Search Results

Powered Muscle Stimulator (Model name:MagGraver F200) is indicated to be used for:

• · Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen.
  · Strengthening, Toning and Firming of buttocks.

Powered Muscle Stimulator (Model name:MagGraver F200) is a non-invasive therapeutic device. The device produces electromagnetic field that stimulates the tissues of the human body, the device helps to strengthen, tone, and firm the abdomen and buttocks by stimulating muscle.
The device has two output channels and two applicators, one applicator (Form A) is applicable for abdomen and another (Form B) is applicable for buttocks. The applicator can plug in either output channels. The two outputs of device enable simultaneous treatment by two applicators.
The Form A applicator consists of round coil and cooling system. The Form B applicator consists of figure-of-eight coil and cooling system.
There is a pressure kit is used to monitor abdomen muscle contraction by monitor the pressure between applicator and abdomen, the pressure kit is only used with Form A applicator.
The device is equipped with a color touch screen that significantly facilitates the use of the device. The on-screen information guides the user step-by-step through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen. During the therapy the device keeps information about the applied therapy type, remaining therapy time and main therapy parameters on the screen. The screen angle can be adjusted.

I'm sorry, but this document does not contain the information required to fulfill your request. The document is an FDA 510(k) clearance letter and summary for a Powered Muscle Stimulator (MagGraver F200). While it addresses device safety and effectiveness in comparison to a predicate device, it does not describe:

1. Acceptance criteria for an AI/algorithm-based device and reported performance against those criteria. This device is a physical electromedical device, not an AI/algorithm-based diagnostic or therapeutic tool.
2. Sample sizes for test sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, or standalone algorithm performance. These concepts are relevant to the validation of AI/ML models, which is not the subject of this document.
3. Ground truth establishment or training set details. Again, these relate to AI/ML model development and validation.

The primary performance data presented relates to non-clinical bench testing of the magnetic field intensity and pulse characteristics, and compliance with general medical device standards (e.g., IEC 60601-1 for safety). There is no mention of a performance study proving the device meets acceptance criteria related to AI/ML.

Therefore, I cannot extract the requested information from the provided text.

Ask a specific question about this device

BionicGym is intended to stimulate healthy muscles in order to exercise, improve or facilitate muscle performance. It is not intended to be used in conjunction with therapy or treatment of medical conditions of any kind. None of the training programs or operational parameters are designed to target injured or ailing muscles.

The BionicGym Powered Muscle Stimulator is a home use, wearable device in the form of a double thigh wrap garment. The electronics are housed in a control unit that is fitted into a pocket on the right thigh garment. The control unit generates electrical pulses which are distributed to hydrogel electrodes positioned within the thigh garments and in contact with the user's thighs. The control unit delivers pulses to the muscles via the electrodes in defined patterns, which cause controlled contractions of the legs. The program characteristics determine the leg muscle contractions, which may be tetanic or sub-tetanic, the latter of which can induce cardiovascular and aerobic demand, thus the user receives an exercise workout. The intensity of the workout can be selected from a suite available via a smart device (e.g. phone) based application ('App'). The workout can be paused or stopped from either the App or the control unit.

The principle of operation of the BionicGym Powered Muscle Stimulator is that the pulse pattern delivered to the thigh electrodes is a composite of pulses shared between the electrode array. Repeating the pulse pattern induces contractions of the large muscle groups in the legs (quadriceps, hamstrings, gluteal and calf muscles), exercising the legs and raising the user's heart rate.

The provided document is a 510(k) summary for the BionicGym Powered Muscle Stimulator. It outlines the device's technical specifications and compares it to a predicate device, focusing on non-clinical performance testing. However, it does not include data from a clinical study with acceptance criteria and reported device performance. The information is limited to non-clinical testing performed to demonstrate substantial equivalence to a predicate device.

Therefore, I cannot provide a table of acceptance criteria and reported device performance based on a clinical study from this document, nor can I answer questions related to sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, multi-reader multi-case studies, standalone performance, type of ground truth used from a clinical study, or training set details. This information would typically be found in a clinical study report, which is not part of this 510(k) summary.

