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510(k) Data Aggregation
(13 days)
TERATECH MODEL 10V5 SMART PROBE
The TERATECH Model 10V5 Smart Probe is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body; specific indications for use a tabulated in Section 4.3 of this submission.
The TERATECHModel 10V5 Smart Probe is intended for use with the Model TERATECH 2000 , a portable ultrasound imaging system.
Here's a breakdown of the acceptance criteria and study information for the TERATECH Model 10V5 Smart Probe, based on the provided document:
This 510(k) summary does not contain acceptance criteria in the traditional sense of performance metrics (e.g., sensitivity, specificity, accuracy) from a clinical study. Instead, the device's acceptance is based on its substantial equivalence to existing predicate devices.
The "study" that proves the device meets the acceptance criteria is the comparison to predicate devices to demonstrate substantial equivalence.
Here's the information extracted and organized:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Key elements for Substantial Equivalence Determination) | Reported Device Performance (Characteristics of TERATECH Model 10V5 Smart Probe) |
|---|---|
| Design and Materials: Identical or substantially similar to predicate device. | Identical in design and materials to the Acuson 10V4. |
| Intended Use: Subset of or equivalent to predicate device's intended uses. | Intended uses and mode of operation are a subset of those of the predicate (Acuson 10V4 and Acuson Aspen Ultrasound Systems). The document lists specific clinical applications and modes of operation that are "previously cleared by FDA" (P) under various K-numbers, indicating they align with existing clearances for the predicate or similar devices. The 10V5 Smart Probe is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body (e.g., Fetal, Abdominal, Intra-operative, Pediatric, Small Organ, Neonatal/Adult Cephalic, Trans-rectal, Trans-vaginal, Musculo-skeletal, Cardiac, Peripheral Vessel). |
| Technological Characteristics: Equivalent to predicate device. | Operates with the TERATECH Model 2000 portable imaging system. Technical specifications for the 7 Mhz / 128 Phased Array probe are provided (Pitch: 0.110mm, Elevation Width: 6.0mm, Geometric Focus: 36.5mm, Azimuth Radius: Flat, Azimuth Length: 14.1mm). Implicitly, these characteristics are considered equivalent or not raising new questions of safety and effectiveness compared to the predicate. |
| Acoustic Output: Within safe and effective levels (post-clearance report required). | A post-clearance special report is required to contain complete information, including acoustic output measurements based on production line devices. If these values are unacceptable, the 510(k) clearance may not apply. |
| Safety and Effectiveness: Does not raise new questions of safety or effectiveness. | The FDA's determination of substantial equivalence implies that the device does not raise new questions of safety or effectiveness compared to the predicate devices. |
2. Sample Size Used for the Test Set and the Data Provenance
This document does not describe a test set or data provenance in terms of clinical study participants or imaging datasets. The "test" for substantial equivalence primarily relies on a comparative analysis of device specifications, intended uses, and modes of operation against legally marketed predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. No ground truth establishment for a test set is described.
4. Adjudication Method for the Test Set
Not applicable. No test set or adjudication method 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 a 510(k) for a diagnostic ultrasound transducer, not an AI-assisted diagnostic tool.
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. It's a hardware component (transducer) for an ultrasound system, inherently requiring a human operator.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" here is the established safety and effectiveness of the predicate devices (Acuson 10V4 Sequoia™ Ultrasound System and Harmonic Imaging, Acuson Aspen™ Ultrasound System, and other previously cleared devices referenced by K-numbers for specific clinical applications). The new device is deemed acceptable because it performs equivalently or is a subset of these already approved devices.
8. The Sample Size for the Training Set
Not applicable. This device does not use a training set for machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set is involved.
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