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Air Compression Leg Massager is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in people who are in good health. Air Compression Leg Massager simulates kneading and stroking of tissues by using an inflatable garment.

Air Compression Leg Massager is a portable and rechargeable device. It is intended to be an over-the-counter portable inflatable tube massage system which simulates kneading of tissue with the hards by use of inflatable presure cuffs. It can be used to temporarily increase blood circulation and temporarily relieve minor muscle aches and pains.

Air Compression Leg Massager supplied clean and non-sterile, utilizes the pneumatically controlled by an electronically controlled air pump unit. A pump, battery and control components are protectively housed in a plastic case of Controller.

Function buttons and light emitting diode (LED) indicators on the user interface. There is a charging port at the bottom of Controller for connecting the alternating current (AC) adapter plug.

Each leg wap has an air hose for connection to Controller, and both encase a 2-chamber air bladder inside. It can be wrapped and massaged separately by the two chambers. The soft medical fabric of wraps provides patient comfort and biocompatibility compliance.

Air Compression Leg Massager is also capable of providing the warming and vibration, these are included for an improved user experience.

The provided text does not contain detailed information about acceptance criteria for device performance or a study that specifically proves the device meets those criteria. The document is a 510(k) summary for an Air Compression Leg Massager, primarily focusing on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with specific acceptance criteria and results for the subject device.

The "Performance Data" section (VIII) lists several non-clinical tests performed to support the substantial equivalence determination, but these are primarily related to safety, electromagnetic compatibility, battery safety, and software validation, not the direct clinical performance of improving circulation or relieving aches and pains.

Therefore, many of the requested details cannot be extracted from this document. However, I can summarize what is present:

What is present in the document:

• Non-clinical tests performed: Biocompatibility, Electrical Safety and EMC, Battery Safety, and Software Verification and Validation.
• Result of these tests: They "passed" or "demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels."
• Overall Conclusion: The device is considered "as safe, as effective, and performs as well as the primary predicate device and secondary predicate device" based on this analysis and non-clinical tests.

What is NOT present in the document (and thus cannot be filled in):

• A table of acceptance criteria and reported device performance for clinical effectiveness (e.g., specific metrics for pain relief or circulation increase).
• Sample size used for a performance test set.
• Data provenance (e.g., country of origin, retrospective/prospective) for a performance test set.
• Number of experts used or their qualifications for establishing ground truth (as no clinical performance study is detailed).
• Adjudication method for a test set.
• Information on a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or effect size.
• Information on a standalone (algorithm only) performance study.
• The type of ground truth used for clinical performance.
• The sample size for the training set (as it's a physical device, not an AI/ML algorithm that requires a training set in the described sense).
• How the ground truth for the training set was established.

Based on the available information, here's a summary of the compliance for the listed non-clinical tests:

Study that proves the device meets the acceptance criteria:

The document states that the substantial equivalence determination is supported by these non-clinical performance data. It does not describe a clinical study measuring the device's efficacy in achieving "temporary relief of minor muscle aches and pains" or "temporary increase in circulation," as the FDA often relies on technological similarity to a predicate device for this type of claim, assuming the predicate's effectiveness. The listed tests are primarily aimed at ensuring the device's safety and fundamental operational integrity as an inflatable tube massager.

Therefore, for the clinical performance claims (pain relief, circulation increase), the "study" is implicitly the demonstration of substantial equivalence to already cleared predicate devices that have established these claims, rather than a de novo clinical trial with specific clinical acceptance criteria for the subject device.

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Buzzy® is intended to control pain associated with needle procedures (e.g., injections, vascular access, cannulation, lab draws, blood donation, dialysis, cosmetic and dental injections) and the temporary relief of minor injuries (muscle or tendon aches, splinters, and bee stings).

VibraCool® is intended for the temporary relief of minor injuries (muscle or tendon aches) and the treatment of myofascial pain post-surgery. It is also indicated for use prior to or during physical therapy to treat myofascial pain caused by trigger points, restricted motion and muscle tension.

