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General surgical fluid irrigation and infiltration.

The principles of operation and technology incorporated in the 1000 Pressure Infusor are equivalent to pressurized irrigation systems, which use compressed nonflammable gases within a closed bladder (inflatable cuff to apply direct pressure externally to a bag of fluid for infusion of fluids).

The provided text is a 510(k) summary for the "1000 Pressure Infusor" device. A 510(k) submission is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (predicate device) that is not subject to premarket approval.

This document describes a medical device called a "Pressure Infusor" for general surgical fluid irrigation and infiltration, not an AI/ML powered device.

Therefore, most of the requested information about acceptance criteria, study design for AI/ML performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies is not applicable to this type of device and submission.

The 510(k) summary focuses on demonstrating substantial equivalence to existing, legally marketed predicate devices, rather than presenting a performance study against specific acceptance criteria for a novel technology like AI/ML.

Here's a breakdown of what can be extracted or inferred from the provided text, and what is explicitly not present due to the nature of the device:

1. Table of Acceptance Criteria and Reported Device Performance

Not Applicable. This document does not present a table of specific quantitative acceptance criteria or reported performance data in the way an AI/ML device submission would. The submission focuses on demonstrating substantial equivalence to predicate devices, meaning its performance characteristics are assumed to be similar and acceptable if proven equivalent in function and safety.

The "performance" demonstration for this type of device would typically involve showing that it achieves the intended function (pressurizing fluid bags for irrigation/infiltration) safely and effectively, similar to the predicate devices. This usually involves:

• Materials Compatibility: Ensuring materials in contact with fluids are safe.
• Pressure Control: Demonstrating the device can achieve and maintain appropriate pressure ranges without exceeding safe limits.
• Leakage/Integrity: Proving the system is robust and leak-proof.
• Biocompatibility: If applicable, ensuring materials are biocompatible.
• Sterilization Validation: If the device or components are sterile.

However, none of these specific performance criteria or results are quantified or tabulated in this 510(k) summary.

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

Not Applicable. There is no "test set" in the context of an AI/ML algorithm evaluation mentioned in this document. The submission is for a physical medical device (Pressure Infusor).

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

Not Applicable. Ground truth, in the context of expert consensus, is irrelevant for a mechanical device like a pressure infusor.

4. Adjudication Method for the Test Set

Not Applicable. There is no "test set" or diagnostic decision to adjudicate.

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

No. An MRMC study is not relevant for this type of physical device. Such studies are used for evaluating diagnostic performance, often in imaging, involving human readers and AI assistance.

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

Not Applicable. This is a physical device, not an algorithm.

7. The Type of Ground Truth Used

Not Applicable. The concept of "ground truth" (expert consensus, pathology, outcomes data) as applied to AI/ML diagnostics is not relevant here. The "truth" for this device lies in its mechanical function, safety, and effectiveness.

8. The Sample Size for the Training Set

Not Applicable. This is a physical device, not an AI/ML algorithm that requires a 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 algorithm, this question is not relevant.

Summary of Device and 510(k) Submission:

• Device Name: 1000 Pressure Infusor
• Indication for Use: General surgical fluid irrigation and infiltration.
• Device Description: Uses compressed nonflammable gases within a closed bladder (inflatable cuff) to apply direct pressure externally to a bag of fluid for infusion.
• Substantial Equivalence Claim: The device's principles of operation and technology are similar to other irrigation devices (listed as predicates) previously found substantially equivalent by the FDA.
• Predicate Devices:
  • MX820-5 Pressure Infusor 500cc / MX820-10 Pressure Infusor 1000cc (Medex, Inc. - K800560)
  • Nezhat-Dorsey Hydro-Dissection Universal Bag Squeezer (Davol, Inc. - K953574)
  • Automatic Surgical Irrigation Pump/Autocuff (Alton Dean Medical, Inc./Spartamed, Inc. - K922286)
  • Niagara Pump, 3.0 Liter High Volume (Cabot Medical Systems - K924530)
  • Big Bag 3000 (Byron Medical - K973133)
  • Lapro Flow 3000 (ASSC - K980089)
• FDA Decision: The FDA determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.

