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The Sterile syringes for single use with/without needle is intended to be used for medical purposes to inject fluid into or withdraw fluid from body.

The Sterile Syringes for Single Use with/without Needle is a three-piece, sterile, single use hypodermic syringe with a 6% (Luer) male connector/lock fitting in various sizes. The syringe assembly consists of a lubricated polypropylene barrel with a graduated scale, a lubricated synthetic rubber stopper and a polypropylene plunger rod. The plunger rod is pulled back to aspirate fluids or depressed to inject or expel fluids.

This document is a 510(k) premarket notification for a medical device (Sterile syringes for single use with/without needle). It outlines the performance data provided to support the claim of substantial equivalence to a predicate device, rather than defining novel acceptance criteria for an AI/ML powered device and proving those are met.

Therefore, many of the requested details about acceptance criteria, ground truth establishment, sample sizes for AI/ML training/test sets, expert adjudication, and MRMC studies are not applicable or extractable from this specific document.

The document focuses on demonstrating that the new syringe device performs equivalently to existing legally marketed predicate devices by complying with established international and FDA-recognized standards for mechanical, physical, chemical, and biological properties.

Here's a breakdown of what can be extracted and what cannot:

What can be extracted:

• Device Name: Sterile syringes for single use with/without needle
• Intended Use: "intended to be used for medical purposes to inject fluid into or withdraw fluid from body."
• Study Type: This is a premarket notification (510(k)) which relies on demonstrating substantial equivalence to a predicate device, not necessarily a de novo clinical study proving novel performance criteria for an AI/ML algorithm. The performance data is primarily for physical, chemical, and biological characteristics of the syringe, not AI/ML performance.
• Acceptance Criteria & Reported Performance Table: While not in the typical "AI/ML performance" format, the document lists specific standards and states that "All evaluation acceptance criteria were met."

• Ground Truth Type: For this device, the "ground truth" is defined by the established international standards and testing methodologies (e.g., ISO, ASTM, USP) for physical, chemical, and biological properties of syringes, rather than expert labels on medical images or outcomes data.
• Sample Size:
  • Test set: The document doesn't explicitly state sample sizes for each test, but implies that sufficient samples were tested to demonstrate compliance with the referenced standards. For example, "The shelf life of 5 year is determined based on stability studies which include ageing test according to FDA recognized standard ASTM F1980-16," which would involve a specific number of samples over time.
  • Training set: Not applicable, as this is not an AI/ML device requiring a training set.
• Data Provenance: The manufacturing and testing entities are based in China (Wepon Medical Technology CO., Ltd. in Zhejiang, China, and Shanghai Ling Fu Technology Co., Ltd. in Shanghai, China). The data would be retrospective in the sense that it was collected during product development and validation for submission, rather than a prospective clinical trial.

What cannot be extracted (because it's not an AI/ML device):

• Number of experts used to establish ground truth & qualifications: Not applicable; ground truth is standard compliance.
• Adjudication method for test set: Not applicable.
• MRMC comparative effectiveness study: Not applicable.
• Effect size of human readers improvement with AI vs. without AI assistance: Not applicable.
• Standalone (algorithm only) performance: Not applicable.
• How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) pertains to a conventional medical device (syringes) and demonstrates substantial equivalence by meeting recognized performance standards, not by evaluating an AI/ML algorithm's diagnostic or predictive capabilities.

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Sterile Syringes for Single Use are sterile, single-use, disposal, without needle and manually operated syringes intended to use with a 6% conical fitting device for injection of drug into the body. The syringes are intended for use immediately after filling and are not intended to contain the fluid/medication for extended periods of time.

KDL Sterile Syringes for Single Use are composed of barrel, plunger, and a moveable piston. The plunger does not contact any part of the fluid path, rather the plunger which attaches to the piston and the barrel are fluid path components. Materials of construction for the components have been shown to meet the applicable requirements of ISO 10993-1. Additionally, there is a small amount of lubricant for moving the plunger smoothly along the inside surface of the barrel. The connector is a universal luer threaded style connector. The device is used in general medicine in clinical, hospital, or other settings of healthcare professionals. The Sterile Syringes for Single Use have different specifications, include 1ml, 3ml, 10ml, 20ml and 30ml.

