Search Results

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, Musculo-skeletal Superficial and Musculo-skeletal Conventional, Transrectal.

The sarano is a mobile diagnostic ultrasound system. This system has flat linear array, convex and with a frequency range of approximately 2 to 15 MHz. It has B mode, M mode, or in a combination of modes. Also the sarano has two kinds of monitor; CRT and LCD. The former is standard model and latter is optional model.

This is a 510(k) Premarket Notification for a diagnostic ultrasound system (sarano) and its associated transducers. The document describes the device, its intended use, and conformance to safety standards. However, it does not contain any information about clinical performance studies, acceptance criteria for device accuracy, or expert evaluations of image quality or diagnostic capability.

Therefore, I cannot provide the requested information regarding acceptance criteria and the study that proves the device meets them from the provided text.

Specifically:

1. A table of acceptance criteria and the reported device performance: This information is not present in the document. The document primarily focuses on the device's technical specifications, intended uses, and compliance with safety and measurement standards.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set, sample size, or data provenance information is provided as there are no clinical performance studies 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): No ground truth establishment information is provided as there are no clinical performance studies described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: No adjudication method is described.
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: No MRMC study is mentioned, nor is any AI component.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No standalone algorithm performance is mentioned, nor is any AI component.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): No ground truth type is specified.
8. The sample size for the training set: No training set information is provided, as there is no mention of a machine learning or AI component.
9. How the ground truth for the training set was established: No ground truth establishment for a training set is provided.

The document discusses the device's adherence to voluntary and measurement standards like IEC 60601-1 (safety), UL60601-1 (safety), AIUM NEMA UD2 (acoustic output measurement), and AIUM NEMA UD3 (real-time display of thermal and mechanical acoustic output indices). These are safety and performance standards for the physical device and its acoustic output, not clinical performance or diagnostic accuracy.

The FDA's letter of substantial equivalence (K082224) is based on the device being substantially equivalent to a predicate device (Shimadzu Corporation sarano K061641), implying that its performance characteristics are similar to a previously cleared device, rather than requiring new clinical performance studies for diagnostic accuracy for this specific submission.

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

The SDU-2200Pro is a mobile diagnostic ultrasound system. This system has flat linear array, convex linear and sector probe with a frequency range of approximately 2 to 15 MHz. It has B mode, M mode, Pulsed Doppler mode, Continuous Doppler mode, Color mode, Real time 3D mode, or in a combination of modes.

The provided document is a 510(k) summary for the Shimadzu SDU-2200Pro Diagnostic Ultrasound System. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving the device meets specific performance acceptance criteria through clinical studies in the way you've outlined for AI/ML devices.

Therefore, the document does not contain information about:

• Acceptance criteria in terms of measurable performance metrics (e.g., sensitivity, specificity, accuracy) for a specific diagnostic task.
• A study conducted to prove the device meets acceptance criteria, as would be done for an AI/ML device.
• Sample sizes used for test sets.
• Data provenance (country of origin, retrospective/prospective).
• Number of experts or their qualifications to establish ground truth for a test set.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes for human reader improvement with AI.
• Standalone (algorithm only) performance studies.
• The type of ground truth used (e.g., pathology, outcomes data).
• Sample size for training sets.
• How ground truth for training sets was established.

Instead, this document 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, Real-time 3D mode, or combinations).
• Intended Use: Broad diagnostic ultrasound imaging and Doppler analysis for various clinical applications (Fetal, Abdominal, Pediatric, Small Organs, Neonatal Cephalic, Adult Cephalic, Cardiac, Transvaginal, Peripheral Vascular, Musculo-skeletal Superficial, Musculo-skeletal Conventional).
• Safety Considerations: Compliance with international safety and acoustic output standards (IEC 60601-1, UL60601-1:2003, AIUM NEMA UD2, AIUM NEMA UD3).
• Substantial Equivalence: The device is deemed substantially equivalent to a previously cleared predicate device (Shimadzu SDU-2200Pro, K061637). This typically means that the new device has the same intended use, technological characteristics, and safety and effectiveness profile as the predicate, or if it has different technological characteristics, these do not raise new questions of safety and effectiveness and the device is as safe and effective as the predicate.
• Transducer Configurations: A list of various transducers and their specific cleared indications for use (marked 'P' for previously cleared or 'N' for new indications for that specific transducer model/application combination).

