Search Results

THE MINOP® DISPOSABLE INTRODUCER IS INDICATED TO OBTAIN AND MAINTAIN A TEMPORARY PATHWAY INTO THE VENTRICULAR SYSTEM OF THE BRAIN.

The MINOP® Disposable Introducer is a single used to obtain ventricular access and facilitate endoscope insertion. The MINOP® Disposable Introducer consists of an introducer sheath and a ventricular obturator.

The document provided is a 510(k) premarket notification for the MINOP® Disposable Introducer. This type of submission relies on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical studies with detailed acceptance criteria and standalone performance metrics typically associated with AI/ML device evaluations.

Therefore, many of the requested categories related to AI/ML device studies (such as MRMC studies, training set details, expert qualifications for ground truth, etc.) are not applicable to this submission.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal acceptance criteria in a quantitative table for multiple performance metrics. Instead, it refers to equivalence to a predicate device and internal standards for peel force.

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

• Sample Size: Not specified in the document. The performance data section vaguely refers to "Performance testing" and "Results of the peel force testing" without giving specific numbers of units tested.
• Data Provenance: The testing was "in-vitro" and relates to the physical properties of the device components. There is no information regarding country of origin or whether it was retrospective or prospective, as it's not a clinical study involving patient data.

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

Not Applicable. This is an invivo mechanical/material performance test, not a study requiring expert readers to establish ground truth. The "ground truth" here is the physical measurement of peel force against defined internal standards.

4. Adjudication Method for the Test Set

Not Applicable. There's no "adjudication" in the sense of reconciling divergent expert opinions, as this is a physical performance test.

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

No. An MRMC study was not done. The submission relies on substantial equivalence to predicate devices, supported by in-vitro mechanical testing.

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

Not Applicable. This is a physical medical device, not an AI/ML algorithm.

7. The Type of Ground Truth Used

The ground truth used for the peel force analysis was "Medcomp's internal standards for force at break." This refers to a predefined, objective standard for mechanical performance.

8. The Sample Size for the Training Set

Not Applicable. This device did not involve machine learning; therefore, there was no training set.

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

Not Applicable. As there was no training set, this question is not relevant.

Ask a specific question about this device

The Introducer Sheath is a device used to make a channel through the brain into the ventricular system.

The Introducer Sheath includes two parts, a peelaway sheath and a blunt ended obturator, which fits inside the sheath. The Introducer Sheath provides an atraumatic passage into the ventricular system.

The provided document is a 510(k) premarket notification for a medical device called the "Medtronic PS Medical Endoscope Introducer." This type of document focuses on demonstrating substantial equivalence to a previously legally marketed device, rather than providing detailed acceptance criteria and a specific study proving the device meets those criteria.

Therefore, many of the requested details about performance, sample sizes, ground truth establishment, and comparative effectiveness studies are not available in this document. The document's purpose is to show that the new device is as safe and effective as existing ones, based on similar design and intended use.

Here's an analysis based on the information available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of acceptance criteria or specific performance metrics that the Medtronic PS Medical Endoscope Introducer was tested against in a formal study.

Instead, the document asserts technological comparison and substantial equivalence to predicate devices (Navigational F Sheath and Codman Peel Away Sheath) based on:

• Device configuration/contents: Peel Away Sheath, Obturator
• Sterility Method: EtO (Ethylene Oxide)
• Sterile: Sterile single-use device
• Intended Use: To make a channel through the brain into the ventricular system.

The "reported device performance" is implicitly that it performs like the predicate devices, enabling the creation of a channel through the brain for ventricular access. No quantitative performance data is provided.

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

This information is not provided in the document. As a 510(k) submission based on substantial equivalence, it relies on the established safety and effectiveness of the predicate devices. There is no mention of a specific test set or data derived from testing the Medtronic PS Medical Endoscope Introducer.

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

This information is not provided. Ground truth establishment for a test set is typically part of a dedicated performance study, which is not detailed in this 510(k) submission.

4. Adjudication Method for the Test Set

This information is not provided.

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

No, an MRMC comparative effectiveness study was not done (or at least, not reported in this document). The 510(k) process for this device relies on demonstrating equivalence to predicate devices, not on a human-in-the-loop study with AI.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

This device is a physical medical instrument, not an algorithm or AI. Therefore, the concept of "standalone (algorithm only)" performance is not applicable to this product.

7. The Type of Ground Truth Used

The "ground truth" here is not clinical outcome data or expert consensus on performance of the new device. Instead, the "ground truth" for this 510(k) submission is implicitly the established safety and effectiveness of the predicate devices (Navigational F Sheath (K931973) and Codman Peel Away Sheath (K883607)), which allow for the "creation of a channel through the brain into the ventricular system." The new device is deemed substantially equivalent in its design, materials, and intended use.

