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The Open FMsealer is intended for use in general and gynecological surgery and other open surgical procedures where ligation of vessels, including lymph vessels, is desired. The system creates a vessel ligation (seal) by the application of heat (coagulation) to vessels interposed between the jaws of the device. The Open FMsealer can be used to seal and ligate vessels up to 7mm and tissue bundles as large as will fit in the jaws of the instrument.

The Open FMsealer has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these purposes.

An electrosurgical cutting and coagulation device (and accessories) is a device intended to remove tissue and control bleeding by use of high-frequency electrical current (see 21 CFR §878.4400). It is classified as a Class II (510(k)) device.

The Open FMsealer is a device intended for sealing of vessels and for soft tissue cutting and coagulation. The device is designed to be used only with the FMwand Generator (K130606). The two-piece device consists of a sterile, single-use patient-contacting shears section (Open FMsealer) and an accessory cable (Power Module or PM) that connects the FMsealer to the generator. The dual footpedal connects to the rear of the generator and can be used to activate the FMsealer if desired by the user.

The Open FMsealer is a hand-held surgical instrument intended for use in open surgical procedures where ligation of vessels or cutting and coagulation of soft tissue is desired. The Open FMsealer consists of a scissor-like handle with two actuation buttons and jaws to grasp the tissue to be affected.

The Open FMsealer is connected to the FMwand Generator (K130606) by the Power Module. The connectors on both ends of the Power Module are designed to fit only the FMwand Generator and FMwand sterile, disposable accessories. The power module and FMwand Generator were previously cleared as part of K130606.

This system creates sealing, cutting and coagulation by the application of heat and compression to tissue bundles and vessels interposed between the iaws of the instrument. Like the predicate device, the Open FMsealer includes actuation buttons that can be used to activate the device.

The Open FMsealer has been shown (in animal studies) to cut and seal vessels up to and including 7mm in diameter, lymphatics and tissue bundles as large as will fit into the jaws of the device.

This 510(k) summary describes the "Open FMsealer" intended for vessel sealing and soft tissue cutting and coagulation in surgical procedures. The device uses ferromagnetic induction to generate heat, similar to its predicate device, the FMwand Ferromagnetic Surgical System (K130606). It also claims substantial equivalence to the LigaSure Vessel Sealing System (K043273).

Here's an analysis of the provided information according to your requested criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the format of pass/fail thresholds for specific quantitative metrics. Instead, it describes performance characteristics and states that the device "passed all bench tests" and "is at least as effective as the predicate device." The performance testing focused on demonstrating substantial equivalence to the predicate devices.

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

• Sample Size for Test Set: The document mentions "animal studies" for performance testing, including "acute and chronic animal studies" and "testing on animals and animal tissues." However, specific sample sizes (number of animals, number of vessels/tissue bundles, etc.) are not provided in the summary.
• Data Provenance: The studies were prospective animal studies. The country of origin for the data is not specified but implicitly US-based, given the FDA submission.

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

The document does not mention the use of human experts to establish ground truth for the animal studies. It refers to "tissue histological analysis" which would be performed by pathologists, but no details are given regarding the number or qualifications of such experts.

4. Adjudication Method for the Test Set

Since human experts are not mentioned as establishing ground truth in a consensus-based manner, no adjudication method (e.g., 2+1, 3+1) is described or applicable in the context of this summary. The results of the animal studies and histological analyses would likely be interpreted by the researchers performing the studies and potentially reviewed by veterinary pathologists.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The clearance of this device was "not based on human clinical testing." The studies focused on animal models and bench testing to demonstrate technical and performance equivalence to predicate devices.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable to the Open FMsealer. This is a physical surgical device, not an AI algorithm. Its performance is inherent in its design and operation, not through an algorithm operating independently.

7. The Type of Ground Truth Used

The ground truth for the performance evaluations appears to be based on:

• Animal Outcomes Data: Specifically, successful vessel sealing and tissue coagulation, indicated by "vessel sealing strength" and outcomes from "acute and chronic animal studies."
• Pathology/Histology: "Tissue histological analysis" was performed, which relies on microscopic examination of tissue by pathologists to confirm the effects of the device (e.g., cell necrosis, collagen denaturation, seal integrity).
• Bench Test Measurements: Quantitative measurements of physical parameters (e.g., thermal performance, seal strength).

8. The Sample Size for the Training Set

Not applicable. This device is a physical surgical instrument and does not use a "training set" in the context of machine learning.

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

Not applicable. As above, there is no "training set" for this device.

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The FMwand Handpiece SE is indicated for cutting and coagulation of soft tissue during surgical procedures, and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.

The FMwand Handpiece SE is a sterile, single-patient use, soft tissue cutting and coagulation device intended to be used with the FMwand Generator and FMwand Power Module (both previously cleared in 510(k) #K130606) and also with an effective user-supplied smoke evacuation system.

Here's a breakdown of the acceptance criteria and study information for the FMwand Handpiece SE, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for performance; instead, it establishes substantial equivalence to predicate devices primarily through design and functional similarity, coupled with bench testing to confirm the added smoke evacuation feature. The performance is reported implicitly by comparing its features and functions to the predicate devices and confirming the smoke evacuation functionality.

2. Sample Size for the Test Set and Data Provenance

The document does not specify a distinct "test set" in the context of clinical or performance data. The primary performance assertion for the new feature (smoke evacuation) was demonstrated through bench testing. Therefore:

• Sample Size for Test Set: Not applicable/not specified in terms of clinical or "case" samples. Performance was demonstrated via bench testing.
• Data Provenance: Bench testing data. The document does not provide details on country of origin or if it was retrospective/prospective, as it's laboratory-based testing.

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

This information is not provided in the document. Given that the primary performance evaluation for the new feature was bench testing for smoke evacuation effectiveness, the concept of "ground truth established by experts" as seen in clinical studies (e.g., for diagnostic AI) does not directly apply in the same way. The efficacy would be measured against objective physical criteria during bench testing.

4. Adjudication Method for the Test Set

This information is not provided nor is it applicable, as the evaluation type was bench testing for smoke evacuation, not a reader-based clinical study requiring adjudication.

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

No, an MRMC comparative effectiveness study was not reported or performed. The device is an electrosurgical handpiece, and its improvements are mechanical/functional (integrated smoke evacuation), not related to AI-assisted interpretation or diagnostic accuracy in human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not relevant to this device.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, in the sense of bench testing. The document states that "The ability of the FMwand Handpiece SE to effectively remove smoke from the surgical site was shown through bench testing." This constitutes a standalone (algorithm-only if thinking broadly about the device's function) evaluation of the new smoke evacuation feature, without human intervention in the smoke removal process itself (beyond activating the device). The device's electrosurgical cutting and coagulation function is also evaluated intrinsically.

7. The Type of Ground Truth Used

For the new smoke evacuation feature, the ground truth was based on objective measurements during bench testing to demonstrate the effectiveness of smoke removal. For the core electrosurgical functions (cutting and coagulation), the ground truth is established by the device's design and mechanism (ferromagnetic induction heating) being substantially equivalent to the cleared predicate device (K130606), which itself would have demonstrated its intended functionality during its own clearance process.

8. The Sample Size for the Training Set

This information is not applicable as the device is a medical instrument and not an AI/ML algorithm that requires a "training set" in the computational sense.

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

This information is not applicable for the reasons stated in point 8.

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