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EpiFaith Syringe is intended for use with an epidural needle for detecting a loss of resistance, which aids a clinician in verifying needle tip placement in the epidural space.

The EpiFaith is a loss of resistance syringe with spring loaded piston, which can provide a means for detecting entry into the epidural space. Based on the principle of LOR technique, the piston will simultaneously move forward when the pressure drop occurs due to the spring force. The moving of the piston can provide a visual signal to indicate the LOR as well as verify the needle tip placement in the epidural space. The EpiFaith syringe is compatible to a 16-18 gauge epidural needle with Luer or NRFit connector. The user can push the plunger to increase the pressure after the syringe is connected to an inserted needle. Then, the user can advance the needle until the visual signal occurring. Because the piston is spring loaded, the automatic ejection of the syringe will happen when the LOR occurring, resulting in the movement of the piston. There are two different models of EpiFaith Syringe. The proposed models are listed below. The only difference between two models is the type of the connector.

This document, K192421, is a 510(k) summary for the EpiFaith Syringe. It describes the device, its intended use, and a comparison to a predicate device (K182268) to demonstrate substantial equivalence.

It's important to note that this 510(k) submission is for a medical device (a syringe), not an AI/ML-enabled medical device. Therefore, the questions related to AI/ML performance, ground truth, human readers, and training/test sets are not directly applicable to this document. The "Performance Data" section discusses traditional non-clinical tests for a medical syringe.

However, I will extract the available information as best as possible, interpreting "acceptance criteria" and "device performance" in the context of a non-AI/ML medical device.

1. Table of Acceptance Criteria and Reported Device Performance

For this medical device, acceptance criteria relate to its physical properties and functional performance as a syringe, not diagnostic or predictive accuracy. The performance data is based on non-clinical tests.

The document states: "Design Verification activities were performed on subject device and all necessary tests were verified to meet the required acceptance criteria." and "the material change of syringe piston meets the requirements that are considered essential for its intended use".

2. Sample size used for the test set and the data provenance

This document does not specify exact sample sizes for the non-clinical tests (e.g., how many syringes were tested for friction or leakage). The tests are typically performed on a statistically relevant sample size according to the respective ISO standards. The data provenance is from Flat Medical Co., Ltd., Taipei City, Taiwan, the device manufacturer. The tests are non-clinical (bench testing), not retrospective or prospective human subject data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable as the validation is for a physical medical device (syringe) performing mechanical and biocompatibility functions, not an AI/ML model requiring expert review for diagnostic ground truth. The "ground truth" for these tests are objective measurements (e.g., force, leakage presence/absence, biochemical reactions).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication typically refers to expert consensus in diagnostic studies, which is not relevant here. The tests are based on objective, measurable criteria defined by international standards.

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

Not applicable. This is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance is based on objective measurements and adherence to established international standards (e.g., ISO 7886-1 for syringes, ISO 10993 for biocompatibility). For example, a "friction force" reading compared against a defined maximum in the standard, or absence of leakage as per the standard.

8. The sample size for the training set

Not applicable. This is a manufactured physical device, not an AI/ML model that undergoes a "training" phase.

9. How the ground truth for the training set was established

Not applicable. See point 8.

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EpiFaith Syringe is intended for use with an epidural needle for detecting a loss of resistance, which aids a clinician in verifying needle tip placement in the epidural space.

The EpiFaith is a loss of resistance syringe with a spring-loaded piston, which can provide a means for detecting entry into the epidural space. Based on the principle of the LOR technique, the piston will simultaneously move forward when the pressure drop occurs due to the spring force. The moving of the piston can provide a visual signal to indicate the LOR as well as assist in verifying the needle tip placement in the epidural space. The EpiFaith syringe is compatible to a 16-18 gauge epidural needle with Luer or NRFit connector. The user can push the plunger to increase the pressure after the syringe is connected to an inserted needle. Then, the user can advance the needle until the visual signal occurs. Because the piston is spring loaded, the automatic ejection of the content of the syringe will happen when the LOR occurs, resulting in the movement of the piston. There are two different models of EpiFaith Syringe. The proposed models are listed in Table 4.1. The only differences between two models are the type of the connector and color.

The provided text describes a 510(k) submission for the EpiFaith Syringe, a loss-of-resistance syringe used for detecting entry into the epidural space. This document is a summary and primarily focuses on demonstrating substantial equivalence to a predicate device (AutoDetect Syringe K041590) through characterization and non-clinical performance testing.

The document does not include information on a clinical study (MRMC, standalone, or otherwise) involving human readers or expert consensus for establishing ground truth from clinical images. The performance data described are exclusively non-clinical bench tests and compliance with recognized standards.

Therefore, many of the requested items related to clinical study design, sample sizes for test/training sets, expert consensus, and human reader performance are not applicable or not present in this 510(k) summary.

Here's a breakdown of the information that is available based on the provided text:

Acceptance Criteria and Device Performance (Non-Clinical)

The performance data for the EpiFaith Syringe are entirely based on non-clinical bench testing and adherence to recognized standards. The acceptance criteria are implicitly defined by compliance with these standards.

1. Table of Acceptance Criteria and Reported Device Performance

Information Not Present in the Provided Document:

The following requested items are typically associated with clinical studies, especially those involving AI/imaging devices, and are not found in this 510(k) summary as it pertains to a mechanical medical device (syringe):

2. Sample sizes used for the test set and the data provenance: Not applicable; no clinical test set data presented.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable; no clinical ground truth established from expert readings.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable; no clinical test set.
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 MRMC study was done, as this is a mechanical syringe, not an AI/imaging device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No standalone algorithm performance provided, as this is a mechanical syringe.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for clinical ground truth. The "ground truth" for this device would be defined by the physical and material properties meeting the specifications of the listed international standards.
8. The sample size for the training set: Not applicable; no training set data relevant to AI/machine learning.
9. How the ground truth for the training set was established: Not applicable; no training set ground truth relevant to AI/machine learning.

Summary of the Study Proving Device Meets Acceptance Criteria:

The study proving the EpiFaith Syringe meets its acceptance criteria is a series of non-clinical bench tests and evaluations demonstrating compliance with a comprehensive list of international and consensus standards for piston syringes, biocompatibility, sterilization, packaging, and specific functional performance metrics (e.g., visual indicator response, O-ring resistance, human factors on a simulator). The document states that "Conformity to these standards demonstrates that the proposed EpiFaith Syringe met the standards' established acceptance criteria for the device." The rationale for substantial equivalence relies on these non-clinical tests showing the device performs comparably to the predicate and meets its intended use. No clinical trials or studies involving human patients or complex data interpretation (like AI in imaging) were conducted or are required for this type of device and submission.

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