In summary, the provided text does not contain the information requested in your prompt regarding acceptance criteria and performance studies for an AI/ML device. It is a regulatory submission for a conventional ultrasound system demonstrating substantial equivalence based on its physical and functional characteristics and compliance with recognized standards.

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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, Musculo-skeletal Superficial and Musculo-skeletal Conventional, Transrectal.

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, Real time 3D mode, Color mode, or in a combination of modes.

The provided document is a 510(k) summary for the SHIMADZU MEDICAL SYSTEMS SDU-1200Pro Ultrasound Imaging System. It outlines the device's intended use and compliance with safety standards. However, it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in terms of diagnostic accuracy or reader performance.

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, Real-time 3D, Color mode).
• Intended Use/Indications for Use: A list of clinical applications for which the device is intended (Fetal, Abdominal, Pediatric, Small Organs, Neonatal Cephalic, Adult Cephalic, Cardiac, Transvaginal, Peripheral Vascular, Musculo-skeletal Superficial, Musculo-skeletal Conventional, Transrectal). These are "previously cleared by FDA" (indicated by 'P' in the tables) or "new indication" (indicated by 'N').
• Safety Considerations: Compliance with international and national safety and acoustic output standards (IEC 60601-1, UL60601-1:2003, AIUM NEMA UD2, AIUM 1998, AIUM NEMA UD3).
• Substantial Equivalence: A claim that the device is substantially equivalent to a predicate device (Shimadzu SDU-1200Pro K061643), which is the basis for 510(k) clearance.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving their fulfillment, as these details are not present in the provided text.

Specifically, the following information is missing from the document:

1. A table of acceptance criteria and the reported device performance: The document only lists intended uses and safety standards. There are no quantitative performance metrics (e.g., sensitivity, specificity, accuracy for a particular clinical task) or acceptance criteria for such metrics.
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method: Not mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: This is an ultrasound imaging system, not an AI-assisted diagnostic device, and no such study is mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a medical imaging device, not an algorithm.
7. The type of ground truth used: Not applicable, as no performance study is described.
8. The sample size for the training set: Not applicable, as no algorithm training is mentioned.
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: Fetal, Abdominal, Pediatric, Small Organs (Specify), Neonatal Cephalic, Adult Cephalic, Cardiac, Transrectal, Transvaginal, Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial. Small Organ (Specify): Thyroid, Testicles, Breast. Other (Specify): Real time 3D.

The SDU-1100 is a mobile diagnostic ultrasound system. This system has flat linear array, convex linear and sector probe with a frequency range of approximately 2 to 15 MHz. It has B mode, M mode, Pulsed Doppler mode, Real time 3D mode, Color mode, or in a combination of modes.

This document, K071291, is a 510(k) Summary for the SHIMADZU MEDICAL SYSTEMS SDU-1100 Ultrasound Imaging System. It describes the device, its intended use, and indicates which transducers support various clinical applications and operation modes. However, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document is a submission to the FDA for market clearance, stating the device's substantial equivalence to a predicate device. It lists standards the device has been designed to meet (IEC 60601-1, AIUM NEMA UD2, AIUM 1998, AIUM NEMA UD3) for safety and acoustic output, but these are design standards, not performance acceptance criteria against a specific clinical study.

Therefore, I cannot provide the requested information from the provided text. The document is primarily an "Indications for Use" statement and regulatory approval letter, not a clinical study report.

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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, Musculo-skeletal Superficial and Musculo-skeletal Conventional, Transrectal.
Mode of Operation: A, B, M, PWD, CWD, Color Doppler, Power (Amplitude) Doppler, Color Velocity Imaging, Combined (B/M, B/PWD, CFM(B)/PWD, CFM(B)/CFM(M), B/CWD, CFM(B)/CWD), Tissue Harmonic Imaging.

The SDU-2200Pro is a mobile diagnostic ultrasound system. This system has flat linear array, convex linear and sector probe with a frequency range of approximately 2 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 text is a 510(k) summary for the SHIMADZU MEDICAL SYSTEMS SDU-2200Pro Ultrasound Imaging System. This document outlines the device's intended use and compliance with safety standards, but it does not contain information about acceptance criteria for performance, a study proving device performance against acceptance criteria, or details regarding sample sizes, ground truth establishment, or expert involvement for such a study.

