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The Levita Magnetic Surgical System is designed to grasp and retract the body and the fundus of the gallbladder in laparoscopic cholecystectomy procedures; the liver in bariatric procedures; the pillar of the diaphragm and peripillar tissue in bariatric or hiatal hernia procedures; the prostate and periprostatic tissue in prostatectomy procedures; and the colon, rectum, and pericolorectal tissue in colorectal procedures to facilitate access and visualization of the surgical site. The device is indicated for use in patients with a BMI range of 20-60-kg/m2.

The Grasper Tip, 12.5 is designed to grasp and retract the pillar of the diaphragm and peripillar tissue in bariatric or hiatal hernia procedures to facilitate access and visualization of the surgical site. The device is indicated for use in patients with a BMI range of 20-60 kg/m2.

The Magnetic Surgical System comprises two hand-held instruments, the Magnetic Grasper and the external Magnetic Controller. The Magnetic Grasper, disposable and provided sterile for single use, comprises two main components: a detachable Grasper Tip (6.5cm overall length) and a Shaft with Handle. An optional 12.5cm length Grasper Tip (also single use, disposable, and provided sterile) may be used as a replacement for the 6.5cm Grasper Tip and can be used interchangeably with the Shaft.

The Magnetic Grasper is actuated via its pistol-grip handle with two distinct scissor-type motions to open and close the Grasper Tip jaws. Once the Magnetic Grasper is inserted through a compatible ≥ 10 mm laparoscopic port to the surgical site and the Grasper Tip is attached to the desired tissue, the Grasper Tip can be detached from the Shaft and controlled externally using the Magnetic Controller. Traction of the tissue is maintained through the magnetic field attraction between the Grasper Tip and the Magnetic Controller.

The Magnetic Controller is a non-sterile, reusable unit with handles that is held external to the body and emits a magnetic field that attracts the detachable Grasper Tip. Once the Grasper Tip is attached to the desired tissue and detached from the Shaft, the Magnetic Controller is placed external to the body to magnetically attract the Grasper Tip to manipulate the target tissue. Adjusting the distance between the Magnetic Controller and the Grasper Tip will modulate the magnetic attraction used for tissue retraction/mobilization. If desired, the user can connect the Magnetic Controller to a commercially available surgical support arm that is compatible with its arm mount.

The provided text describes the 510(k) clearance for the Levita Magnetic Surgical System. Here's a breakdown of the requested information.

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions acceptance criteria were met across various tests, but it does not specify the numerical criteria or detailed performance metrics for each. It generally states that the device "passed all tests and met all acceptance criteria."

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

For the clinical study:

• Sample Size: Thirty (30) subjects.
• Data Provenance: Prospective, single-arm, open-label clinical study conducted at three (3) sites in Santiago, Chile.

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

The document does not explicitly state the number of experts used to establish ground truth or their specific qualifications for the clinical study. It mentions that "five (5) surgeons" performed the surgeries and evaluated the device's performance, implying their clinical judgment served as the ground truth. However, their specific qualifications (e.g., years of experience, specialization) are not detailed beyond being "surgeons."

4. Adjudication Method for the Test Set

The document does not specify an adjudication method like 2+1 or 3+1. Given it was a single-arm, open-label study where surgeons performed the procedures and evaluated outcomes, the assessment of safety and performance endpoints likely relied on the treating physicians' observations and reporting, aligned with the study protocol. There is no mention of an independent adjudication committee for specific endpoints.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done for this submission. The clinical study was a single-arm study evaluating the device's performance directly, not comparing human readers with and without AI assistance.

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

This device is a physical surgical system (magnetic grasper and controller), not an algorithm or AI software. Therefore, the concept of "standalone (algorithm only)" performance is not applicable. The device's performance inherently involves human surgeons operating it.

7. The Type of Ground Truth Used

For the clinical study, the ground truth was established by clinical observation and assessment by the operating surgeons based on predefined safety and performance endpoints. This can be categorized as expert consensus/clinical judgment from the treating surgeons. The document states:

• "The study results met all predefined safety and performance endpoints."
• "The MSS was able to grasp the pillar of the diaphragm or peripillar tissue to adequately mobilize the liver, achieving an effective exposure of the target tissue."

