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The Solitaire™ Platinum Revascularization Device is intended to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

Device Description

The subject 4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices are designed to restore blood flow in patients experiencing ischemic stroke due to large intracranial vessel occlusion. The device is designed for use in the neurovasculature such as the internal carotid artery. M1 and M2 segments of the middle cerebral artery, basilar, and the vertebral arteries.

AI/ML Overview

The provided text describes the Solitaire™ Platinum Revascularization Device and its performance data to establish substantial equivalence with a predicate device. The information primarily focuses on bench testing and biocompatibility rather than clinical studies involving human or animal subjects for the new devices (4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices).

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The table below combines information from multiple sections of the document to present the acceptance criteria and the conclusion for each test. The "Reported Device Performance" column reflects the conclusion stated in the document, which consistently indicates that the device met the acceptance criteria and is substantially equivalent to the predicate.

Test Category / Description	Method	Acceptance Criteria	Reported Device Performance
Biocompatibility
Cytotoxicity	ISO 10993-5	Viability is ≥70%.	The subject 4-20-05 and 6-24-06 devices met the acceptance criteria for ISO 10993-5 and are substantially equivalent to the predicate device.
Sensitization	ISO 10993-10	Test article does not elicit a sensitization response.	The subject 4-20-05 and 6-24-06 devices met the acceptance criteria for ISO 10993-10 and are substantially equivalent to the predicate device.
Irritation	ISO 10993-10	Differences in the mean test and control scores of the extract dermal observations are < 1.0.	The subject 4-20-05 and 6-24-06 devices met the acceptance criteria for ISO 10993-10 and are substantially equivalent to the predicate device.
Acute Systemic Toxicity	ISO 10993-11	No abnormal clinical signs and weight loss in excess of 10%. Temperature rise ≥0.5°C	The subject 4-20-05 and 6-24-06 devices met the acceptance criteria for ISO 10993-11 and are substantially equivalent to the predicate device.
Hemolysis	ISO 10993-4	No significant differences between the test article extract and negative control article results. The test article is considered non-hemolytic.	The subject 4-20-05 and 6-24-06 devices met the acceptance criteria for ISO 10993-4 and are substantially equivalent to the predicate device.
Partial Thromboplastin Time	ISO 10993-4	Clotting times are similar to the negative control and the reference material (HDPE) indicating the device materials are not an activator of the intrinsic coagulation pathway.	The subject 4-20-05 and 6-24-06 devices met the acceptance criteria for ISO 10993-4 and are substantially equivalent to the predicate device.
Platelet and Leukocyte Count	ISO 10993-4	Test article does not adversely affect the platelet and leukocyte components of the blood compared to the reference material.	The subject 4-20-05 and 6-24-06 devices met the acceptance criteria for ISO 10993-4 and are substantially equivalent to the predicate device.
Complement Activation C3a and SC5b-9 Assay	ISO 10993-4	Levels of C3a and SC5b-9 are comparable and less than the positive control.	The subject 4-20-05 and 6-24-06 devices met the acceptance criteria for ISO 10993-4 and are substantially equivalent to the predicate device.
Thrombosis	ISO 10993-4	Thrombo-resistance properties are acceptable in clinical use.	The subject 4-20-05 and 6-24-06 devices met the acceptance criteria for ISO 10993-4 and are substantially equivalent to the predicate device.
Bacterial Mutagenicity Test	ISO 10993-3	Test article is considered non-mutagenic.	The subject 4-20-05 and 6-24-06 devices met the acceptance criteria for ISO 10993-3 and are substantially equivalent to the predicate device.
In-vitro Mouse Lymphoma Assay	ISO 10993-3	Test article is considered non-mutagenic.	The subject 4-20-05 and 6-24-06 devices met the acceptance criteria for ISO 10993-3 and are substantially equivalent to the predicate device.
In-vivo Mouse Micronucleus Assay	ISO 10993-3	Test article is considered non-mutagenic.	The subject 4-20-05 and 6-24-06 devices met the acceptance criteria for ISO 10993-3 and are substantially equivalent to the predicate device.
Bench Testing
Delivery Force	Measurement through representative tortuous anatomical model.	Stent must be below delivery force specification.	The subject 4-20-05 and 6-24-06 devices met the acceptance criteria for delivery force and are substantially equivalent to the predicate device.
Re-sheathing Force	Measurement through representative tortuous anatomical model.	Stent must be below re-sheathing force specification.	The subject 4-20-05 and 6-24-06 devices met the acceptance criteria for re-sheathing force and are substantially equivalent to the predicate device.
Multiple Re-sheathing Durability	Evaluation in a representative tortuous model beyond recommended passes/re-sheathings.	The subject 4-20-05 and 6-24-06 devices must reliably deploy and resheath up to four (4) times.	The subject 4-20-05 and 6-24-06 devices showed no irregularities, breaks, kinks, body marker migration, glue separations, or other observed defects after all deployment and re-sheathing attempts. The devices met the acceptance criteria and are substantially equivalent to the predicate device.
Body Marker Tensile	Testing of laser weld strength of Platinum/Iridium markercoil to Nitinol distal finger.	Body marker should be greater than or equal to existing tensile strength specification.	The subject 4-20-05 and 6-24-06 devices met acceptance criteria for body marker tensile and are substantially equivalent to the predicate device.
Body Marker Radiopacity	Verification analysis of body markers.	The radiopaque body markers must be visible using standard catheter laboratory equipment.	The subject 4-20-05 and 6-24-06 devices met acceptance criteria for body marker radiopacity and are substantially equivalent to the predicate device.
Proximal Marker to Distal Marker	100% in-process measurement of laser cut and electro-polished stent length.	Length of stent must meet all inspection criteria.	The subject 4-20-05 and 6-24-06 devices met acceptance criteria for proximal marker to distal marker and are substantially equivalent to the predicate device.
Af Temperature	100% in-process tracking of heat set parameters.	Temperature should be less than or equal to existing Af temperature specification.	The subject 4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices met acceptance criteria for Af and are substantially equivalent to the predicate device.
Radial Force	100% in-process measurement.	Stent must be within existing radial force specification.	Radial force was measured 100% in-process. The subject 4-20-05 and 6-24-06 devices met acceptance criteria for radial force and are substantially equivalent to the predicate device.

