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Microwave Ablation Generator is indicated for the coagulation (ablation) of soft tissue. The device is not intended for cardiac use.

Microwave ablation is a kind of thermal ablation technology used in the treatment of soft tissue, utilizing electromagnetic waves in the microwave energy spectrum (300 MHz to 300 GHz) to produce tissue-heating effects. The oscillation of polar molecules produces frictional heating, ultimately generating tissue necrosis.

Microwave Ablation Generator consists of microwave source, pump, foot pedal etc. It is a software-controlled microwave generator that delivers the microwave energy at a working frequency of 2450 MHz and can meet various clinical needs of soft tissue ablation therapy. Microwave Ablation Generator delivers microwave energy to Microwave Ablation Antennas into the target tissue through Microwave Ablation Cable(sterile or non-sterile cable). When reaching the target temperature, the soft tissue will be damaged, leading to irreversible necrosis. The Microwave Ablation Temperature Probe is applied to monitor the temperature of the target location and to protect important organs and tissues in the periphery of the lesion from unexpected damage by microwave energy. Coagulated zones are monitored during treatment using appropriate imaging techniques.

The provided document is a 510(k) Premarket Notification from the FDA for a Microwave Ablation Generator. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria for a new device's performance. Therefore, detailed information required by the request, such as sample sizes, data provenance, number and qualifications of experts, and ground truth establishment, is not present because this type of submission typically relies on non-clinical performance and equivalence to a previously cleared device.

However, I can extract the acceptance criteria for non-clinical performance tests and the reported performance, as well as general information about the submission.

Here's the information that can be extracted from the provided text:

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

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

This information is not provided in the document, as the submission is a 510(k) based on non-clinical performance and substantial equivalence, not a clinical study with patient samples. The document focuses on technical specifications and international standards compliance.

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 information is not provided. The submission relies on engineering and regulatory experts to ensure compliance with standards and equivalence to a predicate device. There is no mention of "ground truth" establishment in the context of expert consensus on medical images or diagnostic outputs.

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

This information is not provided. Adjudication methods are typically relevant for clinical studies involving human interpretation or outcome assessment, which is not the focus of this 510(k) submission.

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

There is no mention of an MRMC comparative effectiveness study, nor is the device an AI-assisted diagnostic tool. This device is a Microwave Ablation Generator.

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

This concept is not applicable to the device. The "Microwave Ablation Generator" is a medical device for coagulation of soft tissue, not a standalone algorithm. Performance is assessed through compliance with technical standards and physical testing.

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

The concept of "ground truth" in the context of medical imaging or diagnostic accuracy is not applicable to this device's submission. The "truth" for this device's performance is established by its compliance with recognized electrical safety, electromagnetic compatibility, specific performance standards, and software validation according to established engineering and regulatory guidelines. The "Thermal Effects Test" results would be compared against expected thermal ablation patterns or temperatures.

8. The sample size for the training set

This information is not provided and is not relevant for this type of device submission. The device is not an AI/ML algorithm that requires training data in the traditional sense.

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

This information is not provided and is not relevant for this type of device submission.

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Microwave Ablation Antennas, in conjunction with the compatible Microwave Ablation Generator, is intended for coagulation (ablation) of soft tissue. This device is not intended for cardiac use.

Microwave ablation is a kind of thermal ablation technology used in the treatment of soft tissue, utilizing electromagnetic waves in the microwave energy spectrum (300 MHz to 300 GHz) to produce tissue-heating effects. The oscillation of polar molecules produces frictional heating, ultimately generating tissue necrosis. Microwave Ablation Antennas generally consist of the Microwave Ablation Antennas, Microwave Ablation Cable. This device is single-use and sterilized by EO. During ablation, Microwave Ablation Antennas will be punctured into the target tissue of the patients. In order to achieve the intended use, Microwave Ablation Antennas shall be connected with Microwave Ablation Generator which deliver microwave energy to Microwave Ablation Antennas through Microwave Ablation Cable (sterile or non-sterile cable). When reaching the target temperature, the soft tissue will be damaged leading to irreversible necrosis. Coagulated zones are monitored during treatment using appropriate monitoring techniques.

The provided text is a 510(k) summary for the Canyon Medical Inc. Microwave Ablation Antennas (K241825). This document focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance, rather than presenting a clinical study to prove device performance against specific acceptance criteria in a human clinical trial setting.

Therefore, much of the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not available in this type of regulatory submission. These details are typically found in clinical study reports.

However, based on the non-clinical test summary, we can infer some "acceptance criteria" related to the device's engineering performance and safety.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria for clinical performance and corresponding device performance data from a clinical study. Instead, it lists non-clinical tests and states that the "results from testing performed confirm the design requirements." This implies that the device met the acceptance criteria for each listed non-clinical test.

