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510(k) Data Aggregation
(78 days)
Total 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, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic variant; old, remote osteomyelitis with an extended drainage-free period; nonunion, 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. Smith & Nephew Oxinium DH femoral heads are for single use only.
The Oxinium DH femoral heads are designed for use with existing Smith & Nephew hip stems featuring a 12/14 taper and will articulate against existing acetabular shell and liner constructs. A complete list of hip stems and acetabular components intended for use with the Oxinium DH heads is provided in Tables 1 and 2, respectively. The overall design of the Oxinium DH femoral heads is based upon the existing Total Hip 12/14 Taper Femoral Heads cleared via K021673 and the Oxinium femoral heads cleared as part of K022958 for Total Hip Femoral Heads & Liners.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Smith & Nephew Oxinium DH Femoral Heads:
The provided document (K081566) is a 510(k) Summary of Safety and Effectiveness for a medical device. It's important to understand that 510(k) clearances are based on demonstrating "substantial equivalence" to a predicate device, rather than proving stand-alone clinical efficacy through randomized controlled trials. Therefore, the information you're requesting regarding "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of performance metrics like sensitivity, specificity, human reader improvement with AI, etc., will likely not be present in this type of regulatory submission.
Instead, the "acceptance criteria" for a 510(k) device like this are typically related to:
- Mechanical performance: Ensuring the device meets strength, durability, and biocompatibility standards.
- Indications for Use: Confirming the device is intended for the same or similar purposes as the predicate device.
- Design and Materials: Demonstrating similarity in overall design and materials to a legally marketed predicate.
The "study" proving these criteria are met is often a combination of mechanical testing and a comparison to predicate devices.
Given this context, here's the information extracted from the provided text, addressing your questions where possible:
1. Table of Acceptance Criteria and Reported Device Performance
Note: As explained above, "acceptance criteria" for a 510(k) submission are generally not expressed in clinical performance metrics (like sensitivity/specificity) but rather in engineering and design equivalence.
| Acceptance Criteria Category | Reported Device Performance (from text) |
|---|---|
| Mechanical Performance | "A review of the mechanical testing results indicated that the Smith & Nephew Oxinium DH femoral heads are equivalent to devices currently used clinically and are capable of withstanding expected in vivo loading without failure." |
| Indications for Use | The stated Indications for Use are identical to the predicate devices, covering rehabilitation of hips damaged by trauma, inflammatory/degenerative joint disease, avascular necrosis, fractures, etc. |
| Design & Materials | "The Smith & Nephew Oxinium DH femoral heads are similar in overall design, indications, and materials to the Total Hip 12/14 Taper Femoral Heads cleared via K021673 and the Oxinium femoral heads cleared as part of K022958 for Total Hip Femoral Heads & Liners." |
| Biocompatibility | (Not explicitly detailed in the provided text, but implied through substantial equivalence to predicate devices likely already deemed biocompatible.) |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable in the context of clinical performance evaluation (like for diagnostic AI). The "test set" here refers to the samples used in mechanical testing. The document states "A review of the mechanical testing results," implying tests were conducted, but does not specify the sample size (e.g., number of heads tested for fatigue, static strength, etc.).
- Data Provenance: Not applicable in the context of clinical data. The "data" primarily comes from mechanical laboratory testing performed on the device prototypes or production samples. The country of origin for such testing is not specified. It is a prospective test in the sense that the device was manufactured and then tested to confirm its properties.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. For mechanical testing, "ground truth" is established by engineering standards, specifications, and physical measurements, not by expert consensus in a clinical sense. The review of these results would be done by internal engineers, potentially external consultants, and ultimately FDA reviewers.
- Qualifications of Experts: Not specified. If "experts" refers to those who designed or evaluated the mechanical tests, they would typically be biomechanical engineers, materials scientists, or other relevant technical professionals.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing clinical ground truth (e.g., diagnosis from imaging). For mechanical testing, the "adjudication" is typically a direct comparison of measured values against established engineering specifications or performance of predicate devices. There isn't a "consensus" process for adjudicating if a material broke at a certain load.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating diagnostic tools or AI systems where human readers interpret results. This submission is for a physical implantable device (femoral head) and focuses on mechanical and material equivalence.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No. This question is irrelevant to the device described. This is a physical orthopedic implant, not an algorithm or AI system.
7. The Type of Ground Truth Used
- Ground Truth Type:
- For mechanical performance: Engineering specifications, material properties, and performance data from predicate devices. The "ground truth" is that the device must withstand "expected in vivo loading without failure," which is assessed via standardized biomechanical testing (e.g., fatigue testing, static load testing to ISO or ASTM standards, though specific standards aren't cited in this summary).
- For design, materials, and indications: The characteristics and performance of the legally marketed predicate devices (K021673 and K022958).
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This document is not describing an AI/machine learning model, so there is no "training set" in that context. If interpreted very broadly as the historical data used to design the device, it would be the cumulative knowledge and clinical experience with previous hip prostheses, but specific numbers are not given.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable, as there is no "training set" in the common understanding for an AI/ML device. The "ground truth" for the design of the device is based on established biomechanical principles, historical clinical performance of similar devices, and regulatory standards for orthopedic implants.
In summary: The K081566 document is a regulatory submission for substantial equivalence for a physical medical device. It relies on a comparison to existing, legally marketed predicate devices and demonstrates equivalence through mechanical testing and design/material similarity, rather than clinical performance studies (like those used for diagnostic AI or new drug approvals). The terms "acceptance criteria" and "study" in this context are interpreted differently than they would be for software-as-a-medical-device (SaMD) or AI medical devices.
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(27 days)
K9640094, K9906661, K002747
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.
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