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510(k) Data Aggregation
(72 days)
The Concentric Embolic Pearls are intended for use in the embolization of hypervascularized tumors in the peripheral vasculature.
The Concentric Embolic Pearls are non-resorbable, hydrogel-based spherical microbeads. The Embolic Pearls are delivered via a catheter in an amount and size appropriate for the targeted area. The Embolic Pearls slow/stop blood flow to hypervascularized tumors by occluding the blood vessel which provides blood flow to the tumor.
The provided text describes the Concentric Embolic Pearls, an arterial embolization device, and its successful clearance via a 510(k) pathway. However, it does not contain a detailed study with specific acceptance criteria, reported device performance metrics, or information on reader studies, training/test set sizes, or ground truth establishment in the way typically seen for AI/ML-based devices.
The document primarily focuses on demonstrating substantial equivalence to predicate devices through various testing summaries. Therefore, I will create a table representing the stated equivalence, and then address the other points based on the information provided in the document, noting where information is absent.
Acceptance Criteria and Device Performance (Based on Substantial Equivalence Claim)
The document states that the Concentric Embolic Pearls are "substantially equivalent to the existing legally marketed predicate devices" and that all characteristics/attributes are "either identical or substantially equivalent." The acceptance criteria, therefore, are implicitly the performance and safety characteristics demonstrated by the predicate devices.
Acceptance Criteria Category | Reported Device Performance (Concentric Embolic Pearls) |
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Performance & Functional | "Successfully passed all performance and functional testing performed demonstrating that the device performs in accordance with the requirements of the Product Specification." |
Material/Chemical Safety | "No harmful levels of residuals, monomers, or leachables are detectable." |
Biocompatibility | "Substantially equivalent to the negative control article and no significant adverse reactions were noted." |
In-vivo Delivery | "Consistent delivery of the Embolic Pearls to the treatment site." |
In-vivo Safety (Vessel Damage) | "No vessel damage occurs when the Embolic Pearls are deployed to the treatment site." |
In-vivo Performance (Comparison to Predicate) | "Performed similarly to the EmboGold Microspheres." |
Intended Use | "Embolization of hypervascularized tumors in the peripheral vasculature." (Matches predicate's general use) |
Study Details:
Given the nature of the device (a physical medical device, not an AI/ML algorithm), many of the requested categories are not applicable or not detailed in this type of 510(k) summary. I will address each point based on the provided text:
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A table of acceptance criteria and the reported device performance: (See table above). The acceptance criteria are largely implied by successful completion of various tests showing equivalence to predicate devices and meeting product specifications.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size (In-vivo animal testing): Not explicitly stated. The document mentions "in-vivo animal testing performed" but does not quantify the number of animals or trials.
- Data Provenance: Not specified. Animal testing is implied, and could be internal R&D. The country of origin is not mentioned. It would be prospective in nature for these tests.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of this device type and the reported testing. Ground truth for a physical embolic device typically involves objective measurements (e.g., in-vitro flow testing, material analysis) and expert observation/assessment during animal studies (e.g., by veterinarians, pathologists, interventional specialists), but the number and qualifications are not specified here.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as this is not a reader study for image interpretation.
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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 MRMC study was done. This is not an AI-assisted device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm-only device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For material and chemical safety: Analytical chemistry results, biocompatibility studies (e.g., cytotoxicity tests, sensitization, irritation indices).
- For functional performance: In-vitro bench testing against engineering specifications (e.g., flow rates, delivery consistency).
- For in-vivo performance and safety: Observations during animal studies, potentially histopathological examination of tissues, imaging results (e.g., angiography) to assess delivery and vessel damage.
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The sample size for the training set:
- Not applicable. This is not a machine learning device that requires a "training set."
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How the ground truth for the training set was established:
- Not applicable.
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