Search Results

Ask a specific question about this device

The Aplio v4.0R001 is intended to be used for the following type of studies: fetal, abdominal, intraoperative, pediatric, small organs, neonatal cephalic, adult cephalic, cardiac, transrectail, transvaginal, transesophageal, peripheral vascular and musculo-skeletal (both conventional and superficial).

Elastography is indicated for determining the relative elasticity of a lesion.

The Aplio XG v4.0R001 is a mobile system. This system is a Track 3 device that employs 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 FDA 510(k) premarket notification for the Toshiba Aplio XG (v4.0R001) SSA-790A Ultrasound System (K092179) focuses on the substantial equivalence of the device to existing predicate devices and the safety considerations. It outlines the intended uses for various transducers and notes the addition of "Elastography (New)" as an intended use for several of them.

However, the document does not contain a detailed description of acceptance criteria for Elastography, nor does it present a specific study proving the device meets particular acceptance criteria with reported performance metrics. The submission is primarily about demonstrating substantial equivalence and safety, not about presenting the results of a performance study with quantitative acceptance criteria for a new feature like Elastography.

The document states: "Elastography is indicated for determining the relative elasticity of a lesion." This is an indication for use, not an acceptance criterion or a performance claim with specific metrics.

Therefore, based on the provided text:

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

• Not provided. The document does not define specific acceptance criteria (e.g., sensitivity, specificity, accuracy, precision for elasticity measurements) or present a table of reported device performance against such criteria for the Elastography feature.

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

• Not provided. The document does not describe any specific test set size for evaluating Elastography performance, nor does it mention the data provenance (country of origin, retrospective/prospective).

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

• Not provided. There is no mention of experts establishing ground truth for a test set related to Elastography in this document.

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

• Not provided. 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:

• Not applicable / Not provided. The document does not describe an MRMC comparative effectiveness study for Elastography, nor does it mention AI assistance. The device is an ultrasound system with a new imaging mode (Elastography), not an AI-powered diagnostic tool in the sense of comparing human reader performance with and without AI.

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

• Not applicable / Not provided. Elastography in this context is an ultrasound imaging mode, which inherently involves a human operator acquiring and interpreting the images. It's not a standalone algorithm without human involvement in its operation or interpretation.

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

• Not provided. No type of ground truth is specified for evaluating the Elastography feature. For a substantial equivalence submission, the primary "ground truth" implicitly relies on established performance of the predicate devices and general safety standards for ultrasound.

8. The sample size for the training set:

• Not provided. As this is not a submission for an AI/CAD system in the modern sense, there is no concept of a "training set" described for the Elastography feature. The development of an imaging mode is typically based on physics and engineering principles, and clinical validation would follow.

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

• Not applicable / Not provided. See point 8.

Summary based on the provided text:

The provided 510(k) summary focuses on establishing substantial equivalence for the Toshiba Aplio XG ultrasound system and its various transducers, especially regarding the addition of "Elastography (New)" as an indication for use. It outlines the safety considerations and references adherence to various IEC and AIUM standards. However, it does not contain the detailed performance data, acceptance criteria, or study methodologies that would typically be associated with proving a novel AI/CAD device meets specific performance claims. For a new imaging mode like Elastography, the FDA's process at that time (2009) would have primarily looked at the technical safety and performance of the imaging modality itself, and the clinical utility for diagnostic purposes would be demonstrated through subsequent clinical literature and use, rather than a single premarket comparison study with specific acceptance criteria detailed in the 510(k) summary itself.

Ask a specific question about this device

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: fetal, abdominal, intraoperative, pediatric, small organs, neonatal cephalic, cardiac, cardiac, transrectal, transvaginal, transesophageal, peripheral vascular and musculo-skeletal (both conventional and superficial).

The Aplio XG v4.0 is a mobile system. This system is a Track 3 device that employs 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 510(k) Premarket Notification for the Aplio™ XG (v4.0) SSA-790A Ultrasound System does not contain detailed acceptance criteria, a study proving the device meets those criteria, or specific performance metrics with sample sizes. This document primarily focuses on establishing substantial equivalence to a predicate device (Toshiba Ultrasound Diagnostic System Aplio XG MODEL SSA-790A V3.0 K082119) and outlining the intended uses and associated transducers.