The document focuses on non-clinical testing to demonstrate that the device meets safety and performance standards comparable to an existing device, rather than proving effectiveness against specific clinical acceptance criteria.

Here's what can be extracted regarding the device's testing and a comparison to its predicate:

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical):

The document details compliance with various international standards for electrical safety, electromagnetic compatibility, and biocompatibility, as well as software verification and validation. These standards serve as the "acceptance criteria" for non-clinical performance. The "reported device performance" is a statement of compliance.

Regarding the other points, the document states:

2. Sample size used for the test set and the data provenance: Not applicable. This document describes non-clinical performance testing and comparison to a predicate device, not a clinical study with a test set of patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth and expert consensus are typically associated with clinical validations of diagnostic or prognostic devices. This device is a muscle stimulator.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a muscle stimulator, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a physical muscle stimulator, with software controlling its function. Its "performance" is its ability to stimulate muscles according to its programmed parameters, which is assessed through bench testing and compliance with standards.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the traditional sense for a diagnostic device. For the non-clinical tests, the "ground truth" is defined by the objective pass/fail criteria of the international standards (e.g., specific current leakage limits, biocompatibility results) and engineering specifications for bench tests.

8. The sample size for the training set: Not applicable. This document does not describe a machine learning algorithm or a training set. The software mentioned is traditional control software.

9. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device

Transcutaneous Electrical Nerve Stimulation (TENS): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. Powered Muscle Stimulation (PMS): It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

Not Found

This is a K143268 510(k) premarket notification for a TENS and Powered Muscle Stimulator device. It is a clearance letter from the FDA, not a study report. Therefore, the document does not contain any information regarding acceptance criteria or a study that proves the device meets specific acceptance criteria.

The document primarily focuses on:

• Substantial Equivalence: The FDA has determined the device is substantially equivalent to legally marketed predicate devices for the stated indications for use. This means it has similar therapeutic effects and is as safe and effective as other legally marketed devices.
• Regulatory Classification: The device is classified as Class II, under regulation 21 CFR 890.5850 for Powered Muscle Stimulator, with product codes NGX and NUH.
• General Controls: The letter advises the manufacturer to comply with general controls provisions of the Act, including registration, listing, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.
• Indications for Use: It specifies the intended uses for the TENS function (temporary relief of pain in various body parts due to strain) and the Powered Muscle Stimulation function (to stimulate healthy muscles to improve and facilitate muscle performance).
• Type of Use: It is intended for Over-The-Counter Use.

Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth, or MRMC studies because this information is not present in the provided text. The FDA clearance letter confirms regulatory approval based on demonstrating substantial equivalence to existing devices, rather than presenting a detailed performance study with acceptance criteria.

Ask a specific question about this device

The QB1 Powered Muscle Stimulator System (NMES) &Transcutaneous Electrical Nerve Stimulator System (TENS); QB-1000 is a multifunctional electrotherapy device with two treatment modes that allow for neuromuscular electrical stimulation (NMES) and transcutaneous electrical nerve stimulation (TENS).

Indications for Use:

As an NMES device, indications are for the following conditions:

• Relaxation of muscle spasms
• Retardation or prevention of disuse atrophy
• Increasing local blood circulation
• Re-educating muscles
• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
• Maintaining or increasing range of motion

As a TENS device, indications are for the following conditions:

• Symptomatic relief and management of chronic intractable pain
• Adjunctive treatment for post-surgical and post-trauma acute pain

The CyMedica Orthopedics QB1 System is a multifunctional electrotherapy device with two stimulation channels and two treatment modes that allows for neuromuscular electrical stimulation (NMES) and transcutaneous electrical nerve stimulation (TENS). The principles of electrotherapy emulate the process observed during a voluntary muscle contraction. The QB1 system delivers stimulation based on the principles of NMES and TENS. NMES pulses stimulate motor points of target muscles, causing a muscle contraction. This can help re-educate and strengthen muscles following an injury or surgery. TENS blocks the pain signal sent from the affected area on nerve pathways.

The OB1 NMES and TENS systems are prescription devices in the USA and are intended to be used following the directions of a healthcare provider. The device may be used in a healthcare facility setting or by a patient or lay operator in a home environment.

