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The DP-9900 Digital Ultrasonic Diagnostic Imaging System with added transducer is a general-purpose, fully digital ultrasound system for abdominal, gynecologic and obstetric, small parts, and cardiac applications.

The system is intended to use for the following type of studies: fetal organ. abdominal, pediatric, small organs, neonatal cephalic, cardiac, transvaginal, peripheral vascular, and musculo-sletal (both conventional and superficial). This device is intended to adult, pregnant woman, pediatric and neonate. The Device is a prescription device intended to be used by or on the order of a physician or similarly qualified health care professional. This Device is not intended for home use.

The DP-9900 Digital Ultrasonic Diagnostic Imaging System with added transducer is a general purpose, mobile, software controlled, ultrasound diagnostic system. This ultrasonic device is designed to project ultrasound waves into body tissue and to present the returned echo information on the monitor. The resulting information is displayed in B-Mode, M-Mode, or in the combined mode (i.e. B/M-Mode). This system is a Track 1 device that employs an array of probes that include linear array and convex linear array with a frequency range of approximately 2.5 MHz to 10 MHz. The modification will provide users with two new transducers, provide new frequency point, improve imaging enhancement, change system implement protocol by integrating some boards into one and reducing some boards, etc.

The provided document is a 510(k) premarket notification for a medical device, which focuses on demonstrating substantial equivalence to existing devices rather than proving specific performance against acceptance criteria in a clinical study. As such, much of the requested information regarding acceptance criteria, study design, and ground truth establishment is not present in this type of regulatory submission.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it focuses on demonstrating that the modified device remains "as safe, as effective as well as the legally marketed predicate devices."

The reported "device performance" is primarily in the context of compliance with safety and technical standards, and its ability to function as intended.

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

The document explicitly states: "No clinical testing was required." This indicates that there was no "test set" in the sense of a set of patient data used for clinical performance evaluation. The evaluation appears to be based on technical and safety testing, and a comparison to predicate devices, rather than a prospective or retrospective study on a patient sample.

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

Not applicable, as no clinical testing with a specific "test set" requiring expert-established ground truth was conducted.

4. Adjudication method for the test set

Not applicable, as no clinical testing with a test set requiring adjudication was conducted.

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 a diagnostic ultrasound system and does not describe AI functionality or involve a reader performance study with AI assistance.

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

Not applicable. This device does not describe AI algorithms.

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

Not applicable, as no clinical testing requiring ground truth for diagnostic accuracy was conducted. The "ground truth" in this context is the established safety and effectiveness of the predicate devices and compliance with technical standards.

8. The sample size for the training set

Not applicable, as there is no mention of a training set for an algorithm.

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

Not applicable, as no training set was mentioned.

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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Pediatric, Small organ, Neonatal Cephalic, Cardiac, Transrectal, Transvaginal, Peripheral Vascular, Musculo-skeletal, Musculo-skeletal Superficial.

The DP-9900 Digital Ultrasonic Diagnostic Imaging System with added transducer is a general purpose, mobile, software controlled, ultrasound diagnostic system. This ultrasonic device is designed to project ultrasound waves into body tissue and to present the returned echo information on the monitor. The resulting information is displayed in B-Mode, M-Mode, or in the combined mode (i.e. B/M-Mode). This system is a Track 1 device that employs an array of probes that include linear array and convex linear array with a frequency range of approximately 2.5 MHz to 10 MHz. The modification will provide users with an additional transducer and change the acoustic lens of some transducers along with the addition of software functions.

1. Acceptance Criteria and Reported Device Performance:

There are no explicit acceptance criteria or reported device performance metrics mentioned in the provided text. The submission focuses on demonstrating substantial equivalence to a predicate device.

2. Sample Size and Data Provenance for Test Set:

No specific test set or clinical study with a defined sample size is described. The document states, "No clinical testing was required," indicating that the device was not evaluated through clinical trials for this submission.

3. Number of Experts and Qualifications for Ground Truth:

Not applicable, as no dedicated clinical testing or ground truth establishment for a test set is described.

4. Adjudication Method for Test Set:

Not applicable, as no dedicated clinical testing or adjudication process for a test set is described.

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

No MRMC study or any form of comparative effectiveness study involving human readers with or without AI assistance is mentioned.

6. Standalone Algorithm Performance:

The document does not describe a standalone algorithm performance study. The submission is for a traditional diagnostic ultrasound imaging system, not an AI-based algorithm.

7. Type of Ground Truth Used:

Not applicable, as no ground truth for a specific test set is described. The device's safety and effectiveness were primarily evaluated through laboratory testing and comparison to existing standards and a predicate device.

8. Sample Size for Training Set:

Not applicable, as this is not an AI/ML-based device that would require a training set.

9. How Ground Truth for Training Set Was Established:

Not applicable, as this is not an AI/ML-based device that would require a training set and corresponding ground truth.

Summary of Information from the Provided Text:

The provided 510(k) summary for the DP-9900 Digital Ultrasonic Diagnostic Imaging System and its added transducer (75L60HB) primarily relies on:

• Substantial Equivalence: The core argument is that the device is substantially equivalent to a legally marketed predicate device (K053346).
• Laboratory Testing: "Laboratory testing was conducted to verify that the DP-9900 digital ultrasonic diagnostic imaging system with added transducer met all design specification and was substantially equivalent to the currently marketed Predicate Device as above."
• Compliance with Standards: The device was found to conform to applicable medical device safety standards (e.g., NEMA UD 2, IEC 60601-1, IEC 60601-1-2) regarding thermal, mechanical, electrical safety, biocompatibility, and acoustic output.
• No Clinical Testing: The document explicitly states, "No clinical testing was required."