Therefore, many of the requested sections cannot be filled from the provided text.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not present in the provided document. The document lists "Modes of Operation" for various clinical applications and transducers, indicating whether they are "previously cleared by FDA" (P) or a "new indication" (N). However, it does not specify quantitative acceptance criteria (e.g., minimum accuracy, sensitivity, specificity) for these modes or report performance data against such criteria.

The "Modes of Operation" essentially indicate the capabilities of the device rather than its quantitative performance against specific criteria.

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

This information is not present in the provided document. The 510(k) summary focuses on substantial equivalence based on technical specifications and intended use, rather than clinical trial data with test sets.

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

This information is not present in the provided document.

4. Adjudication Method for the Test Set

This information is not present in the provided document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI vs Without AI Assistance

This information is not present in the provided document, and it's highly unlikely for an ultrasound system from 2009. The document does not mention AI.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This information is not present in the provided document, and it's highly unlikely for an ultrasound system from 2009. The device is a diagnostic ultrasound system, implying human operation and interpretation.

7. The Type of Ground Truth Used

This information is not present in the provided document. As no performance studies are detailed, no ground truth methodology is described.

8. The Sample Size for the Training Set

This information is not present in the provided document. The document doesn't describe any machine learning or AI components that would require a "training set."

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

This information is not present in the provided document. (See point 8).

Summary of available information related to acceptance and study:

The provided document is a 510(k) Premarket Notification, which primarily seeks to demonstrate "substantial equivalence" of the Aplio™ XG (v4.0) SSA-790A Ultrasound System to a legally marketed predicate device (Toshiba Ultrasound Diagnostic System Aplio XG MODEL SSA-790A V3.0 K082119).

The "study that proves the device meets the acceptance criteria" in the context of a 510(k) for an ultrasound system typically refers to:

• Conformance to standards: The document explicitly states that the device is "designed and manufactured in conjunction with the Quality System Regulation, IEC 60601-1 (applicable portions), IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4, IEC60601-2-37, IEC 62304 and the AIUM-NEMA UD2 Output Measurement Standard as applied to Track 3 Ultrasound systems and the AIUM-NEMA UD3 Output Display Standard." Meeting these recognized standards serves as evidence of safety and effectiveness, implicitly defining an "acceptance criterion" for fundamental device performance and safety.
• Comparison to predicate device: The core of a 510(k) is the comparison to a predicate. The tables detailing "Intended Use" and "Mode of Operation" for each transducer (e.g., PST-25BT, PVT-375MV) show whether a particular mode or application was "previously cleared by FDA" (P) with the predicate device (K082119) or is a "new indication" (N). This implies that the current device is accepted if its performance for existing indications is equivalent to the predicate, and new indications are justified through other means (though not detailed here).

Specifics on "new indications" (N): The document lists several "new indications" (e.g., for transducer PVT-375MV, Fetal and Abdominal applications now include B, M, PWD, Color Doppler, Combined, THI, Dynamic Flow, Power, CHI 2D, and 3D modes as "N"). For these new indications, the submission would typically include data (often bench testing, phantom studies, or limited clinical data) to demonstrate their safety and effectiveness. However, this specific data and its acceptance criteria are not included in this summary.

In essence, the "acceptance criteria" here are mainly regulatory conformance and substantial equivalence to a previously cleared device, rather than detailed, quantitative clinical performance metrics against specific benchmarks as might be seen for novel AI-powered diagnostic devices.

Ask a specific question about this device

The Aplio XG is intended to be used for the following types of studies; fetal, abdominal, intraoperative, pediatric, small organs, neonatal cephalic, adult cephalic, cardiac, transrectal, transvaginal, transesophageal, peripheral vascular and musculo-skeletal (both conventional and superficial).

The Aplio XG Ultrasound System is a mobile system. This system is a Track 3 device that employs 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 a Toshiba Aplio XG Version 3.0 Diagnostic Ultrasound System. This document is a regulatory submission for medical devices and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study results and acceptance criteria in the manner you might find for a novel AI/CADe device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not present in the provided document. The document primarily lists the intended uses for various transducers and indicates whether these uses were "Previously Cleared by FDA" (P) or are "N= new indication." There is no section detailing performance metrics or studies to prove the device meets specific acceptance criteria.