In NMES mode, the QB1 system provides two therapeutic treatment programs: Post-Operative and Strength. Its simplified programming makes the device convenient for home use; after placing the electrodes and selecting the program as prescribed by a healthcare professional, the patient only needs to increase the intensity to a comfortable level to begin therapy. The OB1 NMES Post-Operative and Strength programs utilize an electrical stimulus that, when properly applied, activates specific muscles or muscle groups to help treat disuse muscle atrophy and to reeducate muscles. This is achieved via a closed loop feedback system that minimizes energy delivery to the targeted treatment areas.

In NMES mode, the OB1 system consists of a Conductive garment with an incorporated NMES pod, User Interface device with a battery charger, NMES electrodes, and electrode gel.

The QB1 device also offers a TENS program for pain management. The QB1 TENS system consists of a TENS pod. User Interface device with a battery charger. TENS electrodes, and electrode gel.

The QB1 User Interface is programmed with an embedded software to manage the treatment programs and communicate with the User Interface touchscreen, NMES conductive garment, and TENS pod. The User Interface allows the user to select a treatment from the available treatment programs stored in the memory component of the NMES conductive garment and TENS pod. The User Interface utilizes a touchscreen and tactile buttons for user control. The User Interface device is powered by an internal rechargeable 3.7 V Lithium Ion battery that, when fully charged, can deliver at least three-20 minute treatments before requiring a recharge. The QB1 USB charger can fully recharge the battery in approximately five hours.

The QB1 system accessories include:

• . OB1 electrodes for NMES application
• OB1 electrodes for TENS application
• QB1 electrode gel ●

The provided text describes a 510(k) premarket notification for the CyMedica Orthopedics QB1 Powered Muscle Stimulator System (NMES) & Transcutaneous Electrical Nerve Stimulator System (TENS). This document contains information about the device's indications for use, technological characteristics, and performance data, primarily focusing on non-clinical testing to demonstrate substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria for a study demonstrating device performance as requested in the prompt, nor does it specify a study with acceptance criteria being met.

Therefore, many of the requested details cannot be extracted directly from this document. The document describes several non-clinical tests conducted to establish safety, effectiveness, and substantial equivalence, but not a study designed to meet specific performance acceptance criteria in the way envisioned by the prompt.

Here's a breakdown of what can be extracted or inferred from the provided text, and what cannot:

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

• Cannot be provided. The document lists various standards the device was tested against (e.g., IEC 60601-1, IEC 60601-2-10 for electrical safety, ISO 10993 for biocompatibility, IEC 62366 for usability), and states that the device "meets all standard requirements" or "complies" with these standards. It also mentions "low current and voltage values" and "maximum current densities of QB1 are lower than Kneehab XP and MediStim XP." However, it does not explicitly define specific "acceptance criteria" (e.g., a minimum sensitivity or specificity_ and then report the device's performance against those criteria. The performance reported is primarily compliance with established safety and efficacy standards and lower electrical outputs compared to predicates.

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

• Cannot be provided for performance metrics related to acceptance criteria. The document states that a "human factors and usability study was conducted to validate the usability of the QB1 system in the home environment." It doesn't specify the sample size for this usability study. For other tests (electrical safety, EMC, software verification, biocompatibility, risk management), these are typically bench tests or analyses, not studies involving human subjects with a "test set" in the sense of clinical performance data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable/Cannot be provided. This question is typically relevant for studies evaluating diagnostic or prognostic algorithms where expert consensus establishes ground truth (e.g., image interpretation). This document describes a medical device (muscle stimulator) undergoing non-clinical testing for safety and functional equivalence, not a diagnostic algorithm.

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

• Not applicable/Cannot be provided. Similar to point 3, this is relevant for studies involving the interpretation of data, where multiple experts might disagree and an adjudication process is needed. The testing described here does not involve such a process.

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/No. This device is a muscle stimulator, not an AI-powered diagnostic or interpretive tool that assists human "readers" (like radiologists). Therefore, an MRMC comparative effectiveness study of the type described would not be relevant. The document's effectiveness claims are based on meeting safety standards and having comparable or lower electrical output parameters than predicate devices.