The tables within the document (pages 5-20) are "Ultrasound Device Indications Statements" for various transducers. These tables indicate whether certain imaging modes (such as B-mode, M-mode, PWD, CWD, Color Doppler, Power Doppler, Color Velocity Imaging, Combined modes, and Tissue Harmonic Imaging) are "new indications" (N) for specific clinical applications (e.g., Fetal, Abdominal, Pediatric, Small Organ, Cardiac, Transvaginal, Peripheral Vascular, Musculo-skeletal). This is a statement of intended use and cleared functionalities, not a performance study result.

The 510(k) process is primarily a premarket notification demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive new performance studies with specific acceptance criteria that would typically be described in an efficacy trial.

Therefore, based solely on the provided text, the requested information cannot be fully extracted.

Here's a breakdown of what can be inferred or what is explicitly missing:

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

• Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for a specific clinical task. The acceptance criteria for 510(k) clearance generally revolve around compliance with recognized safety and performance standards (like IEC 60601-1, AIUM NEMA UD2, UD3) and demonstrating substantial equivalence to a predicate device in terms of intended use, technology, and safety/effectiveness.
• Reported Device Performance: No quantitative performance data (e.g., sensitivity, specificity, accuracy, image quality scores) is provided in the document. The "performance" described is in terms of the range of clinical applications and imaging modes supported by the device and its various transducers, which were deemed "substantially equivalent" to the predicate device (Shimadzu SDU-2200, K003514).

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

• Sample Size: Not mentioned.
• Data Provenance: Not mentioned; it's implicit that any comparative data would have been from internal testing or comparison with the predicate device, but no specifics are given.

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

• Number of Experts: Not mentioned.
• Qualifications of Experts: Not mentioned.

4. Adjudication method for the test set:

• Adjudication Method: Not mentioned.

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:

• MRMC Study: No MRMC study is mentioned. This device is an ultrasound imaging system, not an AI-assisted diagnostic tool as described in the context of improving human reader performance.

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

• Standalone Performance: Not applicable for this device as it's an imaging system, not an algorithm being tested for standalone diagnostic performance.

7. The type of ground truth used:

• Type of Ground Truth: Not applicable, as no performance study requiring ground truth is described.

8. The sample size for the training set:

• Training Set Sample Size: Not applicable, as this is an ultrasound imaging system, not an AI model requiring a training set.

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

• Ground Truth for Training Set: Not applicable.

Summary of available information related to "acceptance criteria" and "study":

The acceptance criteria for this 510(k) clearance are primarily based on:

1. Safety Compliance: Adherence to voluntary and measurement standards like IEC 60601-1, UL60601-1:2003, AIUM NEMA UD2, and AIUM NEMA UD3. The document explicitly states the device "has been designed to meet" these standards.
2. Substantial Equivalence: The FDA's determination that the SDU-2200Pro is "substantially equivalent" to a legally marketed predicate device (Shimadzu SDU-2200, K003514) for the stated indications for use. This means it has similar intended use, technological characteristics, and raises no new questions of safety and effectiveness.

The "study" or evidence provided to meet these criteria is the submission package itself, which typically includes:

• Comparison of technological characteristics to the predicate device.
• Documentation of compliance with safety standards and acoustic output measurements.
• Statement of intended use (as seen in the tables from pages 5-20).

There is no detailed clinical performance study with specific quantitative acceptance criteria or results presented in this 510(k) summary. This is typical for traditional hardware medical devices demonstrating substantial equivalence, as extensive clinical trials with performance metrics are often not required unless significant new technological features or intended uses are introduced that raise new safety or effectiveness concerns.

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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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This device is intended to be used for the radiography in the hospital with X-ray devices. The object of this device is total patient population. As mentioned at "Intended Use" in this clearance letter, the intended use of DAR-8000f is the same as that of predicate device of DAR-7000(K050925). Consequently, the indications for use of DAR-8000f are also the same as that of DAR-7000, and there are no additional indications.

Not Found

The provided text is a 510(k) clearance letter from the FDA for a device called DAR-8000f. This type of document does not typically contain the detailed technical studies, acceptance criteria, or performance data that would be generated by the manufacturer to demonstrate substantial equivalence.

Instead, a 510(k) clearance primarily focuses on:

• Substantial Equivalence: Demonstrating that a new device is as safe and effective as a legally marketed predicate device.
• Intended Use: Defining how the device is meant to be used.
• Regulatory Classification: Assigning the device to a specific regulatory class.

