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Disposable Sterile Syringe is intended to inject fluids into or withdraw fluids from the body.

Disposable Sterile Syringe, is a plastic syringe designed for intended to inject fluids into or withdraw fluids from the body. The product is a single use, sterile, non-toxic, non-pyrogenic, disposable syringe that consists of a barrel, plunger, Piston, Needle tube, Needle hub and Needle cap.

All specifications of product subject to the same design and the difference between each specification is syringe volume and needle size. The product is available in a variety combination of needle size and syringe volume.

The provided text describes the 510(k) summary for a Disposable Sterile Syringe (K221777) and its substantial equivalence to a predicate device. This document is a regulatory submission for a medical device that does not involve AI or complex software, and therefore, many of the requested details regarding acceptance criteria, study methodologies for AI/software performance (e.g., sample size for test sets, expert adjudication, MRMC studies, standalone performance, ground truth for AI), and training set information are not applicable.

The device is a simple, physical product (a syringe) and its "performance" is assessed through adherence to established international and ASTM standards for physical, chemical, and biological properties, as well as sterility and packaging integrity. The acceptance criteria for such a device are primarily defined by these international standards.

Here's an attempt to address the points based on the provided document, highlighting what is applicable and what isn't:

Device: Disposable Sterile Syringe (K221777)
Purpose: Intended to inject fluids into or withdraw fluids from the body.

This device is a traditional medical device, not an AI/Software as a Medical Device (SaMD). Therefore, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" refers to compliance with recognized standards and biocompatibility testing, rather than performance metrics like sensitivity, specificity, or AUC for an AI algorithm.

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

The acceptance criteria for this device are its compliance with various ISO and ASTM standards. The "reported device performance" is essentially that the device "meets the requirements of related standards" and that "there are no negative impacts from the materials that are used in the proposed device."

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

• Sample Size: The document does not specify exact sample sizes for each test. For medical device testing, samples are typically chosen according to relevant standard methods (e.g., lot-based sampling conforming to AQL – Acceptable Quality Level).
• Data Provenance: Not explicitly stated regarding country of origin for the non-clinical test data. The tests were performed by "Weihai Shengjie Medical Technology Co., Ltd." in China, where the manufacturing entity is located. The tests are "nonclinical" (laboratory-based) and are implicitly prospective for the purpose of demonstrating compliance.

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 physical device, not an AI algorithm requiring expert ground truth for image interpretation or diagnosis. The "ground truth" is provided by the universally recognized and standardized test methods and their defined acceptance limits (e.g., ISO, ASTM standards).

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

• Not Applicable. No human interpretation or adjudication of case data is involved for this type of device submission. Compliance is determined by objective physical, chemical, and biological test results against predefined standard thresholds.

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-assisted device.

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

• Not Applicable. This is not an AI algorithm.

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

• The "ground truth" for this medical device's performance is compliance with established international and national standards (ISO, ASTM). These standards define the acceptable physical, mechanical, chemical, and biological properties for the device. For example, for biocompatibility, the ground truth is "no cytotoxicity" as per ISO 10993-5, determined by validated laboratory methods.

8. The sample size for the training set

• Not Applicable. This device uses traditional manufacturing and testing, not machine learning, so there is no "training set."

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

• Not Applicable. As there is no training set for an AI/ML model, this question is irrelevant.

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The Auto-disable Syringe for Fixed-dose Immunization is intended for use in the aspiration and injection of fluids for medical purpose.

Not Found

Based on the provided FDA 510(k) letter, it is not possible to describe the acceptance criteria and the study that proves the device meets those criteria for the following reasons:

• Device Type: The document is a 510(k) clearance letter for an Auto-disable Syringe for Fixed-dose Immunization, which is a physical medical device (piston syringe), not a software or AI-based device.
• Study Type: For physical medical devices like syringes, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" typically refer to performance testing (e.g., plunger force, leakage, dose accuracy under various conditions, sterility, material biocompatibility, auto-disable mechanism function) rather than studies involving expert readers, ground truth establishment, or AI algorithm performance metrics (sensitivity, specificity, AUC).
• Lack of Performance Data: The provided text is an official FDA clearance letter, which confirms substantial equivalence to a predicate device and outlines regulatory obligations. It does not contain the detailed performance study results, acceptance criteria, sample sizes, or ground truth methodologies that would be submitted within the 510(k) application itself. These details are part of the technical documentation reviewed by the FDA but are not typically included in the public clearance letter.