Buzzy® and VibraCool® devices are external use, skin contacting vibration devices that can be used with heat (for VibralCool® Flex, VibraCool® Pro UE and VibraCool® Pro LE)or cold therapy (for all Buzzy® and VibraCool® models) to provide pain relief. The brand names encompass the same two shapes of vibrating devices using the same motor. Buzzy Pro and VibraCool Pro are a new shape with the same motor submitted in this 510K. To accommodate various uses and anatomical locations, the Buzzy and VibraCool devices are available in three different shapes and are provided with different sets of accessories.

The provided text describes the acceptance criteria and the study that proves the device meets those criteria for the Buzzy® and VibraCool® devices, not a medical imaging AI device. Therefore, much of the requested information regarding AI acceptance criteria, sample sizes for test and training sets, expert qualifications, ground truth establishment, and MRMC studies is not applicable to this document.

However, I can extract the relevant information concerning the device's performance validation based on the provided text.

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

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

The document does not explicitly state "acceptance criteria" in a tabulated format with numerical targets that the device had to meet for pain reduction. Instead, it refers to a clinical study that evaluated the device's effect on pain.

Implicit "Acceptance Criteria" (based on study results):

• Reduced pain during/after vaccination. The study results show a statistically significant reduction in pain scores for the Buzzy group compared to the control.

Reported Device Performance (from Clinical Study - Table 4):

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

• Sample Size: N = 60 (for the clinical study in infants).
• Data Provenance: The document does not specify the country of origin. It indicates it was a "Prospective, randomized study" of infants receiving the MMR vaccine.

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

• Number of Experts: Not explicitly stated as "experts" for ground truth, but "nurses and parents" rated the pain using the FLACC scale. No specific qualifications (e.g., years of experience) are provided for these raters.

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

• Adjudication Method: Not specified. Pain was rated by nurses and parents, but it's not clear if there was any conciliation or adjudication process if their ratings differed.

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 not an AI device. The study evaluated the direct effect of the Buzzy device on pain compared to a control.

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

• Standalone Performance: Not applicable, as this is a non-AI therapeutic device.

7. The type of ground truth used

• Type of Ground Truth: Pain scores rated by nurses and parents using the FLACC (Faces, Legs, Arms, Cry, Console) scale, which is an observational pain scale. This could be considered observational/clinical assessment data as ground truth.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This is a non-AI device; there is no "training set" in the context of machine learning. The clinical study described in Table 4 is the validation study for the device's efficacy.

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

• Ground Truth Establishment for Training Set: Not applicable, as there is no training set for an AI model.

Summary of Non-AI Related Information from Document:

The document outlines the FDA's 510(k) clearance for Buzzy® and VibraCool® devices based on their substantial equivalence to a predicate device (K130631 Buzzy®). The primary changes and justifications for substantial equivalence include:

• Addition of VibraCool models: Justified by using the same vibration device, external use, and supporting clinical data for vibration + heat/cold therapy for pain.
• Addition of "Pro" lines (Buzzy Pro, VibraCool Pro): Justified as being identical in materials, motor, circuitry, functionality, and intended use, differing only in shape.
• Updated Indications for Use: Clarified "needle procedures" for Buzzy with examples, and refined VibraCool's indications regarding myofascial pain, stating these clarifications do not introduce new questions of safety/effectiveness.
• Expanded Patient Population: Buzzy with cold pack is now indicated for 1 year and older (vs. 4+), and VibraCool/Pro with hot pack for 12 years and older. This was supported by a clinical study.

Non-Clinical Testing:

• Temperature testing (device surface and skin surface).
• Seal integrity/strength testing of hot packs.
• Shelf stability tests of hot packs.
• Electrical safety and electromagnetic compatibility (IEC 60601-1, IEC 60601-1-11, CFR 47 FCC Part 15).

