Search Results

The Sterile Hypodermic Syringe with needle, for Single Use is intended to be used for medical purposes to inject fluid into body.

The Sterile Hypodermic Syringe for Single Use is intended for manual and single use only to aspirate and inject of fluids for medical purpose, which consists of a hypodermic needle and a luer lock syringe. The proposed device is available in a variety combination of syringe volume and needle gauge (refer to Table 1).

The provided document is a 510(k) Summary for a Sterile Hypodermic Syringe with needle for Single Use. This type of device is a physical medical instrument, not a software or AI/ML-based device.

Therefore, the document does not contain any information related to:

• Acceptance criteria for an AI/ML device
• Study data proving an AI/ML device meets acceptance criteria
• Sample sizes for test sets (in the context of AI/ML)
• Number of experts for ground truth establishment
• Adjudication methods
• Multi-Reader Multi-Case (MRMC) comparative effectiveness studies
• Standalone algorithm performance
• Training set details (sample size, ground truth establishment)

The document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical tests (e.g., biological evaluation, sterility, mechanical performance) and comparison of technical characteristics, as summarized in the "Non-Clinical Test Conclusion" and "Substantially Equivalent (SE) Comparison" sections.

In summary, the provided text does not describe an AI/ML device or its associated acceptance criteria and performance study as requested. It pertains to a physical medical device.

Ask a specific question about this device

Sterile Hypodermic Syringe for Single Use, with/without needle:
The sterile hypodermic syringe for single use, with/without needle is intended for use in the aspiration of fluids for medical purposes.

Sterile Hypodermic Needle for Single use:
The sterile hypodermic needle for single use is intended for use with syringes in the aspiration of fluids for medical purposes.

Sterile Hypodermic Syringe for Single Use, with/without needle:
The sterile hypodermic syringe for single use, with/without needle is intended for used in the aspiration and injection of fluids for medical purposes.

Sterile Hypodermic Needle for Single use:
The sterile hypodermic needle for single use is intended for use with syringes in the aspiration and injection of fluids for medical purposes.

The device is delivered in the following configurations:
Needle Gauge: 18,19,20,21,22,23,24,25,26,27,28,29,30G
Needle Length: 1/6"-1 1/2"
Syringe Volume: 1,2,3,5,10,20,30,50,60,100 ml

Sterile Hypodermic Syringe for Single Use, with/without needle and Sterile Hypodermic Needle for Single use materials are as noted in the table below:
Needle cap: PP
Needle tube: Stainless Steel
Needle hub: PP
Barrel: PP
Plunger stopper: Isoprene rubber
Plunger: PP
Ink: Black
Lubricant: Silicone oil
Adhesive: Epoxy resin
Colorant: PP masterbatch

The contact level of the subject device is blood path, indirect, and the contact duration is limited contact (<24 hours).

I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the format you specified.

The document is a 510(k) premarket notification for "Sterile Hypodermic Syringe for Single Use, with/without Needle, Sterile Hypodermic Needle for Single Use." It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific performance acceptance criteria.

Here's what is missing from the text to fulfill your request:

• A table of acceptance criteria and the reported device performance: While the document mentions compliance with various ISO standards (e.g., ISO 80369-7, ISO 7886-1), it does not explicitly list the specific acceptance criteria for each parameter within these standards, nor does it present the reported device performance against those criteria in a tabular format. It only states that "All of the pre-determined acceptance criteria were met."
• Sample size used for the test set and the data provenance: The document indicates that "bench testing" was performed for performance and that "verification test" was done for biocompatibility and sterility, but it does not specify the sample sizes used for these tests or the data provenance (e.g., country of origin, retrospective/prospective).
• Number of experts used to establish the ground truth... and the qualifications: This information is typically relevant for studies involving human interpretation or subjective assessment, such as image analysis devices. For a physical medical device like a syringe or needle, "ground truth" would be established by objective measurements and standardized tests, not expert consensus. Therefore, this question is not applicable in this context.
• Adjudication method: Similar to the point above, adjudication methods like 2+1 or 3+1 are used for resolving disagreements among experts in subjective assessments. This is not applicable to the performance testing of a syringe or needle.
• If a multi reader multi case (MRMC) comparative effectiveness study was done...: This type of study is for evaluating diagnostic devices where human readers interpret data. It is not relevant to the described medical device.
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: This is relevant for AI/ML-driven devices and is not applicable here.
• The type of ground truth used: As mentioned, for this type of device, ground truth is established through adherence to international standards and objective measurement, not expert consensus, pathology, or outcomes data in the usual sense.
• The sample size for the training set: This refers to the development of AI/ML models, which is not applicable to this device.
• How the ground truth for the training set was established: Not applicable.

