(86 days)
The OTI Di-thex Ophthalmic Diathermy Unit is intended to be used for producing haemeostasis in the anterior and posterior segment of the eye, for conjunctival welding (coaptation), retinal coagulation using endodiathermy tips, and for cutting in ophthalmic surgery, using a high frequency current applied by a bipolar probe.
The system consists of a central control unit that supplies radio frequency energy to a handpiece. The unit can be used for standard diathermy procedures, and can be also used as a cutting instrument for membrane dissection in the eye with the appropriate handpieces and tips. Power level is microprocessor-controlled, and the power-level setting is shown by a bar-graph display on the front panel. The system has a set of alarms which alert the user and suspend operation for such cases as overtemperature, overvoltage, and computer errors.
Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and study data for the Di-rhex Ophthalmic Diathermy System:
Summary of Device Performance Data and Acceptance Criteria:
This 510(k) submission for the Di-rhex Ophthalmic Diathermy System relies on substantial equivalence to predicate devices rather than establishing specific quantitative acceptance criteria and performing a rigorous statistical study to meet those criteria. The primary "acceptance criterion" appears to be demonstrating that the device is equivalent in safety and efficacy to existing legally marketed devices, as summarized in section (c) of the "Performance Data."
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Power Output Specifications Met | "The Di-rhex has had power output tests that confirm the specifications." (No specific range or numerical results provided.) |
| Safety Standards Compliance | "The Di-rhex has a safety test from the Canadian Standards Association." (Specific standard or results not detailed.) |
| Software Functionality and Reliability | "The system software has had extensive validation testing." (No details on the scope, methods, or results of validation.) |
| Clinical Safety and Efficacy for Intended Use | "The Di-rhex has had a clinical evaluation in Canada." (No details on the study design, sample size, endpoints, or specific outcomes. The conclusion merely states it's equivalent in safety and efficacy to predicate devices based on this evaluation, among other data.) |
| Equivalence to Predicate Devices (Dutch Ophthalmic USA system, Surgitron Diathermy System) in terms of Safety and Efficacy for intended uses: - Hemostasis in anterior/posterior eye - Conjunctival welding (coaptation) - Retinal coagulation - Cutting in ophthalmic surgery using HF current | "The OTI Di-thex Ophthalmic Diathermy System is equivalent in safety and efficacy to the legally-marketed predicate devices." This is a general statement based on the overall performance data (non-clinical and clinical), rather than a specific comparative study with defined endpoints relative to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance:
- Non-clinical Tests: No sample size is specified for power output tests or software validation. Data provenance would be from internal testing by Ophthalmic Technologies Inc.
- Clinical Tests: The document states "The Di-rhex has had a clinical evaluation in Canada."
- Sample Size: Not specified. No number of patients or procedures is mentioned.
- Data Provenance: Canada (prospective, as it was an "evaluation" of the new device).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Clinical Evaluation: Not specified. The document does not describe how ground truth was established for the clinical evaluation. Given it was a "clinical evaluation," it would inherently involve medical professionals, but their number and specific qualifications (e.g., years of experience, subspecialty) are not provided.
- Non-clinical Tests: Ground truth for these would typically be defined by engineering standards and internal specifications, not expert consensus in the medical sense.
4. Adjudication Method for the Test Set:
- Not specified. There is no mention of an adjudication process for the clinical evaluation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No. The document does not mention an MRMC study. The clinical evaluation appears to be a single-center, uncontrolled assessment, rather than a comparative effectiveness trial involving multiple readers and cases. The claim of equivalence is based on the overall performance compared to predicate devices, not through a direct comparative study with human readers assisted by AI. (Note: Diathermy is a direct energy delivery device, not an imaging AI device, so an MRMC study in the context of interpreting results with AI assistance would not be applicable here.)
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- N/A. This device is a surgical instrument. "Standalone" performance with "algorithm only without human-in-the-loop performance" doesn't directly apply as it's not an AI diagnostic/interpretive algorithm. Its "standalone" performance lies in its ability to deliver the specified energy (which was assessed via power output tests) and function safely (software validation, safety tests). The intended use inherently involves a human operator.
7. The Type of Ground Truth Used:
- Non-clinical Tests: Ground truth for power output tests would be the device's engineering specifications and calibration standards. For software validation, it would be the software requirements and functional specifications.
- Clinical Evaluation: The type of ground truth used for the clinical evaluation is not explicitly stated. However, for a surgical device evaluation, it would implicitly be the clinical judgment of the operating surgeons and post-operative assessment of patient outcomes (e.g., successful hemostasis, coagulation effect) based on standard medical practice. It's not pathology, or a separate "consensus" in the diagnostic sense, but rather the observed clinical results.
8. The Sample Size for the Training Set:
- N/A. This device is a hardware system, not an AI algorithm that requires a "training set" of data in the machine learning sense. The device is designed, tested against specifications, and evaluated clinically.
9. How the Ground Truth for the Training Set Was Established:
- N/A. As above, it's not an AI algorithm with a training set. The "ground truth" for its design and testing would be engineering principles, safety standards, and clinical requirements for ophthalmic diathermy.
§ 886.4100 Radiofrequency electrosurgical cautery apparatus.
(a)
Identification. A radiofrequency electrosurgical cautery apparatus is an AC-powered or battery-powered device intended for use during ocular surgery to coagulate tissue or arrest bleeding by a high frequency electric current.(b)
Classification. Class II.