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To be used in conjunction with 3.0T GE HD series Magnetic Resonance scanners to produce diagnostic images of the shoulder that can be interpreted by a trained physician.

The NeoCoil 3.0T 8-Channel Shoulder Array Coil is a multi-element phased array receive only coil used for obtaining diagnostic images of the shoulder in Magnetic Resonance Imaging Systems. Compared to predicate devices, the submitted device offers easier patient setup and greater SNR due to its compatibility with 3.0T MRI scanners.

The submitted device consists of semi-flexible foam covered housing, consisting of eight antennas. The antennas are uniquely positioned with the appropriate overlap to cancel out mutual coupling effects from adjacent antennas or decoupled from an adjacent antenna using a transformer. Pre-amplifier decoupling reduces any remaining decoupling between the antennas.

The coil is held in place over the imaging area via a cross body strap. A system interface cable connects to the coil at the top of the housing. The flexible foam covered housing along with the body strap enable the proper positioning on the patient before laying down and holds the coil in place while scanning is being performed.

To ensure safety, each antenna is equipped with active and passive transmit decoupling circuits. Active decoupling is achieved via diodes that receive signals from the scanner to turn the coil to a high impedance state during system RF transmit. Crossed diodes are installed on each antenna acting as passive switches. These passive switches provide additional safety in case the active circuitry does not receive signal from the scanner.

The NeoCoil 3.0T 8-Channel Shoulder Array Coil is a multi-element phased array receive-only coil designed for obtaining diagnostic images of the shoulder in Magnetic Resonance Imaging Systems. The provided 510(k) summary outlines the device's technical specifications and a study supporting its substantial equivalence to predicate devices. However, it does not fully detail all the requested information regarding a clinical study with detailed acceptance criteria and expert ground truth establishment for diagnostic performance.

Here's an analysis based on the provided document:

Acceptance Criteria and Reported Device Performance

The submission focuses on "substantial equivalence" to predicate devices rather than establishing specific clinical diagnostic performance acceptance criteria for the new coil itself. The key performance metrics mentioned are Signal-to-Noise Ratio (SNR) and image uniformity. The document implies that if these are comparable or better than predicate devices, the device is acceptable for its intended use of producing diagnostic images.

It is important to note that the document does not provide specific numerical targets or results for SNR and image uniformity. It states that "SNR and image uniformity testing was performed which support the conclusion that the submitted device satisfies design objectives" and that the device is "substantially equivalent" to predicate devices. This indicates a comparative assessment rather than an absolute performance threshold.

Study Details for Device Performance

Based on the provided K071611 document:

1. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
   The document does not specify a "test set" in the context of clinical images or diagnostic cases. The performance study mentioned relates to technical performance (SNR and image uniformity) of the coil itself, likely conducted in a lab setting rather than with patient data. Therefore, details about data provenance or a patient-based test set are not provided.

2. 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 applicable, as the performance testing described is technical (SNR, image uniformity) and does not involve diagnostic interpretation by experts or a clinical ground truth for a test set.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
   Not applicable, as there is no mention of a diagnostic test set requiring expert adjudication.

4. 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 device is a passive MRI coil and does not incorporate AI. The study described is a technical comparison to predicate devices, not a clinical multi-reader study.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
   Not applicable. This is a hardware device (MRI coil), not an algorithm. Its "standalone" performance refers to its physical and electromagnetic characteristics. The document indicates that technical testing (SNR, image uniformity) was performed on the coil itself to demonstrate its operational characteristics.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   For the technical performance aspects (SNR and image uniformity), the "ground truth" would be established by physical measurements and engineering specifications, often compared to the performance of predicate devices or industry benchmarks. There is no mention of clinical ground truth (e.g., pathology, clinical outcomes) as the study was not a clinical diagnostic efficacy trial.

7. The sample size for the training set:
   Not applicable. This device is a hardware component. There is no "training set" in the context of machine learning or algorithms. Its design and manufacturing are based on engineering principles and prototypes.

8. How the ground truth for the training set was established:
   Not applicable, as there is no training set for this hardware device.

