(223 days)
Hip Modular Spacer: The Hip Modular Spacer, which consists of a modular head and stem, is indicated for temporary use (maximum 180 days) as an adjunct to total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process and where gentamicin is the most appropriate antibiotic based on the susceptibility pattern of the infecting micro-organisms. The head and stem components are inserted into the acetabular cavity and femoral medullary canal, respectively, following removal of the existing acetabular and femoral components and radical debridement. The device is intended for use in conjunction with systemic antibiotic therapy (standard treatment approach to an infection). The Hip Modular Spacer is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g. resection arthroplasty, fusion etc.).
Knee Modular Spacer: The Knee Modular Spacer, which consists of a modular femoral, tibial insert component, is indicated for temporary use (maximum 180 days) as an adjunct to total knee replacement (TKR) in patients undergoing a two-stage procedure due to a septic process and where gentamicin is the most appropriate antibiotic based on the susceptibility pattern of the infecting micro-organism(s). The device is applied on the femoral condyles (femoral component) and on the tibial plate (tibial component) following removal of the existing implant and radical debridement. The use of the tibial insert component is optional, when a large tibial defect is present. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). The Knee Modular Spacer is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g. resection arthroplasty, fusion etc.). Because of the inherent mechanical limitations of the device materials (gentamicin/polymethylmethacrylate), the device is only indicated for patients who will consistently use traditional mobility assist devices (e.g., crutches, walkers, canes) throughout the implantation period.
The Modular Spacers are sterile, single-use devices intended for temporary use (maximum 180 days) as joint replacements. The Hip Modular Spacer is composed of two components (a head and a stem) that are intended to be used together to form a temporary hip spacer; the components are available in a range of sizes. The Knee Modular Spacer is composed of three independent components (a femoral component, a tibial component and a tibial insert component) that are intended to be used together to form a temporary knee spacer; the components are available in a range of sizes. The devices are made of fully formed polymethylmethacrylate (PMMA), which is radioopaque, and contains gentamicin and color additives to give a green color. The Modular Spacers provide a functional-mechanical mode of action; they provide patients a temporary implant allowing for a natural range of motion and partial weight-bearing during treatment. They are designed to preserve soft tissue to prevent further complications, such as muscular contraction, and to facilitate the subsequent joint replacement procedure.
The provided text describes a medical device, the Garventis Modular Spacer (Hip and Knee), and its premarket notification (510(k)) to the FDA. The submission focuses on demonstrating substantial equivalence to predicate devices through various tests rather than a clinical study evaluating diagnostic performance. Therefore, many of the requested categories related to clinical study design, human readers, and expert ground truth are not applicable.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
The document outlines several types of tests performed to demonstrate the device's safety and effectiveness compared to predicate devices. The acceptance criteria are generally implied to be meeting the standards of the referenced ISO and ASTM guidelines.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Material Properties: | |
| Biocompatibility | Met acceptance criteria per ISO 10993, demonstrating materials are safe, suitable, and appropriate for intended use. |
| Mechanical Performance: | |
| Static testing (resin) | Met acceptance criteria (ISO 5833). |
| Fatigue testing (resin) | Met acceptance criteria (ASTM F2118). |
| Fatigue testing (device spacer) | Met acceptance criteria (ISO 7206-4, ISO 7206-6, ASTM F1800, ISO 14243-1). |
| Surface roughness testing (spacer device) | Met acceptance criteria (ISO 4287-97). |
| Head size comparison (femoral head) | Met acceptance criteria (ISO 7206-9). |
| Disassembly test (femoral head) | Met acceptance criteria (ISO 7206-9). |
| Pharmacological Performance: | |
| Antibiotic elution testing | Data presented to demonstrate performance. Specific quantitative acceptance criteria or results are not detailed in this summary. |
| Bacterial anti-adhesivity testing | Data presented to demonstrate performance. Specific quantitative acceptance criteria or results are not detailed in this summary. |
| Sterility & Shelf Life: | |
| Sterility | Data presented to show sterility. |
| Packaging integrity | Data presented to show suitability and integrity of packaging. |
| Shelf life | Data presented to support proposed shelf life. |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable. The studies conducted are primarily non-clinical performance tests on the device itself (materials, mechanical properties, drug elution) rather than clinical studies on patient data.
- Data Provenance: Not applicable for device performance testing. These are laboratory-based tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth for these types of engineering and materials tests is established by adhering to recognized international standards (ISO, ASTM) and measuring physical, chemical, and mechanical properties.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is not a diagnostic device requiring expert adjudication of results.
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/imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical performance tests, the "ground truth" is based on established engineering and material science standards (e.g., ISO 10993 for biocompatibility, ISO 5833 for static testing, ASTM F2118 for fatigue testing). The device performance is compared against the requirements and specifications defined by these standards.
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.
§ 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.(b)
Classification. Class II.