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Ultrasonic pulsed echo imaging and measurement for fetal imaging and other abdominal as well as pediatric, small organ, cardiac.

Model SSI-600/SSI-800 are linear and convex electronic scanning ultrasonotomograph with a built-in digital scan converter (DSC) and main CPU module. The unit allows heart, abdominal organic and fetal tomographic images to be observable on a video monitor. The main unit of SSI-600 is portable and separable from other equipment to be carried for its use at another place as well as being usable in combination with a 10-inch video monitor and a special photographic unit. The main unit of SSI-800 is able to combine with a 12-inch video monitor and a special photographic unit.

This is a 510(k) premarket notification for an ultrasound system, not a study evaluating a device's performance against specific acceptance criteria.

The document describes the SonoScape SSI-600/SSI-800 Diagnostic Ultrasound Systems with C343 Convex Array and L751 Linear Array transducers. The primary purpose of this 510(k) submission is to demonstrate substantial equivalence to a previously legally marketed predicate device (Medison SonoAce 600 K000030), not to provide a detailed study with acceptance criteria and performance data in the way you've outlined.

Therefore, the specific information requested in your prompt (acceptance criteria table, sample sizes, ground truth experts, adjudication methods, MRMC studies, standalone performance, training set details) cannot be extracted from this document because such information is not typically included in a 510(k) summary for a diagnostic ultrasound system intended to demonstrate substantial equivalence based on technological characteristics and intended use.

Here's a breakdown of what can be inferred or stated based on the document, and what cannot:

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

  • Cannot be provided. This document doesn't define acceptance criteria for a performance study. It lists technological characteristics of the device (e.g., scanning methods, display modes, grey scale, frequency range) and its intended uses. The "performance" being reported is that these characteristics are comparable to the predicate device, leading to a determination of substantial equivalence.

• 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 describe a clinical performance study with a test set.

• 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 describe a clinical performance study with expert-established ground truth.

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

  • Cannot be provided. The document does not describe a clinical performance study requiring 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:

  • Cannot be provided. This is a diagnostic ultrasound system, not an AI-assisted diagnostic device. No MRMC study is mentioned.

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

  • Cannot be provided. This is a diagnostic ultrasound system, not an algorithm. Standalone performance as described is not relevant to this submission.

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

  • Cannot be provided. As no performance study is detailed, no ground truth is discussed.

• 8. The sample size for the training set:

  • Cannot be provided. This document does not describe a machine learning algorithm that would have a training set.

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

  • Cannot be provided. As explained in point 8.

In summary, this document is a regulatory submission demonstrating substantial equivalence of a general diagnostic ultrasound system, not a clinical study report with performance metrics against acceptance criteria. The "study" here is the comparison against the predicate device based on technical specifications and intended use.

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Ultrasonic pulsed echo imaging and measurement for fetal imaging and other abdominal as well as pediatric, small organ cardiac.
Small organs includes: thyroid, parathyroid, parotid, submaxillary gland, testes and breast.
Pediatric Intended Uses include: Cardiology, Abdomen, Peripheral Vasa.

Model CTS-485 is a linear/convex electronic scanning ultrasonotomograph with a built-in digital scan converter (DSC) and main CPU module. The unit allows heart, abdominal organic and fetal tomographic images to be observable on a video monitor. The main unit is portable and is separable from other equipment to be carried for its use at another place as well as being usable in combination with a 9-inch video monitor and a special photographic unit.

The provided document is a 510(k) Premarket Notification Summary for the SIUI CTS-485 Ultrasound Imaging System. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving a device meets specific acceptance criteria through a study with performance metrics. As such, the document does not contain the acceptance criteria or a study proving the device meets acceptance criteria in the way typically expected for an AI/ML device or a device with new performance claims.

Instead, the document details the device's technical specifications and intended uses, and asserts its substantial equivalence to a predicate device (MEDISON Co. SONOACE 600, K000030). The FDA's letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and find the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976...". This means the device is considered safe and effective because its characteristics are similar enough to a device already on the market, not because it has met specific, novel performance benchmarks.

Therefore, I cannot populate the requested table and sections as the information is not present in the provided text.

Here's why and what information is available:

• Acceptance Criteria and Reported Device Performance: This document does not list specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or corresponding reported device performance values from a clinical study. It focuses on technical specifications (e.g., display modes, grey scale, frequency of probe, depth, gain) and intended uses.
• Study Information (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set): No such study is described or referenced in this 510(k) summary. The submission relies on demonstrating substantial equivalence through comparison of technological characteristics and intended use to a predicate device. The only "test" mentioned is a future "postclearance special report" for acoustic output measurements based on production line devices, which is a safety/engineering test, not a performance study as typically understood for AI/ML or new clinical claims.

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