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The Habib Hexablate 10 is intended to be used to assist in coagulation of tissue during intraoperative surgical procedures.

The Habib Hexablate 10 is a bipolar radiofrequency (RF) device that consists of a handle and an array of seven parallel electrodes which extend out from the handle. The electrode configuration consists of six electrodes in a ring and one electrode in the center of the ring. The Habib Hexablate 10 has an attached cable which connects the device to an RF Generator. The electrodes are inserted into tissue and the tissue is coagulated using RF power. The Habib Hexablate 10 is designed for use in surgery and is a single use device.

The provided text is a 510(k) premarket notification for the Habib Hexablate 10, an electrosurgical cutting and coagulation device. This type of submission generally focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than comprehensive de novo clinical studies with detailed acceptance criteria and standalone performance metrics.

Based on the provided text, the following can be extracted:

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

The document does not explicitly state quantitative acceptance criteria or detailed reported device performance in a table format. It broadly states:

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 does not specify a sample size for a test set. It mentions "Performance testing" but does not elaborate on the methodology, number of samples, or data provenance (country of origin, retrospective/prospective). This is typical for a 510(k) where the focus is often on bench testing and comparison to an existing device rather than a new clinical trial.

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)

No information is provided regarding experts used to establish ground truth.

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

No information is provided regarding an adjudication method.

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

No MRMC comparative effectiveness study was performed or mentioned, as this device is not an AI-powered diagnostic tool. It is an electrosurgical device for tissue coagulation.

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

A standalone performance evaluation was done in the sense that the device itself was tested for its ability to function as intended and meet design specifications. However, this is not in the context of an "algorithm only" or "AI" standalone performance, as the device is a physical electrosurgical tool. The "Performance Data" section indicates that the device was evaluated to ensure it "functions as intended and meets design specifications."

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

The document does not specify the type of ground truth. Given the nature of the device (electrosurgical for tissue coagulation), ground truth would likely be established through objective measurements of coagulation zone size, tissue necrosis, temperature profiles, and potentially histological examination of treated tissue in preclinical models, but these details are not provided in the summary.

8. The sample size for the training set

No information is provided regarding a training set. This is not applicable as the device is not an AI/machine learning model 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 an AI/machine learning model.

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The Habib Hexablate is intended to be used to assist in coagulation of tissue during intraoperative surgical procedures.

The Habib Hexablate is a bipolar radiofrequency (RF) device that consists of a handle and an array of seven parallel electrodes which extend out from the handle. The electrode configuration consists of six electrodes in a ring and one electrode in the center of the ring. The Habib Hexablate has an attached cable which connects the device to the Habib Hexablate Switch Unit and then to an RF Generator. The electrodes are inserted into tissue is coagulated using RF power. The Habib Hexablate is designed for use in surgery and is a single use device.

The provided text describes the Habib Hexablate device and its 510(k) submission (K071103) for market clearance. However, it does not contain the detailed information required to fill out the table describing acceptance criteria and a study proving the device meets those criteria, or all the associated study design parameters.

The document is a summary of safety and effectiveness, a 510(k) clearance letter, and an indications for use statement. It provides a high-level statement about performance data but no specifics on acceptance criteria or the study methodology used.

Here's a breakdown of what can be extracted and what is missing:

Information that can be extracted:

• Device Name: Habib Hexablate
• Intended Use/Indications For Use: To assist in coagulation of tissue during intraoperative surgical procedures.
• Predicate Device: Habib 4X (K051420)
• Description of Technological Differences: The Habib Hexablate has the same basic technological characteristics as the Habib 4X, both using bipolar RF energy through electrodes to create a volume of coagulated tissue. The primary difference is the size and shape of the coagulation zone and the Hexablate's aspiration feature through the center electrode to remove fluids and gases.
• Statement on Performance Data: "Performance testing was done to ensure that the Habib Hexablate functions as intended and meets design specifications. Sufficient data was obtained to show that the device is substantially equivalent to the predicate device, and meets safety and effectiveness criteria."

Information that is missing from the provided text and cannot be generated:

• A table of acceptance criteria and the reported device performance: Explicit acceptance criteria and specific performance results are not detailed. The document only states "meets design specifications" and "meets safety and effectiveness criteria."
• Sample size used for the test set and data provenance: No information on the number of cases, patients, or origin of data.
• Number of experts used to establish the ground truth for the test set and their qualifications: Not mentioned.
• Adjudication method for the test set: Not mentioned.
• If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size: Not mentioned. This type of study is more common for imaging/diagnostic devices, not typically for electrosurgical coagulation devices focused on tissue effect.
• If a standalone (algorithm only without human-in-the-loop performance) was done: Not applicable as this is a physical medical device, not an AI algorithm.
• The type of ground truth used: Not explicitly stated, though for a coagulation device, ground truth would likely involve measurements of coagulation zone size/shape, tissue histology post-coagulation, or animal model observations.
• The sample size for the training set: Not applicable for this type of device and study as described.
• How the ground truth for the training set was established: Not applicable.

Conclusion based on provided text:

The provided document (a 510(k) summary and clearance letter) confirms that performance testing was conducted and data were found sufficient to establish substantial equivalence to a predicate device (Habib 4X, K051420) and meet safety and effectiveness criteria for tissue coagulation during intraoperative surgical procedures. However, the specific details of these performance tests, including explicit acceptance criteria, performance metrics, study design (sample sizes, ground truth establishment, expert involvement), and results, are not present in this summary. These details would typically be found in the full 510(k) submission or associated test reports, which are not included here.

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