8. The Sample Size for the Training Set

The document describes a physical medical device and primarily focuses on its hardware components and clinical performance. There is no mention of a "training set" in the context of an algorithm or AI model development. Therefore, this information is not applicable.

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

As there is no mention of a "training set" for an algorithm, this question is not applicable.

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The Surgeon Controlled Arm is indicated for use to hold and position a rigid laparoscope/endoscope and the Magnetic Controller of the Levita Magnetic Surgical System in minimally invasive interventions where the Levita Magnetic Surgical System is indicated for use.

The Surgeon Controlled Arm for the Levita Magnetic Surgical System (MSS) comprises two collaborative surgeon-controlled arms, which along with their controllers, control software, and custom attachments, are intended to hold and control the Magnetic Controller of the commercially available MSS (most recently cleared under K191762) using an arm and to hold and control a commercially available endoscope with camera using the second arm. The design of the surgeon-controlled arms, referred to as the Scope Arm and the Magnet Arm, includes several redundant safety features that make them well suited for use with the MSS in the operating room environment, including hardware and software safety controls.

When mounted on the Scope Arm, an endoscope can be pivoted and translated as controlled by the user, while maintaining minimal motion at the point where the endoscope enters the patient's body via a standard trocar. Similarly, when mounted on the Magnet Arm, the Magnetic Controller can be moved to different positions on or away from the abdominal wall.

The Surgeon Controlled Arm includes the following components:

• (1) Two Carts, which are the Scope Cart and the Magnet Cart. Each Cart includes a surgeoncontrolled arm mounted on top of a moveable cart with custom attachments. One arm functions as a Scope Arm to hold a commercially available endoscope with endoscopic camera. The other arm functions as a Magnet Arm and includes a Magnet Holder to hold the Magnetic Controller of the MSS;
• (2) a Scope Holder for attachment and detachment of a compatible commercially-available endoscope to the end of the Scope Arm:
• (3) a Foot Controller for foot-actuated selection of the active arm and foot-actuated remote control for one of the arms at a time;
• (4) custom-programmed software, the Levita Custom Control Software Program.

The Surgeon Controlled Arm provides for computer control of a dual- arm device with motorized axes to hold and control the movements of a rigid endoscope and the Magnetic Controller of the Levita MSS during the minimally-invasive procedures cleared for the MSS (most recently cleared under K191762). The user selects the active arm and controls its movement using a Foot Controller. Only one arm is enabled for computer-controlled movement at any given time; while one arm is being moved, the other arm remains stationary. The user may also manually move the arms (i.e. hand guiding) at any time without the use of the Foot Controller.

For the Scope Arm, the reference point for scope movement is established as the Trocar Point and is set by the user, who positions the endoscope near the trocar inserted in the body opening (e.g. the abdominal fascial layer) and presses the Teach Trocar button on the Scope Adaptor. The Custom Control Software Program then calculates the required individual movements of the Scope Arm motorized axes relative to the Trocar Point in order to achieve the desired total movement of the endoscope with respect to the endoscope view. Once the Custom Control Software Program completes the Teach Trocar procedure, the Foot Controller is enabled, allowing the user in a standing position by the operating table to direct endoscope movement by using their foot to press on switches corresponding to the allowed movement directions.

For the Magnet Arm, the same arm hardware, software, and Foot Controller are employed to move the Magnetic Controller also in the same directions.

Based on the provided text, the device in question is the "Levita Magnetics Dual Robotic Arm Accessory" (also referred to as "Surgeon Controlled Arm"). The document is a 510(k) summary for FDA clearance. It describes the device, its intended use, comparison to a predicate device, and performance data submitted to demonstrate safety and effectiveness.

Here's an analysis of the acceptance criteria and study information, addressing your points:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with specific quantitative targets for each test. Instead, it describes various performance tests conducted and generally states that the device "meets functional requirements" or that tests were "performed successfully."