Clinical Testing:

• A prospective, randomized study evaluated the effect of Buzzy on pain in 60 infants (12-month olds) receiving the MMR vaccine.
• Results: The Buzzy group showed significantly lower average pain scores (FLACC scale) during and after vaccination compared to the control group (p=.001 for both). Pulse was also lower after injection for Buzzy (p=.037).
• Ground Truth: Pain rating by nurses and parents using the FLACC scale.

The conclusion is that based on non-clinical testing and clinical evidence from published studies, the new and modified devices do not raise new issues of safety or effectiveness and are substantially equivalent to the predicate.

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The device can work in multiple function modes as following with different indication for use:

1. The red light is intended to treat periorbital wrinkles.
2. The blue light is intended to treat mild to moderate inflammatory acne.
3. The Red + IR is intended to treat periorbital wrinkles.

The TheraFace LED device is a lightweight device which uses specified wavelengths of LED light. For LED light irradiation function, the device produces light in the red light region of the spectrum (633±10nm), combination of IR and Red light (830nm±10nm&633 ± 10 nm), or in the blue light region of the spectrum(415±10nm).

The TheraFace LED device consists of a main control unit and its attachment applicators for the LED irradiation ring, which can be controlled by the device control button. The device is powered by one internal lithium rechargeable battery which can be charged by an external batterv charger.

Red light mode: In Red light irradiation mode, the device utilizes Light Emitting Diodes to emit The output is adjustable to one wavelength with a narrow spectral bandwidth in red light. It provides narrow bands of red-light energy and is intended to treat periorbital 633±10nm. wrinkles.

Blue light mode: In blue light irradiation mode, the device utilizes Light Emitting Diodes to emit blue light. The output is adjustable to one wavelength with a narrow spectral bandwidth in 415 ±10nm. It provides narrow bands of blue light energy to facial skin, and is intended to treat mild to moderate inflammatory acne.

Red+ IR mode: When the device is operated in the red combined with infrared light mode, it emits LED light in the RED (633 nm) and IR (830 nm) spectrum on facial skin. It is intended to treat periorbital wrinkles.

This document is a 510(k) summary for the TheraFace LED device, asserting its substantial equivalence to previously cleared devices. It does not contain information about acceptance criteria, device performance metrics, or study details in the format requested.

Specifically, the document states:

• "There were no clinical studies performed." (Page 9)
• It outlines "Performance Standards Applied" (Page 8-9) which are a series of bench tests for electrical safety, electromagnetic compatibility, and biocompatibility, designed to show the device meets general safety standards, similar to predicate devices. These are not acceptance criteria related to efficacy or clinical performance.
• It mentions "PERFORMANCE TESTING BENCH" (Page 9) including a "Usability Study Report" and "TheraFace LED Light Power Density Test Report," but provides no details on acceptance criteria or results from these reports.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the 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. Multi-reader multi-case (MRMC) comparative effectiveness study details.
6. Standalone performance details.
7. Type of ground truth used.
8. Sample size for the training set.
9. How the ground truth for the training set was established.

This document focuses on technical and safety comparisons to predicate devices, not on clinical performance studies.

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This device is intended for facial stimulation and is indicated for over-the-counter cosmetic use.

SonicLift (Model: ST261) is a non-invasive facial toning device intended for at-home cosmetic use. It has two treatment modes - Vibration Mode and Micro-current Mode. In the Vibration Mode, mechanical vibration at the frequency of 108.7Hz can help to relax facial muscles. In the Micro-current Mode, the low voltage micro-current impulses are emitted from dual probes that are designed for optimal contact with faces of all shapes and sizes. SonicLift, Model: ST261 allows you to adjust the current output from 0 to 280 microamps for a personalized comfort level.

This document is a 510(k) premarket notification for the Pretika SonicLift, Model ST261. It aims to demonstrate substantial equivalence to predicate devices (NuFace and WAHL FRESH FACE) for facial stimulation and cosmetic use. The document focuses on demonstrating safety and performance through bench testing and comparison to existing standards, rather than a clinical study with specific performance metrics against an established ground truth that would be associated with typical diagnostic AI/ML device submissions.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) for a physical device (facial stimulator) rather than a diagnostic AI/ML algorithm, the "acceptance criteria" are primarily related to safety and electrical performance standards, and comparison to predicate devices, rather than diagnostic accuracy metrics like sensitivity, specificity, or AUC. The "device performance" likewise refers to compliance with these standards and physical characteristics.

