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The Neurotech Recovery is intended for home use. Sale of the device has been restricted to sale under a prescription order from a licensed practitioner.

The Neurotech Recovery - Back Conductive Garment for the back and associated accessories are indicated for use with Neurotech Stimulators to facilitate the frequent and correct positioning and repositioning of large, multiple, and/or difficult to reach stimulation sites associated with the low back.

The Neurotech Recovery - Back Conductive Garment for the abdomen and associated accessories are indicated for use with Neurotech Stimulators to facilitate the frequent and correct positioning and repositioning of large, multiple, and/or difficult to reach stimulation sites associated with the abdominal area.

The Neurotech Recovery is a non-sterile, reusable conductive garment for single patient use only. It acts as an interface between the adhesive electrodes on the patient's skin and the Neurotech Plus electrical stimulator which provides Neuromuscular Electrical Stimulation (NMES) or Transcutaneous Electrical Nerve Stimulation (TENS).

The Neurotech Recovery is available as two options, each targeting separate areas of the human anatomy;

• 1. The Neurotech Recovery for the lower back which is constructed of the following materials: Main Panels: 89% Nylon & 11% Spandex laminated to Polyurethane, Silver Trace, Binding: 100% Cotton & Hook and Loop Fastener: 100% Nylon
• 2. The Neurotech Recovery for the abdomen which is constructed of the following materials; Main Panels: 100% Nylon, Binding: 82% Nylon & 18% Elastane, Hook and Loop Fastener: 100% Nylon & Foam Padding: 100% Polyurethane

Included with each Neurotech Recovery conductive garment are conductive gel pads, an extender strap and instructions for use. The device is intended be available by prescription only.

I am sorry; your request cannot be fulfilled. The document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for a medical device (Neurotech Recovery conductive garment) and primarily focuses on its description, intended use, technological characteristics (stating no new characteristics affect safety/effectiveness), and substantial equivalence to predicate devices. It explicitly states: "No clinical tests have been submitted as part of this premarket notification."

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The Neurotech Plus device is indicated for the following:

In combination Neuromuscular Electrical Stimulation (NMES) and Transcutaneous Electrical Nerve Stimulation (TENS) modes, models 431, 432, 433, 434, 436, 439 & 440:

NMES Indications:
Maintain or increase the range of motion
Prevention or retardation of disuse atrophy
Re-educate muscles
Relax muscle spasms
Increase local blood circulation
Prevention of venous thrombosis of the calf muscles immediately after surgery

TENS Indications:
Symptomatic relief and management of chronic, intractable pain
Relief of pain associated with arthritis
Adjunctive treatment in the management of post-surgical and post-trauma pain
Adjunctive therapy in reducing the level of pain and symptoms associated with osteoarthritis of the knee (models 431, 432 and 433 only)

In Neuromuscular Electrical Stimulation (NMES) only mode, models 437 & 441:

NMES Indications:
Maintain or increase the range of motion
Prevention or retardation of disuse atrophy
Re-educate muscles
Relax muscle spasms
Increase local blood circulation
Prevention of venous thrombosis of the calf muscles immediately after surgery

In Transcutaneous Electrical Nerve Stimulation (TENS) only mode, model 438:

TENS Indications:
Symptomatic relief and management of chronic, intractable pain
Relief of pain associated with arthritis
Adjunctive treatment in the management of post-surgical and post-trauma pain

The Neurotech Plus is a portable, two-channel; battery operated system which can provide both Neuromuscular Electrical Stimulation (NMES) and Transcutaneous Electrical Nerve Stimulation (TENS). The device is intended be available by prescription only. Included with the Neurotech Plus control unit, are a lead wire assembly, electrodes and instructions for use.

The Neurotech Plus contains ten program sets which have been each allocated an individual type number. Seven of these types offer a combination of NMES and TENS programs. There are two types which offer only NMES programs and one which has only TENS programs.

The lead-wire assembly contains the ID chip (EEPROM) that identifies the required program set. Each of the program set options are pre-programmed during manufacturing and no access to the configuration is available to either the end user or clinician. When each lead wire is connected to the unit and the outputs (A, B, C or D) to the electrodes, the two channels may be operated independently through the unit. Detailed diagrams for correct device usage and placement of the electrodes are available as part of the instructions for use.

