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The Smart Coil is indicated for the embolization of:

• Intracranial aneurysms
• · Other neurovascular abnormalities such as arteriovenous malformations and arterioyenous fistulae
• · Arterial and venous embolizations in the peripheral vasculature

The Smart Coil is an endovascular embolization coil for the treatment of aneurysms or other vascular abnormalities. The Smart Coil functions to selectively embolize targeted segments of the vasculature by packing a sufficient quantity of platinum coils to achieve occlusion. The Smart Coil consists of three components: a Coil, a Detachment Pusher (attached to Coil), and a Detachment Handle (packaged separately).

The provided text describes the Penumbra Smart Coil, a neurovascular embolization device. The 510(k) premarket notification (K160832) is primarily for a change in the detachment pusher pull wire tensile strength specification to improve manufacturability.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the sample size used for the tensile and simulated use tests. It only mentions that "Design Verification testing was repeated for all attributes affected by change to device specifications."

The data provenance is not explicitly stated in terms of country of origin. The study appears to be prospective as it involves repeated design verification testing for a specific product modification.

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

The document does not mention the use of experts to establish ground truth for the tensile or simulated use tests. These tests appear to be engineering-based performance assessments.

4. Adjudication Method for the Test Set:

Not applicable, as the tests are objective engineering assessments rather than subjective evaluations 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:

Not applicable. This device is a physical medical device (embolization coil), not an AI diagnostic or assistive technology. Therefore, an MRMC study related to AI assistance for human readers is not relevant.

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

The concept of "standalone performance" typically applies to AI algorithms. For this physical device, the "standalone" performance is represented by the direct engineering tests (Tensile and Simulated Use) without human intervention in the device's function during the test.

7. The Type of Ground Truth Used:

For the Tensile test, the "ground truth" is the engineering specification for the minimum break force.
For the Simulated Use test, the "ground truth" is the successful delivery and detachment of the embolic coils within a representative anatomical model. These are inherently tied to mechanical performance requirements.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the Ground Truth for the Training Set was Established:

Not applicable, as there is no training set for this type of medical device.

In summary:

The study conducted for the Penumbra Smart Coil (K160832) was a set of design verification tests focused on the mechanical performance of the device, particularly in light of a change to the detachment pusher pull wire tensile strength specification. The acceptance criteria were met by successfully passing these engineering tests. The study did not involve human readers, AI, or traditional clinical endpoints for establishing ground truth, but rather engineering specifications and simulated performance.

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The Penumbra Smart Coil System is indicated for the embolization of:

• · Intracranial aneurysms
• · Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae
• · Arterial and venous embolizations in the peripheral vasculature

The Smart Coil functions to selectively embolize targeted segments of the vasculature by packing a sufficient quantity of bare platinum coils to achieve occlusion. The Smart Coil System consists of three components: a Coil Implant attached to a Detachment Pusher and a Detachment Handle.

The provided text is a 510(k) premarket notification for the Penumbra Smart Coil. This document is a regulatory submission to the FDA aiming to demonstrate that a new medical device is substantially equivalent to a legally marketed predicate device.

Crucially, this document is NOT a study that proves the device meets acceptance criteria. Instead, it's a justification for market clearance based on a comparison to an already approved device. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria, device performance metrics, sample sizes for test or training sets, expert qualifications, or adjudication methods for a new study.

The document explicitly states:

• "A literature review was conducted to substantiate the safe and effective performance of the Smart Coil and Smart Coil Detachment Handle, as well as its substantial equivalence to the predicate device." This indicates that no new primary clinical study was performed for this specific 510(k) submission to establish performance against acceptance criteria.
• "Review concluded that revised labeling is appropriate." The core of this 510(k)'s purpose is to update the Instructions for Use (IFU), specifically revising a precaution and updating the manufacturer's address. It's not about proving new performance.
• "The Penumbra Smart Coil was found to have a safety and effectiveness profile that is similar to the predicate device." The "study" here is a comparison to a predicate device that was already cleared for market (K143218, cleared March 18, 2015).

