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The EMBA Hourglass® Peripheral Embolization Device (PED) is indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature in 6-8mm blood vessels. The device is not indicated for use in blood vessels subject to repetitive motion, such as extremity or pulmonary vessels.

The Hourglass® Peripheral Embolization Device (PED) consists of a covered, implantable, self-expanding hourglass-shaped structure (Embolic Device) preloaded in a catheter-based Delivery System. The Embolic Device is intended to be deployed to the target site in the vasculature under fluoroscopic guidance. The product is shipped sterile and labeled for single use only.

This FDA 510(k) summary (K200083) indicates that the device, EMBA Hourglass® Peripheral Embolization Device (PED), is substantially equivalent to a predicate device (K171845). The submission explicitly states that "no additional testing is required" for the current device because it is considered substantially equivalent to its predicate.

Therefore, based on the provided document, there are no specific acceptance criteria or details of a study performed specifically for this device (K200083). Instead, the justification for substantial equivalence relies on the testing of the predicate device.

However, I can extract the information regarding the comparison between the subject device and the predicate device, and the general statement about performance testing.

Here's a breakdown of the requested information, where applicable:

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

Since the document states that "no additional testing is required" for the subject device (K200083), there are no new acceptance criteria or reported performance unique to this submission. The substantial equivalence is based on the predicate device's performance.

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

• Sample Size: Not applicable. No new test set for K200083. The document states that "bench, animal, and clinical testing performed for the predicate device are adequate."
• Data Provenance: Not applicable for K200083. The origin of data for the predicate device's testing is not mentioned in this document.

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

• Not applicable. No new test set and no ground truth establishment for K200083.

4. Adjudication method for the test set:

• Not applicable. No new test set for K200083.

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 embolization device, not an AI-assisted diagnostic tool.

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

• Not applicable. This device is a physical embolization device, not an algorithm.

7. The type of ground truth used:

• Not applicable for K200083. The "ground truth" for the predicate device's performance would likely have involved direct observation of embolization effectiveness in animal models, and clinical outcomes if clinical studies were part of its submission.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device.

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

• Not applicable. This is not an AI/machine learning device.

Key takeaway from the document:

The regulatory strategy for K200083 is based on substantial equivalence to a predicate device (K171845). The primary difference noted is the Delivery System length (80cm vs. 120cm). All other design and material characteristics, as well as manufacturing processes, are stated to be identical. Due to these similarities and a risk analysis concluding no new or modified risks, the prior performance testing (bench, animal, clinical) and biocompatibility testing of the predicate device are deemed sufficient for this new submission.

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The EMBA Peripheral Embolization Device (PED) is indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature in 6-8mm blood vessels. The device is not indicated for use in blood vessels subject to repetitive motion, such as extremity or pulmonary vessels.

The EMBA™ HOURGLASS™ Peripheral Embolization Device (PED) consists of a covered, implantable, self-expanding structure (Embolic Device) preloaded in a catheter-based Delivery System. The Embolic Device is intended to be deployed to the target site in the vasculature under fluoroscopic guidance. The product is shipped sterile and labeled for single use only.

This document describes the EMBA™ HOURGLASS™ Peripheral Embolization Device (PED). The information provided focuses on the device's substantial equivalence to predicate devices rather than a detailed study proving it meets specific quantitative acceptance criteria for performance metrics in a clinical setting.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table of quantitative acceptance criteria for performance metrics (e.g., specific thresholds for occlusion rates, migration rates, etc.) that the device was evaluated against in a clinical study. Instead, it lists various comparative performance tests conducted to demonstrate substantial equivalence to predicate devices. These tests focused on design and functional characteristics to show that technological differences do not raise new safety or effectiveness concerns.

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

• Sample Size: Human Use Clinical Testing was conducted on n=51.
• Data Provenance: The document does not specify the country of origin. The study appears to be a prospective human use clinical study, although full details are not provided in this summary.

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

• The document does not mention the number of experts used to establish ground truth for the clinical test set or their specific qualifications. It only states that human use clinical testing was conducted to evaluate "safety and effectiveness endpoints," implying clinical assessment by medical professionals.

4. Adjudication Method for the Test Set:

• The document does not specify the adjudication method used for the clinical test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No, this was not an MRMC comparative effectiveness study. The text discusses comparative performance testing against predicate devices, but this refers to bench testing and animal testing, and for the human use study, it was to evaluate safety and effectiveness endpoints of the EMBA device itself, not to compare human readers with and without AI assistance. The device is a physical medical implant, not an AI diagnostic tool.

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

• This question is not applicable as the EMBA™ HOURGLASS™ Peripheral Embolization Device is a physical medical device, not a software algorithm. Its "standalone" performance would typically refer to its mechanical and functional performance in in-vitro or animal models, which was indeed performed as "comparative performance testing."

7. The Type of Ground Truth Used:

• For the human use clinical testing, the "ground truth" would implicitly be clinical outcomes data assessed by medical professionals, related to the safety and effectiveness of the device's embolization. For the non-clinical performance tests (Kink Radius, Trackability, Migration Resistance, Occlusion Effectiveness, etc.), the "ground truth" was established by engineering and scientific measurements against predefined specifications or comparison with predicate device performance.

8. The Sample Size for the Training Set:

• This question is not applicable as the device is a physical medical implant, not an AI algorithm that requires a "training set" in the context of machine learning.

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

• This question is not applicable for the same reason as point 8.

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