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The Closed System Transfer Device (CSTD) for preparation, reconstitution, compounding and administration of drugs, including antineoplastic and hazardous drugs. This closed system mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug or vapor concentrations outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols, and spills and also prevents microbial ingress.

The Closed System Transfer Device is a sterile, single use, Closed System drug Transfer Device (CSTD) for preparation, reconstitution, compounding and administration of antineoplastic and hazardous drugs. The Closed System Transfer Device consists of a piston syringe set (Dispensing Connector), an adaptor to the medication vial (Vial Adaptor), an adaptor for the IV bag for injection (Spike Adaptor), and Infusion Set.

The provided text is a 510(k) summary for a medical device (Closed System Transfer Device, CSTD) and focuses on demonstrating substantial equivalence to a predicate device. It does not describe an AI/ML-based device or a study involving human readers or ground truth established by experts. Therefore, I cannot extract the information required to populate the fields related to acceptance criteria and the study proving an AI/ML device meets them.

The text discusses:

• Device Name: Closed System Transfer Device (CSTD)
• Indications for Use: Preparation, reconstitution, compounding, and administration of drugs (including antineoplastic and hazardous drugs), minimizing individual and environmental exposure to drug vapor, aerosols, and spills, and preventing microbial ingress.
• Predicate Device: Equashield Closed System Drug Transfer Device (CSTD) (K170706)
• Non-Clinical Testing: A series of tests conducted to verify compliance with various ISO standards (e.g., ISO 594-1, ISO 7886-1, ISO 22413) and biocompatibility testing (e.g., Acute Systemic Toxicity, Cytotoxicity, Hemolysis, Skin Sensitization).
• No Clinical Study: The document explicitly states "No clinical study is included in this submission."

Given this content, I am unable to provide information on:

1. A table of acceptance criteria and reported device performance for an AI/ML model.
2. Sample size and data provenance for an AI/ML test set.
3. Number and qualifications of experts for AI/ML ground truth.
4. Adjudication method for an AI/ML test set.
5. MRMC study effects for AI assistance.
6. Standalone AI algorithm performance.
7. Type of ground truth (expert consensus, pathology, outcomes data) for AI/ML.
8. Sample size for the AI/ML training set.
9. How ground truth for the AI/ML training set was established.

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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.

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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 disposable sterile syringe with safety needle is intended for use in the aspiration of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.

The disposable sterile syringe with needle is intended for use the aspiration of fluids for medical purpose.

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

The disposable safety needles are intended to be used with a luer slip or luer lock syringe for aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick.

Not Found

This document is a 510(k) clearance letter from the FDA for various disposable sterile syringes and safety needles. It does not contain information about the acceptance criteria or a study proving a device meets those criteria, as it is related to general medical devices (syringes and needles), not an AI/ML powered device.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert qualifications because this information is not present in the provided text.

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Disposable IV catheter is intended to be inserted into a Patient's peripheral vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. These devices may be used for any patient with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. The 22-18 GA devices are suitable for use with power injectors set to a maximum pressure of 300 psi when access ports not suitable for use with power injectors are removed.

The Safety Straight IV Catheter System is a safety device designed to minimize blood exposure. It includes a passive needle-shielding mechanism designed to reduce accidental needle stick injury. The system consists of the following key parts: protector, needle, catheter, catheter hub, wedge, catheter hub wings, needle hub, vent fitting, safety clip, lid, valve tube, actuator, anti-reflux valve.
Straight IV Catheter System is the same as The Safety Straight IV Catheter System except for the safety device designed to minimize blood exposure.
Safety Closed IV Catheter System is a safety device designed to minimize blood exposure. It includes a passive needle-shielding mechanism designed to reduce accidental needlestick injury. The closed system is designed to keep blood contained within the device throughout the insertion process, which may prevent potential exposure for clinicians and patients. The system consists of the following key parts: protector, needle, catheter, catheter hub, wedge, catheter hub wings, septum, needle hub, safety clip, needle shield, extension tubing, pinch clamp, Luer adapter with single port, vent fitting, heparin plug, needleless connector, Luer adapter with dual port.
Closed IV Catheter System is the same as Safety Closed IV Catheter System except for the safety device designed to minimize blood exposure. The 18-22 gauge catheter systems are capable of withstanding high pressure injection procedures.
Needleless Safety Closed IV Catheter System is a safety device designed to minimize blood exposure. It includes a passive needle-shielding mechanism designed to reduce accidental needlestick injury. The closed system is designed to keep blood contained within the device throughout the insertion process, which may prevent potential exposure for clinicians and patients. The system consists of the following key parts: protector, needle, catheter hub, wedge, catheter hub wings, septum, needle hub, safety clip, needle shield, extension tubing, pinch clamp, Luer adapter with single port, vent fitting, needleless connector, Luer adapter with dual port.
Needleless Closed IV Catheter System is the same as Needleless Safety Closed IV Catheter System except for the safety device designed to minimize blood exposure. The 18-22 gauge catheter systems are capable of withstanding high pressure injection procedures.

The provided text is a 510(k) summary for a Disposable IV catheter. It outlines the device's features, intended use, and a comparison to a predicate device (K183399, Nexiva IV Catheter System) to establish substantial equivalence.