The provided text is a 510(k) summary for the "Sterile Syringes for Single Use". This document describes the device, its intended use, and the studies conducted to demonstrate its substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the studies that prove the device meets them, based on the provided text:

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

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a pass/fail format. Instead, it describes compliance with recognized international standards (ISO and ASTM) and specific tests conducted. The "Performance" column in the table below represents the device's conformance to these standards and the completion of the described tests.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample sizes used for any of the performance tests. It only states that the device was "tested" and "evaluated."

Regarding data provenance: The testing appears to be conducted by the manufacturer, Shanghai Kindly Enterprise Development Group Co., Ltd. within China, or by a testing facility on their behalf. The studies are prospective as they are conducted specifically to support this regulatory submission for the proposed device (non-clinical testing).

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 section is not applicable to this device and the type of studies conducted. The device is a sterile syringe, and the studies are primarily non-clinical performance and biocompatibility tests against established international standards. "Ground truth" in the context of expert consensus (like in AI/medical imaging studies) is not relevant here. The "ground truth" is defined by the technical specifications and performance requirements of the ISO and ASTM standards.

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

This section is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving multiple human readers interpreting results, especially in complex diagnostic scenarios or AI performance evaluation. The studies for this device are non-clinical, laboratory-based performance tests against 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

This is not applicable. The device is a disposable, manually operated syringe, not an AI-powered diagnostic tool. Therefore, no MRMC study or evaluation of human reader improvement with AI assistance was conducted or warranted.

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

This is not applicable. The device is a physical medical device (syringe), not an algorithm or software. Therefore, the concept of "standalone algorithm performance" does not apply.

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

The "ground truth" for the non-clinical tests is based on established international standards and validated testing methodologies described within those standards (e.g., ISO 7886-1, ISO 80369-7, ISO 10993 series, USP , ISO 11135, ASTM F88/F88M-15, ASTM F1929-15, ISTA 3A:2018, ASTM F1980-16). These standards define acceptable performance limits and test procedures.

8. The sample size for the training set

This is not applicable. As a physical medical device, there is no "training set" in the context of machine learning or deep learning algorithms.

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

This is not applicable for the same reason as point 8.

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The Sterile syringes for single use with/without needle are intended to be used for medical purposes to inject fluid into or withdraw fluid from body.

The Sterile Syringes for Single Use with/without Needle is a three-piece, sterile, single use hypodermic syringe with a 6% (Luer) male connector/lock fitting in various sizes. The syringe assembly consists of a lubricated polypropylene barrel with a graduated scale, a lubricated synthetic rubber stopper and a polypropylene plunger rod. The plunger rod is pulled back to aspirate fluids or depressed to inject or expel fluids.

The document describes the acceptance criteria and performance data for the "Sterile syringes for single use with/without needle," but it does not involve a study with a test set of data, ground truth, or expert consensus in the way that AI/ML device studies typically do. This is a traditional medical device (syringes) rather than an AI/ML diagnostic or prognostic tool.

Therefore, many of the requested fields are not applicable.

Here's the information extracted from the provided text, focusing on the available details:

1. Table of Acceptance Criteria and Reported Device Performance

The device's performance is demonstrated by compliance with various international standards and specific tests. The "acceptance criteria" are implied by the requirements of these standards.

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

• Sample Size: Not explicitly stated. The document refers to "testing" and "evaluations" according to various standards, which would define the sample sizes for those specific tests.
• Data Provenance: Not explicitly stated, but the testing was conducted to comply with international standards (ISO, ASTM, USP), indicating standard laboratory and manufacturing quality control procedures. The manufacturer is Zhejiang Kangkang Medical-Devices CO., Ltd. in China, so likely some testing occurred there.

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

Not applicable. This is a physical medical device, not an AI/ML system requiring expert interpretation for ground truth.

4. Adjudication method for the test set

Not applicable. This does not involve adjudication of expert readings.

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 not an AI/ML device.

7. The type of ground truth used

The "ground truth" for this device's performance is established by its adherence to the technical and safety specifications outlined in the referenced international standards (e.g., ISO, ASTM, USP). For instance, the ground truth for "sterilization" is the result of tests confirming a certain sterility assurance level; for "biocompatibility," it's the outcome of biological tests.

8. The sample size for the training set

Not applicable. This is not an AI/ML device; there is no "training set."

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

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

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