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The Dornoch Transposal Ultra System is self-powered suction / vacuum pump intended to collect and dispose of liquid waste within Hospital Operating Rooms, Pathology Labs, Surgical Outpatient Centers, and Doctor's Offices.

The Transposal Ultra System (Ultra System) provides a closed, self-contained, reusable cylinder suction system intended to collect and dispose of waste fluids produced through surgical procedures. The Ultra System is composed of two essential components, the Ultra Suction Cart and the Ultra Evac. The Ultra Cart can be used repeatedly until either 33L (Duo) or 52L (Quad) of fluid has been collected. Once full, the Cart is moved from the OR to the Ultra Evac. The two systems are connected together with the coupler unit on the Ultra Evac. The cleaning / wash cycle is then initiated and the automatic emptving and cleaning occurs.

The provided documentation for the Dornoch Ultra Suction Cart and Evac (K133786) does not contain comprehensive information on acceptance criteria or a detailed study proving the device meets specific performance metrics in the way typically expected for medical imaging AI devices, for example.

This device is a Class II powered suction pump, which falls under different regulatory requirements than more complex diagnostic AI systems. The approval is based on achieving substantial equivalence to existing legally marketed predicate devices, rather than meeting specific performance thresholds derived from clinical outcomes or expert consensus.

Here's an analysis based on the information provided, highlighting what is available and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information:

• Specific numerical performance metrics (e.g., suction pressure, flow rate, volume capacity, cleaning efficacy rates, failure rates) are not provided as "acceptance criteria" in this summary. The "acceptance criteria" for software are mentioned but not detailed.
• The actual "reported device performance" is largely framed as compliance with safety standards and substantial equivalence, rather than quantitative performance against specific predefined functional benchmarks.

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

• Test Set Sample Size: Not applicable in the context of this device's approval pathway. There isn't a "test set" in the sense of a clinical dataset for performance evaluation against ground truth, as would be common for AI/diagnostic devices.
• Data Provenance: The testing focused on compliance with international safety and performance standards (IEC, ISO). This is laboratory-based testing rather than data from human subjects or clinical settings, or retrospective/prospective data collection.

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

• This is not applicable. The device's approval is based on engineering and safety standard compliance, and substantial equivalence to established devices. Ground truth from experts (like radiologists for an imaging device) is not part of this type of regulatory submission. The "ground truth" here is adherence to engineering specifications and safety standards, likely evaluated by engineers and regulatory bodies.

4. Adjudication Method for the Test Set

• Not applicable. Since there's no clinical "test set" in the usual sense, there's no adjudication method involving multiple human readers.

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

• No. This device is a fluid management system, not a diagnostic or AI-driven system designed to assist human readers. Therefore, an MRMC study is not relevant and was not performed.

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

• No. The device itself is a standalone medical device (suction system). It does not contain an "algorithm" in the AI sense, nor does it require human-in-the-loop performance measurement as one would describe an AI diagnostic tool. Its performance is inherent to its mechanical and electrical function.

7. The Type of Ground Truth Used

• The "ground truth" in this context is adherence to international safety and performance standards (IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, ISO 10079-1), and internal software acceptance criteria defined by the manufacturer.
• It also relies on a comparison to predicate devices, where the "ground truth" is that the predicate devices are legally marketed and considered safe and effective.

8. The Sample Size for the Training Set

• Not applicable. This device does not use machine learning or AI algorithms that require a "training set."

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

• Not applicable. As there is no training set, there is no ground truth established for one.

Conclusion:

The Dornoch Ultra Suction Cart and Evac (K133786) received 510(k) clearance based on demonstrating substantial equivalence to predicate devices and compliance with recognized electrical and medical suction equipment safety standards. The "performance data" refers to successful completion of these standard-specific tests and internal software validation, rather than clinical performance data against a "ground truth" derived from patient outcomes or expert consensus in a clinical study format common for more complex diagnostic devices (especially AI/ML-enabled ones). Clinical data and conclusions were explicitly stated as "not needed for this device" due to its nature and regulatory classification.

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The Dornoch Transposal Ultra System is self-powered suction / vacuum pump intended to collect and dispose of liquid waste within Hospital Operating Rooms, Pathology Labs, Surgical Outpatient Centers, and Doctor's Offices.

