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Intended to be used by or under the direction of a physician for 3-D clinical imaging in fetal applications. This is only to be used in conjunction with the 2D Ultrasound Imaging System marketed under the model name 'Sonata' or 'Telocin', labeled as 2D Ultrasound Imaging System manufactured by Tetrad Corporation.

Adds 3-D imaging capability to commercial 2-D ultrasound imaging system. Hardware includes Pentium IV 2.8 GHz, Frame Grabber digital via real time memory mapping in RAM, Video out via Sonata System, System keyboard control. Software features include Volume data acquisition w/frame grabbing of digital data b/w while scanning free-hand, Conditioning and transformation of the acquired data into a Cartesian volume, Surface rendering, Segmentation of structures from 3-D data.

Here's an analysis of the provided 510(k) summary regarding the Sonata 3-D device, focusing on acceptance criteria and the study:

Acceptance Criteria and Device Performance for Sonata 3-D

Based on the provided documents, it is not possible to complete a table of acceptance criteria and reported device performance, nor to describe a study proving the device meets these criteria. The 510(k) submission for the Sonata 3-D primarily focuses on establishing substantial equivalence to a predicate device (Sonora Medical Systems Baby Face K994385, later updated to K1722606).

The provided text does not contain any information about:

• Specific performance metrics (e.g., accuracy, sensitivity, specificity, resolution) for the Sonata 3-D.
• Quantitative acceptance criteria established for the device.
• Results of any clinical or technical performance studies that would measure the device's performance against such criteria.
• Details about a test set, ground truth, experts, or adjudication methods for any such study.
• Information on training sets or how their ground truth was established.

The core of this 510(k) is a comparison of technical features and intended use to a legally marketed predicate device. The FDA's decision letter (K042620) confirms substantial equivalence based on a review of the submission, but this process typically involves demonstrating that the new device is as safe and effective as the predicate, often through feature-by-feature comparison rather than independent clinical performance studies that define and meet specific acceptance criteria in the same way a de novo or PMA submission might.

Information from the Provided Documents:

1. Table of Acceptance Criteria and Reported Device Performance:

The 510(k) filing primarily aims to show that the Sonata 3-D has the "same intended use" and "same technological characteristics" as the predicate device or that differences "do not raise different questions of safety and effectiveness."

2. Sample size used for the test set and the data provenance:

• Not applicable / Not provided. The document does not describe a performance study with a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable / Not provided. No ground truth establishment is described for a test set.

4. Adjudication method for the test set:

• Not applicable / Not provided. No test set or ground truth adjudication process is mentioned.

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:

• No. The device described is a "3-D Visualization Tool" and a "Digital Ultrasound Imaging System" that adds 3-D imaging capability to 2-D systems. It is not an AI-assisted diagnostic device, and no MRMC study or AI-related effectiveness is mentioned.

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

• No. This is a hardware/software system for 3D visualization, not a standalone algorithm. Performance in the context of 510(k) for this type of device is typically demonstrated through comparison to the predicate's functionality and safety.

7. The type of ground truth used:

• Not applicable / Not provided. No specific ground truth for performance evaluation is described. The "ground truth" in a 510(k) for substantial equivalence often relates to the known performance and safety profile of the predicate device, against which the new device's features and intended use are compared.

8. The sample size for the training set:

• Not applicable / Not provided. This document does not describe a machine learning algorithm requiring a training set.

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

• Not applicable / Not provided. No training set is mentioned.

Summary of the Study (as described in the 510(k) documentation):

The "study" presented in these 510(k) documents is a comparison to a predicate device for the purpose of demonstrating substantial equivalence.

• Predicate Device: Sonora Medical Systems Baby Face (K994385, later referenced as K1722606).
• Methodology: A feature-by-feature comparison was conducted (as shown in "Comparison Chart for Substantial Equivalence" on page 2 of the second document). This comparison highlights:
  • Basic Function: Both add 3-D imaging capability to commercial 2-D ultrasound systems.
  • Hardware: Differences in processor (Cyrix 266 MHz vs. Pentium IV 2.8 GHz), frame grabber technology (VHS/S-VHS input vs. digital via real-time memory mapping in RAM), and control (handheld controller vs. system keyboard control). These hardware differences would typically be reviewed to ensure they don't introduce new safety/effectiveness concerns.
  • Software Features: Both perform volume data acquisition, conditioning/transformation into a Cartesian volume, and surface rendering. Both also perform segmentation of structures from 3-D data. Importantly, both predicate and new device explicitly state "No quantitative evaluation" and "No measurements or calculations." This absence of quantitative metrics is a key point in establishing equivalence concerning performance.
• Conclusion of the Comparison: The submitter concludes, and the FDA agrees, that the Sonata 3-D is substantially equivalent to the predicate. The FDA's letter (K042620, dated Dec 23, 2004) states they "have determined the device is substantially equivalent... to legally marketed predicate devices."

In essence, the "study" for this 510(k) was a detailed technical and functional comparison against a known, legally marketed device, rather than an independent clinical trial with predefined performance acceptance criteria.

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The TETRAD Model TC-C52-, -C84V-, -C95-, -CLA76-, -L74-ATP Transducers are intended for diagnostic ultrasound imaging or fluid flow analysis of the human body; specific indications for use are tabulated in Section 4.3 of this submission.

