Search Results

Date Cleared

2023-05-10

(76 days)

Product Code

GCJ,GEI

Regulation Number

Type

Traditional

Panel

HandX Instrument - Monopolar Spatula

Reference & Predicate Devices

K984240,K203603

Intended Use

The HandX™ is intended to assist in the control of Human Xtensions laparoscopic instruments including needle holder, grasper and monopolar instruments, for endoscopic manipulation of tissue, including grasping, approximation, ligation, suturing, cutting and/or coagulation, during laparoscopic surgical procedures. The HandX™ monopolar instruments are connected by a standard cable to a standard electrosurgical power source. It is intended to be used by trained physicians in an operating room environment in accordance with its Instructions for Use

Device Description

The Monopolar Scissors is a single-use, disposable, ETO sterilized instrument for use with the HandX™ device. The Monopolar Scissors is connected to the HandX and transmits the motors' rotations to articulate the movement of the Monopolar Scissors' end effector. It is designed to address surgeons' needs relating to the application of monopolar diathermy for various surgical purposes.

AI/ML Overview

The provided text describes the HandXTM Monopolar Scissors, a single-use, disposable, ETO sterilized instrument. The device is intended to assist in the control of Human Xtensions laparoscopic instruments for endoscopic manipulation of tissue in various surgical procedures involving grasping, approximation, ligation, suturing, cutting, and/or coagulation.

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

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

The document broadly states that "All tests met the predefined acceptance criteria" for various bench tests. However, it does not explicitly list specific numerical acceptance criteria or quantitative performance results for each test. Instead, it confirms that the device passed these tests.

Test Category	Specific Tests	Acceptance Criteria	Reported Device Performance
Biocompatibility Testing	Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Material-Mediated Pyrogenicity	Not explicitly defined, but based on ISO 10993-1:2018, ISO 14971:2019, and FDA guidance documents, the materials should not cause unacceptable biological reactions or risks when in limited (≤24 hours) contact with tissue or bone.	"Based upon the biological risk assessment and the results of biocompatibility testing performed on the device, it can be concluded that the device can be considered biocompatible for use as intended."
Electrical Safety and EMC	Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, IEC 60601-2-18, and IEC 60601-1-6.	The device must meet the electrical safety and electromagnetic compatibility requirements of the specified IEC standards to ensure safe operation and prevent interference with other equipment.	"The Monopolar Scissors was found to fully comply with the requirements of the IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, and IEC 60601-2-18, and IEC 60601-1-6."
Bench Testing	Instrument Dimensional Attribute, Articulation Angle and Roll Range Measurement, Roll and Grasp Torque Measurement Method, Instrument Articulation latency, Impedance Test, Dielectric Strength, Insulation Integrity test, Generator Cable Compatibility with Extension Cables, Proximal Seal Test, Tip Integrity, Deflection Integrity, Cutting Integrity, Performance Test (instrument integrity following simulated use), Human Factors Summative Evaluation, Human Factors Labeling Validation, Instrument Corrosion Test	Predefined acceptance criteria for each test to demonstrate that design outputs meet design input requirements and that the device is safe and effective for its intended use. These would typically include specific ranges or thresholds for dimensions, angles, torques, electrical properties, structural integrity after use, and user interaction.	"All tests met the predefined acceptance criteria. The testing identified no new questions of safety and effectiveness."
Performance Testing - Animal (Swine Model)	Safety (thermal damage evaluation using temperature probes and histopathology evaluation) and functional performance and usability comparison with a reference device.	For safety, thermal damage and histopathology results should be acceptable and comparable to the reference device. For performance and usability, the device should function effectively and be usable by qualified personnel, as assessed by questionnaires.	"It can be concluded that the Monopolar Scissors instrument passed all the per-defined acceptance criteria for safety, performance and usability." "Temperature and histopathology evaluations were performed following slits formation on porcine tissue... as compared to the reference device ENDOPATH® Scissors... in various working modes... and in different energy levels."