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Automatic Disposable Biopsy Needle is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lung, thyroid, lymph nodes, breast and muscle. It is not intended for use in bone.

Semi-Automatic Disposable Biopsy Needle is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lung, thyroid, lymph nodes, breast and muscle. It is not intended for use in bone.

Coaxial Biopsy Needle is intended for use as a guiding needle in obtaining core biopsy samples from soft tissues such as liver, kidney, prostate, spleen, lung, thyroid, lymph nodes, breast and muscle. It is not intended for use in bone.

Automatic Disposable Biopsy Needle, Semi-automatic Disposable Biopsy Needle and Coaxial Biopsy Needle are hand-operated, non-electronic, surgical instruments.

Automatic Disposable Biopsy Needle is designed for the automatic extraction of a specimen from soft tissues, while causing minimal surrounding tissue damage, for tissue pathological examination/ testing. Automatic Disposable Biopsy Needle is first loaded and then inserted into the edge of the target tissue. Then, the inner needle rod is threaded into the target lesion (automatic firing), then, the outer needle tube is fired to push forward, and the tissue sample is cut through the relative movement of the outer needle tube and the inner needle rod of the biopsy needle, later, the tissue sample is cut off and stored in the sampling groove. Finally, specimen was removed after withdrawing the biopsy needle.

Semi-automatic Disposable Biopsy Needle is designed for the extraction of a specimen from soft tissues, while causing minimal surrounding tissue damage, for tissue pathological examination/testing. The semi-automated biopsy needle requires manual advancement of the inner needle to expose the specimen notch. With pressure on its plunger, a spring action rapidly advances the outer needle (cutting cannula) over the specimen notch of the inner needle.

Coaxial Biopsy Needle is used with biopsy needles to guide the insertion of biopsy needle into the soft tissue under imaging control (ultrasound, X-ray, CT, etc.). It is supplied with trocar tip stylet with or without blunt tip needle.

All of these devices are sterile with a Sterility Assurance Level (SAL) of 10-6, nonpyrogenic and single-use devices. The ultrasound, X-ray, CT and other equipments are used to guide the puncture and sampling. These devices cannot be used under MRI.

The provided text is a 510(k) premarket notification for M Biopsy /SureCore Automatic Disposable Biopsy Needle, M Biopsy /SureCore Semi-automatic Disposable Biopsy Needle, and M Biopsy /SureAim Coaxial Biopsy Needle. It primarily focuses on demonstrating substantial equivalence to a predicate device (K222865) based on design modifications. These modifications include extending indications to breast and muscle tissues, adding a swab component, and introducing new models within existing specifications.

Crucially, this document does not contain the acceptance criteria or a detailed study proving the device meets those criteria in the way typically expected for a software-based AI/ML medical device submission (e.g., performance metrics like sensitivity, specificity, AUC). The tests described are primarily related to the physical performance, biocompatibility, and sterility of the biopsy needles themselves, and their ability to obtain tissue samples. The "study" mentioned for the indication extension is an in vivo biopsy sampling from animal to compare the sampling performance.

Therefore, I cannot provide a detailed answer to your request in the format you've specified because the provided document does not contain the information about acceptance criteria and a study proving the device meets them in the context of an AI/ML device per your typical requirements.

Here's what can be extracted and inferred based on the provided document, addressing the points you requested, but with the caveat that it does not fit the typical AI/ML device study format:

Acceptance Criteria and Study for M Biopsy /SureCore and /SureAim Biopsy Needles

The provided document describes the safety and performance testing for a medical device (biopsy needles) which is not an AI/ML device. The "acceptance criteria" and "study" are therefore presented in terms of device functionality, material compatibility, and intended use as a physical instrument, rather than diagnostic performance metrics (e.g., sensitivity, specificity, AUC) typically associated with AI/ML systems.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated as a number of "cases" or "patients" in the context of a diagnostic test. For the in vivo animal study, the sample size is not specified. For the swab performance testing, "aged samples" are mentioned, but the quantity is not detailed.
• Data Provenance: The in vivo animal study data provenance is not specified (e.g., country of origin). The studies are "non-clinical testing" conducted by Canyon Medical Inc. (China). The data for physical/chemical tests (shelflife, EO/ECH residuals) would be from in-house lab testing.

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

This is not applicable to this submission. The "ground truth" for these physical medical devices is established through engineering and biological testing (e.g., successful tissue sample retrieval, material integrity, sterility, biocompatibility), not through expert clinical consensus on diagnostic images.

4. Adjudication Method for the Test Set

This is not applicable as there is no diagnostic test performance being adjudicated by multiple experts for a test set.

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

No, an MRMC comparative effectiveness study was not conducted because this is a physical biopsy needle, not a software-based AI/ML device that assists human readers.

