(203 days)
The STRATUSOCT™ is a high resolution tomographic device for the viewing and axial cross sectional imaging of posterior ocular structures. It is used for in vivo imaging and measurement of the retinal nerve fiber layer, macula, and optic disk. The STRATUSOCT™ with Retinal Nerve Fiber Layer ("RNFL") & Macula Normative Database is a quantitative tool for the comparison of retinal nerve fiber layer and the macula in the human retina to a database of known normal subjects. It is intended for use as a diagnostic device to aid in the detection and management of ocular diseases, including but not limited to, macular edema, central serous retinopathy, and glaucoma.
The STRATUSOCT™ with RNFL & Macula Normative Database is a microprocessor-based low-coherence digital instrument employing low coherence interferometry to generate inages of internal ocular tissue microstructures. The device measures optical reflections or backscatter from tissue using a scanning optical beam. Results obtained for the Retinal Nerve Fiber Layer and the Macula can be compared to a database of known normal human patients.
The provided text focuses on the 510(k) summary for the STRATUSOCT™ with RNFL & Macula Normative Database, primarily discussing its intended use, device description, and substantial equivalence to a predicate device.
Unfortunately, the document does not explicitly state specific acceptance criteria (numerical thresholds for performance metrics) or provide a detailed study that proves the device meets such criteria.
Instead, the submission emphasizes that:
- Clinical evaluation was performed to support expanded indications for use. "Clinical evaluation performed on the STRATUS with RNFL & Macula Normative Database supports the expanded indications for use statement and demonstrates the device is substantially equivalent to the predicate device and does not raise new questions regarding safety and effectiveness with respect to ophthalmoscopes and ultrasonic pulsed echo imaging systems."
- Clinical data was collected on a statistically significant number of normal human patients. "Clinical data was collected on a statistically significant number of normal human patients and analyzed to support the inclusion of the Macula Normative Database in the STRATUSOCT™."
- Testing was deemed necessary to ensure safety and effectiveness. "As described in this 510(k) Summary, all testing deemed necessary was conducted on the STRATUSOCT™ with RNFL & Macula Normative Database to ensure that the device is safe and effective for its intended use when used in accordance with its Instructions for Use."
Given this, I cannot construct the table of acceptance criteria and reported device performance as requested, nor can I provide detailed answers to many of the bullet points, as the specific information is not present in the provided text.
However, I can extract what is implied and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the document. The submission focuses on substantial equivalence to a predicate device and demonstrating safety and effectiveness for expanded indications, rather than meeting specific performance thresholds. | The clinical evaluation was sufficient to demonstrate substantial equivalence and support expanded indications, indicating that the device performs comparably to the predicate and is safe/effective for its intended uses. No specific metrics (e.g., sensitivity, specificity, accuracy) are reported. |
2. Sample size used for the test set and the data provenance
- Sample size for test set: The document states "statistically significant number of normal human patients" for the clinical data collected to support the Macula Normative Database. However, an exact numerical sample size is not provided.
- Data provenance: Not explicitly stated (e.g., country of origin). The data supported the "inclusion of the Macula Normative Database," implying it was used to establish or validate the normative values.
- Retrospective or prospective: Not specified in the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided in the document. The "normative database" suggests comparison to known normal subjects, but the process of establishing "ground truth" for disease states or for the normative data itself (e.g., by expert consensus or other diagnostics) is not detailed.
4. Adjudication method for the test set
- This information is not provided in the document.
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
- An MRMC study is not explicitly mentioned. The device is described as a "quantitative tool for the comparison... to a database of known normal subjects," which is a diagnostic aid. The document does not describe studies on human reader performance improvement with this specific device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- The device is a "diagnostic device to aid in the detection and management of ocular diseases." The "normative database" component is likely a standalone feature comparing patient data to established norms. However, no specific "algorithm-only" performance metrics (e.g., sensitivity, specificity of the device itself in diagnosing disease without human interpretation) are provided. The focus is on the device being a "quantitative tool" for comparison.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the "normative database," the ground truth is implicitly defined by "known normal subjects." For aiding in the detection and management of diseases, the "ground truth" for the clinical evaluation is not specified but would likely involve established diagnostic criteria for those ocular diseases. The document does not detail how these "known normal subjects" or disease diagnoses were confirmed (e.g., by expert consensus, other gold standard tests, pathology).
8. The sample size for the training set
- The document refers to a "database of known normal subjects" and clinical data collected on a "statistically significant number of normal human patients" to support the inclusion of the Macula Normative Database. This implies that these "normal human patients" form the basis of the normative database, which acts as a reference or "training" set for comparison. However, a specific numerical sample size for this database is not provided. The submission mainly discusses the clinical evaluation to support the expanded indications based on this database.
9. How the ground truth for the training set was established
- The ground truth for the "normative database" is established by using "known normal subjects." The criteria or methods used to definitively classify these subjects as "normal" are not detailed in the provided text.
§ 886.1570 Ophthalmoscope.
(a)
Identification. An ophthalmoscope is an AC-powered or battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye.(b)
Classification. Class II (special controls). The device, when it is an AC-powered opthalmoscope, a battery-powered opthalmoscope, or a hand-held ophthalmoscope replacement battery, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.