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510(k) Data Aggregation
(75 days)
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:
- 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.
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
- Adjudication method for the test set.
- 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.)
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done. (Again, not an AI device.)
- The type of ground truth used (expert consensus, pathology, outcomes data, etc).
- The sample size for the training set. (Not an AI device with a training set in the typical sense).
- 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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(14 days)
The Sonix Ultrasound Imaging System is intended for the following applications: Ophthalmic, Abdominal, Cardiac, Intraoperative (specific), 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, peribheral 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 Sonix 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 Morde, 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 electrocardiography (ECG) display feature and support for a 3-lead 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 Sonix 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.
I am sorry, but the provided text does not contain specific acceptance criteria, study details, or performance metrics for the Sonix Ultrasound Scanner as you requested. The document is primarily a 510(k) summary for premarket notification, focusing on:
- Device Description: General features and function of the ultrasound system and its accessories.
- Intended Uses: A broad list of clinical applications for the system and various transducers.
- Comparison to Predicate Devices: Establishing substantial equivalence based on intended use, principles of operation, and technological characteristics.
- Safety Considerations: Compliance with general safety standards and acoustic output limits.
- Transducer Specifications: Detailed tables outlining the modes of operation and new/previously cleared indications for each transducer.
There is no mention of:
- Specific acceptance criteria (numerical thresholds for performance).
- Any particular study (e.g., clinical trial, bench study with performance data) to prove device meets acceptance criteria.
- Sample sizes used for test sets or training sets.
- Data provenance (country of origin, retrospective/prospective).
- Number of experts or their qualifications to establish ground truth.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes for human reader improvement with AI.
- Standalone algorithm performance.
- Type of ground truth used (e.g., pathology, outcomes data).
- How ground truth was established for the training set.
The document highlights the device's compliance with general safety and acoustic output standards, but these are not presented as performance acceptance criteria in the context of clinical efficacy or diagnostic accuracy.
Therefore, I cannot populate the table or answer the specific questions you've posed based on the provided text.
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(247 days)
MR-Touch™, is a software and hardware option intended for use with GE Signa® MR systems. It is indicated for magnetic resonance imaging of the human body.
MR-Touch™ generates transverse sectional information related to the relative stiffness of soft tissue. It consists of hardware as well as acquisition and reconstruction software. The hardware components induce vibrations into the scan subject. The MR-Touch™ acquisition software is an evolutionary improvement to the gradient echo sequence. The sequence synchronizes the induced vibrations to acquire a series of phase-contrast images over time. The phase-contrast imaging technique measures motion or displacement. The displacement from the induced vibrations is detected using the timeseries of phase-contrast images. The displacement information is reconstructed and presented as strain wave and relative stiffness images.
When used with a GE Signa® MR system, MR-Touch™ is capable of producing transverse images of internal body structures such as muscle and liver.
When interpreted by a trained physician, these images may provide information that can be useful in determining a diagnosis.
MR-Touch™ is a combined software and hardware accessory for use with a GE Signa® MR System. It is an evolutionary improvement of the existing phase-contrast imaging feature included with existing GE Signa® MR Systems. The Resoundant hardware component consists of an acoustic wave generator coupled through a length of flexible tubing with a passive transducer to induce small vibrations in the scan subject. The software includes both image acquisition and reconstruction components. The acquisition software is a gradient echo sequence that acquires a series of phase-contrast images over time. It also synchronizes the low frequency and low magnitude induced vibrations generated by Resoundant. The phase-contrast imaging technique measures motion or displacement. During reconstruction, the displacement from the induced vibrations is detected using the timeseries of phase-contrast images. MR-Touch™ then presents the reconstructed displacement information as strain wave and relative stiffness images (referred to as Elastograms).
The GE Healthcare MR-Touch™ Option for GE Signa® MR Systems is an accessory designed to generate transverse sectional information related to the relative stiffness of soft tissue. It comprises hardware for inducing vibrations and software for image acquisition and reconstruction. The primary claim is substantial equivalence to existing MR systems and elastography ultrasound systems.
1. Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria for the MR-Touch™ Option in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy) for a specific diagnostic task. Instead, the "acceptance" is based on demonstrating substantial equivalence to predicate devices and verifying certain functional aspects.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Functional Equivalence to Existing Phase-Contrast Imaging | MR-Touch™ is described as an "evolutionary improvement of the existing phase-contrast imaging feature included with existing GE Signa® MR Systems." It offers a "more convenient method to visualize a time-series of phase-contrast images and the ability to induce synchronized vibrations in the scan subject during acquisition." This implies it performs at least as well as, if not better than, the predicate in its core imaging function. |
| Elastography Output Equivalence to Cleared Ultrasound System | The "Elastography relative-stiffness images (Elastograms)" are stated to be "substantially equivalent to the output of the previously cleared Ultrasonix SonixTouch Elastography imaging mode, which provides color-coded images to differentiate between tissues based on stiffness." |
| Repeatability of Results | "Confidence studies prove that MR-Touch™ produces repeatable results." (No specific quantitative metric or range for repeatability is provided). |
| Ability to Differentiate Tissues of Different Stiffness | "Confidence studies prove that MR-Touch™... can reliably differentiate between tissues of different stiffness." (No specific quantitative metric or threshold for differentiation is provided). |
| Safety and Electromagnetic Compatibility (EMC) | The Resoundant hardware was evaluated against IEC 60601-1 (Medical Electrical Equipment - Part 1: General Requirements for Safety standard) and IEC 60601-1-2 (Collateral Standard: Electromagnetic Compatibility - Requirements and Tests - Second Edition with Amendment 1). The conclusion of substantial equivalence implies it met these safety and EMC standards. |
| Image Quality and Visualization | "Sample images demonstrate the strain wave and Elastogram outputs." "When used with a GE Signa® MR system, MR-Touch™ is capable of producing transverse images of internal body structures such as muscle and liver." (This implies adequate image quality for diagnostic interpretation by a trained physician, though specific metrics are absent). |
| Regulatory Substantial Equivalence | The FDA's 510(k) clearance letter confirms that the device is "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." This is the ultimate acceptance criterion for a 510(k) submission. |
2. Sample Size and Data Provenance (for test set)
The document is unclear regarding a dedicated "test set" in the context of clinical performance evaluation. The "Summary of Studies" mentions "Sample images" and "confidence studies" but gives no specifics on:
- Sample Size: Not specified for any performance evaluation.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). It is common for 510(k) submissions, especially for accessories and evolutionary improvements, to rely on internal testing, phantoms, and existing predicate device performance rather than large-scale clinical studies.
3. Number and Qualifications of Experts for Ground Truth
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
- Ground Truth Establishment: The document does not describe how ground truth was established for any "test set." The statement "When interpreted by a trained physician, these images may provide information that can be useful in determining a diagnosis" suggests diagnostic interpretation by a physician is the intended clinical use, but this is not defined as a ground truth mechanism for device validation.
4. Adjudication Method
Not discussed or specified. Given the nature of the submission (substantial equivalence based on technical and functional similarity rather than a new clinical claim requiring high-stakes diagnostic accuracy), a formal adjudication method for a test set is unlikely to have been implemented or required.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. The submission focuses on the device's technical performance and equivalence to existing technologies, not on improving human reader performance with or without AI assistance. The "AI" component here is the image processing and reconstruction software, not a diagnostic AI intended to aid human readers.
6. Standalone Performance Study
The "Summary of Studies" section describes "confidence studies" that "prove that MR-Touch™ produces repeatable results and can reliably differentiate between tissues of different stiffness." This inherently evaluates the standalone performance of the algorithm in generating the strain wave and elastogram outputs. However, specific performance metrics (e.g., accuracy against a known stiffness standard, precision) are not provided. The study does not describe a "human-in-the-loop" component for these specific tests, making them standalone evaluations of the device's ability to produce consistent and differentiate images.
7. Type of Ground Truth Used
For the "confidence studies" demonstrating repeatability and differentiation of stiffness, the ground truth would most likely have been:
- Phantom Studies: Using materials with known and varied stiffness properties.
- Known Physical Properties: Measuring the physical properties of the materials used in the "confidence studies" (e.g., using a mechanical testing device to confirm differences in stiffness).
- The document implies the output (elastograms) themselves are the useful information, rather than a comparison to an external clinical ground truth like pathology or outcomes data.
8. Sample Size for the Training Set
The document does not mention any "training set" in the context of machine learning. The MR-Touch™ system is described as an "evolutionary improvement" to existing gradient echo sequences and phase-contrast imaging, implying traditional image processing and reconstruction algorithms rather than a deep learning model that requires a labeled training set.
9. How Ground Truth for the Training Set Was Established
Not applicable, as no training set for machine learning is described.
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