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

Sample Size for Test Set: The document does not explicitly state numerical sample sizes for most of the bench tests (e.g., how many devices were tested for delivery force). For "Multiple Re-sheathing Durability," it implies that devices were tested for "up to four (4) times" deployment and re-sheathing, but not the number of physical devices sampled. For "Proximal Marker to Distal Marker" and "Radial Force," it states "100% in-process" measurement, which implies all manufactured units were tested. For biocompatibility tests, details on sample sizes are not provided within this summary sheet.
Data Provenance: The data is from "bench testing" and "biocompatibility" studies, primarily conducted in a laboratory setting. There is no information regarding the country of origin of the data. The data is prospective as it was generated specifically for the submission.

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 is not applicable. The tests described are primarily physical/mechanical bench tests and in-vitro/in-vivo (animal for biocompatibility) biocompatibility tests. "Ground truth" in the context of expert consensus (like for medical image interpretation) is not relevant for these types of engineering and biological safety evaluations. The acceptance criteria are based on established standards (ISO) and internal specifications.

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

This is not applicable. The tests are directly measured against predefined numerical or qualitative acceptance criteria. There is no expert adjudication process for the results of these bench or biocompatibility tests mentioned.

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

An MRMC comparative effectiveness study was not done. This document pertains to the regulatory submission for a physical medical device (revascularization device) and focuses on engineering performance and biocompatibility, not on AI-assisted diagnostic or interpretative tasks typically assessed by MRMC studies.

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

A standalone performance study of an algorithm was not done. This device is a physical medical device, not a software algorithm.

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

The "ground truth" for the bench tests are the established engineering specifications and physical properties of the device, as measured by standard laboratory methods. For biocompatibility, the ground truth is based on biological safety standards (e.g., ISO 10993 series) which define acceptable biological responses. There is no "expert consensus," "pathology," or "outcomes data" specifically mentioned as ground truth for these specific validation tests of the new devices, as the focus is on physical and material properties, and the new devices are considered substantially equivalent to a predicate.

8. The sample size for the training set

This is not applicable. The document describes the performance testing of a physical medical device (Solitaire™ Platinum Revascularization Device), not a machine learning or AI algorithm that requires a "training set."

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

This is not applicable, as there is no training set for this type of device submission.

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