(169 days)
The device is indicated for use as a dispenser, a measuring device and an oral fluid transfer device. It is used to inject fluids into the body via extension sets and feeding tubes in neonatal and small pediatric patients.
The NeoMed Sterile Syringe is specifically designed for administration of enteral liquids to neonatal patients. The NeoMed Sterile Syringe is a standard piston syringe which is incompatible with luer-lock and intravenous devices. The NeoMed Sterile Syringes are compatible with NeoMed enteral-only connectors, the NeoMed orange extension sets and feeding tubes to form a dedicated system that prevents wrong-route administration of non-IV fluids and other competitive enteralfeeding tube, extension set type products that do not utilize a luer-lock system. They possess translucent barrels to provide visualization of fluid contents and volume, and patented orange lettering/gradient markings which coordinate with NeoMed orange extension sets and feeding tubes. NeoMed Sterile Syringes are manufactured as a single piece molded barrel that does not rely on adapters to create an oral tip. The NeoMed Sterile Syringes possess design features that prevent connectivity to luer type devices, and hence prevents the chance that a feeding tube could be infused into the IV line. The NeoMed Sterile Syringes will be available in 1ml, 3ml, 6ml, 35ml, and 60ml individual packs.
The NeoMed Sterile Syringe device consists of the following components:
- Syringe Barrel
- Syringe Plunger
- Svringe Gasket
- Syringe Tip
- Syringe Cap
This document describes the NeoMed Sterile Syringe and its substantial equivalence to a predicate device. However, it does not contain the specific detailed information typically found in an acceptance criteria study report for an AI/ML medical device.
Therefore, I cannot populate the table and answer all the questions as requested based on the provided text. The document focuses on performance testing to demonstrate functional equivalence to a predicate device rather than on specific clinical study results with acceptance criteria in the context of an AI/ML algorithm.
Here's what can be extracted and what cannot:
Information that CANNOT be extracted from the provided text:
- A table of acceptance criteria and the reported device performance: No specific acceptance criteria are defined in terms of metrics (e.g., sensitivity, specificity, accuracy) for a study. The performance is described as "functionally equivalent" and performing its "intended use."
- Sample sized used for the test set and the data provenance: No information on specific test sets, sample sizes, or data provenance (country, retrospective/prospective).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no mention of a clinical study using expert ground truth.
- Adjudication method: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no external ground truth beyond standard device testing is mentioned.
- The sample size for the training set: Not applicable, as this is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.
Information that CAN be extracted and inferred:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional equivalence to predicate device (Baxa Syringe K951871) | "Bench testing has demonstrated that the NeoMed Sterile Syringe is functionally equivalent to predicate Baxa Syringe and that any minor differences do not affect safety or effectiveness." |
| "Design verification performance test results demonstrate that the NeoMed Sterile Syringe performs its intended use and that any minor differences from the predicate do not affect safety or effectiveness." | |
| Biocompatibility | "The NeoMed Sterile Syringe materials that come in direct contact with the patient have a long history of use in syringe manufacturing and are biocompatible according to ISO 10993 test results." |
| Safe and effective performance for intended use | "Bench testing... demonstrated that... any minor differences do not affect safety or effectiveness." |
| "Design verification performance test results demonstrate that the NeoMed Sterile Syringe performs its intended use and that any minor differences from the predicate do not affect safety or effectiveness." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document mentions "Bench testing" and "Design verification performance test results." However, it does not specify sample sizes for these tests, data provenance, or whether the study was retrospective or prospective. It refers to standard laboratory testing rather than real-world patient data.
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):
Not applicable. This is a medical device, not an AI/ML algorithm that relies on expert ground truth for performance evaluation in a clinical setting. The "ground truth" for this device would be defined by engineering specifications and objective performance measurements for fluid delivery, measurement accuracy, and material properties.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as this is not a study involving human interpretation or subjective assessments requiring adjudication.
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. This is a physical medical device (syringe), not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or reported here.
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 consensus, pathology, outcomes data, etc):
For this device, the "ground truth" for performance would be based on engineering specifications, established standards, and objective physical measurements during bench testing. For example, volume accuracy, force required for operation, material integrity, and secure connection with intended enteral devices.
8. The sample size for the training set:
Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established:
Not applicable.
In summary, the provided text describes a 510(k) submission for a traditional medical device (syringe) that relies on bench testing and material biocompatibility to demonstrate substantial equivalence, not an AI/ML device that would require the specified types of studies and acceptance criteria.
§ 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).