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510(k) Data Aggregation
(60 days)
The Panorama MR Imaging System is indicated for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon the NMR parameters (proton density, flow velocity, spin-lattice relaxation time (T1), and spin-spin relaxation time (T2)) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.
Philips' Panorama Enhancements includes changes to the operating limits for dB/dt and additional software improvements.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Philips Panorama Enhancements, structured according to your request.
Please note: This document describes a submission for a Magnetic Resonance Imaging (MRI) System, specifically "Panorama Enhancements". The information provided is primarily focused on demonstrating substantial equivalence to existing predicate devices, rather than a clinical study establishing new diagnostic performance metrics for an AI algorithm. Therefore, many of your requested points related to AI performance, ground truth, and expert evaluation are not applicable or extractable from this type of documentation.
Acceptance Criteria and Study for Philips Panorama Enhancements
This submission focuses on demonstrating substantial equivalence of the "Panorama Enhancements" to previously cleared MRI systems (Philips Panorama 0.6T/0.23T and Philips Intera family). The acceptance criteria for this type of submission are primarily related to meeting performance standards and maintaining safety and effectiveness comparable to the predicate devices. The "study" described is essentially a comparison table (Substantial Equivalence Chart) demonstrating how the new enhancements align with or are within the acceptable ranges of the predicate devices.
1. A table of acceptance criteria and the reported device performance
Since this is a substantial equivalence submission for an MRI system enhancement, the "acceptance criteria" are implied to be the specifications and performance characteristics of the predicate devices, and the "reported device performance" is how the new "Panorama Enhancements" compare to these predicates.
| Parameter | Acceptance Criteria (Predicate Devices - K013858, K974844, K001796) | Reported Device Performance (Panorama Enhancements - 0.6T MR Imaging System) | Reported Device Performance (Panorama Enhancements - 0.23T MR Imaging System) |
|---|---|---|---|
| Gradient Coils | Water-cooled self-shielded gradient system (K013858, K974844) | Same (Water-cooled self-shielded gradient system) | Same (Water-cooled self-shielded gradient system) |
| Max. Gradient Strength (0.6T) | 20 mT/m (K013858) | 23 mT/m | N/A |
| Max. Gradient Strength (0.23T) | 16 mT/m (x,y direction), 18 mT/m (z direction) (K974844) | N/A | 21 mT/m |
| Max. Slew Rate (0.6T) | 40 T/m/s (K013858) | 75 T/m/s | N/A |
| Max. Slew Rate (0.23T) | 25 T/m/s (x,y direction), 40 T/m/s (z direction) (K974844) | N/A | 50 T/m/s |
| RF amplifiers | Max power 9 kW (K013858) for 0.6T; 5 kW solid state (K013858) for 0.23T | Same (Max power 9 kW) | Same (5 kW solid state) |
| RF transmitter coils | Upper and lower, planar coils, integrated in magnet, water cooling. Tuning adjusted to 0.6T/0.23T field strength (K013858) | Same | Same |
| Receive only RF coils | Head, Head and Neck, Neck, Extremity, Body and Spine, Multipurpose, TMJ, Breast, Shoulder (K013858, K974844, K002539, K981959, K013528, K983143) | Same and Synergy Head and Neck | Same and Synergy Body |
| Magnet Façade | Fiberglass enclosure (K013858, K974844) | New design, cover backdoor of ABS, otherwise material the same. | New design, cover backdoor of ABS, otherwise material the same. |
| Base Software | Windows 2000 based Graphical User Interface and scan / reconstruction software with multi-tasking capability (K013858) | Same | Same |
| MRGP software | Interventional MRI capabilities (K013858) | Same | Same |
| Imaging sequences | Field Echo, Spin Echo, Dual Echo, Dual Spin Echo, Inversion Recovery, Dual Inversion Recovery, Fast Spin Echo, EXPRESS, CBASS, MRCP, MRA, STIR, FLAIR, TSHIRT, RF-FAST, CE-FAST, DWISE (K013858) | Same | Same |
| Acquisition and reconstruction techniques | Presaturation, MAST, ODA, PCS, no phase wrap-around, no slice wrap around, dynamic imaging, cardiac gating, optimized bandwidth, turbo multislice, MAO, chemical fat saturation, phase conjugate symmetry, read conjugate symmetry, true res, true slice, elliptic encoding, RAM, CODA, MTC, dynamic examination curve, contrast dynamic imaging, reconstruction filters, respiratory gating, multiplanar reconstruction, maximum intensity projection, phase correction, fat/water suppression, ADC map. SENSE capability. SyncraScan (K013858, K001796) | Same | Same |
| User Interface | Layout, see Figure 2a (K013858) | Layout change, see Figure 2b. | Layout change, see Figure 2b. |
