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Diagnostic ultrasound imaging or Doppler analysis of the human body as follows: Fetal, Abdominal, Pediatric, Small Organs (Thyroid, Testicles, Breast), Neonatal Cephalic, Adult Cephalic, Cardiac, Transvaginal, Transrectal, Peripheral Vascular, Musculo-skeletal Conventional, and Musculo-skeletal Superficial.

The SDU-1200Pro is a mobile diagnostic ultrasound system. This system has flat linear array, convex linear and sector probe with a frequency range of approximately 1.5 to 15 MHz. It has B mode, M mode, Pulsed Doppler mode, Continuous Doppler mode, Color mode, or in a combination of modes.

The provided document is a 510(k) Summary for the SHIMADZU SDU-1200Pro Ultrasound Imaging System. It describes the device, its intended use, and indicates that it has been determined substantially equivalent to a predicate device. However, it does not contain information about specific acceptance criteria or a study proving the device meets those criteria, as typically found in clinical performance studies of AI-based devices.

The document primarily focuses on:

• Device Description: A mobile diagnostic ultrasound system with various probes and imaging modes (B mode, M mode, Pulsed Doppler, Continuous Doppler, Color mode, etc.).
• Intended Use/Indications for Use: A comprehensive list of clinical applications for which the SDU-1200Pro and its various transducers are intended (e.g., Fetal, Abdominal, Pediatric, Cardiac, Peripheral Vascular), and the specific imaging modes available for each application (marked with 'N' for new indication in this submission).
• Safety Considerations: Compliance with voluntary and measurement standards like IEC 60601-1, UL60601-1, AIUM NEMA UD2, and AIUM NEMA UD3.
• Substantial Equivalence: FDA's determination that the device is substantially equivalent to the predicate device, Shimadzu SDU-2200 (K003514).

Therefore, based solely on the provided text, I cannot complete a table of acceptance criteria and reported device performance or answer most of the specific questions about clinical studies, ground truth, and sample sizes. This type of detailed performance data is typically found in the full 510(k) submission, not necessarily in the publicly available summary or Indications for Use statement.

Here's a breakdown of what can and cannot be answered from the provided text:

1. A table of acceptance criteria and the reported device performance

Cannot be provided. The document does not describe specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy values) or reported performance metrics from a study. The FDA clearance is based on substantial equivalence to a predicate device, meaning its performance characteristics are deemed similar enough to an already cleared device, rather than requiring new, specific performance targets to be met via a clinical study with detailed metrics.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Cannot be provided. The document does not mention any test set, sample size, or data provenance for performance evaluation.

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)

Cannot be provided. The document does not mention ground truth establishment or expert involvement for a clinical study.

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

Cannot be provided. The document does not mention any adjudication method for a test set.

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

Cannot be provided. The SDU-1200Pro is a diagnostic ultrasound system (hardware and software for image generation), not an AI-assisted diagnostic software. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance would not be applicable or described for this type of device.

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

Cannot be provided. This is not an AI-algorithm-only device. It is a diagnostic ultrasound system.

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

Cannot be provided. No clinical study or ground truth information is presented in the document.

8. The sample size for the training set

Cannot be provided. As this is not an AI-based device, there is no mention of a training set.

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

Cannot be provided. As this is not an AI-based device, there is no mention of a training set or its ground truth.

Summary of what the document does provide regarding device clearance:

The SDU-1200Pro was cleared through the 510(k) pathway based on substantial equivalence to the predicate device, Shimadzu SDU-2200 (K003514). This means the FDA determined that the new device is as safe and effective as a legally marketed device and does not raise different questions of safety and effectiveness. This typically involves demonstrating that the device has the same intended use, technological characteristics, and similar performance to the predicate, or that any differences do not raise new safety or effectiveness concerns. The provided document details the broad clinical applications and imaging modes for which the device and its various transducers are cleared. It also lists compliance with relevant safety and acoustic output standards.

In essence, the document confirms regulatory clearance for a diagnostic ultrasound system based on substantial equivalence, but it does not contain the kind of clinical study details usually associated with novel AI device performance evaluation.

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Diagnostic ultrasound imaging or Doppler analysis of the human body as follows: Fetal, Abdominal, Pediatric, Small Organs (Thyroid, Testicles, Breast), Neonatal Cephalic, Adult Cephalic, Cardiac, Transvaginal, Peripheral Vascular, Muscular, Musculo-skeletal Superficial and Musculo-skeletal Conventional, Transrectal.

