(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 | $\pm$ 30 degrees | $\pm$ 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% | < 0.5% (for standard 24-2 pattern) |
| Total Test Time | 4 to 5 minutes for both eyes | 5 to 15+ minutes per eye (dependent on test) |
It's crucial to note that the document does not present quantitative results from a specific clinical study aimed at proving diagnostic accuracy (e.g., sensitivity, specificity, agreement with clinical diagnosis) against predefined acceptance criteria for visual field assessment. The "Performance Data" section primarily addresses safety and technical characteristics, and then performs a feature-by-feature comparison to the predicate device to establish substantial equivalence.
2. Sample size used for the test set and the data provenance
The document does not describe a specific clinical test set for diagnostic performance or accuracy. The performance data primarily refers to conformance with product specifications (electrical safety, EMC, IR radiation safety) and a feature comparison. There is no mention of a patient cohort or a dataset used to "test" the device's ability to measure visual field abnormalities from a diagnostic perspective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Since no specific clinical test set for diagnostic accuracy is described, there is no mention of experts establishing ground truth. The device's "Visual Field Defect Assessment" is stated to use "Population sample normal database comparison," which likely refers to an internal reference database rather than expert-adjudicated ground truth for a test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as no dedicated clinical test set with human ground truth assessment is described.
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
There is no mention of an MRMC comparative effectiveness study involving human readers with or without AI assistance. The TrueField Analyzer is described as an "objective device that monitors involuntary responses in the patient's pupils," implying a direct measurement by the device itself, rather than an AI assisting human interpretation of images. The device's technology is a departure from the predicate device which relies on "User feedback (button press)."
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The TrueField Analyzer is described as an "automated perimeter" and an "objective device" that "automatically manages the stimulus presentation and video data acquisition; data analysis, storage and presentation of results for review." This implies a standalone performance mode for the measurement and initial analysis of visual fields. However, the document does not report specific performance metrics (e.g., sensitivity, specificity, accuracy) for this standalone performance in the context of diagnosing visual field defects. The performance data focuses on technical and safety specifications, and comparison of features to a predicate.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document mentions "Population sample normal database comparison" for visual field defect assessment. This suggests the ground truth for identifying abnormalities is based on statistical deviation from a normative database of healthy individuals, rather than expert consensus on specific cases, pathology, or long-term outcomes for a test cohort.
8. The sample size for the training set
The document does not specify a "training set" sample size. While the device uses a "Population sample normal database" for comparison, the size and nature of this database are not disclosed, nor is it referred to as a "training set" in the context of an AI/machine learning model. The technology, while automated, is described in terms of "regression based multifocal analysis" rather than deep learning that would typically involve a distinct training set.
9. How the ground truth for the training set was established
Not applicable, as a distinct "training set" with established ground truth as commonly understood in modern AI/ML device submissions is not described. The "Population sample normal database" would have been established by performing tests on a group of healthy individuals to define the normal range of visual field responses, but the methodology for this is not detailed in the provided text.
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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
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- 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 clinicalpurpose and use | Visual field examination / tomeasure visual field defects | Visual field examination / tomeasure visual field defects |
| Visual system stimulus | Sparse-stimulusmultifocal stimulus | Single spot of variableluminance and size |
| Measurementtechnology | Video camera based pupilmeasurement | User feedback (button press) |
| Visual functionassessment | Regression basedmultifocal analysis | Threshold or suprathresholdsensitivity to spots |
| Visual field defectassessment | Population sample normaldatabase comparison | Population sample Normaldatabase 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.
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[sm10670-0 Ref. 1]
| TrueField Analyzer | HFA-II | |
|---|---|---|
| Number of stimulilocations | # Test Pattern24 T30-2440 T30-4060 T30-6024 T10-2444 O30-44 | # Test Pattern54 Central 24-276 Central 30-268 Central 10-268 Peripheral 30/60-2 |
| Eccentricity limits ofstandard 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 visualfield test area sampled | 88% | < 0.5%8 |
| Total test time | 4 to 5 minutes for both eyes | 5 to 15+ minutes per eye9 |
4 Again for convenience of comparison the HFA-II background luminance is given in cd/m² – normally the HFA-II background luminance is specified in apostilbs (31.5 apostilbs = 10 cd/m ).
