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The SonixTABLET Ultrasound Imaging System is intended for the following applications: Abdominal, Cardiac, Intraoperative Neurological, Fetal, Pediatric, Small Parts, Neonatal / Adult Cephalic, OB/GYN, Transesophageal, Transrectal, Transvaginal, Peripheral Vascular, Musculoskeletal conventional, Musculoskeletal superficial, Pelvic, Vascular Access, Transcranial.

The system also provides the ability to measure anatomical structures {fetal, abdominal, pediatric, small organ, cardiac, transvaginal, peripheral vessel, musculo-skeletal} and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

The SonixTABLET Ultrasound Scanner is a new multi-purpose mobile, software controlled diagnostic ultrasound system with on-screen thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude Doppler Mode, a combination of modes, or Harmonic imaging on a Flat Panel Display. The user interface includes specialized controls, a minimized computer keyboard, and touch panel on an ergonomic console.

The system has an optional electrocardiography (ECG) display feature and support for a 3lead ECG cable assembly. The systems provide measurement capabilities for anatomical structures and fetal biometry that provide information used for clinical diagnostic purposes. The system has a PW and CW audio output feature and cine review, image zoom, labeling, biopsy, measurements and calculations, image storage and review, printing, and recording capabilities. The systems include a Digital Imaging and Communications (DICOM) module which enables storage.

The system is designed for use in linear, convex and phased array scanning modes, and supports linear, convex, microconvex and phased array probes.

The biopsy kits are accessories to the SonixTABLET Ultrasound Scanner. These accessories are made up of a polymeric bracket. There are features on the bracket that prevent the bracket from being oriented incorrectly when attached to the transducer. The brackets are not sterile and will be covered with a sterile sheath prior to use. These brackets are designed to accept and retain the needle guides in a mechanically secure way through the medium of the sterile sheath. The brackets are reusable. The needle guide is a separate sterile polymeric part that attaches to the bracket through a sterile sheath. The needle guides will support various sized needle guides are sold in sterile kits that contain multiple needle guides, sterile sheaths, ultrasound transmission gel, and bands.

Here's a breakdown of the acceptance criteria and study information for the SonixTABLET Ultrasound Scanner, based on the provided document:

The document is a 510(k) Summary for the SonixTABLET Ultrasound Scanner, focusing on the addition of two new transducers (m4DC7-3/40 and L40-8/12) to a previously cleared device. As such, the "acceptance criteria" discussed are largely related to substantial equivalence to predicate devices and compliance with relevant safety and performance standards for ultrasound systems, rather than specific performance metrics for a novel AI device feature. The document does not describe a study involving human readers or AI assistance in the context of diagnostic performance. Instead, it focuses on the device's adherence to regulatory standards and its intended use.

Therefore, many of the requested sections (2, 3, 4, 5, 6, 7, 8, 9) cannot be fully answered as they pertain to a type of study not detailed in this 510(k) submission.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for an ultrasound system, the acceptance criteria are generally based on compliance with recognized standards and substantial equivalence to predicate devices, particularly regarding safety and fundamental performance. Specific performance metrics like sensitivity/specificity for a diagnostic task are not detailed for the overall ultrasound system in this type of submission unless a new diagnostic claim is being made.

• ISPTA(d): 720mW/cm2
• TIS/TIB/TIC: 0.1 - 6.0 (Range)
• Mechanical Index (MI): 1.9 (Maximum)
• ISPPA(d): 0 - 700W/cm2 (Range)
  These limits are stated to be "the same as predicate Track 3 devices." |
  | Safety - Electrical | Compliance with IEC 60601-1 (1988) Medical Electrical Equipment, Part 1: General Requirements for Safety, and IEC 60601-2-37: Particular Requirements For The Safety Of Ultrasonic Medical Diagnostic And Monitoring Equipment. | The system is designed to comply with these standards. |
  | Biocompatibility | Transducer patient contact materials must be biocompatible. | "Transducer patient contact materials are biocompatible." |
  | Intended Use | The intended uses for the added transducers (m4DC7-3/40 and L40-8/12) must align with general diagnostic ultrasound applications and modes of operation as previously cleared or as new, appropriate indications. | The document lists specific clinical applications and modes for the new transducers (marked with "N" for New indication and "P" for Previously cleared under K102997), covering various anatomical regions and imaging modalities (B-mode, M-mode, PW Doppler, Color Doppler, Power Doppler, Combined modes, and notes for features like Elastography, 3D imaging, biopsy guidance). |