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

• Not applicable/No. This device is an electrotherapy device with hardware and embedded software. Its "performance" is its ability to deliver specified electrical stimulation safely and effectively. The tests are effectively "standalone algorithm" tests in that they evaluate the device itself (including its software), but not in the diagnostic performance sense often implied by this question. The device's operation inherently involves user interaction (e.g., selecting programs, adjusting intensity), so it's not strictly an "algorithm-only" performance without any human involvement for its intended use, but the testing focuses on the device's adherence to technical standards.

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

• Not applicable/Cannot be provided in the context of diagnostic "ground truth." For this device, "ground truth" would relate to the physical and electrical parameters it's designed to produce. Compliance with standards (e.g., IEC 60601-2-10 for nerve and muscle stimulators) and comparison to predicate device characteristics serve as the reference for its functional performance and safety.

8. The sample size for the training set

• Not applicable/No training set. This is a hardware medical device with embedded software, not a machine learning model that requires a distinct "training set." The software validation mentioned is about verifying requirements, not training a model.

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

• Not applicable/No training set. As above, there is no training set for this type of device.

Summary of available information regarding performance and testing (not explicitly "acceptance criteria met by a study"):

Device: QB1 Powered Muscle Stimulator System (NMES) & Transcutaneous Electrical Nerve Stimulator System (TENS)

Performance Data and Basis for Substantial Equivalence:

The submission relies on non-clinical testing data to demonstrate substantial equivalence, focusing on safety and function.

• Safety: The QB1 system was tested for:

  • Electrical safety: Compliance with IEC 60601-1, IEC 60601-2-10 ("Particular requirements for the basic safety and essential performance of nerve and muscle stimulator"), and IEC 60601-1-11 ("Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment"). The system "compiles with" these standards.
  • Electromagnetic compatibility (EMC): Compliance with IEC 60601-1-2. The system "compiles with" this standard.
  • Biocompatibility: Compliance with ISO 10993-1, ISO 10993-5 (in vitro cytotoxicity), and ISO 10993-10 (irritation and skin sensitization).
  • Risk Management: Compliance with ISO 14971.
  • Usability: Compliance with IEC 60601-1-6 and IEC 62366. A "human factors and usability study was conducted to validate the usability of the QB1 system in the home environment." The "results of the study support the instructions for successfully using the device as intended" and "substantiates the acceptability of the risks identified."
  • Software Verification & Validation Testing: Validated in accordance with FDA Guidance (May 11, 2005). The tests "demonstrated that the software version meets its design requirements."

• Effectiveness/Functional Equivalence:

  • The document implies effectiveness by demonstrating that the QB1 system's electrical output parameters (waveform, shape, voltage, current, duration, frequency, etc.) are comparable to or "lower" than predicate devices (Kneehab XP, K110350, and MediStim XP, K082011), ensuring it "poses no new safety risks" and "is substantially equivalent to the predicate."
  • Specifically, in "OB1 Design Verification & Validation, QB-0030-034, Section 018", it is stated that "the maximum current densities of OB1 are lower than Kneehab XP and MediStim XP" despite differences in electrode size. It also notes that "OB1 waveforms are at lower voltage and current and therefore power levels than the Kneehab XP and MediStim XP."

This information focuses on technical compliance and comparative electrical characteristics rather than specific performance metrics against pre-defined acceptance criteria in a clinical study.

Ask a specific question about this device

Indications for EMS use are:

• Prevention or retardation of muscle disuse atrophy
• Relaxation of muscle spasms
• Increasing local blood circulation
• Muscle re-education
• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
• Maintaining or improving range of motion of extremities

Indications for TENS use are:

• Symptomatic relief and management of chronic, intractable pain, and
• Adjunctive treatment for post-surgical and post-trauma acute pain

SWISSSTIM is a battery-powered device for transcutaneous nerve and neuromuscular electro-stimulation. It has two channels (outputs) of stimulation, each with independent intensity control. The unit delivers synchronous, low voltage stimulation impulses at both of its outputs. The stimulation output voltage waveforms are in form of trains of monophasic, rectangular impulses. Such waveform character is true, when the outputs are connected to any resistor in a range from 100 Ω to 10,000 Ω.