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

This submission is for a physical device and relies on bench testing and comparison to predicate devices, not an AI/ML algorithm that operates on a "test set" of patient data. Therefore, the concept of a "test set" with a sample size and data provenance in the context of an AI/ML device is not applicable here.

• The biocompatibility tests (Cytotoxicity, Sensitization, Irritation) would have involved specific biological samples (e.g., L929 cells, guinea pigs) as per ISO standards. However, the exact sample sizes for these biological tests are not provided in this summary.
• The electrical safety, EMC, software, and waveform tests are engineering bench tests, not involving patient data.

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

This information is not applicable. This device is not a diagnostic AI/ML device where "ground truth" for patient data would be established by medical experts for a test set. The "ground truth" for this device's safety and performance is based on compliance with established engineering and biocompatibility standards (IEC, ISO, USP) and comparison to predicate devices, which are defined by regulatory frameworks rather than expert consensus on specific cases.

4. Adjudication Method for the Test Set

Not applicable, as there is no "test set" of patient data requiring adjudication in the context of an AI/ML diagnostic device.

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

No. This is not a diagnostic AI/ML device. MRMC studies are typically used to evaluate the performance of diagnostic devices (often imaging-based AI) compared to human readers.

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

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

7. The Type of Ground Truth Used

The "ground truth," in the context of this device's submission, is compliance with recognized international standards for medical device safety and performance (IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2, ISO 10993-5, ISO 10993-10), and the demonstrated substantial equivalence to legally marketed predicate devices (NuFace, WAHL FRESH FACE). This is a regulatory "ground truth" rather than a clinical "ground truth" of disease presence/absence.

8. The Sample Size for the Training Set

Not applicable, as this is not an AI/ML device that requires a "training set" of data.

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

Not applicable, as there is no "training set" for this device.

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Control pain associated with injections, venipuncture, IV starts, cosmetic injections and the temporary relief of minor injuries (muscle or tendon aches, splinters and bee stings). Also intended to treat myofascial pain caused by trigger points, restricted motion and muscle tension

Not Found

The document provided is an FDA 510(k) clearance letter for the device "Buzzy®". This type of document is a regulatory approval, not a scientific study report. Therefore, it does not contain the information requested regarding acceptance criteria, study details, or performance metrics of the device.

The letter confirms that the FDA has reviewed the manufacturer's premarket notification and determined that the device is substantially equivalent to legally marketed predicate devices. It lists the "Indications for Use" for the Buzzy® device, but it does not present any data from studies proving that the device meets those indications with specific performance metrics.

To address your specific questions:

1. A table of acceptance criteria and the reported device performance: This information is not present in the provided FDA letter.
2. Sample size used for the test set and the data provenance: Not available in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available in this document.
4. Adjudication method for the test set: Not available in this document.
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 available in this document. This device is a therapeutic vibrator, not an AI-assisted diagnostic tool, so an MRMC study with AI assistance would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not available in this document. As it is not an algorithm-based device, this is not relevant.
7. The type of ground truth used: Not available in this document.
8. The sample size for the training set: Not available in this document.
9. How the ground truth for the training set was established: Not available in this document.

In summary, the provided FDA 510(k) clearance letter is a regulatory document affirming substantial equivalence, not a clinical study report that would detail the performance metrics or the underlying studies used for validation.