This is a 510(k) premarket notification for a medical device (Neurotech Plus, Type 413) and, as such, it does not describe an acceptance criteria study in the way one might for an AI/ML device or software performance. This document focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use, rather than presenting a performance study with acceptance criteria and results.

However, I can extract information related to the device's characteristics and the comparison made to establish substantial equivalence, which is a form of meeting "acceptance criteria" in the context of a 510(k):

1. Table of Acceptance Criteria and Reported Device Performance

In a 510(k) submission, "acceptance criteria" is not explicitly stated as performance metrics like sensitivity/specificity for a diagnostic AI. Instead, substantial equivalence is established by demonstrating that the new device has the same intended use and similar technological characteristics to a legally marketed predicate device, or that any differences do not raise new questions of safety or effectiveness. The "reported device performance" is essentially the detailed technical specifications of the Neurotech Plus and how they compare to the predicate devices.

The tables (7.1 through 7.10) in the document provide a detailed comparison of the Neurotech Plus models with their respective predicate devices across various electrical stimulation parameters. These comparisons serve as the basis for demonstrating that the new device performs "as well as or better than" the listed predicate.

Below is an example of an abstracted table, as the original tables (7.1-7.10) are extensive and detailed for each model. I will use the information from Table 7.1 for Model 431 as an example comparison, highlighting how the new device's parameters compare to the predicate devices.

Abstracted Comparison Table (Example for Neurotech Plus Model 431 vs. Predicates)

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

The document explicitly states: "No new clinical tests have been submitted as part of this premarket notification." Therefore, there is no "test set" in the context of patient data, nor is there information on sample size or data provenance from a prospective or retrospective study. The primary "test" for this submission is a comparison of engineering specifications against predicate devices.

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

Since no new clinical tests were conducted and no patient-specific "test set" was used, there were no experts involved in establishing a "ground truth" for such a test set. The "ground truth" for a 510(k) is implicitly the established safety and effectiveness of the predicate devices.

4. Adjudication Method for the Test Set

Not applicable, as no new clinical test set requiring adjudication was used.

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

Not applicable. This is a 510(k) for a TENS/NMES device, not an AI/ML diagnostic or treatment assistance software. No MRMC study was performed.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This is a hardware medical device (Neurotech Plus, Type 413), not a standalone algorithm.

7. The Type of Ground Truth Used

In the context of a 510(k), the "ground truth" for demonstrating safety and effectiveness relies on the previously established regulatory clearance of the predicate devices. The technological characteristics and intended use of the Neurotech Plus were compared to these already approved devices. The ground truth is effectively the regulatory precedent set by the predicate devices.

8. The Sample Size for the Training Set

Not applicable, as this is not an AI/ML device and therefore does not involve a training set.

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

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

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BMR Face is intended for facial stimulation and is indicated for over the counter cosmetic use

BMR Face. Type 371/372* (* Type 372 is simply a black version of Type 371) is a twochannel, battery operated cosmetic device which is intended for use on the face. The device consists of a rechargeable electronic device which connects to an applicator. Each side paddle of the applicator contains a set of replaceable twin conductive gel pads which deliver electrical impulses to the face. The BMR Face device operates by applying Transcutaneous Electrical Nerve Stimulation (TENS) to the facial area. Low-level electrical impulses are sent from the stimulator unit via an applicator to gel pads that are positioned anterior to each ear and strategically over the cranial nerve #7 of the face, 3 programs are available to the user and these vary in treatment times from 10 to 20 minutes. Power is derived from a 3.6V NiMH rechargeable battery pack that is pre-installed in the unit and there is no capability for charging the unit whilst any treatment is ongoing. All internal connections of the unit are over molded to prevent moisture ingress.

The provided text describes a 510(k) submission for the "BMR Face, Type 371 & Type 372" device. It focuses on demonstrating substantial equivalence to a predicate device ("Rejuvenique® System") rather than presenting a study to prove the device meets specific acceptance criteria for performance in a clinical outcome.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets them in the context of clinical effectiveness or performance as an AI/ML device.

