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The SLENDERTONE® Evolve Abs, Type 735 is indicated for the improvement of abdominal muscle tone, for strengthening of abdominal muscles, and for the development of a firmer abdomen.

The SLENDERTONE® Evolve Abs, Type 735 is a portable neuromuscular electrical stimulator intended to deliver electrical stimulation to the abdominal muscles. The device includes a control unit, abdominal garment, 3 adhesive gel pads (electrodes), USB cable and instructions for use. It contains twelve pre-installed programs.

The control unit is connected to the abdominal belt garment via three magnetic connectors. The control unit contains the primary controls for operation of the device and push buttons are available for switching the unit on or off and to increase or decrease the stimulation intensity. The SLENDERTONE® Evolve Abs, Type 735 contains an Organic Light-Emitting Diode (OLED) display which indicates status relating to battery charge and stimulation. Power is derived from a 3.7V Li-Po rechargeable battery pack and the unit can be recharged by using the supplied USB cable.

The SLENDERTONE® Evolve Abs, Type 735 is rated as IP22 for ingress protection. The user has no access to the wiring or connectors within the garment. For purposes of hygiene, the garment may be cleaned and instructions for garment care are included in the user manual.

The provided document is a 510(k) summary for the SLENDERTONE® Evolve Abs, Type 735, a powered muscle stimulator. It does not contain information about a clinical study or acceptance criteria based on human performance or AI performance.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (SLENDERTONE® Corefit Abs8, Type 734) by comparing technological characteristics and citing compliance with safety standards.

Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes for test/training sets, ground truth establishment, expert involvement, or MRMC studies for this specific device based on the given text.

The document states:

• Indications for Use: Improvement of abdominal muscle tone, strengthening of abdominal muscles, and development of a firmer abdomen.
• Performance Data (Safety Standards): The device complies with several international safety standards (IEC 60601-1, IEC 60601-1-6, IEC 60601-1-2, IEC 60601-2-10, IEC 60601-1-11, and IEC 62133 for batteries). These standards typically involve engineering and electrical safety tests, not clinical efficacy studies for the stated indications.
• Conclusion: The device is considered substantially equivalent to the predicate device, and any differences in technological characteristics do not raise new issues of safety or effectiveness.

To answer your request, a clinical study demonstrating the efficacy of this specific device for its indications would be required, which is not present in this 510(k) summary. The document explicitly states "Performance data has demonstrated that the SLENDERTONE® Evolve Abs, Type 735 is as safe and effective as the predicate device and is substantially equivalent," but this "performance data" refers to compliance with electrical and safety standards, not a clinical trial proving its effectiveness in improving muscle tone or firmness.

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The Innovo is a transcutaneous electrical stimulator indicated for the treatment of stress urinary incontinence in adult females.

The Innovo is indicated for prescription use only.

The Innovo is a single channel, rechargeable, non-implanted electrical stimulator that is intended for the treatment of stress urinary incontinence.

The Innovo is comprised of the following main components, along with accessories:

• Controller
• Body Garments (right and left)
• Gel Pads (8 surface electrodes)
• Battery Charger
• Lead Wire
• Neck Strap

The Controller generates the electrical stimulation patterns for coupling the stimulation signals to the body when sued with the Gel Pad electrodes and lead wire. The Body Garments, equipped with 8 surface electrodes, are worn by the patient and cover the buttocks, lateral pelvis, and upper thighs. The electrodes have a skin conductive adhesive hydrogel laver, a current dispersing layer, and a garment conductive adhesive hydrogel layer.

The four electrodes on the right side are combined into a single equivalent electrode (and similarly as are the electrodes on the left side). The electrical stimulation current is passed across the pelvic area (from the right side to the left site), thereby stimulating the pelvic floor muscles.

Innovo Device Acceptance Criteria and Study Analysis

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Innovo device are primarily derived from the "Summary of Clinical Information" and "Benefit-Risk Determination" sections, particularly an observed meaningful clinical improvement for the target condition.

2. Sample Sizes and Data Provenance

The primary clinical evidence supporting the Innovo device comes from two studies:

• Study 1 (Germany - Sham Controlled Trial):
  • Sample Size: N=50 women (N=24 in treatment arm, N=26 in control/sham arm completed 12 weeks of treatment). This study was "prematurely stopped."
  • Data Provenance: Germany, prospective, randomized, double-blinded, sham-controlled.
• Study 2 (USA - Randomized Non-Inferiority Study):
  • Sample Size: N=180 subjects (N=89 in Innovo group, N=91 in iTouch Sure group).
  • Data Provenance: USA (12 US sites), prospective, multicenter, randomized, non-inferiority clinical study.

