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Disposable Microwave Therapeutic Antennas is used with the Microwave Therapeutic System, which is indicated for the coagulation (ablation) of soft tissue. The Disposable Microwave Therapeutic Antennas is not intended for cardiac use.

Disposable Microwave Therapeutic Antennas 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.

Disposable Microwave Therapeutic Antennas is composed of radiator, handle, microwave cable with/without cooling tubes. The microwave 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 operator. The radiator is composed of a needle tip, a needle shaft, a cooling tube, and a coaxial cable. The metal parts are connected by a welding process, and the non-metal parts are connected by qlue. The needle and needle shaft are made of medical stainless steel, and the shape of the needle is a trianqular pyramid tip or pyramid type tip, which is mainly used for percutaneous puncture and microwave radiation; the handle is made of ABS material, the cooling tube is made of stainless steel to cool the needle bar all the way, the thermocouple is arranged in the handle to effectively monitor the temperature of the ablation needle not to exceed 45 degrees.

Disposable Microwave Therapeutic Antennas is provided sterile, for single use.

The provided text details the 510(k) summary for "Disposable Microwave Therapeutic Antennas" (K201265), comparing it to a predicate device (K183153) and a reference device (K133821). The core of the submission is to demonstrate substantial equivalence, focusing on technical performance and safety rather than on clinical effectiveness in a comparative sense (e.g., human-in-the-loop studies or ground truth established by experts interpreting images).

Based on the provided text, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily based on demonstrating substantial equivalence to the predicate device in terms of safety and functionality. The performance data provided is entirely non-clinical.

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

• Test Set Sample Size: Not applicable in the context of an AI/human-in-the-loop study. The "test set" here refers to non-clinical testing. For the in vitro tissue ablation studies, the sample size or details of the tissue models used are not explicitly stated. The type of data is non-clinical performance data from laboratory tests, including electrical safety, EMC, performance (IEC 60601-2-6), shelf life (accelerated aging), thermal effects, package verification, sterilization validation, and biocompatibility.
• Data Provenance: Not explicitly stated regarding the origin of the non-clinical data, but implied to be from internal testing by Nanjing ECO Microwave System Co., Ltd. The studies were not retrospective or prospective clinical studies but rather laboratory-based performance and safety evaluations.

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

• This information is not applicable as the device is not an AI diagnostic/interpretative device requiring expert-established ground truth from medical images. The ground truth for this device's performance is established through physical measurements, material science testing, and engineering standards compliance in a laboratory setting.

4. Adjudication Method for the Test Set

• Not applicable. There is no "adjudication" of expert opinions for a test set, as this is a non-AI hardware device approval. Performance is measured against engineering specifications and regulatory standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. An MRMC study was not conducted or required for this 510(k) submission. This is a device for physical ablation, not for interpretation of medical images or aiding human readers in diagnosis. The submission explicitly states: "Clinical testing is not required."

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

• Not applicable. This device is hardware; there is no standalone algorithm. Its performance is evaluated through physical and electrical tests, not as an algorithm's output.

7. The Type of Ground Truth Used

• The "ground truth" for this medical device is based on established engineering standards, material science properties, electrical safety parameters, and verified physical performance characteristics (e.g., achieving intended thermal effects/ablation in in vitro models). It is not expert consensus, pathology, or outcomes data in the clinical sense, as clinical testing was not required for this submission. The in vitro tissue ablation studies served as the proxy for functional ground truth related to the device's main purpose.

8. The Sample Size for the Training Set

• Not applicable. There is no "training set" in the context of an AI algorithm, as this is solely a hardware device.

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

• Not applicable. As there is no training set for an AI algorithm, there is no ground truth established for it.

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

The Microwave Therapeutic System is a host machine will be used together with Disposable Microwave Ablation Needle for ablation of soft tissue. The Microwave Therapeutic System consists of microwave source, control system, display system and temperature measurement system. It is a software-controlled microwave generator that deliver the microwave energy at a working frequency of 2450 MHz. The generator of the microwave therapeutic system is composed of a casinq, a power module, a control feedback unit, a display module, a microwave transmitting module, a water circulation module, and a temperature measurement module.

The provided text describes a 510(k) summary for the Microwave Therapeutic System (K201262) and compares it to a predicate device (K183153). While it discusses device performance and testing, it explicitly states that clinical testing is not required and does not present data from a study that proves the device meets specific acceptance criteria based on a clinical outcome or a comparison to human performance with or without AI assistance. Instead, the submission relies on non-clinical data to demonstrate substantial equivalence to a legally marketed predicate device.

Therefore, many of the requested elements for describing the acceptance criteria and the study that proves the device meets them cannot be found in the provided text, as this type of study was not performed or required for this particular regulatory submission.

Here's a breakdown of what can be extracted or inferred from the text, and what is not present:

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

The document does not provide a table for acceptance criteria of clinical or human performance, as no such study was conducted. It implicitly relies on the device meeting established electrical safety, EMC, and performance standards for microwave therapy equipment, and software validation guidance.

The "performance" criteria are based on compliance with standards rather than clinical outcomes. The text states:

• Electrical Safety: ES60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
• Electromagnetic Compatibility: IEC 60601-1-2 Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance -- Collateral Standard: Electromagnetic disturbances --Requirements and tests
• Performance (General): IEC 60601-2-6 Medical electrical equipment Part 2-6: Particular requirements for the basic safety and essential performance of microwave therapy equipment
• Software validation: In compliance with FDA guidance for software contained in Medical devices.
• Shelf Life: "Accelerated aging tests were conducted to confirm the validity of the 8 years shelf life for 1 machine." (No specific acceptance criteria or results are given beyond "confirm the validity").
• Thermal Effects test and Temperature monitoring test: Referencing "FDA Guidance Premarket Notification (510(K)) Submissions for Electrosurgical Devices for General Surgery." The text mentions "the test result prove that single needle ablation can also achieve the intended use, the performance meet the requirements of IEC 60601-2-6, the temperature measurement accuracy meet the requirements of intended use". Again, no specific quantitative criteria or results are provided.

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

• Test set sample size: Not applicable/provided. No clinical test set data is described. The non-clinical tests were conducted on the device itself.
• Data provenance: Not applicable/provided. No human data for a test set is listed.

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

• Number of experts: Not applicable. No human expert review was part of the reported performance evaluation.
• Qualifications of experts: Not applicable.

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

• Adjudication method: Not applicable. No human review or adjudication process is mentioned as part of the submission's performance evaluation.

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

• MRMC study: No. The device is a Microwave Therapeutic System for ablation of soft tissue, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is irrelevant to this device type and was not performed.

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

• Standalone performance: The "performance" described pertains to the standalone operation of the microwave therapy device itself, based on engineering tests against established standards. This is not an AI algorithm's standalone performance, but the device's functional performance. The text indicates that these tests found the device to meet the respective standards, such as IEC 60601-2-6.

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

• Ground truth: For the device's performance, the "ground truth" is defined by compliance with established international and FDA-recognized standards for electrical safety, EMC, and microwave therapy equipment (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-6), as well as FDA guidance for software validation and specific thermal effects testing. These are engineering and regulatory benchmarks, not clinical ground truth derived from patients or expert consensus on clinical outcomes.

8. The sample size for the training set

• Training set sample size: Not applicable. This is a medical device, not an AI/ML algorithm that requires a training set of data for its primary function.

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

• Ground truth for training set: Not applicable, as there is no training set for this type of device.

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