I will infer "acceptance criteria" as the general successful completion of the tests listed, and "reported device performance" as the documented successful outcome of these tests.

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

• Test Set Sample Size:
  • For Simulated Use/Design Validation Testing: "three surgeons who perform laparoscopic surgery, representing the intended user." This implies a sample size of 3 for this specific validation.
  • For Human Factors Testing: "30 testers representing intended users." This specifies a sample size of 30 for human factors validation.
  • For other tests (Electrical Safety, Software V&V, Bench/Mechanical, Cybersecurity, Sterilization), the sample size would typically refer to the number of devices or software units tested, which is not specified but implicitly assumed to be sufficient for regulatory compliance.
• Data Provenance: The document does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective. Given it's an FDA 510(k) submission, the studies would typically be prospective for validation purposes, conducted by the manufacturer or a contracted lab, likely in the US or a country with comparable regulatory standards.

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

• For Simulated Use/Design Validation Testing: "three surgeons who perform laparoscopic surgery." Their qualification is that they "perform laparoscopic surgery." No specific experience (e.g., years) is mentioned.
• For Human Factors Testing: "30 testers representing intended users." The specific qualifications (e.g., medical professionals, years of experience) beyond "intended users" are not detailed.
• For other tests, ground truth is established via established engineering standards, software testing methodologies, or laboratory validations rather than expert medical consensus.

4. Adjudication Method for the Test Set

The document does not describe any formal "adjudication method" (like 2+1 or 3+1 consensus) for the "test set" in the context of expert review.

• For the Simulated Use/Design Validation Testing with three surgeons, it's implied that their collective assessment determined if the device specifications conformed to intended use and user needs. The document does not specify a disagreement resolution process or voting mechanism for these three surgeons.
• For Human Factors Testing, the assessment of "successful performance" and "no unexpected device-related events" would be based on the outcomes observed during the testing with the 30 participants, likely against predefined pass/fail criteria from a human factors study protocol. No expert adjudication is mentioned here.

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 conducted or described in this 510(k) summary. This type of study is more common for diagnostic AI devices where human performance (e.g., radiologists interpreting images) is directly compared with and without AI assistance on a set of cases. The Levita Magnetics Dual Robotic Arm Accessory is a surgical instrument system, not a diagnostic imaging AI.

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

The concept of "standalone" performance, typically applied to AI algorithms, doesn't directly apply here in the same way. The software (Levita Custom Control Software Program) is an integral part of the robotic arm's control system. Its "performance" is evaluated as part of the overall system's functional and safety testing (e.g., software V&V, latency of arm motion, adherence to safety limits), rather than as a standalone diagnostic algorithm. The device, by its nature, is human-in-the-loop (surgeon-controlled).

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluations is based on:

• Engineering Standards and Specifications: For electrical safety, EMC, and most bench/mechanical tests (e.g., strength, durability, velocities, accelerations, latency, range of motion, safety limits). The "ground truth" is compliance with these predefined technical and safety specifications.
• FDA Guidance Documents and Regulatory Standards: For software V&V, cybersecurity, sterilization, and human factors. The "ground truth" is adherence to these regulatory requirements and best practices.
• User Needs and Intended Use: For the simulated use/design validation and human factors testing, the ground truth is whether the device effectively meets user needs and functions as intended in a simulated clinical environment. This is established by observing and evaluating the performance of the device by representative users. There's no "pathology" or "outcomes data" ground truth as this is not a diagnostic device.

8. The Sample Size for the Training Set

The document does not mention a "training set" or "training data." This is because the device is a hardware-based robotic surgical assist system with integrated control software, not a machine learning or AI algorithm that requires a distinct training phase. The software is custom-programmed, not "trained" in the machine learning sense from a dataset.

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

Since there is no "training set" in the machine learning context, this question is not applicable. The software's functionality is based on its design specifications, algorithms, and logical programming, verified through traditional software engineering V&V processes.