The acceptance of this device for market clearance is based on its substantial equivalence to previously cleared predicate devices, specifically the Toshiba SSA-790A, Aplio XG Version 2.2, and the Hitachi Medical Systems America Inc. HI VISION 900 Diagnostic Ultrasound Scanner. The "study that proves the device meets the acceptance criteria" in this context is the comparison to these predicate devices as detailed in the 510(k) submission, confirming that the new device does not raise new questions of safety or effectiveness.

Here's an attempt to structure what can be extracted from the provided text, while noting the significant lack of the detailed study information you requested:

Acceptance Criteria and Study for Toshiba SSA-790A, Aplio XG Version 3.0 Diagnostic Ultrasound System

Based on the provided 510(k) Summary, the acceptance criteria and study detailed below are primarily focused on demonstrating substantial equivalence to predicate devices rather than proving a specific performance metric against a defined acceptance threshold for a novel AI/CADe functionality. The document does not contain the detailed clinical study information typically associated with proving performance characteristics of an AI/CADe device (e.g., sensitivity, specificity, reader performance improvements, sample sizes of test sets, expert qualifications, or adjudication methods).

1. Table of Acceptance Criteria and Reported Device Performance:

Since explicit quantitative acceptance criteria for performance metrics (like sensitivity or specificity) are not provided in this 510(k) summary (which is typical for ultrasound systems establishing equivalence rather than new AI/CADe performance), this table represents the intended uses and the status of those indications (new vs. previously cleared), which is the primary "performance" aspect evaluated for this type of submission.

Note: The "acceptance criteria" here are implied by the 510(k) process itself, which requires demonstrating that the new device is as safe and effective as a legally marketed predicate device. The "reported device performance" is the confirmation that the device's capabilities align with previously cleared indications or new indications that do not raise new questions of safety or effectiveness. For new indications (marked 'N'), the submission would typically provide justification, but this level of detail is not in the provided summary.

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

• Not provided. The document does not describe specific test sets, sample sizes, or data provenance (e.g., country of origin, retrospective/prospective) for a performance study. Its focus is on the device's technical specifications and intended uses in comparison to predicate devices.

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

• Not provided. There is no mention of ground truth establishment, expert reviews, or qualifications in the context of a performance study.

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

• Not provided. This information is not relevant to the type of 510(k) submission presented, which does not detail a clinical performance study with 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:

• Not applicable / Not provided. This document precedes common AI/CADe applications in ultrasound systems and does not describe an MRMC study comparing human reader performance with and without AI assistance. The device is a diagnostic ultrasound system, not an AI or CADe device.

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

• Not applicable / Not provided. The device is an ultrasound system, not an algorithm being evaluated in a standalone capacity.

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

• Not provided. As no specific performance study with ground truth is detailed, this information is absent. For an ultrasound system like this, the "ground truth" for demonstrating equivalence would typically involve engineering and bench testing, comparison to predicate device specifications, and possibly clinical validation of image quality and diagnostic capabilities, but not in the sense of a definitive diagnostic ground truth for an AI algorithm.

8. The sample size for the training set:

• Not applicable / Not provided. This device is a diagnostic ultrasound system, not an AI model, so there is no mention of a training set for an algorithm.

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

• Not applicable / Not provided. As there is no AI model or training set discussed, this information is not present.

In summary, the provided 510(k) document is a regulatory filing for a diagnostic ultrasound system (Toshiba SSA-790A, Aplio XG Version 3.0), focusing on demonstrating substantial equivalence to predicate devices based on its intended uses and technical specifications. It does not contain the detailed clinical study performance data or AI/CADe-specific information that your questions are designed to elicit.

Ask a specific question about this device

The Aplio XG is intended to be used for the following type of studies: fetal, abdominal, intraoperative, pediatric, small organs, neonatal cephalic, adult cephalic, cardiac, transrectal, transvaginal, transesophageal, peripheral vascular and musculo-skeletal (both conventional and superficial).

The Aplio XG Ultrasound System is a mobile system. This system is a Track 3 device that employs 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.

