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The DIAGNOSTIC ULTRASOUND SYSTEM APLIO 500 MODEL TUS-A500, APLIO 400 MODEL TUS-A400 and APLIO 300 MODEL TUS-A300 is indicated for the visualization of structures, and dynamic processes with the human body using ultrasound and to provide image information for diagnosis in the following clinical applications: fetal, abdominal, intra-operative (abdominal), pediatric, small organs, trans-vaginal, trans-rectal, neonatal cephalic, adult cephalic, cardiac (both adult and pediatric), peripheral vascular, transesophageal, and musculoskeletal (both conventional and superficial).

The DIAGNOSTIC ULTRASOUND SYSTEM APLIO 500 MODEL TUS-A500. APLIO 400 MODEL TUS-A400 and APLIO 300 MODEL TUS-A300 are mobile system. These systems are Track 3 devices that employ a wide array of probes that include flat linear array, convex linear array, and sector array with a frequency range of approximately 2 MHz to 12 MHz.

The provided text is a 510(k) summary for the Toshiba DIAGNOSTIC ULTRASOUND SYSTEM APLIO 500 MODEL TUS-A500, APLIO 400 MODEL TUS-A400, and APLIO 300 MODEL TUS-A300 Version 2.1. It primarily focuses on demonstrating substantial equivalence to a predicate device (Toshiba DIAGNOSTIC ULTRASOUND SYSTEM APLIO 500 MODEL TUS-A500 / APLIO 400 MODEL TUS-A400 / APLIO 300 MODEL TUS-A300 V2.0; 510(k) control number K110870) and outlining the intended uses for various transducers.

Based on the provided document, the information requested in your prompt about acceptance criteria and a study proving performance (specifically in the context of AI/ML or new clinical parameters) is not present. This document predates the widespread regulatory submissions for AI/ML devices in medical imaging, and its focus is on general ultrasound system functionality and traditional clinical applications.

Therefore, I cannot provide a table of acceptance criteria and reported device performance for AI features, nor can I provide details about sample sizes for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC comparative effectiveness studies, or standalone algorithm performance studies related to AI.

The document does include detailed tables for each transducer showing the "Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:", listing various clinical applications and modes of operation. For each application, it indicates whether it's a "P" (previously cleared by FDA) or "E" (added under this appendix) indication, or "N" (new indication) for a very few. This is essentially a declaration of the intended uses, but it does not specify performance acceptance criteria or provide study results to demonstrate performance for these applications.

The document mentions compliance with several standards, such as IEC 60601-1 and its parts, IEC 62304, and AIUM-NEMA UD2/UD3 standards. These are general safety and performance standards for medical electrical equipment and ultrasound output measurement/display. They are compliance standards, not specific acceptance criteria for AI or diagnostic performance in patient studies.

In summary, the provided content is a regulatory submission for device clearance based on substantial equivalence to a predicate device, focusing on intended uses and compliance with general safety and performance standards. It does not contain the kind of detailed information about acceptance criteria and performance studies you're asking for, particularly concerning AI or specific diagnostic efficacy metrics.

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• Imaging of the extremities (Foot and Hand), joints (knee, shoulder, ankie, wrist and elbow), and body (chest, abdomen and pelvis). MJAJ-192A is intended to be used on the Toshiba Vantage Titan 3T MR System.

The 4ch Flex SPEEDER (MJAJ-192A), is a phased array coil that can receive NMR signal from the extremities, joints, and trunk of the human body. The 4ch Flex SPEEDER is mechanically flexible, and can wrap around various regions mentioned above. The 4ch Flex SPEEDER (MAJA-192A) consists of four coil elements and PC board. The coil elements shape single loop and the four single loop coil elements are arranged to the row. The coil is decoupled during transmission from QD whole body by means of activating the PIN diodes. MJAJ-192A is intended to be used on the Toshiba Vantage Titan 3T MR System.

This submission describes a new coil (4ch Flex SPEEDER, MJAJ-192A) for a Magnetic Resonance (MR) diagnostic device. The acceptance criteria and the study for this device primarily focus on safety and imaging performance, rather than diagnostic accuracy like an AI-powered system.

Here's an analysis of the provided text with respect to your request:

Acceptance Criteria and Device Performance

Since this is an MR coil, the acceptance criteria are not in terms of traditional diagnostic performance metrics like sensitivity/specificity but rather in physical and imaging quality characteristics. The document doesn't explicitly state a table of acceptance criteria with corresponding performance metrics in the format you requested, as it's a 510(k) summary for substantial equivalence to a predicate device. However, we can infer the key criteria that were assessed for safety and image quality.