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The Night Shift is indicated for prescription use for the treatment of adult patients with positional obstructive sleep apnea with a non-supine apnea-hypopnea index

The Night Shift is worn around the neck to reduce the amount of time the user sleeps in the supine position as a treatment for positional obstructive sleep apnea. Night Shift combines hardware and firmware to detect when the user attempts to sleep in the supine position and can initiate vibro-tactile feedback with increasing intensity until the user shifts to a non-supine position. The initiation of positional feedback from the Night Shift is turned on is programmable to allow the user to fall asleep (if they must) on their back. Each night the Night Shift is worn, it monitors sleep position (% time supine), behavioral sleep efficiency, and snoring levels (% time snoring > 40 and 50 dB) as well as the frequency, duration and intensity of the feedback (when applied). These data can be optionally transferred via the USB port to the Night Shift Web Portal where the user can generate a report to assess how well the positional feedback is working. A "trial" protocol can include one night with no feedback to establish a baseline and two nights with feedback to assess compliance/efficacy. Utilization information is saved on the device that allows reports to be generated that compares daily use by month and monthly averages for one year. The portal also allows the device to be reformatted (to eliminate all previously recorded data) for a new user, adjust the feedback settings to a new user's personal preferences, and/or upgrade the firmware. For large healthcare organizations that limit internet access, desktop software is provided as an alternative to the portal.

Here's a breakdown of the acceptance criteria and the study details for the Advanced Brain Monitoring, Inc. Night Shift device, based on the provided text:

Acceptance Criteria and Reported Device Performance

Study Details for Clinical Tests:

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

   • Test Set Sample Size for Primary Effectiveness Endpoint: 27 patients with pre-treatment positional obstructive sleep apnea with a non-supine AHI 20).
   • Data Provenance: Not explicitly stated, but the study was a clinical study conducted to evaluate safety and efficacy, implying prospective data collection. The location (country of origin) is not mentioned.

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

   • This information is not provided in the given text. Ground truth for sleep studies typically involves highly trained sleep technologists and physicians interpreting polysomnography (PSG) data. However, the document does not specify the number or qualifications for this particular study.

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

   • This information is not provided in the given text.

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

   • No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study evaluated the device's performance in treating sleep apnea and recording sleep parameters, not how human readers improve with or without AI assistance in interpreting diagnostic data from the device. The Night Shift is a therapeutic and monitoring device, not an AI diagnostic interpretation tool.

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

   • Yes, the study primarily assessed the standalone performance of the Night Shift device. While it is a prescription device, its effectiveness was measured by its ability to reduce supine sleep and associated AHI, as well as its accuracy in measuring sleep parameters (position, TST, SE) independently. Human interaction is primarily for setup, compliance, and physician review of the generated reports, but the core therapeutic and monitoring function is standalone.

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

   • The ground truth for sleep parameters (AHI, supine time, TST, SE) appears to be Polysomnography (PSG), a gold standard for sleep disorder diagnosis. For the "Accuracy of Supine Position Measurement" endpoint, the ground truth was "video recordings plus chest sensor." For subjective measures (ESS, FOSQ), the ground truth was the participant's self-reported scores.

7. The sample size for the training set:

   • This information is not provided in the given text. The document describes a clinical validation study, not the development or training phase of an algorithm.

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

   • This information is not provided as the training set details are not mentioned.

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The AMES Therapy Device is a rehabilitative exercise therapy device that uses assisted movement to measure, evaluate, exercise, re-educate and strengthen muscles, and to increase joint range of motion. It also uses muscle vibration for muscle relaxation.

