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Administration of Intravenous fluids and drugs. The Tuta Healthcare Pty. Burette In Line (150ml) is a device used to administer fluids from a container to a patient's vascular system Through a cannula inserted into a vein.

The Tuta Healthcare Burette - In Line (150 mL) is designed administer fluids from a container to a patient's vascular system through a needle catheter inserted into a vein. The pump helps to control the rate of flow of fluids from the container to the patient. The design of the Burette - In Line (150 mL) and Baxter Healthcare's In-Line Buretrol Extension Set are similar in terms of components of , PVC tubing, roller regulators and perforators.

The provided text describes a 510(k) submission for a medical device, the Tuta's Burette - In Line (150 mL). This type of submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. This is typically done through a comparison of technological characteristics and performance data.

However, the provided document does not contain the information requested regarding acceptance criteria and a study proving a device meets them in the context of an AI/ML or diagnostic device. The device described is an "Administration Set, Intravascular," which is a physical burette for fluid administration, not a software algorithm or a diagnostic tool.

Therefore, I cannot provide the requested table and details because:

• Acceptance Criteria for a diagnostic/AI device: The document discusses equivalence to a predicate device, not specific performance metrics (like sensitivity, specificity, AUC) that would be relevant for an AI/ML or diagnostic device. The "acceptance criteria" here are implied by the demonstration of substantial equivalence in performance to the predicate device in terms of flow rate and biocompatibility.
• Study proving device meets acceptance criteria (for AI/ML): The study conducted was "Laboratory bench testing" to assess flow rate and "biocompatibility testing" for materials. These are engineering and material science tests, not clinical studies with patients, experts, ground truth, or statistical analysis typically associated with evaluating AI/ML models.
• Sample size and data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth, training set information: These are all concepts relevant to the evaluation of AI/ML or diagnostic devices, which are not applicable to the physical burette described in the document.

In summary, the provided document describes a predicate device comparison for a fluid administration set, not an AI/ML or diagnostic device with performance metrics related to accuracy or human-in-the-loop improvements.

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Administration of Intravenous fluids and drugs.

The Tuta Healthcare Pty. Limited Blood Administration Set is a device used to administer fluids, blood and blood products from a container to a patient's vascular system Through a catheter or venous access system inserted into a vein.

Use of Needle-Free Access site may aide in the prevention of needlestick injury.

The Tuta Healthcare Blood/Solution Administration Set is designed administer fluids from a container to a patient's vascular system through a needle catheter inserted into a vein. The pump helps to control the rate of flow of fluids from the container to the patient.

The provided text describes a 510(k) summary for the Tuta Healthcare Blood/Solution Administration Set, comparing it to the legally marketed Baxter Healthcare's Solution Administration Set (K924721). The submission aims to demonstrate substantial equivalence, focusing on design, materials, intended use, and performance.

However, the document does not contain the kind of detailed information typically found in studies for AI/ML-enabled medical devices or diagnostic devices, especially regarding acceptance criteria, specific performance metrics (like sensitivity, specificity, AUC), sample sizes for test/training sets, expert qualifications, or adjudication methods for ground truth, as these are not relevant to this type of device (an administration set) or the type of substantial equivalence submission presented.

The study referenced is a laboratory bench testing to assess the new device against the predicate device.

Here's a breakdown of the information that is available in the provided text in relation to your questions:

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

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

• Sample Size for Test Set: Not specified. The document states "Laboratory beach testing has been performed," but does not provide details on the number of units or test repetitions.
• Data Provenance: The testing was "Laboratory beach testing," implying it was conducted in a controlled environment. The manufacturer is based in Australia, but the testing location is not explicitly stated. It is a prospective study as tests were performed specifically for this submission.

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 device is an administration set, not a diagnostic device requiring expert interpretation of results or establishing ground truth based on clinical expert consensus. The "ground truth" here is the performance of the predicate device and established safety standards.

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

Not applicable. This device is an administration set. Adjudication methods are typically relevant for diagnostic studies where there's variability in interpretation or a need for consensus on clinical findings.

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 device is not an AI-enabled diagnostic tool, and no human reader studies were conducted.

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

Not applicable. This device does not have an algorithm or AI component.

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

The "ground truth" in this context is the performance of the legally marketed predicate device (Baxter Healthcare's Solution Administration Set K924721) and adherence to recognized safety and performance standards (e.g., biocompatibility testing per General Program Memorandum #G95).

8. The sample size for the training set

Not applicable. There is no "training set" as this is a physical medical device and not an AI/ML model.

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

Not applicable, as there is no training set. The "ground truth" for comparison is the predicate device's established performance and regulatory compliance.

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The Tuta Healthcare Pty. Limited Arthroscopy Flushing set (80.601) is a gravity system for fluid management during arthroscopic procedures. During these procedures, the fluid is used to (1) distend the site, enabling good visibility and (2) flush it continuously to clear debris (loose bodies or cartilage fragments away).

The Tuta Healthcare Arthroscopy Flushing set is designed to provide controlled Irrigation to a joint during arthroscopic procedures. action of the hand pump help to remove blood, tissue debris, loose bodies and foreign matter from the joint cavity. The click clamps are used to block the flow of fluid.

The provided text describes a 510(k) summary for Tuta's Arthroscopic Flushing Device. However, it does not contain information regarding a study, acceptance criteria, or device performance metrics.

Therefore, I cannot fulfill the request to provide:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance.
3. Number of experts or their qualifications for establishing ground truth.
4. Adjudication method for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size.
6. If a standalone performance study was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

The document is a 510(k) premarket notification for an Arthroscopy Flushing Set, focusing on establishing substantial equivalence to a legally marketed predicate device (Edwards Orthopedic Division, Baxter Healthcare Irrigation Set K883300). The 510(k) process primarily demonstrates that a new device is as safe and effective as a predicate device, often without requiring new clinical studies if the technology and intended use are similar. The information provided confirms the device name, manufacturer, intended use, and substantial equivalence to a predicate device, as well as the FDA's clearance letter.

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