Therefore, the requested information, which pertains to AI/software performance evaluation (e.g., MRMC studies, standalone algorithm performance, expert ground truth, training/test set details), is not applicable to the device described in this specific FDA document. The document describes a physical medical device, not an AI or imaging diagnostic software.

To answer your question, one would need to see the actual performance data and study reports submitted as part of the 510(k) application for a software device, not this physical syringe.

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The Sterile Hypodermic Syringe for Single Use with/without need 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, and for the injection of insulin into parts of the body below the surface skin.

The sterile insulin syringe for single use with needle, with the callbration 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.

• Disposable Sterile Syringe, with/without needle; luer/luer-lock: Piston, Plunger, Barrel. EO Sterilized. Prescription use. Single use. 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. Length 83-152mm, Diameter 50-31mm, Tip type luer/luer-lock, Needle tip configuration long bevel angle, Nozzle type Luer / Lock, 6% conical, 1,2 mm, Barrel marking specs 0.01ml-0.5ml, Graduation legibility Legible, Needle cover color Transparent, Lubricant composition Dimethicone, Barrel transparency Transparent/ UV resistant, Needle cover strength 15N (min. 2N max. 15N), Hub/needle bond strength min. 22-69 N. Complied with ISO 7886-1, ISO 7864, ISO 9626. Volume 1mL, 2mL, 2.5mL, 3mL, 5mL, 10mL, 20mL, 25mL, 30mL, 50mL. Sizes 18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G. Needle Lengths 13-38 mm. Piston material Isoprene Rubber, Barrel material PP, Plunger material PP, Needle material PP, SUS304. SAL 10-6. Endotoxin Limit 20 EU per device. Biocompatibility Complied with ISO 10993-4/5/10/11 (Cytotoxicity, Irritation, Sensitization Acute Systemic Toxicity, Hemolytical effect).

• Sterile Insulin Syringe for Single use, with needle: Needle Cap, Needle, Piston, Plunger, Barrel, End Cap. EO Sterilized. Prescription use. Single use. 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. Complied with ISO 8537. Volume 0.5ml, 1ml volumes with fixed needle. Needle Lengths 8mm. Piston material Isoprene Rubber, Barrel material PP, Plunger material PP, Needle material SUS304, Needle Cap material PE, End Cap material PE. SAL 10-6. Endotoxin Limit 20 EU per device. Biocompatibility ISO 10993-4/5/10/11 (Cytotoxicity, Irritation, Sensitization Acute Systemic Toxicity, Subchronic Toxicity, Hemolytical effect).

• Sterile Hypodermic needle for Single use: Protective cap, Needle, Adhesives, Needle hub. EO Sterilized. Prescription use. Medical professionals and trained care givers. Protective cap, Needle, Adhesives, Needle hub. Single use. For Manual Use Only, For Single Use only. Complied with: ISO 7864, ISO 9626. Sizes 18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G, 28G, 30G. Needle Lengths 13-38 mm. Protective cap materials PP, Adhesive Epoxy resin, Needle Hub materials PP, Needle material SUS304. SAL 10-6. Endotoxin Limit 20 EU per device. Biocompatibility Complied with ISO 10993-4/5/10/11 (Cytotoxicity, Irritation, Sensitization Acute Systemic Toxicity, Hemolytical effect).

The provided text is a 510(k) summary for medical devices (syringes and needles). It does not describe a study involving an AI model or a device that uses AI. Instead, it focuses on demonstrating substantial equivalence of the submitted devices to a predicate device through performance testing against established international standards for medical devices.

Therefore, the requested information regarding acceptance criteria and a study proving an AI device meets those criteria cannot be extracted from this document. The document primarily details the physical and performance specifications of the syringes and needles themselves.

To directly answer your request based on the provided document, I must state that the information related to AI model acceptance criteria, test sets, ground truth establishment, expert adjudication, MRMC studies, and training set details are not present in the provided text. The document describes a traditional medical device submission, not an AI/ML-enabled medical device.