The AMES Therapy Device is an electromechanical physical therapy device that combines 3 motion assemblies (one for the ankle, one for the wrist, and one for the thumb-and-fingers), 5 therapeutic vibrators, and a visual feedback unit, all contained in one device. The patient is seated in a separate conventional chair or wheelchair so that the appropriate limb can be attached to the AMES Therapy Device for therapy. The AMES Therapy Device includes assisted movement to the limb being treated and applies simultaneous vibration to the antagonist muscle. The device provides visual feedback to the patient to indicate whether he/she is producing the requisite force (torque) in assisting the device's motion and encourages the patient to keep working the agonist muscle. The feedback also includes a force (torque) "target," set to a level by the the patient can achieve repeatedly during therapy without becoming too fatigued, but that is also moderately challenging. The torque produced by the patient is indicated on the video touch screen. Testing and reporting on the patient's therapy and functional status can be performed at each therapy session prior to or following administration of therapy. Data for each session include therapy delivery (date, duration, performance) and test results. Two tests are carried out during the treatment session to measure: 1) active range-of-motion, and 2) strength. These test scores permit the therapist: (i) to determine each patient's baseline status at the time that the patient first receives the AMES therapy, and (ii) to monitor changes in rehabilitation status during the course of the patient's therapy. This testing enables therapists to modify the treatment regimen in response to observed improvements and to determine when is no longer benefitting from the therapy. The AMES Therapy Device is non-invasive and there is no electrical stimulation involved in the device, nor any recording of bioelectric potentials. No heat is applied by the AMES Therapy Device.

Here's an analysis of the AMES Therapy Device's acceptance criteria and studies, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state specific quantitative acceptance criteria or detailed performance metrics from a clinical study. Instead, it focuses on demonstrating that the device performs as designed and is substantially equivalent to predicate devices. The "performance" described is largely qualitative or pertains to general safety and functionality.

Regarding the Absence of Detailed Performance Criteria:

It's crucial to understand that for a 510(k) submission, particularly for devices with well-established predicate technology, the primary goal is often to demonstrate substantial equivalence rather than to prove novel efficacy against specific, high-bar performance criteria. The "acceptance criteria" here are more about meeting recognized safety standards, demonstrating intended functionality, and showing comparability to legally marketed devices.

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "clinical evaluations" and "safety data from clinical evaluations" but does not specify the number of participants or the size of these evaluations.
• Data Provenance: Not explicitly stated. The document does not mention the country of origin of the data. It implies the data is prospective as it refers to "clinical evaluations" of the AMES Therapy Device itself, rather than retrospective analysis of existing data.

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

This information is not provided in the document.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

No MRMC comparative effectiveness study is mentioned. The submission focuses on demonstrating the device's own safety and functionality, and its substantial equivalence to predicate devices, not on comparing the efficacy or improvement of human readers (or therapists in this context) with or without AI assistance. The AMES Therapy Device is described as a standalone physical therapy device, not an AI-assisted diagnostic or interpretation tool.

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

The AMES Therapy Device is a physical therapy device with a human (patient) interacting directly with it, guided by a therapist. It's not an algorithm-only device in the diagnostic or imaging sense. The device itself is "standalone" in the sense that its performance evaluation (safety, functionality) does not involve a human interpreting its output for diagnostic purposes. However, a human is inherently "in-the-loop" as a patient receiving therapy and a therapist managing the treatment.

7. The Type of Ground Truth Used

Given the nature of the device (physical therapy), "ground truth" in the typical AI/diagnostic sense (e.g., pathology, expert consensus on imaging) is not directly applicable. For the AMES Therapy Device, the "ground truth" during its "clinical evaluations" would likely relate to:

• Observed clinical safety outcomes: Was there skin irritation? Were there adverse events?
• Device functionality: Did the device perform its movements, provide vibration, and measure torque/ROM as designed?
• Patient feedback/clinical assessment: Did the patient tolerate the therapy? Did therapists observe expected changes in patient status during the course of therapy (as the device aids in monitoring ROM and strength, but doesn't "diagnose").

The document primarily highlights "Safety data from clinical evaluations... to evaluate the safety of the device with respect to skin integrity." This suggests observed clinical safety outcomes were a primary "ground truth" during its human-use testing.

8. The Sample Size for the Training Set

This information is not applicable and not provided. The AMES Therapy Device, as described, is an electromechanical physical therapy device. It does not appear to employ machine learning or AI algorithms that would require a "training set" in the context of typical AI device development.

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

This information is not applicable for the same reasons as point 8.

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The electrical muscle stimulation (EMS) operation mode is indicated for the improvement of abdominal muscle tone, and for the development of a firmer abdomen.

The therapeutic vibrator (Vibration) operation mode is indicated for the promotion of muscle relaxation.

