(276 days)
The B-Scan module is used for imaging the internal structure of the eye, including the opaque media and posterior pathology, for the purpose of diagnosing pathological or traumatic conditions in the eye. The probe is intended to be used on both adult and pediatric patients that require imaging of the eye.
The B-Scan device is designed as an ultrasound B-Scan, which uses pulsed echo ultrasound to image the structure of the eye. It utilizes an eye-contact probe to generate and receive the ultrasound pulse signals and provides a graphic display of returning pulse echoes to indicate the various structures.
All of the critical functions of the B-Scan are calculated in the same manner as in the predicate device, B-Scan Plus. The software algorithms for clinically critical functions remain the same as in the predicate device. However, the user interface and the workflow of B-Scan have enhancement to support cybersecurity implementation.
Both the subject device and predicate device are compatible with the Connect Software (K070943, K123349) and 4Sight (K152573). The software improvements in Connect were focused on enhancing features that optimize integration with the personal computer's processing, data storage, display, and printing capabilities.
The energy source for the B-Scan is USB power as in the predicate device, B-Scan Plus.
The software utilized on both the Connect and 4Sight platforms is fundamentally identical in core clinical functions, including image scanning, rendering, IOL calculations, data storage, and report formatting. Additionally, the key features within the B-Scan module do not differ significantly between the two systems, nor do they make an impact on the established clinical workflow.
Track 1 is being followed for this 510(k) submission.
Here's a breakdown of the acceptance criteria and the study details for the B-Scan Ultrasonic Imaging System, based on the provided FDA 510(k) clearance letter:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device rather than explicitly stating pre-defined "acceptance criteria" for a novel device performance. However, we can infer acceptance criteria from the comparison table (Table 2) and the performance data section, where the subject device's performance is either "Same" or "SE" (Substantially Equivalent) to the predicate, or explicitly lists performance metrics.
For quantitative metrics, the "acceptance criteria" for the subject device can be interpreted as performing comparably or within acceptable limits relative to the predicate device, or meeting specific new specifications.
| Parameter | Acceptance Criteria (Inferred/Stated) | Reported Device Performance (B-Scan) | Remarks/Proof |
|---|---|---|---|
| Clinical Accuracy (Line) | ±3% (for 60mm Depth Setting) | 12MHz: | |
| 60mm Depth Setting | |||
| Clinical Accuracy: ±3% | Bench Test: Physical Accuracy and Range Test | ||
| Accuracy Range (Line) | 60 mm (for 60mm Depth Setting) | 12MHz: | |
| 60mm Depth Setting | |||
| Accuracy Range: 60 mm | Bench Test: Physical Accuracy and Range Test | ||
| Clinical Accuracy (Area) | ±15% (for 60mm Depth Setting) | 12MHz: | |
| 60mm Depth Setting | |||
| Clinical Accuracy: ±15% | Bench Test: Physical Accuracy and Range Test | ||
| Accuracy Range (Area) | 60 mm (for 60mm Depth Setting) | 12MHz: | |
| 60mm Depth Setting | |||
| Accuracy Range: 60 mm | Bench Test: Physical Accuracy and Range Test | ||
| Image Preview Time | Displayed within 2 seconds of pressing probe button | Image preview is displayed within 2 seconds of pressing probe button (average time recorded across 5 probes). | Bench Test: The specific bench test for this is not named explicitly, but is mentioned within the comparison table as part of the performance metrics. |
| Cleaning & Disinfection | Validation per procedures in Instruction for Use | Reprocessing validation test was conducted on the proposed device. | Reprocessing Validation Test |
| Biocompatibility | Meet requirements of ISO 10993 series (Cytotoxicity, Ocular Irritation, Skin Sensitization) | The proposed device has been tested and met the requirements according to the ISO 10993 series standard for Biocompatibility. | Biocompatibility Testing |
| Software V&V | Documentation provided as recommended by FDA guidance | Software verification and validation testing were conducted, and documentation was provided. | Software Verification and Validation Testing |
| Cybersecurity Compliance | Documentation provided in accordance with FDA guidance | Cybersecurity compliance was implemented, and documentation was provided. | Cybersecurity Implementation and Documentation |
| Electrical Safety & EMC | Meet requirements of IEC 60601-1, IEC 60601-1-2 | The proposed device has been tested and met the requirements. | Thermal, mechanical, and electrical safety and electromagnetic compatibility testing |
| Mechanical/Thermal Durability | Meet design specifications (implied) | Accelerated Thermal Cycling Test; Plastic Component UV Assessment; Transit Performance Test; USB cable Pull Test; B-Scan Integrated Life Testing Verification Report | Bench Tests (listed) |
| Button Actuation | Meet design specifications (implied) | Button actuator Validation Test | Bench Test: Button actuator Validation Test |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a sample size for patients or images used in any clinical or test set. The performance data mostly refers to bench testing and validation against standards.
- The only mention of a "sample" related to performance is "average time recorded across 5 probes" for the image preview time. This refers to hardware units, not patient data.
- Data Provenance: Not applicable, as no external data set or clinical study on patients is described beyond bench tests. The focus is on device specifications and in-house validation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. The submission does not describe a study involving expert readers establishing ground truth for a test set of images for diagnostic performance evaluation. The "Performance" section outlines bench tests and compliance with recognized standards.
4. Adjudication Method for the Test Set
Not applicable. Since there's no mention of a clinical test set requiring human expert review to establish ground truth, there is no adjudication method described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document does not describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor does it quantify improvement in human readers with AI assistance. The device is purely an imaging system, and there is no mention of AI assistance for image interpretation.
6. Standalone (Algorithm Only Without Human-in-the-loop Performance)
The device described is an "B-Scan Ultrasonic Imaging System," which is a diagnostic tool that produces images for human interpretation. It does not contain an AI algorithm for standalone diagnostic performance. Its performance is related to image acquisition parameters, accuracy of measurements, and adherence to safety/design standards.
7. Type of Ground Truth Used
For the quantitative performance claims (e.g., Clinical Accuracy Line/Area), the ground truth was established by physical measurements against known standards or calibrated references during bench testing ("Physical Accuracy and Range Test"). For other aspects, the ground truth is adherence to technical specifications, safety standards, and validated manufacturing/reprocessing procedures.
8. Sample Size for the Training Set
Not applicable. This device is an ultrasound imaging system, not an AI-driven diagnostic algorithm that requires a "training set" of data in the typical machine learning sense. The software aspects mentioned are primarily for device control, image rendering, data storage, and report formatting, enhanced for cybersecurity and usability – not for learning from data to perform a diagnostic task.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set mentioned for an AI algorithm.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.