The sarano is a mobile diagnostic ultrasound system. This system has flat linear array, convex linear and with a frequency range of approximately 2 to 15 MHz. It has B mode, M mode, or in a combination of modes.

The provided document, K061641, is a 510(k) Premarket Notification for the "sarano" Ultrasound Imaging System by Shimadzu Medical Systems. This document is a regulatory submission for market clearance and does not contain details about specific clinical studies or performance evaluation results against pre-defined acceptance criteria related to diagnostic accuracy or clinical effectiveness.

Instead, it focuses on demonstrating substantial equivalence to a predicate device (Shimadzu Corporation SDU-1100 (K050510)). The performance information provided is primarily related to the device's adherence to voluntary safety and measurement standards, and its intended uses and operational modes across various transducers.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study that proves the device meets those criteria in the way you've outlined for diagnostic performance.

However, I can provide information based on the typical requirements for a 510(k) submission for an ultrasound system, which often involves compliance with recognized standards.

Here's an interpretation of the available information in the context of what would generally be considered "acceptance criteria" for this type of device and how the document implicitly "proves" they are met:

Acceptance Criteria and Device Performance (Based on Regulatory Compliance)

The acceptance criteria for the Shimadzu "sarano" ultrasound system are implicitly defined by its compliance with recognized industry and regulatory standards for safety and acoustic output. The device "demonstrates" meeting these criteria by stating its adherence to them.

1. Table of Acceptance Criteria and Reported Device Performance

Study Details (Limitations)

The provided document does not describe a clinical study in the traditional sense, with a test set, ground truth, experts, or comparative effectiveness. A 510(k) submission primarily relies on demonstrating substantial equivalence to a legally marketed predicate device, often through engineering and performance testing against standards, rather than new clinical effectiveness trials.

Therefore, the following information cannot be extracted from the provided text:

2. Sample size used for the test set and the data provenance: Not applicable; no clinical test set for diagnostic performance is described. The "test set" implicitly refers to the device and its components undergoing engineering and safety testing according to the standards listed.
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 applicable; no expert-driven ground truth establishment for a diagnostic performance test is described. The "ground truth" here is the adherence to the technical specifications outlined in the referenced standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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 applicable. This device is an ultrasound imaging system, not an AI-driven image analysis tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this submission is compliance with the technical specifications and safety limits defined by the referenced standards (e.g., IEC 60601-1, AIUM NEMA UD2, AIUM NEMA UD3). This is typically verified through laboratory testing, measurement, and adherence to design controls, not clinical outcomes or expert consensus on diagnostic images from a specific study.
8. The sample size for the training set: Not applicable; this is not an AI/machine learning device requiring a training set for diagnostic classification.
9. How the ground truth for the training set was established: Not applicable.

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Diagnostic ultrasound imaging or Doppler analysis of the human body as follows: Abdominal, Cardiac Adult, Cardiac Pediatric, Fetal, Small Organ (Thyroid, Testicles, Breast), Neonatal Cephalic, Adult Cephalic, Peripheral vessel, Trans-rectal, Trans-vaginal. Modes of Operation: A, B, M, PWD, CWD, Color Doppler, Power (Amplitude) Doppler, Color Velocity Imaging, Combined (B/M, B/PWD, Color/PWD, B/PWD/M, Color/M and Color/PWD/M mode).

Diagnostic Ultrasound System SDU-2000 with various transducers: 2.5 MHz PA SECTOR, 3.5 MHz PA SECTOR, 5.0 MHz PA SECTOR, 3.5 MHz R40 CA CONVEX, 3.5 MHz R76 CA CONVEX, 7.5 MHz LA LINEAR ARRAY, 5.5 MHZ TV CONVEX.

This document is a 510(k) premarket notification decision letter for the Shimadzu Medical Systems Echo View SDU-2000 Diagnostic Ultrasound System. It outlines the FDA's determination of substantial equivalence and lists the intended uses for various transducers.

Based on the provided text, there is no specific study described that proves the device meets acceptance criteria. The document is a regulatory approval letter, not a clinical study report. It grants permission to market the device based on a determination of substantial equivalence to existing devices, implying that the device is expected to meet certain performance characteristics indirectly through that equivalence.

The letter mentions a "postclearance special report" containing "acoustic output measurements based on production line devices" which implies that further performance data would be collected and submitted after clearance but does not detail acceptance criteria or study results for initial approval.

