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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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