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The SonoScape S8 device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Abdomen, Cardiac, Small Organ (breast, testes, thyroid), Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Pediatric, Fetal, Cephalic, OB/Gyn and Urology.

The SonoScape S8 ultrasound system is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. The all digital architecture with progressive dynamic receive focusing allows the system to maximize the utility of all imaging transducers to enhance the diagnostic utility and confidence provided by the system. The exam dependent default setting allows the user to have minimum adjustment for imaging the patient, while the in-depth soft-menu control allows the advanced user to set the system for different situations. The architecture allows cost-effective system integration to a variety of upgrade-able options and features. The SonoScape S8 System is configured as a portable model. The system is designed with the latest technology, using the same quality procedures as ultrasound systems, which have been available in the market for years. This SonoScape system is a general purpose, software controlled, diagnostic ultrasound system. Its basic function is to acquire ultrasound data and display the image in B-Mode (including Tissue Harmonic Image), M-Mode, TDI, Color-Flow Doppler, Pulsed Doppler and Power Doppler, or a combination of these modes, 3D/4D.

The provided document is a 510(k) Premarket Notification Summary for the SonoScape S8 Diagnostic Ultrasound System. It outlines the device description, intended use, and substantial equivalence to predicate devices. However, this document does not contain information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, details of comparative effectiveness studies (MRMC), or standalone algorithm performance.

The document primarily focuses on establishing the device's substantial equivalence to previously cleared devices (GE Voluson 730 Diagnostic Ultrasound System and Shenzhen Mindray DC-7 Ultrasound) based on its technological characteristics and intended uses.

Therefore, I cannot populate the requested tables and information as the necessary data is not present in the provided text. The document is a regulatory submission for market clearance, not a clinical performance study report.

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

Clinical Application: Ophthalmic, Fetal, Abdominal, Intra-operative (Specify)6, Intra-operative (Neuro), Laparoscopic, Pediatric, Small Organ (Specify)7, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-urethral, Trans-esoph. (non-Card.), Intra-luminal, Other (Specify), Cardiac Adult, Cardiac Pediatric, Trans-esoph. (Cardiac), Other (Specify), Peripheral vessel, Other (Specify), Musculo-skel (conventional), Musculo-skel (superficial)

Mode of Operation: B, M, PWD, CWD, Color Doppler, Combined, Others

Notes:

1. Combined modes are: B+M, B+M+Color, B+PW, B+PW(CVI), B+PW+Color
2. Harmonics (Tissue and Contrast) - Previously Cleared
3. Angio - Previously Cleared
4. Real-time 3D imaging- New
5. Real-time Bi-plane imaging- New
6. Intraoperative applications include: Cardiac, Vascular Previously Cleared
7. Small Parts applications include: Thyroid, scrotum, prostate, breast - Previously Cleared

The M2424 is a diagnostic ultrasound device. It consists of a system console containing the power supply and electronic circuitry required to generate the image, a display screen, and a connection to the separate transducer. It is substantially equivalent to the generic class of ultrasound systems including previous versions of the Philips Medical Systems M2424 (K002470) system and the Voluson 730 (K003525).

The 21315 transducer is substantially equivalent to the generic class of ultrasound transducers including previously cleared Philips Medical Systems transducers (K002470).

The M2424 system and 21315 transducer function in a manner identical to all ultrasound systems and transducers. The system circuitry generates an electronic voltage pulse which is transmitted to the transducer. In the transducer, a piezo electric array converts the electronic pulse into a ultrasonic pressure wave. When coupled to the body, the pressure wave transmits through body tissues. The differing acoustic properties of the tissues in the body reflect some of the transmitted energy back to the transducer, where it is converted back to electrical signals, processed, and sent back to the system. In the system, advanced signal processing technologies further convert the returned signals into images of the tissues. The Doppler functions of this system process the Doppler shift frequencies from the echoes of moving targets (such as blood), to detect and graphically display the Doppler shifts of these tissues as flow.

The provided text is a 510(k) summary for the Philips Ultrasound M2424 Diagnostic Ultrasound System with the 21315 ultrasound transducer. It describes the device, its intended use, and argues for substantial equivalence to predicate devices. Crucially, this document is a regulatory submission for a diagnostic ultrasound system, not an AI/ML powered device. Therefore, the concepts of acceptance criteria, study design for AI performance, sample sizes for test and training sets, ground truth establishment by experts, and MRMC studies are not directly applicable in the AI/ML context that your detailed questions imply.

The information provided focuses on demonstrating the device's technical specifications, safety, and equivalence to existing ultrasound systems, rather than advanced algorithmic performance.