This is a 510(k) premarket notification for the Toshiba Aplio XG SSA-790A (v2.2) Diagnostic Ultrasound System and its associated transducers. The document primarily focuses on demonstrating substantial equivalence to predicate devices and lists the intended uses and safety considerations. It does not contain information typically found in acceptance criteria or a study proving that the device meets specific performance metrics in the way an AI/ML device submission would.

Therefore, I cannot extract acceptance criteria and a study that proves the device meets those criteria from the provided text in the manner requested for AI/ML performance.

Here's why and what information can be provided:

• Device Type: This is a diagnostic ultrasound system, not an AI/ML device. For such medical imaging systems, FDA clearance typically relies on demonstrating safety and effectiveness based on established performance standards (e.g., electrical safety, acoustic output, image quality, and clinical functionality) rather than a statistically robust clinical performance study with specific acceptance criteria like accuracy, sensitivity, or specificity.
• "Acceptance Criteria" in this context refers to regulatory compliance and equivalence, not clinical performance metrics for a specific algorithm. The "acceptance criteria" here are met by demonstrating that the device conforms to relevant industry standards and is substantially equivalent to a legally marketed predicate device.
• "Study that proves the device meets the acceptance criteria" refers to the entire 510(k) submission process itself. The process of compiling and submitting the necessary documentation (including comparisons to predicate devices, engineering tests, and adherence to safety standards) is the "study" that proves regulatory acceptance.

Based on the provided text, here's what can be extracted, framed within the context of a traditional medical device submission:

1. Table of Acceptance Criteria and Reported Device Performance (Regulatory Equivalence / Compliance)

• Toshiba SSA-790A, Aplio XG Version 2.00 Diagnostic Ultrasound (K072000)
• General Electric Co. VOLUSON E8 Ultrasound System (K061682) |
  | Compliance with Regulatory Class II Requirements | Classified as II, Review Category: Tier II. Product Codes: 90-IYN, 90-IYO, 90-ITX. |
  | Adherence to Safety Standards (General Controls) | Designed and manufactured in conjunction with Quality System Regulation, IEC 60601-1, IEC 60601-1-2, IEC60601-2-37, AIUM-NEMA UD2, and AIUM-NEMA UD3. |
  | Intended Use Statement Consistency | Intended for fetal, abdominal, intraoperative, pediatric, small organs, neonatal cephalic, adult cephalic, cardiac, transrectal, transvaginal, transesophageal, peripheral vascular, and musculo-skeletal studies. This aligns with predicate devices (K072000) for all listed applications and transducer modes (as indicated by 'P' in the detailed tables). |
  | Acoustic Output within Approved Levels (Post-Clearance) | A post-clearance special report is required containing complete information, including acoustic output measurements based on production line devices, as requested in Appendix G. (This is a condition for clearance, implying that meeting these levels is an acceptance criterion). |

Note: Specific quantitative performance metrics (e.g., image resolution, penetration depth, frame rates) are typically part of internal design specifications and testing for traditional ultrasound devices but are not explicitly detailed as "acceptance criteria" in this FDA summary document, which focuses on regulatory clearance. The "performance" here is primarily about functional equivalence and safety.

Regarding the other requested information (which is more relevant for AI/ML studies):

• 2. Sample size used for the test set and the data provenance: Not applicable. This document does not describe a clinical study with a test set of images for algorithm performance evaluation. It's a regulatory submission for a hardware/software system.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for the same reason as above.
• 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: No. This is a traditional device clearance, not an AI/ML effectiveness study.
• 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is an ultrasound system that is operated by a human.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of an AI/ML evaluation. For an ultrasound system, "ground truth" would relate to the physical accuracy of its measurements and image rendering against known standards, and its safety.
• 8. The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.
• 9. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device

The Aplio XG is intended to be used for the following type of studies; fetal, abdominal, intraoperative, pediatric, small organs, neonatal cephalic, cardiac, transrectal, transvaginal, transesophageal, peripheral vascular and musculo-skeletal (both conventional and superficial).

