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The M5 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in abdomen, gynecology, obstetrics, small parts (breast, testes, thyroid, etc.), pediatrics, transcranial, cardiac, peripheral vascular, urology, orthopedics, intraoperative and musculoskeletal (general and superficial) exams.

The M5 Diagnostic Ultrasound System is a general purpose, mobile, software controlled ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B-Mode, M-Mode, Color mode, PW mode, CW mode, Power mode, DirPower mode or the combined mode (i.e. B/M Mode). This system is a Track 3 device that employs an array of probes that include linear array, convex array and phased array with a frequency range of approximately 2.0 MHz to 12.0 MHz.

The provided 510(k) summary for the M5 Diagnostic Ultrasound System is a general submission for a diagnostic medical device and as such, does not contain information about acceptance criteria or specific study results that prove the device meets acceptance criteria defined by performance metrics like sensitivity, specificity, or AUC.

Instead, the submission focuses on demonstrating substantial equivalence to pre-existing legally marketed predicate devices. This means the device is being cleared based on its similarity in technological characteristics, functionality, intended uses, and safety to already approved devices, rather than through extensive clinical performance studies with specific acceptance criteria that would typically be seen for novel AI/ML-driven devices.

Therefore, many of the requested categories of information related to AI/ML device performance studies are not applicable to this document.

Here's a breakdown of the available and unavailable information based on your request:

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

• Acceptance Criteria: Not explicitly stated in terms of performance metrics (e.g., sensitivity, specificity, accuracy). The acceptance criteria for this type of submission are primarily about demonstrating substantial equivalence to predicate devices in terms of technology, safety, and intended use as per FDA regulations for traditional 510(k) clearances.
• Reported Device Performance: Not reported in terms of specific diagnostic performance metrics. The document states that the system has been "evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical and mechanical safety" and found to conform to applicable medical safety standards (UD 2, UD 3, IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-37, IEC 60601-1-4 and ISO 10993-1). This is about engineering and safety performance, not diagnostic accuracy.

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 submission does not describe a clinical performance study with a test set of patient data to evaluate diagnostic accuracy.

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 such test set or ground truth establishment is described.

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

• Not applicable. No such test set or adjudication process 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. This device is a diagnostic ultrasound system, not an AI/ML-driven diagnostic aid that assists human readers. No MRMC study is mentioned.

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

• Not applicable. This is a hardware/software system, not a standalone AI algorithm. Its performance is inherent to its ability to acquire and display ultrasound images.

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

• Not applicable. No ground truth for diagnostic performance is described. The "ground truth" in this context is the general understanding of diagnostic ultrasound capabilities as established by predicate devices and standards.

8. The sample size for the training set:

• Not applicable. This submission does not describe an AI/ML algorithm that requires a training set in the conventional sense.

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

• Not applicable. As above, no training set for an AI/ML algorithm is described.

In summary, the provided document is a 510(k) premarket notification that demonstrates substantial equivalence based on technical specifications and safety standards, rather than clinical performance data from studies commonly associated with AI/ML device clearances.

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The device is intended for use by a qualified physician for ultrasound evaluation of abdominal, cardiac, small parts (breast, testes, thyroid, etc.), peripheral vascular, fetal, transrectal, transvaginal, intraoperative (abdominal, thoracic, and vascular etc.), pediatric, neonatal cephalic, musculoskeletal (general and superficial).

The M5 Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B-Mode, M-Mode, Color mode, PW mode, CW mode, Power mode, DirPower mode or the combined mode (i.e. B/M Mode). This system is a Track 3 device that employs an array of probes that include linear array, convex array and phased array with a frequency range of approximately 2.0 MHz to 12.0 MHz.

The provided text describes a 510(k) Pre-Market Notification for the KOS-3001 M5 Diagnostic Ultrasound System. It asserts substantial equivalence to predicate devices and describes the intended use and safety considerations. However, it does not contain any information regarding acceptance criteria or a specific study proving the device meets those criteria.

The document mainly focuses on:

• Device Identification: Name, submitter, date prepared.
• Classification: Regulatory class, review category, product codes.
• Marketed Devices: Listing predicate devices for substantial equivalence.
• Device Description: General description, modes of operation, probe types, and frequency range.
• Intended Use: Clinical applications for which the device is intended.
• Safety Considerations: Compliance with FDA guidance and medical device safety standards (NEMA UD 2, NEMA UD 3, IEC 60601-1, etc.).
• FDA Clearance Letter: Formal letter from the FDA stating substantial equivalence and listing cleared transducers and their clinical applications.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about a study proving these criteria are met, as this information is not present in the provided text.

To answer your specific questions in the context of this document:

1. A table of acceptance criteria and the reported device performance: Not available in the provided text. The document asserts safety and effectiveness through compliance with standards and substantial equivalence to predicate devices, but no specific performance criteria or results are listed.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not available in the provided text.
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 available in the provided text.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not available in the provided text.
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 available in the provided text. This device is a diagnostic ultrasound system, not an AI-powered image analysis tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as there is no mention of an algorithm for standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not available in the provided text.
8. The sample size for the training set: Not applicable as there is no mention of a training set for an AI algorithm.
9. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device

The device is intended for use by a qualified physician for ultrasound evaluation of fetal, abdominal, pediatric, neonatal cephalic, cardiac, small parts, transvaginal, transrectal, peripheral-vascular, muscular-skeletal(conventional and superficial).

The M5 is a portable general purpose, mobile, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, PW-Mode, Color-Mode, Power-Mode, Dirpower-Mode or the combined mode (i.e. B/M-Mode).This system is a Track 3 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 14 MHz.

This 510(k) summary describes a diagnostic ultrasound system (M5) and its transducers. The document primarily focuses on regulatory information and intended use rather than specific performance studies with acceptance criteria, ground truth, or statistical analyses. Therefore, much of the requested information cannot be extracted from the provided text.

Here is the information that can be extracted or reasonably inferred:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or detailed device performance metrics in terms of clinical accuracy or diagnostic efficacy. Instead, it refers to compliance with established standards and substantial equivalence to predicate devices. The "reported device performance" is implicitly that the device is "as safe and effective as the legally marketed predicate devices" for its stated intended uses.

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

This information is not provided in the document. The filing refers to "testing" performed for safety and effectiveness but does not detail any clinical studies, their sample sizes, or data provenance (e.g., country of origin, retrospective/prospective nature).

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

This information is not provided in the document, as no specific clinical study with ground truth establishment is detailed.

4. Adjudication Method for the Test Set

This information is not provided in the document, as no specific clinical study with adjudication is detailed.

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 information is not provided in the document. The device is a diagnostic ultrasound system; there is no mention of AI assistance or MRMC studies.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

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

7. The Type of Ground Truth Used

This information is not provided in the document, as no specific clinical study with ground truth is detailed. The basis for safety and effectiveness is primarily stated as conformance to standards and substantial equivalence to predicate devices, rather than a direct comparison against a clinical ground truth for a new indication.

8. The Sample Size for the Training Set

This information is not provided in the document. There is no mention of a "training set," which typically refers to data used for machine learning models.

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

This information is not provided in the document for the reasons stated above.

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