Technical specifications for the Model TC-C52-, -C84V-, -C95-, -CLA76-, -L74-ATP Transducers are as follows:
| Specifications | Tetrad TC-
C52-ATP | Tetrad TC-
C84V-ATP | Tetrad TC-
C95-ATP | Tetrad TC-
CLA76-ATP | Tetrad TC-
L74-ATP |
|---------------------|-----------------------|------------------------|-----------------------|-------------------------|-----------------------|
| Center Frequency | 3.0 MHz
nominal | 6.0 MHz
nominal | 6.0 MHz
nominal | 4.0 MHz
nominal | 6.0 MHz
nominal |
| Number of Elements | 128 | 128 | 128 | 128 | 128 |
| Radius of Curvature | 40 mm | 12 mm | 8 mm | 76 mm | NA |
| Bandwidth -6dB | 70% nominal | 60% nominal | 60% nominal | 50% nominal | >50% |
| Elevation width | 15 mm | 5.5 mm | 4 mm | 15 mm | 5.5 mm |
| Elevation Focus | 80 mm | 25 mm | 25 mm | 75 mm | 25 mm |
| Lens material | silicone | Silicone | silicone | silicone | silicone |
| Pitch | 0.3 mm | 0.2 mm | 0.15 mm | 0.6 mm | 0.2 mm |

The provided 510(k) summary (K0191182) describes the submission for “TETRAD Model TC-C52-, -C84V-, -C95-, -CLA76-, -L74-ATP Transducers.” This document focuses on demonstrating substantial equivalence to existing predicate devices rather than proving a device meets specific performance criteria through a detailed clinical study.

Therefore, many of the requested information points, such as specific acceptance criteria for diagnostic performance, sample sizes for test sets, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, and training set details, are not applicable or available in this type of submission.

The primary "study" that proves the device meets acceptance criteria in a 510(k) for a diagnostic ultrasound transducer is a comparison to a legally marketed predicate device and a demonstration that the new device is "substantially equivalent" in terms of technological characteristics and intended use.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this submission are based on demonstrating substantial equivalence to the predicate devices (ATL HDI 3000 and HDI 5000 Systems transducers C5-2, C8-4V, C9-5, C3.5, R76, L7-4). The "performance" is a comparison of technical specifications and the conclusion that the new transducers are functionally similar and have the same intended uses.

TETRAD Model TC-C84V-ATP: Center Frequency: 6.0 MHz nominal; Elements: 128; Radius of Curvature: 12 mm; Bandwidth -6dB: 60% nominal; Elevation width: 5.5 mm; Elevation Focus: 25 mm; Lens material: Silicone; Pitch: 0.2 mm.

TETRAD Model TC-C95-ATP: Center Frequency: 6.0 MHz nominal; Elements: 128; Radius of Curvature: 8 mm; Bandwidth -6dB: 60% nominal; Elevation width: 4 mm; Elevation Focus: 25 mm; Lens material: silicone; Pitch: 0.15 mm.

TETRAD Model TC-CLA76-ATP: Center Frequency: 4.0 MHz nominal; Elements: 128; Radius of Curvature: 76 mm; Bandwidth -6dB: 50% nominal; Elevation width: 15 mm; Elevation Focus: 75 mm; Lens material: silicone; Pitch: 0.6 mm.

TETRAD Model TC-L74-ATP: Center Frequency: 6.0 MHz nominal; Elements: 128; Radius of Curvature: NA; Bandwidth -6dB: >50%; Elevation width: 5.5 mm; Elevation Focus: 25 mm; Lens material: silicone; Pitch: 0.2 mm.

The document explicitly states: "The acoustic output levels of the TETRAD Transducers are equal to or slightly lower than those of their respective corresponding ATL Transducers." This is a key safety comparison. |
| Acoustic Output Levels | Acoustic output levels should be comparable to or lower than the predicate devices to ensure safety. | Stated to be "equal to or slightly lower than those of their respective corresponding ATL Transducers." A post-clearance special report is required to provide complete acoustic output measurements based on production line devices (Appendix G, Sept 30, 1997 guidance). This indicates a commitment to meet the safety thresholds outlined in that guidance. |
| Differences from Predicate | Any differences from the predicate device must not raise new questions of safety or effectiveness. The only substantive differences found during prior clearance (K002193 for TC-C3-ATP) were deemed acceptable. | The only substantive differences identified were related to the acoustic output levels, which were determined to be equal to or slightly lower than the predicate, thus not raising new questions of safety or effectiveness. |

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

• Sample Size for Test Set: Not applicable. This 510(k) submission does not describe a clinical trial with a "test set" of patients or images for diagnostic performance evaluation in the way an AI/CADe device would. The evaluation is based on comparing technical specifications and intended use to predicate devices already on the market.
• Data Provenance: Not applicable for a typical "test set" as defined for diagnostic performance. The data provenance for the comparison essentially refers to the existing regulatory clearances and technical specifications of the predicate ATL devices (ATL HDI 3000 and HDI 5000 Systems).

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

• Number of Experts: Not applicable. No dedicated "ground truth" establishment by experts for a test set is described in this type of submission for ultrasound transducers.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. No clinical test set requiring adjudication is described.

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

• MRMC Study: No, an MRMC study was not done. This type of study is not relevant for demonstrating substantial equivalence of an ultrasound transducer in a 510(k) submission focused on technical specifications and intended use comparison. MRMC studies are typically used for assessing the impact of AI/CADe devices on human reader performance.
• Effect Size of Human Readers Improve: Not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

• Standalone Study: No, a standalone study was not done. This device is an ultrasound transducer, a hardware component, not an algorithm. Its performance is inherent to its physical and electronic characteristics when connected to an ultrasound system.

7. The Type of Ground Truth Used

• Type of Ground Truth: Not applicable. No "ground truth" derived from expert consensus, pathology, or outcomes data is used in this submission to evaluate the transducer's diagnostic performance in the context of clinical accuracy. The "ground truth" for substantial equivalence is the existing regulatory clearance and established safety/effectiveness profile of the predicate devices based on their technical specifications and intended uses.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This is not an AI/ML device that requires a training set.

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

• Ground Truth for Training Set: Not applicable.

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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:

• 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.

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.

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