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The Levita Magnetic Surgical System is designed to grasp and retract the body and the fundus of the gallbladder in laparoscopic cholecystectomy procedures; the liver in bariatric procedures; the prostate and periprostatic tissue in prostatectomy procedures; and the colon, rectum, and pericolorectal procedures to facilitate access and visualization of the surgical site. The device is indicated for use in patients with a BMI range of 20-60-kg/m².

The Levita Magnetic Surgical System is composed of two hand-held instruments, the Magnetic Grasper and external Magnetic Controller. The Magnetic Grasper (sterile, single use), comprised of a distal detachable Grasper Tip attached to a Shaft with handle, is actuated via its pistol-grip handle with two distinct scissor-type motions to open and close the detachable Grasper Tip jaws. Once the Magnetic Grasper is inserted through a compatible ≥ 10 mm laparoscopic port and the Grasper Tip is attached to the desired tissue, the Grasper Tip can be detached from the Shaft and controlled externally using the Magnetic Controller. Traction of the tissue is maintained through the magnetic field attraction between the Grasper Tip and the Magnetic Controller. The Magnetic Controller (non-sterile, reusable) is a single unit with handles that is held external to the body and emits a magnetic field that attracts the Grasper Tip. Once the Grasper Tip is attached to the desired tissue and detached from the Shaft, the Magnetic Controller is placed external to the body to magnetically attract the Grasper Tip to manipulate the target tissue. Adjusting the distance between the Magnetic Controller and the Grasper Tip will modulate the magnetic attraction used for tissue retraction/mobilization. If desired, the user can connect the Magnetic Controller to a commercially available surgical support arm that is compatible with its arm mount.

The Levita Magnetic Surgical System is a medical device designed to grasp and retract soft tissues and organs during surgical procedures. The device, which consists of a Magnetic Grasper and an external Magnetic Controller, received an administrative change related to its previous substantial equivalence (SE) determination from the FDA on April 15, 2020. The change was an update to its indications for use, expanding its application to colorectal procedures.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for the Test Set

• Sample Size: The document specifies an "animal study... in the porcine model." It does not explicitly state the number of animals used in the test set.
• Data Provenance: The study was an "animal study," specifically in a "porcine model." The country of origin of the data is not specified, nor is whether it was prospective or retrospective, though animal studies for device approval are typically prospective.

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

• Number of Experts: The document states, "Surgeons reported that the MSS was the same or better than conventional laparoscopic graspers." It does not specify the exact number of surgeons (experts) involved in this assessment.
• Qualifications of Experts: The experts are referred to as "Surgeons." No further details on their specific qualifications (e.g., years of experience, subspecialty) are provided in the provided text.

4. Adjudication Method for the Test Set

• The document does not describe a formal adjudication method (e.g., 2+1, 3+1). The assessment seems to be based on the reports of "surgeons."

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

• No MRMC comparative effectiveness study is mentioned in the provided text. The study described is an animal study evaluating the device's performance, not a comparison of human readers with and without AI assistance.

6. Standalone (Algorithm Only) Performance Study

• The Levita Magnetic Surgical System is a physical surgical instrument, not an AI algorithm. Therefore, a standalone (algorithm only) performance study is not applicable and was not performed. The performance evaluation focuses on the instrument's ability to manipulate tissue.

7. Type of Ground Truth Used

• For the in vivo performance, the ground truth was established by direct observation and assessment of the device's performance during simulated surgical procedures in live animals (porcine model). This included:
  • Direct visualization of access and visualization of the target tissue.
  • Monitoring for device-related serious or severe adverse events.
  • Pathological assessment for post-excision or intraoperative tissue trauma.
  • Subjective feedback from "Surgeons" regarding the device's effectiveness compared to conventional instruments.

8. Sample Size for the Training Set

• The supplied text does not refer to a "training set" in the context of machine learning or AI models, as the Levita Magnetic Surgical System is a physical surgical device. Therefore, this question is not applicable.

9. How Ground Truth for the Training Set Was Established

• As the device is a physical surgical system and not an AI/ML product, the concept of a "training set" and establishing ground truth for it does not apply.

