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The intended uses of this system and its accessories are as follows: Evaluating Soft Tissue by Ultrasound Imaging, using B-mode and M-mode: for Fetal, Abdominal, 3-D Visualization (non measuring), Small organ (thyroid and breast), Musculoskeletal (Conventional), Peripheral Vessel, Transvaginal, Transrectal and Needle Guidance.

The devices referenced in this submission represent a highly portable, softwarecontrolled, diagnostic ultrasound system with accessories. This submission does not include technology or control feature changes or deviations from indications for use different from those demonstrated in previously cleared devices, inclusive of the predicate devices so claimed. The devices included in this submission are as follows: Voyager Ultrasound System utilizing as hardware and firmware an ultrasound engine contained in a very small in-line enclosure with only an 'image-freeze' control button; A probe, C-4, of a mechanical configuration providing a single crystal sector scan, or M-mode operation, at an ultrasonic frequency of approximately 4 (±12%) MHz; A probe, C-10, a mechanical configuration providing a single crystal sector scan, or M-mode operation, at an ultrasonic frequency of approximately 8.0 (±20%) MHz; A probe EC, a mechanical configuration providing a single crystal sector scan, or M-mode operation, at an ultrasonic frequency of approximately 8,0 (±20%) MHz. Software able to reside in a laptop inclusive of a non-metrological 3-D image rendering capability and, a means to enable the use of needle guidance techniques on each probe model.

The provided document describes a 510(k) submission for the Ardent Sound Voyager Compact Imaging System, specifically regarding the addition of M-Mode capabilities and an Endocavity probe.

Based on the content, here's a breakdown of the acceptance criteria and the study information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to predicate devices and compliance with relevant safety standards rather than establishing new performance acceptance criteria for a novel device. The "acceptance criteria" presented are fundamentally about meeting established safety and performance benchmarks for diagnostic ultrasound systems as defined by regulatory standards and existing cleared devices.

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

The document explicitly states: "No additional clinical testing is required, as the indications for use are not a novel indication as shown by the predicate devices in Section 1.5." This indicates that no clinical test set (i.e., patient data) was used for this submission. The "testing" primarily involved engineering and performance verification against 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, as no clinical test set or human interpretation ground truth was established for this submission. The submission relies on technical compliance and equivalence to predicate devices, which would have had their own ground truth establishment studies during their original clearances.

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

Not applicable, as no clinical test set requiring expert adjudication was used.

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 submission is for a diagnostic ultrasound system and its probes, not an AI-assisted diagnostic tool. No MRMC study was performed.

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

Not applicable. This is not an algorithm-only device.

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

For the technical performance of the device (acoustic output, biocompatibility, cleaning):

• Acoustic Output: Measured values against industry standards (AIUM, NEMA, IEC).
• Biocompatibility: Lab testing results against ISO 10993-1.
• Cleaning/Disinfection: Verification against established effectiveness protocols.

For the substantial equivalence claim regarding clinical utility:

• Predicate devices: The "ground truth" for the clinical effectiveness and safety of the intended uses (B-mode, M-mode, specific applications like fetal, abdominal, etc., and needle guidance) is based on the prior clearance of the predicate ultrasound systems. The submission asserts that the new device's intended uses and operating modes are "available in the predicative devices."

8. The sample size for the training set

Not applicable. This is not a machine learning device that requires a training set.

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

Not applicable, as there is no training set for this device.

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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: B and M-mode imaging for: Fetal, Abdominal, 3-D Visualization (non-measuring), Small organ, Pediatric, Cephalic, Transvaginal, Musculoskeletal (conventional and superficial), Peripheral Vessel and Needle Guidance.

The devices referenced in this submission represent a transportable, software-controlled, diagnostic ultrasound system with accessories. This submission does not include technology or control feature changes nor deviations from indications for use different from those connonstrated in previously cleared devices operating in ultrasound B-Mode or M-Mode, inclusive of the predicate devices so claimed.

The devices included in this submission are as follows:

Seeker/Spark Ultrasound System utilizing as hardware and firmware an ultrasound engine contained in a stand-alone enclosure with separate control panel, for connection to a host PC via a USB port:

A probe, 128 element convex array (for Seeker only), at an ultrasonic frequency of approximately 4 MHz, model CLA4, part number 9650-0003.

A probe, 128 element convex endocavity array at an ultrasonic frequency of approximately 6.5 MHz, model ENDO-6.5, part number 9650-0001.

A probe, 128 element linear array at an ultrasonic frequency of approximately 10 MHz, model L10, part number 9655-0003.

A probe, 128 element linear array at an ultrasonic frequency of approximately 12 MHz, model L12, part number 9655-0002.

A probe, 128 element linear array at an ultrasonic frequency of approximately 16 MHz, model HFLA, part number 9655-0004.

Software able to reside in a Windows-based PC inclusive of a non-metrological 3-D image rendering capability.

The provided document (K060800) is a 510(k) Premarket Notification for the Seeker/Spark Ultrasound System. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing direct acceptance criteria based on performance studies.

Therefore, the typical metrics for device performance (such as sensitivity, specificity, or AUC) and their corresponding acceptance criteria, along with the study details to prove them, are not explicitly present in this type of submission.

Instead, the "acceptance criteria" here are met by demonstrating that the new device has the same technological characteristics, comparable key safety and effectiveness features, and identical intended uses and operating modes as existing predicate devices. The study proving this takes the form of adherence to recognized standards and a comparison to predicate devices, rather than a clinical trial with performance metrics.

Here's a breakdown of the information requested, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, the submission is based on substantial equivalence, not on specific performance metrics against pre-defined acceptance criteria for a novel device. The "acceptance criteria" are implied by the similarity to predicate devices and compliance with safety standards.

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

• Sample Size for Test Set: Not applicable in the context of this 510(k) submission. No clinical "test set" in the traditional sense of patient data was used for a de novo performance evaluation. The evaluation is based on technical specifications and comparison to predicate devices.
• Data Provenance: Not applicable. No patient data (retrospective or prospective) from any country of origin was used for direct performance testing.

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

• Number of Experts: Not applicable. No ground truth for a test set was established by experts in the context of this submission. The device is deemed substantially equivalent based on its technical specifications and intended use being similar to already approved devices.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There was no test set or expert adjudication process for performance evaluation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC Study: No, an MRMC comparative effectiveness study was not done. The submission is not for a new diagnostic algorithm requiring comparative clinical performance.

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 imaging system, not a standalone algorithm. Its function is to acquire and display images for human interpretation, sometimes with non-metrological 3D rendering.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

• Type of Ground Truth: Not applicable. For a substantial equivalence claim, the "ground truth" is that the predicate devices are safe and effective, and the new device is sufficiently similar to share that established safety and effectiveness profile.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. There is no mention of a "training set" as this is a hardware and software system, not an AI/ML algorithm that undergoes a training phase with labeled data.

9. How the Ground Truth for the Training Set Was Established

• Ground Truth for Training Set: Not applicable for the reasons stated above.

In summary, this 510(k) submission for the Seeker/Spark Ultrasound System relies on demonstrating substantial equivalence to existing, legally marketed predicate devices. This means that the device meets "acceptance criteria" by being sufficiently similar in technology, safety, and intended use as devices already approved by the FDA, rather than proving performance against specific quantitative metrics in a clinical study. The testing mentioned primarily relates to compliance with medical device safety standards (e.g., electrical safety, electromagnetic compatibility, acoustic output, biocompatibility).

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