| Normal Operating Mode (Time Varying) | According to IEC 60601-2-33 FDIS script 2001-11-02, default (K013858) for 0.6T; ≤ 40 T/s (K974844) for 0.23T | ≤ 35.4 T/s (IEC60601-2-33, second edition, directly determined) | ≤ 35.4 T/s (IEC60601-2-33, second edition, directly determined) |
| First Level Controlled Operating Mode (Time Varying) | According to IEC 60601-2-33 FDIS script 2001-11-02, default (K013858) for 0.6T; ≤ 60 T/s (K974844) for 0.23T | ≤ 44.3 T/s (IEC60601-2-33, second edition, directly determined) | ≤ 44.3 T/s (IEC60601-2-33, second edition, directly determined) |
| Normal Operating Mode (Radiofrequency Absorption) | Limited to a maximum level of 1.2 W/kg (K013858, K974844) | Same | Same |
| First Level Controlled Operating Mode (Radiofrequency Absorption) | Limited to a maximum value of 3.2 W/kg (K013858, K974844) | Same | Same |
| Acoustic Noise (Typical) | 87 dBA (average) 102 dBA (peak) (K013858) for 0.6T; A-weighted average value |
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(78 days)
The device is indicated for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone.
The device is also indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is designed to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality (e.g., malignancy). When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.
The Sanarus Centrica™ Core Tissue Biopsy System consists of a sticking probe, tissue cutter, control unit and specimen container. The sticking probe is operated by the control unit and utilizes cold temperatures at its tip to engage the tissue to be sampled. The tissue cutter is coaxially mounted around the sticking probe and is used to core the tissue specimen. The tissue cutter will be available in several gauge sizes and lengths.
The provided text describes the Sanarus Centrica™ Core Tissue Biopsy System and its substantial equivalence to a predicate device. However, it does not contain information about specific acceptance criteria or a study that definitively "proves" the device meets these criteria in the way described by the prompt's request for performance metrics, ground truth establishment, or sample sizes for testing.
Instead, the document states that the new device has "the same indications for use and technological characteristics as the predicate device" and that "Testing confirms that the quality of samples obtained with the Sanarus Centrica™ Core Tissue Biopsy System is equivalent to the predicate device and that the use of a cooled probe to engage the tissue does not affect the histological evaluation." This indicates a substantial equivalence (SE) pathway, which primarily relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than requiring a detailed clinical study demonstrating specific performance metrics against pre-defined acceptance criteria.
Therefore, many of the requested fields cannot be directly extracted from the provided text.
Here's a breakdown of what can and cannot be answered based on the provided input:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Implicit: Quality of samples is equivalent to predicate device. | "Testing confirms that the quality of samples obtained with the Sanarus Centrica™ Core Tissue Biopsy System is equivalent to the predicate device." |
| Implicit: Use of cooled probe does not affect histological evaluation. | "Testing confirms... that the use of a cooled probe to engage the tissue does not affect the histological evaluation." |
| Implicit: Same indications for use as predicate. | "The Sanarus Centrica™ Core Tissue Biopsy System has the same indications for use... as the predicate device." |
| Implicit: Same technological characteristics as predicate. | "The Sanarus Centrica™ Core Tissue Biopsy System has the same... technological characteristics as the predicate device." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not specified.
- Data provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not specified. The document globally refers to "histological evaluation" without detailing the process or personnel involved in ground truth establishment for a specific test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified.
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
- No MRMC comparative effectiveness study is described. The device is a biopsy system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable, as this is a physical biopsy device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The document mentions "histological evaluation," implying pathology as the ground truth for tissue sample quality.
8. The sample size for the training set
- Not applicable/not specified. The device is not an AI algorithm that requires a training set in the typical sense. The "testing" mentioned is likely engineering or preclinical testing to demonstrate equivalence.
9. How the ground truth for the training set was established
- Not applicable/not specified.
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