The EMS mode of this device has four different stimulation programs. The medical professional or patient under medical supervision can select any of these four stimulation programs, as appropriate for their treatment objectives. For each stimulation program, the medical professional or patient selects the desired phases of the stimulation programs as well as the stimulation duration; the impulse frequencies and impulse durations are different and all are preset at the factory.

There are no user accessible controls that can change either the frequency or impulse duration during a treatment. The user accessible controls are the ON/OFF button, the SELECT button and the two (2) buttons that control menu access and intensity levels for the 2 independent channels. The stimulus is a low voltage, low frequency, rectangular waveform.

The TENS mode of this device has ten (10) programs. The TENS mode is what has been added to this device and therefore modifies the Indications for Use from the predicate device, K022175. The TENS mode is controlled in the same fashion as the EMS mode of the SWISSSTIM.

The device is housed in a plastic enclosure and is powered by four (4) AAA batteries. Accessories include output cables, batteries, User's Manual, storage case and electrodes. There is no provision for an AC adapter and the unit cannot be connected to any AC electrical power circuit.

From a technical perspective, the SWISSSTIM delivers stimulation pulses of 50v (peak value) ± 10% onto 500Ω at maximum settings, which corresponds to 100 mA (peak value) current intensity. The impulse frequencies produced by the device are in a range of 1 Hz to 120 Hz, depending on the choice of stimulation program. The voltage waveforms are rectangular monophasic with duration time from 20 us to 1000 us. The current impulses are monophasic on 500 Ω load. The tetanization stimulation signal includes ramp, which slowly increases the contraction intensity during treatments.

The EMS function is used as a therapeutic tool, specifically for rehabilitation purposes as noted in the Indications for Use (please see Section B). An example is prevention of disuse muscle atrophy that may occur after musculoskeletal injuries such as damage to bones, joints, muscles, ligaments and tendons. The TENS functions address pain mitigation, whether chronic or acute pain; TENS is a non-invasive, safe nerve stimulation intended to reduce such pain. A number of systematic reviews or meta-analyses have confirmed TENS effectiveness for postoperative pain, osteoarthritis, and chronic musculoskeletal pain.

The provided text describes the SWISSSTIM device, a battery-powered transcutaneous nerve and neuromuscular electro-stimulation device. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than independent performance validation studies with human subjects. Therefore, much of the requested information regarding sample sizes, expert ground truth, adjudication methods, and MRMC studies is not typically found in such a submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria & Reported Device Performance:

The document outlines performance characteristics of the SWISSSTIM and compares them to predicate devices (P4-PHYSIO and Styline 882). The acceptance criteria are implicit in showing similar technical characteristics and safety profiles to the legally marketed predicate devices.

Study Proving Acceptance Criteria:

The study that proves the device meets the acceptance criteria is primarily a non-clinical performance and substantial equivalence comparison study against two predicate devices: P4-PHYSIO (K022175) and Styline 882 (K092448).

• Non-Clinical Performance Data: The document states, "The SWISSsm device (and predicate devices) have also been analyzed in accordance with the AAMI/ANSI standard 'AAMI NS4:1986/(R)2009: AAMI Standard for Transcutaneous Electrical Nerve Stimulators' Electrode/Skin Impedance Model (ESIM)". This involved electrical performance testing, likely using bench testing methods and an ESIM to simulate skin impedance.
• Substantial Equivalence Argument: The core of the submission relies on demonstrating that the SWISSSTIM has similar technological characteristics (design, materials, energy source, waveforms, programs), indications for use, safety features, and operational parameters as the legally marketed predicate devices. Visual comparisons of voltage and current waveforms across different load resistances (500 ohms, 2000 ohms, 10000 ohms, and ESIM) are provided to support this. The detailed comparison table further highlights similar safety and efficacy aspects.
• Compliance with Standards: The device's manufacturing quality (ISO 9001/2000, ISO 13485/2003) and electrical safety (IEC-601-2-10 European Safety Standard and all EC medical device directives) were tested and reported to be compliant. Electromagnetic Compatibility (EMC) and Electrical Safety tests were conducted according to FDA recommended testing with "Pass" results for all listed standards (EN 55011, EN 61000-4-2, EN 61000-4-3, EN 61000-4-6, EN 61000-4-8).