The new device with its proprietary name/model number of Gymform Dual Flex Belt/WB-162 is a single device featured with two modes of operation, independent each other - the electrical muscle stimulation for abdominal muscles conditioning and the therapeutic vibrator for abdominal muscles relaxation.

Upon selected the electrical muscle stimulator (EMS) mode, the flex belt will function as an electrical muscle stimulator capable to achieve toning and firming of muscles in the abdominal region via using transcutaneous electrical muscle stimulation which is a technology for muscle conditioning by sending a stream of electric impulses to the motor nerve of muscle via the pair of single-patient/multiple-application biocompatible cutaneous electrodes on the inner surface of the flex belt, the muscle responds to each electric impulse by producing a contractile twitch, just as it would create voluntary muscle contractions during normal training & strengthening practice, and continues to contract until the electric impulse is over the muscle then returns to its relax state. The level of muscle contraction and relaxation is determined by the electric impulse intensity and the duration applied to the motor nerve of muscle, in which is user selectable via the flex belt control panel.

Upon selected the therapeutic vibrator (Vibration) mode, the Gymform Dual Flex Belt (new device) will function as a therapeutic vibrator to perform muscles relaxation. The therapeutic vibrator (Vibration) mode employs the method of electric muscle massage that simulates natural massage movement of a massage therapist, using oscillating movement of the eccentric motor that installed in the instrument casing to produce linear pulling vibrations to relaxing the abdominal muscle region of a patient.

The provided text is a 510(k) Summary of Safety and Effectiveness for the Gymform Dual Flex Belt. It compares the device to a predicate device, the Slendertone FLEX Abdominal Training System Type 515 (K030708), to establish substantial equivalence.

Based on the document, here's an analysis of the acceptance criteria and study information:

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the typical sense of numerical thresholds for performance metrics. Instead, it relies on demonstrating substantial equivalence to a predicate device. The primary "performance" is compliance with safety standards and showing "same effectiveness" as the predicate device.

• IEC 60601-1 (General Requirements for Safety)
• IEC 60601-1-2 (Electromagnetic Compatibility)
• IEC 60601-2-10 (Particular requirements for the safety of nerve and muscle stimulators)
• ISO 10993-5 (In Vitro cytotoxicity)
• ISO 10993-10 (Tests for irritation and delayed-type hypersensitivity)
• Complies with FDA safety requirements and IEC 60601-2-10 |
  | Effectiveness: Similar to predicate device | "effectiveness test report of Gymform Dual Flex Belt demonstrates that the new device has same effectiveness of predicate device." (Specific metrics for effectiveness are not detailed in this summary.) |
  | Technological Characteristics: Similar to predicate device | The EMS mode is "designed, developed and built on the identical technology of electrical muscle stimulation." While specific output parameters differ (e.g., frequency ranges, max intensity levels), the overall mode of action is identical. The document states "verification and validation tests demonstrated the Gymform Dual Flex Belt maintains same safety and effectiveness as that of the cleared predicate device." |
  | Intended Use/Indications: Identical to predicate device | The EMS mode of the Gymform Dual Flex Belt is indicated for "improvement of abdominal muscle tone, and for the development of a firmer abdomen," which is stated as "essentially identical to the predicate device." |

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

The document mentions an "effectiveness test report" but does not provide any details regarding the sample size used, the characteristics of the test participants, or the data provenance (e.g., country of origin, retrospective or prospective nature of the study). It only states that the report demonstrates "same effectiveness" as the predicate device.

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

The document does not provide information about experts or ground truth establishment for an effectiveness study. The assessment of effectiveness appears to be based on an internal report that concluded similar effectiveness to the predicate device, but the methodology of that assessment is not detailed.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method.

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

No MRMC comparative effectiveness study is mentioned or implied. The device is a direct-to-consumer electrical muscle stimulator, and comparative effectiveness studies of this nature are generally not required for 510(k) clearance in this context. The comparison is primarily against the performance characteristics of the predicate device for substantial equivalence.

