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The Nuvo 9000 Endocavitary Coils are three separate receive-only coils used to obtain diagnostic images of the anus, prostate, and cervix. The coils are designed to be inserted into either the rectum or vagina before imaging. The coils are delivered in a sterile state and are disposable, single-use devices. The indications for use are the same as for standard MR Imaging. The Nuvo 9000 Endocavitary Coils are designed for use with MRI Scanners manufactured by Marconi Medical Systems, Inc. and GE Medical Systems, Inc.

The Nuvo 9000 Endocavitary Coils are three receive only RF Coils designed to provide diagnostic images of the anus, prostate and cervix in Magnetic Resonance Imaging. The Nuvo 9000 Endocavitary Coils are singleuse disposable devices that are delivered and packaged in a sterile state. The Nuvo 9000 Endocavitary Coils are designed for use with Marconi Medical Systems and GE Medical Systems MRI Scanners.

The indications for use are the same as for standard imaging:

The Marconi MRI Scanners and GE MRI Scanners are indicated for use as NMR devices that produce images that: (1) correspond to the distribution of protons exhibiting NMR signal, (2) depend upon NMR parameters (proton density, spin lattice relaxation time T1, 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.

The Nuvo 9000 Endocavitary Coils are three separate disposable, receive-only MRI coils. The three separate coils are the prostate probe, the cervical probe, and the anal probe. The Nuvo 9000 Endocavitary Coils provide significant improvement in signal-to-noise ratios (SNR) and image resolution. The coils are designed to be inserted into either the rectum or vagina for imaging and can be used in conjunction with the USA Instruments' Insight Plus 9000 Torso and Pelvis Coil. The shape and dimensions of the three coils are similar to ultrasound probes used in endocavitary applications. The coils are housed in a rigid plastic housing and are connected to an interface box via a cable. An external immobilization device is also provided with the coils to stabilize the coil and limit motion. The physical structure of the coils, and use of an immobilization device, increases patient comfort and ease of positioning.

This document describes the Nuvo 9000 Endocavitary Coils, a Magnetic Resonance Imaging (MRI) accessory cleared through a 510(k) premarket notification (K011683). The submission primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with acceptance criteria in the context of diagnostic accuracy.

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1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not include specific quantitative acceptance criteria related to diagnostic performance or accuracy, nor does it report such device performance. The submission for the Nuvo 9000 Endocavitary Coils is a 510(k) summary, which typically demonstrates substantial equivalence to a legally marketed predicate device rather than fulfilling performance criteria of a new diagnostic algorithm.

Instead, the submission focuses on comparing the design, materials, intended use, and safety features of the Nuvo 9000 Endocavitary Coils to existing predicate devices. The "Performance" in this context refers to engineering and safety aspects, not diagnostic image interpretation performance.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the "acceptance criteria" (which in this context are primarily related to safety and substantial equivalence, not diagnostic performance) is a comparison to predicate devices. The entire Section 9, "Safety and Effectiveness," is dedicated to detailing how the Nuvo 9000 Endocavitary Coils are "Similar to" other 510(k) cleared products for various features. This constitutes the "study" for a 510(k) submission where direct clinical performance data is not typically required if substantial equivalence can be demonstrated.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size for Test Set: Not applicable. This submission relies on substantial equivalence to predicate devices, not a test set of patient data to evaluate algorithmic performance.
• Data Provenance: Not applicable. The "data" here is descriptive comparison to existing, cleared devices.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• Number of Experts: Not applicable. Ground truth for diagnostic performance is not established in this type of submission. The safety and effectiveness are established by comparison to already cleared devices that are used by trained physicians to interpret images.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. No test set requiring expert adjudication for ground truth was used.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• MRMC Study: No, an MRMC comparative effectiveness study was not conducted or reported for the Nuvo 9000 Endocavitary Coils in this summary. The device is an accessory (coil) for MRI, not an AI diagnostic algorithm.
• Effect Size of AI assistance: Not applicable, as this is not an AI device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• Standalone Study: No, a standalone performance study was not conducted or reported. This device is an MRI accessory, not a standalone diagnostic algorithm.

7. Type of Ground Truth Used:

• Type of Ground Truth: Not applicable for diagnostic performance. For the purpose of this 510(k), the "ground truth" for safety and basic functionality is simply the established safety and functionality of the predicate devices. The "indications for use" for the images produced by MRI scanners (with these coils) rely on interpretation by a "trained physician," indicating that human expert interpretation is the standard for diagnostic "ground truth."

8. Sample Size for the Training Set:

• Sample Size for Training Set: Not applicable. This device is an MRI accessory, not an AI algorithm requiring a training set.

9. How the Ground Truth for the Training Set Was Established:

• How Ground Truth for Training Set Was Established: Not applicable.

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