Search Results

SpaceFlex Knee disposable cement spacer molds are indicated for use to mold a temporary total knee replacement (TKR) for skeletally mature patients undergoing a two-stage procedure due to a septic process. The molded temporary knee prosthesis is indicated for an implantation period of 180 days or less. Because of inherent mechanical limitations of the device material (G3A Bone Cement), the molded temporary prosthesis is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers) throughout the implant period.

G21 SpaceFlex Knee system are disposable cement spacer molds made of polypropylene (PP) intended to be filled with low-viscosity polymethyl methacrylate bone cement directly in the operating room. Once the bone cement has hardened, the SpaceFlex Knee system creates a polymethyl methacrylate based bone cement spacer for patients undergoing a two-stage procedure following a periprosthetic joint infection. The device can be used in either the left or right knee joint. The SpaceFlex Knee molds are single-use and cannot be re-sterilized.

The provided text describes the regulatory clearance of the G21 s.r.l SpaceFlex Knee, a disposable cement spacer mold. This device is classified as Class II and is indicated for use in molding a temporary total knee replacement for skeletally mature patients undergoing a two-stage procedure due to a septic process.

However, the provided document does not contain information about an AI/ML-based medical device study. Instead, it focuses on the substantial equivalence of a physical medical device (a knee spacer mold) to existing predicate devices, based on typical mechanical and material performance testing.

Therefore, I cannot extract the information required by your request about acceptance criteria and a study proving an AI/ML device meets those criteria, as the document details a different type of medical device and a different type of clearance process.

To answer your request, I would need a document describing the study and acceptance criteria for an AI/ML-driven medical device, not a physical orthopedic device.

Ask a specific question about this device

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.

Ask a specific question about this device

The Remedy® Shoulder Spacer, which consists of a modular head and stem, is indicated for temporary use (maximum 180 days) as an adjunct to total or hemi-shoulder replacement 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 glenoidal cavity and humeral medullary canal, respectively, following removal of the existing prosthetic 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® Shoulder 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 Remedy® Shoulder Spacer is a sterile, single-use device intended for temporary use (maximum 180 days) as shoulder replacement.

The Remedy® Shoulder Spacer is composed of two components (a head and a stem) that are intended to be used together to form a temporary shoulder spacer; the components are available in a range of sizes.

The device is made of fully formed polymethylmethacrylate (PMMA), which is radioopaque and contains gentamicin. The stem component has also an inner stainless steel reinforcing structure.

The Remedy® Shoulder Spacer provides a functional-mechanical mode of action; it provides patients a temporary implant allowing for a natural range of motion and partial weight-bearing during treatment. It is designed to preserve soft tissue to prevent further complications, such as muscular contraction, and to facilitate the subsequent joint replacement procedure.

This document appears to be a 510(k) Summary for a medical device called the "Remedy® Shoulder Spacer." It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study designed to meet specific acceptance criteria in the way one would for an AI/ML powered device.

Therefore, many of the requested categories for AI/ML device studies (like sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this document as it describes a physical orthopedic implant, not a software algorithm.

Below is an attempt to map the available information to the closest relevant categories, with explanations for why certain sections are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

As this is not an AI/ML device, the concept of "acceptance criteria" for diagnostic performance metrics (e.g., sensitivity, specificity, AUC) is not present. Instead, the document discusses performance testing designed to demonstrate safe and effective mechanical function and material properties, and equivalence to a predicate device. The "acceptance criteria" would be compliance with relevant standards and demonstration of properties comparable to the predicate.

2. Sample size used for the test set and the data provenance

This is not applicable for a physical device 510(k) submission in the context of diagnostic "test sets." The performance data is based on laboratory testing of the device itself and its components, according to established engineering and material science protocols. There is no biological "data" in the sense of patient images or clinical outcomes that would have "provenance."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable. "Ground truth" in this context refers to a standard of truth for diagnostic or clinical outcome data, which is not evaluated here. The "truth" for device performance is established through physical and chemical testing against engineering standards and comparison to a predicate device.

4. Adjudication method for the test set

This is not applicable. There is no clinical "test set" requiring adjudication by experts.

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

This is not applicable as this is not an AI/ML device or a diagnostic device involving "human readers."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable as this is not an AI/ML device.

7. The type of ground truth used

This is not applicable in the AI/ML sense. The "ground truth" for the device's acceptable performance is defined by:

• Compliance with recognized standards: e.g., ISO for biocompatibility, sterilization standards.
• Engineering and material science principles: for mechanical strength, fatigue, material composition.
• Comparative data to a legally marketed predicate device: demonstrating that the new device is "substantially equivalent" in terms of safety and effectiveness.

8. The sample size for the training set

This is not applicable as this is not an AI/ML device. There is no concept of a "training set" for a physical orthopedic implant.

9. How the ground truth for the training set was established

This is not applicable as this is not an AI/ML device.

Ask a specific question about this device