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The Levita Magnetic Surgical System is designed to grasp and retract the body and the fundus of the gallbladder in laparoscopic cholecystectomy procedures, the liver in bariatric procedures, and the prostatic tissue in prostatectomy procedures to facilitate access and visualization of the surgical site. The in patients with a BMI range of 20-60 kg/m2.

The Levita Magnetic Surgical System is composed of two hand-held instruments, the Magnetic Grasper and external Magnetic Controller. The Magnetic Grasper (sterile, single use), comprised of a distal detachable Grasper Tip attached to a Shaft with handle, is actuated via its pistol-grip handle with two distinct scissor-type motions to open and close the detachable Grasper Tip jaws. Once the Magnetic Grasper is inserted through a compatible The Magnetic Controller (non-sterile, reusable) is a single unit with handles that is held external to the body and emits a magnetic field that attracts the Grasper Tip. Once the Grasper Tip is attached to the desired tissue and detached from the Shaft, the Magnetic Controller is placed external to the body to magnetically attract the Grasper Tip to manipulate the target tissue. Adjusting the distance between the Magnetic Controller and the Grasper Tip will modulate the magnetic attraction used for tissue retraction/mobilization. If desired, the user can connect the Magnetic Controller to a commercially available surgical support arm that is compatible with its arm mount.

Here's a summary of the acceptance criteria and study details for the Levita Magnetic Surgical System, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size (Test Set): 30 subjects
• Data Provenance:
  • Country of Origin: Santiago, Chile (Fundacion Arturo Lopez Perez)
  • Retrospective or Prospective: Prospective clinical study

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

• Number of Experts: 5 investigators (surgeons)
• Qualifications: The document identifies them as "surgeons" and "investigators" participating in a clinical study for prostatectomy procedures. Specific experience levels (e.g., years of experience or specialization) are not detailed in this document.

4. Adjudication Method for the Test Set:

• The document states that "Investigators reported that adequate retraction was achieved since it was not necessary to replace the MSS with another instrument to retract the prostate during the procedure." and "All eleven events resolved with no clinical sequelae and were categorized as not related to the subject device."
• This suggests that the surgeons themselves were the primary adjudicators of effectiveness and relatedness of adverse events during the procedure. There is no mention of an independent adjudication panel or a numerical adjudication rule (e.g., 2+1, 3+1). The study describes itself as a "single-arm, open label study."

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

• No, a MRMC comparative effectiveness study was not done.
• This was a single-arm study evaluating the device's performance in a new indication (prostatectomy), primarily to demonstrate safety and effectiveness for that specific use extension compared to the predicate device, not to show human reader improvement with AI assistance. The device itself is a surgical instrument, not an AI diagnostic tool.

6. Standalone (Algorithm Only) Performance:

• Not applicable. This device is a surgical instrument, not an algorithm, and thus does not have "standalone" algorithm performance in the typical sense of AI/diagnostic devices. Its performance is intrinsically linked to its use by a human surgeon.

7. Type of Ground Truth Used:

• Expert Consensus/Clinical Observation during Surgery: The "ground truth" for effectiveness was established by the clinical judgment of the participating surgeons during the procedure. Specifically, effectiveness was defined as the "ability to adequately retract the prostate to achieve an effective exposure of the target tissue," and "Adequate retraction was deemed to be achieved if it is not necessary to replace the Levita Magnetic Surgical System with another instrument to retract the prostate during the procedure." Safety was based on the absence of severe or serious adverse events reported by the investigators.

8. Sample Size for the Training Set:

• Not applicable / No specific training set mentioned. This is a medical device, not an AI model, so there isn't a "training set" in the machine learning sense. The device's design and previous versions (predicate devices) would have undergone development and testing, but a distinct "training set" for an algorithm is not relevant here.

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

• Not applicable. As a surgical device and not an AI model, the concept of establishing ground truth for a training set does not apply. The development would have involved engineering, material science, and prior clinical experience with similar devices, leading to verification and validation activities. The clinical study described in the document is for validation of its performance in an extended indication, not for training an algorithm.

