(77 days)
The Global Bipolar System is indicated for the following:
- Non-inflammatory degenerative joint disease including osteoarthritis, osteonecrosis, avascular necrosis and post traumatic arthritis;
- rheumatoid arthritis;
- arthritis secondary to a variety of diseases and anomalies and correction of functional deformity such as congenital hip dysplasia or ankylosing spondylitis;
- revision procedures where other treatment or devices have failed; and
- treatment of proximal femoral non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement.
The Global Bipolar System consists of a bipolar liner, full lock ring liner, and a metal retaining ring. The system is to be used with existing femoral heads distributed by Smith & Nephew.
The provided text is a 510(k) summary for the "Global Bipolar System," a hip joint femoral prosthesis. This document focuses on demonstrating substantial equivalence to previously marketed devices rather than presenting a study with specific acceptance criteria and performance data in the way one would expect for a diagnostic or AI-driven device.
Therefore, many of the requested points regarding acceptance criteria, study design, expert involvement, and ground truth are not applicable to this type of regulatory submission for a mechanical implant. The evaluation here hinges on material, design, and intended use comparison.
Here's an analysis based on the provided text, addressing the points where information is available or can be inferred:
Acceptance Criteria and Device Performance (Not Applicable - Substitution with Equivalence Claim)
The document does not detail specific quantitative acceptance criteria or a "reported device performance" in the typical sense for a diagnostic device (e.g., accuracy, sensitivity, specificity). Instead, the acceptance criterion for regulatory approval is the demonstration of substantial equivalence to predicate devices.
| Acceptance Criterion (Implicit for device approval) | Reported Device Performance (Claimed for approval) |
|---|---|
| Mechanical equivalence to predicate devices | "capable of withstanding expected in vivo loading without failure" |
| Similarity in intended use | "The system is to be used with existing femoral heads distributed by Smith & Nephew." |
| Similarity in materials | (Implied by equivalence claim and statement "The components share the same intended use, material, and design features...") |
| Similarity in design features | (Implied by equivalence claim and statement "The components share the same intended use, material, and design features...") |
-
A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated as quantitative metrics (e.g., "Must achieve X% accuracy"). The implicit acceptance criterion is substantial equivalence to predicate devices in terms of intended use, materials, design features, and mechanical performance.
- Reported Device Performance: The document states that a "review of the mechanical test data indicated that the Global Bipolar System is equivalent to devices currently on the market and are capable of withstanding expected in vivo loading without failure." No specific numerical performance values (e.g., shear strength, fatigue life cycles) are provided in this summary.
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document does not mention a test set sample size in the context of clinical or diagnostic performance. The evaluation is based on mechanical testing and comparison to predicate devices, not clinical studies with patients.
- Data Provenance: The mechanical test data would typically be generated in a lab setting, likely in the US where Smith & Nephew is based. No specific country of origin or retrospective/prospective nature is stated for this mechanical testing data.
-
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 is a mechanical implant, not a diagnostic device where "ground truth" is established by experts interpreting images or clinical data. The "ground truth" for mechanical performance would be established by standardized engineering tests and specifications.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. There is no "test set" requiring adjudication by human experts in this type of submission.
-
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 mechanical implant, not an AI-driven or diagnostic device that would involve human readers or AI assistance.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This is a mechanical implant; there is no algorithm or standalone performance to evaluate.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the mechanical performance, the "ground truth" would be engineering specifications and mechanical testing standards (e.g., ISO, ASTM standards for orthopedic implants), which determine if the device meets strength, fatigue, and other biomechanical requirements. No clinical ground truth (pathology, outcomes) is discussed in the context of this submission's evidence for performance.
-
The sample size for the training set:
- Not Applicable. There is no "training set" as this is not a machine learning or diagnostic device.
-
How the ground truth for the training set was established:
- Not Applicable. There is no "training set" for this device.
§ 888.3390 Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis is a two-part device intended to be implanted to replace the head and neck of the femur. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular component made of an alloy, such as cobalt-chromium-molybdenum, and ultra-high molecular weight polyethylene. This generic type of device may be fixed to the bone with bone cement (§ 888.3027) or implanted by impaction.(b)
Classification. Class II.