Therefore, the input document does not contain the information requested regarding acceptance criteria and the study that proves the device meets them. It only verifies that the FDA has reviewed the manufacturer's submission and determined it to be substantially equivalent to a predicate device.

To answer your questions, one would need to access the actual 510(k) submission data provided by the manufacturer to the FDA, which is generally not public information in this level of detail unless specifically released or part of a summary.

In summary, based solely on the provided text, I cannot extract the requested information.

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This device is intended to be used for radiography in the hospital with X-ray devices.

Not Found

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a device named DAR 8000i. This document does not contain information regarding:

• Acceptance criteria for device performance
• Details of a study proving the device meets acceptance criteria (including sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details).

This letter primarily focuses on the FDA's "substantial equivalence" determination, regulatory classifications, and general compliance requirements, rather than a detailed performance study.

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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, Musculo-skeletal Superficial and Musculo-skeletal Conventional, Transrectal.

The SDU-1100 is a mobile diagnostic ultrasound system. This system has flat linear array, convox array, and sector probe with a frequency range of approximately 2 to 15 MHz. The system can operate in B mode, M mode, Pulsed Doppler mode, Color mode, or in a combination of modes.

The provided text describes a 510(k) premarket notification for the SHIMADZU MEDICAL SYSTEMS SDU-1100 Ultrasound Imaging System. This document generally focuses on establishing substantial equivalence to a predicate device based on intended use and safety standards, rather than detailing a specific clinical study with acceptance criteria and performance metrics described in clinical terms (e.g., sensitivity, specificity, accuracy).

Therefore, based solely on the provided text, a comprehensive table of acceptance criteria and proven device performance as typically expected for clinical evaluation studies (e.g., diagnostic accuracy metrics) cannot be extracted. The acceptance criteria in this context are related to meeting established regulatory and safety standards, and demonstrating substantial equivalence for the stated indications for use.

Below is an attempt to structure the available information regarding acceptance criteria and the "study" (which in this case refers to the submission process for substantial equivalence).

Acceptance Criteria and Device Performance (Based on provided 510(k) Summary)

The "acceptance criteria" for the SDU-1100, as presented in this 510(k) submission, are primarily centered around demonstrating substantial equivalence to a predicate device and adherence to relevant safety and performance standards for ultrasound systems. The "reported device performance" is implicitly that the device meets these standards and is considered safe and effective for its indicated uses.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

The provided 510(k) summary does not mention a specific test set, sample size, or clinical data provenance (e.g., country of origin, retrospective/prospective). 510(k) submissions for general ultrasound imaging systems typically rely on technical performance data, adherence to standards, and comparison to a predicate device rather than extensive new clinical studies to demonstrate diagnostic accuracy through a "test set" in the way a novel diagnostic algorithm might. The "study" here is the submission that demonstrates substantial equivalence.

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

This information is not provided in the 510(k) summary. Given that it's a submission for a general ultrasound imaging system, the "ground truth" is typically defined by existing medical consensus, established imaging protocols, and the performance characteristics of the predicate device. Clinical trials with expert-adjudicated ground truth are not typically a primary component of a 510(k) for this type of device unless new and complex claims are being made.

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

This information is not provided as the document does not describe a clinical study involving a test set needing expert adjudication.

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 type of study is not mentioned in the provided document. The SDU-1100 is described as a diagnostic ultrasound imaging system, not an AI-powered diagnostic assistance tool.

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

This information is not applicable as the SDU-1100 is a hardware imaging device, not a standalone algorithm.

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

For this type of device, the "ground truth" for substantial equivalence is generally based on:

• Established performance of the predicate device: The GE Logiq 500 (K991611).
• Compliance with recognized industry standards: IEC 60601-1, AIUM NEMA UD2, AIUM 1998 Acoustic Output Measurement and Labeling Standard, AIUM NEMA UD3. These standards define acceptable levels of safety and performance.
• Bio-compatibility and electrical safety testing: Implied by adherence to IEC 60601-1.
• Technical specifications and engineering data: Used to demonstrate that the device functions as intended and within safe limits (e.g., acoustic output).

8. The sample size for the training set

This is not applicable as the document describes a hardware device submission, not a machine learning algorithm that requires a training set.

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

This is not applicable for the same reason as #8.

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