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Disposable TPE Infusion Set is used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein.

The applicant device is single-use, sterile disposable infusion device, which is intended to be used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein.

The protective cap is intended to protect the needle; The puncturing needle is made of Polyethylene and used to pierce the container; the catheter is made of thermoplastic elastomer (TPE) and used to connect various components, there is no DEHP used in the proposed device; the drip is transparent so that the user can observe the dropping condition of the medical solution, and it has a filtration mesh which can prevent the micro particle with diameter larger than 200 um to from entering human vessel; Flow regulator is used to adjust the flow rate from zero to maximum; Infusion needle is inserted into human vessel for medical solution transfusion, it is made of stainless steel.

The proposed device is provided sterilized.

The provided document is a 510(k) summary for a Disposable TPE Infusion Set. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not include detailed information regarding specific acceptance criteria, a comprehensive study report with performance metrics, sample sizes for test and training sets, expert qualifications, or adjudication methods for establishing ground truth, which are typically found in studies relevant to AI/ML software.

The document states: "Laboratory testing was conducted to validate and verify that disposable infusion set met all design specifications and was substantially equivalent to the predicate device." This indicates that physical and functional tests were performed on the device to ensure it met pre-defined engineering and safety standards, rather than a clinical study evaluating an algorithm's performance.

Therefore, many of the requested details about acceptance criteria and study particulars for a software/AI device cannot be extracted from this document.

Here's a breakdown of what can be inferred or what is explicitly missing based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: Not explicitly stated in terms of specific thresholds for performance metrics (e.g., accuracy, sensitivity, specificity) for a software device. For this hardware device, acceptance criteria would typically relate to physical properties, flow rates, sterility, material biocompatibility, and mechanical integrity. The document only generally states the device "met all design specifications."
• Reported Device Performance: No specific performance metrics (like accuracy, sensitivity, etc.) are reported in the document. The general statement is that it "met all design specifications" and was "substantially equivalent to the predicate device."

2. Sample Sizes Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not specified. This document pertains to a physical medical device (infusion set), not a software algorithm. Testing would involve a certain number of manufactured units, but the count is not provided.
• Data Provenance: Not applicable in the context of clinical "data provenance" for algorithm training/testing. The testing performed would be laboratory-based validation of the physical device.

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

• Number of Experts: Not applicable. For a physical infusion set, ground truth is established through engineering specifications, validated test methods (e.g., flow rate testing, material testing, sterility testing), and adherence to standards, not expert clinical consensus on images or diagnoses.
• Qualifications of Experts: Not applicable.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

• Adjudication Method: Not applicable for a physical device. Test results are typically compared against pre-defined engineering specifications.

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

• MRMC Study: No. This is a physical medical device, not an AI/ML diagnostic tool requiring human reader comparison.

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

• Standalone Performance: No. This refers to an algorithm's performance, which is not relevant here.

7. The Type of Ground Truth Used

• Type of Ground Truth: For this device, ground truth would be established by validated engineering specifications, international standards (e.g., for sterility, biocompatibility, flow rate), and material properties testing. It's not based on expert consensus, pathology, or outcomes data in the way a diagnostic AI would be.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. There is no software algorithm or "training set" mentioned or implied for this physical device.

9. How the Ground Truth for the Training Set was Established

• Ground Truth for Training Set: Not applicable.

In summary, the provided 510(k) summary for the Disposable TPE Infusion Set is for a conventional physical medical device. It does not contain the type of information related to AI/ML software performance, acceptance criteria, study design (like sample sizes, expert involvement, and ground truth establishment) that your questions are designed to elicit. The "study" referenced is general laboratory testing to confirm the device meets its design specifications and is substantially equivalent to a predicate device.

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Disposable Infusion Set is used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein.

The applicant device is plastic, single-use, sterile disposable infusion device, which is intended to be used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein. The protective cap is intended to protect the needle; The puncturing needle is made of Polyethylene and used to pierce the container; the catheter is made of Polyvinyl chloride and used to connect various components, there is no DEHP used in the proposed device; the drip is transparent so that the user can observe the dropping condition of the medical solution, and it has a filtration mesh which can prevent the micro particle with diameter larger than 200 um to from entering human vessel; Flow regulator is used to adjust the flow rate from zero to maximum; Infusion needle is inserted into human vessel for medical solution transfusion, it is made of stainless steel. The proposed device is provided sterilized.

The provided text describes a 510(k) summary for a Disposable Infusion Set and does not contain information about acceptance criteria, device performance, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

The document discusses:

• Device Name: Disposable Infusion Set
• Intended Use: To administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein.
• Device Description: Plastic, single-use, sterile infusion device with components like a protective cap, puncturing needle, catheter (no DEHP), drip with filtration mesh, flow regulator, and infusion needle.
• Test Conclusion: "Laboratory testing was conducted to validate and verify that disposable infusion set met all design specifications and was substantially equivalent to the predicate device."
• Predicate Device: Tianjin Medis Disposable Infusion Set (K060082)
• Substantial Equivalence Conclusion: The subject device is substantially equivalent to the predicate device.

Therefore, I cannot provide the requested information as it is not present in the given text. The information provided focuses on the regulatory submission process and the declaration of substantial equivalence based on unspecified "laboratory testing" and "design specifications."

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Blood Transfusion Set is used to administer blood from a container (plastic bag or glass bottle) to a patient's vascular system through a needle or catheter inserted into a vein.

The proposed device is plastic, disposable and sterile blood transfusion set, which is intended to be used to administer the blood from the container to a patient's vascular system through a needle or catheter inserted into a vein via gravity method.

The blood transfusion set consists of protective cap of the closure-piercing device, closure piercing device, tubing, drip, flow regulator, transfusion needle and needle sheath. In addition, there are two kinds of the transfusion set, one has a drug-adding feature and the other hasn't.

There are two specifications of transfusion needle, which are 0.9# transfusion needle and 1.2# transfusion needle.

The proposed device is provided sterilized.

The provided text describes a 510(k) submission for a Blood Transfusion Set, and thus there is no information about acceptance criteria or a study proving that a device meets acceptance criteria. The document is a premarket notification for a medical device seeking substantial equivalence to a predicate device.

Specifically:

• No acceptance criteria or device performance table is provided. The document states that "Laboratory testing was conducted to validate and verify that Blood Transfusion Set met all design specifications and was substantially equivalent to the predicate device," but it does not specify what those design specifications or acceptance criteria were, nor does it report specific performance metrics.
• No information on sample size for test sets or data provenance is available. No clinical or performance study details are included in this summary.
• No information on experts for ground truth or adjudication methods is available. There is no mention of a ground truth in the context of this device's submission, as it relates to a physical device rather than an AI or diagnostic algorithm.
• No MRMC comparative effectiveness study or standalone algorithm performance study was mentioned. These types of studies are typically relevant for AI/ML-based diagnostic devices, which is not the case here.
• The type of ground truth used is not applicable/not mentioned. For a physical device like a blood transfusion set, "ground truth" would not be established in the same way as for a diagnostic algorithm. The validation would likely involve engineering and biocompatibility testing against predefined standards.
• No information on training set sample size or how ground truth was established for a training set is available. This is not relevant for the type of device described.

In summary, the provided document is a 510(k) summary for a Blood Transfusion Set, focusing on its description, intended use, and substantial equivalence to a predicate device, rather than detailed performance studies or AI-specific validation criteria.

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