(25 days)
The instrument is used for measuring the corneal thickness of the eye.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Ophthalmic, A-mode (P=previously cleared by FDA).
The PachPen device is designed as an ultrasound pachymeter which uses pulsed echo ultrasound to measure the corneal thickness of the eye. It utilizes an eye-contact probe to generate and receive the ultrasound pulses, and provides a numeric display of returning pulse echoes to indicate the thickness of the cornea.
This document is a 510(k) summary for the PachPen Pachymeter, an ultrasound device for measuring corneal thickness. As such, it is a submission for regulatory clearance and does not contain a detailed study report with acceptance criteria and device performance data in the structured format requested.
The document confirms the device's substantial equivalence to a predicate device (AccuPach V Pachymeter K042752), which is the basis for its regulatory clearance. However, it does not provide the specific performance data from a clinical or technical study proving the device meets an explicit set of acceptance criteria.
Therefore, many of the requested fields cannot be directly populated from the provided text.
Here's an attempt to answer based on the available information and highlighting what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Hypothesized based on device type) | Reported Device Performance (Not explicitly stated in this document) |
|---|---|
| Accuracy of corneal thickness measurement (e.g., ± X microns) | Not provided (The document states substantial equivalence to a predicate device, implying similar performance, but specific values are not listed) |
| Precision/Reproducibility of measurements (e.g., within Y microns) | Not provided |
| Measurement Range (e.g., Z to W microns) | Not provided |
| Biocompatibility of eye-contact probe | Implicitly met by substantial equivalence to predicate device with similar materials. |
| Electrical Safety (IEC 60601-1 compliance) | Implicitly met by substantial equivalence and general controls. |
| Electromagnetic Compatibility (EMC) | Implicitly met by substantial equivalence and general controls. |
Self-correction: The document does not explicitly state acceptance criteria or report specific performance metrics for the PachPen device. Its clearance is based on substantial equivalence to a predicate device. For a full study report, these details would be necessary.
2. Sample Size used for the test set and the data provenance
- Sample Size: Not specified.
- Data Provenance: Not specified. Since it's a 510(k) summary for substantial equivalence, the data likely relates to the technical specifications and comparison with the predicate device, rather than a large clinical study directly evaluating the new device's performance against ground truth in human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not specified in this document. The submission is for substantial equivalence to an existing device, rather than a de novo clinical validation requiring expert-established ground truth for a new diagnostic claim.
4. Adjudication method for the test set
- Not applicable/Not specified.
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. This device is an ultrasound pachymeter, a measurement tool, not an AI-assisted diagnostic imaging system for human interpretation. Therefore, an MRMC study related to AI assistance is not relevant or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, in a sense. The PachPen Pachymeter is a standalone device designed to provide a numeric measurement. Its performance would be evaluated as a standalone instrument, but not in the context of an "algorithm only" in the way AI or image processing algorithms are typically described.
7. The type of ground truth used
- Not explicitly stated for the PachPen device. For a pachymeter, ground truth for accuracy studies would typically involve:
- Phantom measurements: Using phantoms with precisely known thicknesses.
- Comparative measurements: Against a highly accurate reference standard pachymeter or other established measurement method.
- Histology/Pathology (less common for in-vivo devices): Ex-vivo tissue measurements.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/machine learning device.
Summary of what the document does provide:
- Device Description: The PachPen is an ultrasound pachymeter that uses pulsed echo ultrasound with an eye-contact probe to measure corneal thickness.
- Indications for Use: Measuring the corneal thickness of the eye.
- Predicate Device: AccuPach V Pachymeter (K042752).
- Regulatory Clearance Basis: Substantial equivalence to the predicate device.
- Transducer: A-mode 10.5 MHz, which is the same as used in the predicate device.
- Regulatory Class: Class II, under "Ultrasonic pulsed echo imaging system" (21 CFR 892.1650).
Key Takeaway: This 510(k) summary is a regulatory filing demonstrating substantial equivalence, not a detailed technical or clinical study report. It relies on the predicate device's established performance, rather than presenting new, detailed performance data for the PachPen itself.
§ 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.