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The REFLECTION 3 Acetabular System is 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, osteonecrosis, avascular necrosis, post 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 diseased and anomalies, and congenital dysplasia; old remote osteomyelitis with and an extended drainage-free period, in which case, the patient should be warned of an above normal danger of infection postoperatively; 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 R3 Acetabular System is for single use only. The R3 Acetabular System is intended for cementless use.

The REFLECTION 3 Acetabular System consists of Acetabular shells and liners. The R3 shells are manufactured from titanium alloy. The design of the shells and liners are similar to the REFLECTION 3 Acetabular Shell, the 10MRad REFLECTION 3 Acetabular Liner cleared under K061253 and the DePuy Pinnacle Acetabular Shell cleared under K033273. The REFLECTION 3 liners are manufactured from cross-linked polyethylene. The proposed modifications will include:

• · The addition of Asymmetric Porous Coating to the outside of the R3 Acetabular Shell
• · The addition of the R3 MAX shell with Asymmetric Porous Coating to the outside of the shell
• · The addition of the R3 MAX shell with Titanium Bead Porous Coating to the outside of the shell

The Acetabular shells feature two locking grooves that correspond to locking beads on the XLPE liners, as cleared in K061253. There are also 12 indentions in the face of the shell that mate with twelve tabs of the XLPE liner to prevent rotation. The R3 Acetabular Shells and the R3 MAX shells will be offered in sizes 40mm-68mm.

This document is a 510(k) summary for the Smith & Nephew REFLECTION 3 Acetabular System. It states that the device is substantially equivalent to previously cleared devices.

Here's an analysis based on the provided text:

Key Takeaway: This 510(k) submission primarily relies on substantial equivalence to previously cleared predicate devices, rather than presenting a de novo study with specific performance acceptance criteria and a detailed study proving those criteria were met. Therefore, many of the requested sections will state "Not applicable" or reflect that a comparative effectiveness study was not the basis of this particular submission.

Here's a breakdown of the requested information:

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

   Acceptance Criteria	Reported Device Performance
   Design Features: Similar to predicate devices	Similar to Smith & Nephew REFLECTION Acetabular System (K920430, K932755, K990666), REFLECTION Interfit Shell (K9640094, K990666), 10MRad REFLECTION Acetabular Liner (K002747), REFLECTION 3 Acetabular System (K061253), and DePuy Orthopaedics Inc. Pinnacle Acetabular System (K033273).
   Overall Indications: Similar to predicate devices	Similar to predicate devices (as listed in Section A. Intended Use and Indications for Use).
   Materials: Similar to predicate devices	R3 shells: titanium alloy. Liners: cross-linked polyethylene. Similar to predicate devices.
   Safety and Effectiveness: Demonstrated through design control activities and substantial equivalence.	"Design Control Activities have been completed and the results indicated that the subject device is safe and effective." The FDA's substantial equivalence determination implies acceptance of this claim based on comparison to predicates.

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

   • Sample Size: Not applicable. This submission relies on substantial equivalence and design control activities, not a clinical test set with a specific sample size.
   • Data Provenance: Not applicable for a dedicated test set. The data presented here is descriptive of the device modifications and comparisons to existing devices.

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. There was no specific test set requiring expert ground truth establishment for performance evaluation in this 510(k) summary.

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

   • Not applicable. No test set was described that required an adjudication method.

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 not an AI-based device, and no MRMC comparative effectiveness study was performed or described in this document.

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

   • Not applicable. This is a physical medical device (hip prosthesis components), not an algorithm or AI system.

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

   • Not applicable in the context of a performance study for this submission. The "ground truth" for this 510(k) is the established safety and effectiveness of the predicate devices. The modifications were assessed through "Design Control Activities."

8. The sample size for the training set

   • Not applicable. This is not a machine learning or AI device that requires a training set.

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

   • Not applicable. As above, no training set was used.

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The REFLECTION 3 Acelabular System is indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as meumatoid adhritis, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avasular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis and diastrophic variant; old, remote osteomyelitis with an extended drainage-free period; non-union; femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteotomy; or Girdlestone resection; fracture dislocation of the hip; and correction of deformity.

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

The REFLECTION 3 Acetabular System consists of acetabular shells and liners. The REFLECTION 3 Shells are manufactured from titanium alloy. The REFLECTION 3 liners are manufactured from XLPE. The design of the shells and liners are similar to the REFLECTION Acetabular Shell, the REFLECTION Interfit Shell, and the 10MRad REFLECTION Acetabular Liner.

Device Acceptance Criteria and Study Details:

This submission (K061253) describes the REFLECTION 3 Acetabular System, a hip joint prosthesis. The provided document is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to legally marketed predicate devices, rather than a de novo clinical study with specific acceptance criteria and performance metrics.

Therefore, the typical structure for reporting acceptance criteria and study results, as requested in the prompt, is not directly applicable to this type of regulatory submission in the same way it would be for a novel device undergoing extensive clinical trials for efficacy and safety.

The "acceptance criteria" here is not a set of performance metrics achieved in a study, but rather the FDA's determination of "substantial equivalence" to predicate devices. The "study" that "proves" the device meets this acceptance criteria is the 510(k) submission itself, which provides comparative information.

Based on the provided information, here's a breakdown in the requested format, acknowledging the nature of a 510(k) with its focus on substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not applicable in the context of this 510(k) submission. A 510(k) typically relies on comparisons to existing, legally marketed predicate devices, supported by bench testing and Design Control Activities, rather than a "test set" from a prospective clinical study with performance endpoints.
• Data Provenance: Not applicable. The submission refers to "Design Control Activities" which would encompass various engineering tests, material characterization, and comparisons, but not specific patient data from a "test set" in the sense of a clinical trial. The "provenance" here is manufacturing data and engineering analysis.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Not applicable. Ground truth, in the sense of clinical diagnoses or outcomes for a test set, is not established for this type of submission. The "ground truth" for a 510(k) revolves around demonstrating equivalence to already approved devices. The FDA, with its regulatory experts, reviews the evidence provided by the manufacturer.

4. Adjudication Method for the Test Set

• Not applicable. There is no "test set" requiring adjudication in this type of submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done for this 510(k) submission. This type of study is more common for diagnostic devices where human reader performance is a key metric.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not applicable. This is a physical medical device (hip implant), not a software algorithm.

7. The Type of Ground Truth Used

• The "ground truth" in this 510(k) submission is the established safety and effectiveness of the legally marketed predicate devices (REFLECTION Acetabular System, REFLECTION Interfit Shell, and 10MRad REFLECTION Acetabular Liner). The submission implicitly uses the regulatory history and performance of these predicates as the benchmark ("ground truth") against which the new device is compared for substantial equivalence.

8. The Sample Size for the Training Set

• Not applicable. This is not a machine learning or AI device that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

• Not applicable.

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