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510(k) Data Aggregation
(42 days)
The RyMed Technologies InVision-Plus™ Injection Port Systems are intended for single patient use in intravenous and blood administration sets without need for needles, thus eliminating the potential for needle-stick injuries during use.
The RyMed Technologies INVISION-PLUS™ Injection Port Systems are composed of either a Heparin Lock Injection Port, or a Y - Injection Port that contain a specialized two part valve made from medical grade Silicone material. The female luer housing, guide washer, and heparin lock are made from medical grade plastics. The valve provides excellent fluid Flow Rates, low Priming Volumes, and reseals after extended use.
The provided document is a 510(k) premarket notification for a medical device (RyMed Technologies INVISION-PLUS™ Injection Ports), not a study report for an AI/ML device. Therefore, the specific information requested in points 2-9 (related to AI/ML study design) is not applicable or cannot be extracted from this document.
However, I can extract and present the acceptance criteria for the device and its reported performance based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria | Reported Performance (RyMed InVision-Plus™) |
|---|---|---|
| Fluid reflux | <0.015 ml | 0.012 ml (Met criteria) |
| Fluid flow rate w/18 ga catheter | ≥ 1.30 mL/second | 1.47 mL / sec. (Met criteria) |
| Priming volume | < 0.04 mL | 0.0333 mL (Met criteria) |
| Reseal after IV Push (when using normal saline) | Must reseal after 96 hours use | Met criteria |
| Reseal after IV Drip (when using normal saline) | Must reseal after 96 hours use | Met criteria |
| Reseal (when using blood) | Must reseal after 24 hours use | Met criteria |
| Reseal (when using lipids) | Must reseal after 48 hours use | Met criteria |
Explanation of how the device meets acceptance criteria:
The document explicitly states "Met criteria" in the "RyMed InVision-Plus™" column for each of the reseal tests. For fluid reflux, flow rate, and priming volume, specific numerical values are provided that fall within the defined acceptance criteria (e.g., 0.012 mL fluid reflux is less than the <0.015 mL acceptance criteria).
Regarding the AI/ML specific criteria (Points 2-9):
The provided document is a Summary of Safety and Effectiveness for the RyMed Technologies INVISION-PLUS™ Injection Ports, which is a medical device (injection port system). This document describes the device's functional characteristics and its substantial equivalence to a predicate device for market clearance (510(k) submission).
It does not involve Artificial Intelligence (AI) or Machine Learning (ML). Therefore, the questions related to:
- Sample size for test set and data provenance
- Number of experts for ground truth and their qualifications
- Adjudication method for the test set
- Multi-reader multi-case (MRMC) comparative effectiveness study
- Standalone algorithm performance
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Sample size for the training set
- How ground truth for the training set was established
are not applicable to this device and cannot be answered from the provided text. The performance data presented are from bench testing of the physical medical device.
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