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Kinesia is intended to monitor physical motion and muscle activity to quantify kinematics of movement disorder symptoms such as tremor and assess activity in any instance where quantifiable analysis of motion and muscle activity is desired.

Kinesia™ is designed to monitor and record motion and electrical activity of muscle to quantify kinematics of movement disorders such as tremor for research and diagnostic purposes. The patient unit consists of a wrist module and ring sensor. Motion sensors including accelerometers and gyroscopes are integrated into a finger worn unit to capture three dimensional motions. The finger worn sensor unit is worn on a finger band and is connected to a wrist worn module by a thin flexible wire. The wrist module provides an input for two channels of electromyography, battery power, on board memory, and an embedded radio for real-time wireless transmission of the collected signals. The wrist module is worn on a comfortable, adjustable wristband.

The signals are communicated between the patient module and the computer unit using wireless technology based on 2.4-2.484 GHZ frequencies. Kinesia will consist of four major components:

1. Patient Module(consists of ring and wrist module)

2. Computer Unit

3. Electromyography Leads

4. Interface Software

5. The Patient Module includes a user worn ring and wrist module connected by a thin cable. The patient module monitors eight channels of data including three channels of accelerometers (linear acceleration sensors), three channels of gyroscopes (angular velocity sensors), and two channels of electrical muscle activity (EMG). The data can be transmitted in real-time over a wireless telemetry link to a computer or be stored in onboard memory. The wireless link can either transmit only (one-way) or transmit and receive (two-way). The basic functional feature of the component is to acquire signals from the subject, perform analog-to-digital conversion (when appropriate), encode, format, and transmit the signals to the Computer Unit or store data in on board memory. The Patient Module will operate on DC power from either rechargeable or replaceable batteries. The Patient Module includes a push button patient diary so the patient can indicate when they have taken their medication and when their symptoms are severe.

6. The Computer Unit will have the ability to only receive (one-way) or receive and transmit (two-way) data from the Patient Module. The basic functional feature of this component is to receive data packets from the patient unit, perform error detection and correction, and then send the data to the PC Operator interface where the data can be monitored in real time or stored and analyzed at a later time.

3: The Electromyography Leads provide an input for two channels of EMG recordings. The leads provide five standard snap connector inputs including two differential channels of EMG and a patient ground. The leads are connected to a lemo connector. The lemo connector attaches to the lemo input on the Patient Unit wrist module.

4. The Interface Software program consists of several software modules that allow the user to acquire, store, and review data as acquired by the hardware.

The provided text describes the Kinesia™ device, its intended use, and its performance testing against various voluntary standards. However, it does not contain specific acceptance criteria, a detailed study proving device performance against such criteria, or information on sample size, data provenance, ground truth establishment, or expert involvement as requested.

The "Performance Testing" section states that Kinesia™ will be tested to certain voluntary standards (e.g., FCC Part 15.109, IEC60601-1 series). This indicates that the device intended to comply with these standards, but the document does not provide the results of these tests or specific acceptance criteria met.

Therefore, based solely on the provided text, a table of acceptance criteria and reported device performance, and details of a study meeting these criteria, cannot be fully generated.

Here's a breakdown of what can be extracted and what is missing:

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

Missing Information (Not found in the provided text):

• Specific quantitative acceptance criteria: The document lists standards but does not specify the pass/fail thresholds or performance metrics (e.g., accuracy, precision, sensitivity, specificity) for quantifying movement disorder symptoms or activity.
• Actual test results: The document states the device will be tested to these standards but does not provide any reported device performance data against these or any other criteria.

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

• Test set sample size: Not provided.
• Data provenance: Not provided. The document outlines regulatory compliance testing (e.g., electrical safety, EMC), but not a clinical or performance study with a "test set" in the context of, for example, classifying tremor.

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/Not provided. The listed "Performance Testing" refers to compliance with voluntary engineering and safety standards, not a study involving expert-adjudicated ground truth for clinical performance.

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

• Not applicable/Not provided.

