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Ultrasound scanner and transducers for B, Tissue and Contrast Harmonic Imaging, M, PWD, CWD, Color Doppler, Vector Flow Imaging and combined mode imaging and Elastography.

Signal Analysis.

Guidance of biopsy needles, geometrical measurements and calculation of parameters. And optimal 3-D unit can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen.

An optional Vector Flow Imaging (VFI) module: Color Flow Mapping (CFM) imaging mode with the ability to visualize both the axial and the transverse velocity.

Clinical Applications:

• Fetal (Sometimes called Obstetrics)
• Abdominal
• Intra-operative
• Intra-operative (Neuro) (sometimes called Neuro Surgical)
• Pediatrics
• Small Organ (Sometimes called Small Parts)
• Neonatal Cephalic (Cephalic is sometimes called trans-cranial)
• Adult Cephalic (Cephalic is sometimes called trans-cranial)
• Trans-rectal
• Trans-vaqinal
• Trans-urethral
• Musculo-skeletal (Conventional)
• Musculo-skel. (Superficial)
• Cardiac Adult
• Peripheral Vessel (Sometimes called Peripheral Vascular)

Diagnostic ultrasound imaging or fluid flow analysis of the human body.

Ultrasound scanner and transducers for B, Tissue and Contrast Harmonic Imaging, M, PWD, CWD, Color Doppler, Smart Flow Imaging, combined mode imaging, and Elastography.

Signal Analysis.

Guidance of biopsy needles, geometrical measurements and calculation of parameters. A 3-D unit that can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen.

An optional Smart Flow Imaqinq module: Color Flow Mapping (CFM) imaqinq mode with the ability to visualize both the axial and the transverse velocity.

The provided document is a 510(k) Pre-market Notification from Carestream Health, Inc. for their "Touch Ultrasound" device. It outlines the device's indications for use and compares its technological characteristics to predicate devices. However, it does not contain a specific study demonstrating that the device meets explicit acceptance criteria in terms of performance metrics like sensitivity, specificity, accuracy, or other quantitative measures.

The document focuses on demonstrating substantial equivalence to legally marketed predicate devices, which is the primary requirement for a 510(k) submission. This is achieved by showing that the new device has the same intended use and similar technological characteristics, or if there are differences, that these differences do not raise new questions of safety and effectiveness.

Therefore, I cannot extract the specific details you requested regarding acceptance criteria and a study that proves the device meets them, because such information is not present in this type of regulatory submission. The document explicitly states: "FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements..."

However, I can extract information regarding the device's characteristics and the non-clinical tests performed to ensure safety and equivalence.

Here's a breakdown of what the document does provide, addressing your numbered points where possible, and noting where information is absent:

1. A table of acceptance criteria and the reported device performance

This information is not provided in the document. The 510(k) submission establishes substantial equivalence to predicate devices, not direct performance against specific numerical acceptance criteria (e.g., sensitivity, specificity for diagnostic accuracy). The performance is implied to be equivalent to the predicate devices.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not provided in the document. The submission focuses on non-clinical tests (acoustic output, safety, etc.) and comparison to predicate devices, not on a clinical test set with human subjects to evaluate diagnostic performance.

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)

This information is not provided in the document, as there is no described clinical test set for diagnostic performance.

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

This information is not provided in the document, as there is no described clinical test set for diagnostic performance.

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

This information is not provided in the document. The device described is an ultrasound system, not an AI-powered diagnostic assistance tool.

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

This information is not provided in the document. The device is a diagnostic ultrasound system, not a standalone algorithm.

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

This information is not provided in the document, as there is no described clinical test set for diagnostic performance.

8. The sample size for the training set

This information is not provided in the document, as the submission does not describe an AI/algorithm that requires a training set.

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

This information is not provided in the document, as the submission does not describe an AI/algorithm that requires a training set.

Information that is available in the document regarding the device and its testing:

• Device Name: Touch Ultrasound
• Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body.
• New Modes Added in this Submission: Elastography, Smart Flow Imaging (also referred to as Vector Flow Imaging [VFI]), Continuous Wave Doppler (CWD/CW), Contrast Harmonic Imaging (CHI or Ci).
• Non-Clinical Tests Performed (to ensure safety and equivalence):
  • Acoustic output (conforming to AIUM/NEMA UD-2 & UD-3 standards; Ispta 720 mW/cm² and MI 1.9, TI ≤ 6.0)
  • Thermal safety (conforming to IEC 60601-1, IEC 60601-2-37, IEC 62359)
  • Electrical safety (conforming to IEC 60601-1, IEC 60601-2-37)
  • Electromagnetic safety (conforming to IEC 60601-1-2)
  • Mechanical safety (conforming to IEC 60601-1, IEC 60601-2-37)
  • Biocompatibility (conforming to EN ISO 10993-1)
  • Software lifecycle processes (conforming to IEC 62304)
  • Risk Management (conforming to ISO 14971)
• Comparison to Predicate Devices: The document extensively compares the "Touch Ultrasound" (modified device) to several predicate devices (e.g., K150342 Carestream Health Touch Ultrasound, K140428 bk2300, K043524 Pro Focus 2202, K100919 Pro Focus 2202, K130619 Acuson S1000) in terms of imaging modes (B, THI, M, PWD, CFM, CHI, CWD, VFI, Elastography) and clinical applications (Fetal, Abdominal, Intraoperative, Neurosurgery, Pediatrics, Small Parts, Adult Cephalic, Neonatal Cephalic, Transrectal, Transvaginal, Transurethral, Musculo-skeletal, Cardiac, Peripheral Vessel). The modified device incorporates certain modes that were previously present in one or more of the predicate devices.
• Transducers: All transducers in the submission were previously cleared by FDA. No changes to physical design or patient contact materials. All patient contact materials are biocompatible. All transducers are "Track 3" transducers.

In summary, this document demonstrates the safety and substantial equivalence of the "Touch Ultrasound" device based on engineering and non-clinical performance standards, and comparison of technological characteristics and intended uses with predicate devices already on the market. It does not present clinical study data for diagnostic performance with acceptance criteria.

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The system is intended for use by qualified physicians for ultrasound evaluation. Specific clinical applications and exam types include: Fetal (including Obstetrics), Abdominal, Intraoperative, Intraoperative Neuro (also known as Neurosugery), Pediatric, Small Organ (also known as Small Parts), Neonatal Cephalic (also known as Neonatal Transcranial), Adult Cephalic (also known as Adult Transcranial), Transrectal, Transvaginal, Transurethral, Musculoskeletal (Conventional and Superficial), Cardiac Adult, Peripheral Vessel (also known as Peripheral Vascular). Indicated uses are different for different transducers. The Product Data sheet for the system contains a table listing the indicated uses for each transducer that can be used with the system. The bk3000 ultrasound system is not intended for ophthalmic use or any use causing the acoustic beam to pass through the eye. The Cardiac Adult application is not intended for direct use on the heart.

Touch Ultrasound supports the following scanning modes and combinations thereof: B-mode (incl. Tissue Harmonic Imaging), M-mode, CFM mode, Amplitude (Power) Doppler mode. The system can perform simple geometric measurements, and perform calculations in the areas of Vascular, Urology, Cardiology and OB/GYN applications. The system can guide biopsy- and puncture needles. An optional 3-D module can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen. Transducers are linear arrays, convex arrays, and phased arrays. The patient contact materials are biocompatible. All transducers used together with bk 2300 are Track 3 transducers.

The provided text is a 510(k) Summary for the "Touch Ultrasound" device. It describes the device, its intended use, and compares it to a predicate device to establish substantial equivalence. However, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria in the context of diagnostic performance or clinical effectiveness.

The document focuses on regulatory compliance, safety, and technological equivalence. It mentions:

• Acoustic output limits: Ispta ≤ 720 mW/cm² and MI ≤ 1.9 (Track 3, non-ophthalmic), and Thermal Index (TI) ≤ 6.0. These are safety limits, not diagnostic performance acceptance criteria.
• Clinical measurement accuracy: Stated as being "described and accuracies are provided in the User Information." However, the actual criteria and reported performance are not provided in this document.
• Safety standards compliance: Lists several IEC and ISO standards related to acoustic output measurement, thermal/mechanical indices, electrical safety, electromagnetic compatibility, risk management, biocompatibility, and software lifecycle processes. These are general safety and quality assurance standards, not diagnostic performance studies.

Therefore, I cannot populate the requested table or answer most of the questions about acceptance criteria and performance studies because that information is not present in the provided text.

Here is a summary of what can be extracted from the text regarding acceptance criteria and the study (related to safety and equivalence, not diagnostic performance):

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not provided. The document does not describe any clinical test sets or diagnostic performance studies. The "testing" mentioned is related to safety and engineering standards.

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. No diagnostic performance test set or ground truth establishment is described.

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

• Not applicable / Not provided. No diagnostic performance test set 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

• Not applicable. This device is a diagnostic ultrasound system, not an AI-based system, and no MRMC study is mentioned.

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

• Not applicable. This is not an AI-based algorithm.

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

• Not applicable / Not provided. No diagnostic performance ground truth is mentioned. The ground truth for safety testing would be compliance with specified technical standards.

8. The sample size for the training set

• Not applicable / Not provided. This is not an AI-based device that would require a "training set" in the machine learning sense.

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

• Not applicable / Not provided.

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