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The CoapTech PUMA-G Pediatric System is intended to affix the stomach to the anterior abdominal wall facilitating the initial percutaneous placement of a gastrostomy feeding tube. The PUMA-G Pediatric System is intended to be utilized in pediatric patients that meet criteria for minimum weight (15 kg) and appropriate abdominal wall thickness (between 0.6 cm and 3.0 cm), as stated in the instructions for use.
To Aid in Percutaneous Access to the Stomach During Gastrostomy Tube Placement.

The PUMA-G Pediatric System is a medical device designed to aid in the initial placement of permanent feeding tubes, which are placed via percutaneous gastrostomy. Historically, gastrostomy tubes have been placed using either endoscopy or radiography (e.g., fluoroscopy) for visualization. The PUMA-G Pediatric System provides visualization by ultrasound, allowing the user to assess the future gastrostomy tract prior to placement. The PUMA-G Pediatric System contains three main custom components: a balloon catheter, a guidewire, and an external magnet. An internal magnet within the balloon catheter is placed orogastrically into the stomach, where it is pulled up to the anterior abdominal wall by the external magnet. After filling the balloon with fluid, the user's existing ultrasound is used for visualization of the future gastrostomy tract and for ultrasound-guided needle placement. The guidewire is then inserted and snared by the balloon, and the paired unit (balloon catheter and guidewire) is then pulled out the mouth. A gastrostomy tube is then placed over the guidewire using either the Sachs-Vine PUSH technique or the Ponsky PULL technique.

The provided FDA 510(k) clearance letter and summary for the PUMA-G Pediatric System describe a medical device designed to aid in the initial placement of gastrostomy feeding tubes. The summary outlines some performance testing, including a small safety clinical study. However, the document does not contain the detailed acceptance criteria or the specific study design elements (beyond a "small safety clinical study" and "single-center study") that would typically be reported for an AI/software device that needs to meet performance criteria for metrics like sensitivity, specificity, or accuracy based on a test set.

The PUMA-G Pediatric System appears to be a mechanical device with an ultrasound visualization component, not an AI/software-driven diagnostic or assistive device that would rely on a test set with ground truth established by experts and MRMC studies. The "performance data" mentioned focuses on mechanical, biocompatibility, and sterilization aspects, along with a safety study.

Therefore, many of the requested information points (e.g., sample size for the test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set details) are not applicable or not present in the provided document, as they pertain to the rigorous evaluation of AI/software algorithm performance against established ground truth, which is not the primary focus of this device's clearance.

Based on the provided information, here's an attempt to answer the questions, highlighting where information is absent or non-applicable:

Device Description

The PUMA-G Pediatric System is a medical device designed to aid in the initial percutaneous placement of a gastrostomy feeding tube. It utilizes a balloon catheter with an internal magnet and an external magnet to coapt the stomach to the anterior abdominal wall. Users then employ their existing ultrasound for visualization and guided needle placement. The system also includes a guidewire.

Acceptance Criteria and Performance Study Analysis (Based on Provided Document)

Given the nature of the device as a mechanical aid with ultrasound visualization (rather than an AI/software algorithm for diagnosis or image analysis), the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are focused on safety, functional performance, and effectiveness in facilitating the procedure, rather than typical AI performance metrics.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria for performance metrics in the way one would see for an AI algorithm (e.g., sensitivity, specificity thresholds). Instead, the performance is described qualitatively and through the outcomes of a safety study.

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The CoapTech PUMA-G System (PUMA-G) is intended to affix the stomach to the anterior abdominal wall facilitating the initial percutaneous placement of a gastrostomy feeding tube in adults and adolescents of sufficient size ("Transitional Adolescent B" patients 18 to 21 years of age with no special considerations compared to adults).

The PUMA-G System is a medical device designed to aid in the initial placement of permanent feeding tubes, which are placed via percutaneous gastrostomy. Historically, gastrostomy tubes have been placed using either endoscopy or radiography (e.g., fluoroscopy) for visualization. The PUMA-G System provides visualization by ultrasound, allowing the user to assess the future gastrostomy tract prior to placement. The PUMA-G System contains three main custom components: a balloon catheter, a guidewire, and an external magnet. An internal magnet within the balloon catheter is placed orogastrically into the stomach, where it is pulled up to the anterior abdominal wall by the external magnet. After filling the balloon with fluid, the user's existing ultrasound is used for visualization of the future gastrostomy tract and for ultrasound-guided needle placement. The guidewire is then inserted and snared by the balloon, and the paired unit (balloon catheter and guidewire) is then pulled out the mouth. A gastrostomy tube is then placed using the guidewire and Seldinger technique.