The document primarily provides a list of ISO standards that the device complies with, stating general compliance rather than detailed performance results against quantifiable acceptance criteria for each specific test. It explicitly states, "No clinical testing was performed" and "No clinical study is included in this submission," further indicating the absence of human-centric studies.

Ask a specific question about this device

The Sterile Hypodermic Syringe 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 insulin syringe for single use with the calibration unit of insulin for U-100, is a device intended for medical purposes for the manual aspiration of insulin, and for the injection of insulin into parts of the body below the surface skin.
The sterile insulin syringe for single use with the calibration unit of insulin for U-40 is a device intended for medical purposes for the manual aspiration of insulin, and for the injection of insulin into parts of the body below the surface skin.
The Sterile Hypodermic Needle for single use is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.

The Sterile Hypodermic Syringe for Single use, with/without needle; luer/luer-lock consists of a Piston, Plunger, and Barrel. It is EO Sterilized and intended for Prescription use by Medical professionals and trained care givers. It is for single use and operates by pulling and pushing the plunger along inside the barrel to take in and expel fluids. It comes in various lengths, diameters, tip types, needle tip configurations, nozzle types, barrel marking specs, volumes, sizes, and needle lengths. Materials include Isoprene Rubber, PP, PE, and SUS304.
The Sterile Insulin Syringe for Single use, with needle consists of a Needle Cap, Needle, Piston, Plunger, Barrel, and End Cap. It is EO Sterilized and intended for Prescription use by patients. It is for single use and operates by pulling and pushing the plunger along inside the barrel to take in and expel fluids. It comes in 0.3ml, 0.5ml, and 1ml volumes with fixed needles of 8mm and 13mm lengths. Materials include Isoprene Rubber, PP, PE, and SUS304.
The Sterile Hypodermic needle for Single use consists of a Protective cap, Needle, Adhesives, and Needle hub. It is EO Sterilized and intended for Prescription use by Medical professionals and trained care givers. It is for single use and for Manual Use Only. It comes in various sizes and needle lengths. Materials include PP, Epoxy resin, and SUS304.

This document is a 510(k) summary for hypodermic syringes, insulin syringes, and hypodermic needles. It describes the devices, their indications for use, and a comparison to a predicate device (K190002). The document primarily focuses on demonstrating substantial equivalence to the predicate device through comparisons of technological characteristics and compliance with recognized performance standards. It certifies that the devices meet various ISO standards and biological evaluation requirements.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly present a "table of acceptance criteria and reported device performance" as you might expect for a diagnostic AI device with metrics like sensitivity, specificity, or AUC. Instead, for these medical devices (syringes and needles), acceptance criteria are met through compliance with established international standards for design, performance, and biocompatibility. The reported device performance is stated as "Complied with" these standards.

Here's how we can infer the acceptance criteria and reported performance from the text:

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

The document does not specify sample sizes for test sets in the traditional sense of a clinical trial or algorithm evaluation. The testing referenced refers to compliance with ISO standards, which typically involve specific sampling plans and test methods for manufacturing quality control and performance validation.

• Test Set Sample Size: Not explicitly stated as individual numbers for device testing. Compliance with ISO standards implies that appropriate sample sizes were used according to those standards for each specific test (e.g., performance, biocompatibility).
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The studies are "performance testing" and "biocompatibility studies" conducted to demonstrate compliance with international standards.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not applicable to this type of device and submission. "Ground truth" established by experts (like radiologists) is relevant for diagnostic medical devices or AI algorithms. For syringes and needles, the "ground truth" is defined by the technical specifications and performance requirements outlined in the ISO standards themselves, verified through physical and chemical testing.

4. Adjudication Method for the Test Set:

This information is not applicable. Adjudication methods (e.g., 2+1) are used to resolve disagreements among multiple human readers in the context of diagnostic evaluations, typically for AI or imaging studies. For the direct performance testing of syringes and needles against standards, there isn't a "ground truth" established by human readers that requires adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

This information is not applicable. MRMC studies are designed to compare the diagnostic performance of human readers, often with and without AI assistance, especially in radiology or pathology. This submission is for physical medical devices (syringes and needles), not a diagnostic AI system, so such a study would not be relevant.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

This information is not applicable. This refers to the performance of a software algorithm or AI model without human intervention. The devices being reviewed are physical medical instruments (syringes and needles), not software or AI.

7. Type of Ground Truth Used:

The "ground truth" in this context is adherence to the technical specifications and safety/performance parameters defined by internationally recognized standards (e.g., ISO 7886-1 for syringes, ISO 7864/9626 for needles, ISO 8537 for insulin syringes, and ISO 10993 series for biocompatibility). This is established through objective technical measurements and laboratory test results that demonstrate the device meets these pre-defined (standardized) criteria. It is not expert consensus, pathology, or outcomes data in the sense of diagnostic device validation.

