(81 days)
The F.A.S.T. 1™ Intraosseous Infusion System is intended for intraosseous infusion as an alternative to intravenous access to facilitate emergency resuscitation through the use of drugs and fluids.
The F.A.S.T. 1™ Intraosseous Infusion System has been designed to provide a means, as an alternative to intravenous infusion, for facilitating emergency resuscitation of adults through the administration of fluids and drugs. The F.A.S.T. 1™ Intraosseous Infusion System has been designed for use on the adult sternum. It consists of a primary component - the infusion tube, and secondary components - the introducer for placing it through the skin into the sternum of the patient, the target / strain-relief patch, and a protector dome. There is also an infusion tube removal tool.
The provided 510(k) summary for the F.A.S.T. 1™ Intraosseous Infusion System does not contain specific acceptance criteria with numerical performance targets or a detailed study section with reported device performance metrics against those criteria. Instead, it offers a general overview of testing and a qualitative comparison to predicate devices, asserting substantial equivalence.
Therefore, I cannot populate a table with acceptance criteria and reported device performance as requested.
However, I can extract information related to the study design and ground truth as available in the provided text.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document with quantitative targets. | General qualitative statements of meeting or exceeding performance of predicate devices and safety/effectiveness requirements. |
| Biocompatibility (ISO 10993-1 as modified in FDA General Program memorandum #G95-1) | Passed evaluation. |
| Sterilization (ANSI/ISO 11137 (R2-94)) | Passed evaluation. |
| Mechanical performance of Luer connectors (ISO 594) | Passed evaluation. |
| Meeting or exceeding performance of predicate devices | F.A.S.T. 1™ meets or exceeds the performance. |
| Meeting or exceeding safety and effectiveness requirements for adult emergency intraosseous infusion | F.A.S.T. 1™ meets or exceeds the requirements. |
| Safety in use (e.g., proper depth control, minimized leakage) | Data supports assertions of safety. |
| Effectiveness in use (e.g., correct placement, vascular access time, success rate, resistance to pull-out) | Data supports assertions of effectiveness. |
| High positive ratings from civilian and military paramedics | Received highly positive ratings. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for specific test sets. Data was acquired from:
- Excised human sternums
- Human cadavers
- Live human subjects (volunteers) in simulations/simulated clinical trials
- Data Provenance: The document states "Data have been obtained from tests conducted by or for Pyng Medical Corp., and from published literature." It does not specify the country of origin, but Pyng Medical Corp. is based in Vancouver, B.C., Canada. The nature of the studies involving cadavers and excised sternums implies a retrospective element in the use of biological material, while live human volunteer simulations would be prospective in nature.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified.
- Qualifications of Experts: The document mentions that the device was "evaluated by both civilian and military paramedics." It does not provide further details on the number or specific qualifications (e.g., years of experience) of these individuals in establishing a formal ground truth for data evaluation.
4. Adjudication method for the test set:
- Adjudication Method: Not specified.
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:
- MRMC Study: Not applicable. The device described is a physical medical device (intraosseous infusion system), not an AI-assisted diagnostic or imaging tool involving human "readers." The "evaluations" mentioned were likely related to user experience and performance of the physical device by paramedics.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. This is a physical, manually operated device, not an algorithm. The device itself (mechanism for depth control, patch, etc.) has "standalone" characteristics in terms of its mechanical function, which were tested.
7. The type of ground truth used:
- The concept of "ground truth" as typically applied to AI/diagnostic studies is not directly transferable to this device submission. However, the closest equivalents to establishing "truth" about the device's performance involved:
- Direct observation and measurement: Mechanical tests (masses, forces, strengths).
- Physiological outcomes/anatomical assessment: Testing with excised human sternums, human cadavers to confirm penetration depth into the marrow space, and effectiveness of fluid delivery.
- User feedback/expert evaluation: Simulated clinical trials with human volunteers and assessments by civilian and military paramedics for aspects like ease of use, successful insertion, and overall ratings.
- Adherence to standards: Compliance with biocompatibility, sterilization, and mechanical performance standards (ISO, ANSI).
8. The sample size for the training set:
- Training Set Sample Size: Not applicable in the context of device development as described. The document refers to "development" and "testing" but does not delineate a formal machine learning "training set." Device refinement would have occurred iteratively based on engineering tests and feedback from the various test environments.
9. How the ground truth for the training set was established:
- Training Set Ground Truth Establishment: Not applicable as a formal "training set" for an algorithm is not described. The "truth" about the device's design effectiveness and safety during its development would have been established through a combination of engineering specifications, direct observation of performance in various test environments (simulators, cadavers, excised sternums), and iterative design improvements based on these findings.
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).