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The REMEDY PLUS Hip 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 and vancomycin are the most appropriate antibiotics based on the susceptibility pattern of the infecting micro-organism(s).
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 antimicrobial antibiotic therapy (standard treatment approach to an infection).
The REMEDY PLUS Hip 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.).

The UNITE PLUS Bone Cement is intended for the fixation of a REMEDY PLUS spacer device to the host bone.

The REMEDY PLUS Hip Spacer is comprised of modular components, which are available in different sizes to accommodate variations in patient anatomy. The REMEDY PLUS Hip Spacer includes stems in various sizes and lengths, and femoral heads in various diameters. The modular design of the REMEDY PLUS Hip Spacer allows the surgeon to choose a femoral head offset which best matches the patient's anatomy.

The REMEDY PLUS Hip Spacer is a sterile, single-use device intended for temporary use (maximum 180 days) as a joint replacement. The implants are made of fully formed polymethylmethacrylate (PMMA), which is radiopaque, and contains gentamicin and vancomycin. The hip device has an inner stainless steel (AISI 316 ESR stainless steel) reinforcing structure.

The UNITE PLUS Bone Cement is a PMMA, radiopaque bone cement, containing gentamicin and vancomycin, designed for the fixation of prosthesis to the living bone. The UNITE PLUS Bone Cement is provided sterile.

Here's an analysis of the acceptance criteria and study as described in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence rather than explicit quantitative acceptance criteria for device performance. However, based on the clinical study, the implicit "acceptance criteria" appear to be similar or superior clinical outcomes compared to the predicate device and literature.

| Acceptance Criteria (Implicit) | Reported Device Performance (REMEDY PLUS Hip Spacer / GV Spacer) |
| Mechanical Performance: * Similar mechanical performance as predicate devices. | Performance testing included: * Stem fatigue per ISO 7206-4 * Neck fatigue per ISO 7206-6 * Femoral head/stem disassembly based on ISO 7206-13 * Chemical and physical properties of cement (for UNITE PLUS Bone Cement) |
| Biocompatibility: * Biocompatible materials. | Biocompatibility data was collected (details not provided in the summary). |
| Sterilization & Shelf Life: * Device capable of being sterilized and maintaining function over shelf life. | Sterilization, pyrogenicity, bacterial endotoxin, and shelf life testing were performed. |
| Antibiotic Elution: * Appropriate and sustained antibiotic elution kinetics. | Antibiotic elution kinetics were performed (details not provided in the summary). |
| Clinical Efficacy (Composite Success): * Comparable or superior composite success rate (Stage 1 and Stage 2 success) as compared to the G Spacer and existing literature. Stage 1 success: absence of Girdlestone, arthrodesis, amputation, or spacer-related death. Stage 2 success: absence of two or more positive cultures of microorganisms at reimplantation. | * All Subjects: GV Spacer: 89.6% (N=48), G Spacer: 71.6% (N=81). GV Spacer significantly higher (p=0.01262). * Hip Subjects: GV Spacer: 84% (N=25), G Spacer: 66.7% (N=51). GV Spacer 17.3% higher. * Comparison to Predicate: Predicate success rate (82.2%) comparable to GV Spacer. * Comparison to Rothman Institute Literature: Rothman (71.3%) lower than GV Spacer. |
| Clinical Efficacy (Stage 1 Outcomes): * Comparable or superior Stage 1 success rate as compared to the G Spacer and existing literature. | * All Subjects: GV Spacer: 91.7% (N=48), G Spacer: 85.2% (N=81). GV Spacer higher, but not statistically significant (p=0.213). * Hip Subjects: GV Spacer: 88% (N=25), G Spacer: 84.3% (N=51). GV Spacer 3.7% higher. * Comparison to Predicate: Predicate Girdlestone (4.4%), deep infections (8.9%). * Comparison to Rothman Institute Literature: Rothman (89.5%) comparable to GV Spacer. |
| Clinical Efficacy (Stage 2 Outcomes): * Comparable or superior Stage 2 success rate as compared to the G Spacer and existing literature. | * All Subjects: GV Spacer: 97.7% (N=43), G Spacer: 84.1% (N=69). GV Spacer statistically superior (p=0.0198). * Hip Subjects: GV Spacer: 95.5%, G Spacer: 79.1%. GV Spacer 16.4% higher. * Comparison to Predicate: Predicate treatment success 83% (N=116). * Comparison to Rothman Institute Literature: Rothman (80.7%). GV Spacer compares favorably. |
| Safety - Inter-Stage Reoperations: * Similar rates of inter-stage reoperations (spacer exchanges, debridements) as compared to the G Spacer, predicate, and literature. | * All Subjects - Spacer Exchange: GV Spacer: 10.4% (N=48), G Spacer: 9.9% (N=81). Similar rates. * All Subjects - Spacer Debridement: GV Spacer: 6.25% (N=48), G Spacer: 0% (N=81). GV Spacer higher. * Hip Subjects - Spacer Exchange: GV Spacer: 12% (N=25), G Spacer: 11.8% (N=51). Similar rates. * Comparison to Predicate/Literature: Similar to reported rates (e.g., Predicate spacer exchange 6.8%, Gomez 11.9% for spacer exchange, Cancienne 10.8% for debridement). |
| Safety - Acute Kidney Injury (AKI): * AKI rates within the range reported in literature for PJI patients with antibiotic-loaded spacers. | * All Subjects: GV Spacer: 10.2% (N=49), G Spacer: 3.7% (N=81). Both within literature range (8.5% to 20%). * Hip Subjects: GV Spacer: 16% (N=25), G Spacer: 5.9% (N=51). Both within literature range. * Mention of literature suggesting high-dose, intra-operatively molded spacers may have higher risk than preformed, low-dose spacers like GV Spacer. |