Inferred Acceptance Criteria and Reported Device Performance

Study Information

The provided document describes a 510(k) submission for substantial equivalence. This type of submission relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device. It typically doesn't involve a separate, large-scale clinical study for diagnostic efficacy in the way an AI algorithm might.

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

   • The document mentions "Sample phantom images and clinical images are presented in Appendix F & G." However, it does not specify the sample size (e.g., number of patients or images) used for these clinical images.
   • The provenance of the data (country of origin, retrospective/prospective) is not explicitly stated in this summary.

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

   • This information is not provided as the study likely did not involve establishing a diagnostic ground truth with human experts in the typical sense for an AI device. The evaluation of an MR coil's performance usually involves technical experts (e.g., medical physicists, MRI technologists) and radiologists for visual image quality assessment, often without a formal "ground truth" establishment for diagnostic accuracy being explicitly detailed in a 510(k) summary.

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

   • This information is not provided. Given the nature of a 510(k) for an MR coil, formal adjudication methods for diagnostic discrepancies are generally not applicable or described in this summary.

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, an MRMC comparative effectiveness study was not done as this device is an MR coil, not an AI-powered diagnostic tool intended to assist human readers. Therefore, there is no effect size related to human reader improvement with or without AI assistance. The study focuses on the coil's intrinsic performance and equivalence to a predicate.

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

   • Not applicable. This device is a passive MR coil, not an algorithm. Its performance is always in conjunction with an MR system and human operator/radiologist.

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

   • For the imaging performance, the "ground truth" would likely be the visual quality and diagnostic utility of the images produced by the coil, often assessed by radiologists who compare them to images obtained with the predicate device. This is typically a qualitative or semi-quantitative expert assessment rather than a formal diagnosis-level ground truth like pathology for a disease. The summary states "Sample phantom images and clinical images are presented," indicating visual comparison was part of the evaluation.

7. The sample size for the training set:

   • Not applicable. This device is an MR coil, not an AI algorithm, so there is no training set in the context of machine learning.

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

   • Not applicable. As there is no training set, this question is not relevant.

In summary: The provided document is a 510(k) summary for an MR coil, demonstrating substantial equivalence to a predicate device based on safety parameters and general imaging performance. It does not contain the detailed clinical study information typically found for AI/CAD devices relating to diagnostic accuracy, reader performance, or specific ground truth methodologies. The "study" here is primarily focused on technical verification and validation, along with qualitative assessment of clinical images to show equivalence.

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Intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric examinations. Intended for use by a qualified/trained doctor or technologist on both adult and pediatric subjects taking diagnostic radiographic and fluoroscopic exposures of the whole body, skull, spinal column, chest, abdomen, extremities and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.

The main function of the KALARE (DREX-KL80) is to perform fluoroscopy/radiography of the examinations of the gastrointestinal tract examination, support for endoscopy, nonvascular contrast study, general abdominal radiography and general skeletal radiography. Using fluorescent scintillation effects of X-rays that have passed through the patient's body. image information is obtained for medical diagnosis and treatment.

The provided text is a 510(k) summary for the Toshiba KALARE (DREX-KL80) X-Ray Diagnostic Table System. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance metrics for a new, independent device evaluation.

Therefore, the requested information for acceptance criteria, device performance, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not available within this document.

Here's an explanation based on the provided text:

Acceptance Criteria and Study Information Unavailable

The document is a "SUMMARY OF SAFETY AND EFFECTIVENESS" for a 510(k) premarket notification. The core of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, not to perform novel clinical or performance studies with predefined acceptance criteria.

Key points from the document indicating this:

• Section 11. SUBSTANTIAL EQUIVALENCE: States, "The KALARE (DREX-KL80) is of comparable type and is substantially equivalent to the GE Precision 500D R&F X-ray (K081091)." This is the primary "proof" for a 510(k) device.
• Section 13. CONCLUSION: Re-affirms, "The KALARE (DREX-KL80) complies with the same or equivalent standards and has the same intended use as the predicate device."
• FDA Response Letter: States, "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... to legally marketed predicate devices."

Because this is a substantial equivalence submission for an X-ray diagnostic table system (a hardware device), the FDA clearance is based on the device meeting established electrical, radiation safety, and performance standards as outlined in 21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard and IEC60601-1 standards and its collateral standards, and demonstrating that its specifications are comparable to the predicate device.