The provided text describes the PUMA-G System, a medical device intended to affix the stomach to the anterior abdominal wall to facilitate the initial percutaneous placement of a gastrostomy feeding tube.

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

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria in a formal table or list. However, the "Performance Data" section describes the types of performance data collected and the conclusions drawn regarding effectiveness and safety.

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The Alpha Control Liner System is to be used exclusively for exoprosthetic fittings of the upper limbs.

The Alpha Control Liner System is an interface solution designed to provide the Complete Control System Gen2 with amputee muscle contraction signals needed for the pattern recognition algorithms. The Alpha Control System integrates electronics into a fabric covered elastomeric prosthetic liner to non-invasively detect muscle contractions and convert the signals into a digital format. The Alpha Control System is a substitute for the EMG Interface Cable currently provided with the Complete Control System Gen2. Patients can achieve control of their devices and benefit from quick donning and doffing of the prosthesis. The Alpha Control System simplifies electrode placement and allows a prosthetist to spend less time fabricating the prosthesis as well as adjusting system settings and configurations.

The Alpha Control System is used in conjunction with the Coapt Complete Control System Gen2 and does not require an additional battery.

The Alpha Control System contains the following components.

• Alpha Control Liner (gel-lined user interface)
• Alpha Control Module (re-packaged Complete CO-AMP consolidated EMG amplifier, Covered under 510(k) number K162891)
• Module Cap (secures the Module inside the Liner)
• Alpha Control Lock (socket suspension and connection to Complete Controller)
• Electrodes (Covered under 510(k) number K190416)
• Fabrication aids for the Lock

The provided text does not contain detailed information about specific acceptance criteria and a study proving the device meets them in the format requested. The document is a 510(k) Premarket Notification from the FDA to Coapt Blair Lock for the Alpha Control Liner System. It primarily focuses on demonstrating substantial equivalence to a predicate device (Coapt Complete Control System Gen2) through non-clinical performance data.

Here's an analysis of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists several non-clinical performance tests that the Alpha Control Liner System passed, which can be interpreted as demonstrating the device meets internal requirements, national, and international standards. However, specific numerical acceptance criteria (e.g., "force must be > X Newtons") are not provided. The results are simply reported as "Pass".

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

The document does not specify the sample sizes used for any of the non-clinical tests. It states that "validation testing was performed on the finished device," but does not detail the number of units or iterations. The provenance of the data is "internal" and "in-house performance testing" by Coapt LLC and WillowWood Global LLC. The document does not mention external (e.g., country of origin) or retrospective/prospective data for these tests.

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

This information is not provided. The non-clinical tests are largely engineering and materials testing, which rely on established standards and protocols rather than expert medical interpretation for "ground truth" in the same way a clinical diagnostic test would.

4. Adjudication Method for the Test Set:

This information is not applicable and, therefore, not provided. The non-clinical tests do not involve human interpretation requiring adjudication.

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

No MRMC comparative effectiveness study was mentioned. The document explicitly states, "No human clinical testing was required to support the medical device as the indications for use is equivalent to the predicate device." This indicates that the evaluation was primarily based on non-clinical engineering and biocompatibility testing. The device is a "cutaneous electrode" for exoprosthetic fittings, not a diagnostic imaging or AI-driven decision support system that typically requires MRMC studies.

6. Standalone (Algorithm Only) Performance:

The device (Alpha Control Liner System) is described as an "interface solution designed to provide the Complete Control System Gen2 with amputee muscle contraction signals needed for the pattern recognition algorithms." It integrates electronics to detect muscle contractions and convert signals into a digital format. While it converts signals, it is a component for a pattern recognition algorithm (part of the predicate device, Coapt Complete Control System Gen2), not the algorithm itself or a standalone algorithm. Therefore, "standalone (i.e. algorithm only without human-in-the loop performance)" is not applicable to this device description. The performance testing focuses on its physical and electrical integrity and its ability to integrate with the larger system.

