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The Laparoscopic FMsealer is an electrosurgical instrument intended for use in open and laparoscopic surgical procedures, including general and gynecologic procedures where ligation and division of vessels, including lymph vessels, is desired. It can be used to ligate and divide vessels up to and including 7 mm and bundles as large as will fit in the jaws of the instrument.

The Laparoscopic 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.

Electrosurgical cutting and coagulation devices (and accessories) are devices intended to remove tissue and control bleeding by use of high-frequency electrical current (see 21 CFR §878.4400). They are classified as Class II (510(k)) devices.

The Laparoscopic FMsealer is a sterile, single-patient use, hand-held surgical instrument intended for ligation and division of vessels. The Laparoscopic FMsealer must be connected to a generator (Domain Surgical's FMwand Generator) by an accessory cable (Domain Surgical's FMwand Power Module). It is capable of blunt dissection, grasping and division of tissue enclosed within its jaws during open or laparoscopic procedures. The outer diameter of the instrument shaft is 5mm, with a working length of 36cm.

The Laparoscopic FMsealer includes a rotation knob, front lever and two actuation buttons. The rotation knob, located at the distal end of the handle, allows for a full 360 degrees of rotation of the jaws to improve visibility of the tissue as well as permit access to tissues on differing planes. The front lever closes the jaws of the device which allows pressure to be applied to the tissue between the jaws. The actuation buttons activate the transfer of current from the generator to the tip of the device which creates the heat necessary for sealing and dividing.

This system creates sealing, cutting and coagulation of heat and compression (from the opposing jaws of the device) to tissue bundles and vessels interposed between the jaws of the instrument.

The Laparoscopic FMsealer has been shown to cut and seal vessels (veins and arteries) up to and including 7mm in diameter.

This document describes the Premarket Notification for the "Laparoscopic FMsealer." The acceptance criteria and the study that proves the device meets them are outlined.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly present a table of "acceptance criteria" with quantitative performance metrics for the Laparoscopic FMsealer, such as specific burst pressures for sealed vessels. Instead, it states that the device "passed all bench tests performed" and details the types of tests conducted. The key performance claim is its ability to seal vessels up to and including 7mm. The comparison to predicate devices focuses on technological characteristics and overall safety and effectiveness.

Here's a summary of the implicit acceptance criteria based on the described tests and the reported performance:

2. Sample Sized Used for the Test Set and the Data Provenance:

The document provides the following information regarding test samples:

• Ex-Vivo Vessel Sealing Test Results: 2mm-7mm Porcine Arteries. (The exact number of arteries or samples tested is not specified in this summary. "Porcine" indicates animal origin, not human.)
• In-vivo GLP Acute Animal Study - Laparoscopic Stress Testing: Animal study. (The specific species and number of animals are not detailed in this summary.)
• In-vivo GLP Chronic Animal Study - Vessel Sealing: Animal study. (The specific species and number of animals are not detailed in this summary.)
• Provenance: All animal studies (Ex-vivo and In-vivo) are based on animal tissue/models. The GLP (Good Laboratory Practice) designation indicates a regulatory standard for non-clinical laboratory studies. The studies are prospective in nature as they are specifically conducted to evaluate the device.

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

The document does not specify the number of experts or their qualifications for establishing ground truth for the animal studies or ex-vivo tests. In medical device submissions, animal studies are typically overseen by veterinarians and surgical specialists, and their observations and measurements serve as the "ground truth" for success or failure criteria (e.g., successful hemostasis, lack of thermal injury, absence of late complications). However, these details are not provided in this summary.

4. Adjudication Method for the Test Set:

The document does not explicitly state an adjudication method (like 2+1 or 3+1). For the reported tests (Ex-Vivo and In-vivo Animal Studies), results would typically be objectively measured (e.g., burst pressure, direct observation of tissue integrity, histological evaluation) rather than requiring consensus among human experts for interpreting results in the same way clinical image interpretation studies might. Data analysis would follow standard statistical methods for the parameters measured.

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 to this device submission. The Laparoscopic FMsealer is an electrosurgical instrument for vessel sealing, not an AI-powered diagnostic or interpretive tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant. The studies performed were for direct device performance and safety.

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

This is not applicable to this device. As an electrosurgical instrument, its performance is inherently human-in-the-loop as it is manipulated by a surgeon. There is no "algorithm only" performance to evaluate in this context.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

The ground truth for the performance studies primarily relies on:

• Direct observation and measurement: In both ex-vivo and in-vivo animal studies, the success of vessel sealing (e.g., hemostasis, lack of bleeding, integrity of the seal) would be directly observed.
• Pathology/Histology: For chronic animal studies, tissue samples would likely be sent for histological examination to assess seal quality, thermal injury, and healing over time.
• Functional outcomes: For the animal studies, the functional outcome related to the intended use (ligation and division of vessels) is evaluated.

8. The Sample Size for the Training Set:

This is not applicable. The Laparoscopic FMsealer is a physical medical device, not a machine learning model. Therefore, there is no "training set" in the context of AI/ML. Device development involves engineering design, prototyping, and iterative testing, not explicit data training sets.

