(28 days)
The A-scan 100 is an ophthalmic A-scan system intended to be used for measurement of axial distances in the eye and for the calculation of the power of an implanted intraocular lens (IOL), indicated for patients requiring intraocular lenses.
The A-scan 100 is a compact device Ultrasonic ophthalmic A-scan system that uses the principles of sonar (pulsed ultrasound) to measure the axial length of the eyes. The device includes four popular formulas to calculate the implanted IOL power, using the Ultrasound Axial Length measurement. The results may be printed through a PC computer printers.
The provided text indicates that the device, an Ophthalmic Ultrasonic A-scan System A-scan 100, is substantially equivalent to a predicate device (OTI i-scan, K960622). However, it does not contain a detailed study report with specific acceptance criteria, reported device performance figures, or information on study methodologies for clinical performance.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Anticipated) | Reported Device Performance |
|---|---|
| Accuracy | The A-scan 100 has had accuracy tests. (No specific values provided) |
| Ultrasonic Emissions | Ultrasonic emissions tests performed. (No specific results provided) |
| Electrical Safety | Electrical safety tests performed. (No specific results provided) |
| Software Validation | Software validation tests performed. (No specific results provided) |
| Clinical Equivalence | The A-scan 100 is equivalent in safety and efficacy to the legally-marketed predicate device. (No specific clinical performance metrics provided) |
Missing Information:
- Specific numerical acceptance criteria for accuracy, precision, or other performance metrics. The document only states that tests were conducted.
- Actual numerical results or metrics for the device's performance against any established criteria.
2. Sample Size Used for the Test Set and the Data Provenance
According to the document:
- Sample Size: "Clinical tests: Not required." This indicates that no separate clinical test set was used for this 510(k) submission, as the device's equivalence was established through non-clinical testing and comparison to a predicate.
- Data Provenance: Not applicable for clinical tests, as none were conducted.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and their Qualifications
Missing Information: Not applicable, as no clinical test set was used requiring ground truth established by experts.
4. Adjudication Method for the Test Set
Missing Information: Not applicable, as no clinical test set was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
Missing Information/Not Applicable: The document explicitly states "Clinical tests: Not required." Therefore, no MRMC study was performed or reported for this submission.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
The device is an "Ophthalmic Ultrasonic A-scan System" and likely involves direct measurement rather than an algorithm performing a standalone diagnostic task. While "software validation tests" were performed, there's no indication of a standalone algorithm performance evaluation in the context of interpretation or diagnosis without human involvement. The focus is on the device's ability to measure axial length and calculate IOL power.
7. The Type of Ground Truth Used
Missing Information/Not Applicable: Since clinical tests were not required, the concept of establishing ground truth for a clinical dataset does not apply here. The "accuracy tests" would have likely used a known standard or calibrated phantom as ground truth, but the details are not provided.
8. The Sample Size for the Training Set
Missing Information/Not Applicable: The device is described as an "Ophthalmic Ultrasonic A-scan system that uses the principles of sonar (pulsed ultrasound) to measure the axial length of the eyes." It includes "four popular formulas to calculate the implanted IOL power." This description suggests a deterministic system based on physical principles and established formulas, rather than a machine learning or AI-based system that would require a "training set" in the conventional sense.
9. How the Ground Truth for the Training Set was Established
Missing Information/Not Applicable: As there is no indication of a machine learning component requiring a training set, this information is not relevant to this submission.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The provided 510(k) summary for the A-scan 100 does not describe a clinical study with acceptance criteria and reported performance in the traditional sense of evaluating diagnostic accuracy against a ground truth. Instead, it relies on demonstrating substantial equivalence to a legally marketed predicate device (OTI i-scan, K960622) through non-clinical testing.
The relevant section, "(6) Performance Data," states:
- (a) Non-clinical tests: "The A-scan 100 has had accuracy tests, ultrasonic emissions tests, electrical safety tests, and software validation tests."
- (b) Clinical tests: "Not required."
- (c) Conclusions: "The A-scan 100 is equivalent in safety and efficacy to the legally-marketed predicate device."
This means the "study" that proves the device meets the acceptance criteria is a compilation of engineering and bench testing, not a human clinical trial. The exact acceptance criteria for these non-clinical tests (e.g., accuracy within a certain tolerance for axial length measurement) are not detailed in the provided document, nor are the specific results of those tests. The conclusion of equivalence is based on these non-clinical tests demonstrating that the new device performs comparably to the predicate device in terms of fundamental operational and safety characteristics.
§ 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.