this submission.

Here is the information that can be extracted or deduced from the provided document:

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

The document mentions that the submission was prepared in accordance with the "Guidance Document for Testing Acetabular Cup Prostheses," dated May 1995. This guidance document would contain the specific acceptance criteria for each test. The actual numerical acceptance criteria for each test are not explicitly stated in the provided text, nor are the specific numerical results.

The following types of mechanical tests were performed:

• Push-out Testing
• Torque-to-Failure Testing
• Lever-out Testing
• Fatigue Testing
• Post-Fatigue Push-out Testing

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

• Sample Size: Not specified in the provided text.
• Data Provenance: The document does not specify the country of origin for the test data. Given the "Submitted by Smith & Nephew, Inc. Advanced Surgical Devices Division, Cordova, Tennessee," it is highly likely the testing was conducted in the USA or by a facility contracted by a US entity for a US submission. The testing is a prospective assessment of the device's mechanical properties, not human-derived data.

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 submission is for a medical device (acetabular liners) and involves mechanical testing, not a diagnostic algorithm that requires expert-established ground truth from images or clinical data. The "ground truth" here is the physical performance of the device against engineering standards.

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

• Not applicable. As this is mechanical testing of a physical device, there is no expert adjudication process in the sense of clinical interpretations or diagnoses. The "adjudication" is compliance with engineering standards and guidance.

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. No MRMC study was conducted. This device is a physical implant, not an AI-assisted diagnostic tool. No human readers or AI were involved in the testing for this submission.

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

• Not applicable. This is a physical medical device. There is no algorithm to evaluate.

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

• The "ground truth" for this submission is established through physical mechanical testing according to recognized engineering standards and FDA guidance documents (specifically, the "Guidance Document for Testing Acetabular Cup Prostheses," dated May 1995). The acceptance criteria outlined in such guidance documents serve as the standard for performance.

8. The sample size for the training set

• Not applicable. There is no "training set" in the context of mechanical testing for a physical medical device. This term applies to machine learning models.

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

• Not applicable. As above, there is no training set for a physical device's mechanical testing.

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Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.

Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.

The Reflection 3 Acetabular System is for single use only and is intended for cementless use.

Subject of this Traditional Premarket Notification are CoCr and Oxinium Femoral Head line additions in sizes 40 and 44mm and R3 XLPE Acetabular Liner line additions with inner diameters of 40 and 44mm.

The provided text is a 510(k) summary for medical devices (CoCr and Oxinium Femoral Heads and R3 XLPE Liners) seeking clearance based on substantial equivalence. It does not describe an AI/ML device or a study proving that the device meets acceptance criteria. Instead, it details the device description, intended use, and argues for substantial equivalence to previously cleared predicate devices.

Therefore, I cannot extract the information required in your request about acceptance criteria, study details, sample sizes, expert involvement, or ground truth, as these elements are specific to the evaluation of AI/ML performance studies, which is not present in this document.

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