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The Imagio Ultrasound Imaging System is intended for the following applications: Abdominal, Small Parts, Musculoskeletal conventional, and Musculoskeletal superficial.

The system also provides the ability to measure anatomical structures {abdominal, small organ, and 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 Imagio Ultrasound Imaging System is a 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 echo data and display it in B-Mode, Pulsed (PW) 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 systems provide measurement capabilities for anatomical structures that provide information used for clinical diagnostic purposes. The system has a PW 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 scanning modes, and supports linear array probes.

The Imagio Ultrasound Imaging System is comprised of the following subsystems provided by Analogic Corporation, (previously Ultrasonix), and used in common with the predicate device:

• Modulo - ultrasound acquisition subsystem:
  • ultrasound transmit and receive electronics;
  • transducer interface connection to transducer accessory;
  • computer control, image formation, and image processing;
• control console;
• clinical display;
• L14-5/38 transducer;
• ultrasound imaging software;

The above subsystems from the predicate device are incorporated in the Imagio Ultrasound Imaging System together with the following Seno Medical designed components: Cart Mechanical Design

• frame;
• casters;
• wheel locking;
• adjustable height mounting arm for console and display;
• cart electrical;
  • electrical wiring and optical cables;
  • power distribution unit;
• enclosures;
• USB alpha-numeric keyboard assembly.

Note that the Analogic software has been modified to remove support for applications and transducers not needed by Seno Medical customers.

The provided document, a 510(k) Premarket Notification for the Imagio® Ultrasound Imaging System (K182628), states that clinical testing was NOT required to support substantial equivalence due to the device utilizing the same technology and principles as an existing predicate device (Sonix MDP Ultrasound Scanner, K080935).

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, as a specific clinical study for this device's performance was explicitly deemed unnecessary for its clearance.

In summary, based on the provided text:

• 1. A table of acceptance criteria and the reported device performance: Not provided/Not applicable as no clinical study was conducted.
• 2. Sample sized used for the test set and the data provenance: Not applicable.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• 4. Adjudication method for the test set: Not applicable.
• 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. This device is an ultrasound imaging system, not an AI-assisted diagnostic tool in the sense of image interpretation.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• 7. The type of ground truth used: Not applicable.
• 8. The sample size for the training set: Not applicable.
• 9. How the ground truth for the training set was established: Not applicable.

The clearance was based on substantial equivalence to a predicate device already cleared by the FDA, relying on the fact that "Diagnostic ultrasound and imaging has a long history of safe and effective performance" and the technical specifications and safety standards compliance of the Imagio system itself. The document, however, does provide "Acoustic Output Limits" that the device must conform to for safety, which could be considered a form of acceptance criteria:

Acoustic Output Limits (Acceptance Criteria Mentioned for Safety)

The document states, "The devices acoustic output limits are: *The limits are the same as predicate Track 3 devices." This implies the Imagio system meets these limits, but no specific performance data for these parameters from a study within this document is presented. Rather, compliance with these limits and other safety standards (e.g., electrical, EMC, biocompatibility) was "verified through independent evaluation with ongoing manufacturer surveillance."

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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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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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