Here's an analysis of what can be extracted, acknowledging the limitations for an AI/ML context:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't outline specific, quantitative acceptance criteria in the way one would expect for an AI/ML model's performance (e.g., sensitivity, specificity thresholds). Instead, the "acceptance criteria" for this traditional medical device are regulatory in nature, based on demonstrating substantial equivalence to predicate devices.

The "reported device performance" is framed in terms of meeting these equivalence criteria:

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

This information is not provided in the document as it pertains to a traditional device clearance, not an AI/ML performance study. There isn't a "test set" in the sense of a dataset for evaluating algorithm performance. The evaluation is based on engineering comparisons and adherence to standards.

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

This information is not provided and is irrelevant for a traditional ultrasound device submission. There is no concept of "ground truth" established by experts for image interpretation in the context of this 510(k) summary, as it's not an AI/ML product.

4. Adjudication Method for the Test Set:

This information is not provided and is irrelevant for this type of device submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. This type of study is specifically designed to evaluate the impact of an AI algorithm on human reader performance, which is not applicable to a conventional ultrasound system.

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

No, a standalone algorithm performance study was not done. This pertains to AI/ML models, which this device is not. The M2424 is the diagnostic ultrasound system itself, not an algorithm that interprets images.

7. The Type of Ground Truth Used:

Not applicable. For a diagnostic ultrasound system, the "ground truth" of its operation is its ability to produce diagnostic images and perform fluid flow analysis as intended, verified through engineering tests and comparison to predicate devices, rather than through labeled data for an algorithm.

8. The Sample Size for the Training Set:

Not applicable. This device does not involve a "training set" in the context of machine learning.

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

Not applicable. As a traditional ultrasound system, there is no "training set" or a process of establishing ground truth for it in the AI/ML sense.

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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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The ASU-1000 and Volume mode software, like other marketed diagnostic ultrasound systems and 3-D rendering packages, is indicated for imaging body structures in two and three dimensions to aid in the diagnosis of disease or abnormality.

Diagnostic Ultrasound imaging and Doppler analysis of the human body as follows: Fetal, Abdominal. Combined Modes: B/M, B/PWD. Other Indications or Modes: 3-D rendering of fetal and maternal structures in Obstetrics.

Diagnostic Ultrasound imaging and Doppler analysis of the human body as follows: Fetal, Abdominal. Combined Modes: B/M, B/PWD, M/CD, B/PWD/CD. Other Indications or Modes: 3-D rendering of fetal and maternal structures in Obstetrics.

This premarket notification has been submitted by Aloka Co., Ltd. and covers the Aloka ASU-1000 transducer and associated Volume Mode 3-D rendering software. The proprietary name for the transducer is the Aloka ASU-1000 diagnostic ultrasound transducer. The 3-D rendering software is "Volume Mode". The common name for this type of device is a diagnostic ultrasound transducer and associated accessories. The Aloka ASU-1000 and Volume mode software can be used on the Aloka SSD-1700 and SSD-1400 diagnostic ultrasound systems. These systems function in the same manner as other diagnostic ultrasound devices. High frequency sound waves are transmitted into the body by a piezo-electric transducer. In the body, differences in the acoustic impedance of different tissues reflect a certain amount of the ultrasound energy back to the transducer, where it is processed into slice images. The slice images are processed by the Volume Mode software into a 3-D surface rendering of the target tissues.

The provided text is a 510(k) summary for the Aloka ASU-1000 transducer and associated Volume Mode 3-D rendering software. It focuses on demonstrating substantial equivalence to previously marketed devices rather than presenting a performance study with specific acceptance criteria and detailed quantitative results.

Therefore, much of the requested information regarding an acceptance criteria table, detailed study design, sample sizes, expert involvement, and ground truth establishment cannot be extracted from this document as it does not contain such a study report.

Here's what can be inferred or stated based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

• No specific quantitative acceptance criteria or reported device performance metrics are explicitly stated in the document. The basis for clearance is "substantial equivalence" to existing devices, implying that its performance is considered comparable, not necessarily meeting a predefined quantitative threshold.
• The document lists several qualitative statements about how the device performs similarly to or is acceptable in comparison to other marketed devices. These can be considered the "performance" aspects being highlighted for substantial equivalence, though they are not numerical acceptance criteria.

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

• Not explicitly stated. The document does not describe a clinical study with a "test set" in the context of AI/algorithm performance. The clearance is based on substantial equivalence to predicate devices, implying that the established safety and effectiveness of the predicate devices are extended to this new device based on its similar design and performance characteristics.