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

This is not applicable as the device is a physical muscle stimulator, not an algorithm or AI system. Its performance is inherent in its electrical output and mechanical function.

7. The Type of Ground Truth Used

The document does not specify the type of "ground truth" used for effectiveness testing. Given the nature of a muscle stimulator, effectiveness might be assessed through metrics such as muscle contraction force, muscle circumference changes, or perceived muscle tone/firmness, but these details are not provided. The primary ground for clearance is "comparison of the electric muscles stimulation (EMS) mode" against a predicate.

8. The Sample Size for the Training Set

This question is not applicable as the Gymform Dual Flex Belt is a physical medical device, not a machine learning model. There is no concept of a "training set" in the context of this 510(k) submission.

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

This question is not applicable for the same reason as point 8.

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Relieves minor muscle aches and pains; Relieve muscle spasm; Temporarily Improve local circulation; Temporarily reduces the appearance of cellulite; Relieves minor muscle aches and pains, relieves muscle spasm and improves local circulation during Burn rehabilitation

The LPG devices are intended for practitioners who work in specific fields but all are substantially equivalent devices: ES1 for Endermologie; Cellu M6 for Endermologie and therapeutic applications; S6 sport for sport applications, before, after exercise and rehabilitation after injuries; ES/M60 for therapeutic applications and cosmetic applications on the face or on small area; LPG Equine for animal treatment. These devices are substantially equivalent to the ES1 therapeutic massager because the mode of operation and operating parameters and specifications are basically the same. Each LPG device comprises a main console housing a vacuum pump and a computerized regulation system. All of them contain treatment heads (from 5 to 12), that are designed to accommodate all parts of the body. ES1, Cellu M6, S6, LPG Equine devices have a main motorized head, the other device contain auxiliary heads (non-motorized) only. The equine device head is the largest in order to be able to be applied on the horse's body surface. The suction power of all these machines range from 50mBar to 500mBar which is represented by a scale from 1 to 10; for a specific machine and application, the suction power must be cyclically interrupted to provide vibration to the skin which is another stimulation for the tissues.

The provided text describes a 510(k) summary for the LPG Therapeutic Massager/Vibrator, which details its substantial equivalence to existing devices and its intended uses. However, it does not contain the kind of detailed study information (like acceptance criteria, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC study results) that would be needed to fill out the requested table and answer all questions directly.

The document states, "Our objective is not to substantiate new claims but to prove that the exempt claims are appropriate for the burn victim and that the product is safe and effective for its general uses when used in burn rehabilitation." This indicates that the 510(k) submission primarily relies on demonstrating substantial equivalence to predicates for its claims, rather than presenting a novel clinical study with explicit acceptance criteria for device performance.

One study is mentioned: "Doctor Gavroy compared treatment on burn victim with LPG and rhythmicity and LPG without rhythmicity." However, no details about the study design, sample size, methodology, or results are provided to determine how it would "prove" the device meets specific acceptance criteria.

Therefore, many of the requested fields cannot be filled from the provided document.

Here's an attempt to answer based on the available information, with explanations for what cannot be provided:

Acceptance Criteria and Device Performance Study for LPG Therapeutic Massager/Vibrator

The provided 510(k) summary for the LPG Therapeutic Massager/Vibrator (K990445) does not explicitly define acceptance criteria in terms of specific performance metrics that the device had to meet in a study. The submission relies on demonstrating substantial equivalence to legally marketed predicate devices for its intended uses. The "performance" is implicitly demonstrated through the device's adherence to the established indications for use of the predicate devices and its design and specifications being comparable.

The objective stated is: "Our objective is not to substantiate new claims but to prove that the exempt claims are appropriate for the burn victim and that the product is safe and effective for its general uses when used in burn rehabilitation." This suggests the efficacy for established claims is taken as given based on substantial equivalence, with a specific focus on the applicability of these claims to burn rehabilitation.

1. Table of Acceptance Criteria and Reported Device Performance

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