(273 days)
The TrueField Analyzer is an automated perimeter used to aid in measurement of visual field abnormalities.
For the assessment of visual field abnormalities.
The TrueField Analyzer is an automated perimeter that is used to aid in measurement of visual field abnormalities. It is an objective device that monitors involuntary responses in the patient's pupils to a series of multi-focal visual stimuli presented to the eyes. The system presents stimuli and monitors the pupil responses in both eyes independently and concurrently.
The device includes:
- a bilateral image display system for providing individual visual stimulus to the patient's eyes (both eyes are concurrently and independently stimulated)
- A pair of video cameras for monitoring the patient's pupils again concurrently and independently
- A personal computer equipped to run Windows XP Professional Service Pack 2 operating system.
- The TrueField Software system. The TrueField Software automatically manages the stimulus presentation and video data acquisition, ensuring synchronization between the display and video image acquisition; data analysis, storage and presentation of results for review.
The TrueField Analyzer uses a different fundamental technology to the predicate device. It combines standard multi-focal stimulus and analysis technology (as used in other perimetry devices, for example K003442, K983983) with computerized pupil monitoring (for example K920937) allowing the device to objectively measure the visual field map of a patient. In doing so it is substantially equivalent to the predicate device (K954167).
Based on the provided 510(k) summary for the TrueField Analyzer, here's a detailed breakdown regarding acceptance criteria and the study (or lack thereof) that supports its performance:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy targets) for the TrueField Analyzer's performance in diagnosing visual field abnormalities. Instead, the performance data section focuses on demonstrating the device's conformance to product specifications (electrical safety, EMC, IR radiation safety) and a comparative table of technical specifications with the predicate device (Humphrey Field Analyser - HFA-II).
The core performance claim relies on "substantial equivalence" to the predicate device, implying that its performance is implicitly accepted as equivalent to a device already deemed safe and effective.
Here's a table summarizing the technical specifications that are presented as "performance data" in comparison to the predicate, which indirectly serve as a basis for proving its functionality and equivalence:
| Feature/Criteria | TrueField Analyzer Performance | HFA-II (Predicate) Performance (for comparison) |
|---|---|---|
| General | ||
| Intended Clinical Purpose | Visual field examination / to measure visual field defects | Visual field examination / to measure visual field defects |
| Product Code | HPT | HPT |
| Regulation | 886.1605 | 886.1605 |
| Device Class | I | I |
| Technical/Operational | ||
| Visual System Stimulus | Sparse-stimulus multifocal stimulus | Single spot of variable luminance and size |
| Measurement Technology | Video camera based pupil measurement | User feedback (button press) |
| Visual Function Assessment | Regression based multifocal analysis | Threshold or suprathreshold sensitivity to spots |
| Visual Field Defect Assessment | Population sample normal database comparison | Population sample Normal database comparison |
| Stimulus Luminance | 290 cd/m² | 0.025 - 3,183 cd/m² (or 0.08 – 10,000 apostilbs) |
| Background Luminance | 10 cd/m² | 10 cd/m² (31.5 apostilbs) |
| Number of Stimuli Locations | 24 T30-24, 40 T30-40, 60 T30-60, 24 T10-24, 44 O30-44 | 54 Central 24-2, 76 Central 30-2, 68 Central 10-2, 68 Peripheral 30/60-2 |
| Eccentricity Limits of Std Test Area | ± 30 degrees | ± 24 degrees (for central 24-2, common test) |
| Stimulus Spot Size | 4, 11 or 14 degrees arc angle (segments) | 0.43 degrees (Goldmann standard size III spot) |
| Stimulus Spot Spacing | ~7.5 to 12.5 degrees (cortically scaled) | Uniform 6° grid spacing (standard patterns) |
| Proportion of Visual Field Test Area Sampled | 88% |
§ 886.1605 Perimeter.
(a)
Identification. A perimeter is an AC-powered or manual device intended to determine the extent of the peripheral visual field of a patient. The device projects light on various points of a curved surface, and the patient indicates whether he or she sees the light.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.