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510(k) Data Aggregation
(208 days)
ENROXTECH, INC.
This device is intended to transmit light for illumination purposes from the light source to endoscopes.
A 5mm fiber-optic light transmitting core with durable protective sleeve and stainless steel couplings at each end. One coupling is for the light source and the opposite end for connection to an endoscope. The core is inserted into a durable and reusable silicone rubber sheath. One length is available: 7.5 Feet. Field replaceable fiber-optic core.
The provided document is a 510(k) premarket notification for a medical device called "Endo-Cord," which is a surgical lamp (fiber-optic light transmission cable). The primary purpose of this submission is to demonstrate substantial equivalence to legally marketed predicate devices.
The document describes non-clinical testing performed to establish the device's substantial equivalence, focusing on light transmission properties, cleaning validation, and sterilization validation. It does not describe a study involving human subjects, AI assistance, or expert readers, which would be relevant for devices that perform diagnostic interpretations or require human-in-the-loop performance studies (e.g., AI algorithms for medical image analysis).
Therefore, I can only provide information based on the presented non-clinical "study" for this specific device. Many of your requested points relate to studies involving human expertise and AI, which are not applicable to the information given for the Endo-Cord.
Here's the information parsed from the document:
1. A table of acceptance criteria and the reported device performance:
| Parameter | Acceptance Criteria (Implicit) | Reported Device Performance (Endo-Cord) | Predicate Device (Sunoptics) Performance | Result |
|---|---|---|---|---|
| Light Transmission - High | Within reasonably close proximity to predicate (quantitative criteria not explicitly stated but implied by comparison) | Average: 650 | Average: 618 | 5.0% difference from Sunoptics. Concluded as substantially equivalent. |
| Light Transmission - Medium | Within reasonably close proximity to predicate | Average: 314 | Average: 305 | 2.8% difference from Sunoptics. Concluded as substantially equivalent. |
| Light Transmission - Low | Within reasonably close proximity to predicate | Average: 28 | Average: 27 | 3.6% difference from Sunoptics. Concluded as substantially equivalent. |
| Cleaning Validation | Meets AAMI TIR30 Cleaning of Reusable Medical Devices standard | Meets AAMI TIR30 | N/A (implicit that predicate similarly cleans) | Meets standard. |
| Steam Sterilization Validation | Supports a sterility assurance level (SAL) of 10-6 | Supports a cycle of Prevacuum, 130° C, 4 min exposure, 20 min drying cycle with SAL 10-6 | N/A (implicit that predicate similarly sterilizes) | Supports specified cycle and SAL. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size:
- For the light transmission testing, the ranges (e.g., "639-658") suggest multiple measurements were taken for both the Endo-Cord and Sunoptics cords, but the exact number of cords tested or measurements taken per cord is not specified.
- For cleaning and sterilization validation, specific sample sizes are not provided, only that the validation "meets" the standard.
- Data Provenance: Not specified, but generally, such tests for FDA submissions are conducted domestically (USA) in a controlled laboratory setting. It is not a retrospective or prospective clinical study.
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 study is a non-clinical, bench-top performance and validation study of a physical device (light cable). It does not involve human interpretation or subjective assessment that would require expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. As a non-clinical performance study, there is no need for adjudication of human interpretation.
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
- No. An MRMC comparative effectiveness study was not done. This device is a fiber-optic light cable for illumination, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a hardware device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" for the non-clinical testing was based on objective physical measurements (e.g., light intensity output) compared against a predicate device and adherence to recognized industry standards (AAMI TIR30 for cleaning, and ISO/AAMI standards for sterilization, implied by the SAL of 10-6).
8. The sample size for the training set
- Not applicable. This is a hardware device, not a machine learning algorithm. Therefore, there is no training set.
9. How the ground truth for the training set was established
- Not applicable. As there is no training set, no ground truth was established for it.
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