(27 days)
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
| Acceptance Criteria (for 510(k) Substantial Equivalence) | Reported Device Performance (as per 510(k) submission) |
|---|---|
| Intended Use: Device's intended uses are substantially equivalent to predicate devices. | The REFLECTION 3 Acetabular System's intended use is for individuals undergoing primary and revision surgery for hips damaged by trauma, inflammatory joint disease (rheumatoid arthritis), noninflammatory degenerative joint disease (NIDJD) including osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, pelvic fracture, old remote osteomyelitis, non-union, unmanageable femoral neck/trochanteric fractures, femoral osteotomy, Girdlestone resection, fracture dislocation, and deformity correction. This is stated to be substantially equivalent to the predicate devices. |
| Design Features: Device's design features are substantially equivalent to predicate devices. | The REFLECTION 3 Shells are titanium alloy, and the REFLECTION 3 liners are XLPE. The design of the shells and liners are described as "similar to" the REFLECTION Acetabular Shell, REFLECTION Interfit Shell, and 10MRad REFLECTION Acetabular Liner. This is stated to be substantially equivalent to the predicate devices. |
| Material Composition: Device's material composition is substantially equivalent to predicate devices. | The materials used (titanium alloy for shells, XLPE for liners) are implicitly considered substantially equivalent to those of the predicate devices based on the submission's claim of overall substantial equivalence. |
| Safety and Effectiveness: Results of Design Control Activities indicate the device is safe and effective. | The submission states, "Design Control Activities have been completed and the results indicate that the subject device is safe and effective." This is part of the evidence presented to support substantial equivalence to the predicate devices, which are already deemed safe and effective. No specific performance metrics (e.g., success rates, complication rates, wear rates) are provided here as "reported device performance." The "performance" is demonstrated through comparison and inference to the predicate. |
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.
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.