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• 1. Relaxation Training
• 2. Muscle Re-education

The MuscleSense™ II is an EMG (Electromyography) device intended for medical use for muscle re-education and relaxation training. The MuscleSense II, AT , and Pathway MR-25 are all indicated for relaxation training and muscle reeducation. All three devices are used in conjucnction electrodes. The MuscleSense™ II tnresold sensitivity testing confirmed the device to fall within an acceptable sensitivity range to effectively monitor muscle activity. There is no electrical current being delivered to the patient. The device is supplied with pre-gelled conductive electrodes which have been cleared for marketing by the Food and Drug Administration under K851522/A. The device is battery powered or by a UL544 approved wall mounted power supply.

The provided text is a 510(k) summary for the MuscleSense™ II EMG device. While it describes the device's intended use and specifications, it does not contain any information about a study that proves the device meets specific acceptance criteria.

The summary states: "The MuscleSense™ II threshold sensitivity testing confirmed the device to fall within an acceptable sensitivity range to effectively monitor muscle activity." However, this is a general statement and does not provide details about acceptance criteria or the study methods used.

Therefore, I cannot populate the requested table and answer the subsequent questions fully. Here's why and what information would be needed:

Missing Information:

• Specific Acceptance Criteria: The document mentions "an acceptable sensitivity range" but does not define what that range is or any other specific performance metrics (e.g., accuracy against a known standard, precision, correlation with other EMG devices under specific conditions).
• Study Details: There is no mention of a formal study being conducted, its design, methodology, or results.
• Sample Size, Ground Truth, Experts, Adjudication, etc.: All of these details are dependent on a described study, which is absent from the provided text.

Based only on the provided text, here's what can be inferred or stated:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
No information provided. The text only mentions "threshold sensitivity testing" without details on experimental design or sample size.

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):
No information provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
No information provided.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is an EMG device, not an AI-assisted diagnostic tool for "human readers." No such study is mentioned or implied.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device itself is a "standalone" EMG device used for measurement. The description of "threshold sensitivity testing" implies an evaluation of the device's intrinsic measurement capabilities, which is a form of standalone performance assessment, but no details of such a study are given.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
No information provided. For EMG sensitivity, ground truth would typically involve a known electrical signal input or comparison to a gold-standard device, but this is not detailed in the summary.

8. The sample size for the training set:
Not applicable/No information provided. Device testing is described, not an AI training process.

9. How the ground truth for the training set was established:
Not applicable/No information provided. Device testing is described, not an AI training process.

In summary, the provided 510(k) document is very limited in its description of performance testing beyond a general statement of compliance. To answer these questions fully, a detailed study report or test protocol would be required.

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The Safety Poncho, Slider Poncho and the Pelvic Holder are intended for use to assist cooperative patients who require minimum support in wheelchair. The devices are labeled for prescription use and are not intended for lay use.

These devices are vest and pelvic holder style wheel chair accessories used to assist cooperative patients who require minimum support in a wheelchair. These devices are made of wolyester, cotton, nylon and vinyl configured into either a mesh or weave substrate. Each device utilizes straps for securing (tie) the patient in place.

This 510(k) summary (K96-3489) for the Smith & Nephew DonJoy "Safety Poncho, Slider Poncho and the Pelvic Holder" devices does not contain the information required to answer your request.

Here's why:

• Type of Device: This submission is for physical medical devices (wheelchair accessories) designed to assist cooperative patients with minimal support in a wheelchair. It is not an AI/ML-based diagnostic or imaging device.
• Nature of Evaluation: The summary states: "These devices have been commercially distributed for over four years and have not been associated with an MDR type complaint." This indicates that the regulatory clearance is based on a history of safe use and substantial equivalence to existing devices, rather than a performance study involving metrics like sensitivity, specificity, or accuracy that would be relevant for AI/ML devices.

Therefore, the following information is not present in the provided text:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study results.
6. Standalone (algorithm only) performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How the ground truth for the training set was established.

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These devices are Universal Gait Belt, Wheelchair Belt, Foam Limb Restraint, Double Buckle Limb Restraint, Comfort Safety Belt, Comfort Slider Belt, Universal Roll Belt and belt style restraints used to restrain patients in a wheelchair or bed. The devices are labeled for prescription use and are not intended for lay use.

These devices are made of polyester, cotton, nylon and polyethelen configured into either a mesh or weave substrate. Each device utilizes straps for securing (tie) the patient in place.

This 510(k) summary (K96-3490) is for patient restraint devices, not a digital health device or AI-powered medical device. Therefore, the requested information about acceptance criteria, study details, ground truth, and AI performance metrics is not applicable to this submission.

