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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Ophthalmic, Fetal, Abdominal, Intraoperative (vascular/epicardial), Pediatric, Small Organ (thyroid, scrotum and breast), Neonatal Cephalic, Adult Cephalic, Cardiac (Adult & Pediatric), Transesophageal, Transrectal, Transvaginal, Peripheral Vascular.

Diagnostic Ultrasound Imaging and Doppler Analysis of the human body as follows: Abdominal, Adult Cephalic.

Diagnostic Ultrasound Imaging and Doppler Analysis of the human body as follows: Fetal, Small Organ (prostate), Transrectal, Transvaginal.

Diagnostic Ultrasound Imaging and Doppler Analysis of the human body as follows: Intraoperative (vascular/epicardial), Pediatric, Cardiac, Peripheral Vascular.

This premarket notification describes modifications to the indications for the Sonos 5500 M2424A system with the 21330A probe, and the addition of two probes. The common names for these devices are the Phased Array, Endocavity Probe and Intraoperative Probe for Sonos 5500 Ultrasound Imaging System. The classification names for these devices are: Ultrasonic Pulsed Doppler Imaging System, Ultrasonic Pulsed Echo imaging System and Diagnostic Ultrasound Transducer.

The provided text is a 510(k) summary for modifications to the Sonos 5500 Ultrasound Imaging System and its transducers. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study with acceptance criteria and performance data for a new AI/CADe device.

Therefore, the document does not contain the information required to fill out the table and answer the study-related questions (items 1 through 9). The approval is based on the devices functioning "in the same way as their predicate devices" and having "no new technological changes" except for patient contact materials. The provided "Indications for Use Form" lists clinical applications and modes of operation, indicating whether they are "new," "previously cleared," or "added under Appendix E," but these are intended use statements, not performance data or acceptance criteria for a study.

Specifically:

• A table of acceptance criteria and the reported device performance: Not available. The document asserts substantial equivalence without providing specific performance metrics or acceptance criteria for the new indications or probes against a defined standard.
• Sample size used for the test set and the data provenance: Not applicable, as there is no mention of a diagnostic performance study, test set, or data provenance.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• Adjudication method: Not applicable.
• If a multi-reader, multi-case (MRMC) comparative effectiveness study was done: No, this is not mentioned.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No, this is not mentioned.
• The type of ground truth used: Not applicable.
• The sample size for the training set: Not applicable, as there is no mention of a training set for an algorithm.
• How the ground truth for the training set was established: Not applicable.

The 510(k) summary primarily focuses on regulatory compliance, outlining the modifications and asserting that the modified devices are substantially equivalent to existing, legally marketed predicate devices. The "study" mentioned pertains to biocompatibility testing for new patient contact materials, not clinical performance for diagnostic accuracy.

This document is a 510(k) summary for modifications to an existing ultrasound system and its transducers. It *does not contain* information about a study proving a device meets acceptance criteria related to diagnostic performance for a new AI/CADe device. The approval is based on substantial equivalence to predicate devices. Therefore, the requested information cannot be extracted from the provided text.

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Diagnostic Ultrasound Imaging of the human body in the applications detailed below.
Clinical Applications:

• Intra-Operative: Cardiovascular
• Pediatric
• Cardiac Adult
• Cardiac Pediatric
• Peripheral Vessel

The new intra-operative transducer has equivalent functionality to the existing transducer now being used. The new intra-operative transducer has new patient contact materials.

This 510(k) submission (K971116) is for a new intra-operative imaging transducer (Model 21380A) for the Sonos 5500 Imaging System. The submission states that the only significant change from the predicate device (21275A, K944048) is the new patient contact materials. Therefore, the studies and acceptance criteria are focused on ensuring the safety and equivalence of these new materials and the continued functionality of the transducer.

Since the device is a transducer for an ultrasound imaging system and the core functionality is claimed to be the same as the predicate device, with changes only to patient contact materials, the acceptance criteria and supporting studies are centered on material biocompatibility and continued equivalent imaging performance, rather than a clinical efficacy study with human readers or complex diagnostic accuracy metrics.

Here's an attempt to structure the information based on the provided text, acknowledging that detailed study methodologies are not fully present in this summary document:

Acceptance Criteria and Reported Device Performance

Study Information

The provided 510(k) summary is high-level and does not offer explicit details on sample sizes, data provenance, expert qualifications, or adjudication methods for specific studies. Instead, it relies on the concept of "substantial equivalence" to a predicate device.

1. Sample sizes used for the test set and the data provenance:

• Not explicitly stated for a clinical test set. The submission refers to a "detailed comparison of the transducers" in the full 510(k) report, which would likely include technical performance data. For the new patient contact materials, biocompatibility testing would have been performed on material samples, not patient data.
• Data Provenance: Not specified, but given the nature of a 510(k) for a transducer, the "data" would likely originate from internal engineering and safety testing, rather than a large-scale clinical trial with patient data.

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

• Not applicable in the context of this 510(k) summary. This submission is not based on a diagnostic accuracy study requiring expert adjudication of images or clinical outcomes. The "ground truth" for the material change would be laboratory testing results for biocompatibility and engineering specifications for performance.

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

• Not applicable. As this is not a diagnostic accuracy study, there is no need for expert adjudication of medical cases.

4. 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. This is an ultrasound transducer, not an AI-powered diagnostic algorithm. Therefore, an MRMC study related to AI assistance for human readers is not relevant to this submission.

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

• No. This device is a transducer, a hardware component of an imaging system, not a standalone algorithm.

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

• For functionality and efficacy: The ground truth is implied to be the established performance characteristics and clinical utility of the predicate device (21275A). The new device asserts "equivalent functionality" and "no significant differences in safety and efficacy." Supporting data would typically involve technical performance metrics (e.g., image resolution, penetration, Doppler accuracy) compared against specifications and potentially the predicate device.
• For safety (new patient contact materials): The ground truth would be established through biocompatibility testing (e.g., cytotoxicity, sensitization, irritation tests as per ISO 10993 standards) against established safety limits for medical devices.

7. The sample size for the training set:

• Not applicable. This device is a hardware component. There is no "training set" in the context of machine learning.

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

• Not applicable. There is no "training set" for this type of device submission.

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