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/Not provided. The Kinesia™ device is described as a monitor and recorder of motion and electrical activity, not an AI-assisted diagnostic tool for human readers.

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

• Not applicable/Not provided in the context of clinical performance algorithms. The device itself is a standalone measurement instrument.

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

• Not applicable/Not provided in the clinical sense. The "ground truth" for the listed performance testing would be the specifications and requirements of the voluntary standards themselves (e.g., measured leakage current must be below X mA).

8. The sample size for the training set

• Not applicable/Not provided. This document does not describe the development of a machine learning algorithm; it describes a medical device with sensors and a software interface.

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

• Not applicable/Not provided.

Conclusion based on provided text:

The document focuses on the technical description, intended use, and intent to comply with general safety and electromagnetic compatibility (EMC) standards. It does not provide details of a clinical performance study with specific acceptance criteria related to its quantitative analysis capabilities, nor does it include information about data sets (training or test), ground truth establishment, or expert involvement in such a study. The information provided is consistent with a 510(k) summary for a monitoring device primarily demonstrating substantial equivalence through technological characteristics and compliance with recognized safety standards.

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The Family of Crystal 20 Monitors are intended for monitoring and recording of physiological signals to aid in research and/or diagnostic purposes.

The device is not intended for use as life support equipment such as vital signs monitoring in intensive care units.

The Family of Crystal 20 Monitors® are designed to monitor physiological signals such as cardiovascular, neurological, and muscular for the purpose of research and diagnostic purposes. The Crystal 20 Monitor is a device that is programmable to the type of physiological signals being monitored such as EEG, EOG, EMG, ENG, ECG, PSG, airflow, pulse oximetry, respiratory effort, temperature, blood pressure, etc. The signals are communicated between the patient module and the computer unit using wireless technology based on frequencies such as but not limited to 902-928 MHz, 2.4 - 2.484 GHZ, Wireless Medical Telemetry Bands (WMTS), 608-614 MHz, 1395-1400 MHz, or 1429-1432 MHz. The communication between the patient module and computer unit can also be wired (instead of wireless). The Family of Crystal 20 Monitors® will consist of three major components:

1. Patient Module;

2. Computer Unit; and

3. Interface Software

4. The Patient Module can have up to 32 channels and the ability to either transmit only (one-way) or transmit and receive (two-way). The basic functional feature of the component is to acquire signals from commercially available electrodes / sensors that are attached to the subject, perform analog-to-digital conversion (when appropriate), encode, format, and transmit the signals to the Computer Unit. The Patient Unit will also have on-board memory capability that will permit the physiological data to be stored inside the patient unit. The Patient Module will contain no-touch connectors to enable connections to commercially available electrodes / sensors.

5. The Computer Unit will have the ability to only receive (one-way) or receive and transmit (two-way). The basic functional feature of this component is to receive data packets, performs error detection and correction, and then sends the data to the PC Operator interface where the data can be monitored in real time or stored and analyzed at a later time.

This 510(k) summary is for the "Family of Crystal 20 Monitors" and, as such, focuses on substantial equivalence to predicate devices rather than providing detailed clinical study results with acceptance criteria. Medical device 510(k) submissions, particularly for devices like physiological signal monitors, often rely on non-clinical performance data and comparison to predicate devices to demonstrate safety and effectiveness.

Therefore, the requested information regarding acceptance criteria, study data, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is largely not present in this document. The document describes the device, its intended use, and its classification, but does not include a performance study with acceptance criteria in the way one might find for an AI/ML-driven diagnostic device.

Here's an analysis based on the provided text, highlighting what is (and isn't) available:

Acceptance Criteria and Device Performance (Not explicitly stated for clinical performance in this document)

This document does not explicitly state specific acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) for clinical performance, nor does it report the device's performance against such criteria. The submission is a 510(k) for a physiological signal monitor, which typically focuses on demonstrating technical performance (e.g., signal quality, frequency range, safety) and substantial equivalence to existing predicate devices.

