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The FMX314 Surgical Platform is composed of FMX314 Instruments that are used in minimally invasive abdominal laparoscopic surgery:

• The FMX314 Introducer is intended to establish a path of entry for laparoscopic instruments for use during minimally invasive abdominal laparoscopic surgery in combination with the FMX314 Instruments.

• The FMX314 Instruments are intended for use in minimally invasive abdominal laparoscopic surgical procedures for grasping, mobilizing, dissecting, cutting, cauterizing, ligating, and suction irrigation of tissues and vessels during laparoscopic procedures.

The FMX314 Surgical Platform is a single-port laparoscopic surgery platform, featuring single-use, disposable articulating surgical instruments for the purpose of doing minimally invasive abdominal laparoscopic surgery by closely mimicking multi-port laparoscopic surgery. The FMX314 Surgical Platform is composed of the reusable FMX314 Introducer, the single-use FMX314 Hub Cap & Sealing Unit, and the single-use FMX314 Instruments that are used as part of laparoscopic surgery according to the intended use. The FMX314 Surgical Platform does not require a larger diameter incision than standard laparoscopic surgery (compatible with a single, standard 15mm trocar) and will utilize currently marketed conventional 15mm laparoscopic access devices (trocars), rigid 5mm laparoscopes, and instrument compatible handles for instrument manipulation and monopolar cutting and cauterizing.

The FMX314 Introducer is a reusable, single port access device for abdominal laparoscopic surgical procedures to be used in combination with a standard 15 mm trocar, FMX314 Hub Cap & Sealing Unit assembly (accessory), and the FMX314 Introducer is designed for introducer is designed for introducing, holding, supporting and guiding the FMX314 Instruments and a standard, rigid 5 mm laparoscope. The cavity at the top of the FMX314 Introducer (hub) is designed to place the single-use FMX314 Hub Cap & Sealing Unit. The FMX314 Hub Cap & Sealing Unit is designed to maintain pneumoperitoneum in the abdomen during the surgical procedure, whether or not one or more FMX314 Instruments are inserted in the instrument lumen(s) of the Introducer. Locking recesses in the hub guide the correct placement of the FMX314 Sealing Unit. The bayonet fitting at the hub is designed to properly position the single-use FMX314 Hub Cap & Sealing Unit on the FMX314 Introducer and to lock the FMX314 Sealing Unit in the hub. By turning the FMX314 Hub Cap clockwise a "click" is heard indicating that the FMX314 Hub Cap & Sealing Unit is locked into position. Prior to its reuse after completion of a procedure the FMX314 Introducer has to be disassembled and sterilized per Instructions For Use.

The FMX314 Surgical Platform comprises six (6) disposable articulating laparoscopic surgical instruments (i.e. FMX314 Grasper, Maryland, Clip Applier, Scissors, Hook-knife, and Suction/Irrigation Instrument). The FMX314 Instruments are locked into position in the instrument clamps of the FMX314 Introducer to activate a triangulated approach within the surgical field and facilitate independent anterior/posterior mobility. Each instrument is capable of 360 degree axial rotation of the end-effector as well as multidirectional lateral and superior/inferior mobility.

The FMX314 Instruments and FMX314 Hub Cap & Sealing Unit are provided sterile and are single-use, disposable. When the surgical procedure is completed, the single-use FMX314 Instruments as well as the FMX314 Hub Cap & Sealing Unit are removed from the Introducer and discarded according to standard hospital protocol.

The provided text describes the 510(k) premarket notification for the FMX314 Surgical Platform. It outlines the device's indications for use, its comparison to predicate devices, and the non-clinical performance data used to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists various performance tests and states that the device "PASSED all testing" or "PASSED required testing." Specific quantitative acceptance criteria are generally not provided in this summary, only the qualitative outcome.

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

• Non-Clinical Performance Tests: Sample sizes are not explicitly mentioned for the various bench tests. They are generally reported as "PASSED required testing" or "PASSED all testing."
• Animal Model Studies (in vivo): The document states "The animals were each processed through a surgical procedure..." but does not specify the number of animals used for either the acute or chronic studies. The data provenance is stated as "animal model in vivo study."
• Human Cadaver Study (ex vivo): The document mentions "A human cadaver study was performed..." but does not specify the number of cadavers used. The data provenance is "ex vivo cadaver studies."
• Usability Study: This was conducted during the animal and cadaver studies, implying the sample size would correlate to the users performing those studies, but no specific number is provided for users or cases.

The document does not explicitly state the country of origin for the data from these studies.

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

The document does not specify the number of experts or their qualifications for establishing ground truth in any of the studies (bench, animal, cadaver, or usability). It mentions "negative feedback was given by the user" for the cadaver study and "feedback that was obtained from each of the users" for the usability study, implying at least one user/expert per study.

4. Adjudication Method for the Test Set

The document does not describe any formal adjudication method (e.g., 2+1, 3+1, none) for any of the studies. The results are reported as "PASSED" or "no negative feedback," suggesting a direct verification against predefined criteria rather than a multi-expert consensus adjudication process for discrepancies.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done comparing human readers with AI assistance versus without AI assistance. The device is a surgical platform, not an AI-powered diagnostic tool, so this type of study would not be applicable.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)

Not applicable. The FMX314 Surgical Platform is a physical surgical device designed for human use, not a standalone algorithm.

7. Type of Ground Truth Used

• Non-Clinical Performance Tests: The "ground truth" for these tests would be the established engineering specifications, national/international standards (e.g., ISO 10993-1, AAMI/ANSI ES60601-1, IEC 60601-2-2, IEC 60601-2-18, ISO 11137), and internal requirements for factors like friction, mobility, stiffness, sterilization, and shelf life.
• Animal Model Studies: The ground truth involved "defined criteria" for tissue testing (cut accuracy, coagulation depth, thermal spread and damage, tissue adherence, compatibility) evaluated both grossly and histopathologically. This suggests a combination of quantitative measurements and expert pathological assessment.
• Human Cadaver Study: "Relevant human landmarks" and "dimensional and functional adequacy" were assessed, implying a physical verification against anatomical expectations and user experience.
• Usability Study: The ground truth was based on "feedback" from intended users regarding the unpacking, installation, surgical procedure, and reprocessing steps.

8. Sample Size for the Training Set

Not applicable. The FMX314 Surgical Platform is a physical medical device. It does not utilize machine learning or AI algorithms that require a "training set."

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

Not applicable, as there is no training set for this device.

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