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The Cordless coil is a receive type surface coil. When used in the MAGNETOM Concerto and C! MR systems, it is indicated for use as a when about in alle interese to produce transverse, sagittal, coronal and oblique images of internal structures of the brain and body surface. The images produced reflect the spatial distribution of protons exhibiting magnetic resonance. Spectra allow the molecules containing the nucleus under investigation to be distinguished. The NMR properties that determine the image and spectra appearance are spin density, spin-lattice relaxation time (T1), and spin-spin echo time (T2) of the corresponding nucleus. When interpreted by a trained physician, these images and spectra provide information that can be useful in making diagnoses.

The Cordless Coil. It is a set consisting of two coils. The coupling loop is connected with a cable and one receive coil is inductively coupled to the other.

The provided text describes a 510(k) summary for a Cordless Coil for MRI systems, focusing on its substantial equivalence to predicate devices rather than directly presenting explicit acceptance criteria and a detailed study proving performance against those criteria.

However, based on the information provided, we can infer the approach taken by the manufacturer to demonstrate safety and effectiveness for substantial equivalence.

Here's an analysis of the provided text in the context of your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria or report specific performance metrics for the Cordless Coil. Instead, it asserts substantial equivalence to predicate devices. This implies that the performance of the Cordless Coil is expected to be as good as or similar to the predicate devices, without introducing new safety risks.

• Acceptance Criteria (Inferred): Performance (image quality, signal-to-noise ratio, spatial distribution of protons, T1/T2 characteristics that allow for diagnosis) to be similar to legally marketed predicate devices without introducing new safety risks.
• Reported Device Performance: The document states, "The Cordless Coil for MAGNETOM Concerto and C! described in this Premarket Notification has the same intended use and similar technical characteristics as the devices listed above. In summary, Rapid Biomedical and Siemens are of the opinion that the Cordless coil does not introduce any new safety risks and is substantially equivalent to, and performs as well as, the predicate devices." This is a qualitative assertion of equivalence rather than a quantitative performance report.

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

The document does not provide any details about a specific test set, sample size, or data provenance (e.g., country of origin, retrospective/prospective) for evaluating the Cordless Coil's performance directly. The basis of substantial equivalence is comparison to predicate devices, rather than a de novo clinical study with a distinct test set.

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

Since no distinct test set with ground truth is described, there's no information about the number or qualifications of experts used to establish ground truth. The intended use statement mentions "When interpreted by a trained physician, these images and spectra provide information that can be useful in making diagnoses," implying that trained physicians are the ultimate interpreters of the images, but this is not about establishing ground truth for a study.

4. Adjudication Method:

Given the lack of a described test set and ground truth establishment, there is no information on any adjudication method (e.g., 2+1, 3+1, none).

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

There is no mention of an MRMC comparative effectiveness study being performed, nor any effect size regarding human reader improvement with or without AI assistance. This device is a hardware component (MRI coil), not an AI-powered diagnostic tool.

6. Standalone (Algorithm Only) Performance Study:

There is no mention of a standalone algorithm performance study. This is a hardware device, not an algorithm.

7. Type of Ground Truth Used:

Since no specific performance study with a test set is described, there is no information regarding the type of ground truth used (e.g., expert consensus, pathology, outcomes data).

8. Sample Size for the Training Set:

This device is a hardware component (MRI coil), not an AI/machine learning algorithm that requires a training set. Therefore, there is no information on a training set sample size.

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

As above, there is no information on how ground truth for a training set was established, as this is not an AI/ML device.

Summary of the Study (as described for substantial equivalence):

The "study" presented here is a substantial equivalence argument based on technical characteristics and intended use comparison to legally marketed predicate devices.

• Name of Study: Not explicitly named as a formal "study," but rather a 510(k) "Premarket Notification" demonstrating substantial equivalence.
• Objective: To demonstrate that the Cordless Coil for MAGNETOM Concerto and C! MR Systems is as safe and effective as existing predicate devices.
• Methodology (Inferred from 510(k) process): Comparison of the new device's design, materials, performance specifications (which are not detailed in this summary), and intended use against those of the predicate devices. The rationale is that if the new device has "the same intended use and similar technical characteristics" and "does not introduce any new safety risks," then it is substantially equivalent.
• Predicate Devices Used:
  • Coils used with Siemens Medical Solutions MAGNETOM Concerto (K003192, cleared 12/21/2000)
  • Coils used with Siemens Medical Solutions MAGNETOM C! (K043030, cleared 12/09/2004)
• Evidence for Equivalence: Conformance to FDA recognized NEMA Standards for performance and safety parameters, and IEC standard IEC 60601-2-33: 2002 for safety issues with Magnetic Resonance Imaging Devices.
• Conclusion: The manufacturer's opinion is that the Cordless coil does not introduce any new safety risks and is substantially equivalent to, and performs as well as, the predicate devices. The FDA concurred with this determination, as indicated by the clearance letter.