3 The HFA-II includes a variety of test patterns at various eccentricity limits, such as 10, 24, 30 and 60 degrees as governed by the various test protocols of that device. Despite those options the vast majority of standard testing on the HFA-II is done with the Central 24-2 test pattern, which has a visual field range of ±24° (degrees). Furthermore when the Central 30-2 test is used, only the inner points matching the Central 24-2 test patterns are used to calculate the Pattern Deviations. For these reasons the HFA-II eccentricity limits for the standard test area are noted here as ±24°.
4 For the T30-24 test. Note that the TFA stimulus is not a circular spot, rather each region is a segment of the total visual field under investigation, and is scaled to account for the hill of vision. The inner ring of the T30-24 stimulus subtends an annulus from 1° to 5° eccentricity, the second ring from 5° to 16° and the third from 16° to 30°. Each annulus is partitioned into 4, 8 and 12 segments respectively, evenly spaced and bounded on the horizontal and vertical meridians thus preserving the quadrants and hemifields of the visual fields. For the T30-24 test pattern the polar angles of the regions in the inner, middle and outer annulus are 90, 45 and 30 degrees respectively giving broadly proportionally sized regions.
3 Goldmann standard size III spot. This is the default spot size used by the HFA unless it is explicitly overridden by the operator. The vast majority of HFA-II tests are conducted with a size III spot.
ී For the T30-24 test. As per the description in footnote 4 above the TrueField Analyzer stimulus test pattern is cortically scaled and spaced to ensure complete coverage of the visual field test area excluding the central fixation disk (subtending the central 1° region).
7 For the standard test patterns (such as 24-2) It is possible to achieve a 4.2° spacing using the HFA-II central 24-2 and the 24-1 test patterns (that is conduct two tests per eye) and then merge the results using features of the HFA software. In practice this is an extremely rare event as it more than doubles the required test time.
8 For the standard central 24-2 test pattern which uses 54 spots each subtending 0.43° of arc (using the standard Goldmann size III stimulus) over the visual field test area eccentricity limits of ±24°, that gives a total coverage = 54 × tan (0.43/2) / tan (24) = 0.003836 = 0.38%. For the central 30-2 test pattern (76 spots each of 0.43° arc over the ±30° of the field) the coverage is = 76 × tan (0.43/2) / tan (30) = 0.32%. In the case of the Central 10-2 test pattern (68 spots each of 0.43° arc over the ±10° of the field) the coverage is = 68 × tan (0.43/2) / tan (10) = 3.1%
³ A series of the HFA-II 750 perimeter using the central 30-2 test pattern (most comparable to the TrueField Analyzer T30-24 pattern in terms of field limits of ±30°) report average test durations to be approximately: SITA Fast 5 minutes, Fastpac 9.4 minutes and Full Threshold 14.6 minutes per eye. (Bengtsson B, et al. 1988 Acta Ophthalmol. Scand. 76:431-7).
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Seeing Machines Limited c/o Alan Donald Matrix Medical Consulting, Inc. 11440 West Bernardo Ct. Suite 300 San Diego, CA 92127-1644
Re: K063310 Trade/Device Name: TrueField Analyzer™ Regulation Number: 21 CFR 886.1605 Regulation Name: Perimeter, Automatic, AC-Powered Regulatory Class: I Product Code: HPT Dated: July 18, 2007 Received: July 20, 2007
Dear Mr. Donald:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
AUG - 3 2007
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
M.B. Egelston, MD
Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
| 510(k) Number: | K063310 |
|---|---|
| Device Name: | TrueField Analyzer |
| Indications For Use: | For the assessment of visual field abnormalities. |
| Prescription Use(21 CFR 801 Subpart D) | ✓ | AND/OR | Over-The-Counter Use(21 CFR 801 Subpart C) | |
|---|---|---|---|---|
| -------------------------------------------- | --- | -------- | ------------------------------------------------ | -- |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Marsha L. Burke Nicholas
(Division S Division of Ophthalmic Ear, Nose and Throat Devises
510(k) Number K063310
§ 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.