The Aplio XG Ultrasound System is a mobile system is a Track 3 device that employs 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 document is a 510(k) summary for the Toshiba SSA-790A, Aplio XG Version 2.00 Diagnostic Ultrasound System. This document focuses on establishing substantial equivalence to previously cleared predicate devices and does not contain detailed information about specific acceptance criteria, study designs, sample sizes, expert qualifications, or ground truth establishment typically found in performance studies for new algorithms or AI-driven devices.

The information provided primarily relates to the intended use and safety considerations based on existing standards, rather than the results of novel performance studies. The "acceptance criteria" discussed in the document are about the device's adherence to regulatory standards and its equivalence to predicate devices, not specific performance metrics in a clinical study.

Therefore, many of the requested items (e.g., specific acceptance criteria values, sample sizes for test/training sets, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, ground truth types for training/test sets) cannot be extracted from this document as it does not describe such a study.

However, I can extract the information that is present:

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the nature of this 510(k) (substantial equivalence to predicate devices), the "acceptance criteria" are implied to be the safety and performance characteristics of the predicate devices. The "reported device performance" is that the new device is substantially equivalent to these predicates.

The document lists various transducers and the clinical applications they are cleared for, along with the available operating modes. "P" indicates "Previously Cleared by FDA" (implying equivalence to previous versions/predicate devices) and "E" indicates "Added under Appendix E (LTF)", meaning these indications were already covered by the previous 510(k) for that specific transducer model. "N" indicates "new indication" for the specific transducer and mode combination.

Since this document is a 510(k) summary for an ultrasound system, the acceptance criteria are generally based on meeting the performance and safety standards of the predicate devices and applicable industry standards. There are no quantitative performance metrics (e.g., sensitivity, specificity for disease detection) for a specific clinical task mentioned in this document that would be applicable for the requested table format.

The "performance" is demonstrated by its substantial equivalence to the following predicate devices:

1. Toshiba SSA-790A, Aplio XG Version 1.00 Diagnostic Ultrasound; 510(k) control number K063130
2. Siemens Medical Solutions U.S.A. Acuson Sequoia Ultrasound System; 510(k) control number K052410

The device (Aplio XG Version 2.00) meets the acceptance criteria by being demonstrated as substantially equivalent to these predicate devices for the listed clinical applications and operating modes. Specific performance characteristics for images for each clinical indication (e.g., image resolution, penetration depth, contrast) are usually detailed in the full 510(k) submission, not typically summarized quantitatively in the publicly available summary letter like this one.

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

Not applicable. This document is a 510(k) summary establishing substantial equivalence to predicate devices and adherence to consensus standards. It does not describe a clinical performance study with a test set of patient data to evaluate a new algorithm or AI device.

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. This document does not describe a study involving expert-established ground truth for a test set.

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

Not applicable. This document does not describe a study involving ground truth 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

Not applicable. This document does not describe an MRMC study. It is a 510(k) for a diagnostic ultrasound system, not an AI-assisted interpretation device.

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

Not applicable. This is not an AI algorithm.

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

Not applicable. This document does not describe a study with a ground truth dataset in the context of diagnostic accuracy. The "ground truth" for this submission is implicitly the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

Not applicable. This document does not describe the development or testing of an AI algorithm requiring a training set.

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

Not applicable. This document does not describe the development or testing of an AI algorithm requiring a training set.

Ask a specific question about this device

The Aplio XG System is intended to be used for the following types of studies: feta, abdominal, intraoperative, pediatric, small organs, neonatal cephalic, adult cephalic, cardiac, transrectal, transvaginal, transesophageal, peripheral vascular and muscoloskeletal (both conventional and superficial.

The Aplio XG Ultrasound System is a mobile system. It is a Track 3 device that employs a wide array of probes that include flat linear array, convex linear array, and sector array with a frequency range of 2 MHz to 12 MHz

The provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria. It is a 510(k) summary for an ultrasound imaging system, detailing its features, intended use, and substantial equivalence to a predicate device, along with a list of compatible transducers and their cleared indications.

Therefore, I cannot extract the requested information, including:

1. A table of acceptance criteria and reported device performance.
2. Sample size for the test set and data provenance.
3. Number of experts and their qualifications for establishing ground truth.
4. Adjudication method.
5. MRMC study details or effect size of AI assistance.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

Ask a specific question about this device