7. Type of Ground Truth Used:

For the non-clinical tests, the "ground truth" refers to established engineering standards, material specifications, and functional requirements. For example, "Liner Thickness" would be compared against a specified design tolerance, and "Biocompatibility" against the criteria outlined in ISO 10993 standards. There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for these non-clinical tests.

8. Sample Size for the Training Set:

This information is not applicable and not provided. The Alpha Control Liner System is a hardware component that collects and processes sEMG signals. It does not inherently learn or require a "training set" in the context of machine learning. The pattern recognition algorithms are part of the predicate device, and details about their training are not discussed in this submission for the Alpha Control Liner System.

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

This information is not applicable and not provided, as the device itself does not use a "training set."

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The ControlSeal Electrodes are intended for non-invasive use with recording and monitoring equipment of Electromyography (EMG).

The ControlSeal Electrode is an accessory designed for recording of biopotential signals. It is a non-invasive electrode that records biopotential signals from the surface of the skin. It has a standard mating thread that enables connection to electrical conductors of compatible devices.

The ControlSeal Electrode contains the following components:

• . 316L Stainless Steel ControlSeal Electrode Dome
• Passivated 18-8 Stainless Steel Phillips Flat Head 2-56 Screw .
• Stainless Steel Tooth Lock Washer .
• . Protective Cap
• Conducting Ring-Terminal .
• Buna-N Rubber O-Ring .

This FDA 510(k) summary describes the ControlSeal Electrode (ELSB), a cutaneous electrode intended for non-invasive use with Electromyography (EMG) recording and monitoring equipment. The submission seeks to demonstrate substantial equivalence to a predicate device, the Dome Electrode (K190416).

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria for the internal tests (Mechanical Fit, Voltage Continuity, etc.) are inferred from the "Pass" result and the general purpose of such tests in medical device validation. The document states "The ControlSeal Electrode meets all the requirements for overall design, safety, and biocompatibility results, confirming that the design output meets the design inputs and specifications for the device," which serves as a general overarching acceptance statement for these tests.

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

The document does not explicitly state the sample size for the test set used in the non-clinical performance data. It mentions "The ControlSeal Electrodes were also tested internally to ensure that it meets device specifications & requirements and operates as intended." No specific number of electrodes or test subjects is provided for these internal tests (Mechanical Fit, Voltage Continuity, Signal Detection, etc.).

There is no mention of data provenance (e.g., country of origin, retrospective/prospective) because no human clinical or retrospective study data is presented. The studies are non-clinical (bench testing) and "internal."

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

Not applicable. This was a non-clinical (bench) study. There was no "ground truth" derived from expert interpretation of images or patient data. The ground truth for the non-clinical tests would be the established engineering specifications and recognized consensus standards (IEEE 2010-2012 and ISO 10993-1).

4. Adjudication Method for the Test Set

Not applicable. There was no expert adjudication involved as this was a non-clinical (bench) study. The results of the tests (e.g., "Pass") were determined by comparison to predefined specifications or standard requirements.

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 cutaneous electrode for EMG, not an AI-powered diagnostic or assistive tool. No MRMC study was performed.

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

Not applicable. This is a passive medical device (electrode), not an algorithm.

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

The "ground truth" for the non-clinical tests conducted would be the established engineering specifications, performance standards as defined by the company's design inputs, and the requirements of recognized consensus standards such as IEEE 2010-2012 and ISO 10993-1. For example, for the "Signal Detection Test," the ground truth would be the ability to reliably detect EMG signals of a certain quality, as defined by the specific test protocol. For mechanical tests, it would be compliance with dimensional tolerances, strength requirements, etc.

8. The Sample Size for the Training Set

Not applicable. There is no mention of a training set as this is not an AI/ML device.

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

Not applicable. There is no mention of a training set as this is not an AI/ML device.

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The COMPLETE CONTROL System Gen2 is to be used exclusively for external prosthetic fittings of the upper limbs.

