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510(k) Data Aggregation
(308 days)
The MISHATM Knee System is indicated for patients with medial compartment knee osteoarthritis that have failed to find relief in surgical and/or non-surgical treatment modalities and are still experiencing pain that interferes with activities of daily living and are also unwilling to undergo or ineligible for total knee replacement due to age or absence of advanced osteoarthritis.
The MISHATM Knee System (Figure 1) is a prescription use, extra-capsular knee implant device that is comprised of a tibial base subassembly, femoral base subassembly, absorber subassembly, piston subassembly and locking screws. The tibial base subassembly, femoral base subassembly, piston subassembly and absorber subassembly are provided pre-assembled, and the implant is fixed with locking screws to the medial cortices of the distal femur and proximal tibia to share the loads with the knee joint. The articulating ball-and-sockets allow the implant to accommodate the natural motions of the knee. The implant bases and locking screws are made of titanium alloy and the sockets are CoCrMo alloy. The compressive component of the absorber is made of polycarbonate urethane. The femoral balls, tibial balls, and the internal lining of the absorber are made of carbon-fiber-reinforced polyetheretherketone (CFR-PEEK). The implant comes in two sizes (small and large) and right or left configurations.
The provided text describes the results of a clinical study for the MISHATM Knee System (formerly Calypso Knee System) and various non-clinical (bench) studies to demonstrate its safety and effectiveness.
Here's an analysis of the acceptance criteria and study data based on your request:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Special Controls/Primary Endpoint) | Reported Device Performance and Results |
|---|---|
| Clinical Performance: | Clinical Study Results (Primary Endpoint): |
| Composite Clinical Success (CCS) at 24 months, demonstrating non-inferiority to HTO: - Clinically significant improvement ($ \ge $20% change AND $ \ge $10 points) from baseline on WOMAC pain questions in KOOS. - Clinically significant improvement ($ \ge $20% change AND $ \ge $10 points) from baseline on WOMAC function questions in KOOS. - Freedom from specified device-related serious adverse events (Deep infection requiring surgical intervention, Damage to adjacent neurovascular or ligament structures necessitating reconstruction, Non-union (HTO only)). - Maintenance of implant integrity by radiographic assessment. - (Additional explicit failure criterion: conversion to arthroplasty through 24 months). Non-inferiority margin (δ) of -0.10. | Achieved. - Success Rate (Multiple Imputation): - Calypso Knee group: 83.5% - Control (HTO) group: 57.2% - Difference: Calypso Knee group led the Control (HTO) group by 26.3%. - WOMAC Pain endpoint responder (Crude Observed, N=72): 95.8% (Calypso), 87.9% (HTO) - WOMAC Function endpoint responder (Crude Observed, N=72): 91.7% (Calypso), 81.3% (HTO) - No Safety Endpoint Event (CEC) (Crude Observed, N=81): 95.1% (Calypso), 93.8% (HTO) - No Endpoint Implant Integrity Failure (Crude Observed, N=81): 98.8% (Calypso), 98.8% (HTO) - No Endpoint Subsequent Surgical Intervention (Crude Observed, N=81): 98.8% (Calypso), 98.8% (HTO) The study conclusion of non-inferiority was found to be robust through sensitivity analysis for missing data. |
| Non-clinical Performance Testing (Mechanical Function & Durability): 1. Absorber Unloading Capacity: Minimum compressive resistance force $ \ge $15 lbs at implanted length. 2. Durability, Wear, and Corrosion Resistance: - Mean polymeric wear rate $ \le $ 6.1 mm³ per one million cycles. - Mean metallic wear rate $ \le $ 0.004 mm³ per one million cycles. - Implant materials corrosion resistant. - Implant functionality maintained for $ \ge $ 10 million simulated gait cycles. 3. Static Strength: Will not fracture or break under static compressive load up to 60 lbs. | Bench Study Results: 1. Absorber Unloading Capacity: All specimens exceeded the performance criteria ($ \ge $ 15 lbs). 2. Durability, Wear, and Corrosion Resistance: - Mean polymeric wear rate: 0.248 mm³ per one million cycles (Met criterion $ \le $ 6.1). - Mean metallic wear rate: 0.004 mm³ per one million cycles (Met criterion $ \le $ 0.004). - No evidence of corrosion after immersion in simulated in vivo environment. - All test articles remained functional throughout testing (10.3 million cycles). 3. Static Strength: All articles survived a static compressive load of 65 lbs without permanent deformation or damage (Met criterion $ \le $ 60 lbs). |
| Biocompatibility: Patient-contacting components demonstrated to be biocompatible. | Achieved. Testing per ISO 10993 series showed: - Cytotoxicity: Non-cytotoxic - Irritation: Non-irritant - Sensitization: Non-sensitizing - Implantation Effects: Null to minimal reactivity - Material Mediated Pyrogenicity: Non-pyrogenic - Systemic Toxicity, Genotoxicity, Carcinogenicity: Non-systemically toxic/genotoxic/carcinogenic (addressed via chemical characterization and toxicological risk assessment). A 26-week rabbit study showed no local or systemic toxicological effects. |
| Sterility & Pyrogenicity: Performance data support sterility and pyrogenicity of sterile components. | Achieved. - Sterility: Validated to SAL 10-6 using VDMax25 method (ANSI/AAMI/ISO 11137-1/-2). - Pyrogenicity: All tested devices passed BET with $ \le $ 1 EU/device, meeting ANSI/AAMI ST72:2011. |
| Shelf-life: Performance data support shelf life (sterility, package integrity, device functionality). | Achieved. Non-clinical performance testing confirmed a 5-year shelf-life. |
| MR Compatibility: Safety and compatibility in MR environment. | MR Conditional: - Displacement Force: Translation deflection angle of piral; maximum spatial gradient (D)(4) (bx). - Torque: No torque. - Image Artifacts: Maximum artifact size approx. 37 mm from implant with gradient echo pulse sequence (3.0 T MR scanner). - RF Induced Heating: Maximum temperature rise $ < $ 6°C after 60 min continuous exposure (whole-body SAR at 2 W/kg). |
2. Sample Sizes and Data Provenance:
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Clinical Study (Test Set):
- Calypso Knee Group: 81 subjects (prospective).