The "Predicate" section lists "Crystal Monitor Model 16, K013863 and Siesta System, K003175." This indicates the primary method of demonstrating effectiveness is likely through comparison to these legally marketed devices, asserting that the new device performs similarly and is at least as safe and effective.

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

Not applicable/Not provided in this document. This document does not describe a clinical performance study with a test set of patient data to evaluate the device's diagnostic accuracy. The submission focuses on the technical specifications and intended use of a physiological signal acquisition system.

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

Not applicable/Not provided in this document. Since no clinical performance study with a test set is described, there's no mention of experts establishing ground truth.

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

Not applicable/Not provided in this document. No clinical performance study is detailed.

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/Not provided in this document. The device is a physiological signal monitor, not an AI-driven diagnostic tool intended to assist human readers in interpreting images or data. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this device type and is not mentioned.

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

Not applicable/Not provided in this document. This device is for acquiring physiological signals; it does not contain a standalone algorithm for diagnostic interpretation in the sense of AI/ML performance. Its function is to provide raw or processed physiological data to clinicians for their interpretation.

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

Not applicable/Not provided in this document. Given the nature of the device as a physiological signal monitor, ground truth would typically refer to the accuracy of the measurement itself rather than the accuracy of a diagnostic output. The document doesn't detail specific accuracy studies, but rather focuses on overall functionality and safety in comparison to predicate devices.

8. The sample size for the training set

Not applicable/Not provided in this document. This device is not an AI/ML system that requires a "training set" of data for algorithm development.

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

Not applicable/Not provided in this document. As there is no training set for an AI/ML algorithm, this question is not relevant to the provided text.

Summary of what the document DOES provide:

• Device Description: The Family of Crystal 20 Monitors® is designed to monitor physiological signals (e.g., EEG, EOG, EMG, ECG, PSG, airflow, pulse oximetry, respiratory effort, temperature, blood pressure) for research and diagnostic purposes.
• Components: Patient Module, Computer Unit, and Interface Software.
• Key Features: Up to 32 channels, one-way or two-way transmission, analog-to-digital conversion, encoding, formatting, wireless (various MHz and GHz bands, including WMTS and ISM) or wired communication, on-board memory in the Patient Module, error detection/correction in the Computer Unit.
• Intended Use: Monitoring and recording of physiological signals to aid in research and/or diagnostic purposes.
• Contraindication: Not intended for use as life support equipment or vital signs monitoring in intensive care units.
• Predicate Devices: Crystal Monitor Model 16 (K013863) and Siesta System (K003175). The substantial equivalence claim is based on comparison to these devices.
• Regulatory Information: Classified as an Electroencephalograph (21 CFR 882.1400), Class II.
• K Number: K042039.

In conclusion, this 510(k) summary is typical for a device primarily focused on signal acquisition and hardware, demonstrating equivalence to already cleared devices rather than presenting novel clinical performance data through a structured study with specific acceptance criteria as would be expected for a new diagnostic algorithm or AI product.

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The Crystal Monitor® Model 16 is intended for wireless monitoring and recording of physiological signals to aid in research and/or diagnostic purposes.

The device is not intended for use as life support equipment such as vital signs monitoring in intensive care units.

The Crystal Monitor Model 16 is an eight-channel, programmable, wireless data acquisition system intended to monitor and record physiological signals. Any channel can be programmed to monitor any physiological signal. Harnesses connect electrodes or sensors from the patient to the patient unit. The patient unit, worn by the patient, acquires, amplifies, and digitizes physiological signals. These signals are then transmitted by radio frequency to a computer unit connected via a serial port to a personal computer (PC). The data is then displayed in real-time and can be stored on the PC.