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

No, a standalone performance evaluation was not done. This is a physical medical instrument, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by:

• Physical Performance Bench Testing: Verification that the device can successfully obtain tissue samples, the swab functions as intended (tissue removal, no residue), and the dimensions/mechanics are within specifications.
• Material Testing: Biocompatibility testing (per ISO 10993), sterility testing (per SAL 10-6 requirements), EO/ECH residual testing (per ISO 10993-7).
• Animal Studies: For the extended indications (breast and muscle), performing in vivo biopsy sampling in animals to compare performance with predicate devices.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" as this is not an AI/ML device.

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

This is not applicable.

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Automatic Disposable Biopsy Needle is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lung, thyroid and lymph nodes. It is not intended for use in bone.

Semi-Automatic Disposable Biopsy Needle is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lung, thyroid and lymph nodes. It is not intended for use in bone.

Coaxial Biopsy Needle is intended for use as a guiding needle in obtaining core biopsy samples from soft tissues such as liver, kidney, prostate, spleen, lung, thyroid and lymph nodes. It is not intended for use in bone.

Automatic Disposable Biopsy Needle, Semi-automatic Disposable Biopsy Needle and Coaxial Biopsy Needle are hand-operated, non-electronic, surgical instruments.

Automatic Disposable Biopsy Needle is designed for the automatic extraction of a specimen from soft tissues, while causing minimal surrounding tissue damage, for tissue pathological examination/ testing. Automatic Disposable Biopsy Needle is first loaded and then inserted into the edge of the target tissue. Then, the inner needle rod is threaded into the target lesion (automatic firing), then, the outer needle tube is fired to push forward, and the tissue sample is cut through the relative movement of the outer needle tube and the inner needle rod of the biopsy needle, later, the tissue sample is cut off and stored in the sampling groove. Finally, specimen was removed after withdrawing the biopsy needle.

Semi-automatic Disposable Biopsy Needle is designed for the extraction of a specimen from soft tissues, while causing minimal surrounding tissue damage, for tissue pathological examination/testing. The semi-automated biopsy needle requires manual advancement of the inner needle to expose the specimen notch. With pressure on its plunger, a spring action rapidly advances the outer needle (cutting cannula) over the specimen notch of the inner needle.

Coaxial Biopsy Needle is used with biopsy needles to quide the insertion of biopsy needle into the soft tissue under imaging control (ultrasound, X-ray, CT, etc.). It is supplied with trocar tip stylet with or without blunt tip needle.

All of these devices are sterile with a Sterility Assurance Level (SAL) of 10-6, nonpyrogenic and single-use devices.

This submission is a 510(k) Pre-Market Notification for a traditional medical device (a biopsy needle), not an AI/ML-enabled device. As such, the information provided does not include the details typically found in submissions for AI/ML devices regarding acceptance criteria, training/test sets, expert adjudication, or MRMC studies.

The document focuses on demonstrating substantial equivalence to predicate devices through technical characteristics, non-clinical bench testing (biocompatibility, packaging, shelf life), and the assertion that "Bench testing is sufficient to demonstrate performance of the device. No preclinical testing of the subject device is necessary" and "Performance Test is sufficient to demonstrate safety and effectiveness of the subject devices with the predicate devices."

Therefore, I cannot extract the requested information about acceptance criteria for an AI/ML device, training/test set details, expert ground truth establishment, or clinical study methodologies (like MRMC) from this document.

The document discusses the following types of tests and their conformity:

1. Acceptance Criteria and Device Performance (Summary of Non-Clinical Testing):

The acceptance criteria are not explicitly numerical thresholds like sensitivity/specificity for an AI model. Instead, they are met by demonstrating compliance with recognized consensus standards and by comparing performance to predicate devices. The "reported device performance" is essentially that the device passed these tests and met the design requirements.

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

• This information is not applicable and not provided in the context of this traditional medical device submission. The "test set" here refers to physical devices undergoing bench testing, not a dataset for an AI model.
• The data provenance would be that the tests were conducted by the manufacturer according to specified standards.

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

• Not applicable as this is not an AI/ML device requiring expert-labeled ground truth for a test set. Ground truth for the device's performance is established through objective physical and chemical testing against established standards and comparisons to predicate devices.

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

• Not applicable. This concept is relevant for AI/ML model training/testing, not for physical device bench testing.

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 is not an AI/ML device used for reading or interpretation.

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

• Not applicable. This is a physical biopsy needle, not an algorithm.

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

• Ground truth for this device's performance is based on pre-defined engineering specifications, material properties, sterility assurance levels, biocompatibility standards, and functional requirements (e.g., puncture force, resistance to breakage, sample integrity). It is not derived from clinical outcomes or expert consensus on image interpretation.

8. The sample size for the training set:

• Not applicable. This device does not involve a "training set" in the context of machine learning.

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

• Not applicable. No machine learning training set is involved.

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