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510(k) Data Aggregation
(129 days)
Elixbo PM545 is indicated for use as magnetic resonance diagnostic device that produces axial, sagittal, coronal and oblique cross sectional images, and that displays the anatomical and pathological information of the head, body, or extremities. When interpreted by a trained physician, these images yield information that can be useful in determining a diagnosis.
The proposed device, Elixbo PM545, is a Magnetic Resonance Imaging System that utilizes a 0.45 Tesla permanent magnet in an open gantry design. It's indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross sectional images, and that display the internal structure and/or function of the head, body, or extremities. These images when interpreted by a trained physician vield information that may assist in diagnosis. The MRI system is composed of magnet, gradient & shimming system, RF system, spectrometer, temperature controller, patient table system, isolation transformer, respiratory gating unit, chiller and control system. The system software, Prospect, based on Windows® XP professional operating system is an interactive program with user friendly interface. The proposed device includes twelve receiving coils which are Head Coil, Neck Coil, Knee Coil, Shoulder Coil, Wrist Coil, Breast Coil, Ankle Coil, Body Coil (14"), Body Coil (17"), Body Coil (20"), General Purpose Coil (6"), and General Purpose Coil (9").
The provided document describes the safety and effectiveness information for the Elixbo PM545 Magnetic Resonance Imaging System, submitted as a 510(k) premarket notification. This submission indicates that the device's performance was evaluated through non-clinical bench tests and a comparison to a predicate device, rather than a clinical study with specific acceptance criteria for diagnostic performance metrics like sensitivity or specificity.
1. Table of Acceptance Criteria and Reported Device Performance:
The acceptance criteria for the Elixbo PM545 are primarily based on compliance with international standards for medical electrical equipment and a determination of substantial equivalence (SE) to a legally marketed predicate device (mStar MPF4500, K073457). The "device performance" in this context refers to its ability to meet these technical standards and operate comparably to the predicate device.
| Acceptance Criteria Category | Specific Criteria / Standard | Reported Device Performance (Elixbo PM545) |
|---|---|---|
| Safety and Electrical | IEC 60601-1: General Requirements for Safety | Conforms to IEC 60601-1:1988 + A1:1991 + A2:1995 |
| IEC 60601-2-33: Basic Safety and Essential Performance of MR Equipment | Conforms to IEC 60601-2-33:2002 + A1:2005 + A2:2007 | |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2: Electromagnetic Compatibility | Conforms to IEC 60601-1-2: 2007 |
| Image Quality Parameters (NEMA Standards) | NEMA MS 1-2008: Signal-to-Noise Ratio (SNR) | Demonstrated compliance |
| NEMA MS 2-2008: Two-Dimensional Geometric Distortion | Demonstrated compliance | |
| NEMA MS 3-2008: Image Uniformity | Demonstrated compliance | |
| NEMA MS 5-2010: Slice Thickness | Demonstrated compliance | |
| Biocompatibility | ISO 10993-5: In Vitro Cytotoxicity | Conforms to ISO 10993 series standards |
| ISO 10993-10: Irritation & Delayed-Type Hypersensitivity | Conforms to ISO 10993 series standards | |
| ISO 10993-10: Irritation & Skin Sensitization (2010) | Conforms to ISO 10993 series standards | |
| Functional Equivalence | Intended Use | Same as predicate (magnetic resonance diagnostic device producing axial, sagittal, coronal, oblique images for head, body, or extremities for diagnosis) |
| Installation Type | Fixed (Same as predicate) | |
| Magnet Type | Permanent (Same as predicate) | |
| RF Amplifier Max Power | 6 kW (Same as predicate) | |
| Pulse Sequences | SE, GRE, FSE, FSE+FC, FSE+Sat, LSDWI, TOF2D, TOF3D, FLAIR, STIR, SPGR2D, SSFSE2D, SSFSE3D (Same as predicate) | |
| Maximum Gradient Strength | 25mT/m (Same as predicate) | |
| Slew Rate | 78mT/m/ms (Same as predicate) | |
| Static Field Strength | 0.45T (Same as predicate) | |
| Peak and A-Weighted Acoustic Noise | Peak: <99dB, A-Weighted: 81.5dB (Same as predicate) | |
| Operation Mode | Normal (Same as predicate) | |
| Safety Parameter Display | SAR (Same as predicate) | |
| Max SAR for transmit Coil | 0.0851 W/kg (Same as predicate) | |
| Potential Emergency Condition | Yes (Same as predicate) | |
| Level of Concern of Software | Minor (Image Enhance) / Moderate (Scan Control) (Same as predicate) | |
| Identified Differences from Predicate | Coil | Similar (Head, neck, knee, body, wrist, shoulder, ankle, breast, general coil) - differences reviewed and concluded not to affect safety/effectiveness. |
| Gating/Triggering | Respiration (Similar) - differences reviewed and concluded not to affect safety/effectiveness. | |
| Max dB/dt | 19.06 T/s (Similar) - differences reviewed and concluded not to affect safety/effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes non-clinical bench tests and a comparison to a predicate device. It does not mention a traditional clinical test set involving human subjects or patient data to evaluate diagnostic performance metrics like sensitivity, specificity, or accuracy. The "test results" refer to engineering and performance tests to demonstrate compliance with standards and equivalence to the predicate. Therefore, information on sample size and data provenance (country of origin, retrospective/prospective) for a clinical test set is not provided because such a study was not presented.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
No information is provided regarding experts or ground truth establishment for a diagnostic performance study, as the submission relies on bench testing and comparison to a predicate device.
4. Adjudication Method for the Test Set:
Not applicable, as no external adjudication method for a clinical test set is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC study was performed or described in this submission. The device approval relies on substantial equivalence to an existing device, which typically does not require a comparative effectiveness study showing improvement with AI assistance.
6. Standalone Performance Study:
No standalone (algorithm only without human-in-the-loop performance) study for diagnostic performance was conducted or described. The device is a Magnetic Resonance Imaging System, where the human physician is always "in the loop" for interpretation. The "performance" described relates to technical specifications meeting safety and imaging standards.
7. Type of Ground Truth Used:
No "ground truth" (expert consensus, pathology, outcomes data) as typically understood for diagnostic device performance evaluation was used in this 510(k) submission. The "truth" for the evaluation was based on compliance with established technical standards (IEC, NEMA, ISO) and demonstrating that the device's technical specifications and intended use were substantially equivalent to the predicate device.
8. Sample Size for the Training Set:
Not applicable. The document describes a traditional MRI device and its regulatory submission, not an AI/ML-based device that would typically involve a "training set" of data.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no mention of a training set or ground truth for such a set in this submission.
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