The Crystal Monitor Model 16 incorporates state-of-the-art wireless technology for viewing and recording physiological signals such as EEG, EKG, EMG, and EOG. This 8channel monitor is the most unobtrusive, flexible, and convenient way of measuring and transmitting physiological signals. Subjects can now be untethered during studies while real time data is collected and displayed. The Crystal Monitor Model 16 wireless physiological signal monitor consists of a Transmitter (also called the Patient Unit), a Receiver Assembly (a Receiver [also called the Computer Unit], receiver cable, and power supply), accessories (Universal Differential Harness, mounting band, electrolyte gel, screwdriver, batteries, and Test Pack), and a PC Operator Interface Software program.

The Patient Unit collects signals from electrodes attached to the subject, performs analogto-digital conversion, encoding, formatting, and transmitting of all signals. The signals are transmitted via a radio transmitter. The Computer Unit receives the transmitted data packets, performs extensive error detection and correction, and then sends the data through a Receiver cable to the PC Operator interface where the data can be stored, monitored in real time, or analyzed at a later time.

The Crystal Capture program consists of several software components that allow the user to acquire, store, and view physiological data as acquired by the Crystal Monitor Transmitter. The software provides a simple graphical interface for setting up and managing data acquisition. The Crystal Configuration Wizard allows customization of the number of input channels (1-8), ranges (micro- to millivolts), and sampling rate. Configurations can be saved allowing the user to program the Crystal Monitor for numerous applications.

The provided text describes a 510(k) premarket notification for the Crystal Monitor Model 16, an 8-channel wireless data acquisition system for physiological signals. It details the device's technical characteristics, intended use, and substantial equivalence to existing devices. However, the document does not contain a study that proves the device meets specific acceptance criteria in terms of clinical performance or accuracy of physiological signal measurement against a ground truth.

Instead, the document focuses on regulatory compliance and technical specifications. The "acceptance criteria" discussed are primarily related to safety, electromagnetic compatibility, and adherence to voluntary standards.

Here's an analysis based on the information provided and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

• FCC Part 15.109, Class B digital device
• FCC Part 15.249, Intentional radiator, FCC ID#N9Y0007
• IEC 60601-1-2 Medical Electrical Equipment, Part 1 General requirements for safety
• EN 61000-4-2: 1995 Electrostatic discharge immunity test
• EN 61000-4-3: 1995 Radiated, radio-frequency, electromagnetic field immunity test
• EN 61000-4-4: 1995 Electrical fast transient/burst immunity tests
• EN 61000-4-6: 1996 Immunity to conducted disturbances induced by radio-frequency fields
• EN-55011 Electromagnetic Emissions
• IEC 601-2-26 (environmental conditions: 10° to 50° C, 25-95% humidity) |
  | Functional Equivalence to Predicate Devices: | "The Crystal Monitor Model 16 is technically the same as the Crystal-EEG Model 15 with the exception of software, labeling, and production company." It states they have "the same hardware, board designs, drawings, and all available accessories." |
  | Wireless Signal Transmission (Implicit Functionality): | Acquires, amplifies, and digitizes physiological signals, then transmits them by radio frequency to a computer for display and storage. Performs "extensive error detection and correction" upon reception. |
  | Programmability (Implicit Functionality): | 8-channel, programmable (number of channels 1-8, ranges micro- to millivolts, sampling rate). |
  | Real-time Display and Storage (Implicit Functionality): | Data is "displayed in real-time and can be stored on the PC." |

Missing Information: It's crucial to understand that this document does not present clinical performance acceptance criteria such as accuracy of EEG readings, signal-to-noise ratio, or agreement with a gold standard for physiological signal interpretation. The "reported device performance" above is a summary of capabilities and compliance with safety/EMC standards, not clinical efficacy.

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

• None provided. The document describes regulatory compliance testing (e.g., EMC, electrical safety) but does not detail human subject testing or clinical performance evaluation with a "test set" of patient data.

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. No clinical test set or ground truth established by experts is described for clinical performance.

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

• Not applicable. No clinical test set or adjudication method is described.

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 such study was done or described. This device is a physiological signal monitor, not an AI-based diagnostic tool that assists human readers.

