(49 days)
3nethra neo is used as a wide field retinal imaging digital camera for photo documentation of ocular diseases that manifest in infants.
The 3nethra neo is a compact, portable and easy to use, mydriatic, digital wide field imaging camera used for the photo documentation of ocular diseases that manifest in infant eyes. 3nethra neo needs to be connected to a computer for running the application software, to store, view, retrieve, and export the digital ophthalmic images. The 3nethra neo has a hand-held probe unit, a control box and a foot-pedal control unit. Warm white LED with intensity control via foot-pedal is used to provide illumination to the eye in order to capture images.
Here's a breakdown of the acceptance criteria and the study proving the device meets those criteria, based on the provided text:
Acceptance Criteria and Device Performance
The document doesn't explicitly state "acceptance criteria" in a table format with specific quantitative targets that the device must meet to be cleared. Instead, it details performance testing results, and the overall conclusion is that these results "supportive of substantial equivalence to the predicate devices." The clinical performance data also aims to demonstrate equivalence in diagnostic capability.
However, we can infer some criteria from the performance testing section. The device's performance is presented in comparison to established standards and its predicate devices.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Electrical Safety | Complies with IEC 60601-1 |
| Electromagnetic Compatibility (EMC) | Complies with IEC 60601-1-2 |
| Ophthalmic Instrument Standards | Complies with ISO 15004-2 and ANSI Z80.36 (Group 1 instrument requirements) |
| Central Resolving Power | Greater than 60 lp/mm (verified using an artificial eye and clinical setups, and for the full FOV region) |
| Biocompatibility (Skin Sensitization) | Complies with ISO 10993-10:2010 |
| Biocompatibility (Intracutaneous Reactivity) | Complies with ISO 10993-10:2010 |
| Biocompatibility (Cytotoxicity) | Complies with ISO 10993-5:2009 |
| Clinical Sensitivity for detecting any stage ROP | 97.4% (Observer 1) and 99.3% (Observer 2) |
| Clinical Specificity for detecting any stage ROP | 81.1% (Observer 1) and 75.6% (Observer 2) |
| Kappa for clinical decision and agreement | 0.60 and 79% (Observer 1); 0.90 and 95% (Observer 2) |
| Inter-rater agreeability for staging | 0.8 and 73.4% agreement |
| Identification of Zone 3 ROP | All (n=27) Zone 3 diseases correctly identified by both observers |
Study Details
The document describes a clinical study to evaluate the performance of the 3nethra neo device.
2. Sample size used for the test set and the data provenance:
- Sample Size: 128 premature Asian Indian Infants (144 sessions were analyzed).
- Data Provenance: From 35 neonatal centers in India (implied by "premature Asian Indian Infants"). The study was prospective in nature, as infants were screened using both devices "alternately with either device first."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Two Retinopathy of Prematurity (ROP) specialists.
- Qualifications: "Two ROP specialists masked to the origin of the randomly presented images." No further specific qualifications (e.g., years of experience) are provided in this document excerpt.
4. Adjudication method for the test set:
- The two ROP specialists "reported the presence of retinal immaturity, maturity or on the stage of Retinopathy of Prematurity (ROP) and zone of involvement, for each eye, in each session and reached a 'decision' on whether to treat, follow-up or discharge the baby based on the findings in both eyes." This suggests a consensus-based adjudication, but the exact method (e.g., 2+1, discussions, independent review) is not explicitly detailed beyond "reached a 'decision'". The "kappa for clinical decision and agreement" also indicates an assessment of their agreement.
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:
- This was not an MRMC comparative effectiveness study involving AI assistance for human readers. The study compared the imaging new device (3nethra neo) to a predicate device (RetCam), both used by human readers (ROP specialists). The document does not mention any AI component or AI assistance for readers in the clinical study.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, a standalone algorithm performance study was not described. The clinical study evaluates the 3nethra neo imaging device when used by human ROP specialists.
7. The type of ground truth used:
- The ground truth was established by expert consensus/adjudication of two ROP specialists. They made diagnoses and clinical decisions based on images from both devices. (Note: The study compares the imaging device's performance to a predicate, with expert readers acting as the "interpreters" of the images to determine the clinical ground truth within the study context).
8. The sample size for the training set:
- The document does not provide information about a training set or its sample size. This is expected as the device being described is an imaging camera, not a standalone AI diagnostic tool.
9. How the ground truth for the training set was established:
- As no training set is mentioned for the 3nethra neo in this document, this information is not applicable/provided.
§ 886.1120 Ophthalmic camera.
(a)
Identification. An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.(b)
Classification. Class II (special controls). The device, when it is a photorefractor or a general-use ophthalmic camera, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.