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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal - OB/GYN, Abdominal, Small Organs (breast, thyroid, testicle), Pediatric, Neonatal Cephalic, Trans-Vaginal, Trans-Rectal, Peripheral Vascular. Typical examinations performed using the system are: General abdominal and pelvic studies including organ surveys. assessment, and retroperitoneal cavity studies. Study of small parts and superficial structures including breasts, shoulders, thyroid, and the abdominal wall. Pediatric scans of organs, superficial, and bony structures. Monitoring procedures for infertility studies (other than in vitro fertilization). First, second and third trimester pregnancy studies. Neonatal head studies. Podiatry scans of superficial structures including muscles, tendons and bones. Prostate, bladder and rectum visualization. Tissue Harmonic Imaging (THI) is a B-Mode imaging technique that enables a dramatic reduction in naturally occurring artifacts caused by interaction of certain tissue types and low frequency soundwaves. Seven of the twelve probes offered with the system will be indicated for Tissue Harmonic Imaging (THI-Mode). The THI-Mode will be used for fetal, abdominal, pediatric, and small organ clinical applications.

The Combison® 530/Voluson® 530D scanner is a multiple-mode, multipleapplication ultrasound imaging system. The cart-mounted console contains an ultrasound generator/receiver offering a full complement of conventional operating modes, software-based parameter controls, and recording. The selection of twelve transducers offered with the system permits a wide range of clinical applications. In addition to the initial operational settings for each transducer preprogrammed in the system, user-customized parameter settings for each transducer may be inserted by the operator and stored for recall as needed via the system control panel. Customization includes transmit focusing, filtering, image enhancement processing, dynamic window curve selection. Controls are also provided to select display format (single and various combinations), to activate zoom features, and to utilize the cine loop function. The Combison® 530/Voluson® 530D uses digital beamforming technology. The Combison® 530/Voluson® 530D supports a variety of linear and convex probes for wide variety of applications. It is an ultrasound scanner, which provides high resolution, high penetration performance, and various measurement functions. Probes are supported in frequencies from 3.5 MHz to 7.5 MHz. The Combison® 530/Voluson® 530D provides high quality images and various measuring functions. Biopsy guidelines are provided on screen to assist in the collection of tissue samples, using biopsy guide adapters offered as an optional accessory. Operating Modes of the Combison® 530/Voluson® 530D are B, B/B, B/M, M and, Doppler, Volume and Power Doppler Mode. Management of patient history is possible by image-filing function. High-resolution images are provided by utilizing a technology called digital dynamic receive focusing. The Tissue Harmonic Imaging (THI-Mode) Option consists of a software add-on.

This 510(k) Premarket Notification is for the addition of a Tissue Harmonic Imaging (THI-Mode) option to the Combison® 530/Voluson® 530D Diagnostic Ultrasound System. The submission claims substantial equivalence to the Medison SA8800/HDI 1500 System (K974269), which also features THI-Mode.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of acceptance criteria or reported device performance in the typical sense of quantitative metrics. Instead, the acceptance is based on demonstrating substantial equivalence to a predicate device (Medison SA8800/HDI 1500 System with THI-Mode, K974269) by showing that:

• Intended Use is the same: The THI-Mode is intended for fetal, abdominal, pediatric, and small organ clinical applications, which aligns with the predicate device.
• Technological Characteristics are similar: The device operates identically to predicate devices in principle (piezoelectric material, sound wave reflection, electrical signal conversion) and the THI-Mode is a software add-on.
• Acoustic Output Limits are within acceptable ranges:
  • TIS/TIB/TIC: 0.0 - 4.0 (Range)
  • ISPTA.3: 720 mW/cm² (Maximum)
  • MI: 1.9 (Maximum)
    These limits are stated to be the same as "predicate Track 3 devices." This implicitly means the reported performance in terms of acoustic output meets the established safety limits for such devices, which is a form of acceptance criteria for safety.
• New Indications for Use (with THI) are cleared: The FDA clearance explicitly lists several transducers (S-AB, S-ACP 3-5, S-ACP 4-7, S-NLP, S-VAW 3-5, S-VAW 4-7, S-VNW) for which Tissue Harmonic Imaging (N) is a new indication, indicating that the device has been found safe and effective for these applications when using THI.

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

The document does not provide information on a specific test set, its sample size, or data provenance (country of origin, retrospective/prospective). The submission relies on demonstrating substantial equivalence to an already cleared device, implying that the safety and effectiveness of THI technology were established with the predicate device (K974269).

