(58 days)
The IRIDEX OtoProbe is intended for use in surgical procedures for use in incision, excision, coagulation, and vaporization of soft and fibrous tissue including osseous tissue in the medical specialty of ENT surgery. The IRIDEX OtoProbe is cleared for use for the particular indications of the compatible laser system to which it is attached.
The IRIDEX OtoProbe is comprised of the following main components:
- A glass fiber optic protected by a medical grade stainless steel needle and handle at the distal (patient) end and by a plastic jacket at the proximal (laser connection) end: and
- . A universal SMA laser connector.
The IRIDEX OtoProbe is provided as a sterile, single use laser energy delivery system device (accessory). The universal SMA connector at the proximal end of the optical fiber delivery device is designed to be attached to the optical fiber Laser Port of the IRIDEX OcuLight laser system or other 532 nm laser system with universal SMA compatibility that has been qualified by IRIDEX for use with the IRIDEX OtoProbe.
This document is stating "substantial equivalence" of the IRIDEX OtoProbe to previously cleared predicate devices, rather than establishing new performance criteria through a study. Therefore, the traditional acceptance criteria and study data format you've requested for a device proving it meets acceptance criteria are not directly applicable here.
Here's how to interpret the provided information in the context of your request:
The core of this submission is about demonstrating that the new device, IRIDEX OtoProbe, is as safe and effective as existing, legally marketed devices, not about proving specific numerical performance targets.
The document doesn't report on a study designed to establish new performance metrics for the IRIDEX OtoProbe, nor does it provide a table of acceptance criteria and reported device performance in the way you've outlined. Instead, it relies on the established safety and effectiveness of its predicate devices.
Let's break down why your requested categories either aren't addressed or have a different interpretation in this context:
1. A table of acceptance criteria and the reported device performance
- Not applicable in the direct sense. This document does not present a table of numerical acceptance criteria (e.g., sensibility, specificity thresholds) and corresponding measured performance for the IRIDEX OtoProbe.
- Implicit "Acceptance Criteria": The implicit acceptance criteria here are that the IRIDEX OtoProbe:
- Shares the same or similar indications for use as the predicate devices.
- Has similar device operation, overall technical, and functional capabilities as the predicate devices.
- Is substantially equivalent in safety and effectiveness to the predicate devices.
- Reported Device Performance: The document states that "The review of the indications for use and technical characteristics provided demonstrates that the IRIDEX OtoProbe is substantially equivalent to the predicate devices." This is the "reported performance" against the implicit acceptance criteria of substantial equivalence.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. There is no "test set" or clinical study data presented in this 510(k) summary that required a sample size for patient data or a specific provenance. The "test" here is a comparison of the device's design, indications, and functional features to those of the predicate devices.
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)
- Not applicable. This submission doesn't involve clinical "ground truth" derived from expert consensus on patient data. The "ground truth" for substantial equivalence is the FDA's acceptance of the predicate devices' safety and efficacy, and a comparison of the new device to those established devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Since there's no clinical "test set" requiring ground truth establishment, no adjudication method was used.
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 a physical medical device (laser probe accessory), not an AI-powered diagnostic or assistive tool. MRMC studies are irrelevant in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. Again, this is a physical medical device, not an algorithm. Standalone performance studies in the AI sense are not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Implicit "Ground Truth": The "ground truth" is the regulatory clearance and established safety/effectiveness profiles of the identified predicate devices (Lumenis EndoOto Probe, CeramOptec MegaBeam Fiber Optic Delivery System, Biolitec Megabeam Endo-ENT Probe). The IRIDEX OtoProbe is considered "equivalent" based on its design, intended use, and functional characteristics aligning with these already cleared devices.
8. The sample size for the training set
- Not applicable. There is no "training set" in the context of an algorithm or AI model for this device.
9. How the ground truth for the training set was established
- Not applicable. As there's no training set, there's no ground truth establishment for one.
In summary:
The provided document is a 510(k) summary for a medical device accessory seeking clearance via the "substantial equivalence" pathway. This pathway does not typically involve new clinical studies to establish performance against new acceptance criteria. Instead, it relies on demonstrating that the new device is fundamentally similar in design, function, and intended use to devices already cleared by the FDA. Therefore, the detailed study-related information you requested is not present in this type of regulatory submission.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.