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The Magnetic Surgical System is designed to grasp and retract the body and the fundus of the gallbladder in laparoscopic cholecystectomy procedures and the liver in bariatric procedures to facilitate access and visualization of the surgical site. The device is indicated for use in patients with a BMI range of 20-60 kg/m².

The Levita Magnetic Surgical System is composed of two hand-held instruments, the Magnetic Grasper Device and external Magnetic Controller. The Magnetic Grasper Device (sterile, single use), comprised of a distal Detachable Grasper attached to a Delivery/Retrieval shaft with Handle, is actuated via its pistol-grip Handle with two distinct scissor-type motions to open and close the Detachable Grasper jaws. Once the Magnetic Grasper Device is inserted through a compatible ≥ 10 mm laparoscopic port and the Detachable Grasper is attached to the desired tissue, the Detachable Grasper can be detached from the Delivery/Retrieval Shaft and controlled externally using the Magnetic Controller. Traction of the tissue is maintained through the magnetic field attraction between the Detachable Grasper and the Magnetic Controller. The Magnetic Controller (non-sterile, reusable) is a single unit with handles that is held external to the body and emits a magnetic field that attracts the Detachable Grasper. Once the Detachable Grasper is attached to the desired tissue and detached from the Delivery/Retrieval Shaft, the Magnetic Controller is placed external to the body to magnetically attract the Detachable Grasper to manipulate the target tissue. Adjusting the distance between the Magnetic Controller and the Detachable Grasper will modulate the magnetic attraction used for tissue retraction/mobilization. If desired, the user can connect the Magnetic Controller to a commercially available surgical support arm that is compatible with its arm mount.

This document is a 510(k) summary for the Levita Magnetic Surgical System, focusing on a modification to its Indications for Use. The core of the submission demonstrates that the modified device remains substantially equivalent to its predicate.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the "Special Controls" for the Magnetic Surgical System (21 CFR 878.4815), which mandate specific performance data. The device performance is then reported against these special controls.

• No severe or serious adverse events related to the device.
• No device failure or malfunctions.
• Adequately grasped and retracted the liver for effective exposure.
• Not necessary to use another instrument for retraction.
• Overall procedure times similar to published averages.
• All cases performed with a reduced port technique, avoiding an incision for a liver retractor. |
  | (2) Non-clinical performance data must demonstrate that the system performs as intended under anticipated conditions of use, specifically: (a) Magnetic field strength characterization and (b) Ability of internal surgical instrument(s) to couple, de-couple, and re-couple. | Met: No technological changes to the device that would affect magnetic field strength or coupling. Previously conducted non-clinical performance testing applies. |
  | (3) Patient-contacting components must be demonstrated to be biocompatible. | Met: No changes to the device's patient-contacting components. Previously conducted biocompatibility testing applies. |
  | (4) Performance data must demonstrate the sterility of patient-contacting device components. | Met: No changes to the device that would affect sterility. Previously conducted sterility testing applies. |
  | (5) Methods and instructions for reprocessing reusable components must be validated. | Met: No changes to the device that would affect reprocessing. Previously conducted validation of reprocessing methods and instructions applies. |
  | (6) Performance data must support shelf life by demonstrating continued sterility and functionality. | Met: No changes to the device that would affect shelf life. Previously conducted shelf life testing applies. |
  | (7) Training must be developed and validated by human factors testing and analysis to ensure users can follow instructions for safe use. | Met: The training program was updated for the revised Indications for Use (liver retraction in bariatric patients with higher BMI). A new human factors validation was deemed unnecessary because: 1) device design is unchanged, 2) no new use problems identified, 3) use-related hazards and mitigations are unchanged, and 4) critical tasks and errors remain the same. This was supported by clinical performance data from the two studies where investigators had used the updated training program, and the studies met safety and effectiveness endpoints. Previously conducted human factors testing applies. |
  | (8) Labeling Requirements (Magnetic field safezones, Instructions for proper use, Screening checklist, Reprocessing instructions, Shelf life, Use life). | Met: The labeling complies with the stated special controls. |

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

• Total Test Set Sample Size: 103 subjects
  • Retrospective Study: 73 subjects
    • Country of Origin: Not explicitly stated, but the study was conducted at "Duke Center for Metabolic and Weight Loss Surgery" in the US.
    • Data Provenance: Retrospective (patients between October 2016 and August 2017).
  • Prospective Study: 30 subjects
    • Country of Origin: Santiago, Chile (Hospital La Florida).
    • Data Provenance: Prospective, single-arm, open-label study.

