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The indication for use for the Transmit/Receive Quadrature Body Coil 3.0T expands the INTERA 3.0T system capability as a diagnostic device that produces transverse, sagittal, coronal and oblique cross-sectional images based upon 'H metabolites, and that displays the internal structure of the whole body. These images when interpreted by a trained physician, yield information that may assist in diagnosis

The Transmit Receive Quadrature Body Coil 3.0T is a bird-cage type transmit/receive coil designed for use in the Intera 3.0T system. In transmit mode the coil is used in almost every kind of scan. In receive mode the coil is mainly used for imaging with a large field of view. The QBC has a fixed position inside the gradient coil.

The provided text describes a 510(k) submission for a medical device, the "Transmit/Receive Quadrature Body Coil 3.0T." This document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a performance study with acceptance criteria in the typical sense of algorithm-based or diagnostic efficacy studies.

Therefore, many of the typical acceptance criteria and study details you'd expect for an AI or diagnostic imaging device are not applicable to this submission. The "acceptance criteria" here are primarily regulatory: demonstrating that the new device is as safe and effective as a legally marketed predicate device.

Here's how to address your request based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The "study" proving the device meets these (mostly implicit) acceptance criteria is the substantial equivalence comparison presented in the 510(k) submission itself.

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

• Not Applicable. This is a hardware component submission based on substantial equivalence. There is no test set of patient data or images mentioned for performance evaluation in the context of diagnostic accuracy, as would be expected for an AI or diagnostic tool. The comparison is against an existing hardware component.

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

• Not Applicable. See point 2. There's no clinical "ground truth" establishment in this type of submission.

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

• Not Applicable. See point 2.

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. This is a hardware component (MRI coil), not an AI device. No MRMC study was conducted or mentioned.

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

• No. This is a hardware component (MRI coil), not an algorithm.

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

• Not Applicable (in the clinical diagnostic sense). The "ground truth" for this submission is regulatory: the proven safety and effectiveness of the predicate device (the Quadrature Body Coil used with the INTERA 1.5T system), to which the new device is being compared for substantial equivalence.

8. The sample size for the training set

• Not Applicable. There is no "training set" as this is not an AI or algorithm-driven device.

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

• Not Applicable. There is no "training set" or corresponding ground truth establishment process.

In summary:

This 510(k) submission for the Transmit/Receive Quadrature Body Coil 3.0T is a technical submission focused on demonstrating that a new hardware component built for an existing MR system is substantially equivalent to a previously cleared hardware component for a different MR system from the same manufacturer. The "study" here is the engineering and regulatory comparison of design, materials, and intended use, rather than a clinical performance study involving patient data.

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INTERA I/T is a whole body 1.5T Magnetic Resonance Diagnostic Device being extended with optional hardware extensions to aid in the performance of interventional procedures in the head, body and extremities, which may be facilitated by MR techniques, such as real time imaging.

The INTERA I/T is based on the same platform as Philips INTERA 1.5T system (predicate device) with the same intended use but extended with additional hardware features. The optional hardware extensions are meant to aid in the performance of interventional procedures in the head, body and extremities, which may be assisted by existing MR techniques, such as real time imaging. The extension provides the facility to transfer the patient including the patient tabletop from a diagnostic imaging device of other modality (workspot), e.g. X-ray, to the MR system viceversa. These additional workspots are located outside the 0.5mT-fringe field of the MR system. The INTERA I/T will be offered in three optional versions: INTERA I/T Standard, INTERA I/T Neurosurgery, and INTERA I/T CV. The hardware extensions comprise of: Adaptation of the standard MR patient support system, Additional Patient Table (workspot outside the 0.5 mT fringefield), Interactive Display with a rail ceiling suspension, Interventional received RF-coils: Synergy Flex (circular) Large, Medium and Rectangular, and Interventional accessories: Head tilting device (Trendelenburg positioning possibility), straps and an add-on table top extension.

This document is a 510(k) summary for the Philips INTERA I/T Magnetic Resonance Diagnostic Device. It states that the INTERA I/T is substantially equivalent to a predicate device, the Philips INTERA 1.5T system (ref. K001796).

Based on the provided text, there is no specific study described that proves the device meets acceptance criteria. Instead, the document argues for substantial equivalence to a predicate device. This means the device's safety and effectiveness are asserted based on its similarities to an already legally marketed device, rather than through independent studies with predefined acceptance criteria.

Therefore, the following information is not available in the provided text:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for test sets.
• Number of experts used to establish ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone performance study.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

Summary of available information regarding acceptance criteria and proof of effectiveness:

The document explicitly states:

• Acceptance Criteria (Implied): Substantial Equivalence to the predicate device, Philips INTERA 1.5T (K001796). This implies that the device's performance, particularly regarding safety, should be identical or very similar to the predicate device.
• Study Proving Acceptance Criteria: The document does not describe a study in the traditional sense (e.g., a clinical trial or performance evaluation with specific metrics). Instead, it makes the following claims:
  • "The safety parameters of the INTERA I/T remains the same as with its predicate device INTERA 1.5T (ref.K0001796)."
  • "The safety and effectiveness of the INTERA I/T are the same with its predicate device the INTERA 1.5T (ref K001796.)."
  • "It does not induce other safety issues and warnings than already valid for its predecessor and predicate device."
  • "The INTERA I/T is substantially equivalent to the predicate device Philips INTERA 1.5T with FDA ref. K001796."

This approach of demonstrating substantial equivalence is common for 510(k) submissions, where a new device is compared to a legally marketed predicate device rather than undergoing extensive new clinical trials if its technological characteristics and intended use are similar. The submission relies on the established safety and effectiveness of the predicate device.

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