However, the document does not describe a study in the context typically expected for acceptance criteria for an AI/ML powered medical device, such as a multi-reader, multi-case study, or standalone algorithm performance. This document is for a traditional medical device (IV catheter) and focuses on engineering and biocompatibility testing against recognized standards.

Therefore, many of the requested categories related to AI/ML device studies (like sample sizes for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance for an algorithm, and ground truth types) are not applicable to the information contained in this 510(k) summary for an IV catheter.

I will attempt to extract the relevant "acceptance criteria" and "device performance" based on the provided engineering and performance standards.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by compliance with the referenced ISO and ASTM standards. The reported device performance is that it met these standards.

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

• The document does not specify exact sample sizes for each test mentioned (e.g., how many catheters were burst tested, how many were put through flow rate tests, etc.). The phrase "bench testing" is used, implying laboratory tests on manufactured samples.
• Data provenance is not provided geographically, but it is implied to be from the manufacturer's (Shinva Ande Healthcare Apparatus Co., Ltd.) testing facilities, which are based in China.
• The tests are "non-clinical," meaning they are not conducted on human subjects. They are prospective in the sense that they are performed on device samples to verify compliance.

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

• Not applicable as this is not an AI/ML-powered device or a study involving expert consensus on images/data. The "ground truth" here is compliance with engineering and biological standards, determined through validated test methods.

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

• Not applicable. Adjudication methods are typically for subjective assessments, primarily in clinical or image-based studies. These are objective engineering and biological tests against established 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:

• Not applicable as this is not an AI/ML-powered device. No human reader studies (with or without AI assistance) were performed or are relevant for this type of medical device's 510(k) submission.

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

• Not applicable as this is not an AI/ML-powered device.

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

• For this traditional medical device, the "ground truth" is defined by compliance with internationally recognized engineering performance standards (ISO, ASTM) and biocompatibility standards (ISO 10993 series), and that test results meet the specified requirements of these standards.

8. The sample size for the training set:

• Not applicable as this is not an AI/ML-powered device. There is no "training set."

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

• Not applicable as this is not an AI/ML-powered device.

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The Disposable Enteral Feeding Syringe with Enfit Connector is indicated for use as a dispenser, a measuring device, and a fluid transfer device. It is used to deliver fluids into the gastrointestinal system of a patient who is physically unable to eat and swallow. The enteral feeding syringes are intended to be used in clinical or home care setting by users ranging from laypersons (under the supervision of a clinician) to clinicians, in all age groups.

The proposed device is a disposable enteral feeding syringe provided in a variety of size from 1ml-60ml (1ml, 2ml, 2.5ml, 3ml, 5ml, 10ml, 30ml, 50ml and 60ml). The device is composed by barrel with ENFit connector, piston (plunger and plunger stopper), lubricant and tip cap (with or without). The piston is made of polyisoprene synthetic rubber, without DEHP or natural latex. This device incorporates a female ENFit connector for connection to an enteral access device with a male ENFit connector. They are two types of syringe: Side connector ENFit syringe and central connector ENFit syringe. The size of the central connector ENFit syringes range from 1ml to 5ml, and they are the low dose tip syringes; and side connector ENFit syringes range from 10ml to 60ml, and they are the standard syringes. The Disposable Enteral Feeding Syringe with Enfit Connector relies on the interference matching between piston and inner chamber wall of the barrel to ensure the sealing of liquid in the inner chamber of the barrel. The plunger and the plunger stopper constitute a sealing assembly. By pushing and pulling the plunger, the plunger stopper can be driven to move freely inside the barrel, similar to the piston structure, so as to realize the suction and infusion of fluid. The proposed syringe is sterile. Sterile device was sterilized by Ethylene Oxide Gas to achieve a SAL of 10 ° and supplied sterility maintenance package which could maintain the sterility of the device during the shelf of five years.

The provided text is a 510(k) Premarket Notification for a Disposable Enteral Feeding Syringe with Enfit Connector. It details the device, its intended use, comparison to a predicate device, and performance data to support substantial equivalence.

However, the information requested in your prompt (acceptance criteria, study details, sample sizes, expert involvement, ground truth, etc., particularly in the context of an AI/human-in-the-loop study) is not present in this document.

This document describes a medical device, which is a physical product (a syringe), and not a software device or an AI/ML algorithm that would typically involve the type of study details you are asking for. The performance data presented (biocompatibility, sterilization, shelf life, and bench performance testing like connector and syringe testing) are standard for physical medical devices and do not involve AI assistance, human readers, or image interpretation.

Therefore, I cannot provide the requested information based on the given input.

Reasoning for lack of information:

• Device Type: The device is a "Disposable Enteral Feeding Syringe with Enfit Connector," a physical medical device. The types of acceptance criteria and studies you're asking about (MRMC, human readers, AI assistance, ground truth for training sets) are typically relevant for AI/ML-enabled medical devices, often in diagnostic imaging or other data interpretation fields.
• Study Types Mentioned: The studies mentioned are:
  • Biocompatibility testing (ISO 10993)
  • Sterilization testing (ISO 11135)
  • Shelf life testing (accelerated aging)
  • Bench performance testing (ISO 80369-3, ISO 80369-20, ISO 7886-1)
  • No clinical studies were deemed necessary due to substantial equivalence to a predicate device, and certainly no studies involving AI or multi-reader interpretations.

If you have a document describing an AI/ML medical device, I would be happy to analyze it against your criteria.

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