(155 days)
The BIRMINGHAM HIP Dual Mobility Insert is intended for use in BIRMINGHAM HIP Resurfacing (BHR) System revision surgeries in cases where an acetabular cup is retained and the femoral component revised.
The BIRMINGHAM HIP Dual Mobility Insert prosthesis is a cross-linked UHMWPE (XLPE) insert intended for use in BIRMINGHAM HIP Resurfacing (BHR) System revision surgeries in cases where a BHR acetabular cup is retained and the femoral component revised. The device consists of an XLPE insert component designed to articulate against the retained BHR acetabular cup. The insert is also designed to interface with Smith & Nephew femoral heads and THA femoral stems. During low level activity the articulation occurs between the femoral ball head and the insert with the insert remaining in a neutral position. During high level activities requiring a larger range of motion the femoral stem contacts the insert and articulation between the insert and shell will occur. The inserts are supplied in 11 sizes between 38-58mm to match the core BHR acetabular cup size range.
Here's a breakdown of the acceptance criteria and the study information for the Smith & Nephew BH Dual Mobility Insert, based on the provided document:
This document is a 510(k) summary for a medical device (BH Dual Mobility Insert), which focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed clinical study results often associated with AI/software devices. Therefore, several of your requested points (like sample size for training, number of experts for ground truth, MRMC studies, standalone performance with AI, etc.) are not applicable to this type of submission.
The "study" here refers to non-clinical bench (mechanical) testing and biocompatibility evaluation, not a clinical trial involving human subjects or an AI algorithm.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (Implicit from context) | Reported Device Performance |
|---|---|---|
| Dislocation Analysis | Met pre-determined acceptance criteria | Met acceptance criteria |
| Range of Motion | Met pre-determined acceptance criteria | Met acceptance criteria |
| Wear Testing | Met pre-determined acceptance criteria | Met acceptance criteria |
| Biocompatibility | In accordance with ISO-10993 | In accordance with ISO-10993 |
| Bacterial Endotoxin | Met acceptable endotoxin limits | Met acceptable endotoxin limits |
Note: The document states "The subject devices with pre-determined acceptance criteria met the acceptance criteria for all tests." The specific numerical or descriptive acceptance criteria themselves are not detailed in this summary document.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify the exact number of devices (samples) used for each mechanical test.
- Data Provenance: Not applicable, as this refers to mechanical bench testing and not human subject data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. This device is a mechanical implant; "ground truth" as it pertains to expert consensus on images or diagnoses is not relevant. The "ground truth" for mechanical properties is typically established by engineering specifications and standards.
4. Adjudication Method (e.g. 2+1, 3+1, none) for the Test Set
- Not Applicable. Adjudication methods are typically for subjective assessments (e.g., image interpretation). Mechanical tests are objective measurements against established standards.
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 a medical device (implant), not an AI/software device that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a mechanical implant, not an algorithm.
7. The Type of Ground Truth Used
- Engineering Specifications and Industry Standards: For mechanical testing (dislocation, range of motion, wear), the "ground truth" or reference for acceptance is compliance with established engineering and performance specifications and relevant ASTM/ISO standards for hip implants.
- ISO-10993: For biocompatibility, the ground truth is adherence to the principles and testing methods outlined in ISO-10993.
- FDA Guidance/ANSI/AAMI ST72: For bacterial endotoxin testing, the ground truth is meeting the acceptable endotoxin limits specified in these guidelines.
8. The Sample Size for the Training Set
- Not Applicable. There is no "training set" as this is a physical medical device, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set for a machine learning model, this question is not relevant.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The device's substantial equivalence and performance claims are supported by a combination of non-clinical (bench) testing and material characterization:
- Biocompatibility Evaluation: Conducted in accordance with FDA's Draft Guidance for Industry and FDA Staff "Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing Within a Risk Management Process." The device is classified as a permanent implant (>30 day body contact). The subject inserts are manufactured from identical polyethylene XLPE materials as the predicate devices, in accordance with ISO 5834-2: 2011. Biocompatibility testing rationales were provided.
- Mechanical Testing: Non-clinical bench tests were performed on the proposed BH Dual Mobility Insert, including:
- Dislocation Analysis
- Range of Motion
- Wear Testing
The document explicitly states that "The subject devices with pre-determined acceptance criteria met the acceptance criteria for all tests."
- Bacterial Endotoxin Testing: Completed and met the acceptable endotoxin limits as stated in FDA Guidance, "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile," "Pyrogen and Endotoxins Testing: Questions and Answers," and ANSI/AAMI ST72.
The conclusion is that based on these test results and additional verification evidence, the BH Dual Mobility Inserts are substantially equivalent to the legally marketed predicate devices (K110135 and K070278).
§ 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.