- Control (HTO) Group: 92 subjects enrolled, 81 subjects included in PS-matched analysis (historical data from "GOAL" study - Atlas IDE study, implying retrospective for the control group).
- Data Provenance: Not explicitly stated, but the mention of a "multicenter clinical study" and an "Atlas IDE study" suggests data from potentially multiple locations, though specific countries are not provided. The sponsor is Moximed Inc. in Fremont, California, giving a US nexus.
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Training Set Sample Size: The document does not provide information about a separate training set for a computational model or algorithm. The clinical data describes a test set for evaluating the device's clinical performance.
3. Number of Experts and Qualifications for Ground Truth (Clinical Study):
- The document does not explicitly state the number of experts or their qualifications used to establish "ground truth" for the clinical endpoints (e.g., WOMAC scores, adverse events, radiographic assessment).
- However, the clinical study involved patient-reported outcomes (WOMAC/KOOS scores), and adverse events were likely adjudicated by a clinical events committee (CEC), which typically consists of medical experts. The "No Safety Endpoint Event (CEC)" in Table 7 implies expert review. Radiographic assessment would also likely involve trained medical professionals (e.g., orthopedic surgeons, radiologists).
4. Adjudication Method (Clinical Study Test Set):
- The document explicitly mentions a "Committee of Experts (CEC)" for Safety Endpoint Events. This implies a specific adjudication process, likely involving multiple experts reviewing cases to determine if events meet predefined criteria.
- For the other components of the Composite Clinical Success (WOMAC scores, implant integrity), the adjudication method is not explicitly detailed as 2+1, 3+1, etc., but rather defined by the objective scoring systems (WOMAC/KOOS) and radiographic assessment by medical professionals.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not explicitly conducted as described for AI evaluation.
- The clinical study was a prospective, multicenter clinical study comparing the device (Calypso Knee System) to a historical control group (HTO) using propensity score matching. This is a comparison between treatments, not a comparison of human readers with vs. without AI assistance.
- Therefore, there is no effect size reported for human readers improving with AI vs. without AI assistance.
6. Standalone Algorithm Performance:
- No, a standalone (algorithm only without human-in-the-loop performance) study was not described. The performance evaluation focuses on the medical device itself (implant and its clinical outcomes) rather than an AI algorithm's diagnostic or predictive capability.
7. Type of Ground Truth Used (Clinical Study):
- For the clinical study, the "ground truth" for the primary and secondary endpoints was based on:
- Patient-Reported Outcomes (PROs): WOMAC pain and function scores from the KOOS Knee questionnaire.
- Clinical Events Committee (CEC) Adjudication: For Safety Endpoint Events (e.g., deep infection, neurovascular damage).
- Radiographic Assessment: For implant integrity.
- Clinical Outcomes/Events: Such as conversion to arthroplasty or subsequent surgical interventions.
8. Sample Size for the Training Set:
- As mentioned in point 2, the document does not describe a "training set" in the context of machine learning or AI algorithm development. The enrollment numbers (81 Calypso subjects, 92 HTO subjects originally, 81 PS-matched HTO subjects) refer to the clinical study's participant count for evaluating the device's effectiveness.
9. How Ground Truth for Training Set was Established:
- Since there's no mention of a separate training set for an AI algorithm, this information is not applicable from the provided text. The clinical study itself established the "performance data" for the device, which formed the basis for its regulatory acceptance.
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