3. Number of Experts and their Qualifications for Ground Truth

The document does not explicitly state the number or specific qualifications of experts used to establish ground truth for the clinical studies. However, the patient population for both studies consists of "women clinically diagnosed with stress urinary incontinence." This implies that the diagnoses were made by qualified medical professionals (e.g., urologists, gynecologists, or primary care physicians with relevant expertise), who would have established the initial inclusion criteria and therefore the "ground truth" of the SUI diagnosis for enrollment.

For objective measures like the 1-hour and 24-hour pad weight tests, the "ground truth" is established by the quantifiable weight of leaked urine, measured according to standardized protocols rather than a subjective expert assessment of individual cases. Similarly, questionnaires like iQoL and MESA rely on patient self-assessment.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for determining the "ground truth" of the test set beyond the initial clinical diagnosis for enrollment and the objective measurements of the primary and secondary endpoints. For quantitative outcomes like pad weight tests, the measurement itself serves as the ground truth. For patient-reported outcomes (QOL questionnaires), the patient's response is the ground truth.

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

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. The studies described are clinical trials evaluating the device's effectiveness and safety directly on patients, not AI-assisted reader performance. Therefore, there is no mention of the effect size of how much human readers improve with AI vs. without AI assistance.

6. Standalone (Algorithm Only) Performance Study

The Innovo device is a physical transcutaneous electrical stimulator, not an AI algorithm. Its "performance" refers to its efficacy in treating SUI in patients, not a standalone algorithm's diagnostic or predictive accuracy. Therefore, a standalone (algorithm only) performance study was not conducted or applicable to this device. The software in the controller manages stimulation patterns but is not described as an AI algorithm.

7. Type of Ground Truth Used

The ground truth used in the clinical studies was based on a combination of:

• Clinical Diagnosis: Women "clinically diagnosed with stress urinary incontinence" (for patient enrollment).
• Objective Outcome Measures:
  • Pad Weight Tests: 1-hour and 24-hour pad weight tests (quantifiable leakage in grams). This could be considered a form of "objective measurement" or "outcomes data" rather than expert consensus on retrospective images.
• Patient-Reported Outcome (PRO) Measures:
  • Incontinence Quality of Life Questionnaire (iQoL)
  • Medical Epidemiologic and Social Aspects of Aging Urinary Incontinence (MESA) Questionnaire
  • Global Impression of Improvement (PGI-I)

8. Sample Size for the Training Set

The document does not mention a "training set" in the context of an AI algorithm or machine learning. The clinical studies (Study 1 and Study 2) served as the primary data for evaluating the device's performance, but these are "test sets" in the clinical trial sense, not an AI training set. Therefore, a sample size for a training set is not applicable here.

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

As noted above, there is no mention of a "training set" for an AI algorithm. If "training set" is instead interpreted as data used to inform the device's design or initial performance parameters, these would likely come from pre-clinical research, feasibility studies, and possibly literature reviews, but the specific methods for establishing ground truth for such development phases are not detailed in this regulatory summary. The "series of smaller feasibility studies conducted during the development of the device" hint at such activities, but specific ground truth establishment for these is not provided.

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The SLENDERTONE® CoreFit Abs 8, Type 734 is indicated for the improvement of abdominal muscle tone, for strengthening of abdominal muscles, and for the development of a firmer abdomen.

The SLENDERTONE® CoreFit Abs 8, Type 734 is a portable neuromuscular electrical stimulator intended to deliver electrical stimulation to the abdominal muscles. The device includes a control unit, abdominal garment, 3 adhesive gel pads (electrodes), USB cable and instructions for use. It contains ten pre-installed programs. The control unit is connected to the abdominal belt garment via three magnetic connectors. The control unit contains the primary controls for operation of the device and push buttons are available for switching the unit on off and to increase or decrease the stimulation intensity. The SLENDERTONE® CoreFit Abs 8. Type 734 contains an Organic Light-Emitting Diode (OLED) display which indicates status relating to battery charge and stimulation. Power is derived from a 3.7V Li-Po rechargeable battery pack and the unit can be recharged by using the supplied USB cable.

