(164 days)
The intended use of this device is transscleral retinal photocoagulation (TSRPC) for retinopexy.
The IRIS DioPexy Probe is a multiple-use fiber optic laser delivery device with integral optics, which terminates with a contact prism tip. It must be directly connected to a compatible IRIS OcuLight SL or SLx (810 nm-infrared) Photocoagulator. The prism tip is designed to deflect laser energy 90° from the axis of the shaft and be simultaneously act as a scleral depressor. The fiber optic cable is 3 meters (10 feet). The DioPexy Probe is shipped from the factory non-sterile in a hard plastic container. The device can be sterilized between each use in this container using Ethylene Oxide (EtO) gas in accordance with the user instructions.
Here's an analysis of the provided text regarding the DioPexy Probe, focusing on acceptance criteria and supporting studies:
It is important to note that the provided 510(k) summary does not contain explicit performance acceptance criteria (e.g., target accuracy, sensitivity, specificity values) or detailed study results proving the device meets such criteria. The document focuses on demonstrating substantial equivalence to predicate devices based on intended use and technological characteristics, rather than reporting on specific quantitative performance metrics from a dedicated clinical study as would be expected for a diagnostic or AI-driven device.
Therefore, many of the requested sections below will indicate "Not Provided" or "Not Applicable" based on the information given.
Acceptance Criteria and Study Analysis for the DioPexy Probe
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (if stated explicitly) | Reported Device Performance (if stated explicitly) |
|---|---|
| Functional Equivalence: Ability to produce chorioretinal adhesions for retinopexy. | The device enables the ophthalmologist to produce chorioretinal adhesions during retinal detachment surgery using delivery of transscleral infrared laser for retinopexy. Physician observes visible pilot/aiming beam on the retina and monitors/titrates burn development. Chorioretinal adhesion also occurs without visible retinal uptake. |
| Safety: Device operates without causing undue harm. | Implied by substantial equivalence to predicate devices (which are presumably safe). Ethylene Oxide (EtO) sterilization ensures sterility between uses. |
| Compatibility: Compatible with IRIS OcuLight SL or SLx photocoagulators. | Stated as a requirement: "It must be directly connected to a compatible IRIS OcuLight SL or SLx (810 nm-infrared) Photocoagulator." |
| Sterilization: Can be sterilized between uses. | Stated: "The device can be sterilized between each use in this container using Ethylene Oxide (EtO) gas in accordance with the user instructions." |
No quantitative performance metrics (e.g., success rate of adhesion, complication rates) that would typically define "acceptance criteria" for a new medical device are explicitly provided in this 510(k) summary. The summary primarily focuses on establishing substantial equivalence based on the device's functional similarity and intended use to existing devices.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): Not provided. The 510(k) summary does not describe a specific clinical "test set" or study population beyond referencing general clinical practice for retinopexy.
- Data Provenance: Not provided. The summary discusses the general principles of retinopexy and existing devices but does not mention specific clinical data collected for the DioPexy Probe itself, let alone its provenance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not provided.
- Qualifications of Experts: Not provided.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/Not provided. No specific test set or clinical study requiring adjudication is described.
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
- MRMC Study: Not applicable. This document describes a laser delivery probe, not an AI-driven or diagnostic device. Therefore, no MRMC study or AI-assistance comparison was conducted or is relevant here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Not applicable. This device is a surgical instrument that relies entirely on human operation and interpretation (the physician monitoring the burn). It is not an algorithm or an autonomous device.
7. The Type of Ground Truth Used
- Type of Ground Truth: Not explicitly defined in terms of a study. For the predicate devices and the DioPexy Probe, the "ground truth" of successful retinopexy would typically be clinical assessment of chorioretinal adhesion and retinal reattachment, observed by an ophthalmologist, potentially confirmed by imaging over time, and ultimately by positive patient outcomes (prevention of severe visual loss). However, this is discussed at a conceptual level of medical practice rather than as the outcome of a specific clinical trial reported in this document.
8. The Sample Size for the Training Set
- Sample Size (Training Set): Not applicable/Not provided. As this is not an AI/machine learning device, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable. As this is not an AI/machine learning device, there is no "training set" or ground truth establishment for it in that context.
§ 886.4390 Ophthalmic laser.
(a)
Identification. An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.(b)
Classification. Class II.