Here's a breakdown of why this information isn't available in the provided text:

• Device Type: This is a physical, electrical stimulator, not an AI-powered diagnostic or therapeutic device. The submission is for a medical device seeking clearance based on substantial equivalence to a legally marketed predicate device.
• Focus of the Submission: The 510(k) submission primarily focuses on comparing the technological characteristics of the new device to the predicate device to demonstrate that it is as safe and effective. It highlights aspects like intended use, indications for use, anatomical site utilized, energy used, materials, biocompatibility, electrical safety, mechanical safety, and adherence to various electrical and safety standards.
• Absence of Clinical Performance Data: The document explicitly states: "Clinical Tests: No new clinical studies have been submitted as part of this Premarket Notification." This confirms that no studies were conducted to measure specific performance metrics (like sensitivity, specificity, accuracy, etc.) against acceptance criteria for a clinical outcome.
• "Acceptance Criteria" in this context: The "acceptance criteria" here refer to the regulatory requirements and standards the device must meet (e.g., IEC 60601-1 for electrical safety, ISO 10993 for biocompatibility) to be deemed substantially equivalent and safe for marketing, not performance metrics related to a diagnostic or therapeutic outcome.

Based on the provided text, I cannot complete the requested tables and information because the document does not present a study proving the device meets performance-based acceptance criteria in the way typically expected for AI/ML devices or studies evaluating clinical effectiveness metrics.

The text only provides a summary of non-clinical tests demonstrating compliance with safety standards and a comparison of technological characteristics to a predicate device.

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The Kneehab XP, Type 412/421, Indications for use are as follows:

In NMES mode (Programs 1-6) the Kneehab XP is intended to:

• Maintain or increase the range of motion.
• Prevention or retardation of disuse atrophy
• Re-educate muscles
• Early post-surgical quadriceps strengthening and improved post surgical knee stability secondary to quadriceps strengthening
• Relax muscle spasms
• Increase blood circulation

In TENS Mode (Programs 7 - 9) the Kneehab XP is intended to:

• Provide symptomatic relief and management of chronic, intractable pain
• Provide an adjunctive treatment in the management of acute, post-surgical or post-traumatic pain
• Provide symptomatic relief and management of intractable pain and relief of pain associated with arthritis
• Provide an adjunctive therapy in reducing the level of pain and symptoms associated with osteoarthritis of the knee

The Kneehab XP, Type 412/421 is a portable, battery operated, combination device which can provide both neuromuscular electronic stimulation (NMES) and transcutaneous electrical nerve stimulation (TENS). The device incorporates multipath®, a patented technology developed by neurotech® which enables the Kneehab XP Conductive Garment to deliver highly focused and accurate NMES muscle contractions. This device also provides a method of pain management and relief through the use of TENS technology.

The Kneehab XP pack consists of a rechargeable control unit, a left or right universally sized garment, a pack of custom adhesive electrodes, a battery charger and instructions for use. The garment is fastened around the thigh and above the kneecap and contains a connector socket into which the control unit is plugged. Power is derived from a 3.6V NiMH rechargeable battery pack that is pre-installed in the unit. A battery charger is included with the device and the device cannot be used while being charged. The adhesive electrodes have an estimated usage capability of 20 sessions when used under the recommended conditions of use.

All internal connections of the unit are over molded to prevent moisture ingress. The user has no access to the wiring or connectors within the garment and is unable to alter the current path. There are nine treatment programs in total (six NMES and three TENS) with a duration of 20 minutes each. Program details are included in the instructions for use. For purposes of hygiene, the garment may be cleaned and instructions for device care are included in the user manual.

The provided document is a 510(k) Summary for the Kneehab XP, Type 412/421. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than providing clinical study data to meet specific performance acceptance criteria. Therefore, the document does not describe a study that proves the device meets specific acceptance criteria.

Instead, it focuses on comparing the technological characteristics and intended uses of the Kneehab XP to existing predicate devices to argue for substantial equivalence. The document primarily highlights technical and functional comparisons rather than performance metrics from a clinical trial.

Based on the provided document, I cannot fulfill all sections of your request as it does not contain the information regarding an acceptance criteria study.