The COMPLETE CONTROL System Gen2 is an advanced control solution designed to provide the functionality of a powered myoelectric prosthesis for upper extremity amputees. The COMPLETE CONTROL System Gen2 employs pattern recognition technology to non-invasively acquire user-specific muscle signals for the control of industry-standard upper extremity prostheses. Patients can achieve control of their devices, eliminate control switching, and benefit from quick and powerful recalibration. The COMPLETE CONTROL System Gen2 simplifies electrode placement and allows a prosthetist to spend less time adjusting system settings and configurations.

The COMPLETE CONTROL System Gen2 is designed to work seamlessly with most major manufacturers' devices as an easy plug-and-play add-on and does not require an additional battery.

The COMPLETE CONTROL System Gen2 is an embedded system that is used in conjunction with an upper-limb prosthetic device. The system has been validated for a specific set of prosthetic elbow, wrist and hand components which are listed in the user manual.

The COMPLETE CONTROL System Gen2 contains the following components:

• COMPLETE CONTROLLER main processor
• Device Interface Cable (clinician-specified termination type)
• EMG Interface Cable (clinician-specified termination type)
• COMPLETE CALIBRATE Button (part of COMPLETE CONTROLLER)
• Fabrication aid for the COMPLETE CONTROLLER
• Socket cut-out template for the COMPLETE CALIBRATE Button
• COMPELTE CONTROLROOM Application
• COMPLETE COMMUNICATOR Dongle

The acceptance criteria and study proving the device meets these criteria are detailed below. It is important to note that this document is a 510(k) summary for a medical device (COMPLETE CONTROL System Gen2), which aims to demonstrate substantial equivalence to a predicate device, not necessarily to independently prove the device's efficacy through extensive clinical trials as would be required for a novel device.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a distinct "test set" in terms of patient data or typical sample sizes seen in clinical trials. The performance evaluation primarily focuses on non-clinical bench testing and adherence to international electrical safety and EMC standards. Therefore, an explicit sample size for human subjects or their data provenance (country of origin, retrospective/prospective) is not applicable in the context of this 510(k) summary, as human clinical testing was not required for this submission. The tests performed were on the device itself.

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

This information is not applicable as the evaluation primarily involved non-clinical bench testing and adherence to standards, not the establishment of ground truth for diagnostic or prognostic interpretations by clinical experts.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as above. The testing was objective measurement against predefined technical specifications and international standards.

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

No, an MRMC comparative effectiveness study was not conducted and is not mentioned in this 510(k) summary. The submission focuses on demonstrating substantial equivalence to a predicate device through technical and performance comparisons, not on measuring human reader improvement with or without AI assistance.

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

The testing described is primarily standalone in nature, as it evaluates the device's adherence to electrical safety standards, EMC, and its internal functionality (cabling, power, Bluetooth, inputs, outputs, calibration, pattern recognition, file save). The "algorithm only" aspect is embedded within the "Calibration and Pattern Recognition Test," which confirms the device's ability to perform its core function. However, this is integrated into the device's overall performance testing rather than a separate, isolated algorithm-only study as might be conducted for an image analysis AI.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests was adherence to established international standards (IEC 60601-1 for electrical safety and physical characteristics, IEC 60601-1-2 for EMC) and the device's own internal design specifications and requirements. For the functional tests, the "ground truth" was whether the device performed its intended function as designed (e.g., connected, powered on, saved files).

8. The Sample Size for the Training Set

The document does not provide information about a "training set" sample size. The device uses "pattern recognition technology to non-invasively acquire user-specific muscle signals." For such systems, the "training set" typically refers to individual patient-specific muscle signal data used to train the system for that particular user. This is a personalized calibration process, not a large, general training dataset used for machine learning model development in the traditional sense as this is a medical device, not a diagnostic AI.

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

As noted above, for myoelectric pattern recognition systems, the "training" involves a user-specific calibration process. The document states, "Patients can achieve control of their devices, eliminate control switching, and benefit from quick and powerful recalibration." This implies that the "ground truth" for each user's calibration is derived from their own movements and muscle signals, allowing the system to learn the unique patterns associated with their intended prosthetic movements. The system does not rely on a pre-established "ground truth" from a large, independent dataset for its core pattern recognition function, but rather on real-time muscle signal acquisition and mapping by the individual user.

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The CoapTech PUMA-G System (PUMA-G) is intended to affix the stomach to the anterior abdominal wall facilitating the initial percutaneous placement of a gastrostomy feeding tube in adults only.

