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This device is intended for remote endarterectomy of peripheral blood vessels during vascular reconstruction.

The MollRing MultiTASC is a single use, sterile and disposable device designed for vascular surgeons use during remote endarterectomy procedures for the facilitation of dissecting, cutting and removing atheromatous plaque core within the peripheral vascular system.

The Subject Device is a fixed, circumferential, blunt-edged, sterile, single use cutting tool. It consists of two stainless steel coaxial metal rings (proximal and distal rings) which are connected by a stainless steel rod and hypo tube system. The modular rod and hypo tube system connects to a plastic operator's handle with selective positions for ring alignment (cutting/dissecting phase).

The device is introduced over the proximal end of the atheromatous plaque core of a peripheral vascular vessel. With the two stainless steel coaxial metal rings in "alignment position", they are advanced to the distal end of the plaque core. As the device transverses the vessel it acts as a conventional circumferential dissection ring stripper, removing the plaque core to the distal endpoint. The device is then switched via the operator handle to "un-alignment position", which spreads the distal and proximal rings, thus cutting and securing the plaque core. Once secured, the device is withdrawn, facilitating the core removal.

Based on the K121415 document, here's a breakdown of the acceptance criteria and the study conducted:

This document is a 510(k) summary for a medical device (MollRing MultiTASC Dissection/Transection Device), not a study report for an AI/ML device. Therefore, the questions related to AI/ML specific aspects (like expert consensus for ground truth, sample sizes for training/test sets, MRMC studies, standalone performance, and human reader improvement with AI) are not applicable to this document. This submission focuses on non-clinical performance and substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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The EndoHelix Endarterectomy Device is intended to remove plaque deposits from arteries.

The EndoHelix endarterectomy device is a tubular device with an expanding helical element at the distal tip. The expandable helical element is controlled by the user with a sliding tab on the handle. The device is designed to be used with or without a guidewire. The device is packaged in an industry standard Tyvek/Mylar pouch and is provided sterile. The EndoHelix device is a single use product and is not intended to be resterilized or reused.

This document, a 510(k) summary for the EndoHelix™ Endarterectomy Device, does not contain the detailed information required to describe the acceptance criteria and the study proving the device meets those criteria.

A 510(k) submission generally focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical efficacy studies with predefined acceptance criteria. The level of detail you are requesting, commonly found in clinical trial reports or pre-market approval (PMA) applications, is not typically present in a 510(k) summary like this one.

Here's a breakdown of why each specific piece of information from your request is largely absent or unaddressed by the provided text:

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

• Absence: The document states, "Testing was performed to assess product compliance with the product specification. Testing included device operation, wire actuation, and bond pull strengths. All product met specification."
• Explanation: This is a very high-level statement. It indicates some testing was done and that the device passed its own specifications, but it does not define what those specifications (acceptance criteria) were, nor does it provide any quantitative performance data. For example, it doesn't give a specific "bond pull strength" target (e.g., 5 N) and the achieved result (e.g., 5.2 N).

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

• Absence: No information provided regarding sample sizes for any tests. The document only mentions "Testing was performed..."
• Explanation: This document focuses on demonstrating substantial equivalence, not on providing results from a controlled clinical study with human subjects. The "testing" mentioned likely refers to bench testing (e.g., mechanical tests, material compatibility) rather than clinical performance testing with a specific "test set" of patients.

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)

• Absence: Not applicable. There is no mention of a "test set" that would require expert-established ground truth.
• Explanation: This type of information is relevant for studies involving diagnostic accuracy or clinical outcomes where a "ground truth" needs to be established (e.g., by expert consenso, biopsy). The EndoHelix device is an interventional device, and the provided document does not include such clinical study details.

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

• Absence: Not applicable. No clinical test set requiring adjudication is described.
• Explanation: Similar to point 3, adjudication methods are used in clinical studies when multiple observers interpret data and discrepancies need to be resolved to establish ground truth. This is not touched upon in this 510(k) summary.

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

• Absence: Not applicable.
• Explanation: This document describes a mechanical endarterectomy device, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study and discussions of "human readers improve with AI" are entirely irrelevant to this submission.