However, I can extract the following relevant information regarding the device and its intended use, which would typically form the basis for performance evaluation in a clinical study:

1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria or reported device performance from a study. It only provides electrical output specifications.

Device Electrical Output Parameters (Technical Characteristics, not performance data):

Intended Use and Indications:

NMES Mode (Programs 1-6):

• Maintain or increase the range of motion.
• Prevention or retardation of disuse atrophy.
• Re-educate muscles.
• Early post-surgical quadriceps strengthening and improved post-surgical knee stability secondary to quadriceps strengthening.
• Relax muscle spasms.
• Increase blood circulation.
  TENS Mode (Programs 7-9):
• Provide symptomatic relief and management of chronic, intractable pain.
• Provide an adjunctive treatment in the management of acute, post-surgical or post-traumatic pain.
• Provide symptomatic relief and management of intractable pain and relief of pain associated with arthritis.
• Provide an adjunctive therapy in reducing the level of pain and symptoms associated with osteoarthritis of the knee.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable, as no performance study data is presented in this 510(k) summary.

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 no performance study data is presented in this 510(k) summary.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no performance study data is presented in this 510(k) summary.

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 is a medical device application for a physical device (electrical stimulator), not an AI/imaging diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device application for a physical device (electrical stimulator), not an algorithm-only device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no performance study data is presented in this 510(k) summary.

8. The sample size for the training set
Not applicable, as no performance study data is presented in this 510(k) summary.

9. How the ground truth for the training set was established
Not applicable, as no performance study data is presented in this 510(k) summary.

Summary of Device and 510(k) Submission:

The Kneehab XP is a portable, battery-operated combination device that provides both Neuromuscular Electrical Stimulation (NMES) and Transcutaneous Electrical Nerve Stimulation (TENS). Its primary purpose within this 510(k) submission is to demonstrate substantial equivalence to previously cleared predicate devices (Kneehab XP Conductive Garment, MediStim XP, MediTens XP, Staodyn Max Preset, 300 PV Complete Electrotherapy System, Bioncicare® Stimulator System). The submission details the technological characteristics, intended use, and indications for use of the Kneehab XP and compares them to these predicate devices, ensuring that there are "no new technological characteristics that could affect safety or effectiveness." The focus is on meeting international safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10) and demonstrating similarity in electrical parameters and functionality to the predicate devices.

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The AvivaFix Conductive Garment – Knee, AvivaFix Conductive Garment – Shoulder, and AvivaFix Conductive Garment - Upper Back (all Type 420) devices are intended for use with Neurotech Stimulator devices. It is intended to aid in the repeatable placement of electrodes (under the guidance of a clinician) and secure them in place.

The AvivaFix Conductive Garment - Knee, AvivaFix Conductive Garment - Shoulder, and AvivaFix Conductive Garment - Upper Back (all Type 420) devices also maintain a level of compression in the areas of electrode placement to maintain electrode placement during treatment.

The AvivaFix Conductive Garment - Knee, Type 420 is intended for use on the knee. The AvivaFix Conductive Garment - Shoulder, Type 420 is intended for use on the shoulder. The AvivaFix Conductive Garment - Upper Back, Type 420 is intended for use on the upper back (cervical) area.

The AvivaFix Conductive Garment - Knee, AvivaFix Conductive Garment - Shoulder, and AvivaFix Conductive Garment - Upper Back (all Type 420) devices and associated accessories are indicated for use with Neurotech Stimulators to facilitate the frequent and correct positioning and repositioning of large, multiple, and/or difficult to reach stimulation sites associated with the shoulder, knee and upper back (cervical) areas.

The AvivaFix Conductive Garment - Knee, AvivaFix Conductive Garment -- Shoulder, and AvivaFix Conductive Garment - Upper Back (all Type 420) are intended for use in conjunction with transcutaneous electrical nerve stimulation (TENS) and neuromuscular electrical stimulation (NMES). The garments aid in the placement of electrodes and secure the electrodes in place. The inner layer of the garment is constructed of Breathoprene", which is a breathable, stretchable fabric developed by AccuMed Technologies as a neoprene substitute to keep skin cooler and drier by wicking away perspiration.