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

• Not applicable. No such test set or ground truth establishment process is described in this document.

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

• Not applicable. No test set requiring adjudication 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:

• No, an MRMC study was not done or reported. This filing precedes the widespread use of sophisticated AI in medical devices and focuses on hardware (transducer) and basic 3D rendering software, not AI-assisted interpretation.

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 or reported. The "Volume Mode 3-D rendering software" is a post-processing tool that works with the transducer to create 3D images for human interpretation, not an autonomous diagnostic algorithm.

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

• Not applicable. No specific ground truth for performance evaluation of an algorithm is mentioned. The device's indications for use are "to aid in the diagnosis of disease or abnormality," implying that the final diagnosis (ground truth) would still be established by a clinician.

8. The sample size for the training set:

• Not applicable. This document describes a medical device seeking 510(k) clearance based on substantial equivalence, not a machine learning model developed with a training set.

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

• Not applicable. As per point 8, no training set for a machine learning model is mentioned.

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Diagnostic ultrasound imaging and Doppler analysis of the human body... Medical disciplines that use transesophageal diagnostic ultrasound include Cardiology, Surgery and Trauma.

The Aloka UST-5258-5 functions in the same manner as other diagnostic ultrasound devices. High frequency sound waves are transmitted into the body by a piezo-electric transducer. In the body, differences in the acoustic impedance of different tissues reflect a certain amount of the ultrasound energy back to the transducer, where it is transmitted via the probe cable to the system console and processed into an image. The Aloka UST-5258-5 transducer can also use the Doppler shift of sound reflected from moving tissues (blood) to detect and display flow.

The provided text is a 510(k) summary for the Aloka UST-5258-5 diagnostic ultrasound transducer. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study of its performance against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study details, and ground truth establishment is not available in this document.

However, based on the information provided, we can infer some aspects:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state quantitative acceptance criteria or detailed performance metrics. Instead, it relies on demonstrating equivalence in technological characteristics and safety to a predicate device (Aloka UST-5228-5).

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

• Sample Size: Not specified. The document primarily focuses on demonstrating substantial equivalence through a comparison of device characteristics rather than a separate clinical or performance study with a defined test set.
• Data Provenance: Not specified. Given the nature of a 510(k) submission for substantial equivalence based on technical characteristics, it's unlikely that a test set with specific data provenance (country, retrospective/prospective) was used in the way one would for a clinical trial of a novel device. The "data" here would be the technical specifications and existing safety data of the device itself and its predicate.

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. Since there is no explicit mention of a test set requiring ground truth establishment by experts, this information is not present. The "ground truth" for a substantial equivalence claim is often the established performance and safety of the predicate device.
• Qualifications of Experts: Not applicable/not specified.

4. Adjudication method for the test set:

• Adjudication method: Not applicable/not specified. There is no indication of a test set requiring adjudication in the context of this 510(k) summary.

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 Study: No. This is a submission for a diagnostic ultrasound transducer, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant and was not performed or described.
• Effect Size: Not applicable.

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

• Standalone Performance: Not applicable. This device is an ultrasound transducer, a hardware component that requires a human operator and an ultrasound system. It does not operate as a standalone algorithm.

7. The type of ground truth used:

• Ground Truth: In the context of this 510(k) for substantial equivalence, the "ground truth" and basis for comparison are the well-established performance, safety, and technological characteristics of the predicate device (Aloka UST-5228-5) and other legally marketed diagnostic ultrasound transducers. The assumption is that if the new device shares these characteristics and meets safety standards, its performance will be equivalent and acceptable.

8. The sample size for the training set:

• Sample Size: Not applicable/not specified. Ultrasound transducers are hardware devices; they do not have "training sets" in the sense of machine learning algorithms. Their design and functionality are based on engineering principles and established medical imaging physics.

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

• Ground Truth Establishment: Not applicable/not specified. As there is no training set, there is no ground truth to establish for it.

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The LP13 is a diagnostic ultrasound transducer for use in laparoscopic surgery. The transducer can be used to image abdominal anatomy during laparoscopic surgical procedures. In Doppler mode, the transducer can provide information about blood flow in abdominal vessels

The LP13 is a diagnostic ultrasound transducer intended to be used in laparoscopic surgical procedures. The transducer is introduced into the abdomen through a trocar following the procedure described in the operator's manual. The distal tip of the device contains the transducer element and is movable. Movement of the transducer is controlled by the levers located on the handle of the device.

The provided text is a Safety and Effectiveness Summary for an ultrasound transducer, outlining its features and comparing it to a predicate device for substantial equivalence. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. Therefore, I cannot fulfill the request.

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