Details not explicitly stated in the document:

2. Sample size used for the test set and the data provenance: This is a 510(k) submission primarily relying on non-clinical bench testing and comparison to predicates. There isn't a "test set" in the context of clinical data or human subjects. The graphical data (waveforms) would represent measurements from the physical devices under various load conditions. The data provenance would be the test labs where these electrical measurements were performed, likely in Switzerland (Valmed's location). This is not specified as retrospective or prospective in a clinical sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for electrical performance is established by measurement instruments calibrated to standards.
4. Adjudication method for the test set: Not applicable for non-clinical bench testing.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This type of study is typically for diagnostic imaging devices involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The device is a physical electro-stimulator, not an algorithm. Its standalone performance is demonstrated through the electrical and safety tests.
7. The type of ground truth used: For the non-clinical performance evaluation, the "ground truth" is derived from physical measurements against established electrical engineering standards and the specified performance of the predicate devices. For safety and efficacy, the ground truth is based on compliance with international standards (ISO, IEC, EC MDD) and a demonstration of substantial equivalence to already cleared devices with known safety and efficacy profiles.
8. The sample size for the training set: Not applicable. This is not a machine learning device that requires a training set.
9. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device

Specific indications: used to apply an electrical current to electrodes on patient's skin to function as:

• Relaxation of muscle spasms
• Prevention or retardation of disuse atrophy
• Muscle re-education
• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
• Maintaining or increasing range of motion
  Clinical settings: The device should only be used under medical supervisions for adjunctive therapy for the treatment of medical diseases and conditions.

A sequenced system for transcutaneous muscle stimulation consists of a stimulator, a sequencer for channel selection, patient cable, and electrodes applied to the skin. Various types of waveforms may be output to generate the desired effect on the muscle(s) to be treated, and the patient is given control of the signal intensity for personal safety and comfort. Sequenced system may have more than on output channel in order to operate bilaterally on the body or to treat multiple regions simultaneously or serially in a prescribed sequence.

The provided document is a 510(k) premarket notification for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the way typically seen for novel devices.

Here's an analysis based on the provided text, addressing your questions where possible:

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

• Acceptance Criteria: The primary acceptance criterion for this 510(k) submission is Substantial Equivalence to the predicate device (HOME CARE Powered Muscle Stimulator, K023000). The specific performance parameters for substantial equivalence are implicitly linked to the predicate device's established safety and effectiveness.
• Reported Device Performance: The document states that the SAN SHIH Powered Muscle Stimulator, 202 is "as safe and effective as, and the function in a manner equivalent to the predicate device."

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

• No clinical test set was used for performance evaluation. The submission explicitly states "Clinical Tests Submitted: None."
• The data provenance for safety and effectiveness is largely based on non-clinical tests (electrical safety, electromagnetic compatibility, specific requirements for nerve and muscle stimulators) rather than studies on human subjects. The device originates from Taiwan, ROC.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. No clinical test set was used, and thus no expert-established ground truth on patient data was required for this particular submission type.

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

• Not applicable. No clinical test set was used.

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-powered diagnostic or assistive tool for human readers. No MRMC study was performed or required.

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

• This device is a standalone therapeutic device (a physical stimulator), not an algorithm. Its performance is inherent in its electrical output and mechanical function, which was assessed through non-clinical testing.

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

• For the non-clinical tests, the "ground truth" was compliance with applicable standards for medical device electrical safety, electromagnetic compatibility, and the particular requirements for safety of nerve and muscle stimulators. These standards serve as the benchmark for safety performance.
• For effectiveness, the ground truth is the established effectiveness profile of the predicate device. The claim is that the new device functions in a "similar manner" for the same "indications for use."

8. The sample size for the training set

• Not applicable. This device is a hardware product, not a machine learning algorithm. Therefore, there is no training set in the AI sense.

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

• Not applicable. As above, there is no training set.