The provided 510(k) summary for the AvivaFix Conductive Garments states that no new clinical studies have been submitted as part of this premarket notification. The submission relies on demonstrating substantial equivalence to legally marketed predicate devices. Therefore, the information requested regarding acceptance criteria, device performance, study details (sample sizes, ground truth, experts, adjudication, MRMC, standalone performance), and training set details for a study proving the device meets acceptance criteria is not applicable or not available in this document.

The document indicates that the device complies with several standards, which are typically used to demonstrate design and manufacturing quality rather than clinical performance against specific acceptance criteria. These standards include:

• 21 CFR 898: Performance standard for electrode lead wires and patient cables.
• ISO 14971:2007: Medical Devices Application of risk management to medical devices.
• ISO 10993-5: Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity.
• ISO 10993-10:2002/Amd. 1:2006: Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization.

The 510(k) summary focuses on the technological characteristics being similar to predicate devices and the device's adherence to relevant safety and biocompatibility standards. It does not contain a study explicitly designed to assess the device's performance against pre-defined acceptance criteria for its intended use through human or AI-based performance metrics.

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Flex Max by Stendertone is indicated for the improvement of abdominal muscle tone, for strengthening of the abdominal muscles and for the development of a firmer abdomen.

Flex Max by Slendertone, Type 517-US is a two-channel battery operated muscle stimulation, system specifically designed to exercise the abdominal muscles. It offers 10 programs to the user and comprises of two main components, an electronic stimulator module which generates the required stimulation signals and an abdominal electrode belt, which connects the signals from the stimulator to the skin electrodes located on the inner surface of the belt. The product is supplied with a double set of double-sided adhesive electrodes, a double set of batteries, an extender belt and an instruction manual. Power is derived from 3 x 1.5 volt (LR03) batteries located in a compartment protected by a removable battery cover. Instructions are provided in the user instructions. For purposes of hygiene, the garment may be cleaned and instructions for device care are included in the user manual.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Flex Max by Slendertone, Type 517-US:

It's important to note that the provided documentation is a 510(k) Premarket Notification for a medical device. This type of submission focuses on demonstrating substantial equivalence to a previously legally marketed device (predicate device), rather than a full de novo clinical trial proving efficacy and safety from scratch.

Therefore, the "acceptance criteria" here are primarily about demonstrating that the new device is as safe and effective as the predicate device, not necessarily defining specific performance metrics for muscle tone improvement. The "study that proves the device meets the acceptance criteria" refers to the entire 510(k) submission process, which relies on demonstrating equivalence rather than a dedicated clinical trial for performance.

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of "Acceptance Criteria" in this context: For a 510(k) submission, the primary "acceptance criterion" is to demonstrate substantial equivalence to a predicate device. This means showing that the new device has the same intended use, indications for use, and similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness. The device met this acceptance criterion, as indicated by the FDA's "substantial equivalence" determination.

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

• Sample Size for Test Set: Not applicable in the context of a new clinical study. The submission primarily relies on the established safety and effectiveness of the predicate device (Slendertone Flex, Type 515, K030708). No new clinical "test set" data from human subjects is provided beyond proving the new device's equivalence to the predicate.
• Data Provenance: Not applicable. No new human data is presented in this submission. The basis for equivalence is drawn from the predicate device’s prior clearance.

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

• Number of Experts: Not applicable. No "ground truth" was established for a new clinical test set in this submission.
• Qualifications of Experts: Not applicable.

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

• Adjudication Method: Not applicable. No clinical test set requiring adjudication was performed as part of this 510(k) submission.

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

• MRMC Study: No. This is a muscle stimulator device, not an imaging/diagnostic device that would typically involve human "readers" or AI assistance in that sense.
• Effect Size of Human Readers with/without AI: Not applicable.

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

• Standalone Performance: Not applicable. This device is a muscle stimulator, not an algorithm. Its operation inherently involves a human user applying it.

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

• Type of Ground Truth: The "ground truth" in this context is the FDA's prior determination of safety and effectiveness for the predicate device. The submission's "proof" relies on demonstrating that the new device is functionally identical or equivalent to this already cleared predicate device. There is no new clinical outcomes data or pathology presented for the Flex Max.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This is not an AI/machine learning device that requires a training set.

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

• Ground Truth for Training Set: Not applicable.