This document is a 510(k) premarket notification for a medical device called SLENDERTONE CoreFit Abs 8, Type 734. It's a review by the FDA to determine if the device is "substantially equivalent" to a legally marketed predicate device. This type of submission relies on comparisons to existing devices rather than extensive clinical studies to prove effectiveness.

Therefore, the provided document does not contain the kind of detailed information about acceptance criteria, efficacy studies, expert adjudication, or MRMC studies that you requested for an AI/ML-based medical device.

The study described here is primarily safety and performance testing against electrical and electromagnetic compatibility standards, and biocompatibility testing of materials. It does not involve a "study that proves the device meets the acceptance criteria" in the sense of demonstrating improvement in muscle tone or strength through a clinical trial with human subjects and outcome metrics.

Here's an explanation based on the provided document, addressing your points where possible, and highlighting what is not present:

Key Takeaway from the Document:
The SLENDERTONE CoreFit Abs 8, Type 734 is an electrical muscle stimulator. Its clearance is based on substantial equivalence to a predicate device (Slendertone System Ultra, Type 390, Model E70/X70), meaning its technological characteristics and intended use are similar enough not to raise new questions of safety or effectiveness. This is not a new technology being proven effective through a clinical trial, but rather a demonstration that a new product design is as safe and performs similarly to an already approved one.

Here's a breakdown of the requested information, with answers based on the document and explanations for what is not applicable or present:

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

   The document does not provide acceptance criteria and reported device performance in terms of clinical efficacy (e.g., specific metrics for "improvement of abdominal muscle tone" or "strengthening of abdominal muscles" that would be measured in human subjects).

   Instead, it discusses biocompatibility testing results and compliance with international safety and performance standards for electrical medical devices.

   Table for Biocompatibility Testing:

   Test	Result	Toxicological Conclusion
   Cytotoxicity Test: MTT Method MEM with 10% FBS Extract	Potential toxicity at extract concentration >=75%	No toxicological risk to users.
   Cytotoxicity Test: MTT Method MEM Extract	No potential cytotoxic potential	No toxicological risk to users.
   Skin sensitization: Buehler test in guinea pigs	Dermal scoring using the Magnusson and Kligman scoring system was graded as 0 (no visible change)	No toxicological risk to users.
   Skin irritation Test: Direct contact	No abnormal signs were observed during the study. The response of skin on test side did not exceed that on the control side.	No toxicological risk to users.

   Performance Testing (Compliance with Standards):
   The document states: "Performance testing was conducted in accordance with the following international standards for safety:" followed by a list of IEC 60601 series standards (e.g., IEC 60601-1, IEC 60601-1-6, IEC 60601-1-2, IEC 60601-2-10, IEC 60601-1-11) and IEC 62133 for battery testing.
   The "acceptance criterion" here is compliance with these standards, which implies the device demonstrated it met the requirements (e.g., limits for leakage current, electromagnetic compatibility, usability, etc.). The specific numerical results of these tests (e.g., exact leakage current measurements) are not detailed in this summary.

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

   This document refers to engineering and biocompatibility testing, not human clinical trials or AI model validation data.

   • Biocompatibility: The tests used guinea pigs for skin sensitization and likely in-vitro cell cultures for cytotoxicity. The sample sizes for these biological tests are not specified in this summary.
   • Electrical Performance: These involve testing the device hardware against electrical and EMC standards. The "sample size" would typically be a few devices subjected to a series of tests in a lab.
   • Data Provenance: Not applicable in the context of clinical data. The tests were conducted to international standards, presumably in a controlled lab environment.

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)

   This is not applicable. The "ground truth" for this device's clearance is its compliance with recognized safety and performance standards and its technological similarity to a legally marketed predicate device. There is no "test set" in the context of clinical images or patient data that would require expert annotation to establish ground truth for an AI algorithm.

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

   Not applicable. There is no human reading or interpretation task that requires adjudication for this type of device clearance.

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. This device is an electrical muscle stimulator, not an AI diagnostic tool that assists human readers. Therefore, an MRMC study is not relevant.

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

   Not applicable. This is not an AI algorithm. Its performance is inherent to its electrical stimulation characteristics and physical design, not software-based interpretation of data.