Essentially, for this type of medical device 510(k) submission, the "study" is the comprehensive documentation and comparison to predicate devices, rather than a clinical trial with specific performance metrics against an established ground truth. The "acceptance criteria" are implicitly met by demonstrating that the device is fundamentally similar to previously cleared devices and adheres to relevant safety standards.

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The SOMATOM Emotion 16 is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes* taken at different angles.

(*spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube, and the simultaneous translation of the patient. )

The Siemens SOMATOM Emotion 16 system is a 16 slice, whole body X-ray computed tomography systems, which features a continuously rotating tube-detector system and functions according to the fan beam principle. The software is syngo-based Somaris/5 software version VB28, which is a command-based program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation.

This document describes a 510(k) submission for the Siemens SOMATOM Project P10G (SOMATOM Emotion 16) Computed Tomography System. The submission details the device, its intended use, and its substantial equivalence to a predicate device.

However, the provided text does not contain any information regarding acceptance criteria, device performance, specific studies with sample sizes, expert qualifications, or ground truth establishment relevant to an AI/ML device.

The document is a standard 510(k) summary for a medical imaging device (CT scanner) from 2005, which predates widespread AI/ML applications in medical devices and the specific types of studies and criteria currently expected for such technologies. The "software" mentioned (syngo-based Somaris/5 software version VB28) refers to the control and reconstruction software for the CT scanner itself, not an AI/ML algorithm for image analysis or diagnosis.

Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving device performance for an AI/ML device based on the provided text. The requested information points to a type of regulatory submission and study design that is not present in this 2005 510(k) summary for a CT hardware system.

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The use of standard CT scanners in Radiation Treatment Planning environments requires a higher geometric accuracy of anatomical data. For the Siemens SOMATOM Emotion CT systems, a dedicated RTP package (including both hardware and software components) will be offered and provides the following features: improved gantry tilt accuracy, reduced table top deflection, externally adjustable gantry laserlights, increased tube positioning accuracy, simplified horizontal positioning of the table, optimized field coverage using extended Field of View. Radiation Treatment Planning (RTP) Package will be used to prepare geometric and anatomical data, which may assist the physician with proposed external beam radiotherapy treatment planning.

A dedicated RTP package for the SOMATOM Emotion CT Systems includes both hardware and software components and further improves the geometric accuracy of anatomical data. The RTP package will provide the following: Improved gantry tilt accuracy, Reduced table top deflection, Externally adjustable gantry laserlights, Increased x-ray tube positioning accuracy, Simplified horizontal positioning of the table, Optimized field coverage using extended Field of View (FOV).

This 510(k) summary (K042229) is for a "Radiation Treatment Planning (RTP) Package" for Siemens SOMATOM CT systems. It focuses on improving the geometric accuracy of anatomical data for radiation therapy.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a formal table of acceptance criteria or quantitative performance metrics for the device. Instead, it describes feature improvements intended to enhance geometric accuracy. The closest information to performance metrics are the qualitative improvements listed and one quantitative measurement for the "Simplified horizontal positioning of the table".

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

The provided document does not specify a test set sample size, country of origin of data, or whether the study was retrospective or prospective.

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

The document does not mention any experts used to establish ground truth or their qualifications. The device described appears to be a hardware/software upgrade to a CT system, and the "performance" described relates to the precision and physical capabilities of the system itself, rather than diagnostic accuracy that would typically require expert ground truth.

4. Adjudication Method for the Test Set:

The document does not describe an adjudication method.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported in this document. The device is an accessory to a CT system focused on improving physical accuracy for radiation treatment planning, not an AI-based diagnostic tool requiring human-in-the-loop performance evaluation.

6. Standalone (Algorithm only without human-in-the-loop performance) Study:

A standalone study as typically understood for an algorithm's diagnostic performance was not conducted or reported. The performance metrics described relate to the physical accuracy of the CT system components, which would have been validated through engineering tests and measurements rather than a "standalone algorithm" study.

7. Type of Ground Truth Used:

The ground truth for this device's "performance" would likely be established through engineering measurements and calibration standards for physical accuracy (e.g., measuring gantry tilt with precise instruments, measuring table deflection under load, measuring laser alignment, and tube positioning with reference phantoms). The document does not explicitly state the type of ground truth used, but given the nature of the device, it would not be expert consensus, pathology, or outcomes data in the typical sense.

8. Sample Size for the Training Set:

The document does not mention or imply a training set sample size. This device is an upgrade to a CT system, not an AI model that undergoes a training phase with a dataset.

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

As there is no mention of a "training set" or AI model in the conventional sense, the establishment of ground truth for a training set (or lack thereof) is not applicable to this submission.

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