Summary of the Study:

The "study" described in the provided document is a 510(k) Premarket Notification submission, not a clinical trial. The manufacturer's strategy was to demonstrate substantial equivalence to a previously cleared predicate device (Slendertone Flex, Type 515, K030708).

• Key Argument: The device is "identical to the predicate device in design, materials, mode of operation, and methods of manufacture," differing only in "the addition of different program offerings to the user."
• Clinical Testing: "No additional clinical studies were provided as part of this submission." This indicates that the manufacturer relied entirely on the established safety and effectiveness of the predicate device and the similarity of the new device to the predicate, along with compliance with international electrical safety and electromagnetic compatibility standards.
• Ground Truth: The "ground truth" for the overall acceptance of the device is rooted in the FDA's previous clearance of the predicate device. By demonstrating substantial equivalence, the new device is deemed to carry the same safety and effectiveness profile as the predicate.

In essence, the "study" for this 510(k) submission primarily involved a technical comparison and regulatory compliance assessment to demonstrate that the Flex Max by Slendertone is sufficiently similar to an already approved device, making new clinical performance data unnecessary for its market clearance.

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The Slendertone System Ultra is indicated for the improvement of abdominal muscle tone, for the strengthening of the abdominal muscles and for the development of a firmer abdomen.

System Ultra, Type 390, Model E70/X70 is a two-channel, battery powered, muscle stimulation system. It is supplied with a three-electrode abdominal belt garment, a hand-held rechargeable control unit, a pack of 3 adhesive backed gel based electrodes, instructions for use and a carry pouch. The control unit is interchangeable between all the cleared System models from the Slendertone® range of garments. There are ten programs available to users of the System Ultra, Type 390, E70/X70. Power is derived from a 3.6V NiMH rechargeable battery pack pre-installed in the unit. All the internal connections are over-molded to prevent moisture ingress. The user has no access to the wiring or connectors within the garment and is unable to alter the current path.

The provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the way typically found for AI/ML devices, such as performance metrics (e.g., accuracy, sensitivity, specificity) against a ground truth.

This document is a 510(k) summary for a muscle stimulator (System Ultra, Type 390, Model E70/X70) by Bio-Medical Research Ltd. It primarily focuses on demonstrating substantial equivalence to a predicate device (Slendertone System-Abs, Type 390, E10/X10) based on technological characteristics and compliance with international safety standards, rather than clinical performance metrics of an AI/ML algorithm.

Therefore, most of the requested information regarding acceptance criteria, reported device performance, sample sizes, expert involvement, ground truth, and specific study types (MRMC, standalone) for an AI/ML device is not applicable or not provided in this document.

Here's a breakdown of what can be extracted and what is missing based on the prompt:

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

• Acceptance Criteria (Implicit): Substantial equivalence to the predicate device in terms of intended use, technological characteristics, and compliance with safety standards. The FDA's approval indicates these implicit criteria were met.
• Reported Device Performance: Not presented as specific performance metrics (e.g., accuracy, precision) as would be for an AI/ML device. The "performance" is implicitly tied to its ability to meet the intended use safely, similar to the predicate. The document states: "System Ultra, Type 390, E70/X70 device complies with the following international safety standards:" followed by a list of IEC standards.

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

• Not applicable / Not provided: This document does not describe a clinical study with a test set in the context of AI/ML performance evaluation. It states, "No new clinical studies have been submitted as part of this premarket notification." The evaluation was based on demonstrating equivalence and compliance to standards.

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

• Not applicable / Not provided: No ground truth establishment by experts for a test set is described.

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

• Not applicable / Not provided: No adjudication method is described as there is no test set in the context of an AI/ML performance study.

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: No MRMC study was done, as this is not an AI-assisted device.

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

• No: This is not an AI/ML algorithm, so no standalone algorithm performance study was relevant or performed.

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

• Not applicable / Not provided: The concept of "ground truth" as used in AI/ML performance evaluation is not relevant to this submission, which relies on equivalence and compliance with engineering standards.

8. The sample size for the training set

• Not applicable / Not provided: There is no AI/ML algorithm, so no training set is mentioned.

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

• Not applicable / Not provided: Not an AI/ML algorithm.