2. Sample Size and Data Provenance:

• Test Set (Clinical Study):
  • GV Spacer (REMEDY PLUS Hip Spacer): 49 subjects (26 hips, 23 knees).
  • G Spacer (REMEDY Hip Spacer): 81 subjects (51 hips, 31 knees).
  • Data Provenance: The data was collected outside of the United States.
    • GV Spacer data: Prospectively collected.
    • G Spacer data: Majority retrospectively collected, some prospectively.

3. Number of Experts and Qualifications for Ground Truth:

The document does not explicitly state the number of experts used to establish ground truth or their specific qualifications for the clinical study. It refers to diagnoses of "periprosthetic joint infection (PJI)" and assessment of "positive cultures of microorganisms," which implies involvement of medical professionals (e.g., infectious disease specialists, microbiologists, surgeons) in these determinations as part of standard clinical practice. However, no specific details are provided about their experience or roles in adjudicating the study outcomes.

4. Adjudication Method for Test Set:

The document does not explicitly describe an adjudication method (e.g., 2+1, 3+1). The outcomes (e.g., absence of positive cultures, Girdlestone procedure, amputation) are presented as direct observations or clinical determinations. It's implied that these outcomes were part of the standard reporting and assessment within the clinical studies, but specific adjudication by a panel is not mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study involving human readers assisting AI or vice versa was not conducted. The clinical study compares two different types of spacers (GV Spacer vs. G Spacer) and compares these to predicate devices and literature, focusing on the clinical outcomes of the devices themselves, not on the effectiveness of human readers or AI assistance.

6. Standalone Performance:

Yes, a standalone performance study was done in the sense that the clinical study evaluated the performance of the device only (REMEDY PLUS Hip Spacer / GV Spacer) without explicit human-in-the-loop assistance for interpretation or decision-making beyond standard surgical practice. The results presented are the direct outcomes observed in patients treated with these spacers.

7. Type of Ground Truth Used:

The ground truth for the clinical study outcomes was based on:

• Clinical Outcomes/Events:
  • Absence of Girdlestone (hip fusion), arthrodesis (knee fusion), amputation, or spacer-related death (for Stage 1 success).
  • Absence of two or more positive cultures of microorganisms at the time of reimplantation (for Stage 2 success).
  • Observation of inter-stage reoperations (spacer exchanges, debridements).
  • Diagnosis of Acute Kidney Injury (AKI).
• Microbiological Data: Positive cultures of microorganisms.

This essentially constitutes a combination of clinical outcomes data and laboratory (microbiological) data.

8. Sample Size for the Training Set:

The document does not mention a training set. The study described is a clinical evaluation of the devices, not an AI or machine learning model that would require a distinct training set. The "samples" referred to are human subjects in a clinical study for device efficacy and safety.

9. How the Ground Truth for the Training Set Was Established:

Since no training set for an AI/ML model is mentioned, this information is not applicable. The ground truth for the clinical evaluation (as discussed in point 7) was established through standard clinical diagnostic procedures, surgical interventions, and microbiological testing within the context of the prospective and retrospective studies.

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