8. The Sample Size for the Training Set

This information is not applicable and not provided. This is a physical device, not an AI or machine learning model that requires a training set.

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

This information is not applicable and not provided.

Ask a specific question about this device

The Delia Localizer and Caroline Guide are indicated for use by neurosurgeons as shunt accessories for patients scheduled to undergo a posterior ventricular catheter placement procedure who are: 1) Adults 2) Have enlarged ventricles 3) Have normal scalp, skull, external ear and orbital anatomy 4) Do not have intracranial mass lesions or any structural abnormalities other than hydrocephalus 5) Have no general contraindications to surgery

The Delia Localizer is a head-band based apparatus that aids the surgeon in identifying the optimal location for placing a posterior burr hole for purposes of inserting a posterior ventricular catheter. It mechanically reduces to practice geometric principles that are already used to manually calculate where to position a posterior burr hole. The Caroline Guide is a mechanical device that helps the surgeon orient a ventricular catheter along a straight line connecting the posterior burr hole entrance point and the frontal target point.

The provided text describes a 510(k) summary for the "Caroline Guide and Delia Localizer" integrated system. However, it does not explicitly state specific numerical acceptance criteria or detail a study designed to prove the device meets these criteria in the typical quantitative manner we might expect for medical device performance evaluation.

Instead, the document focuses on:

• Substantial Equivalence: The primary goal of the 510(k) submission is to demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device (a ventricular catheter stylette).
• Technological Characteristics: It highlights similarities in indications for use, method for advancing the catheter, and patient exposure to materials, while describing how the new device mechanically simplifies existing manual techniques.
• Pre-clinical Testing: This testing focused on confirming geometric principles and mechanical accuracy.
• Clinical Testing: A clinical trial of the Caroline Guide alone was reported in peer-reviewed literature. More recently, a clinical trial of the combined Delia Localizer and Caroline Guide system was approved, and clinical data on its performance was "now available."

Given this, I will reconstruct the "acceptance criteria" and "study" information based on the emphasis of the 510(k) process, which prioritizes safety and effectiveness demonstrated through substantial equivalence rather than explicit quantitative performance metrics like sensitivity/specificity often seen in AI/diagnostic device submissions.

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Device Performance

The concept of "acceptance criteria" in this 510(k) notice is primarily framed around the demonstration of substantial equivalence to a predicate device, and ensuring the new technological features do not adversely affect safety or effectiveness. Specific quantitative performance metrics are not provided as acceptance criteria.

Study Details

The text describes both non-clinical and clinical tests. The primary "study" proving the device meets the substantial equivalence criteria encompasses these findings.

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

• Delia Localizer (Pre-clinical):
  • Test Set: Head CT scans of patients with hydrocephalus (number not specified).
  • Provenance: Not explicitly stated, but implies clinical data from patients with hydrocephalus. The cranial phantoms used were for "differing head sizes."
• Caroline Guide (Non-clinical):
  • Test Set: Not a human sample size, but involved testing with ventricular catheters and the guide tube.
• Caroline Guide (Clinical - standalone):
  • Test Set: Not explicitly stated, but a clinical trial was conducted at the Universities of Iowa and Washington. This trial was reported in peer-reviewed literature in 1995. This would be prospective data given it was a trial.
• Delia Localizer + Caroline Guide (Clinical - combined system):
  • Test Set: Clinical data (number of patients not specified) from a new clinical trial approved by the University of Iowa Institutional Review Board. This would be prospective data.
  • Provenance: University of Iowa.

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

• For the pre-clinical analysis of CT scans, "anatomical analysis" was performed, which implies expert involvement, but the number and qualifications of experts are not specified.
• For the clinical trials, it is implied that neurosurgeons were involved in using and evaluating the device, but their number and specific qualifications for establishing 'ground truth' or evaluating outcomes are not detailed in this summary.

4. Adjudication method for the test set:

• Not specified. The 510(k) summary does not provide details on adjudication methods for either the pre-clinical or clinical studies.

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, an MRMC study was not done. This device is a mechanical surgical guide, not an AI-assisted diagnostic tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply. The comparison is between manual surgical techniques and mechanically guided techniques. The summary states that the new device "mechanically reduces to practice geometric principles that are already used to manually calculate."

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

• Yes, in essence. The pre-clinical tests for the Delia Localizer (validity of geometric principles, accuracy on phantoms) and the non-clinical tests for the Caroline Guide (mechanical accuracy with catheters) can be considered "standalone" evaluations of the device's mechanical function, prior to or separate from human-in-the-loop clinical use.

