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Sterile hypodermic single use syringe with needle or without needle:
The Sterile Hypodermic syringe with needle is intended to be used for medical purposes to inject fluids into or withdraw fluids from the body.

Sterile hypodermic safety syringe (clip type) for single use with needle or without needle:
The sterile hypodermic safety syringes for single use is intended to be used for medical purpose to inject fluids into or withdraw fluids from the body. A fler injection, the anti-needle stick feature is manually activated to aid in the prevention of accidental needle stick injuries.

Sterile hypodermic safety syringes (needle retractable type) for single use with needle:
The needle retractable safety syringe is to be used for intra-muscular or subcutaneous injections into a patient and is intended to prevent needle stick injuries. Needle retractable safety syringe is not intended to be used for withdrawing blood. In addition, when the syringe user breaks the plunger, reuse of the syringe is prevented.

Sterile hypodermic needle for single use:
The Sterile Hypodermic needle intended to be used for medical purposes to inject fluids into or withdraw fluids from the body.

The syringe consists of a plunger & gasket that's fits tightly within a cylindrical tube called a barrel. The plunger can be linearly pulled and pushed along the inside of the barrel, allowing the syringe to take-in and expel liquid or gas through a discharge nozzle at the front (open) end of the barrel. The open end of the syringe may be fitted with a hypodermic needle, a nozzle or tubing to help direct the flow into and out of the barrel. It has three different models of syringe along with needle as below:

• 1. Sterile Hypodermic Syringe with/ without needle for single use
• 2. Sterile Hypodermic Safety Syringe (Clip Type) with/ without needle for single use
• 3. Sterile Hypodermic Safety Syringe (Needle Retractable Type) with needle for single use
• 4. Sterile Hypodermic Needle for single use

In safety syringes a safety feature available, which is activated either manually or automatically. In clip type safety syringe, a clip is attached to the barrel and it is activated manually after use of syringe, which helps to prevent needle stick injury. In retractable type safety syringe a needle retract after use of syringe, which helps to prevent needle stick injury. This feature is activated when plunger is pressed to expel the contents, the base of the plunger attached with the needle and pulling back of the plunger will cause the needle to retract in to the barrel of the syringe.

The provided text is a 510(k) summary for hypodermic syringes and needles. It does not describe acceptance criteria for an AI/ML powered medical device, nor does it detail a study proving its performance. The document pertains to traditional medical devices (syringes and needles) and focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance data and biocompatibility testing, rather than AI/ML related performance metrics.

Therefore, I cannot extract the information required in your request about acceptance criteria and study details for an AI/ML device from this specific document. The request's template (acceptance criteria table, sample size for test/training, number/qualifications of experts, adjudication, MRMC study, standalone performance, ground truth, effect size) is designed for AI/ML device evaluations, which are not present in this 510(k) summary.

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Lifelong Matrix/Lifelong Premium/Safeway syringe with or without needle is intended to be used for medical purposes to inject fluids into or withdraw fluids from the body.

The Lifelong Matrix/Lifelong Premium/SAFEWAY syringe with or without needle is a standard piston syringe that consists of a calibrated hollow barrel and a movable plunger. The needle consists of needle tube, needle hub, needle cap. At one end of the barrel there is a male Luer Slip/Lock connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle or for attaching other devices with a female Luer. The syringe and needles are sterilized by ETO gas. It is a non-pyrogenic and single use device. The main raw materials for syringes are polypropylene and thermoplastic elastomer and for needles raw materials are polypropylene and stainless steel (SS-304).

This document is a 510(k) premarket notification for a medical device (syringes and needles). The key to fulfilling your request is to understand that a 510(k) submission primarily relies on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving novel performance against specific acceptance criteria like an AI/ML device would.

Therefore, the concepts of "acceptance criteria," "study that proves the device meets the acceptance criteria," "sample size for the test set," "data provenance," "number of experts for ground truth," "adjudication method," "MRMC study," "standalone performance," and "training set" do not directly apply in the context of this 510(k) submission for a non-AI/ML device like a syringe.