Ask a specific question about this device

Specific indications: used to apply an electrical current to electrodes on patient's skin to function as:

• Relaxation of muscle spasms
• Prevention or retardation of disuse atrophy ●
• . Muscle re-education
• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
• . Maintaining or increasing range of motion

A sequenced system for transcutaneous muscle stimulation consists of a stimulator, a sequencer for channel selection, patient cable, and electrodes applied to the skin.
Various types of waveforms may be output to generate the desired effect on the muscle(s) to be treated, and the patient is given control of the signal intensity for personal safety and comfort. Sequenced system may have more than on output channel in order to operate bilaterally on the body or to treat multiple regions simultaneously or serially in a prescribed sequence.

The provided document is a 510(k) summary for the EVERLIFE Powered Muscle Stimulator. It outlines the device's intended use and the non-clinical tests performed. However, it explicitly states that no clinical tests were submitted. Therefore, there is no information available to describe acceptance criteria based on clinical performance or a study proving the device meets such criteria.

The substantial equivalence decision for this device was based on comparison to legally marketed predicate devices and non-clinical testing, not on clinical performance criteria.

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

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable/Not provided. The document does not specify quantitative acceptance criteria for device performance based on clinical outcomes or a study proving it meets such criteria. The "Conclusion" section states that the device is "as safe and effective as, and the function in a manner equivalent to the predicate devices" based on product description and non-clinical tests.

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

Not applicable. No clinical test set or data provenance is mentioned as no clinical studies were submitted. Non-clinical testing was performed on the device itself.

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

Not applicable. No clinical test set requiring expert ground truth was performed or submitted.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set was performed or submitted.

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 tool. No MRMC study was performed.

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

Not applicable. This device is a Powered Muscle Stimulator, not an algorithm. The non-clinical tests were performed on the device and its accessories, indicating device-alone performance in terms of safety and waveform output.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Not applicable. No clinical ground truth was established as no clinical studies were submitted. The "ground truth" for the non-clinical testing would be the defined safety standards and specified waveform outputs, confirmed through laboratory measurements.

8. The Sample Size for the Training Set

Not applicable. No training set for an algorithm is mentioned as this is a physical medical device, not an AI/algorithm-based product.

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

Not applicable. No training set is mentioned.

Ask a specific question about this device

Specific indications: used to apply an electrical current to electrodes on patient's skin to function as:

• Relaxation of muscle spasms
• Prevention or retardation of disuse atrophy
• Muscle re-education
• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
• Maintaining or increasing range of motion
  Clinical settings: The device should only be used under medical supervisions for adjunctive therapy for the treatment of medical diseases and conditions.

A sequenced system for transcutaneous muscle stimulation consists of a stimulator, a sequencer for channel selection, patient cable, and electrodes applied to the skin. Various types of waveforms may be output to generate the desired effect on the muscle(s) to be treated, and the patient is given control of the signal intensity for personal safety and comfort. Sequenced system may have more than on output channel in order to operate bilaterally on the body or to treat multiple regions simultaneously or serially in a prescribed sequence.

The provided submission from KINGLY STAR INTL. TECHNOLOGY CO., LTD. for their KINGLY STAR Powered Muscle Stimulator, KS-138 (K062453), does not include acceptance criteria or a study demonstrating the device meets such criteria in the way typically expected for a medical device efficacy study.

Instead, this 510(k) submission relies on substantial equivalence to a predicate device, the TAI SHENG Powered Muscle Stimulator, TS-166 (K031310). The key 'study' referenced is a comparison to the predicate, focusing on technical specifications and safety standards rather than clinical performance metrics.

Here's a breakdown based on your request, highlighting what is and isn't present in the document:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: None provided. No clinical test set data from human subjects is presented.
• Data Provenance: The document states "Non-Clinical Tests Submitted" and "Clinical Tests Submitted: None". The 'data' for demonstrating equivalence primarily comes from comparison of technical specifications and adherence to electrical safety standards. This is not human-centric data.

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

• Number of Experts: Not applicable. No clinical test set requiring expert ground truth was performed for this 510(k) submission. The equivalence is based on engineering and safety assessments.
• Qualifications: Not applicable.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. No clinical test set requiring adjudication was performed.

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

• No, an MRMC comparative effectiveness study was not done. This type of study would involve human readers (potentially radiologists or clinicians interpreting data) and is not relevant for a powered muscle stimulator cleared via substantial equivalence based on technical and safety data.
• Effect Size of Human Readers Improve with AI vs. Without AI Assistance: Not applicable. There is no AI component mentioned, nor is there a study involving human reader performance.