The PUMA-G System is a medical device designed to aid in the initial placement of permanent feeding tubes, which are placed via percutaneous gastrostomy. Historically, gastrostomy tubes have been placed using either endoscopy or radiography (e.g., fluoroscopy) for visualization. The PUMA-G System provides visualization by ultrasound, allowing the user to assess the future gastrostomy tract prior to placement. The PUMA-G System contains three main custom components: a balloon catheter, a guidewire, and an external magnet. An internal magnet within the balloon catheter is placed orogastrically into the stomach, where it is pulled up to the anterior abdominal wall by the external magnet. After filling the balloon with fluid, the user's existing ultrasound is used for visualization of the future gastrostomy tract and for ultrasound-guided needle placement. The guidewire is then inserted and snared by the balloon, and the paired unit (balloon catheter and guidewire) is then pulled out the mouth. A gastrostomy tube is then placed over the guidewire using the Sachs-Vine PUSH technique.

The provided text describes the CoapTech PUMA-G System and its substantial equivalence determination, but it does not contain the detailed information requested for acceptance criteria and a study proving the device meets those criteria.

Specifically, the document states that "Bench and animal performance data were collected to support a substantial equivalence determination" and lists the types of testing performed (balloon performance, magnetic force characterization, coupling strength, capture reliability, biocompatibility, and sterilization). However, it does not provide:

• A table of specific acceptance criteria and reported device performance values. It only gives a high-level summary that the "PUMA-G System can effectively bring together the stomach and anterior abdominal wall while maintaining healthy tissue" and "reliably captures and retains the guidewire."
• Sample sizes, data provenance, or details of the test sets.
• Information about experts used for ground truth, adjudication methods, or MRMC studies.
• Details about standalone algorithm performance if it were an AI device (which it is not).
• The type of ground truth used (beyond implying animal and bench testing results).
• Training set information, as this is a medical device, not an AI/ML algorithm that requires a training set in the conventional sense.

Therefore, I cannot fulfill the request with the provided text. The document focuses on demonstrating substantial equivalence to a predicate device based on functional and safety performance, but not on detailed performance metrics against predefined acceptance criteria in the format requested.

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The Dome Electrodes are intended for non-invasive use with recording and monitoring equipment of Electromyography (EMG).

The Dome Electrode is an accessory designed for recording of biopotential signals. It is a non-invasive electrode that records biopotential signals from the surface of the skin. It has a standard mating thread that enables connection to electrical conductors of compatible devices. The Dome Electrode contains the following components: 316L Stainless Steel Dome Electrode, Stainless Steel Size 4-40 Nut, Stainless Steel Flat Washer, Stainless Steel Split ("Lock") Washer.

I am sorry, but the provided text does not contain the information required to compose the answer in the requested format. The document is an FDA 510(k) premarket notification for a medical device (Dome Electrode) and primarily focuses on demonstrating substantial equivalence to a predicate device.

Specifically, the text does not contain details about:

• Acceptance Criteria Table with Reported Device Performance: No specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) are mentioned, nor are quantitative performance results against such criteria for the Dome Electrode itself in terms of signal processing or diagnostic accuracy. The "Result" column in the Non-Clinical Performance Data section only states "Pass" for various internal mechanical and electrical tests.
• Sample Size for Test Set and Data Provenance: While "Signal Detection Test" and "Validation – Compatible Device" are listed, the document does not specify the sample size (number of subjects, number of electrode placements, duration of recording) for these tests, nor the origin of the data (country, retrospective/prospective).
• Number of Experts and Qualifications for Ground Truth: There is no mention of experts establishing ground truth for any test set or their qualifications. The device is a cutaneous electrode for EMG, not an AI diagnostic tool requiring expert consensus for interpretation.
• Adjudication Method: Not applicable as there's no mention of expert review or consensus.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: This type of study is relevant for AI systems assisting human readers in interpreting images or data. The Dome Electrode is a physical medical device (electrode) and not an AI algorithm. Therefore, no MRMC study was conducted or reported.
• Standalone Performance (Algorithm Only): The device is an electrode, not an algorithm. Standalone performance for an algorithm is not applicable.
• Type of Ground Truth Used: The ground truth for electrode performance would typically be the physical properties of the electrical signals detected. There's no mention of a "ground truth" in the context of expert consensus, pathology, or outcomes data, as would be common for AI/diagnostic devices. The internal tests (voltage continuity, signal detection) likely assess the electrode's ability to pick up and transmit electrical signals, with "Pass" indicating it meets specifications.
• Sample Size for Training Set & How Ground Truth for Training Set was Established: The device is hardware, not a machine learning model. Therefore, there is no "training set" in the context of AI.