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

   The "ground truth" for this 510(k) clearance is:

   • Compliance with established electrical safety and performance standards (IEC 60601 series).
   • Acceptable biocompatibility test results.
   • Demonstrated equivalence of technological characteristics and indications for use to a legally marketed predicate device.
   • Failure of a device to meet specific criteria outlined in these standards (e.g., excessive leakage current, failure of an electrical test) would constitute a "non-compliance" or "failure" against this ground truth.

8. The sample size for the training set

   Not applicable. This device does not use an AI/ML algorithm that requires a training set.

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

   Not applicable. There is no training set for an AI/ML algorithm.

In summary, the provided document describes a 510(k) substantial equivalence submission for a powered muscle stimulator. This process focuses on demonstrating safety and performance equivalence to an existing device through engineering tests and biocompatibility analysis, rather than proving clinical efficacy of a novel technology or validating an AI algorithm with clinical data. Therefore, most of your specific questions related to AI/ML device validation are not applicable to this document.

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The SLENDERTONE® Connect Abs, Type 570 is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. It is indicated for the improvement of abdominal muscle tone, for the strengthening of the abdominal muscles and for the development of a firmer abdomen.

The SLENDERTONE® Connect Abs, Type 570 is a portable, neuromuscular, electrical stimulation system intended to deliver electrical stimulation to the abdominal muscles. The system includes a control unit, abdominal garment, 3 adhesive gel pads (electrodes), USB cable, pouch and instructions for use. One toning program is pre-installed in the unit. Wireless communication is enabled by a Bluegiga BLE113 Bluetooth module. The modified Slendertone Connect Abs device supports a range of mobile devices via both iOS and android mobile applications.

This document is a 510(k) premarket notification for a medical device, the SLENDERTONE® Connect Abs, Type 570. It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed study proving the device meets specific acceptance criteria in a clinical context.

Therefore, the information requested regarding a study for acceptance criteria (sample size, data provenance, number of experts, adjudication, MRMC study, standalone performance, type of ground truth, training set sample size, and ground truth for training set) is not present in this document. This typically means such a study was not required or was deemed unnecessary for a 510(k) submission based on substantial equivalence.

However, the document does list various performance testing conducted in accordance with international safety standards. These tests are the "acceptance criteria" in the context of this submission, demonstrating the device's adherence to safety and essential performance requirements.

Here's the breakdown of what is available and what is not:

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

Regarding the study that proves the device meets the acceptance criteria, the following information is NOT available in the provided text:

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

• Not provided. The document states "Performance testing was conducted," but does not detail the methodology, sample sizes of devices or participants, or data provenance for these engineering and safety tests.

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 for this type of testing. The "acceptance criteria" here relate to engineering safety and performance standards for a powered muscle stimulator, not diagnostic accuracy requiring expert panel review or ground truth establishment in a clinical imaging or diagnostic context.

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

• Not applicable for this type of testing. Adjudication methods are typically used in clinical studies involving interpretation of results, which is not the nature of these engineering and safety compliance tests.

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 powered muscle stimulator, not an AI-assisted diagnostic or interpretation tool. Therefore, an MRMC study is irrelevant.

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

• Not applicable. This device is hardware with firmware/software, not an algorithm in the sense of a diagnostic AI. The "standalone" performance here refers to the device's electrical and mechanical safety compliance.

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

• Not applicable/Implicit. For engineering and safety standards, the "ground truth" is defined by the parameters and methodologies outlined in the referenced international standards (e.g., electrical safety limits, biocompatibility requirements, electromagnetic compatibility limits). Compliance is measured against these defined benchmarks.

8. The sample size for the training set:

• Not applicable. This device uses pre-programmed functionalities and does not indicate any machine learning or AI components that would require a "training set."

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

• Not applicable. As no training set is mentioned or implied.

In summary, this 510(k) submission successfully demonstrates substantial equivalence through a comparison of technological characteristics to a predicate device and via compliance with relevant safety and performance standards, rather than presenting a clinical study with subjective endpoints that would require the detailed information you requested.

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The SLENDERTONE® connect Abs is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. It is indicated for the improvement of abdominal muscle tone, for the strengthening of the abdominal muscles and for the development of a firmer abdomen. The SLENDERTONE® connect Abs, Type 570 is intended for over-the-counter use.