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

The ground truth in this context is the successful clinical outcome and safe use of the device in surgical procedures. This was directly observed and reported by operating surgeons.

• Retrospective Study: 10 participating surgeons. No specific qualifications beyond "surgeon" are provided.
• Prospective Study: 3 participating surgeons. No specific qualifications beyond "surgeon" are provided.

4. Adjudication Method for the Test Set

The document does not describe an explicit adjudication method for the test set in the traditional sense of multiple independent readers evaluating images or data points and then adjudicating discrepancies. The "ground truth" was established by the performing surgeons themselves, who assessed the device's ability to adequately grasp and retract tissue and reported on safety outcomes (adverse events, device failures). Clinical outcome was the primary measure, not subjective reader interpretations.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. The study evaluated the device's safety and effectiveness in a clinical setting, not how human readers' diagnostic performance might improve with or without AI assistance. This device is a surgical instrument, not an AI diagnostic tool.

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

This question is not applicable. The Levita Magnetic Surgical System is a physical surgical instrument, not a software algorithm or AI. Its performance is intrinsically linked to its use by a human surgeon. The "standalone" concept applies to AI algorithms that can process data and make inferences without direct human intervention in the interpretation phase.

7. The Type of Ground Truth Used

The ground truth used was clinical outcome data and observed intraoperative performance, as documented by treating physicians (surgeons). This included:

• Successful completion of the bariatric surgery using the device.
• Adequate liver retraction and visualization of the surgical site.
• Absence of the need to use another instrument for liver retraction.
• Occurrence and type of adverse events (e.g., petechiae, liver capsule abrasions) and their resolution.
• Device failure or malfunctions.
• Procedure times.

8. The Sample Size for the Training Set

No "training set" in the context of machine learning is mentioned or applicable here. This device is a physical medical instrument, not an AI/ML algorithm that requires a data training set. The clinical studies represent performance validation, not data input for model training.

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

This question is not applicable, as there was no AI/ML training set.

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The Magnetic Surgical System is designed to grasp and retract the body and the fundus of the gallbladder in laparoscopic cholecystectomy procedures to facilitate access and visualization of the surgical site. The device is indicated for use in patients within a BMI range of 20 to 34 kg/m².

The Magnetic Surgical System is composed of two hand-held instruments: a Magnetic Grasper Device and an external Magnetic Controller. The Magnetic Grasper Device is comprised of two main components: a Detachable Grasper and a Delivery/Retrieval Shaft. Once the Magnetic Grasper Device is inserted and the Grasper is attached to the desired tissue, the Detachable Grasper can be detached from the Delivery/Retrieval Shaft and controlled externally using the Magnetic Controller. Traction of the tissue is maintained through the magnetic field attraction between the Grasper and the Magnetic Controller. The Magnetic Grasper Device is compatible with a ≥ 10 mm laparoscopic port. The Magnetic Controller is a single unit with handles that is held external to the body and emits a magnetic field that attracts the Detachable Grasper. Once the Detachable Grasper is attached to the desired tissue and detached from the Delivery/Retrieval Shaft, the Magnetic Controller is placed external to the body to magnetically attract the Grasper to manipulate the target tissue. Adjusting the distance between the Magnetic Controller and the Detachable Grasper will modulate the magnetic attraction used for tissue retraction/manipulation.

The provided document is a 510(k) premarket notification for the Levita Magnetics International Corp. Magnetic Surgical System (K171429). This submission is a Special 510(k), meaning it addresses a modification to an already cleared device (predicate device DEN150007). In this specific case, the modification is a labeling change to the Instructions for Use regarding the use life statement.

