Search Results

The Nipro SafeTouch Needle is indicated for general purpose injection of fluid from vials, and to and from parts of the body below the surface of the skin. It includes a needle shield to prevent against accidental needlestick injuries. The needle is compatible with standard Luer-lock syringes.

The Nipro Syringe with SafeTouch Needle is indicated for general purpose injection of fluid from vials, and to and from parts of the body below the surface of the skin. It includes a needle shield to prevent against accidental needlestick injuries.

The Nipro SafeTouch Needle is a disposable hypodermic single lumen needle with attached safety device. The safety device is a needle shield that covers the needle post treatment eliminating accidental needlestick injuries. It is provided with and without a piston syringe.

The Nipro SafeTouch Needle is available in gauges of 18-30, lengths of ½". The needles are available individually or attached to a luer lock syringe in volumes of 1, 3, 5 and 10mL.

The device is sterile, single use only, non-toxic, and non-pyrogenic. It is sterilized by Ethylene Oxide gas and has a shelf-life of 5 years.

The provided text describes specific acceptance criteria and study details for the Nipro SafeTouch Needle and Nipro Syringe with SafeTouch Needle, but it does not describe a study proving the device meets acceptance criteria in the context of an AI/ML device. Instead, it outlines a 510(k) premarket notification for a traditional medical device, comparing it to a predicate device.

The document discusses non-clinical tests and a simulated clinical study, but these are for a physical medical device, not an AI/ML diagnostic or therapeutic system. Therefore, I cannot provide information on items such as multi-reader multi-case studies, standalone algorithm performance, ground truth establishment for AI training sets, or sample sizes for AI training sets, as these concepts are not relevant to the provided text.

However, I can extract the acceptance criteria and performance related to the physical medical device and the simulated clinical study.

Here's the information based on the provided text, focusing on the device's physical and functional properties:

Table of Acceptance Criteria and Reported Device Performance

Ask a specific question about this device

The Nipro Disposable Syringe is intended to inject fluids into or withdraw fluids out of the body.

The NIPRO Disposable syringe is a piston syringe consisting of graduated barrel, plunger rod, gasket and nozzle tip cap. Its function is mechanical and it is intended to inject fluids into or withdraw fluids out of the body. The syringe is sterile, single to only, non-toxic, non-pyrogenic and sterilized by Gamma radiation.

The provided text describes a 510(k) summary for the NIPRO® Disposable Syringe. It outlines the device's purpose, materials, and intended use, and states that non-clinical tests were submitted to demonstrate substantial equivalence to a predicate device (K944355). However, the document does not contain specific acceptance criteria, reported device performance metrics, or details of a study that explicitly proves the device meets such criteria.

The submission focuses on establishing substantial equivalence based on what the device is and that it performs similarly to a predicate, rather than providing quantitative performance data against defined thresholds.

Therefore, many of the requested details about acceptance criteria, study methodologies, and performance metrics cannot be extracted from this document, as they are not present.

Here's a breakdown of what can be inferred or directly stated from the provided text, and what is missing:

Acceptance Criteria and Study to Prove Device Meets Criteria

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated in the provided text. The submission focuses on demonstrating "substantial equivalence" to a predicate device (NIPRO® Disposable Syringe K944355). This implies that the 'acceptance criteria' are implicitly tied to performing similarly to the predicate in terms of "intended use, materials of construction, labeling, and overall performance characteristics," but no specific quantitative thresholds are given.

• Reported Device Performance: Not explicitly detailed with quantitative metrics. The document states:

  "Biocompatibility data, performance testing and comparison testing with the predicate are included in this submission and demonstrate substantial equivalence."
  "The results of the performance testing and the comparison of technological characteristics demonstrate that the NIPRO® Disposable Syringe Gamblegical characteristics device and is a from and ff device and is safe and effective when used as intended."

  This indicates that performance testing was done, but the results (e.g., specific measurements, values) are not reported in this summary.

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

• Sample Size: Not specified.
• Data Provenance: Not specified (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 question is not applicable as the device is a simple mechanical piston syringe, and the "ground truth" concept (e.g., for diagnostic accuracy) does not apply in the same way it would for an AI/diagnostic device. Performance testing likely involved engineering and quality control assessments against recognized standards or internal specifications, rather than expert-derived ground truth. No experts for ground truth establishment are mentioned.

4. Adjudication method for the test set

• Not applicable for this type of device and submission.

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/diagnostic device.

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

• Not applicable. This is not an AI/diagnostic device.

7. The type of ground truth used

• Given the device is a piston syringe, "ground truth" would likely be established through engineering specifications, material standards, and functional performance benchmarks (e.g., fluid delivery accuracy, plunger force, seal integrity, sterility, non-pyrogenicity, non-toxicity). The document mentions "Biocompatibility data" and "performance testing," which would relate to these types of ground truths, but specific methods are not detailed.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device that uses training sets.

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

• Not applicable.

Summary of available information:

The provided 510(k) summary for the NIPRO® Disposable Syringe (Gamma) confirms that:

• The device is a piston syringe for injecting or withdrawing fluids.
• It is sterile, single-use, non-toxic, non-pyrogenic, and sterilized by Gamma radiation.
• The applicant performed "Biocompatibility data, performance testing and comparison testing with the predicate" (NIPRO® Disposable Syringe K944355) to demonstrate substantial equivalence.
• The conclusion is that the device is "safe and effective when used as intended."

However, the detailed quantitative results of these tests, specific acceptance criteria (beyond "substantial equivalence"), sample sizes, and methodologies for establishing ground truth (in the context of advanced diagnostic or AI systems) are not present in this document. This level of detail is typically found in the full submission, not in the publicly available 510(k) summary.

Ask a specific question about this device

The Nipro Hypodermic Needle is intended for use to inject fluids into or withdraw fluids from parts of the body below the surface of the skin.

The subject devices can be classified as single use hypodermic needles as described in 21 CFR 880.5570. Needle sizes include 16-30 Gauge, lengths of ½ to 1 ½ inches, and regular or short bevels.

I'm sorry, but this document does not contain the information requested. The document is a 510(k) premarket notification for Nipro Disposable Needles, and it primarily focuses on establishing substantial equivalence to a predicate device. It does not include details on formal acceptance criteria, device performance studies, sample sizes for test or training sets, ground truth establishment, or multi-reader multi-case studies as described in your request.

Ask a specific question about this device

The Nipro® Hypodermic Needle is intended to be used to inject fluids into or withdraw fluids from parts of the body below the surface of the skin.

The devices that we intend to market are hypodermic needles as described in 21 CFR 880.5570. Two types of hypodermic needles will be available: types L (long) and S (short). Type L hypodermic needles are 11/2 to 11/2 inches long and Type S needles 74 to 1 inch long.

I am sorry but the provided text does not contain detailed information about acceptance criteria, study methodologies, or performance results for the Nipro Hypodermic Needle. The documents provided relate to its 510(k) premarket notification and substantial equivalence to a predicate device, which focuses on regulatory approval rather than a detailed performance study as you described.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or their data provenance.
• Number and qualifications of experts for ground truth.
• Adjudication methods.
• MRMC comparative effectiveness study results.
• Standalone performance details.
• Ground truth type.
• Training set sample size or ground truth establishment for the training set.

The document primarily states that the Nipro Hypodermic Needle is "similar in design, technical, performance, and biological characteristics" to a legally marketed predicate device (K944355) and is intended for injecting or withdrawing fluids under the skin. It does not provide the specific study details you are asking for.

Ask a specific question about this device