Search Results

The Smart Fit TorsoCardiac 1.5T coil is designed to be used in conjunction with a Philips 1.5T MR system to produce diagnostic images of the torso (including chest, abdomen, pelvis), head and neck and heart that can be interpreted by a trained physician.

The Smart Fit Shoulder 1.5T coil is designed to be used in conjunction with a Philips 1.5T MR system to produce diagnostic images of the Shoulder that can be interpreted by a trained physician.

The proposed of Smart Fit Shoulder 1.5T and Smart Fit TorsoCardiac 1.5T are intended to be used in conjunction with a Philips MR-system to enable trained physicians to obtain cross-sectional images of the internal structure of the head, body, or extremities, in any orientation. These images, when interpreted by a trained physician, provide information that may assist diagnosis and therapy planning.

The proposed Smart Fit Torsocardiac 1.5T is a phased array receive-only coil for high resolution diagnostic imaging of the torso (including chest, abdomen, pelvis), head and neck and heart. The coil foam is composed of PU foil, flexible PCB and EVA to provide sufficient flexibility along Left-Right direction for patient body scan. The layers from outside to patient side are: PU foil (outer surface), EVA30 foam, PCBA of the coil and PU foil (inner surface). The foam looks flat at the top surface. A few parts, two feed- board boxes, cable housing and a small connector placed across the central Head-Feet axis are also at the top surface. Inner surface is naturally flat and is bendable along slots to fit well to the patient body.

The proposed Smart Fit Shoulder 1.5T is a phased array receive-only coil for high resolution diagnostic imaging of shoulder. The coil foam is composed of PU foil, flexible PCB and EVA to provide sufficient flexibility along Anterior-Posterior direction for patient shoulder scan. The layers from outside to patient side are: PU foil (outer surface), EVA30 foam, PCBA of the coil, EVA 30 foam, and PU foil (inner surface). A few parts, feed-board boxes, cable housing and a small connector placed across the Head-Feet axis are also at the outer surface. Inner surface is naturally flat and is bendable along slots to fit well to the patient body.

The provided document is a 510(k) Summary of Safety and Effectiveness for Philips Healthcare's Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T MRI coils. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for an AI/ML-driven device through a multi-reader, multi-case study.

Therefore, many of the requested details regarding acceptance criteria for an AI/ML device, ground truth establishment, sample sizes for training/test sets, expert adjudication methods, and MRMC studies are not applicable or explicitly mentioned in this document as it pertains to traditional medical device clearance rather than AI/ML software. The document asserts that "The proposed Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T did not require clinical study since substantial equivalence to the legally marketed predicate device was proven in the comparison in terms of safety and effectiveness."

However, I can extract the information that is present and indicate what is not applicable.

Acceptance Criteria and Device Performance (based on provided text, primarily regarding equivalence to predicate devices and general performance, not AI/ML specific metrics)

• ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012 C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text)
• IEC60601-2-33 Ed. 3.2:2015
• IEC60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION
• IEC60601-1-6 Edition 3.1:2013
• ISO 14971 Ed. 3:2019
• IEC 62366 Edition 1.1: 2020-06 CONSOLIDATED VERSION
• ANSI AAMI ISO10993-1:2018 |
  | Signal-to-Noise Ratio (SNR) | Meets acceptance criteria (implied by compliance with NEMA MS 1-2008(R2020)) |
  | Image Uniformity | Meets acceptance criteria (implied by compliance with NEMA MS 3-2008 (R2020)) |
  | Phased Array Coils Characterization | Meets acceptance criteria (implied by compliance with NEMA MS 9-2008 (R2020)) |
  | RF Coil Heating | Meets acceptance criteria (implied by compliance with NEMA MS 14-2019) |
  | Clinical Image Quality for Diagnostic Use | "No issues with the clinical image quality was seen and images were considered have sufficient quality for diagnostic use." |
  | Biocompatibility | Biocompatibility testing against internal specifications and ISO10993-1 performed. "The safety of PC and PU has been proved in the biocompatibility report." |
  | Risk Management | "all risks are sufficiently mitigated, that no new risks are" (sentence incomplete in document, but implies compliance/mitigation) |
  | Substantial Equivalence | "considered substantially equivalent to the currently marketed and predicate devices" |

Study Information (based on provided text):

1. Sample sizes used for the test set and the data provenance:

   • Test set sample size: Not explicitly stated as a distinct "test set" for performance evaluation in the context of an AI/ML algorithm (which is not this device). However, the document mentions "All clinical images on the proposed coils Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T were evaluated by qualified radiologists." This implies a set of clinical images used for evaluation. The number of images or patients is not provided.
   • Data Provenance: Not specified (e.g., country of origin). The study is descriptive, focusing on demonstrating equivalence to predicates via technical characteristics, standards compliance, and subjective review of image quality rather than analyzing data from a specific patient cohort. The clinical image evaluation mentioned is a retrospective review of images generated by the new coils.

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

   • Number of experts: Not specified beyond "qualified radiologists".
   • Qualifications: "qualified radiologists". No specific years of experience or board certifications are detailed in this summary.
   • Note: This is not an AI/ML device that generates a "ground truth" for classification or detection. The radiologists are evaluating the diagnostic quality of the images produced by the new coils.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not specified. The document only states that images "were evaluated by qualified radiologists." It does not detail any consensus or adjudication process for image quality assessment.

4. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done:

   • No, an MRMC study was NOT done. The document explicitly states: "The proposed Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T did not require clinical study since substantial equivalence to the legally marketed predicate device was proven in the comparison in terms of safety and effectiveness." MRMC studies are typically performed for AI/ML devices to assess reader performance with and without AI assistance; this device is an MRI coil, not an AI/ML algorithm.
   • Effect size of human readers improvement with AI vs. without AI assistance: Not applicable, as no AI assistance is involved with these MRI coils, and no such study was performed.

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

   • Not applicable. This device is an MRI coil, which is a hardware component, not a standalone algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Not applicable in the context of an AI/ML algorithm generating diagnostic output. For this device (an MRI coil), the "ground truth" is implicitly tied to the expectation that the images produced are of sufficient diagnostic quality as determined by "qualified radiologists" (expert opinion on image quality) and meet established technical performance standards (NEMA, IEC, AAMI). There's no disease pathology ground truth being established/compared for an AI model.

7. The sample size for the training set:

   • Not applicable. This is not an AI/ML device that requires a training set.

8. How the ground truth for the training set was established:

   • Not applicable. This is not an AI/ML device.

Ask a specific question about this device