The document describes physical patient restraint devices (Gait Belts, Wheelchair Belts, Limb Restraints, Safety Belts, Roll Belts). The summary states: "These devices have been commercially distributed for over for years and have not been associated with an MDR type complaint." This statement serves as the de facto "proof" that the device meets safety and effectiveness criteria for substantial equivalence, implying a history of safe use rather than a formal clinical study with performance metrics.

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The Economy Restraint, Jacket Restraint, Two Piece Vest Restraint, Safety Vest and Hand Control Mitt are incended for use to assist cooperative patients who require minimum support in wheelchair. The devices are labeled for prescription use and are not intended for lay use.

These devices are vest, jacket and mitt style restraints used to restrain patients in a wheelchair or bed. These devices are made of polyester, cotton, nylon and polyethelen configured into either a mesh or weave substrate. Each device utilizes straps for securing (tie) the patient in place.

This 510(k) summary (K96-3492) describes patient restraints (Economy Restraint, Jacket Restraint, Two Piece Vest Restraint, Safety Vest, and Hand Control Mitt) manufactured by Smith & Nephew DonJoy Inc.

Based on the provided text, the submission focuses on demonstrating substantial equivalence to legally marketed predicate devices rather than proving performance against specific acceptance criteria through a study with detailed statistical analysis. Therefore, most of the requested information regarding acceptance criteria and study design is not present in this document.

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

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated as quantifiable metrics. The implicit acceptance criterion appears to be "no association with an MDR type complaint" over four years of commercial distribution.
• Reported Device Performance:
  • "intended for use to assist cooperative patients who require minimum support in wheelchair."
  • "labeled for prescription use and are not intended for lay use."
  • "vest, jacket and mitt style restraints used to restrain patients in a wheelchair or bed."
  • "made of polyester, cotton, nylon and polyethelen configured into either a mesh or weave substrate."
  • "Each device utilizes straps for securing (tie) the patient in place."
  • "have been commercially distributed for over four years and have not been associated with an MDR type complaint."

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

• Sample Size: Not specified. The performance claim of "commercially distributed for over four years" implies a real-world usage base, but no specific number of devices or patient uses is provided.
• Data Provenance: The data is retrospective, based on a four-year period of commercial distribution. The country of origin is not explicitly stated for the "data," but the manufacturer is based in the USA.

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

• Not applicable. This submission relies on a lack of adverse events from commercial distribution rather than expert-adjudicated test data.

4. Adjudication method for the test set:

• Not applicable. There's no test set in the traditional sense with adjudicated ground truth. The "adjudication" is essentially the absence of adverse event reports (MDRs) during commercial use.

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 physical restraint, not an AI or diagnostic imaging device.

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

• Not applicable. This device is a physical restraint.

7. The type of ground truth used:

• The "ground truth" for the safety aspect is the absence of adverse event reports (MDRs) during commercial distribution. For effectiveness, the "ground truth" is the presumed successful use of the devices for their intended purpose in the market, supported by the lack of complaints.

8. The sample size for the training set:

• Not applicable. There is no "training set" for this type of device submission. The device design is based on established engineering principles for restraints and materials, not machine learning.

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

• Not applicable.

In summary:

This 510(k) summary leverages the established market history and safety record of the devices as evidence for substantial equivalence, rather than providing a detailed study against specific numerical acceptance criteria. The focus is on demonstrating that the devices are similar to existing legally marketed devices and have a safe history of use.

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intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.

The MuscleMax™ Plus is a disposable single patient use (Electrical Muscle Stimulator) intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area. The output waveform consists of a 2200Hz biphasic, symmetrical one period signal (zero net DC component) in a series of low frequency (72 pps) bursts. Testing confirmed the device to fall within the acceptance criteria of 75uC for maximum charge per pulse when tested with a 500, 2K, and 10K Ohm load and the functional battery life of the device to exceed the minimum specification of 100 hours at maximum intensity. Because the wave is an alternating current, there is no net polar effects to cause long-term positive ion concentrations within the tissues beneath either electrode. The ON/OFF and intensity functions are controlled with a dial into the housing to reduce the potential recessed for inadvertent changes in intensity or accidental turning ON of the device. The unit has a green LED indicating when the unit is ON and releasing an electrical current, and a yellow LED indicating the unit is in the 20 second OFF cycle and will begin to release an electrical current within 20 seconds. The yellow LED warns the user not to increase the intensity until the green LED is illuminated to avoid inadvertent increases in output. The device is supplied with pre-gelled conductive electrode pads which have been cleared for marketing by the Food and Drug Administration under K912461. The electrode leads are strain relieved and designed to remain securely attached to the device (not removable), reducing the potential for attaching to AC power lines. The device is powered by four (4) 1.5 volt DC batteries contained within the housing.