Therefore, many of the requested details cannot be extracted from this document because it is not a study report.

Here's what can be gathered, with caveats:

1. A table of acceptance criteria and the reported device performance:

This information is not provided in the document. The document is an FDA clearance letter based on substantial equivalence, not a detailed technical report with performance metrics or acceptance criteria. It focuses on intended uses and regulatory classification.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

This information is not provided in the document. No test set or study is described.

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):

This information is not provided in the document. No information on ground truth establishment or experts is present.

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

This information is not provided in the document.

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:

This information is not provided in the document. The device is a diagnostic ultrasound system, not an AI-assisted device, and no MRMC study is described.

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

This information is not provided in the document. The device is a diagnostic ultrasound system, not an algorithm being tested in standalone mode.

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

This information is not provided in the document.

8. The sample size for the training set:

This information is not provided in the document. No training set is mentioned as this is a traditional medical device, not an AI/ML model for which a training set would typically be described in this context.

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

This information is not provided in the document.

Summary of what the document does provide regarding the device:

• Device Name: Echo View SDU-2000 Diagnostic Ultrasound System
• Manufacturer: Shimadzu Medical Systems
• FDA K Number: K970508
• Regulatory Class: II (21 CFR 892.1550/Procode: 90 IYO)
• Date of Clearance: June 20, 1997 (Received June 23, 1997)
• Transducers covered:
  • 2.5 MHz PA SECTOR
  • 3.5 MHz PA SECTOR
  • 5.0 MHz PA SECTOR
  • 3.5 MHz R40 CA CONVEX
  • 3.5 MHz R76 CA CONVEX
  • 7.5 MHz LA LINEAR ARRAY
  • 5.5 MHZ TV CONVEX
• Intended Use (General): Diagnostic ultrasound imaging or Doppler analysis of the human body.
• Specific Clinical Applications and Modes (Vary by transducer model, see tables in Input):
  • 2.5 MHz PA SECTOR: Abdominal (PWD, Color, Power Doppler), Cardiac Adult (A, B, M, PWD, CWD, Color, Power Doppler, Color Velocity Imaging, Combined), Cardiac Pediatric (A, B, M, PWD, CWD, Color, Power Doppler, Color Velocity Imaging, Combined)
  • 3.5 MHz PA SECTOR: Abdominal (PWD, Color, Power Doppler), Cardiac Adult (B, M, PWD, CWD, Color, Power Doppler, Color Velocity Imaging, Combined), Cardiac Pediatric (B, M, PWD, CWD, Color, Power Doppler, Color Velocity Imaging, Combined)
  • 5.0 MHz PA SECTOR: Abdominal (PWD, Color, Power Doppler), Cardiac Adult (B, M, PWD, CWD, Color, Power Doppler, Color Velocity Imaging, Combined), Cardiac Pediatric (B, M, PWD, CWD, Color, Power Doppler, Color Velocity Imaging, Combined)
  • 3.5 MHz R40 CA CONVEX: Fetal (B, M, PWD, Color, Power Doppler, Color Velocity Imaging, Combined), Abdominal (A, B, M, PWD, Color, Power Doppler, Color Velocity Imaging, Combined)
  • 3.5 MHz R76 CA CONVEX: Fetal (B, M, PWD, Color, Power Doppler, Color Velocity Imaging, Combined), Abdominal (B, M, PWD, Color, Power Doppler, Color Velocity Imaging, Combined)
  • 7.5 MHz LA LINEAR ARRAY: Small Organ (A, B, M, PWD, Color, Power Doppler, Color Velocity Imaging, Combined - specifically Thyroid, Testicles, Breast), Peripheral Vessel (A, B, M, PWD, Color, Power Doppler, Color Velocity Imaging, Combined)
  • 5.5 MHz TV CONVEX: Fetal (B, M, PWD, Color, Power Doppler, Color Velocity Imaging, Combined), Small Organ (B, M, PWD, Color, Power Doppler, Color Velocity Imaging, Combined), Trans-rectal (B, M, PWD, Color, Power Doppler, Color Velocity Imaging, Combined), Trans-vaginal (B, M, PWD, Color, Power Doppler, Color Velocity Imaging, Combined)

The document is primarily a regulatory clearance indicating the device is substantially equivalent to legally marketed predicate devices, not a study detailing specific performance acceptance criteria or results.

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