Detailed breakdown of specific questions:

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 / Not provided. This document is a 510(k) summary for an ultrasound system seeking clearance for new transducers. It does not contain information about a test set or data provenance for a diagnostic performance study in the way a submission for an AI/CADe device would. The "study" here is primarily a demonstration of compliance with engineering standards and substantial equivalence to predicate devices, which typically doesn't involve clinical "test sets" in this context.

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 / Not provided. As above, no diagnostic performance study with a distinct "test set" and "ground truth" established by experts is described for the purpose of demonstrating the device's diagnostic accuracy. The safety and performance are assessed against technical standards and comparison to predicate devices, not through a clinical accuracy study with expert ground truth.

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

• Not applicable / Not provided. No clinical diagnostic performance study requiring an "adjudication method" for a test set is detailed in 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

• No, a MRMC comparative effectiveness study was not done. The document describes a traditional ultrasound imaging system with added transducers, not an AI or AI-assisted diagnostic device. Therefore, there's no mention of human readers improving with or without AI assistance.

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

• No, this is not applicable. The SonixTABLET Ultrasound Scanner is a hardware and software system for real-time ultrasound imaging used by a human operator, not a standalone algorithm.

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

• Not applicable / Not provided. No diagnostic performance study with an explicit "ground truth" for evaluating diagnostic accuracy is presented in this 510(k) summary. The "ground truth" in this context would be the underlying physical principles of ultrasound imaging and engineering specifications, and comparison to images produced by predicate devices, rather than clinical outcomes or pathology for specific diagnoses.

8. The sample size for the training set

• Not applicable / Not provided. This is an ultrasound imaging system, not an AI model that requires a training set.

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

• Not applicable / Not provided. As in 8, this is not an AI model.

In summary, the provided document is a regulatory submission demonstrating the safety and substantial equivalence of an ultrasound device and its transducers to existing devices and standards. It does not contain the kind of clinical study details (test sets, expert ground truth, AI performance metrics, etc.) that would be found in a submission for a novel AI/CADe diagnostic device.

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The SonixTABLET Ultrasound Imaging System is intended for the following applications: Abdominal, Cardiac, Intraoperative Neurological, Fetal, Pediatric, Small Parts, Neonatal / Adult Cephalic, OB/GYN, Transesophageal, Transrectal, Transvaginal, Peripheral Vascular, Musculoskeletal conventional, Musculoskeletal superficial, Pelvic, Nerve block, Vascular Access, Transcranial.

The system also provides the ability to measure anatomical structures {fetal, abdominal, pediatric, small organ, cardiac, transvaginal, peripheral vessel, musculo-skeletal} and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

The SonixTABLET Ultrasound Scanner is a new multi-purpose mobile, software controlled diagnostic ultrasound system with on-screen thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode. Pulsed (PW) Doppler Mode. Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude Doppler Mode, a combination of modes, or Harmonic imaging on a Flat Panel Display. The user interface includes specialized controls, a minimized computer keyboard, and touch panel on an ergonomic console.

The system has an optional electrocardiography (ECG) display feature and support for a 3lead ECG cable assembly. The systems provide measurement capabilities for anatomical structures and fetal biometry that provide information used for clinical diagnostic purposes. The system has a PW and CW audio output feature and cine review, image zoom, labeling, biopsy, measurements and calculations, image storage and review, printing, and recording capabilities. The systems include a Digital Imaging and Communications (DICOM) module which enables storage.

