(169 days)
The Humphrey OCT3 is a high resolution tomographic device for the viewing and axial measurement of posterior ocular structures. It is used in the detection and in the detection and disk. It is intended for use as a diagnostic aid as well as macular edema, central serous retinopathy and glaucoma.
The Humphrey OCT employs the principle of low coherence interferometry based upon the Michelson interferometer. In a Michelson interferometer, the light from a source is split into a sample path and a reference path containing a mirror. Light reflected back from the sample path and the reference path will create an interference pattern on a detector if the optical path lengths between the reference and sample are identical. Adjusting the length of the reference path will allow a semi-transparent sample, such as the retina, to be cross-sectionally scanned. The Super-Luminescent Diode (SLD) used in the Humphrey OCT Scanner permits a short coherence length in air. Accounting for the index of refraction of the eye, this translates to an even shorter coherence length within the retina. The SLD emits near infrared light which is scattered by the various interfaces and structures of the retinal tissue. As the reference arm is moved, a depth profile of the retina is produced which is similar to ultrasound A-scan. The profile plots variations in optical reflectivity between the different layers of the retina. Two mirrors mounted to galvanometers deflect the SLD beam within the eye. Scanning the retina in this manner produces cross-sectional images similar to ultrasound Bscan but of much higher resolution. The tomographic images of the retina produced by the OCT scanner provide an important tool in the diagnosis of retinal disorders and diseases that manifest themselves in the posterior pole of the eye.
The provided document describes a 510(k) Pre-market Notification for the Humphrey OCT 3 (Optical Coherence Tomography Model 3000), seeking substantial equivalence to existing devices. This type of submission generally doesn't include a new, comprehensive clinical study with clearly defined acceptance criteria and performance metrics in the way a PMA (Pre-market Approval) would.
Instead, the submission relies on demonstrating substantial equivalence by referencing existing literature and clinical studies that support the efficacy and safety of Optical Coherence Tomography (OCT) technology in general, and specifically the predecessors or similar devices. It highlights the device's technical specifications and how they align with or improve upon existing, legally marketed predicate devices.
Therefore, many of the requested fields cannot be directly extracted as the information is not presented in the format of a novel clinical trial for device approval. Here's a breakdown based on the provided text:
Acceptance Criteria and Device Performance (Not Applicable - See Explanation Below):
- Explanation: The document does not explicitly state "acceptance criteria" and "reported device performance" in terms of specific numerical thresholds that the Humphrey OCT 3 had to meet in a new study. Instead, it asserts substantial equivalence by referencing prior studies and the known capabilities of OCT technology for imaging and measurement. The claims revolve around the device's ability to image and measure ocular structures, similar to predicate devices.
Table of Acceptance Criteria and Reported Device Performance:
| Feature/Metric | Acceptance Criterion (Implicit/Referenced) | Reported Device Performance (Reference) |
|---|---|---|
| Safety | Not to exceed ACGIH/ICNIRP limits for human ocular exposure | "maximum output power of the IR LED is well below the continuous ACGIH/ICNIRP limit of 2mW." |
| Reproducibility of RNFL & Retinal Thickness | Qualitatively demonstrated in prior studies | "reproducibility of OCT measurements for RNFL and retinal thickness has been tested by numerous clinical trials." (e.g., Konno & Akiba et al (2001), Blumenthal et al (2000)) |
| Early Glaucoma Detection | Improved detection compared to other methods | "increased detection of RNFL damage by the OCT, improves early glaucoma detection." (Zangwill 2000); "OCT was more sensitive than standard automated perimetry or scanning laser polarimetry" (Bowd and Zangwill 2001) |
| Differentiation of Glaucomatous Eyes | Ability to distinguish between non-glaucomatous and glaucomatous eyes | "able to differentiate between non glaucomatous and glaucomatous eyes using the OCT." (Hoh and Greenfield, et al 2000) |
| Discrimination of Normal vs. Glaucomatous Visual Field Loss | No significant difference in sensitivity compared to qualitative stereo photographs | "Qualitative assessments of stereo photographs and OCT measurements had no significant differences in sensitivities." (Zangwill and Bowd 2001) |
| Ability to Image and Measure Ocular Structures | Functional capability similar to predicate devices | "safe and effective tool for the imaging and measurement of ocular structures." |
| Scan Rate | Equivalent or improved compared to predicate | "increased scan rate for high resolution scanning." |
Detailed Information on Studies (Where Applicable):
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Sample Size Used for the Test Set and Data Provenance:
- Not applicable for a single new "test set" for this submission. The document refers to multiple studies.