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

This is not applicable as there is no "training set" for this type of device.

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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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The FMwand Ferromagnetic Surgical System is indicated for cutting and coagulation of soft tissue during surgical procedures, including Gynecologic procedures (open, transabdominal only).

The FMwand Ferromagnetic Surgical System is a soft tissue cutting and coagulation device that consists of the FMwand Generator that is electrically connected to the sterile, single-use FMwand Handpiece by the FMwand Power Module (a resterilizable, reusable accessory cable) and a single-use, sterile air line. Like the predicate device, the handpiece includes actuation buttons that can be used to activate the handpiece tip. Also like the predicate device, an optional footpedal can be used to activate the handpiece. The connectors at both ends of the FMwand Power Module are designed to fit only the FMwand Generator and FMwand sterile, disposable accessories. The FMwand Power Module is provided non-sterile. It is intended to be cleaned and sterilized prior to the initial use and before each subsequent reuse.

The provided 510(k) summary for the FMwand Ferromagnetic Surgical System (K130606) does not describe a study involving an AI/Machine Learning device or a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. This submission is for a traditional medical device (an electrosurgical system) and focuses on demonstrating substantial equivalence to a predicate device through bench testing and compliance with existing standards.

Therefore, many of the requested criteria related to AI/ML device testing (such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set information) are not applicable to this document.

The document primarily discusses that the new device is "substantially equivalent" to an existing predicate device (Domain Surgical System, K121881) by demonstrating that differences do not raise new questions of safety and effectiveness, and that the device functions as intended based on bench testing.

Here's an analysis based on the information available, noting where specific AI/ML related criteria are not met:

1. Table of acceptance criteria and reported device performance:

The document doesn't explicitly state "acceptance criteria" in a quantitative, measurable sense for clinical performance. Instead, it relies on demonstrating that the new device performs identically or equivalently to the predicate device through bench testing and compliance with standards. The "performance" is implicitly deemed acceptable if it matches the predicate and meets relevant safety standards.

Study Proving Device Meets Acceptance Criteria:

The document refers to "bench testing" as the primary study type to demonstrate safety and effectiveness and substantial equivalence.

• "All applicable bench testing was performed with the FMwand Ferromagnetic Surgical System to assure that it functions as intended. Bench tests verified that the generator output was within specification and that the thermal output of the handpiece and tip corresponded to the target values."
• "The FMwand Ferromagnetic Surgical System passed all bench tests performed. Details are found in Section 15: of this submission."
• Biocompatibility testing was performed according to ISO 10993-1 and 510(k) Memorandum G95-1.
• Compliance with electrical safety standards included IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, and IEC 60601-2-2.

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

• Sample Size: Not specified in the provided text. Bench testing typically involves a number of units or measurements, but specific quantities are not given here.
• Data Provenance: Not specified. Bench tests are usually conducted in laboratories by the manufacturer or third-party testing facilities. The country of origin of testing data is not mentioned, and the testing is inherent to the device's design and manufacturing rather than involving patient data. This is a retrospective analysis of the device's physical and electrical properties, not clinical data.

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

• Not Applicable. This is a traditional medical device (electrosurgical system), not an AI/ML device requiring expert ground truth for interpretation of outputs like images. Bench testing involves objective measurements against predefined specifications and standards.

4. Adjudication method for the test set:

• Not Applicable. See point 3. Testing involves objective measurements, not subjective expert reviews that would require adjudication.

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. This is not an AI/ML device. No MRMC study was conducted or is relevant for this type of device.

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

• Not Applicable. This is not an AI/ML device. Standalone performance for an algorithm is not relevant. The device's "standalone" performance refers to its ability to meet specifications when operated.

7. The type of ground truth used:

• For the technical performance of the device (generator output, thermal output, electrical safety): Predefined specifications and recognized international or national safety and performance standards (e.g., IEC 60601 series). These are objective criteria.
• For biocompatibility: ISO 10993 series standards define the "ground truth" for material safety.

8. The sample size for the training set:

• Not Applicable. This is not an AI/ML device. There is no "training set" in the context of machine learning.

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

• Not Applicable. See point 8.

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The Domain Surgical System is indicated for cutting and coagulation of soft tissue during surgical procedures, including Gynecologic procedures (open transabdominal only).

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 (21 CFR §878.4400). It is classified as a Class II (510(k)) device.

The Domain Surgical System is a soft tissue cutting and coagulation device that consists of a generator that is electrically connected to a sterile, single-use handpiece and an optional footswitch. Like the predicate devices, the handpiece includes an actuation button that can be used to activate heating in the handpiece tip. Also like the predicate devices, an optional footswitch can be used to activate the system.

The provided text is a 510(k) summary for the Domain Surgical System, which is an electrosurgical cutting and coagulation device. This submission is intended to modify the Indications for Use statement to add specificity, consistent with its intended use and the indications for use for the legally marketed Peak Surgery System. The device itself was previously cleared by FDA through 510(k) #K110439.

Based on the provided document, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

It's important to note: This submission is an amendment to specify the indications for use, not a new device clearance. All the performance data described above was previously reported and accepted as part of 510(k) #K110439.

