(126 days)
The NovoSci ™ Ready System® is indicated for use in surgical procedures requiring extracorporeal circulation and gas exchange support for 6 hours or less.
The NovoSci" Ready System® is a closed loop extracorporeal system providing circulatory, thermal and gas-exchange support for extracorporeal perfusion. The NovoSci" Ready System® is provided as a sterile system with a non-pyrogenic fluid pathway for single use only and is not to be re-sterilized by the user.
The provided text describes a 510(k) premarket notification for the NovoSci™ Ready System®, an extracorporeal system. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a new, innovative device. Therefore, much of the requested information regarding AI model performance, human reader studies, and detailed ground truth establishment is not applicable to this submission.
Here's a breakdown of the information that can be extracted and explanations for what cannot:
1. A table of acceptance criteria and the reported device performance
The submission does not explicitly list "acceptance criteria" in the way one would for an AI algorithm's performance metrics (e.g., sensitivity, specificity, AUC). Instead, it relies on demonstrating substantial equivalence to a predicate device through non-clinical testing.
| Acceptance Criteria (Implied by Substantial Equivalence to Predicate) | Reported Device Performance (Non-clinical testing) |
|---|---|
| Biocompatibility: Equivalent safety profile regarding interactions with biological systems. | "Biocompatibility...testing were performed to demonstrate equivalence." |
| In-vitro performance: Safe and effective operation in laboratory settings. | "in-vitro...testing were performed to demonstrate equivalence." |
| Performance testing (Mechanical/Functional): Meets functional requirements for extracorporeal circulation and gas exchange. | "performance testing were performed to demonstrate equivalence. These tests included: blood damage, reservoir pressure drop, minimum operating volume, micro air, vacuum pressure, flow rate vs. vacuum." |
| Duration of Use: Capable of supporting extracorporeal circulation and gas exchange for 6 hours or less. | "The NovoSci™ Ready System® is indicated for use in surgical procedures requiring extracorporeal circulation and gas exchange support for 6 hours or less." (This is an indication for use, which implies performance within this timeframe.) |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the given text. Non-clinical testing typically involves bench-top tests, simulations, and material analyses rather than patient-derived "test sets" in the context of an AI device.
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)
This information is not applicable/not provided. Ground truth establishment by experts is relevant for diagnostic AI devices where human interpretation is being benchmarked. For an extracorporeal circulation system, "ground truth" is typically defined by engineering specifications, validated test methods, and compliance with industry standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable/not provided. Adjudication methods are used in studies involving human interpretation or agreement, typically for diagnostic accuracy studies of AI.
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 information is not applicable/not provided. The NovoSci™ Ready System® is a medical device for extracorporeal circulation, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study or AI assistance metrics are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/not provided. As explained above, this is not an AI device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For this type of device, the "ground truth" for non-clinical testing would involve:
- Engineering specifications and standards: Performance parameters like flow rate, pressure drop, and blood damage are compared against pre-defined, acceptable ranges established through engineering principles and regulatory guidelines for similar devices.
- Predicate device performance data: The NovoSci™ Ready System®'s performance is compared against the known, established performance of the legally marketed predicate devices (Jostra MECC System, V-bag, V-box). This acts as a de-facto "ground truth" for what constitutes safe and effective performance.
8. The sample size for the training set
This information is not applicable/not provided. This is not an AI device, so there is no "training set."
9. How the ground truth for the training set was established
This information is not applicable/not provided. As not an AI device, there is no "training set" or ground truth established for it in that context.
§ 870.4360 Nonroller-type blood pump.
(a)
Nonroller-type cardiopulmonary and circulatory bypass blood pump —(1)Identification. A nonroller-type cardiopulmonary and circulatory bypass blood pump is a prescription device that uses a method other than revolving rollers to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either:(i) Full or partial cardiopulmonary bypass (
i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or(ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.
(2)
Classification —Class II (special controls). The special controls for this device are:(i) Non-clinical performance testing must perform as intended over the intended duration of use and demonstrate the following: Operating parameters, dynamic blood damage, heat generation, air entrapment, mechanical integrity, and durability/reliability;
(ii) The patient-contacting components of the device must be demonstrated to be biocompatible;
(iii) Sterility and shelf life testing must demonstrate the sterility of patient-contacting components and the shelf life of these components; and
(iv) Labeling must include information regarding the duration of use, and a detailed summary of the device- and procedure-related complications pertinent to use of the device.
(b)
Nonroller-type temporary ventricular support blood pump —(1)Identification. A nonroller-type temporary ventricular support blood pump is a prescription device that uses any method resulting in blood propulsion to provide the temporary ventricular assistance required for support of the systemic and/or pulmonary circulations during periods when there is ongoing or anticipated hemodynamic instability due to immediately reversible alterations in ventricular myocardial function resulting from mechanical or physiologic causes. Duration of use would be less than 6 hours.(2)
Classification. Class III (premarket approval).(c)
Date premarket approval application (PMA) or notice of completion of product development protocol (PDP) is required. A PMA or notice of completion of a PDP is required to be filed with FDA on or before September 8, 2015, for any nonroller-type temporary ventricular support blood pump that was in commercial distribution before May 28, 1976, or that has, on or before September 8, 2015, been found to be substantially equivalent to any nonroller-type temporary ventricular support blood pump that was in commercial distribution before May 28, 1976. Any other nonroller-type temporary ventricular support blood pump shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.