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The Kneehab XP Controller is indicated for muscle re-education of the quadriceps, maintaining or increasing range of motion of the knee joint, prevention or retardation of disuse atrophy in the quadriceps, early post-surgical quadriceps strengthening and improved post-surgical knee stability secondary to quadriceps strengthening and increasing local blood circulation.

The Kneehab XP Controller is a portable, two-channel transcutaneous electrical muscle stimulator incorporating multipath®, a patented technology developed by neurotech®. It is designed to work in conjunction with the Kneehab XP. Conductive Garment and electrodes to deliver highly focused and accurate quadriceps contractions by using constant current pulses to stimulate the nerves in the quadriceps area of the body. The Kneehab XP controller is supplied with a rechargeable control unit, battery charger and instructions for use. Power is derived from a 3.6V NiMH rechargeable battery pack that is pre-installed in the unit. The controller may be only be connected to the garment/electrodes or the charger due to the utilisation of a single custom connector. All the internal connections of the unit are over-molded to prevent moisture ingress. There are three treatment programs in total with duration of 20 minutes each and details of these are included in the instructions for use.

The provided document describes a 510(k) premarket notification for the Kneehab XP Controller (Type 411), a powered muscle stimulator. This type of submission is used to demonstrate that a device is substantially equivalent to a legally marketed predicate device, rather than proving its safety and effectiveness through extensive clinical trials. Therefore, the document does not contain information about specific acceptance criteria, device performance metrics, or a study designed to explicitly meet such criteria in the way a clinical trial would.

Instead, the "study" described is a demonstration of compliance with established electrical safety and electromagnetic compatibility (EMC) international standards, and an assertion of substantial equivalence to a previously cleared device.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, this document does not present "acceptance criteria" in the typical sense of a clinical trial (e.g., target diagnostic accuracy, sensitivity, specificity) nor does it report performance against such metrics. Instead, the device's "performance" and "acceptance" are demonstrated by its compliance with relevant safety standards and its technological equivalence to a predicate device.

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

This document does not describe a test set or data provenance in the context of a clinical performance study. The "test" involved demonstrating compliance with technical standards through engineering evaluations and documentation, not through patient data.

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

Not applicable. There was no "test set" requiring ground truth established by experts as part of a clinical evaluation. Compliance with standards is verified by testing laboratories and regulatory bodies.

4. Adjudication Method for the Test Set

Not applicable. There was no "test set" requiring expert 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 muscle stimulator, not an AI-powered diagnostic or assistive technology. No MRMC study was performed.

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

Not applicable. This device is a physical muscle stimulator, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context is the existence of established international safety and EMC standards (e.g., IEC 60601 series). Compliance with these standards serves as the benchmark against which the device's technical specifications and test results are evaluated.

8. The Sample Size for the Training Set

Not applicable. There is no concept of a "training set" for this type of device and regulatory submission.

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

Not applicable. There is no concept of a "training set" or "ground truth" for it in this context.

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The Neurotech Kneehab Conductive Garment and associated accessories are indicated for use with Neurotech Stimulators to facilitate the frequent and correct positioning and repositioning of large, multiple, and/or difficult to reach stimulation sites associated with the quadriceps area of the leg.

The proposed Kneehab XP Conductive Garment is an integrated thigh wrap garment designed to be used in conjunction with a Neurotech stimulator and custom electrodes for the application of neuromuscular electrical stimulation (NMES) to the quadriceps muscles of the thigh. The garment is supplied with a set of four custom designed adhesive pads which may positioned on the inner garment outlines according to fit of the user. Instructions are provided in the user instructions for correct electrode placement. For purposes of hygiene, the garment may be cleaned and instructions for device care are included in the user manual.

The provided document is a 510(k) premarket notification for a medical device called the "Kneehab XP Conductive Garment." This submission aims to demonstrate substantial equivalence to previously cleared devices.

Based on the content, here's the information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and the Reported Device Performance:

The document states: "No clinical or non clinical tests were performed to support substantial equivalence." This means there are no specific acceptance criteria or reported device performance metrics established for this particular submission. The basis for clearance is substantial equivalence to predicate devices, not performance against pre-defined criteria.