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

The document primarily discusses bench testing and compliance with standards. It does not mention a "test set" in the context of a clinical study with human or animal subjects for this specific submission (K121881). The tests described are engineering and laboratory tests.

• Sample Size for Test Set: Not applicable to this type of regulatory submission and the tests described.
• Data Provenance: Not applicable. The data is from laboratory and engineering bench tests rather than clinical data from specific countries or retrospective/prospective studies.

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

This section is not applicable. The ground truth for the "test set" (bench testing) is based on engineering specifications and international standards, not expert human assessment.

4. Adjudication method for the test set

This section is not applicable. Adjudication methods like 2+1 or 3+1 typically refer to clinical studies where multiple experts evaluate cases and a consensus or tie-breaking mechanism is used. The tests described are objective engineering and laboratory tests.

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 section is not applicable. This device is an electrosurgical cutting and coagulation device, not an imaging or diagnostic device that would typically involve "human readers" or AI assistance in the way described for an MRMC study.

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

This section is not applicable. This device is a surgical tool, not an algorithm. Its operation inherently involves a "human-in-the-loop" (the surgeon). The "software" mentioned controls the generator, which is part of the overall surgical system, not a standalone diagnostic or interpretive algorithm.

7. The type of ground truth used

The "ground truth" for the tests described are:

• Engineering Specifications: For generator output and thermal output.
• International Standards: For electrical safety (IEC 60601 series) and biocompatibility (ISO 10993-1).
• Design Requirements: For software functionality and performance.

8. The sample size for the training set

This section is not applicable. The device is not an AI/ML algorithm that requires a "training set" in the context of machine learning. The "software" mentioned in the document is a control system software, not a learning algorithm trained on data.

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

This section is not applicable for the same reasons as #8.

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Indications for Use: The Domain Surgical System is indicated for cutting and coagulation of soft tissue.

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 (21 CFR §878.4400). It is classified as a Class II (510(k)) device.

The Domain Surgical System is a soft tissue cutting and coagulation device that consists of a generator that is electrically connected to a sterile, single-use handpiece and an optional footswitch. Like the predicate devices, the handpiece includes an actuation button that can be used to activate heating in the handpiece tip. Also like the predicate devices, an optional footswitch can be used to activate the handpiece.

Here's an analysis of the provided text regarding the Domain Surgical System, focusing on acceptance criteria and supporting studies:

The provided document, K110439, is a 510(k) Summary for the Domain Surgical System, dated July 18, 2011. This summary focuses on demonstrating substantial equivalence to predicate devices, rather than detailing specific acceptance criteria and a comprehensive study showing performance against those criteria. As such, information regarding quantitative performance metrics, ground truth establishment, expert qualifications, and specific sample sizes for particular studies is largely absent.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state a table of quantitative acceptance criteria for device performance. Instead, it relies on demonstrating that the device functions as intended and is as safe and effective as predicate devices.

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

The document mentions "Bench tests" and "Live animal testing" as the primary studies. However, it does not provide specific sample sizes for these tests.

• Provenance: Not explicitly stated, but "Live animal testing" suggests live subjects (animals). Bench tests are typically laboratory-based. The country of origin for the studies is not mentioned.
• Retrospective/Prospective: Not specified. Animal testing is typically prospective, but without details, this cannot be confirmed.

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

This information is not provided in the document. The "ground truth" for electrosurgical device performance is typically objective physical measurements and observed physiological outcomes in an animal model, rather than expert consensus on images or diagnoses.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of electrosurgical device testing (bench and animal), an adjudication method in the context of human readers/experts is not directly applicable. Performance is evaluated based on physical measurements and observed physiological effects.

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 to this device. The Domain Surgical System is an electrosurgical cutting and coagulation device, not an AI-powered diagnostic or assistive tool for human readers/clinicians interpreting data. Therefore, an MRMC study and effects on human reader improvement are outside the scope of this device's function.

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

This is not applicable in the AI sense. However, the bench tests and animal testing can be considered "standalone" in that they assess the device's inherent physical and functional performance independently of human interaction for interpretation (unlike an AI algorithm that provides outputs for human review). The device's operation, however, does involve a human operator (surgeon).

7. The Type of Ground Truth Used

• For bench tests: The ground truth was objective measurements against engineered specifications (e.g., generator output values, handpiece thermal output).
• For biocompatibility: The ground truth was "Successful biocompatibility testing" against established standards (ISO 10993-1 and 510(k) Memorandum G95-1), likely involving in-vitro and in-vivo tests to assess material safety.
• For live animal testing: The ground truth was direct observation of the device's effectiveness in "cutting and coagulating soft tissue" compared to legally marketed electrosurgical devices (predicates). This would involve macroscopic and potentially microscopic assessment of tissue effects.

8. The Sample Size for the Training Set

This is not applicable as the Domain Surgical System is a hardware medical device with software control, but it does not employ a machine learning or AI algorithm that requires a "training set" in the conventional sense. The "training" for such a device involves engineering design, development, and validation against known physical principles and performance requirements.

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

This is not applicable for the reasons stated in point 8. The device's functionality is based on its design and manufacturing specifications, verified through various tests, not through learning from a labeled dataset.

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