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510(k) Data Aggregation
(64 days)
The VuPad ultrasound system is a multi-purpose computer-based ultrasonic diagnostic system for ophthalmic application, intended to both visualize the interior of the eye by means of ultrasound and to make measurements inside the eye, including the measurement of axial length for determination of IOL Power.
The VuPad is a portable ultrasound biometric ruler intended for use in ophthalmic applications. The system allows for the measurement of several key ocular features including axial length (AXL), anterior chamber depth, and lens thickness while also aiding in the calculation of associated IOL power for implanted lenses. The device is used by coupling the probe / transducer to the eye either through direct contact or immersion methods. Available modes are biometric A-scan, and UBM (high frequency B-scan). The A-scan mode of the system features a live A-scan trace with storage for up to five scans. There are five (auto/ manual) examination modes that use three different tissue velocities to calculate individual intraocular distances within the eye (ACD, Lens, and Vitreous). Other features include: post examination review of scans & measurement; five IOL formulas (six refractive and three post refractive) for lens power calculations; an immersion scanning capability for zero corneal compression of the eye while scanning and storage for up to five different user profiles. The B-Scan mode produces a live, two-dimensional image to facilitate the identification and measurement of ocular pathologies in the posterior-chamber of the eye, particularly when view of the chamber is obscured, such as is the case with cataracts. The VuPad is a stand-alone system that runs on a Windows 8 platform and may be networked (by the user) for interface with electronic medical records systems, printing, and other purposes. The system consists of the VuPad console, ultrasound probe(s) and transducer(s), and foot pedal.
The provided text describes the Sonomed VuPad (K140199) as a multi-purpose computer-based ultrasonic diagnostic system for ophthalmic applications, used for visualizing the interior of the eye and making measurements, including axial length for IOL power determination. The submission compares the device to two predicate devices: the E-Z Scan 5500+ A-Scan / B-Scan System (K040668) and the VuMax System (K060626).
However, the provided documentation primarily focuses on establishing substantial equivalence to predicate devices based on similarities in intended use, technology, method of operation, and various functional parameters. It does not contain a dedicated study section with acceptance criteria and a detailed report of device performance against those criteria in a clinical or analytical study context.
The only direct performance metric mentioned for the device itself is "A-Scan Measurement Accuracy: ±0.1 mm (clinical) ±0.02 mm (theoretical)." This is listed in the comparison tables as a similarity to the EZScan AB5500+. The document states that "Electrical, mechanical, environments safety and performance testing according to standard IEC 60601-1, IEC 60601-2-37, and EN/IEC 60601-1-2(2001) are currently pending," implying that detailed performance studies to explicitly "prove the device meets the acceptance criteria" were not yet fully completed or included in the summary at the time of submission.
Therefore, many of the requested details about a study evaluating the device against acceptance criteria cannot be extracted from this document, as such a study is not explicitly described.
Here's the information that can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the "Similarities" table, the clinical measurement accuracy from the predicate device is implicitly adopted as an expected performance level for the VuPad's A-Scan.
| Acceptance Criteria (Implied from Predicate - EZScan AB5500+) | Reported Device Performance (VuPad) |
|---|---|
| A-Scan Measurement Clinical Accuracy: ±0.1 mm | A-Scan Measurement Clinical Accuracy: ±0.1 mm |
| A-Scan Measurement Theoretical Accuracy: ±0.023 mm | A-Scan Measurement Theoretical Accuracy: ±0.02 mm |
| A-Scan Measurement Range: 18 - 40 mm | A-Scan Measurement Range: 18 - 40 mm |
| A-Scan Transducer Frequency: 10 MHz | A-Scan Transducer Frequency: 10 MHz |
| B-Scan Lines per Scan: 128 or 256 (VuMax: 256) | B-Scan Lines per Scan: 256 |
| B-Scan Axial Accuracy (Theoretical): 10 MHz: 0.2088 mm (EZScan) | B-Scan Axial Accuracy (Theoretical): 12.5 MHz: 0.2034 mm; 35 or 50 MHz: 0.0146mm |
| Acoustic Output: ISPTA.3 < 50 mW/cm2; MI < 0.23 | Acoustic Output: ISPTA.3 < 50 mW/cm2; MI < 0.23 |
Study Information (Based on available text):
2. Sample size used for the test set and the data provenance:
- Not explicitly provided. The document relies on substantial equivalence to predicate devices rather than reporting new clinical trial data for the VuPad itself. The A-scan accuracy is stated as a specification, not a study outcome.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/provided. No clinical study with a test set requiring expert ground truth establishment is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/provided.
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/provided. This device is an ultrasound system making direct measurements, not an AI-assisted diagnostic tool that aids human readers in interpretation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The device performs measurements (e.g., axial length, depths), which would be considered a form of "standalone" performance in its context. However, no specific details of a standalone performance study are provided beyond the stated accuracy specifications. The device's operation involves a human operator coupling the probe to the eye.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly provided. For the A-scan measurement accuracy, the "theoretical" accuracy suggests a technical specification based on the system's design and physical principles, while "clinical" accuracy implies historical performance from the predicate device in clinical use, but the specific method of establishing this clinical ground truth (e.g., comparison to optical biometry, surgical measurements) for either device is not detailed.
8. The sample size for the training set:
- Not applicable/provided. This device is an ultrasound system, not explicitly an AI/machine learning device that would require a "training set" in that sense. It performs measurements based on ultrasound signal processing.
9. How the ground truth for the training set was established:
- Not applicable/provided.
Summary of what is known:
The submission for the VuPad (K140199) primarily establishes substantial equivalence to existing predicate devices (E-Z Scan 5500+ and VuMax) by demonstrating similar intended use, technology, and performance specifications. Key performance criteria like A-Scan measurement accuracy and range are presented as specifications that are identical or very similar to the predicate devices. The document does not describe a separate, dedicated clinical or analytical study performed on the VuPad itself to generate new performance data against pre-defined acceptance criteria, beyond the implicit acceptance of the predicate's established performance. The "pending" safety and performance testing suggests that detailed compliance verification was ongoing or would be addressed later, but not part of this 510(k) summary submission as a reported study.
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