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

Bench Testing: The sample size for each specific bench test is not provided. The data provenance is implied to be from internal laboratory testing.
Performance Testing - Animal (Swine Model): The number of animals used is not specified. The study involved qualified personnel performing tasks with both the subject and reference device. This appears to be a prospective study conducted in a controlled environment (animal lab). The country of origin for the data is not explicitly mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Bench Testing: The document does not mention the use of external experts to establish ground truth for bench tests. These tests are typically evaluated against engineering specifications and validated test methods.
Performance Testing - Animal: "Qualified personnel with appropriate experience" executed the evaluation and filled out questionnaires. The specific number or detailed qualifications (e.g., years of experience, specialty) of these personnel are not provided. For thermal damage and histopathology, it is implied that experts (e.g., a pathologist) evaluated the tissue, but their number and specific qualifications are not stated.

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

The document does not describe any specific adjudication method for reconciling varying opinions, as no multiple expert readings of the test results are mentioned. For bench tests, it's typically a direct comparison to predefined criteria. For the animal study, it appears to be based on observations, measurements, and questionnaires by the "qualified personnel."

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, an MRMC comparative effectiveness study was not performed. This device is a surgical instrument, not an AI-assisted diagnostic tool or an imaging device that would typically involve human readers interpreting results. The animal study did compare the device to a reference device, but this was a functional comparison, not an assessment of human reader performance with or without AI assistance.

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

No, this question doesn't apply directly to the HandXTM Monopolar Scissors. It is a physical surgical instrument, not an algorithm. Its performance is always with a human-in-the-loop (the surgeon).

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

Biocompatibility: Ground truth was established by adherence to recognized international standards (ISO 10993-1, ISO 14971) and FDA guidance, with testing for specific biological endpoints (cytotoxicity, sensitization, etc.).
Electrical Safety and EMC: Ground truth was established by compliance with international electrical safety and EMC standards (IEC 60601 series).
Bench Testing: Ground truth was based on engineering design input requirements and validated test methods, with established predefined acceptance criteria.
Performance Testing - Animal: Ground truth for safety was assessed by "thermal damage evaluation using temperature probes and histopathology evaluation according to FDA Guidance Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery Guidance for Industry and Food and Drug Administration Staff." For functional performance and usability, it was through direct observation during surgical tasks and post-procedure questionnaires completed by "qualified personnel." This combines objective measurements (temperature, histopathology) with subjective assessment (usability questionnaires).

8. The sample size for the training set

The concept of a "training set" is not applicable here as the device is a physical surgical instrument, not an AI/ML algorithm that requires training data.

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

Not applicable, as no training set was used.

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K Number

K222011

Device Name

Manufacturer

Date Cleared

2023-01-12

(189 days)

Product Code

GCJ,GEI

Regulation Number

Type

Special

Panel

Reference & Predicate Devices

K160128,K203603

Intended Use

The HandX is intended to assist in the control of Human Xtensions laparoscopic instruments including needle holder, grasper and monopolar instruments, for endoscopic manipulation of tissue, including grasping, approximation, ligation, suturing, cutting and/or coagulation, during laparoscopic surgical procedures. The HandX monopolar instruments are connected by a standard cable to a standard electrosurgical power source. It is intended to be used by trained physicians in an operating room environment in accordance with its Instructions for Use.

Device Description

The HandX™ Monopolar Spatula is a single-use sterile electrosurqical electrode for use with the HandX™ device. The Monopolar Spatula is connected to the HandX™ device and transmits the device motors' rotation to articulate the movement of the end effector of the Monopolar Spatula. It is designed to address surgeons' needs relating to the application of monopolar diathermy for various surgical purposes.

The Monopolar Spatula is connected to a standard electrosurgical unit via a standard generator cable.

AI/ML Overview

This document is a 510(k) summary for the HandX Monopolar Spatula, a medical device. It describes the device's intended use, comparison to a predicate device, and performance data.

