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Disposable Microwave Ablation Needle is used with the Microwave Ablation System. which is indicated for the ablation of soft tissue during open procedures. The Disposable Microwave Ablation Needle is not intended for cardiac use.

Disposable Microwave Ablation Needle is a puncture needle with microwave energy transmission. It is inserted into the human body through puncture, and the tissue is ablated by the thermal energy transformed by the needle tip.

The Disposable Microwave Ablation Needle is composed of an inlet pipe, an outlet pipe, a handle, a needle rod, a medium tube, a radiation pole, and a coaxial transmission cable. It is a sterile disposable product. The coaxial transmission cable connect the Microwave Ablation System to transmit microwaves to the ablation needle (radiator), a handle is set at the connection between the microwave cable and the ablation needle to facilitate the operation of the operator.

The Disposable Microwave Ablation Needle is provided sterile, for single use.

This document describes the 510(k) Premarket Notification for the Disposable Microwave Ablation Needle (K232241). The submission aims to demonstrate substantial equivalence to a predicate device (K201265). It does not include a study proving the device meets specific acceptance criteria as would be found in a clinical trial. Instead, it relies on demonstrating equivalence through non-clinical testing and comparison to an established predicate device.

Here's an analysis of the provided information:

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

The document does not explicitly present a table of "acceptance criteria" with direct performance metrics in the way a clinical study would for efficacy endpoints. Instead, it demonstrates compliance with recognized standards and addresses differences from the predicate device through non-clinical testing. The "performance" is primarily shown through compliance with these standards and the equivalence of the ablation mechanism.

Key Non-Clinical Tests and Standards of Compliance:

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

The document focuses on non-clinical testing, particularly in vitro tissue ablation studies. It does not specify a "sample size" for a test set in the context of human subjects or image data.

• Test Set Description: Not applicable in the context of human or image data. The testing involves "in vitro tissues" for thermal effects and temperature monitoring.
• Data Provenance: Not specified, but the manufacturing company is based in China. The testing appears to be primarily laboratory-based (in vitro), not drawn from human clinical data.
• Retrospective/Prospective: Not applicable, as this is laboratory testing.

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 section is not applicable. The evaluations are based on engineering and scientific principles, compliance with international standards, and in vitro studies for performance, not on expert interpretations of medical images or patient outcomes in a diagnostic context.

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

This is not applicable for the type of non-clinical testing described. Adjudication methods are typically used for establishing ground truth in clinical or image-based studies where expert interpretation is involved.

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 is not applicable. The device is a physical microwave ablation needle, not a software AI-driven medical device aimed at assisting human readers or improving diagnostic accuracy.

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

This is not applicable. The device is a physical therapeutic device, not a standalone algorithm.

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

For the in vitro ablation studies mentioned, the "ground truth" for thermal effects and ablation zone characteristics would typically be established by direct measurement and observation within the experimental setup, often validated against physical principles of microwave energy delivery and tissue heating properties. This is a scientific "ground truth" rather than a clinical one derived from patient data or expert medical opinion. For biocompatibility, the ground truth is established by adherence to ISO 10993 series standards.

8. The sample size for the training set

This is not applicable as there is no mention of a training set for an algorithm or AI model. The submission pertains to a physical medical device.

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

This is not applicable as there is no training set mentioned in the document.

Summary of the Study and Device Proof:

The submitted document ("510(k) Summary") is not a detailed clinical study report but rather a regulatory filing to demonstrate substantial equivalence for a medical device. The "study" referenced is a series of non-clinical tests and analyses designed to show that the proposed Disposable Microwave Ablation Needle is as safe and effective as a legally marketed predicate device.

The proof that the device meets "acceptance criteria" comes from:

• Compliance with recognized international standards: IEC 60601-1, EN 60601-1-2, IEC 60601-2-6, ANSI AAMI IEC 62304, ASTM F 1980, and ISO 10993 series standards.
• In vitro tissue ablation studies: These studies, conducted in accordance with FDA guidance documents, assessed the "Thermal Effects" and "Temperature monitoring" and the "ablation range" of the device, particularly addressing the differences in radiation pole and max power compared to the predicate device. The results of these studies supported the intended use of the proposed device.
• Comparison to a predicate device (K201265): The document meticulously compares the proposed device to the predicate across various characteristics (Table 2). Differences in operating principle description (equivalent), applicator material (biocompatibility assessed), applicator length (affects depth, not safety/performance), outer diameter (affects puncture area, not safety/performance), radiation pole (affects radiation field, in vitro studies support safety), and max power (affects ablation range, in vitro studies support safety) are analyzed and justified as not raising new questions of safety or effectiveness.

In conclusion, the acceptance criteria are largely implicit in the compliance with design, safety, and performance standards, and the demonstration through non-clinical testing that any differences from the predicate device do not introduce new safety or effectiveness concerns. No human clinical study was performed or included in this submission.

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

The Microwave Ablation System is a microwave power (energy) source that can meet the needs of clinical soft tissue microwave thermal ablation therapy. The microwave energy is transmitted to the disposable microwave ablation needle through coaxial transmission cable, and the disposable microwave ablation needle is directly inserted into the targeted soft tissue, and the electromagnetic wave (microwave) is radiated from the front end of the disposable microwave ablation needle to cause the soft tissue to produce heat and rise. When it reaches the temperature of tissue coagulation and necrosis, in-situ inactivation is formed, that is, the purpose of microwave ablation therapy is achieved.

The Disposable Thermometer Needle and Foot Switch are accessories for the proposed device. And the proposed device is used in conjunction with the Disposable Microwave Ablation Needle made by our company.

The provided text describes a 510(k) premarket notification for a Microwave Ablation System. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove the device meets specific acceptance criteria in the way a clinical trial or performance study for a diagnostic device would.

Therefore, much of the requested information regarding acceptance criteria, reported performance, sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, and training set details are not applicable or available from this 510(k) summary. This document primarily focuses on engineering and regulatory compliance rather than clinical performance metrics as might be found in a diagnostic AI device submission.

Here's an attempt to answer the questions based on the provided text, indicating where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present specific quantitative performance acceptance criteria (e.g., accuracy, sensitivity, specificity) for a clinical outcome in the way an AI diagnostic device might. Instead, the "acceptance criteria" are implied by the conformance to various safety, performance, and software standards. The reported "performance" focuses on meeting these standards and demonstrating equivalence to a predicate device.

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

The document explicitly states: "No clinical study is included in this submission." This means there isn't a "test set" of patient data in the context of evaluating a diagnostic or AI-driven device's clinical performance. The testing mentioned (electrical safety, EMC, thermal effects) would involve laboratory setups and devices, not patient data.

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

Not applicable, as no clinical study or test set using patient data for ground truth establishment was conducted or reported.

4. Adjudication method for the test set

Not applicable, as no clinical study or test set requiring expert adjudication was conducted or reported.

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 Microwave Ablation System, which is a therapeutic device, not a diagnostic device that would typically involve human readers or AI assistance for interpretation.

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

Not applicable. This device is a therapeutic system, not an algorithm or AI product. Its performance is related to its physical functions and safety, not an AI's standalone interpretation capability.

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

For the engineering and safety tests, the "ground truth" would be the specifications and requirements defined by the relevant international standards (e.g., IEC 60601 series) and FDA guidance documents. For instance, an electrical safety test's ground truth is whether the device does or does not meet the leakage current limits. This is based on objective measurements against engineering standards, not clinical ground truth like pathology.

8. The sample size for the training set

Not applicable. There is no mention of a training set as this is not an AI/machine learning device.

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

Not applicable. There is no mention of a training set.

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