Summary of the Study type:

The "Summary of Studies" section in the K071611 document indicates that "SNR and image uniformity testing was performed" to support the conclusion of substantial equivalence. This implies that the study was primarily a technical bench study comparing the performance of the NeoCoil 3.0T 8-Channel Shoulder Array Coil with existing predicate devices (USA Instruments Inc. Mark III Phased Array Shoulder Coil (K042009) and NeoCoil 1.5T Shoulder Array Coil Model NC008 (K071311)). The objective was to demonstrate that the new device meets its design objectives and does not introduce new safety concerns compared to legally marketed devices. The review determined that "Use of the NeoCoil 3.0T 8-Channel Shoulder Array does not result in any new potential hazards and does not alter the safety of the MRI scanner."

In essence, for this 510(k) submission, the "acceptance criteria" and "study" are focused on demonstrating technical equivalence (specifically in SNR and image uniformity) and safety to existing devices, rather than a clinical efficacy study with diagnostic endpoints.

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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: General, OB, Gynecology, Abdomen, Fetal Heart, Renal, Neonatal, Pediatric, Vascular, Cardiac, Urology, Breast, Small Parts, Musculoskeletal applications. The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

The SONOACE PICO is a general purpose, mobile, software controlled, diagnostic ultrasound system with on-screen display for themal and mechanical indices related to potential bioeffect mechanisms. Its function is to acquire ultrasound data and to display the data as B-mode, M-mode, Color Doppler, Pulsed (PW) Doppler, Power Doppler, Harmonic imaging and 3D imaging , or as a combination of these modes on the LCD monitor.

The provided document is a 510(k) summary for the SONOACE PICO Diagnostic Ultrasound System, dated May 16, 2006. This type of document is primarily concerned with establishing substantial equivalence to a predicate device, rather than presenting a detailed clinical study demonstrating the device's performance against specific acceptance criteria.

The information provided outlines the device's intended use and technological characteristics, and relies on its similarity to previously cleared devices (K013627, SA8000 Ultrasound system and K043455, SA8000 SE Ultrasound system) to demonstrate safety and effectiveness. It does not include a description of a specific study to prove that the device meets defined acceptance criteria in terms of diagnostic performance (e.g., sensitivity, specificity for a particular clinical condition). Instead, it lists the product safety standards it has been designed to meet.

Therefore, many of the requested sections (e.g., table of acceptance criteria and reported device performance, sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth types, training set sample size, and ground truth establishment for training set) cannot be extracted from this document as they are not typically part of a 510(k) summary focused on substantial equivalence for a diagnostic ultrasound system.

However, I can extract the safety acceptance criteria mentioned:

1. Table of Acceptance Criteria and Reported Device Performance

This document focuses on compliance with general safety and performance standards for diagnostic ultrasound equipment, rather than specific clinical performance metrics. The "reported device performance" in this context refers to the device being designed to meet these standards.

The specific "study that proves the device meets the acceptance criteria" is not detailed in this 510(k) summary. For devices cleared through the 510(k) process, especially for ultrasound systems, substantial equivalence to a predicate device often serves as the basis for demonstrating safety and effectiveness, rather than new extensive clinical performance studies. The document states that "The SONOACE PICO is substantially equivalent to the SA8000 Diagnostic Ultrasound System, cleared via K013627, and the SA8000 SE Diagnostic Ultrasound System, cleared via K043455." This implies that the previous clearance of these predicate devices, based on their safety and performance data, is sufficient to demonstrate the new device's compliance.

A post-clearance special report is required for acoustic output measurements based on production line devices (Appendix G, "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers"), which is a verification step of manufacturing compliance rather than a clinical performance study.

The following information cannot be extracted from the provided document as it relates to clinical performance studies which are not typically required for 510(k) clearance of these types of devices based on substantial equivalence:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not provided.
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 provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided.
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: Not provided (this is not an AI device).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable (this is an ultrasound imaging system, not an algorithm for diagnosis).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not provided.
8. The sample size for the training set: Not applicable (this is a hardware/software system, no AI training specified).
9. How the ground truth for the training set was established: Not applicable.

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