In essence, the "study" proving this device meets acceptance criteria is the demonstration that its design and function are sufficiently similar to multiple existing, approved predicate devices, implying it shares their established safety and effectiveness profile. This is a common pathway for physical medical devices where there isn't a complex diagnostic algorithm or novel biological interaction.

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General surgical fluid irrigation and infiltration.
The 3600 Pressure Infusor indications for use are general surgical fluid irrigation and infiltration.

The principles of operation and technology incorporated in the 3600 Pressure Infusor are equivalent to pressurized irrigation systems, which use compressed nonflammable gases within a closed bladder (inflatable cuff to apply direct pressure externally to a bag of fluid for infusion of fluids.

The provided text is a 510(k) summary for a medical device (3600 Pressure Infusor) and the FDA's response. It does not contain information about acceptance criteria or a study proving device performance in the way typically seen for AI/ML medical devices.

Instead, this document describes a traditional medical device submission for substantial equivalence. The "study" here is essentially the comparison to predicate devices, and the "acceptance criteria" are implied by the FDA's finding of substantial equivalence.

Therefore, many of the requested categories (e.g., sample size for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types) do not apply to this type of regulatory submission.

Here's how to interpret the document in the context of the prompt:

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

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

• Sample Size: Not applicable. This is a comparison to predicate devices, not a performance study with a test set of data.
• Data Provenance: Not applicable.

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

• Not applicable. Ground truth, in the sense of expert consensus on diagnostic or prognostic outcomes, is not part of a substantial equivalence submission for this type of device.

4. Adjudication method for the test set

• Not applicable.

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/ML device, nor is it a study comparing human readers with and without AI assistance.

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

• Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used

• Not applicable in the common sense for AI/ML. The "ground truth" for this submission is established through comparison to legally marketed predicate devices and their established safety and effectiveness.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device that requires a training set.

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

• Not applicable.

In summary: The provided document is a 510(k) premarket notification for a traditional medical device (a pressure infusor). The "study" is the comparison to predicate devices, and the "acceptance criteria" are met by demonstrating substantial equivalence to those legally marketed devices based on shared principles of operation, technological characteristics, and intended use. The concepts of test/training sets, expert consensus for ground truth, and reader studies are not relevant to this type of regulatory submission.

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The device is indicated for use in patients eligible for treatment via general laparoscopic surgical procedures.

The Candidate Device consists of a hand-held trumpet valve suction-irrigator designed to provide pinpoint suction and irrigation to the surgical site during general laparoscopic procedures. This device is designed for use with legally-marketed irrigation pumps, irrigant bags and bottles, and legallymarketed suction sources.

The provided document is a 510(k) summary for the Trump-It II™ and Magnum 250 Trumpet Valve Suction-Irrigation Handpieces. This document focuses on establishing substantial equivalence to a predicate device and does not contain detailed information about specific acceptance criteria or a study proving that the device meets those criteria.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details from the provided text.

The document primarily covers:

• Submitter's Name and Contact
• Device Name and Classification
• Predicate Device identification (Nezhat-Dorsey Hydro-Dissection System & Accessories, K951086)
• Device Description (function, scientific basis, physical/performance characteristics like sterile, disposable, single-use, and materials are proprietary)
• Intended Use Statement (general laparoscopic surgical procedures for eligible patient populations)
• Technological Characteristics Summary
• FDA's 510(k) clearance letter confirming substantial equivalence.
• Indications For Use statement.

It specifically states that the device provides "pinpoint suction and irrigation to the surgical site during general laparoscopic procedures" by combining a hand-held trumpet valve suction-irrigator and a laparoscopic probe. The basis of the 510(k) is substantial equivalence to an existing device, rather than explicit performance criteria described by a detailed study in this document.

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