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For use in removal of fresh, soft clot from vessels of the arterial system. NOT for use in the prevention of distal embolization during endovascular interventions. NOT for use in the carotid arteries.

Device Description

The MSD™ Embolectomy Basket is a single use basket (not a ballon) for capture and removal of emboli. It has five components: a flexible sack of a bio-compatible material; a wire frame of shape-memory-effect alloy (specifically, Nitinol) in its superelastic state; a bio-compatible sheath; a wire linkage within the sheath connecting the frame to a handle.

The flexible, kink resistant wire linkage slides within the sheath. The proximal ends of both the sheath and the wire linkage are mounted to a handle. The distal end of the wire linkage is attached to the frame. The mouth of the sack, made of a thin, flexible material, is bonded to the loop formed by the frame.

The wire frame can be retracted into the sheath by operation of the handle. This process first closes the mouth of the sack and then configures it for retraction with the frame into the sheath.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the MSD™ Embolectomy Basket, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than undergoing a full clinical efficacy study. Therefore, the information provided primarily addresses safety and technical characteristics, and not extensive clinical performance data with specific acceptance criteria in the way a typical clinical trial would.

Based on the provided text, here's a breakdown of the requested information:

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

The document does not explicitly state "acceptance criteria" in a quantitative, pre-defined manner for clinical performance (e.g., a specific percentage of clot removal). Instead, it relies on demonstrating equivalence to predicate devices and proving safety through various tests.

However, we can infer some "performance" metrics and their comparison to the predicate device:

Parameter	Acceptance Criteria (Implied by Predicate Equivalence)	Reported Device Performance (MSD™ Embolectomy Basket)
Intended Use	Equivalent to predicate devices	Removing Arterial Emboli
Configuration	Safe and effective removal of emboli	Sock-shaped basket with mouth bonded to wire frame retractable into a delivery sheath
Deployed Diameter	Within clinically relevant range for emboli removal	Basket: 5 mm - 10 mm (For comparison, predicate balloon: 4 mm - 14 mm)
Catheter Length	Within clinically relevant range	65 cm - 120 cm (For comparison, predicate: 40 cm - 100 cm)
Biocompatibility	No issues relative to material safety	Performed by a licensed laboratory under GLP; results raised no issues relative to material safety.
Structural Adequacy	Forces required for operation are small; component separation forces exceed operational forces	Bench tests quantified; forces to operate were small; forces to separate components exceeded normal operational conditions.
Interactive Forces with Vessels	Equivalent to properly inflated predicate catheter	Animal studies showed Pinteraction forces equivalent to those experienced during use of a properly inflated Fogarty catheter. Measured force levels raised no safety issues.

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

Biocompatibility Tests: The exact number of samples tested is not specified, but it states "All prescribed biocompatibility tests for a device having short-term exposure to blood were performed." No information on the country of origin or whether it was retrospective/prospective is given, other than "performed by a licensed laboratory under GLP."
Bench Tests (Structural Adequacy): Not specified.
Animal Studies (Interactive Forces): Not specified. No information on the country of origin or whether it was retrospective/prospective is given.

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

This information is not provided in the document. The studies described are primarily non-clinical (bench and animal) tests, not human-based clinical trials where expert ground truth would typically be established. Substantial equivalence claims often rely on comparing technical specifications and safety profiles to existing devices, reviewed by FDA experts.

4. Adjudication method for the test set

This information is not provided as it's not a clinical study with human observers or diagnostic outcomes requiring adjudication.

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

There is no MRMC study mentioned. This device is an Embolectomy Basket, a mechanical intervention for clot removal, not an AI-assisted diagnostic tool.

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

This refers to an AI algorithm. The device is a physical medical instrument, an Embolectomy Basket. Therefore, this question is not applicable.

7. The type of ground truth used

Biocompatibility: In vitro and in vivo (animal, if applicable) laboratory assays validated against established safety standards.
Bench Testing: Engineering specifications and mechanical force measurements.
Animal Studies: Direct measurement of physical forces and comparison to established data (e.g., "data from studies in the peer-reviewed literature").

8. The sample size for the training set

This question is typically relevant for AI/ML models. Since this is a physical medical device, there is no training set for an algorithm.

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

As there is no training set for an AI/ML algorithm, this question is not applicable.

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