However, I can extract the acceptance criteria and performance data for the physical medical devices described:

Acceptance Criteria and Device Performance for Physical Medical Devices

The acceptance criteria for these devices are defined by compliance with a series of international ISO standards and USP guidelines. The "device performance" is reported as having "complied with" these standards. No specific quantitative performance metrics (e.g., accuracy, precision, etc.) are provided in a numerical table format for an AI algorithm, as this is not an AI device.

Table of Acceptance Criteria and Reported Device Performance

Regarding an AI-enabled device and its study, the following information is NOT available in the provided document:

• 1. Table of acceptance criteria and reported device performance for an AI model: Not applicable, as this is not an AI device.
• 2. Sample size used for the test set and data provenance: No test set for an AI model is mentioned. The performance testing refers to physical tests on the medical devices themselves.
• 3. Number of experts used to establish ground truth & qualifications: Not applicable for an AI model's ground truth. The ground truth for the physical devices' performance is established by the specifications and test methods within the referenced ISO standards.
• 4. Adjudication method for the test set: Not applicable.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done: "No prospective clinical trials were conducted in support of this 510(K)."
• 6. If a standalone (algorithm only) performance was done: Not applicable, as there is no algorithm.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the physical devices, the "ground truth" is adherence to established engineering and material standards for safety and performance (e.g., fluid aspiration/injection, material biocompatibility, sterility).
• 8. The sample size for the training set: Not applicable, as there is no AI model.
• 9. How the ground truth for the training set was established: Not applicable, as there is no AI model.

In summary, the provided document details a 510(k) submission for conventional medical devices (syringes and needles) and their compliance with relevant international standards, not an AI-enabled medical device. Therefore, the specific criteria requested for AI devices are not found within this text.

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The Disposable Sterile Syringe with Needle is intended for use in the aspiration of fluids for medical purpose.

The Disposable Sterile Syringe is a sterile luer lock syringe which is intended to be used with a hypodermic needle for the aspiration and injection of fluids for medical purpose.

The proposed devices are provided in two types of configurations:

• i. a disposable sterile syringe with sterile hypodermic needle contained in a blister packaging made of PP/PE composite film and coated paper sealed by hot sealing
• ii. a disposable sterile syringe contained in a blister packaging made of PP/PE composite film and coated paper sealed by hot sealing

The disposable sterile syringe with needle is manually operated and intended for single use only, which consists of a needle and a luer lock syringe. The disposable sterile syringe consists of barrel, plunger and piston. The proposed device is available in various combination of syringe volume and needle size.

The provided text describes the 510(k) summary for a Disposable Sterile Syringe and Disposable Sterile Syringe with Needle. It details the comparison of the proposed device to a predicate device (K072739) to demonstrate substantial equivalence.

However, the request asks for "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/imaging device, including details like sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, and training set information.

The provided document does not contain information about an AI/imaging device. Instead, it's a submission for a Disposable Sterile Syringe and Needle, which is a physical medical device, not a software or AI-based diagnostic tool. The "performance tests" described are non-clinical, related to physical characteristics, biocompatibility, sterilization, and packaging integrity, and are tested against established ISO and ASTM standards, not against AI model performance metrics like sensitivity, specificity, or AUC.

Therefore, I cannot fulfill the request using the provided text because it describes a different type of medical device and the requested metrics (related to AI/imaging studies) are not applicable to the content.

There is no information on:

1. A table of acceptance criteria and reported device performance specific to AI/imaging metrics like accuracy, sensitivity, specificity, etc. The performance criteria provided are for physical characteristics, biocompatibility, and sterilization.
2. Sample size for a test set, data provenance, experts, adjudication methods, MRMC studies, standalone performance, or ground truth establishment related to an AI/imaging model. The "test set" here refers to samples of syringes and needles used for physical and biological testing.
3. Training set sample size or ground truth establishment for an AI model.

The document focuses on demonstrating substantial equivalence to a predicate device based on similar indications for use, technological characteristics, and conformance to relevant device-specific and biological safety standards for syringes and needles.

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