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

• Not applicable in the context of an "algorithm" as typically referred to in AI/diagnostic studies. The device's primary function is data acquisition and display, not automated interpretation or standalone diagnostic decision-making beyond what an electroencephalograph intrinsically does (i.e., record signals). The "software components" described are for acquiring, storing, and viewing, not for AI-driven standalone analysis.

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

• For the safety and EMC standards, the "ground truth" is compliance with the specifications of those standards (e.g., does it emit below a certain level, does it withstand a certain electrostatic discharge).
• For functional equivalence, the "ground truth" is the established performance and design of the predicate device (Crystal EEG Model 15).
• No clinical ground truth (expert consensus on EEG readings, etc.) is mentioned.

8. The sample size for the training set

• Not applicable/Not provided. This is not an AI/machine learning device that would require a "training set" in the conventional sense.

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

• Not applicable/Not provided. As there is no described training set, there is no discussion of how its ground truth was established.

Conclusion:

The provided 510(k) summary for the Crystal Monitor Model 16 focuses on technical specifications, regulatory compliance with safety and EMC standards, and substantial equivalence to a predicate device. It does not present a clinical study with acceptance criteria related to physiological signal accuracy, diagnostic performance, or a "ground truth" derived from patient data interpreted by experts. The "study" referenced in the prompt's question is essentially the device's submission to and compliance with various engineering and safety standards, and its comparison to a previously cleared predicate device.

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The Crystal-EEG Model 10 is a mobile, intermediate range, wireless EEG system intended to be used for measuring and transmitting electroencephalogram (EEG) signals.

The Crystal-EEG Model 10 is a mobile, intermediate range, wireless, EEG system used for measuring and transmitting bioelectric signals such as electroencephalogram (EEG). It consists of a Transmitter, a Receiver Assembly which consists of the receiver, receiver cable, and power supply; the Software; Patient Accessories consisting of EEG Electrodes, headband, battery, and battery connector; and a PC Operator Interface which consists of Operator Interface Software, Transmitter Set-up Cable, and a Personal Computer (optional).

The provided document describes the Crystal-EEG Model 10, an electroencephalograph (EEG) system. The acceptance criteria and the study proving the device meets these criteria are outlined in the "Bench Testing" section.

Acceptance Criteria and Reported Device Performance

Study Information

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

   • Noise Testing: Three Crystal-EEG Model 10 Transmitters were used, totaling 24 channels (8 channels/Transmitter). The input channels were shorted.
   • Signal Transmission Testing: Details on the number of individual tests or channels used for sine wave transmission are not explicitly stated beyond "one typical channel" for the 5 Hz and 20 Hz examples.
   • Filter Accuracy Testing: One Crystal-EEG Model 10 unit was evaluated.
   • Data Provenance: The testing was "Bench Testing," implying a controlled laboratory environment. The country of origin of the data is not specified but is presumed to be internal testing by Cleveland Medical Devices Inc. in Cleveland, Ohio, USA, where the company is located. The nature of the testing is prospective, as it involved actively generating and measuring signals.

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

   • No human experts were used to establish the ground truth for the bench testing. The ground truth was established by known electrical signals (shorted inputs for noise, signal generator for sine waves with known frequencies and amplitudes). This is an objective, instrumental ground truth, not reliant on expert interpretation.

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

   • Not applicable. As the ground truth was established by objective electrical measurements and signal generation, no human adjudication was required.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No. This device is an electroencephalograph (EEG) system, a medical device for measuring bioelectric signals. The provided document details its technical performance characteristics through bench testing. It is not an AI-assisted diagnostic tool, and therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable to this submission.

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

   • Yes, this was effectively a standalone performance evaluation of the device's hardware and software components (apart from the PC operator interface being optional, the core function is the device itself). The "Bench Testing" specifically assesses the device's ability to measure, transmit, and process electrical signals without human interpretation as part of the primary test.

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

   • Objective Instrumental Ground Truth: The ground truth was established by known electrical parameters.
     • For noise: A shorted input represents a theoretically "zero signal" condition, allowing measurement of intrinsic system noise.
     • For signal transmission: A signal generator provides precisely controlled sine waves of known frequency and amplitude.
     • For filter accuracy: A signal generator provides sine waves of known frequencies and a theoretical model predicts the expected attenuation based on the filter design.