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

• Sample size for test set: Not applicable, as no new clinical or non-clinical tests were performed.
• Data provenance: Not applicable.

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

• Number of experts: Not applicable.
• Qualifications of experts: Not applicable.

4. Adjudication method for the test set:

• Adjudication method: Not applicable.

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:

• MRMC study: No, an MRMC study was not done, as no clinical tests were performed. This device is not an AI-based system.
• Effect size: Not applicable.

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

• Standalone study: No, a standalone study was not done. This device is not an algorithm.

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

• Type of ground truth: Not applicable, as no new clinical or non-clinical tests were performed for this submission. The ground truth for the predicate devices would have been part of their original clearance process, but that information is not provided here.

8. The sample size for the training set:

• Sample size for training set: Not applicable, as this device submission did not involve a machine learning algorithm requiring a training set.

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

• Ground truth establishment: Not applicable.

Summary of the Study:

The document explicitly states: "No clinical or non clinical tests were performed to support substantial equivalence." This 510(k) submission relies entirely on demonstrating that the "Kneehab XP Conductive Garment" is substantially equivalent to legally marketed predicate devices (Kneehab XP Conductive Garment, Type 411 - K083105 and Lumbofix™ Conductive Garment - K091317) by showing that it has the same intended use and similar technological characteristics, with the only difference being that it is not packaged with a battery pack, charger, or control unit. Therefore, no new studies, acceptance criteria, or performance data were generated or required for this particular submission.

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Muscle re-education of the quadriceps, Maintaining or increase range of motion of the knee joint, Prevention or retardation of disuse atrophy in the quadriceps, Early post-surgical quadriceps strengthening and improved post-surgical knee stability secondary to quadriceps strengthening, Increasing local blood circulation.

The Kneehab XP Conductive Garment is a portable, two-channel transcutaneous electrical muscle stimulator incorporating multipath®, a patented technology developed by neurotech®. This technology enables the Kneehab XP Conductive Garment to deliver highly focused and accurate quadriceps contractions and operates by using constant current pulses to stimulate the nerves in the quadriceps area of the body. These pulses are designed to cause muscular contractions through the application of electrical stimulation to the peripheral nervous system. The Kneehab XP pack consists of a rechargeable control unit, a left or right universally sized garment, a pack of custom adhesive electrodes, a battery charger and instructions for use. The garment is fastened around the thigh and above the kneecap and contains a connector socket into which the control unit is plugged. Power is derived from a 3.6V NiMH rechargeable battery pack that is pre-installed in the unit. A battery charger is included with the device. This device cannot be used while being charged. All internal connections of the unit are over molded to prevent moisture ingress. The user has no access to the wiring or connectors within the garment and is unable to alter the current path. There are three treatment programs in total with duration of 20 minutes each. Program details are included in the instructions for use. For purposes of hygiene, the garment may be cleaned and instructions for device care are included in the user manual.

The provided text is a 510(k) premarket notification for the Kneehab XP Conductive Garment, Type 411. This document primarily focuses on establishing substantial equivalence to previously marketed devices and does not contain detailed information about a study that describes acceptance criteria and device performance in the format requested.

Specifically, the document does not provide the following information:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for a test set or its data provenance.
• The number or qualifications of experts used to establish ground truth.
• Adjudication methods.
• Details of a multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
• Standalone (algorithm-only) performance results.
• Specific ground truth types used for evaluation (beyond the general indication that a clinical study was submitted).
• Sample size for a training set.
• How ground truth for a training set was established.

The document does mention:

• A clinical study: "A clinical study, 'The effectiveness of the Kneehab™ in strengthening the quadriceps of patients in rehabilitation after anterior cruciate ligament reconstruction'', has been submitted as part of this 510k premarket notification." (Page 2, Section 7)

This indicates that a clinical study was performed and submitted, but the detailed results, methodology, and performance metrics are not included in this summary. The 510(k) summary is designed to demonstrate substantial equivalence, often by referencing conformance to standards and the content of such studies, rather than providing the full study report itself.

Therefore, I cannot populate the requested table and answer the questions based on the provided text alone. The document confirms that a clinical study exists and was submitted, but it does not detail its findings in the manner you've asked for.

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