8. Sample Size for the Training Set:

This information is not applicable. A "training set" is used for machine learning or AI model development. These devices are physical medical products, not AI systems, so there is no training set in this context.

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

This information is not applicable for the reasons stated in point 8.

Ask a specific question about this device

The sterile Hypodermic Syringe 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 Insulin Syringe for Single use with needle, with the callbration unit of insulin for U-100, is a device intended for medical purposes for the manual aspiration of insulin into parts of insulin into parts of insulin into parts of the body below the surface skin.
The sterile Insulin Syringe for Single use with the callbration unit of insulin for U-40, is a device intended for medical purposes for the manual aspiration of insulin into parts of insulin into parts of insulin into parts of the body below the surface skin.
The sterile Hypodermic needle for Single use is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.

The plunger of syringe can be pulled and pushed along inside the barrel, allowing the syringe to take in and expel the fluids through the connector to the patient.
Configuration: Piston, Plunger, Barrel, (Needle) for Hypodermic Syringe; Needle cover, Needle, Piston, Barrel, Plunger, End cap for Insulin Syringe; Protective cap, Needle tube, Adhesives, Needle hub for Hypodermic Needle.
Operation Mode: For manual use only.
Nozzle: Luer Slip, Luer Lock for Hypodermic Syringe and Hypodermic Needle; Fixed Needle for Insulin Syringe.
Volume/Sizes: Luer slip: 1,2,3,5,10,20,30,35,50,60(ml), Luer Lock: 1,2,3,5,10,20,30,35,50,60(ml), 18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G, 28G, 29G, 30G for Hypodermic Syringe; 0.3, 0.5, 1(ml), 29G, 30G, 31G for Insulin Syringe; 18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G, 28G, 29G, 30G for Hypodermic Needle.
Material: Plunger: polypropylene (PP); Barrel: polypropylene (PP); Piston: isoprene rubber; Hypodermic needle: polypropylene (PP), stainless steel; for Hypodermic Syringe; Needle cover: polypropylene (PP); Needle: stainless steel (SUS); Piston: isoprene rubber; Barrel: polypropylene (PP); Plunger: polypropylene (PP); End cap: polypropylene (PP); for Insulin Syringe; Protective cap: polypropylene (PP), Needle tube: stainless steel (SUS), Adhesives: epoxy resin, Needle hub: polypropylene (PP) for Hypodermic Needle.

This document is a 510(k) Summary for a Sterile Hypodermic Syringe for Single use, with/without needle, Sterile Insulin Syringe for Single use, with needle, and Sterile Hypodermic needle for Single use. It does not describe a study in the context of validating an AI/ML device but rather demonstrates substantial equivalence to a predicate device through non-clinical performance testing against recognized standards.

Here's an analysis based on the provided text, addressing the points where information is available:

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

The document lists various ISO standards as the acceptance criteria for product performance, sterilization, and biocompatibility. The reported device performance is that the "test results demonstrated that the proposed device complies with the following standards" or "The test results show that the proposed device complies with the requirements."

There isn't a table directly comparing specific quantitative acceptance criteria with measured device performance values in this summary. Instead, it states compliance with recognized standards.

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 the non-clinical bench tests or the number of individual devices tested to demonstrate compliance with the standards. It only states that "Bench tests were conducted" and "test results demonstrated that the proposed device complies."

The sponsor is Shanghai Kohope Medical Devices Co., Ltd from China. The tests would presumably have been conducted there or by a contract lab on behalf of the manufacturer. The data provenance is not explicitly stated as retrospective or prospective in the context of a clinical study, as these are engineering/materials tests.

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 information is not applicable to the type of device and testing described. The "ground truth" here is compliance with established international and national standards for medical devices (ISO, ASTM, USP), which are quantitative and objective measures, not subjective expert interpretations.

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

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for clinical studies involving expert review of medical images or patient outcomes, not for bench testing of physical device properties against engineering 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 information is not applicable. MRMC studies are used for AI/ML devices involving human readers (e.g., radiologists interpreting images). This submission is for a physical medical device (syringes and needles) and does not involve AI or human readers in an diagnostic capacity.

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

This information is not applicable, as this device does not involve an algorithm or AI.

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

The "ground truth" for this device is defined by the technical specifications and performance requirements outlined in the referenced international and national standards (ISO, ASTM, USP). This is objective, measurable data related to physical properties (e.g., fluid tightness, force required for plunger movement, sterility, endotoxin levels, material biocompatibility, seal strength).

8. The sample size for the training set

This information is not applicable. This is not an AI/ML device that requires a training set.

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

This information is not applicable. This is not an AI/ML device that requires a training set or establishment of ground truth for such a set.

Ask a specific question about this device