(160 days)
The Reprocessed Orbiter ST Steerable Diagnostic Electrophysiology Catheter is intended for temporary intracardiac sensing, recording, stimulation and temporary pacing during the evaluation of cardiac arrhythmias.
The Reprocessed Orbiter ST Steerable Diagnostic Electrophysiology Catheter is a radiopaque, flexible, insulated catheter with a polymer shaft and a 2mm distal tip. The catheter handle has a slider mechanism which, when moved forward or back from the neutral position, results in curvature of the distal tip.
The provided text is a 510(k) Summary for a reprocessed medical device, the "Reprocessed Orbiter ST Steerable Diagnostic Electrophysiology Catheters". It focuses on demonstrating substantial equivalence to a predicate device through functional and safety testing, rather than an AI-driven diagnostic or prognostic device that would have acceptance criteria based on performance metrics like sensitivity, specificity, or AUC.
Therefore, many of the requested items related to AI system performance, such as sample size for test sets, data provenance, expert ground truth adjudication, MRMC studies, and standalone algorithm performance, are not applicable to this type of device submission.
However, I can extract information related to the device's functional and safety testing to present as "acceptance criteria" and "reported device performance" in the spirit of your request.
Here's the closest representation based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
For a reprocessed medical device like this electrophysiology catheter, the "acceptance criteria" are generally based on ensuring that the reprocessed device performs equivalently to a new device and meets established safety and functionality standards. The "reported device performance" reflects the successful demonstration of these criteria through specific validation tests.
| Acceptance Criteria Category | Specific Criteria/Test Outcome | Reported Device Performance (as per document) |
|---|---|---|
| Biocompatibility | Device materials remain safe for patient contact after reprocessing. | Demonstrated successfully. |
| Cleaning Validation | Residual soil and contaminants are effectively removed. | Validated successfully. |
| Sterilization Validation | Device achieves and maintains sterility. | Validated successfully. |
| Functional Testing | ||
| Visual Inspection | Device meets visual quality standards. | Demonstrated successfully. |
| Dimensional Verification | Device dimensions remain within specifications. | Demonstrated successfully. |
| Electrical Continuity and Resistance | Electrical properties remain within specifications. | Demonstrated successfully. |
| Simulated Use | Device performs as intended during simulated clinical use. | Demonstrated successfully. |
| Mechanical Characteristics | Mechanical properties (e.g., steerability, flexibility) remain within specifications. | Demonstrated successfully. |
| Electrical Safety Testing | ||
| Dielectric and Current Leakage | Electrical safety parameters meet standards. | Demonstrated successfully. |
| Packaging Validation | Packaging maintains device integrity and sterility. | Validated successfully. |
| Reprocessing Limits | Not reprocessed more than one (1) time. | Each device marked and tracked to ensure this limit is not exceeded. |
| Source of Reprocessed Device | Only devices not previously reprocessed by other reprocessors. | Innovative Health restricts its reprocessing to exclude devices previously reprocessed by other reprocessors. |
| Equivalence to Predicate | "Safe and effective as the predicate devices." | Innovative Health concludes that the Reprocessed Orbiter ST Steerable Diagnostic EP Catheters are as safe and effective as the predicate devices. |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes (number of catheters) used for each of the functional and safety tests. The provenance of the "data" in this context refers to the reprocessed devices themselves. These are original Orbiter ST Steerable Diagnostic EP Catheters that have been used once and then collected for reprocessing. The document does not specify the country of origin for these used devices, nor does it explicitly state whether the testing data itself is retrospective or prospective, though performance validation studies for reprocessing are typically prospective in their design (i.e., new tests are run on a set of reprocessed devices).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable. Ground truth, in the context of diagnostic AI, refers to a definitive diagnosis or outcome. For a physical medical device, "ground truth" is established through engineering and laboratory testing protocols, and compliance with established standards. This typically involves engineers, quality control specialists, and potentially clinical experts for simulated use environments, rather than experts establishing a "truth" in a diagnostic sense.
4. Adjudication method for the test set
This section is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies where human readers might disagree on a diagnostic assessment. For device performance testing, the results are typically objectively measured against defined specifications, and any deviations would be investigated by engineering/quality teams.
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 section is not applicable. This is a submission for a reprocessed electrophysiology catheter, not an AI-assisted diagnostic or imaging system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable as the device is not an algorithm or AI system.
7. The type of ground truth used
For this device, the "ground truth" or reference standard is:
- Engineering Specifications: The original design and performance specifications of the new predicate device.
- Regulatory Standards: Relevant FDA regulations (e.g., 21 CFR 870.1220 for electrode recording catheters) and consensus standards for biocompatibility, sterility, electrical safety, etc.
- Laboratory Performance Measurements: Objective measurements derived from bench and laboratory testing (e.g., resistance values, dimensional accuracy, mechanical force measurements).
8. The sample size for the training set
This section is not applicable. This device does not involve machine learning or a "training set."
9. How the ground truth for the training set was established
This section is not applicable as there is no training set for this type of device.
§ 870.1220 Electrode recording catheter or electrode recording probe.
(a)
Identification. An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations.(b)
Classification. Class II (performance standards).