7. The sample size for the training set:

   • Not applicable. The device described is an EEG signal acquisition and transmission system, not a machine learning or AI-based system that requires a "training set" in the conventional sense. The "Bench Testing" focuses on the fundamental electrical performance characteristics of the hardware and integrated software.

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

   • Not applicable, as there was no training set.

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The Liberty Valve is intended to allow individuals in a wheelchair to empty their own urine collection leg bag, which may be connected to either an indwelling or non-indwelling catheter, provided the individual possesses the ability to make gross arm and hand movements.

The Liberty Valve consists of a switch box, a solenoid valve with electrical connection, a fuse, battery leads with wiring, and tubing with the necessary connections for attachment to the leg bag and valve. The device is to be mounted to the wheelchair permanently with the clamps and wire ties provided. The switch box regulates the power from the battery which opens the solenoid valve the urine collection leg bag to drain.

Here's an analysis of the provided text, focusing on acceptance criteria and the study proving device performance:

1. Table of Acceptance Criteria and Reported Device Performance

• At 0 °C: 1 minute 53 seconds to drain 500 mL.
• At 23 °C: 1 minute 49 seconds to drain 500 mL.
• At 70 °C: 1 minute 45 seconds to drain 500 mL.
  All tests drained 500 mL from a urine collection bag held ten inches above the valve in less than two minutes. |
  | Operating Temperature Range | The device should operate effectively across a suitable temperature range. | Tests conducted at 0 °C, 23 °C, and 70 °C showed the valve required less than two minutes to drain 500 mL at all these temperatures.
  Recommended: Use at temperatures between 0 °C and 70 °C. |

Note regarding Acceptance Criteria: The provided document does not explicitly state numerical acceptance criteria for current leaks (e.g., "current leaks must be

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The Foot Weight Alarm is intended for use in the weight bearing training of patients with various orthopedic and neurological disabilities, such as malunion fracture, amputation, and cerebral vascular accident. The Foot Weight Alarm helps train patients by limiting the amount of force placed on the leg or helping a patient to reach a set amount of force in order to facilitate the return to normal gait pattern,

The Foot Weight Alarm is a foot shaped insole device to fit inside the patient's shoe to warn the patient when they are putting too little or too much weight on a limited weight bearing foot. It consists of an Insole, a Shoe Pouch which laces to the shoe, a foot unit which fits in the Shoe Pouch and connects to the Insole, a data cable that is used by a health care professional to program the Foot Weight Alarm unit; and Foot Weight Alarm Calibration System used by the health care professional to program the Foot Unit.

The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. It describes a 510(k) summary for the "Foot Weight Alarm" device, focusing on:

• Submitter and Device Information: Name, address, contact, submission date, classification, common/proprietary name.
• Classification and Regulation: Class II, regulated as a powered external limb overload warning device.
• Substantial Equivalence: Claimed equivalence to the BarMed Pty. Ltd. Portable Limb Load Monitor BMLLM-100 (K915 326).
• Device Description: Foot-shaped insole with load sensors, shoe pouch, foot unit, data cable, and calibration system.
• Intended Use: Weight-bearing training for patients with orthopedic and neurological disabilities (malunion fracture, amputation, cerebral vascular accident) to limit or achieve a set amount of force on the leg.
• Summary of Safety and Effectiveness: States the device is similar in application and operation to the BarMed LLM-100, and that its safety and effectiveness are comparable. A table compares features like sensors, alarm, portability, and monitor dimensions.

The document lacks details on specific performance metrics, acceptance criteria, or any studies (standalone or comparative effectiveness) with data on accuracy, precision, sensitivity, specificity, or other quantitative measures. It does not mention sample sizes for test or training sets, ground truth establishment, expert qualifications, or adjudication methods.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, or details about the studies, as this information is not present in the provided text.

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