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

This information is not provided in the document. As there is no explicitly defined "test set" and a study demonstrating performance is not detailed, there is no mention of experts for ground truth establishment.

4. Adjudication Method for the Test Set:

This information is not provided. Given the absence of a detailed study with a test set, adjudication methods are not discussed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI (THI-Mode in this case) assistance was not conducted or reported in this document. The submission focuses on substantial equivalence based on the technological characteristics and safety data of the device and its predicate.

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

The document describes the THI-Mode as a "software add-on" that is a "B-Mode imaging technique that enables a dramatic reduction in naturally occurring artifacts." While this describes the algorithmic function, the submission does not present a standalone performance evaluation of the algorithm separate from the overall ultrasound system and its clinical use by a human operator. The focus is on the integrated system's safety and intended use.

7. The Type of Ground Truth Used:

Ground truth for the performance of the THI-Mode itself is not explicitly defined or used within the context of a dedicated performance study in this document. The approval seems to be based on the established safety and effectiveness of the existing THI technology (as demonstrated by the predicate device K974269) and the physical and technical specifications being within acceptable ranges. The "ground truth" for the overall device's safety and effectiveness implicitly comes from established medical practice for diagnostic ultrasound and previous FDA clearances for the base system and the predicate THI-enabled system.

8. The Sample Size for the Training Set:

The document does not mention a training set or its sample size. The THI-Mode is described as a "software add-on," implying an algorithmic approach. However, there's no detail provided on how this algorithm was developed or "trained."

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

This information is not provided, as there is no mention of a training set in the document.

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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Neonatal Cephalic, Fetal, Pediatric and Neonatal Abdominal. Typical examinations performed using this transducer are: General abdominal studies including organ surveys, assessment, and retro-peritoneal cavity studies. Pediatric scans of organs and bony structures. Neonatal head studies. Biopsy guidance for tissue or fluid sampling.

The S-VNA 5-8(B) transducer is a mechanically steered curved array (Volume) probe. This is identical to the previously cleared (K940942) endocavitary S-VDW 5-8 probe, with the same materials, same acoustic module, and the same technical performance. The primary mechanical difference with the endocavity S-VDW 5-8 probe is the modified (shorter) shaft, designed to allow use on the outer surface of the body. The VOLUSON® Neonatal transducer S-VNA5-8(B) is an electronic wideband sector-transducer with a center frequency of 6.5 MHz and with switchable scan angles. The direction of insonation is forward in relation to the transducer's longitudinal axis. This device is a hand-held, 128 element, curved linear array probe. In addition to B-Mode and M-Mode, this probe can be operated in steerable pulsed Doppler, Color Doppler, Color Power Angio Doppler, and 3D Imaging. Similar to the S-VDW 5-8 transducer, the S-VN A5-8(B) also allows the performance of a 3D volume scan by internally sweeping the array in a lateral direction, automatically upon a key press. The images thus obtained from sectional planes perpendicular to each other can be displayed synoptically on the screen. This device is intended for use with the Combison/Voluson C530D Diagnostic Ultrasound Scanner for transcutaneous imaging as an aid in the detection and assessment of physical and functional abnormalities using established diagnostic criteria.

This submission K984639 is for a diagnostic ultrasound transducer (S-VNA 5-8(B)) and does not contain detailed information about a study with acceptance criteria and reported device performance in the context of clinical accuracy or diagnostic efficacy. Instead, it focuses on demonstrating substantial equivalence to predicate devices and adherence to safety standards for the hardware itself.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set information) cannot be extracted from the provided text as they are not relevant to this type of 510(k) submission.

However, I can provide information based on what is available regarding safety and technological characteristics.

1. Table of Acceptance Criteria and Reported Device Performance

For this specific 510(k) premarket notification, the "acceptance criteria" are primarily related to safety, electrical, and acoustic output standards, and substantial equivalence to predicate devices. The "reported device performance" in this context refers to the device's adherence to these standards and its functional equivalence to existing devices.

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

The document does not describe a clinical performance study with a "test set" in the traditional sense of evaluating diagnostic accuracy or efficacy with patient data. The evaluation is centered on hardware specifications, safety standards, and technological equivalence to predicate devices. Therefore, these details are not provided.

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

Not applicable, as no clinical performance study with a test set requiring expert-established ground truth is described.

4. Adjudication Method for the Test Set

Not applicable, as no clinical performance study with a test set requiring adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done or described in this submission. This type of study is typically used for AI-augmented diagnostic systems to assess the impact on human reader performance, which is not the subject of this 510(k).