Here's an analysis of the provided text in relation to acceptance criteria and study proving device meets those:

The provided text describes a 510(k) premarket notification for a medical device called the "HandX Monopolar Spatula". This document primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than establishing acceptance criteria and conducting a study to prove the device meets those criteria in the context of an Artificial Intelligence (AI) or machine learning device.

The HandX Monopolar Spatula is an electrosurgical electrode, not an AI or machine learning device. Therefore, many of the typical criteria and study elements associated with AI device performance validation (like sensitivity, specificity, MRMC studies, ground truth establishment with experts, training set size, etc.) are not applicable to this submission.

The "acceptance criteria" for this device are primarily related to its physical, electrical, and biological performance, demonstrating it's as safe and effective as existing similar devices.

However, I will extract relevant information from the document that touches upon "acceptance criteria" and "studies" as best as possible, interpreting them within the context of a traditional medical device submission.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, the "acceptance criteria" are implied by successful completion of various tests, demonstrating compliance with standards and equivalence to the predicate. The "reported device performance" is the statement that these tests were passed successfully.

Category / Test Type	Implied Acceptance Criteria	Reported Device Performance
Biocompatibility	Compliance with ISO 10993-1, demonstrating negligible risk of toxicity (cytotoxicity, sensitization, acute systemic toxicity, material mediated pyrogenicity).	"The device was deemed to pose a negligible risk of toxicity and is considered to have met the requirements of ISO 10993-1:2018 and FDA's corresponding guidance and to be safe for use as intended."
Electrical Safety & EMC	Full compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, IEC 60601-2-18, and IEC 60601-1-6.	"The Monopolar Spatula was found to fully comply with the requirements of IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, IEC 60601-2-18, and IEC 60601-1-6."
Bench Testing	Design outputs meet design input requirements; device is safe and effective for intended use; all tests meet predefined acceptance criteria.	"All tests [Dimensional attributes, Seal Test, Tip Pull to Failure] met the predefined acceptance criteria, and testing identified no new questions of safety and effectiveness."
Thermal Effects Testing	Substantially equivalent thermal behavior compared to predicate and reference devices.	"The results supported the substantially equivalent thermal behavior of the Monopolar Spatula compared to the predicate and reference devices." (Based on ex-vivo and in-vivo studies using a porcine model to evaluate thermal behavior and lateral thermal spread).
Human Factors/Usability	Device can be used safely and effectively in accordance with its labeling.	"A summative evaluation study (per IEC 62366-1) confirmed that the device can be used safely and effectively in accordance with its labeling."

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

Sample Size: Not explicitly stated for most tests. For Thermal Effects Testing, it mentions a "porcine model," implying animal subjects, but no specific number of animals or trials. For Human Factors/Usability, a "summative evaluation study" was done, but the number of participants is not provided.
Data Provenance: The document does not specify the country of origin for the data. The studies appear to be pre-market validation studies conducted by the manufacturer, rather than retrospective or prospective clinical data from a specific patient population.

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

Not Applicable in the context of an AI device. For this physical device, "ground truth" generally refers to design specifications, validated measurement techniques, and established safety standards. There is no mention of "experts" establishing a "ground truth" as would be done for diagnostic AI. The "Human Factors/Usability" study would likely involve trained medical professionals, but their role is to test usability, not establish a diagnostic ground truth.

4. Adjudication Method for the Test Set

Not Applicable. As there is no "ground truth" being established by multiple readers/experts in a diagnostic sense, no adjudication method (like 2+1, 3+1) is mentioned or relevant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This is not an AI/diagnostic device. An MRMC study is not relevant to demonstrating the safety and effectiveness of a surgical instrument of this type. The comparison is primarily against a predicate device based on physical, electrical, and biological performance characteristics, rather than diagnostic accuracy or human reader performance.

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

Not Applicable. This is a physical surgical instrument that always requires a human in the loop for its operation. It does not contain an "algorithm" in the sense of an AI/machine learning component that could operate standalone.

