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510(k) Data Aggregation
(111 days)
Paladin Biomedical Corporation ThermoStat 900 Administration Set is intended to be used with the MMS Thermostat 900 Blood and Fluid Warmer. The disposable cartridge and administration set is intended to deliver high volume, rapid administration of blood and physiological fluids when connected to a large bore catheter. The set is intended to help prevent hypothermia in patients receiving large volumes of fluids.
There are two configurations of the administration set the ASH200 (High flow - 2 spike) and ASH300 (high flow - 3 spike). Materials of construction are all known biocompatible materials. The set consists of three major sub assemblies:
- tubing and administration set consisting of tubing, spikes, clamps, luers, . drip chambers
- filter/vent assembly .
- cartridge assembly. .
This document is a 510(k) summary for the Paladin Biomedical Corporation ThermoStat 900 Administration Set. It identifies the device as an infusion fluid warmer and compares it to a predicate device, the Microwave Medical System ThermoStat 900 Blood & IV Fluid Adm. Set (K970045).
Here's an analysis of the provided information about acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria in a table format. Instead, it uses a qualitative equivalency statement.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantially Equivalent (in design, materials, construction, and intended use) to predicate device. | "The Paladin Biomedical Administration Set and the MMS Administration Sets were compared with respect to various attributes (Dimensions, warming method, filter size, flow rate, and maximum pressure) and determined to be the same with respect to materials, design, specifications, construction, and performance." |
| Does not raise any new safety and efficacy concerns compared to the predicate device. | "Since the Paladin device is the same in intended use and technological characteristics as the predicate device, the Paladin device does not raise any new safety and efficacy concerns when compared to these similar legally marketed devices." |
| Capable of safely and accurately performing the stated intended use. | "The descriptive characteristics demonstrate that the Paladin device is substantially equivalent to the predicate device and is capable of safely and accurately performing the stated intended use." |
2. Sample Size Used for the Test Set and the Data Provenance
The document mentions "Bench testing was performed to determine equivalency and performance aspects of the device." However, it does not specify the sample size used for this bench testing. It also does not mention the data provenance (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This document describes a premarket notification for a medical device (an administration set for a fluid warmer). The "ground truth" in this context refers to the performance of the device itself against established engineering specifications or the predicate device's performance. It is a technical evaluation, not a diagnostic one requiring expert interpretation of medical images or patient outcomes in the same way an AI diagnostic tool would.
Therefore, the concept of "experts used to establish ground truth" with qualifications like "radiologist with 10 years of experience" is not applicable here. The equivalency was determined through bench testing and comparison to technical characteristics.
4. Adjudication Method for the Test Set
As mentioned above, the evaluation is based on technical bench testing and comparison to a predicate device's specifications. The concept of an "adjudication method" (like 2+1 or 3+1 for expert consensus) is not applicable in this context. The determination of equivalency would likely involve engineers and regulatory affairs personnel reviewing the test results and comparing them to the predicate device's documented performance.
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 type of study is relevant for AI-powered diagnostic or assistive technologies that directly impact human interpretation of medical data (e.g., radiology images). This device is an administration set for a fluid warmer, a purely mechanical/fluidic device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a mechanical administration set, not an algorithm or AI system. There is no "algorithm only" performance to evaluate.
7. The Type of Ground Truth Used
The ground truth used for this device is technical specifications and performance data of the predicate device, as well as established engineering principles and internal test specifications for the new device. The goal was to demonstrate that the new device's performance (e.g., flow rate, warming method, filter size, maximum pressure) is equivalent to that of the legally marketed predicate device.
8. The Sample Size for the Training Set
This question is not applicable. This is a physical medical device, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set was Established
This question is not applicable. There is no training set for this type of device.
In summary, the provided document focuses on demonstrating substantial equivalence of a physical medical device to a predicate device through bench testing and comparison of technical specifications, rather than evaluating the performance of an AI or diagnostic algorithm.
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