The document primarily focuses on:

• Biocompatibility Testing: Conformance to ISO 10993 standards (cytotoxicity, sensitization, irritation) with "passing results."
• Physical and Electrical Performance: Internal tests for mechanical fit, voltage continuity, and signal detection, all reported as "Pass."
• Comparison to a Predicate Device: Detailed comparison of technological characteristics (dimensions, materials, connection type, indications for use, mechanism of action) to establish substantial equivalence.

Given the nature of the device (a cutaneous electrode) and the content of the 510(k) submission, the study design and reporting requirements are very different from those for an AI/ML-based diagnostic device. The document states, "No human clinical testing was required to support the medical device as it was designed to conform to IEEE 2010-2012 Recommended Practice for Neurofeedback Systems. Cutaneous electrodes have been on the market for many years with proven safety and efficacy." This explicitly indicates that complex clinical studies, particularly those involving human interpretation or AI performance metrics, were not part of this submission for this particular device.

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The COMPLETE CONTROL System is to be used exclusively for external prosthetic fittings of the upper limbs.

The COMPLETE CONTROL System is an advanced control solution designed to enhance the functionality of a powered myoelectric prosthesis for upper extremity amputees. The COMPLETE CONTROL System employs Pattern Recognition technology to acquire, non-invasively, the rich information in muscle signals to enhance the control of industry standard upper extremity prostheses. Patients can achieve intuitive control of their devices, eliminate control switching, and benefit from quick and powerful recalibration. COMPLETE CONTROL simplifies electrode placement and allows a prosthetist to spend less time adjusting system settings and configurations.

The COMPLETE CONTROL System is designed to work seamlessly with most major manufacturers' devices as an easy plug-and-play add-on. COMPLETE CONTROL does not require an additional battery.

The COMPLETE CONTROL System is an embedded system that is used in conjunction with an upper-limb prosthetic device. This device can include any combination of an elbow, wrist, hand or terminal device. It contains several modules, including one for processing surface EMG (CO-AMP), processing and translating the signals (CONTROLLER), along with a controlling training routine (CALIBRATE). Finally, a wireless adapter (COMMUNICATOR) is included with the system setup and is used to provision the entire system.

The COMPLETE CONTROL System contains the following components.

• 1. Device Interface Cable (clinician-specified termination type)
• 2. COMPLETE CONTROLLER main processor
• 3. COMPLETE CALIBRATE patient interface button
• 4. COMPLETE CO-AMP consolidated EMG amplifier
• 5. EMG Interface Cable
• 6. Fabrication aids for the COMPLETE CONTROLLER, COMPLETE CO-AMP, and COMPLETE CALIBRATE
• 7. Socket cut-out template for the COMPLETE CALIBRATE button
• 8. COMPLETE COMMUNICATOR USB dongle
• 9. COMPLETE CONTROLROOM software installation USB dongle

This document, a 510(k) summary for the "COMPLETE CONTROL System" by Coapt, LLC, outlines the device's characteristics and its comparison to a predicate device to establish substantial equivalence for regulatory clearance. It focuses on non-clinical performance data.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in terms of performance metrics (e.g., accuracy, precision, latency) for the device's core function (pattern recognition for myoelectric control). Instead, the "acceptance criteria" are implied to be conformance to various standards and the successful completion of internal validation tests.

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

The document does not mention a test set with a specific sample size used for performance evaluation related to the device's primary function of pattern recognition for myoelectric control. The non-clinical performance data described relates to engineering verification and validation testing of the hardware and software components.

The data provenance for these engineering tests would typically be internal laboratory testing conducted by Coapt, LLC or a contracted testing facility. No information about country of origin of data or retrospective/prospective nature is provided for these engineering tests.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

This information is not applicable and not provided in the document because the performance evaluation relies on engineering tests and conformance to standards, not on clinical ground truth established by experts.