7. The Type of Ground Truth Used

The "ground truth" for this medical device's performance validation is derived from:

Mechanical and Electrical Engineering Standards: Compliance with relevant IEC standards (e.g., IEC 60601 series).
Biocompatibility Standards: Compliance with ISO 10993-1.
Predefined Acceptance Criteria: Established internally by the manufacturer for bench tests (Dimensional attributes, Seal Test, Tip Pull to Failure).
Comparative Performance: Demonstrating substantial equivalence in thermal behavior to a predicate and reference device in animal models.
Usability Standards: Compliance with IEC 62366-1 for human factors/usability.

8. The Sample Size for the Training Set

Not Applicable. This device does not use an AI/machine learning component, so there is no concept of a "training set" for an algorithm.

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

Not Applicable. As per point 8, there is no training set for an algorithm.

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K Number

K212214

Device Name

HandX

Manufacturer

Date Cleared

2021-09-13

(60 days)

Product Code

GCJ,GEI,NAY

Regulation Number

Type

Traditional

Panel

Reference & Predicate Devices

K173919,K203603

Intended Use

Device Description

The Human Xtensions HandX is a handheld powered laparoscopic device. The HandX enables, by its attached instruments Grasper, Needle Holder and Monopolar Hook, the surgeon to perform a variety of minimally invasive surgeries. As the device is controlled by the surgeon's hand, it acts as a "surgeon's hand extension," enhancing maneuverability and control.

The HandX device is electromechanically controlled and includes both hardware and software. The device is comprised of two main parts: the Handpiece and the Instrument. The Handpiece consists of a reusable Control Interface (CI) handle and Handpiece Body that translates the surgeon's maneuvers and movements of their hands by means of control buttons to the instrument-articulating tip. The tip moves according to the CI's direction. Prior to use, a set of Power Cable, Finger Pads, Arc and Spacer are assembled on the Handpiece and the Handpiece is covered with a standard sterile cover (not provided with the HandX device). After use, the Instrument is disposed of, and the Handpiece is cleaned and disinfected per specifications in the Instructions for Use.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study proving the device meets them, based on the provided FDA 510(k) summary for Human Xtensions Ltd.'s HandX device:

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study for novel performance claims. Therefore, the "study" demonstrating the device meets acceptance criteria primarily revolves around usability testing for a new operating mode and showing that this modification does not introduce new safety or effectiveness concerns. There is no large-scale clinical trial data presented to assess diagnostic accuracy or treatment efficacy as might be seen for AI-driven diagnostic tools.

1. Table of Acceptance Criteria and Reported Device Performance

The core "acceptance criteria" here relate to the safety and effectiveness of the new "inverted control mode" and ensuring that the modified device (HandX) remains substantially equivalent to its predicates (HX Device and Monopolar Hook).

Acceptance Criteria (Implicit from 510(k) context)	Reported Device Performance (from "Performance Data" section)
Safety: The addition of the inverted control mode does not introduce new or unacceptable safety risks.	"The testing demonstrated that potential safety-critical consequences are reasonably mitigated by the design of the inverted control mode and its associated instructional materials, which were clear and easy to understand by both novel and experienced users."
Effectiveness: The device, with the new control mode, remains effective for its intended use.	The document states this difference ("inverted control mode") "does not raise new questions of safety or effectiveness, as it does not alter the fundamental therapeutic purpose of the device or its basic principles of operation (users control the inserted instruments in the same manner, just using one or another set of vectors)." It also notes, "The new mode also does not change the key metrics for evaluating device safety and performance, and is supported by successful usability testing." The implication is that since usability was successful, and the fundamental principle of operation remains, effectiveness is maintained. No specific quantitative effectiveness metrics are provided beyond this qualitative statement based on usability.
Usability: The inverted control mode is usable and understandable by target users.	"The company conducted usability testing of the inverted control mode in line with IEC 62366-1:2015 and ANSI/AAMI HE75:2009/(R)2018, as well as FDA's 2016 guidance document. The testing demonstrated that potential safety-critical consequences are reasonably mitigated by the design of the inverted control mode and its associated instructional materials, which were clear and easy to understand by both novel and experienced users."
Substantial Equivalence: The HandX (with new mode) is substantially equivalent to predicate devices.	The overall conclusion of the 510(k) is: "Based on the intended use, technological characteristics, principles of operation, and usability testing, it can be concluded that the HandX is substantially equivalent to its predicate devices." The detailed comparison table in Section 5 shows the similarities and only identifies the addition of the "inverted control mode" as a notable difference, which they argue does not raise new questions of safety or effectiveness.

