(269 days)
The Freedom™ Syringe is intended to inject fluids into, or withdraw fluids from, the body.
The Freedom™ Syringe is a single-use medical device consisting of a calibrated hollow barrel and movable plunger (piston). The plunger contains a rubber stopper on the end that is positioned within the syringe barrel. A small amount of medical-grade silicone is used as a lubricant. The lubricant, stopper on the end of the plunger, and the syringe barrel are the components which make contact with the fluid path of the device. The syringe barrel contains a standard male luer lock connector that is compatible with standard female luer hubs. Freedom™ Syringes have a nominal capacity of 10ml, and are available sterile or non-sterile for further processing. The syringe is available in 5 different plunger colors: white, blue, red, yellow, or green.
The provided text is a 510(k) Summary for the Freedom™ Syringe, a medical device. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study report with specific acceptance criteria and performance metrics for a new, standalone device or AI application.
Therefore, many of the requested categories (e.g., sample sizes for test/training sets, number/qualifications of experts, adjudication methods, MRMC studies, effect sizes, and specific ground truths) are not applicable or not provided in this type of regulatory submission. The document primarily relies on compliance with established consensus standards and comparison to a legally marketed predicate device.
Here's an analysis based on the information available:
1. A table of acceptance criteria and the reported device performance
The document does not present specific acceptance criteria in a quantitative format with corresponding device performance metrics. Instead, it asserts compliance with established international standards for syringes. The "acceptance criteria" are effectively the requirements outlined in these standards.
| Standard Number | Standard Title | Reported Device Performance (Compliance) |
|---|---|---|
| ISO 7886-1 | Sterile hypodermic syringes for single use – Part 1: Syringes for manual use | Conforms to all applicable performance requirements |
| ISO 594-1 | Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment – Part 1: General Requirements | Conforms to all applicable performance requirements |
| ISO 594-2 | ISO 594-2; Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment – Part 2: Lock fittings | Conforms to all applicable performance requirements |
| ISO 11135-1 | Sterilization of health-care products - ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices | Conforms to all applicable performance requirements |
| ISO 10993-1 | Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process | Conforms to all applicable performance requirements |
| ISO 10993-4 | Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood | Conforms to all applicable performance requirements |
| ISO 10993-5 | Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | Conforms to all applicable performance requirements |
| ISO 10993-7 | Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization residuals | Conforms to all applicable performance requirements |
| ISO 10993-10 | Biological evaluation of medical devices - Part 10, Tests for Irritation and Skin Sensitization | Conforms to all applicable performance requirements |
| ISO 10993-11 | Biological evaluation of medical devices - Part 11, Tests for systemic toxicity | Conforms to all applicable performance requirements |
| ANSI/AAMI ST72 | Bacterial endotoxin - Test methods, routine monitoring and alternatives to batch testing | Conforms to all applicable performance requirements |
The document states, "Freedom™ Syringes have been tested to ensure conformance to all applicable performance requirements within the following standards." It does not provide the quantitative test results for these standards in this summary.
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 510(k) Summary. 510(k) summaries typically do not include detailed methodology for specific tests, especially for simple predicate devices like syringes. The tests would likely have been conducted in-house or by accredited testing laboratories as part of product development and regulatory compliance.
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/provided. For a medical device like a syringe, "ground truth" in the context of expert consensus (like in image analysis for AI) is not relevant. The performance is assessed against physical and biological standards, not expert interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided. Adjudication methods are typically associated with subjective interpretation tasks, often in clinical imaging or diagnostics, where agreement among multiple human readers is needed to establish a "ground truth" for ambiguous cases. This is not how a syringe's performance is evaluated.
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/provided. This type of study (MRMC, AI assistance, effect size) is relevant to diagnostic software or AI algorithms, not a basic physical medical device like a syringe.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/provided. "Standalone" performance is a concept for AI algorithms or automated diagnostic systems. The Freedom™ Syringe is a manually operated medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the Freedom™ Syringe is defined by compliance with recognized international and national consensus standards (e.g., ISO 7886-1 for sterile hypodermic syringes, ISO 10993 for biocompatibility) and direct comparison to the performance characteristics of its predicate device as verified through physical and biological testing. It is based on objective, measurable parameters outlined in these standards.
8. The sample size for the training set
This information is not applicable/provided. "Training set" is a term used for machine learning. This document describes a physical medical device, not an AI algorithm. Its design and manufacturing processes are based on engineering principles and regulatory standards, not iterative model training.
9. How the ground truth for the training set was established
This information is not applicable/provided, as there is no "training set" in the context of this device. The physical and biological performance characteristics are established through adherence to manufacturing specifications and testing against established industry standards.
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).