(273 days)
No
The description focuses on automated stimulus presentation, data acquisition, analysis, storage, and presentation, which are standard functions of automated medical devices and do not explicitly mention or imply the use of AI/ML for decision-making, pattern recognition beyond basic analysis, or learning from data. The "Mentions AI, DNN, or ML" section also explicitly states "Not Found".
No
The device is described as an "automated perimeter" used to "aid in measurement of visual field abnormalities" and for "assessment of visual field abnormalities." Its function is diagnostic, to measure and assess, not to treat.
Yes
The device is an "automated perimeter used to aid in measurement of visual field abnormalities" and for "assessment of visual field abnormalities," which directly aligns with the definition of a diagnostic device.
No
The device description explicitly lists hardware components including a bilateral image display system, video cameras, and a personal computer, in addition to the software.
Based on the provided information, the TrueField Analyzer is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to obtain information for diagnostic purposes.
- TrueField Analyzer's Function: The TrueField Analyzer directly interacts with the patient's eyes by presenting visual stimuli and monitoring pupil responses. It does not analyze specimens taken from the body.
- Anatomical Site: The device operates on the eyes, which are part of the living body, not on a specimen taken from the body.
- Input Modality: The input is video camera based pupil measurement, which is a direct measurement of a physiological response, not an analysis of a biological sample.
The TrueField Analyzer is a medical device used for the assessment of visual field abnormalities, but its method of operation falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The TrueField Analyzer is an automated perimeter used to aid in measurement of visual field abnormalities.
For the assessment of visual field abnormalities.
Product codes
HPT
Device Description
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Video camera based pupil measurement
Anatomical Site
Eyes (pupils to a series of multi-focal visual stimuli)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The TrueField Analyzer has been designed and tested to establish conformance with the product specifications, including electrical safety, electromagnetic compatibility and infra-red radiation safety.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
510(k) Summary
AUG - 3 2007
Image /page/0/Picture/3 description: The image shows a stylized eye with a thick eyebrow. The pupil of the eye is filled with a pattern resembling a plus sign or cross. The overall design is simple and graphic, suggesting a focus on vision or healthcare.
seeingmachines
General Information
| Device details: | Name Trade: | TrueField Analyzer | |
|---|---|---|---|
| Common name: | Visual Field Perimeter | ||
| Classification name: | Perimeter, Automatic, AC-Powered | ||
| Regulation number: | 886.1605 | ||
| Product code: | HPT | ||
| Classification panel: | Ophthalmic | ||
| Classification: | Class I device | ||
| Submitter: | Seeing Machines Limited | ||
| Level 3, Innovation Building | GPO Box 782 | ||
| Corner Garran and Eggleston Roads | Canberra ACT 2601 | ||
| Acton ACT 2601 | Australia | ||
| Australia | |||
| Tel: +61 2 6125 6501 | Fax: +61 2 6125 6504 | ||
| Contact person: | Dr. Nick Cerneaz, Chief Executive Officer | ||
| Date summary prepared: | 31 July 2007 |
Intended Use
The TrueField Analyzer is an automated perimeter used to aid in measurement of visual field abnormalities.
Predicate Device Information:
The device has been compared to the following legally marketed devices:
| Company | Device | 510(k) |
|---|---|---|
| Carl Zeiss, Inc | Humphrey Field Analyser (HFA-II) | K954167 |
Device Description
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
[sm10670-0 Ref. 1] Copyright © Seeing Machines Limited 2007 Seeing Machines Limited GPO Box 782 Canberra ACT 2601 Australia Level 3 Innovations Building Corner Eggleston and Garran Roads Acton ACT 2600 Australia Tel +61 2 6125 6501 fax +61 2 6125 6504 www.seeingmachines.com
1
- 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).
Performance Data
The TrueField Analyzer has been designed and tested to establish conformance with the product specifications, including electrical safety, electromagnetic compatibility and infra-red radiation safety.
| TrueField Analyzer | HFA-II | |
|---|---|---|
| Regulation | 886.1605 | 886.1605 |
| Regulation title | Perimeter | Perimeter |
| Product Code | HPT | HPT |
| Device Class | I | I |
| Manufacturer | Seeing Machines | Carl Zeiss Meditec |
| 510(k) | K063310 | K954167 |
| Intended clinical | ||
| purpose and use | Visual field examination / to | |
| measure visual field defects | Visual field examination / to | |
| measure visual field defects | ||
| 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 luminance1 | 290 cd/m² | 0.025 - 3,183 cd/m² |
| Background luminance2 | 10 cd/m² | 10 cd/m² |
Predicate Device Comparison
For ease of comparison with the TrueField Analyzer the HFA-II stimulus luminance is given here in units of candela per square meter (cd/m²). Commonly the units used in relation to the HFA-II are apostilbs, the units differ by a scalar constant and the equivalent range is 0.08 – 10,000 apostilbs.
2
[sm10670-0 Ref. 1]
| TrueField Analyzer | HFA-II | |
|---|---|---|
| Number of stimuli | ||
| locations | # Test Pattern | |
| 24 T30-24 | ||
| 40 T30-40 | ||
| 60 T30-60 | ||
| 24 T10-24 | ||
| 44 O30-44 | # Test Pattern | |
| 54 Central 24-2 | ||
| 76 Central 30-2 | ||
| 68 Central 10-2 | ||
| 68 Peripheral 30/60-2 | ||
| Eccentricity limits of | ||
| standard test area | $\pm$ 30 degrees | $\pm$ 24 degrees3 |
| Stimulus spot size | 4, 11 or 14 degrees arc angle4 | 0.43 degrees5 |
| Stimulus spot spacing | ~7.5 to 12.5 degrees6 | Uniform 6° grid spacing7 |
| Proportion of visual | ||
| field test area sampled | 88% |