4. Adjudication Method for the Test Set

This information is not applicable and not provided in the document, as there was no test set requiring expert adjudication for clinical or performance outcomes.

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

No, an MRMC comparative effectiveness study was not done and is not mentioned in the document. The device is a "Cutaneous Electrode" (Class II, Product Code GXY) that enhances the control of existing prosthetic devices; it's not a diagnostic imaging device where MRMC studies are typically performed. The document explicitly states: "There was no human clinical testing required to support the medical device as the indications for use is equivalent to the predicate device."

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

The document describes "Calibration and Pattern Recognition Test" and "Feature Extraction Test" which would involve the algorithm operating in a standalone manner, processing signals and performing its designated function. However, the exact methodology, metrics, and quantitative results of these algorithm-only tests are not detailed beyond stating they "Passed."

7. The Type of Ground Truth Used

For the engineering tests (e.g., cabling, power, wireless), the ground truth is simply the expected operational output or state of the system (e.g., cable connected correctly, power on, wireless connected). For the "Calibration and Pattern Recognition Test" and "Feature Extraction Test," the ground truth would be the expected or correct pattern recognition output based on the input EMG signals, but the specifics of how this ground truth was defined or evaluated are not elaborated. There is no mention of expert consensus, pathology, or outcomes data as ground truth for these tests.

8. The Sample Size for the Training Set

The document does not mention the sample size for a training set. While the device utilizes "Pattern Recognition technology," the details of its development and training, including the dataset size, are not provided in this 510(k) summary.

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

This information is not provided in the document. Given the use of "Pattern Recognition technology," a training set with associated ground truth (e.g., specific muscle movements or intentions linked to EMG patterns) would typically be required, but the document does not elaborate on this aspect of the device's development.

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The VF LiquiGel is indicated for vocal fold medialization in the treatment of vocal fold insufficiency, where insufficiency may be improved by injection of a soft tissue bulking agent. VF LiquiGel injection augments the size of the displaced or deformed vocal fold so that it may meet the opposing fold at the midline for improved glottal closure. Improved glottal closure may allow improved phonation, improvement of cough, and an improved ability to protect the airway during swallowing. VF LiquiGel is a temporary implant that degrades over time. The product is intended to be durable for a minimum of one month.

Sterile, latex free, non-pyrogenic, highly thixotropic, high yield strength clear gel with a neutral pH. The durability of the gel is due to slow degradation of the synthetic gel carrier. The thixotropic character of the gel allows it to be a very thick and cohesive gel but able to be injected through very fine needles with minimal force.

The provided document is a 510(k) Premarket Notification for the VF LiquiGel device by Coapt Systems, Inc. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive clinical study data (such as those for novel devices or PMAs) that would typically include detailed information on acceptance criteria and specific study outcomes in the way requested.

The document states that "The VF LiquiGel performance data meet the applicable standards and fulfill the device requirements as defined in the user specifications," but does not provide the specific acceptance criteria or detailed results of a study designed to prove the device meets those criteria. Instead, it relies on demonstrating substantial equivalence in design, materials, function, and intended use to a legally marketed predicate device (VF Gel, K080956).

Therefore, I cannot provide all the requested information because it is not contained within the provided text. The document is primarily a comparison to a predicate device to establish substantial equivalence.

Here's the information that can be extracted or inferred:

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

The document does not explicitly present acceptance criteria for performance in a quantitative way. Instead, it compares characteristics of the VF LiquiGel to its predicate, VF Gel, and states equivalency. The "reported device performance" is essentially that it is "Equivalent" to the predicate in all assessed parameters, implying it meets the same functional and safety profiles.

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

The document does not describe a clinical "test set" in the context of a prospective or retrospective study on patients using the VF LiquiGel. The evaluation is based on performance evaluations and comparison testing to the predicate device (Section 10.1, Substantial Equivalence Comparison, 1. Indications Summary; 3. Performance Summary), likely bench testing and material characterization, rather than a clinical study with a patient sample size. Therefore, there's no information on data provenance from human subjects or study design (retrospective/prospective).

