Search Results
Found 1 results
510(k) Data Aggregation
(13 days)
The TETRAD Model TC-EC7-ACP, -L5-, -L7-, -V4-ACP Transducers are 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.
Technical specifications for the Model TC-EC7-ACP, -L5-, -L7-, -V4-ACP Transducers are as follows:
| Specifications | Tetrad TC-EC7-ACP | Tetrad TC-L5-ACP | Tetrad TC-L7-ACP | Tetrad TC-V4-ACP |
|---|---|---|---|---|
| Center Frequency | 7.0 MHz nominal | 6.0 MHz nominal | 8.0 MHz nominal | 4.0 MHz nominal |
| Number of Elements | 128 | 128 | 128 | 128 |
| Radius of Curvature | 12.5 | NA | NA | NA |
| Bandwidth -6dB | 60% nominal | 60% nominal | 60% nominal | 58% nominal |
| Elevation width | 6 mm | 4.1 mm | 4.1 mm | 15 mm |
| Elevation Focus | 22 mm | 20 mm | 20 mm | 90 mm |
| Lens material | Silicone | Silicone | Silicone | Silicone |
| Pitch | 0.2 mm | 0.3 mm | 0.3 mm | 0.5 mm |
- The acceptance criteria are based on the device being "substantially equivalent" to predicate devices.
- The device meets the acceptance criteria as reported in the 510(k) Summary, which states that "The TETRAD Model TC-EC7-ACP, -L5-, -L7-, -V4-ACP Transducers are substantially equivalent to the corresponding Acuson products which are currently in commercial distribution in the United States, since the subject devices are functionally similar."
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state quantitative acceptance criteria in a pass/fail format in the traditional sense, but rather relies on substantial equivalence to a predicate device. The performance is then characterized by direct comparison of specifications to the predicate.
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (TETRAD Transducers) | Predicate Device (Acuson Aspen™ Ultrasound System Transducers) |
|---|---|---|
| Functional Similarity | "functionally similar" to predicate transducers | Acuson Aspen™ Ultrasound System (including Transducers EC7, L5, L7, V4) |
| Same Intended Uses | "have the same intended uses as the corresponding predicate transducers" | Acuson Aspen™ Ultrasound System (including Transducers EC7, L5, L7, V4) |
| Center Frequency | Specified for each model (e.g., TC-EC7-ACP: 7.0 MHz nominal) | Not explicitly detailed but implied to be equivalent post-comparison |
| Number of Elements | 128 for all models | Not explicitly detailed but implied to be equivalent post-comparison |
| Bandwidth -6dB | Specified for each model (e.g., TC-EC7-ACP: 60% nominal) | Not explicitly detailed but implied to be equivalent post-comparison |
| Elevation Width | Specified for each model (e.g., TC-EC7-ACP: 6 mm) | Not explicitly detailed but implied to be equivalent post-comparison |
| Elevation Focus | Specified for each model (e.g., TC-EC7-ACP: 22 mm) | Not explicitly detailed but implied to be equivalent post-comparison |
| Lens Material | Silicone for all models | Not explicitly detailed but implied to be equivalent post-comparison |
| Pitch | Specified for each model (e.g., TC-EC7-ACP: 0.2 mm) | Not explicitly detailed but implied to be equivalent post-comparison |
| Fetal Doppler Applications on Acuson 128XP | "The TETRAD Transducers are not intended for Fetal Doppler applications on the Acuson 128XP (a Track 1 device)." | The predicate transducers likely supported this application. This is noted as a difference, but one that does not preclude substantial equivalence for the other intended uses. |
| Acoustic Output Levels | "equal to or slightly lower than those of their respective corresponding Acuson Transducers." | Not explicitly detailed but implied to be equivalent or higher than TETRAD's. |
2. Sample Size Used for the Test Set and the Data Provenance:
The document does not describe a "test set" in the context of a clinical performance study. The evaluation for substantial equivalence primarily relies on a comparison of technical specifications and intended uses to the predicate device.
- Sample Size for Test Set: Not applicable, as detailed in the document.
- Data Provenance: Not applicable for a typical clinical test set. The data provenance relevant to this submission is the technical specifications of the TETRAD transducers and the established specifications of the predicate Acuson transducers, both for commercial distribution in the United States. The submission itself is prospective for the TETRAD transducers seeking market clearance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
Not applicable, as a clinical "test set" with expert-established ground truth is not described in this 510(k) submission for substantial equivalence. The "ground truth" for the comparison is the established technical specifications and intended uses of the legally marketed predicate device (Acuson Aspen™ Ultrasound System, K991805).
4. Adjudication Method for the Test Set:
Not applicable, as a clinical "test set" requiring adjudication for ground truth is not 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 submission is for diagnostic ultrasound transducers, not an AI-powered diagnostic system. No MRMC studies or AI assistance are mentioned.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This device is a medical accessory (ultrasound transducer), not a standalone algorithm.
7. The Type of Ground Truth Used:
The "ground truth" used for this substantial equivalence determination is the established performance characteristics, technical specifications, and intended uses of the legally marketed predicate device: the Acuson Aspen™ Ultrasound System (including Transducers EC7, L5, L7, V4), cleared under K991805.
8. The Sample Size for the Training Set:
Not applicable. This submission is for a medical device (ultrasound transducer) and does not involve AI or machine learning models that require a "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of device submission.
Ask a specific question about this device
Page 1 of 1