(11 days)
KOWA SL-15 is an ophthalmic device indicated for non-invasive illumination, magnification and observation of the human eye. It consists of a hand-held, battery powered slit-lamp biomicroscope with viewing and illumination optical systems and an AC-powered stand.
KOWA SL-15 is an ophthalmic device indicated for non-invasive illumination, magnification and observation of the human eye. It consists of a hand-held, battery powered slit-lamp biomicroscope with viewing and illumination optical systems and an AC-powered stand.
The provided document is a 510(k) premarket notification for the Kowa SL-15 Slit Lamp. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a clinical study with acceptance criteria, sample sizes, and ground truth establishment in the way typically seen for novel AI/medical device performance claims.
Therefore, many of the requested elements for describing "the acceptance criteria and the study that proves the device meets the acceptance criteria" are not found in this document. This submission primarily relies on engineering and design comparisons to an existing, legally marketed device (the Kowa Portable Slit Lamp SL-14).
Here's an analysis based on the provided text, addressing the points where information is available or noting where it is not applicable for this type of submission:
Summary of Acceptance Criteria and Device Performance (Based on Substantial Equivalence)
The acceptance criteria for the KOWA SL-15 are implicitly set by its substantial equivalence to the predicate device, the KOWA Portable Slit Lamp SL-14. This means the device must perform similarly and be as safe and effective as the predicate. The "study" is a comparative analysis of specifications and design changes.
1. A table of acceptance criteria and the reported device performance
Since this is a substantial equivalence submission for a traditional medical device (not an AI algorithm), the "acceptance criteria" are the specifications and performance characteristics of the predicate device. The "reported device performance" is the KOWA SL-15's specifications, which are deemed "substantially equivalent" for the majority of features.
| Feature / Acceptance Criteria (from Predicate SL-14) | Reported Device Performance (KOWA SL-15) | Met/Not Applicable (NA) | Notes |
|---|---|---|---|
| Indications For Use: Non-invasive illumination, magnification, and observation of the human eye. | Same | Met | Explicitly stated as "Same". |
| Microscope Angle of convergence: 13 degree | Same | Met | Explicitly stated as "Same". |
| Magnification: 10X/16X | Same | Met | Explicitly stated as "Same". |
| Reticles: Built-in both oculars | Same | Met | Explicitly stated as "Same". |
| Magnification change: 16X and 10X changed through movement of objectives. | Same | Met | Explicitly stated as "Same". |
| Range of interpupillary distance adjustment: 50mm to 70mm | Same | Met | Explicitly stated as "Same". |
| Range of examiner's dioptric protection adjustment: -8D to +4D | Same | Met | Explicitly stated as "Same". |
| Slit projection unit Slit selection: Turret | Same | Met | Explicitly stated as "Same". |
| Slit length: 12mm Fixed | Same | Met | Explicitly stated as "Same". |
| Slit width: 0.1, 0.2, 0.8mm and φ12 spot | Same | Met | Explicitly stated as "Same". |
| Light Intensity selection: Three selection: Full, 1/2 and 1/4 | Three selection: Full, 1/4 and 1/16 | Partially Met | Modification: Light intensity options differ, but still offers three selections. Likely considered equivalent in function. |
| Slit projection angle: 60 degree for Horizontal | Same | Met | Explicitly stated as "Same". |
| Filter: Built-in blue filter | Same | Met | Explicitly stated as "Same". |
| Light source: 7.2V, 15W Halogen lamp | 7.5V, 15W Halogen lamp | Partially Met | Modification: Small voltage change for the halogen lamp. |
| Duration of illumination: Approximately 20 minutes | Approximately 40 minutes | Met (Improved) | Modification: Improved battery life. This is a positive change. |
| Electric rating: DC 9V, 15W | DC 8.4V, 15W (Lithium-ion rechargeable battery) | Partially Met | Modification: Change due to new battery type. |
| Power unit Type and electric rating: Charger / Slit lamp stand | Same | Met | Explicitly stated as "Same". |
| Input voltage: AC 100/117/220/240V, 50/60Hz | AC 100-240V, 50/60Hz | Partially Met | Modification: Wider input voltage range, indicating improved compatibility. |
| Power consumption: 70VA | 90VA | Partially Met | Modification: Increased power consumption. This likely relates to the new charging circuitry for the Li-ion battery or the new power unit. |
| EMC compliance with safety standards: - | IEC60601-1-2: 2001 | NA | New: The predicate did not list this, indicating an update to safety standards for the new device. |
| Safety compliance with safety standards: - | IEC60601-1: 1988 | NA | New: The predicate did not list this, indicating an update to safety standards for the new device. |
| Microscope Size: 95mm(W)x214mm(D)x213mm(H) | 221mm(W)x106mm(D)x214mm(H) | Partially Met | Modification: Significant change in dimensions. While different, it is for a hand-held device and likely does not affect fundamental safety/effectiveness for its intended use. |
| Microscope Weight: 900g | 790g | Met (Improved) | Modification: Lighter weight. This is a positive change. |
| Power unit Size: Type A: 190mm(W)x250mm(D)x125mm(H), Type B: 150mm(W)x250mm(D)x97mm(H) | 124mm(W)x253mm(D)x68mm(H) | Partially Met | Modification: Different dimensions for the power unit. |
| Power unit Weight: Type A: 3.5kg, Type B: 2.5kg | 1.25kg | Met (Improved) | Modification: Lighter power unit. This is a positive change. |
Key modifications identified:
- Change to Lithium-ion rechargeable battery.
- Modification of charging circuit for Lithium-ion battery.
- Modification of power unit to switching regulator.
- Change of lamp bulb from 7.2V/15W to 7.5V/15W Halogen lamp.
- Improved illumination duration (40 min vs 20 min).
- Lighter microscope and power unit.
- Updated compliance with EMC and Safety standards.
2. Sample sized used for the test set and the data provenance
- Sample Size for Test Set: Not applicable. This submission relies on engineering comparison and compliance with standards rather than a clinical test set of patient data with a specific sample size.
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. There was no clinical "test set" and thus no ground truth established by experts in this context. The substantial equivalence argument rests on the predicate device's established safety and effectiveness.
4. Adjudication method for the test set
- Not applicable.
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
- Not applicable. This is not an AI device and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. The "ground truth" here is the long-established safety and effectiveness of the predicate device (KOWA Portable Slit Lamp SL-14) based on its market history and regulatory clearance. The KOWA SL-15 is demonstrated to be substantially equivalent through design and specification comparison.
8. The sample size for the training set
- Not applicable. This is not an AI device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable.
§ 886.1850 AC-powered slitlamp biomicroscope.
(a)
Identification. An AC-powered slitlamp biomicroscope is an AC-powered device that is a microscope intended for use in eye examination that projects into a patient's eye through a control diaphragm a thin, intense beam of light.(b)
Classification. Class II (special controls). The device, when it is intended only for the visual examination of the anterior segment of the eye, is classified as Group 1 per FDA-recognized consensus standard ANSI Z80.36, does not provide any quantitative output, and is not intended for screening or automated diagnostic indications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.