Therefore, I cannot populate the requested table and answer the questions because the provided text describes a regulatory submission based on demonstrating substantial equivalence to a predicate device, not a new clinical or performance study with defined acceptance criteria and results.

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The Smart Coil is indicated for the embolization of:
· Intracranial aneurysms

• · Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae
• · Arterial and venous embolizations in the peripheral vasculature

The Smart Coil functions to selectively embolize targeted segments of the vasculature by packing a sufficient quantity of bare platinum coils to achieve occlusion in an identical fashion to the Penumbra Coil System. The Smart Coil System consists of three components: a Coil Implant attached to a Detachment Pusher and a Detachment Handle.

The Penumbra Smart Coil is a medical device designed for the embolization of intracranial aneurysms, neurovascular abnormalities, and arterial and venous embolizations in the peripheral vasculature. The provided document focuses on demonstrating the substantial equivalence of the Penumbra Smart Coil to predicate devices through a series of non-clinical tests.

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

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

The document presents several tables detailing acceptance criteria and results for various non-clinical tests. Due to the extensive nature of these tables, they are summarized below by category. Please refer to the original document for the full detailed tables.

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

The document primarily describes non-clinical testing (bench-top and in vitro/animal studies) for biocompatibility, physical/mechanical properties, sterilization, and shelf life.

• Sample Size: The exact sample sizes for each specific test are not explicitly stated in the summary. For example, for the systemic toxicity test, it mentions "Death in 2 or more animals" as an acceptance criterion, but not the total number of animals tested. The biocompatibility tests refer to "samples," "test articles," "animals," and "groups."
• Data Provenance: Not applicable in the context of clinical data for a device intended for human use. The studies are non-clinical (laboratory and animal studies). The document does not specify the country of origin for the non-clinical data, but it is submitted to the U.S. FDA by a U.S.-based company (Penumbra, Inc., Alameda, CA, USA). The studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices, which are US federal regulations.
• Retrospective/Prospective: These non-clinical studies are inherently prospective in their design, meaning they were planned and executed to evaluate the device's properties.

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 question is not applicable to the provided document. The studies described are non-clinical (biocompatibility, mechanical testing, etc.) and do not involve human subjects or expert clinical evaluation to establish a "ground truth" for diagnostic or treatment efficacy. The "ground truth" for these non-clinical tests would be the measured physical, chemical, or biological responses against predefined scientific or regulatory standards. For example, in histopathology for implant studies, a pathologist would interpret slides, but their role is to report observations against scientific criteria, not establish a "ground truth" for a clinical diagnosis.

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

This question is not applicable. Adjudication methods like 2+1 or 3+1 typically refer to a process where multiple clinical readers (e.g., radiologists) review cases and a discrepancy resolution method is employed, often involving a super-reader. The studies described are non-clinical and do not involve human clinical readers or case 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

This question is not applicable. The Penumbra Smart Coil is a physical neurovascular embolization device, not an AI-powered diagnostic or assistive tool for human readers. The document describes non-clinical testing of the device's material properties, mechanical performance, and biological safety, not its impact on human reader performance in interpreting medical images.

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

This question is not applicable. The Penumbra Smart Coil is a physical medical device, not an algorithm. Therefore, "standalone" algorithm performance is not a relevant concept for this device.

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

The "ground truth" for the non-clinical studies are established by:

• Scientific and regulatory standards: e.g., EN ISO 10993 for biocompatibility, ASTM standards for material testing, EN ISO 11135-1 for sterilization.
• Measured physical/chemical properties: e.g., tensile strength, corrosion presence, hemolytic index.
• Biological responses in controlled in vitro or animal models: e.g., cell lysis grade, sensitization scores, animal physiological responses, histopathological findings.
• Comparison to predicate devices: For several tests (e.g., hemocompatibility, sterilization, shelf life), performance is compared to or demonstrated using methods identical to predicate devices.

8. The sample size for the training set

This question is not applicable. There is no "training set" in the context of physical medical device testing for 510(k) clearance, as this is not a machine learning or AI device. The document describes pre-market non-clinical validation studies.

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

This question is not applicable for the same reason as point 8. No "training set" exists for this type of device submission.

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