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

• Yes, in spirit, a form of "standalone" evaluation occurred, but not in the conventional sense of an algorithm's performance. The primary "standalone" assessment was of the device's adherence to electrical safety and electromagnetic compatibility standards, and its output waveforms, independently of a human user's performance. There is no algorithm in the device that would be evaluated for standalone predictive performance.

7. The Type of Ground Truth Used:

• Ground Truth: For the non-clinical tests, the "ground truth" was regulatory standards (e.g., medical device electrical and electromagnetic compatibility, specific requirements for nerve and muscle stimulators) and engineering specifications (e.g., waveform output). The device was tested to determine if it met these established objective benchmarks. For the intended use claims, the ground truth indirectly relies on the predicate device's established effectiveness for those indications.

8. The Sample Size for the Training Set:

• Sample Size: Not applicable. This device is not an AI/ML algorithm that requires a training set. The "training" in a broad sense would be the engineering design and manufacturing processes, but not a data training set.

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

• Not applicable. As above, there is no AI/ML training set for this device.

Summary of the Study (as described in the 510(k) submission):

The "study" described in this K062453 submission is a non-clinical comparison to a predicate device and adherence to recognized safety and electrical standards.

• Device: KINGLY STAR Powered Muscle Stimulator, KS-138
• Predicate Device: TAI SHENG Powered Muscle Stimulator, TS-166 (K031310)
• Methodology:
  • Non-Clinical Tests: The KS-138 was tested against applicable standards for medical device electrical electromagnetic compatibility and safety, specifically "the particular requirements for safety of nerve and muscle stimulators."
  • Accessories (electrodes and patient cables) were also assessed for safety requirements.
  • System-level testing, including waveform testing, was performed.
  • Comparison of the device's design, intended use, and technical specifications to those of the predicate device.
• Conclusion: The submission concludes that the KINGLY STAR Powered Muscle Stimulator KS-138 is as safe and effective as, and functions in a manner equivalent to, the predicate device TAI SHENG Powered Muscle Stimulator TS-166, thus establishing substantial equivalence.
• Clinical Tests: "None" were submitted.

In essence, this is a regulatory submission for substantial equivalence based on technical specifications and safety standards, not an independent clinical trial demonstrating efficacy against specific acceptance criteria for performance.

Ask a specific question about this device

Specific indications: used to apply an electrical current to electrodes on pation's skin to function as: Relaxation of muscle spasms; Clinical settings: The device should only be used under medical supervisions for adjunctive therapy for the treatment of medical discases and conditions.

TAI SHENG Powered Muscle Stimulator, TS-L166

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance tables, sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, multi-reader multi-case studies, standalone performance, type of ground truth used, or information about the training set.

The document is a letter from the FDA concerning a 510(k) premarket notification for the "TAI SHENG Powered Muscle Stimulator, TS-L166." It primarily states that the device has been determined to be substantially equivalent to legally marketed predicate devices and outlines the regulatory requirements the manufacturer must follow. The "Indications for Use Statement" lists the intended purposes of the device, but it does not contain any performance data or study details.

Ask a specific question about this device

Specific indications: used to apply an electrical current to electrodes on patient's skin to function as: Relaxation of muscle spasms; Prevention or retardation of disuse atrophy Muscle re-education Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis Maintaining or increasing range of motion. Clinical settings: The device should only be used under medical supervisions for adjunctive therapy for the treatment of medical diseases and conditions.

Besmed various models of Powered Muscle Stimulator, BE-560 / BE-580

This document is a 510(k) premarket notification decision letter from the FDA for a powered muscle stimulator. It does not contain the kind of information requested regarding acceptance criteria and a study proving device performance.

The letter states that the FDA has reviewed the submission and determined the device is substantially equivalent to legally marketed predicate devices. This means the device does not require a new premarket approval application (PMA) but can be marketed under general controls provisions.

The enclosed "INDICATIONS FOR USE STATEMENT" lists the intended uses of the device.

Therefore, I cannot provide the requested information from this document.

Ask a specific question about this device