The Dornoch Transposal Ultra System is self-powered suction / vacuum pump.

The provided text is a 510(k) premarket notification letter from the FDA for a device called the "Dornoch Ultra Suction System," which is a powered suction pump. This document does not contain information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, or study details as requested in the prompts.

Therefore, I cannot fulfill your request for this specific document.

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The Dornoch Transposal Ultra System is self-powered suction / vacuum pump intended to collect and dispose of liquid waste within Hospital Operating Rooms, Pathology Labs, Surgical Outpatient Centers, and Doctor's Offices.

The Transposal Ultra System (Ultra System) collects and disposes of waste fluids produced through surgical procedures. The Ultra System is a closed, self contained reusable suction system.

The Ultra Cart System can simultaneously collect fluids from up to four sources without mixing of the fluids. The Ultra Cart System is composed of two pieces of equipment the Transposal Ultra Cart (suction cylinder unit) and the Transposal Ultra Evac (removal and cleaning unit). The Ultra Carts can be used until 52L of fluids are collected. Once full, the Ultra Cart is attached to the Ultra Evac for automatic disposal into the hospital sanitary sewer and cleaning of the reservoir cylinders. Upon completion of the cleaning process, the cylinder lids are then replaced and the Ultra Cart is ready for use.

The Transposal Ultra Roll Stand consists of a vacuum system and up to four reusable canisters. The fluid can be collected in each canister until 2.8L of fluids are collected. The canisters are then transported to the Transposal Safety Station where they are emptied and cleaned.

The provided text pertains to the FDA 510(k) submission for the "Transposal Ultra System," a medical device designed for collecting and disposing of liquid waste in healthcare settings. However, the document does not contain the detailed study information required to fully answer your request regarding acceptance criteria and performance studies.

Specifically, the document states:
"To verify that device design has meet the functional and performance requirements representative samples of the device underwent electrical, mechanical, software, and functional testing in accordance with IEC-60601-1, IEC-60601-1-1, IEC-60601-1-2, IEC-60529, ISO 10079-1 and ISO 10079-3."

This indicates that testing was performed to verify compliance with relevant standards, but it does not provide the specific acceptance criteria, reported performance, or details of a study setup as requested.

Therefore, I cannot provide the complete answer based on the provided text. I can, however, extract the information that is present:

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

The document does not explicitly present a table of acceptance criteria with reported device performance. It only states that functional and safety testing was conducted to verify that the device design met "functional and performance requirements" in accordance with several IEC and ISO standards. The specific requirements from these standards and the corresponding test results are not detailed in this summary.

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

This information is not provided in the document.

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 provided in the document. The device is a physical system for waste collection, not an diagnostic imaging or AI system that typically requires expert-established ground truth.

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

This information is not provided in the document. It is not relevant for this type of device testing.

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

A multi-reader multi-case (MRMC) comparative effectiveness study is not applicable and was not done for this device. This type of study is relevant for AI-powered diagnostic or decision-support systems, not for a physical fluid collection and disposal system.

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

This is not applicable as the device is a physical system, not an algorithm.

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

The concept of "ground truth" as typically used in AI/diagnostic studies is not directly applicable here. For this device, "ground truth" would refer to the objective, measurable performance of the system against its stated functional requirements and applicable safety standards (e.g., vacuum pressure, fluid containment, cleaning effectiveness, electrical safety). The document only states that testing was done to verify these requirements.

8. The sample size for the training set

This information is not provided and is not applicable as this is not an AI/machine learning device.

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

This information is not provided and is not applicable as this is not an AI/machine learning device.

Summary of available information regarding the study:

• Study Purpose: To verify that the device design meets functional and performance requirements.
• Testing Conducted: Electrical, mechanical, software, and functional testing.
• Standards Followed: IEC-60601-1, IEC-60601-1-1, IEC-60601-1-2, IEC-60529, ISO 10079-1, and ISO 10079-3.
• Device Type: A self-powered suction/vacuum pump system for waste fluid collection and disposal.

The document is a "Non-Confidential Summary of Safety and Effectiveness" for an FDA 510(k) submission, which typically provides high-level information rather than detailed study protocols and results.

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