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)

Not applicable. As there is no described clinical test set for this 510(k) submission, there are no experts establishing ground truth for such a set. The "ground truth" for substantial equivalence is based on regulatory and scientific comparison to the predicate device's established safety and effectiveness.

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

Not applicable. There is no described clinical test set requiring 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

Not applicable. This device is a medical implant (a gel), not an AI-assisted diagnostic tool.

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

Not applicable. This device is a medical implant (a gel), not an algorithm.

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

The "ground truth" in this 510(k) context is the established safety and effectiveness profile of the predicate device (VF Gel, K080956) and the scientific understanding of the materials and mechanism of action, validated through material characterization and biocompatibility testing (meeting ISO 10993 and NF/USP requirements). No clinical outcomes data for the subject device are presented to establish ground truth.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device. The "training set" doesn't apply here.

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

Not applicable. This is not an AI/machine learning device.

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The VF Gel is indicated for vocal fold medialization in the treatment of vocal fold insufficiency, where insufficiency may be improved by injection of a soft tissue bulking agent. VF Gel injection augments the size of the displaced or deformed vocal fold so that it may meet the opposing fold at the midline for improved glottal closure. Improved glottal closure may allow improved phonation, improvement of cough, and an improved ability to protect the airway during swallowing. VF Gel is a temporary implant that degrades over time. The product is intended to be durable for a minimum of one month.

Sterile, latex free, non-pyrogenic, highly thixotropic, high yield strength clear gel with a neutral pH. The durability of the gel is due to slow degradation of the synthetic gel carrier. The thixotropic character of the gel allows it to be a very thick and cohesive gel but able to be injected through very fine needles with minimal force.

This document describes a 510(k) summary for a medical device called "VF Gel." The summary focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria with specific performance metrics. Therefore, many of the requested data points (e.g., sample sizes for training/test sets, ground truth establishment, expert qualifications, MRMC studies, standalone performance) are not applicable or available in this type of submission.

Here's a breakdown of the information that can be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The submission does not present a table of quantitative acceptance criteria or specific device performance metrics in the way one might expect for an AI/algorithm-based device. Instead, the "acceptance criteria" are implied by the demonstration of "substantial equivalence" to a predicate device, meaning the new device (VF Gel) is as safe and effective as the legally marketed predicate. The "reported device performance" is essentially that it meets the requirements of a substantially equivalent device.

The table below summarizes the comparison of "VF Gel Plus" (the subject device) to "VF Gel" (the predicate device) from Table 7: Substantial Equivalence Summary, which outlines the characteristics compared to establish equivalence. The "Impact on Safety and Effectiveness" column effectively serves as the "reported device performance" in this context, indicating that the new device does not raise new safety or effectiveness concerns.

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

• Sample Size for Test Set: This information is not provided in the 510(k) summary. The submission focuses on a comparison of characteristics to a predicate device, not a performance study with a test set of patient data.
• Data Provenance: This information is not provided. As it's a device for vocal fold medialization, any "performance evaluations and comparison testing" mentioned are likely preclinical (e.g., benchtop, material characterization), or may refer to clinical experience with the predicate device, but specific data provenance for a test set is absent.

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

• This information is not applicable/not provided. The submission does not detail a study involving expert-established ground truth for a test set in the context of an AI/algorithm. The "ground truth" for this medical device's approval is based on its physical and functional equivalence to a legally marketed predicate device.

4. Adjudication method for the test set:

• This information is not applicable/not provided. There is no described test set or expert adjudication process for such a test set.

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 information is not applicable/not provided. This is a submission for a physical medical implant (gel), not an AI/algorithm. Therefore, an MRMC study related to AI assistance is irrelevant.

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

• This information is not applicable/not provided. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

• The "ground truth" in this context is the established safety and effectiveness of the predicate device. The VF Gel's "ground truth" is that its design, materials, function, and intended use are similar enough to the predicate device that it can be considered substantially equivalent. This is based on material properties, biocompatibility, and functional evaluations rather than expert consensus on patient outcomes or pathology from a dataset.

8. The sample size for the training set:

• This information is not applicable/not provided. This is a physical medical device, not an AI/algorithm that requires a training set.

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

• This information is not applicable/not provided. As above, there is no training set for a physical device.

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