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

No, a standalone algorithm performance study was not done. This submission is for a medical device hardware (ultrasound transducer) and its associated system, not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this submission relates to:

• Engineering specifications and safety standards: The device's physical construction, electrical properties, and acoustic output are measured against established engineering and regulatory limits.
• Predicate device characteristics: The ground truth for substantial equivalence is the previously cleared specifications and performance of the predicate devices (K974813, K974269, and especially K940942 for the core transducer design). The claim is that the new transducer is "identical" or "substantially equivalent" in key aspects.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device requiring a training set.

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

Not applicable. This is not an AI/machine learning device.

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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Transducer S-VNW 5-10: Pediatric, small organs (including thyroid, testicles, salivary gland, breast, and lymph nodes); peripheral vascular; and musculoskeletal-conventional.

Transducer S-VAW 4-7: Fetal, abdominal, pediatrics, and small organs.

Transducer S-VNW 5-10 is a multielement, mechanically steered linear array (volume) probe for use with the Combison 530D Diagnostic Ultrasound System. The center frequency is 7.5 MHz, and the nominal transmit frequency range is 5 to 10 MHz. The scan width is 40 mm and the maximum depth range is 75 mm.

Transducer S-VAW 4-7 is a multielement curved array probe for use with the Combison 530D system. The center frequency is 4.5 MHz, and the nominal transmit frequency range is 4 to 7 MHz. The image starting width is approximately 70 mm and the maximum depth range is 200 mm.

Operating Modes: Both Transducer S-VNW 5-10 and Transducer S-VAW 4-7 operate in B-mode (including three-dimensional volume imaging), M-mode, Pulsed Doppler, and Color Flow modes.

The provided text describes two diagnostic ultrasound transducers, Model S-VNW 5-10 Voluson Small Parts Transducer and Model S-VAW 4-7 Voluson Abdominal Transducer, intended for use with the Combison 530D Diagnostic Ultrasound System. The submission is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed clinical study results or acceptance criteria in the typical sense of a diagnostic AI product.

Therefore, much of the requested information (like specific acceptance criteria values, sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or training set details) is not applicable or not explicitly detailed in this type of regulatory submission for a hardware device like an ultrasound transducer.

Here's an attempt to answer the questions based only on the provided text, with clear indications where information is unavailable:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that "Measurement accuracy, precision of volume reconstruction, electrical and thermal safety, and software performance have been tested in accordance with applicable guidelines and standards with satisfactory results." However, specific numerical acceptance criteria (e.g., "accuracy > 90%") and their corresponding precise performance values are not provided. This level of detail is typically not included in a 510(k) summary for a transducer.

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

• Sample Size for Test Set: Not specified. The document mentions testing was done, but no details on the number of cases or subjects are provided.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not specified.

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

• Number of Experts: Not applicable/Not specified. This pertains to clinical performance evaluation, which is not detailed for this hardware submission. The "ground truth" for a transducer primarily relates to its physical performance characteristics (e.g., accuracy of measurements, safety parameters) rather than diagnostic interpretations requiring human experts to establish ground truth in a clinical sense.
• Qualifications of Experts: Not applicable/Not specified.

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

• Adjudication Method: Not applicable/Not specified. This is relevant for clinical performance studies involving human interpretation or consensus, which is not detailed here.

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:

• MRMC Comparative Effectiveness Study: No. This is a submission for an ultrasound transducer, not an AI-based diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or mentioned.

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

• Standalone Performance Study: Not applicable/No. This device is a diagnostic ultrasound transducer, a hardware component that requires human operation and interpretation. It is not an algorithm that performs in a standalone manner. The performance of the transducer (e.g., image quality, measurement accuracy) is what's being assessed, always in the context of human use.

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

• Type of Ground Truth: The "ground truth" for the tests mentioned (measurement accuracy, precision of volume reconstruction, electrical/thermal safety, software performance, acoustic output) would typically refer to validated engineering measurements against known physical standards, phantom studies, and adherence to regulatory safety limits and technical specifications. It is not clinical "ground truth" derived from pathology or expert consensus on patient cases.

8. The sample size for the training set:

• Sample Size for Training Set: Not applicable/Not specified. This device is a hardware component. The concept of a "training set" is generally associated with machine learning models, which are not detailed as part of this submission. Device design and validation rely on engineering principles and testing against specifications, not machine learning training.

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

• How Ground Truth for Training Set was Established: Not applicable/Not specified. See the explanation for point 8.

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