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

1. Table of acceptance criteria and reported device performance: Not applicable for a substantial equivalence claim based on predicate device comparison for a hardware system. Performance is assumed to be equivalent to the predicate, and compliance is to safety standards.
2. Sample size used for the test set and the data provenance: No clinical test set data is provided. Compliance is based on technical specifications and standards.
3. Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not applicable. This type of study is more common for diagnostic algorithms or imaging techniques where reader performance is a direct output. This is a hardware system.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a hardware system, not an algorithm.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable, as there's no machine learning algorithm being trained.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document demonstrates that the KALARE (DREX-KL80) device meets the regulatory requirements for market clearance by proving its substantial equivalence to an existing predicate device and by conforming to applicable safety and performance standards for X-ray equipment. It does not contain a study with specific clinical acceptance criteria and performance metrics for a novel evaluation.

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Imaging of the extremities (Foot and Hand), joints (knee, shoulder, ankle, wrist and elbow), and body (chest, abdomen and pelvis)

The 4ch Flex SPEEDER is a phased array coil that can receive NMR signal from the extremities, joints, and trunk of the body. The 4ch Flex SPEEDER is mechanically flexible, and can wrap around various regions as mentioned above. The 4ch Flex SPEEDER consists of four coil elements and PC board. The coil elements shape single loop and the four single loop coil elements are arranged to the row. The coil is decoupled during transmission from QD whole body by means of activating the PIN diodes.

Acceptance Criteria and Study Details for the 4ch Flex SPEEDER

The provided document describes the 4ch Flex SPEEDER, a phased array coil for Magnetic Resonance Diagnostic Devices. The document is a 510(k) Summary of Safety and Effectiveness, aiming to demonstrate substantial equivalence to previously cleared devices.

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary for the 4ch Flex SPEEDER, as is common for medical device accessories demonstrating substantial equivalence, does not explicitly state quantitative acceptance criteria or provide a table of performance metrics in the same way a de novo device might. Instead, its primary method of demonstrating equivalency is through comparing its intended use, design, and performance characteristics to legally marketed predicate devices.

The document states: "Sample phantom images and clinical images are presented in Appendix F & G of this submission." This indicates that visual assessment of image quality from both phantom and clinical studies was submitted to demonstrate performance equivalent to the predicate devices. The implicit acceptance criterion is that the image quality (resolution, signal-to-noise ratio, artifact levels, etc.) produced by the 4ch Flex SPEEDER, as evidenced by these sample images, is comparable to, and not worse than, the image quality of the predicate devices.

Since specific quantitative metrics are not provided in this summary, a table for acceptance criteria vs. reported performance cannot be generated with numerical values. However, based on the submission's structure, we can infer the qualitative performance assessment:

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

The 510(k) summary does not specify the sample size for a formal test set in terms of number of patients or images. It mentions "Sample phantom images and clinical images are presented in Appendix F & G." This suggests a qualitative, rather than large-scale quantitative, comparison for equivalence.

The data provenance (country of origin, retrospective/prospective) is also not specified in the provided summary.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The 510(k) summary does not mention the use of experts to establish ground truth for a test set. This type of review by experts is more common for software algorithms or AI devices where diagnostic accuracy is explicitly being measured against a gold standard. For a coil accessory demonstrating substantial equivalence, the focus is typically on the physical and electrical performance leading to acceptable image quality.

4. Adjudication Method

Given that no formal test set with ground truth establishment by experts is described, there is no adjudication method mentioned or implied.

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

No MRMC comparative effectiveness study is mentioned in the 510(k) summary. The device is a hardware accessory (an MRI coil), not an AI algorithm or a diagnostic software tool that directly interprets images. Therefore, the concept of improving human reader performance "with AI vs without AI assistance" is not applicable to this device submission.

6. Standalone Performance Study

The focus of this submission is on the standalone performance of the 4ch Flex SPEEDER as an MRI coil, rather than its performance in conjunction with an AI. The "sample phantom images and clinical images" would reflect the standalone performance of the coil when integrated into a standard MRI system. However, the summary does not detail the methodology or metrics of such a study beyond mentioning the provision of images.

7. Type of Ground Truth Used

For a hardware component like an MRI coil, the "ground truth" for image quality is typically established by physical phantom measurements (e.g., signal-to-noise ratio, uniformity, resolution targets) and the assessment of clinical diagnostic utility by qualified radiologists (though not explicitly detailed in this summary). There is no mention of pathology or outcomes data being used for ground truth in this submission.

8. Sample Size for the Training Set

The concept of a "training set" is typically associated with machine learning or AI models. Since the 4ch Flex SPEEDER is a hardware coil, there is no training set in the context of an algorithm. Its design and development would have involved engineering specifications, simulations, and iterative prototyping and testing, not data training.

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

As there is no training set for this hardware device, this question is not applicable.

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