7. The type of ground truth used:

• Delia Localizer (Pre-clinical): Established geometric principles related to burr hole placement, confirmed by "anatomical analysis of head CT scans" and testing against physical cranial phantoms.
• Caroline Guide (Non-clinical): Mechanical alignment with a "frontal target point."
• Clinical Trials (Caroline Guide alone and combined system): Clinical performance, which for a surgical guidance device typically involves outcomes like successful catheter placement, reduction in complications, accuracy of placement, and patient safety. The specific metrics are not detailed but would be expert-assessed clinical outcomes.

8. The sample size for the training set:

• Not applicable in the typical sense of machine learning. This device is mechanical, not an AI/ML algorithm that requires a "training set." The development of the device would have been基于engineering principles and anatomical knowledge rather than data training.

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

• Not applicable as there is no "training set" in the context of an AI/ML algorithm. The "ground truth" for the device's design principles was established through anatomical and geometric understanding, surgical practice, and pre-clinical verification.

Ask a specific question about this device

The Cordis Cyst Puncture Catheter Kit is intended to facilitate puncturing thick-walled or mobile intracranial cysts, allowing insertion of a ventricular catheter for cyst drainage.

The Cordis Cyst Puncture Catheter kit consists of a ventricular catheter with enlarged holes whose distal tip has been modification allows the sharpended stylet to be inserted through and locked into the distal tip. This facilitates cyst puncture. The kit also includes sharp- and blunt-ended stylets to facilitate catheter placement. The catheter is manufactured from silicone elastomer made radiopaque with barium sulfate.

This is a 510(k) premarket notification for a medical device (Cordis Cyst Puncture Catheter Kit) submitted in 1996. The provided text is a summary of safety and effectiveness, which primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific performance acceptance criteria through a dedicated study.

In the context of 510(k) submissions from this era, a "study that proves the device meets the acceptance criteria" as you've described for AI/software devices is not typically conducted or summarized in this manner. Instead, the focus is on showing similarity in design, materials, manufacturing, and intended use to legally marketed predicate devices, and that these similarities do not raise new questions of safety or effectiveness.

Therefore, many of the specific questions you asked are not directly applicable or answerable from the provided text for this type of medical device submission. However, I can extract information related to what is present and explain why other information is absent.

Here's a breakdown of what can be inferred or stated based on the provided document:

Acceptance Criteria and Reported Device Performance

The document does not specify formal, quantitative "acceptance criteria" for performance in the way a modern AI/software device would. The core "acceptance" is that the device is substantially equivalent to predicate devices. This means that its design, materials, manufacturing methods, and intended use are similar enough not to raise new questions of safety or effectiveness.

Unanswerable or Not Applicable Questions (Based on the Provided Text)

The following questions cannot be answered from the provided text because they pertain to clinical or performance studies typically conducted for devices requiring more extensive proof of safety and effectiveness (e.g., PMA devices, or modern AI/software devices) or for which specific data is not detailed in a Summary of Safety and Effectiveness for a 510(k).

2. Sample size used for the test set and the data provenance: Not applicable. No "test set" in the context of controlled clinical trials or AI evaluation is described. The submission relies on substantial equivalence to predicate devices, which generally means no new clinical data demonstrating performance in a "test set" is required for the 510(k) pathway.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for a test set is described.

4. Adjudication method for the test set: Not applicable. No test set adjudication is described.

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 a medical device (catheter kit), not an AI/software device. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a hardware medical device, not an AI algorithm.

7. The type of ground truth used: Not applicable in the conventional sense of clinical trials. The "ground truth" for a 510(k) is that the predicate devices are safe and effective, and the new device is sufficiently similar.

8. The sample size for the training set: Not applicable. This is a hardware medical device, not a machine learning model.

9. How the ground truth for the training set was established: Not applicable. This is a hardware medical device.

In summary: The provided document is a 510(k) summary focusing on demonstrating substantial equivalence to predicate devices. It relies on comparisons of design, materials, and intended use, rather than presenting clinical study data with defined acceptance criteria and performance metrics typical of more rigorous clinical trials for novel devices or AI/software. The "proof" of meeting "acceptance criteria" (which are implicit substantial equivalence) is the argument that the device is "similar to predicate devices and does not raise any new issues relating to safety and effectiveness for their intended use."

Ask a specific question about this device

The Reigel Tunneling Device is used for tunneling and passing shunt components under the skin for the placement of cerebrospinal fluid shunts from the head to the abdomen.

The Reigel Tunneling Device is used for tunneling and passing shunt components under the skin for the placement of cerebrospinal fluid shunts from the head to the abdomen. The device is supplied sterile. The materials comprising the device have an established history of use in medical product manufacturing.

This 510(k) Premarket Notification for the Reigel Tunneling Device does not contain any information about acceptance criteria or a study proving the device meets them.

The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device based on intended use, materials, and technological characteristics. It is not a clinical study report or a performance evaluation.

Therefore, I cannot provide the requested information, as it is not present in the input text.

Ask a specific question about this device