The system is designed for use in linear, convex and phased arrav scanning modes, and supports linear, convex, microconvex and phased array probes.

The biopsy kits are accessories to the SonixTABLET Ultrasound Scanner. These accessories are made up of a polymeric bracket. There are features on the bracket that prevent the bracket from being oriented incorrectly when attached to the transducer. The brackets are not sterile and will be covered with a sterile sheath prior to use. These brackets are designed to accept and retain the needle guides in a mechanically secure way through the medium of the sterile sheath. The brackets are reusable. The needle guide is a separate sterile polymeric part that attaches to the bracket through a sterile sheath. The needle guides will support various sized needle guides are sold in sterile kits that contain multiple needle guides, sterile sheaths, ultrasound transmission gel, and bands.

The provided text is a 510(k) Summary for the SonixTABLET Ultrasound Scanner. It details the device's characteristics, intended uses, and its substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria, device performance metrics, sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, multi-reader multi-case (MRMC) comparative effectiveness studies, standalone performance studies, or the ground truth establishment for training sets.

Therefore, many parts of your request cannot be answered from the provided document.

The document focuses on demonstrating that the SonixTABLET Ultrasound Scanner is substantially equivalent to previously cleared predicate devices (Sonix Ultrasound Scanner (K093462), Sonix TOUCH Ultrasound Scanner (K083095), SONIX MDP Ultrasound Scanner (K080935)) in terms of intended use, principles of operation, and technological characteristics. This type of submission generally relies on demonstrating equivalence rather than conducting new performance studies with detailed acceptance criteria as would be expected for a novel device.

The "Safety considerations" section mentions compliance with standards related to acoustic output limits, but these are general safety standards, not performance acceptance criteria for diagnostic accuracy.

What can be extracted directly (or inferred) from the provided text:

• Device Name: SonixTABLET Ultrasound Scanner
• Predicate Devices: Sonix Ultrasound Scanner (K093462), Sonix TOUCH Ultrasound Scanner (K083095), SONIX MDP Ultrasound Scanner (K080935)
• Reason for Submission: New product clearance for SonixTABLET Ultrasound Scanner and supporting transducers, due to a name change request and new product clearance.
• Technological Characteristics: Substantially similar to predicate devices, using piezoelectric material, yielding real-time ultrasound images, and having similar modes (2D, PW Doppler, Color Flow Mapping Doppler, Power Doppler, Continuous Wave Doppler).
• Key Safety Standards: IEC 60601-1, IEC 60601-1-2, AIUM AOL, AIUM RTD1-2004, UD-3 of NEMA, and FDA's 510(k) Diagnostic Ultrasound Guidance regarding acoustic output.
• Acoustic Output Limits (reported performance in relation to safety standards):
  • ISPTA (d): 720mW/cm²
  • TIS/TIB/TIC: 0.1 - 4.0 (Range)
  • Mechanical Index (MI): 1.9 (Maximum)
  • ISPPA (d): 0-700W/cm² (Range)
  • These limits are stated to be the same as predicate Track 3 devices.

Summary of Information NOT found in the provided text:

1. A table of acceptance criteria and the reported device performance (in terms of diagnostic accuracy/efficacy). The document focuses on performance relative to safety standards and equivalence to predicates, not specific diagnostic accuracy metrics.
2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
4. Adjudication method for the test set.
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 device is an ultrasound scanner, not an AI or CADe/CADx device mentioned in this context.)
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done. (Again, not an AI device.)
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc).
8. The sample size for the training set. (Not an AI device with a training set in the typical sense).
9. How the ground truth for the training set was established. (Not an AI device with a training set in the typical sense).

Essentially, the provided document is a regulatory submission for substantial equivalence of an ultrasound device, which doesn't typically require the detailed performance study information you've requested for AI/CADx/CADe devices.

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