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

• Absence: Not applicable.
• Explanation: This question refers to the performance of an algorithm (typically AI or software). The EndoHelix is a physical medical device.

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

• Absence: Not applicable.
• Explanation: As discussed, no clinical performance testing with a "ground truth" is detailed in this 510(k) summary.

8. The sample size for the training set

• Absence: Not applicable.
• Explanation: There is no "training set" as this is a physical medical device, not an algorithm that requires training data.

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

• Absence: Not applicable.
• Explanation: Similar to point 8, there is no training set mentioned or implied.

In summary, the provided 510(k) document focuses on demonstrating substantial equivalence based on device description, materials, and a general statement about meeting internal product specifications. It does not contain the detailed clinical or performance study information you are asking for, which would be typical for a dataset used to validate specific acceptance criteria in a clinical context.

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The Carbodissecting Endoscope is designed for use in intraluminal tissue separation during a femoro-popliteal endarterectomy procedure intended to achieve vascular reconstruction. The device is an adjunctive aid in the separation of vessel layers.

The Carbodissecting Endoscope, sterile and single-use, consists of two components: The spatula is a surgical tool used with carbon dioxide (CO2) and saline for atherectomy using carbodissection. The scope is a flexible fiberscope intended for use with the Carbodissecting Endoscope Spatula to provide visual feedback.

The provided 510(k) summary for the "Carbodissecting Endoscope" does not contain information related to acceptance criteria or a study proving the device meets performance criteria in the context of an AI/ML medical device.

This document details the regulatory pathway for a surgical device (an intraluminal artery stripper) and focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use. The "Performance Testing" section primarily refers to compliance with an electrical safety standard (IEC 601-2-18) and mentions "additional bench testing and biocompatibility testing," but provides no specifics on acceptance criteria or detailed study results for functional performance.

Therefore, for almost all the requested information, the answer will be "Not Applicable" or "Not Provided in the document" because the device is a physical surgical tool, not an AI/ML algorithm requiring performance metrics like sensitivity, specificity, or human-in-the-loop studies.

Here's a breakdown based on the provided text, indicating why most items cannot be answered:

1. Table of Acceptance Criteria and Reported Device Performance

| Criterion | Acceptance Criteria | Reported Device Performance |
| :------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
| Electrical Safety | Compliance with IEC 601-2-18 | Device meets the requirements of IEC 601-2-18 (Safety of Medical Electrical Equipment: Particular Requirements for Endoscopes). |
| Biocompatibility | Not explicitly stated, but implied as part of safety testing | Biocompatibility testing has been completed. |
| Bench Testing (Functional) | Not explicitly stated | Additional bench testing has been completed. (No specific functional criteria or results provided in this document). |

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

• Not Applicable. This is a physical surgical device, not an AI/ML algorithm that uses a test set of data. The document does not describe any clinical studies involving patient data for performance evaluation in a hypothesis-testing manner, but rather mentions "bench testing" and "biocompatibility testing."

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 or expert review process as described for AI/ML models is mentioned in relation to proving the device's performance for this surgical tool.

4. Adjudication method for the test set

• Not Applicable. No test set or adjudication process as typically defined for AI/ML models 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 surgical instrument, not an AI-assisted diagnostic or interpretive device. No MRMC study or AI assistance is mentioned.

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

• Not Applicable. This is a manual surgical instrument, not an algorithm.

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

• Not Applicable. Ground truth in the context of AI/ML performance evaluation is not relevant to this device's regulatory submission, which focuses on substantial equivalence based on prior predicate devices and safety testing.

8. The sample size for the training set

• Not Applicable. This is a physical device, not an AI/ML algorithm. There is no concept of a "training set."

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

• Not Applicable. Consistent with item 8.

Summary regarding AI/ML related questions:

The provided 510(k) summary is for a traditional surgical device and predates the common regulatory framework for AI/ML medical devices. Therefore, the questions related to AI/ML specific performance criteria, data sets, ground truth, and human-in-the-loop studies are not applicable to the information contained within this document. The "Performance Testing" section primarily refers to compliance with an electrical safety standard, bench testing (without specifics), and biocompatibility testing, which are standard for physical medical devices.

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