Instead, the submission focuses on comparing the proposed device's characteristics and performance to those of a previously cleared predicate device and demonstrating compliance with relevant industry standards.

Here's how to interpret the document in the context of your request, reframing the information to reflect what is actually present in a 510(k) for this type of device:

For a medical device like the Lifelong Matrix/Lifelong Premium/Safeway syringe with or without needle, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are primarily demonstrated through comparison to a legally marketed predicate device and compliance with established international and national standards. This is typical for a 510(k) premarket notification for a Class II device that is not an AI/ML product.

1. Table of Acceptance Criteria and Reported Device Performance:

Since this isn't an AI/ML device with specific accuracy metrics, the "acceptance criteria" are implicitly met by demonstrating similar technological characteristics and compliance with recognized standards as the predicate device. The "reported device performance" is presented as a comparison to the predicate and confirmation of adherence to these standards.

Here's a table summarizing the key comparisons that serve as the basis for "acceptance" in a 510(k) context for this device:

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: The document does not specify a distinct "test set" sample size in the way an AI/ML study would. Instead, compliance with various ISO and ASTM standards implies specific sample sizes and test methodologies as defined within those standards (e.g., how many syringes are tested for dose accuracy, or how many needles for bond strength). These details are not explicitly itemized in the summary provided, but rather are referenced by the standard itself.
• Data Provenance: The device manufacturer is Lifelong Meditech Private Limited, located in Gurugram, Haryana, India. All testing would have been conducted to demonstrate compliance with international standards (ISO, ASTM, USP) for the purpose of U.S. FDA clearance. The studies referenced are performance testing and biocompatibility testing, which are inherently prospective in nature, conducted on the actual manufactured device Lot(s) to demonstrate their properties.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not Applicable. For a medical device like a syringe and needle, "ground truth" is not established by human experts in the way it is for image interpretation in AI/ML. Instead, performance is measured against objective physical, chemical, and biological standards (e.g., volume accuracy, material composition, sterility, biocompatibility). These measurements are typically performed by technicians and validated by quality control personnel in certified laboratories.

4. Adjudication Method for the Test Set:

• Not Applicable. As "ground truth" is based on objective measurements against standards rather than subjective human interpretation, there is no need for an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No. An MRMC study is relevant for AI/ML devices that assist or replace human readers (e.g., radiologists interpreting images). This device is a syringe, a hardware medical device; its safety and effectiveness are not assessed via human reader performance.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done:

• Not Applicable. This is not an AI/ML algorithm. Its "performance" is assessed directly through physical and chemical testing.

7. The Type of Ground Truth Used:

• The "ground truth" for this device is based on objective measurements against established performance standards and material specifications. This includes:

  • Dimensional accuracy (e.g., needle inner diameter, volume calibration)
  • Physical properties (e.g., bond strength, plunger force, needle sharpness)
  • Chemical properties (e.g., EO residuals, material composition)
  • Biological properties (e.g., sterility, absence of pyrogens, biocompatibility)
  • Functionality (e.g., luer lock compatibility)

  These are defined by standards such as ISO 7886-1, ISO 7864, ISO 9626, ISO 80369-7, ISO 10993 series, ISO 11135-1, ASTM D4169-16, ASTM F1929-15, ASTM F1980-16, and USP guidelines.

8. The Sample Size for the Training Set:

• Not Applicable. This is not an AI/ML device, so there is no concept of a "training set" for an algorithm. The "training" for such a device is in its design, manufacturing process, and quality control, not via data-driven model training.

9. How the Ground Truth for the Training Set Was Established:

• Not Applicable. As there is no training set for an AI/ML algorithm, this question does not apply. The device's design and manufacturing are based on well-established engineering principles and adherence to regulatory and quality standards, the "ground truth" for which are the physical and chemical properties of materials and established mechanical and biological principles.

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