- Examples from referenced studies:
- Hoh and Greenfield et al. (2000): 78 patients (implied origin is clinical study, likely prospective within the context of the original research, but presented retrospectively in this 510(k)).
- Zangwill and Bowd (2001): Studied "normal healthy eyes and eyes with early to moderate glaucomatous visual field loss". Sample size not explicitly stated in this summary, but would be from a clinical research setting.
- Other studies (Konno & Akiba, Blumenthal, Zangwill 2000, etc.) are clinical trials. Data provenance generally implies clinical settings, likely multiple countries given the international scope of research. All referenced studies are retrospective in the context of this 510(k) submission, meaning previously published research.
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Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable for a single new test set. For the referenced studies, ground truth would have been established by attending clinicians, ophthalmologists, and researchers at the institutions conducting those studies. The specific number and qualifications are not provided in this 510(k) document, but generally, ophthalmic studies involving glaucoma or retinal conditions would use qualified ophthalmologists.
- Independent safety analysis: "an internationally recognized expert in the field of optical radiation hazards and safety" performed this.
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Adjudication Method for the Test Set:
- Not applicable for a single new test set. Adjudication methods would have been specific to each referenced clinical study, but are not detailed in this 510(k).
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study is not specifically mentioned as being conducted for this 510(k) submission. The document cites studies that compare OCT's effectiveness against other diagnostic methods (e.g., "OCT was more sensitive than standard automated perimetry or scanning laser polarimetry" or comparison with "retinal nerve fiber layer photography").
- Effect Size of Human Readers with vs. without AI Assistance: Not applicable, as this is a device for imaging and measurement, not an AI-assisted diagnostic algorithm in the sense of comparing human performance. The "AI" (algorithm) here is the OCT's inherent measurement and imaging capability.
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Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Yes, implicitly. The device itself, the Humphrey OCT 3, performs the imaging and provides measurements (e.g., RNFL thickness). The performance of these measurements and interpretations is what the referenced studies evaluate. While a human clinician interprets the OCT images and data, the "standalone" performance refers to the device's ability to produce those accurate and reproducible images and measurements. The studies cited, such as those on "reproducibility of nerve fiber layer thickness measurements by optical coherence tomography," directly assess this standalone capability.
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Type of Ground Truth Used:
- For the referenced studies, ground truth varies:
- Clinical Diagnosis: Differentiation between "non glaucomatous and glaucomatous eyes" (Hoh and Greenfield, et al 2000) implies a clinical diagnosis made by ophthalmologists using a suite of tests.
- Visual Field Tests: Correlation with "visual field defect documented with visual field tests in glaucoma patients" (Shuman et al 1995).
- ONH Photographs: Correlation with "RNFL drop out observed in ONH photographs" (Shuman et al 1995).
- Pathology/Outcome data: Not explicitly mentioned, but the clinical diagnosis of glaucoma often involves an assessment of the optic nerve head (ONH) and visual field, which are surrogates for the underlying pathology.
- For the referenced studies, ground truth varies:
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Sample Size for the Training Set:
- Not applicable. This submission is for a medical device (hardware and software for imaging), not a machine learning model that requires a distinct "training set" in the modern AI sense. The development of the OCT technology itself, its algorithms for image processing and measurement, would have involved extensive engineering and validation, but not a formally defined "training set" in the context of this 510(k). The referenced clinical studies serve as validation of the technology's utility, not as training data for a new ML model.
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How the Ground Truth for the Training Set Was Established:
- Not applicable for the same reason as above. If there were internal software algorithms that learned from data, the ground truth would have been established by engineering teams against known physical principles and clinically relevant measurements. This is not detailed in the 510(k).
§ 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.