Here's an analysis of the provided text regarding the MuscleMax™ Plus, focusing on the requested acceptance criteria and study information:

Based on the provided text, the MuscleMax™ Plus is an Electrical Muscle Stimulator (EMS) device, not an AI/ML-driven device that would typically involve the comprehensive "AI-specific" studies you've outlined. The information describes a hardware device with specific electrical and functional criteria, as opposed to an algorithm that processes data for diagnostic or predictive purposes.

Therefore, many of the requested fields pertaining to AI/ML device studies (like sample sizes for test and training sets, expert ground truth, adjudication, MRMC studies, standalone performance with AI, etc.) are not applicable to this traditional EMS device.

Here's the breakdown of the information that is available or can be inferred, and where the AI-specific questions are not applicable:

MuscleMax™ Plus Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable in the traditional sense for an AI/ML model. The text describes testing of the physical properties and performance of the device. It doesn't specify a "test set" of patient data or a number of devices tested for these criteria. The testing confirmed the device properties.
• Data Provenance: The testing was conducted internally by Smith & Nephew DonJoy Inc. The location is Carlsbad, CA, U.S.A. It's a prospective internal test, though the quantity of units tested is not specified.

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

• Not Applicable. Ground truth for this type of device refers to engineering specifications and performance measurements, not expert annotations of patient data.

4. Adjudication Method for the Test Set

• Not Applicable. This is relevant for subjective assessments or disagreements in AI model ground truth, not for objective electrical and functional device testing.

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

• No. This is not relevant for a direct EMS device. MRMC studies compare human performance (often with and without AI assistance) on clinical cases.

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

• Not Applicable. This device is not an algorithm that operates in a standalone capacity that would be evaluated in this manner. Its "performance" is its ability to meet electrical and functional specifications.

7. The Type of Ground Truth Used

• "Engineering Specifications" / "Bench Testing Results". The "ground truth" for this device's performance is adherence to its designed electrical parameters (e.g., charge per pulse, waveform characteristics) and functional specifications (e.g., battery life, LED operation).

8. The Sample Size for the Training Set

• Not Applicable. There is no "training set" as this is not an AI/ML device.

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

• Not Applicable. There is no "training set" as this is not an AI/ML device.

Summary of the Study that Proves Device Meets Acceptance Criteria:

The provided text states: "Testing confirmed the device to fall within the acceptance criteria of 75uC for maximum charge per pulse when tested with a 500, 2K, and 10K Ohm load and the functional battery life of the device to exceed the minimum specification of 100 hours at maximum intensity."

This indicates an internal engineering and quality assurance testing process performed by Smith & Nephew DonJoy Inc. The "study" here refers to the internal validation and verification processes common for medical devices, specifically bench testing and electrical parameter measurements, to ensure it meets its pre-defined design specifications. The specifics of "how many devices were tested" or "what exact methodology" are not detailed in this summary.

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The application of ice after surgery or injury to reduce swelling and pain is a well established treatment with well know indications and contraindications.

The device consists of a tank containing ice and water, a water pump to circulate cold water, a console containing a means to control and indicate temperature and a pad through which the cold water circulates. The purnp, contained in a waterproof case, is submerged in the ice water bath and connected to the console via insulated tubing through which the chilled water flows to and from the pad. The console is located along this tubing about halfway between the pad and the water bath for easy access by the patient. Leakage current for the device shall not exceed 100uA.

This document describes an ice therapy device. The provided text is a summary of safety and effectiveness, but it does not contain any information about acceptance criteria or a study proving the device meets those criteria, as typically understood in the context of AI/ML devices or diagnostic tools.

The document discusses:

• The general concept of cold therapy after surgery/injury.
• The device's components (tank, pump, console, pad).
• A safety specification: "Leakage current for the device shall not exceed 100uA." This is a single electrical safety standard, not a set of performance acceptance criteria.
• References to existing literature on the benefits of cold therapy, implying its well-established nature, rather than a specific study conducted for this device's performance.
• A comparison to other similar devices on the market, noting they are "more convenient and safer means to apply ice."

Therefore, I cannot fulfill the request as the essential information is missing from the provided text. To answer your questions, I would need a description of:

• Specific performance metrics (e.g., cooling rate, temperature accuracy, duration of cooling, comfort metrics, etc.)
• Target values or ranges for these metrics (acceptance criteria).
• Details of a study that measured these metrics for the device.

Without this information, I cannot complete the table or answer the specific questions about sample sizes, ground truth, expert involvement, or AI-related aspects, as these pertain to a different type of device evaluation than what is presented here.

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