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

Sample Size for Test Set: The document does not specify the exact sample size (number of participants) for the usability testing. It mentions "both novel and experienced users," implying a mix of experience levels, but no specific count.
Data Provenance: The document does not explicitly state the country of origin for the usability testing data. However, the submitter is "Human Xtensions Ltd., Netanya, Israel," suggesting the testing could have been conducted in Israel or elsewhere (e.g., US, given the US legal representation). It was prospective usability testing conducted specifically for this submission.

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

For this type of 510(k) (device modification based on usability), the concept of "ground truth" as it applies to diagnostic image analysis (e.g., presence/absence of disease) is not directly applicable.
Instead, the "ground truth" is established by adherence to usability standards and the ability of users to successfully and safely operate the device. The "experts" involved would implicitly be human factors engineers, clinical experts (surgeons) participating in the usability study, and potentially regulatory experts reviewing the study design and results.
The document does not specify the number or qualifications of these implicit "experts" beyond mentioning "novel and experienced users" in the usability study.

4. Adjudication Method for the Test Set

Adjudication methods like "2+1" or "3+1" are typically used in studies where multiple readers interpret medical images to resolve discrepancies.
This is a usability study for a surgical instrument's control mode. The "adjudication" would involve human factors engineers observing user performance, collecting user feedback, and analyzing quantitative (e.g., task completion time, errors) and qualitative (e.g., subjective ratings, comments) data against pre-defined success criteria for usability and safety.
The document does not describe a specific adjudication method in the sense of reconciling differing expert opinions on a "ground truth" diagnosis. Usability assessment is a different paradigm.

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

No, an MRMC comparative effectiveness study was not done.
- This type of study is common for AI-driven diagnostic tools to show improvement in human reader performance.
- The HandX device is a surgical instrument with a modified control mode, not an AI diagnostic tool.
- The study described is a usability study for the new control mode, not a comparative effectiveness study pitting human readers with vs. without AI assistance.

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

Not applicable.
- The HandX is a physical surgical instrument with electromechanical and software components, designed for human operation. It is not an "algorithm" in the sense of an AI model that operates in a standalone capacity (e.g., analyzing images without human input).
- Its "performance" is inherently human-in-the-loop, as it's a tool controlled by a surgeon.

7. The Type of Ground Truth Used

For the usability study, the "ground truth" is based on usability standards and successful task completion/safe operation.
- This is established by adherence to standards like IEC 62366-1:2015 and ANSI/AAMI HE75:2009/(R)2018, and the observation that "potential safety-critical consequences are reasonably mitigated" and instructional materials were "clear and easy to understand."
- It is not clinical "outcomes data" or "pathology" in the traditional sense for a diagnostic device.

8. The Sample Size for the Training Set

Not applicable / No training set described.
- This device is not an AI/ML algorithm that requires a "training set" of data in the manner that a deep learning model would.
- The software aspect discussed pertains to the control interface logic ("direct control" vs. "inverted control"), which is programmed, not "trained" on a dataset in the AI sense.

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

Not applicable. As there is no described training set for an AI/ML algorithm, the concept of establishing ground truth for it does not apply. The device's functionality is based on engineering design and programming, verified through testing (including usability).

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K Number

K203603

Device Name

Monopolar Hook

Manufacturer

Date Cleared

2021-02-01

(54 days)

Product Code

GCJ,GEI

Regulation Number

Type

Traditional

Panel