(9 days)
The Larsen & Toubro Limited SENORITA Colour Doppler Ultrasound System 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.
Technical specifications for the Larsen & Toubro Limited SENORITA Colour Doppler Ultrasound System are as follows:
System Specifications
Type of protection against electric shocks: Class I
Degree of protection against electric shock for ultrasound probes: Type "BF"
Degree of protection against electric shock For ECG electrodes: Type 'CF"
Degree of protection against hazard of explosion: Not protected
Degree of protections against ingress of liquids: IPXO
Power Requirements AC input: 110 V AC 60 Hz single phase
Fuse: Two (2) 12A, slow blow, glass cartridge fuses in Line and Neutral
Load: Total: 1000A (System: 850 VA, Aux. Output: 150 VA)
Leakage:
This document is a 510(k) Pre-market Notification for the Larsen & Toubro Limited SENORITA Colour Doppler Ultrasound System. It is an older document (dated 2003, cleared in 2004) and focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed clinical study with acceptance criteria and device performance as might be found in a more recent or novel device submission.
Therefore, the information you've requested regarding acceptance criteria and a study proving their fulfillment is not explicitly detailed in this document in the manner typically seen for performance claims of AI/CADe devices.
Instead, the submission for this diagnostic ultrasound system relies on demonstrating that its technical specifications and intended uses are substantially equivalent to already legally marketed predicate devices (TETRAD 2300 E/U Ultrasound Imaging System and Acuson Aspen System). The regulatory approval is based on safety and effectiveness being comparable to these existing devices, rather than a clinical trial demonstrating specific performance metrics against pre-defined acceptance criteria for a novel algorithm.
Here's a breakdown of what can be extracted or inferred based on the provided text, and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
No specific "acceptance criteria" for performance metrics like sensitivity, specificity, or accuracy are provided in the document, nor are there explicit "reported device performance" values against such criteria. This type of detail is typical for software algorithms making diagnostic claims, which this ultrasound system itself is not directly. The "performance" assessment for this device is primarily through technical specifications and comparison to predicate devices.
The closest we get to "performance" are the "Imaging resolution" specifications, which are inherent physical properties of the ultrasound system:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Imaging Resolution (measured in water, assuming f/2) | |
| Axial Resolution (3 MHz) | 1 mm |
| Axial Resolution (5 MHz) | 0.65 mm |
| Axial Resolution (7.5 MHz) | 0.41 mm |
| Lateral Resolution (3 MHz) | 1.025 mm |
| Lateral Resolution (5 MHz) | 0.75 mm |
| Lateral Resolution (7.5 MHz) | 0.49 mm |
Note: These are technical specifications, not clinical performance metrics based on patient studies.
2. Sample size used for the test set and data provenance:
- Sample Size: Not applicable/Not mentioned. The submission relies on technical specifications and substantial equivalence, not a clinical test set for performance evaluation.
- Data Provenance: Not applicable/Not mentioned. There is no clinical data presented.
3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:
- Not applicable/Not mentioned, as no clinical test set for ground truth establishment is described.
4. Adjudication method for the test set:
- Not applicable/Not mentioned, as no clinical test set requiring adjudication is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC study was done. This submission is for a conventional ultrasound imaging system, not an AI or CADe device. Therefore, the concept of human readers improving with AI assistance is not relevant to this document.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No standalone algorithm performance study was done. This is not an algorithm being submitted for clearance, but an ultrasound machine.
7. The type of ground truth used:
- Not applicable/Not mentioned, as no clinical ground truth for a test set is described. The "ground truth" for proving this device's safety and effectiveness relies on its technical specifications meeting established standards and being comparable to predicate devices.
8. The sample size for the training set:
- Not applicable/Not mentioned, as there is no AI/machine learning algorithm being submitted that would require a training set.
9. How the ground truth for the training set was established:
- Not applicable/Not mentioned, as there is no AI/machine learning algorithm or training set described.
Summary of Study Type:
The "study" or evidence provided in this 510(k) submission is primarily:
- Technical Bench Testing and Specifications: The document lists detailed system and imaging specifications (e.g., dimensions, power requirements, imaging resolution in water, array types, frequency ranges). These specifications are inherently measurable and demonstrate the device's technical capabilities.
- Substantial Equivalence Comparison: The core of the 510(k) is the comparison of these technical specifications and the intended uses of the Larsen & Toubro SENORITA system to two predicate devices: TETRAD 2300 E/U Ultrasound Imaging System and Acuson Aspen System. The argument for clearance is that the new device performs within similar parameters and has similar intended uses as these already cleared devices, thus implying comparable safety and effectiveness.
- Compliance with Standards: The document mentions compliance with safety standards like IEC 60601 and UL2601, indicating that the device has undergone testing to ensure electrical and medical device safety.
In essence, this 510(k) demonstrates the device meets the regulatory requirements for clearance by showing its technical characteristics are similar to existing, legally marketed devices, rather than through a clinical performance study with specific acceptance criteria for diagnostic accuracy.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.