Therefore, the document explicitly states that no new performance testing was conducted for this submission, as the modification does not change the performance characteristics of the device. The substantial equivalence is based on the previously conducted testing for the predicate device.

Given this, I cannot provide information on the acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, or standalone performance for this specific 510(k) submission, as no such new studies were part of this filing. The document refers to prior testing for the original clearance of the predicate device.

However, the document lists the Special Controls that were applicable to the original device and implicitly served as general acceptance criteria for its performance. These controls and the claim that the device meets them (based on prior testing) are outlined below.

Acceptance Criteria for the Magnetic Surgical System (Based on Special Controls for the original device DEN150007 and claimed continued compliance for K171429)

Since this 510(k) is for a labeling change and no new performance testing was conducted, there are no new acceptance criteria or reported performance unique to this submission. The Special Controls described in 21 CFR §878.4815 for the Magnetic Surgical System serve as the foundational acceptance criteria that the device (including its substantial equivalent K171429) must meet. The submission claims that previous testing (for DEN150007) demonstrated compliance with these controls.

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

For the following points, as this 510(k) exclusively concerns a labeling change and refers to prior testing, the specific details are not available in this document. The information below reflects that no new studies were conducted for K171429.

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

Not applicable to this 510(k) submission, as no new test set was used. The submission relies on prior testing for the predicate device.

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

Not applicable to this 510(k) submission, as no new test set requiring expert ground truth was used.

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

Not applicable to this 510(k) submission, as no new test set requiring adjudication was used.

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 magnetic surgical system, not an AI-assisted diagnostic tool involving human readers.

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

Not applicable; this device is a physical surgical system, not an algorithm. Its performance is inherent to its mechanical and magnetic properties.

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

For the original predicate device's in vivo testing, presumed ground truth would likely have been direct surgical observation and potentially histological assessment of tissue integrity or adverse events. For non-clinical tests, ground truth would be established by physical measurements and engineering standards. However, these details are not provided in this document.

8. The sample size for the training set

Not applicable; this physical device does not utilize a training set in the context of machine learning or AI.

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

Not applicable; this physical device does not utilize a training set.

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The Levita Magnetic Surgical System is designed to grasp and retract the body and the fundus of the gallbladder in laparoscopic cholecystectomy procedures to facilitate access and visualization of the surgical site. The device is indicated for use in patients within a BMI range of 20 to 34 kg/m2.

The Levita Magnetic Surgical System is composed of two hand-held instruments, the Magnetic Grasper Device and external Magnetic Controller, which are intended to facilitate tissue grasping, retraction and mobilization during laparoscopic cholecystectomy procedures.

1. Magnetic Grasper Device (sterile, single use) is actuated via its pistol-grip handle with two distinct scissor-type motions to open and close the Detachable Grasper jaws as shown in Figure 1. At the distal end is the Detachable Grasper, which is attached to the Delivery/Retrieval Shaft of the full Magnetic Grasper Device. This device requires a >10mm access port to introduce the device into the abdominal cavity. The Detachable Grasper is then coupled (held in place within the abdomen) by the external Magnetic Controller. If the surgeon wishes to use a single 10-12 mm port at the umbilicus such as a Hasson port and that is the port shared by the optic, applying and adjusting the Detachable Grasper may require repetitive placement of the optic in an alternative port. The Detachable Grasper is shown in Figure 2.

2. An External Magnetic Controller (non-sterile, reusable) 3-inch diameter by 2-inch thick b(4) disk magnet, shown in Figure 3. This component holds the Detachable Grasper (magnetically) and is placed on the external abdomen wall.

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

Device: Levita Magnetic Surgical System
Indications for Use: To grasp and retract the body and the fundus of the gallbladder in laparoscopic cholecystectomy procedures to facilitate access and visualization of the surgical site, for patients with a BMI range of 20 to 34 kg/m2.

1. Table of Acceptance Criteria and Reported Device Performance

The document outlines various tests with acceptance criteria and results. Here's a consolidated table:

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