Therefore, the specific information requested in the prompt (acceptance criteria table, sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance) is not detailed as part of this traditional medical device clearance process described. The device's acceptance was based on its demonstrated equivalence to an already approved device and compliance with established safety and performance standards through laboratory testing.

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

The DP-9900 Digital Ultrasonic Diagnostic Imaging System with added transducer is a general purpose, mobile, software controlled, ultrasound diagnostic system. This ultrasonic device is designed to project ultrasound waves into body tissue and to present the returned echo information on the monitor. The resulting information is displayed in B-Mode, M-Mode, or in the combined mode (i.e. B!M-Mode). This system is a Track 1 device that employs an array of probes that include linear array and convex linear array with a frequency range of approximately 2.5 MHz to 10 MHz. This modification will provide users with a wider selection of probe characteristics. And tissue harmonic imaging enhances over image performance.

The provided 510(k) summary for the DP-9900 Digital Ultrasonic Diagnostic Imaging System does not include acceptance criteria or a study proving that the device meets specific acceptance criteria in terms of clinical performance metrics.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and adherence to safety standards. The "testing" section primarily describes engineering verification and conformation to general safety standards for medical devices and acoustic output.

Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is absent:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Test Set: Not applicable (No clinical test set for performance evaluation against specific criteria was required or performed).
• Data Provenance: Not applicable.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Not applicable (No clinical test set with expert ground truth was required or performed).

4. Adjudication Method for the Test Set

• Not applicable (No clinical test set with adjudicated ground truth was required or performed).

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

• Was an MRMC study done? No.
• Effect size of human readers with AI vs. without AI assistance: Not applicable. This is a diagnostic ultrasound system, not an AI-powered image analysis tool for interpretation.

6. Standalone (Algorithm Only) Performance Study

• Was a standalone study done? No. This is a diagnostic imaging device, not a standalone algorithm.

7. Type of Ground Truth Used

• Not applicable (No clinical performance evaluation requiring ground truth was described).

8. Sample Size for the Training Set

• Not applicable (This submission describes a hardware and software system, not a machine learning model that requires a training set of data for performance).

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

• Not applicable.

Summary of Findings from the Provided Text:

The 510(k) submission for the DP-9900 Digital Ultrasonic Diagnostic Imaging System with added transducer is a substantial equivalence (SE) submission, not one that relies on clinical performance data against specific acceptance criteria. The core argument for clearance is that the modified device (with added transducers) shares the same fundamental technology as its predicate devices and conforms to applicable safety standards.

The document explicitly states: "No clinical testing was required." This indicates that the FDA did not deem a clinical study necessary to prove the device's safety and effectiveness for its intended use, likely because its technological characteristics and intended use were very similar to existing, legally marketed predicate devices. The focus was on engineering verification and compliance with standards such as NEMA UD 2, IEC 60601-1, and IEC 60601-1-2 for acoustic output, electrical safety, thermal safety, and biocompatibility.

Ask a specific question about this device

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

The DP-9900 Digital Ultrasonic Diagnostic Imaging System is a general purpose, mobile, software controlled, ultrasound diagnostic system. This ultrasonic device is designed to project ultrasound waves into body tissue and to present the returned echo information on the monitor. The resulting information is displayed in B-Mode, M-Mode, or in the combined mode (i.e. B/M-Mode). This system is a Track 1 device that employs an array of probes that include linear array and convex linear array with a frequency range of approximately 2.5 MHz to 8.5 MHz.

The provided document is a 510(k) premarket notification for the "DP-9900 Digital Ultrasonic Diagnostic Imaging System" and its associated transducers. This submission does not describe an AI medical device with specific performance metrics against acceptance criteria in the typical sense of AI algorithm evaluation. Instead, it demonstrates substantial equivalence to a predicate device for market clearance.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set ground truth) are not applicable or cannot be extracted directly from this type of regulatory submission. The document focuses on technological characteristics, safety standards, and intended use as compared to a predicate device.

Here's an attempt to answer the questions based on the information provided, with an emphasis on what is not applicable or not specified for this type of device and submission.

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

The acceptance criteria for this device are implicitly tied to demonstrating "substantial equivalence" to a legally marketed predicate device (Toshiba SSA-325A JUST VISION 400 Ultrasound Imaging System K990490). This typically involves meeting comparable safety and effectiveness standards, rather than specific numerical performance metrics for an AI algorithm.

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

• Sample size for test set: Not applicable and not specified. This submission is for an ultrasonic imaging system, not an AI algorithm evaluated on a dataset. The "testing" mentioned refers to laboratory verification of engineering specifications and safety standards, not an evaluation on clinical cases.
• Data provenance: Not applicable. No clinical data or patient specific data is mentioned as being used for "testing" in the context of performance evaluation against a ground truth.

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 ground truth for a test set (in the context of image interpretation or diagnosis) was established or used for this regulatory submission.

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 is not an AI device.

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

Not applicable. This is not an AI device. The device itself is an "algorithm only" in the sense that it is a software-controlled ultrasound system, but its performance is judged on its ability to produce images comparable to a predicate, not on a diagnostic algorithm's output.

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

Not applicable. The "ground truth" here is the established safety and effectiveness of the predicate device and compliance with general performance standards for ultrasound systems, rather than a clinical ground truth for diagnostic accuracy.

8. The sample size for the training set

Not applicable. This is not an AI device that requires a training set.

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

Not applicable. This is not an AI device that requires a training set.

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