The SLENDERTONE® Connect Abs, Type 570 is a portable neuromuscular electrical stimulator intended to deliver electrical stimulation to the abdominal muscles. The device includes a control unit, abdominal garment, 3 adhesive gel pads (electrodes), USB cable and instructions for use. It contains one pre-installed program called 'Essential Toning'.

The SLENDERTONE® Connect Abs incorporates a Bluegiga BLE113 Bluetooth module to enable wireless communication and can be paired with a Bluetooth enabled iOS smart device running a Slendertone Connect iOS App, available from the Apple App store. The App implements a virtual control panel on the screen of the smart device where on-screen buttons are provided to the user.

The control unit is connected to the abdominal belt garment via an 8-pin interface. The control unit contains the primary controls for operation of the device and push buttons are available for switching the unit on or off and to increase or decrease the stimulation intensity. These controls remain active while the control unit is wirelessly paired with a smart device and can be used in the event of loss of Bluetooth connection. The SLENDERTONE® connect Abs contains light emitting diodes (LED) which indicate status relating to battery charge, stimulation and bluetooth activity. Power is derived from a 3.7V Li-Po rechargeable battery pack and the unit can be recharged by using the supplied USB cable.

The SLENDERTONE® Connect Abs, Type 570 is rated as IP22 for ingress protection. The user has no access to the wiring or connectors within the garment. For purposes of hygiene, the garment may be cleaned and instructions for garment care are included in the user manual.

This document is a 510(k) premarket notification for a muscle stimulator device, the Slendertone® connect Abs, Type 570. The purpose of this notification is to demonstrate that the new device is substantially equivalent to legally marketed predicate devices.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present acceptance criteria in the typical format of quantitative performance targets (e.g., sensitivity, specificity, accuracy) for clinical outcomes. Instead, the acceptance criteria are implicitly defined by compliance with a set of international safety and performance standards for medical electrical equipment and the demonstration of "substantial equivalence" to predicate devices. The reported "performance" is the demonstration of compliance with these standards and the comparison of technological characteristics to predicate devices.

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

The document describes performance testing against engineering and electrical standards, not a clinical study involving human subjects to evaluate muscle performance outcomes. Therefore, there is no "test set" in the context of a clinical study, no data provenance (country of origin, retrospective/prospective), and no "sample size" of patients/cases used for a clinical evaluation. The sample size for the engineering tests would refer to the number of devices tested, which is not specified but is typically a small, representative sample for such regulatory submissions.

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

Since there is no clinical "test set" with ground truth requiring expert adjudication for diagnosis or outcome, this information is not applicable to this submission. The "ground truth" here is compliance with established international engineering and safety standards, determined by testing procedures.

4. Adjudication Method for the Test Set

As there is no clinical "test set" requiring human interpretation or agreement on a diagnosis or outcome, an adjudication method is not applicable.

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

An MRMC comparative effectiveness study was not performed as part of this submission. This type of study is typically used to evaluate the diagnostic accuracy or effectiveness of an AI system (often in image-based diagnostics) compared to human readers, with or without AI assistance. This device is a muscle stimulator, and the submission focuses on engineering, electrical, and biocompatibility safety and performance, and substantial equivalence to predicates, not diagnostic accuracy.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

A standalone performance study in the context of diagnostic accuracy or clinical outcomes for an algorithm was not performed. The device itself is an electrical muscle stimulator, and while it has a "smart device" app, the "performance data" provided relates to the physical and electrical safety and functionality of the device, not an AI algorithm's standalone clinical performance.

7. Type of Ground Truth Used

The "ground truth" used for this submission is established international and national engineering, electrical, safety, and biocompatibility standards. Compliance is demonstrated through physical testing, measurements, and comparison to predicate device specifications. There is no pathology, expert consensus on clinical outcomes, or patient outcomes data presented in this context for "ground truth."

8. Sample Size for the Training Set

This submission does not involve an AI algorithm that requires a "training set" of data in the typical sense (e.g., for machine learning). The software/firmware in the device controls the electrical stimulation, but it's likely based on predefined programs and parameters, not a learned model from a large dataset. Therefore, there is no training set sample size described.

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

As there is no "training set," the method for establishing its ground truth is not applicable. The "ground truth" for the device's functional logic (i.e., how it's programmed to stimulate muscles) would stem from scientific understanding of neuromuscular stimulation and established therapeutic protocols, not from a data-driven training process for an AI.

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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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