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Pie Medical's Picus 3D ultrasound system is intended to be used by a physician to perform general diagnostic ultrasound studies including cardiac, peripheral vascular, fetal, abdominal, small organ, neonatal cephalic, transrectal and transvaginal.

Device Description

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AI/ML Overview

This 510(k) summary describes a new ultrasound imaging system, the Picus 3D, and compares it to existing predicate devices (Pie Medical 300LC (Picus) K002880 and Esaote AU5 3D K000931) to establish substantial equivalence.

Here's an analysis of the provided information regarding acceptance criteria and studies:

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

The document does not explicitly state "acceptance criteria" or provide a table of performance metrics with specific targets and reported results. Instead, it utilizes a "Comparison Chart for Substantial Equivalence" to demonstrate that the Picus 3D device is comparable in features and functionality to the predicate devices. The underlying acceptance criterion for this submission is that the new device is substantially equivalent to legally marketed predicate devices, meaning it does not raise new questions of safety or effectiveness.

The "reported device performance" is implicitly shown by the detailed feature comparison in the table, demonstrating that the Picus 3D either matches or is equivalent in capability to the predicate devices across various technical specifications and clinical applications. For example, regarding imaging modes, the Picus 3D includes 3D imaging, which was present in one predicate (Esaote AU5 3D K000931) but not the other (Picus K002880), indicating an expansion of capabilities while maintaining equivalence to an existing 3D device.

Here's a summary derived from the comparison chart, focusing on the features presented as comparable for establishing substantial equivalence:

Feature	Predicate 1 (Picus K002880)	Predicate 2 (Esaote AU5 3D K000931)	Picus 3D (This submission)	Acceptance Implication (Substantial Equivalence)
Transducer Type	Linear, Convex	Annular Array, Mechanical Sector, Linear, Convex, Phased Array	Linear, Convex	Matches/equivalent to primary predicate K002880, while Esaote offers broader transducer types. All are established technologies.
2D Freq MHz	2.5-10	2.5-15	2.5-10	Matches primary predicate K002880.
PW Freq MHz	2.5-8	2.25-10	2.5-8	Matches primary predicate K002880.
CW Freq MHz	No	2.25-5.0	No	Matches primary predicate K002880.
Probes MHz (Linear)	5.0-10	5.0-13	5.0-10	Matches primary predicate K002880.
Probes MHz (Convex)	2.5-10	3.5-7.5	2.5-10	Matches primary predicate K002880; broader range than Esaote.
Multifrequency Probes	Yes	Yes	Yes	Equivalent to both predicates.
Special Probes	Transvaginal, Transrectal	Transvaginal, Transrectal, Laparoscopic, Intraoperative	Transvaginal, Transrectal	Equivalent to primary predicate K002880.
Biopsy Attachments	Convex, Linear	Convex, Linear	Convex, Linear	Equivalent to both predicates.
3D Imaging	No	Yes	Yes	Matches predicate Esaote AU5 3D K000931 for 3D functionality.
Real-time 2D Imaging	Yes	Yes	Yes	Equivalent to both predicates.
M-mode	Yes	Yes	Yes	Equivalent to both predicates.
PW Doppler	Yes	Yes	Yes	Equivalent to both predicates.
CW Doppler	No	Yes	No	Matches primary predicate K002880.
CFM Doppler	Yes	Yes	Yes	Equivalent to both predicates.
Power Doppler	Yes	Yes	Yes	Equivalent to both predicates.
Triplex	Yes	Yes	Yes	Equivalent to both predicates.
Monitor Size (inches)	SVGA 15	SVGA 15	SVGA 15	Equivalent to both predicates.
Programmability	10 presets	6 presets	10 presets	Equivalent to primary predicate K002880; better than Esaote.
Digital Archival	Yes	Yes	Yes	Equivalent to both predicates.
VCR	Yes	Yes	Yes	Equivalent to both predicates.
Clinical Applications	Fetal, Abdominal, Small Organ, Neonatal Cephalic, Cardiac, Transrectal, Transvaginal, Peripheral Vascular	Broader list including Intraoperative, Pediatric, Adult Cephalic, Laparoscopic	Fetal, Abdominal, Small Organ, Neonatal Cephalic, Cardiac, Transrectal, Transvaginal, Peripheral Vascular	Matches primary predicate K002880's scope.
Safety (Electrical)	IEC 60601-1	IEC 60601-1	IEC 60601-1	Equivalent to both predicates.
Safety (Ultrasound)	Track 3 (AOD)	Track 3 (AOD)	Track 3 (AOD)	Equivalent to both predicates.

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

This 510(k) summary does not mention any specific test set sample sizes, data provenance, or details of a clinical study for demonstrating performance. This type of submission relies on the concept of substantial equivalence to predicate devices that have already demonstrated safety and effectiveness through their prior market clearance. The data provenance would implicitly refer to the existing clinical use and safety record of the predicate devices.

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 noted above, this 510(k) submission establishes substantial equivalence through feature comparison, not new clinical performance data with ground truth established by experts.

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

Not applicable. No new test set requiring adjudication 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 is not an AI/CAD-focused device 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 an ultrasound imaging system, which is a human-in-the-loop device by nature (operated by a sonographer/physician).

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

Not applicable. No new ground truth establishment is described for this submission. The "ground truth" for demonstrating safety and effectiveness relies on the established performance and safety profiles of the predicate ultrasound devices already on the market.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI-based device that would typically require a training set.

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

Not applicable. No training set is described.

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