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TORC BODY is indicated to be used for: - Improvement of abdominal tone, for strengthening of the abdominal muscles, for development of firmer abdomen. - Strengthening, Toning and Firming of buttocks & thighs.

TORC BODY is a powered muscle stimulator with two outputs. This battery powered unit is designed for men & women to provide exercise technology. The stimulation is the most comfortable & this technology makes it easier to combine active & passive exercise. The TORC BODY stimulator provides selections of different programs for Bottom Thighs muscles (BTS), Abdominal muscles (ABS) & yet customization of stimulation parameters. Four body areas can be treated simultaneously. The electrical muscle stimulator contracts muscles rhythmically to achieve muscle tone and strength. The belts provided with the device are used to place the electrodes in place on the body area to be treated. The lead wires connect the electrodes with the main stimulator unit. The Torc Body muscle stimulator provides comforting and soothing muscle stimulation to achieve the intended use of strengthening, toning and firming of the muscles of abdomen, thighs and buttocks. The user can increase the intensity to get a stronger stimulation and achieve better results. A touch screen LCD user interface simplifies the selection of the programs and displays the selected program, treatment time and other stimulation parameters. Rechargeable batteries power it. The unit can perform anytime & anywhere. Torc Body is suitable for use by all healthy adults. However as with other form of exercise some care is needed when using them.

The provided text is a Special 510(k) summary for the TORC BODY powered muscle stimulator. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, the POWERTONE, MODEL PT-11 (K062439), rather than presenting a study to prove acceptance criteria for novel claims.

Therefore, many of the requested sections about specific study methodologies, sample sizes, expert qualifications, and ground truth establishment will not be directly derivable from this type of regulatory submission. The document primarily highlights the comparison of technical specifications and intended use to show that the modifications made to the TORC BODY do not raise new questions of safety or effectiveness.

Here's an analysis based on the provided text, indicating where information is present versus not applicable for this type of submission:

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

The document does not explicitly state acceptance criteria in terms of numerical performance targets (e.g., specific percentages for sensitivity, specificity, accuracy) for a clinical outcome. Instead, the acceptance is based on demonstrating substantial equivalence to a predicate device by comparing technical specifications and intended use. The "reported device performance" is essentially the alignment of these specifications with the predicate.

Differences noted (not relevant to performance criteria in this context, but design/user interface changes):

• Design: Predicate uses 4.8 VDC battery; Modified uses 24 VDC. Both are microcontroller-controlled.
• Mechanical Size: Predicate: 3.9"(L) x 1.6"(H) x 4.0(W); Modified: 8.0"(L) x 6.0"(W) x 4.0"(H). (Larger form factor for the modified device).
• User Interface & Display: Predicate: MKB Panel and LCD Display; Modified: Touch Screen LCD User Interface.
• Power: Predicate: Four rechargeable NiMH 1.2 VDC batteries; Modified: 24 VDC battery pack (20 cells of NiMH 1.2 VDC).

The "acceptance criteria" here is that the modified device's core technological parameters and intended uses are identical to the predicate device, thereby not raising new questions of safety or effectiveness. The study demonstrating this is the comparison table itself and the accompanying narrative arguing for substantial equivalence.

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

• Not applicable (N/A) for this type of submission. This is a Special 510(k) focused on engineering changes and demonstrating substantial equivalence to a predicate, not a new clinical trial that would require a test set of data. The "test set" is effectively the set of technical specifications and indications for use that are being compared.
• The data provenance would be from internal engineering documentation and specifications of both the modified and predicate devices.

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)

• N/A. Ground truth in the context of clinical studies (e.g., diagnostic accuracy) is not relevant for this engineering-focused substantial equivalence submission. The "ground truth" for the comparison is the documented specifications of the predicate device and the newly modified device.

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

• N/A. Adjudication methods are used in clinical trials to resolve discrepancies in expert interpretation of data. This is not applicable to a submission demonstrating substantial equivalence through technical specification comparison. The FDA's review process serves as the "adjudicator" for the claim of substantial equivalence.

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

• N/A. This device is a powered muscle stimulator, not an AI-driven diagnostic or assistive technology. Therefore, an MRMC study or assessment of human reader improvement with AI assistance is not relevant.

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

• N/A. This device is a physical medical device (muscle stimulator), not an algorithm or software. Its performance is intrinsic to its physical and electronic properties, not an "algorithm only" performance.

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

• N/A for clinical ground truth. The "ground truth" in this context is the technical and performance specifications of the predicate device that have already been cleared by the FDA. The justification for equivalence relies on comparing the modified device's specifications to these established (and accepted) predicate specifications.

8. The sample size for the training set

• N/A. There is no "training set" in the context of this device being a physical stimulator. This term is relevant for machine learning algorithms.

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

• N/A. As there is no training set for a machine learning algorithm, there is no ground truth to establish for it.

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

Ultra Beauty is a microcurrent device that provides facial stimulation for cosmetic purposes. Ultra Beauty provides a suite of treatment options, combining the different modes and applications from various devices available in the market. The device provides three easy to use pre-programmed modes and the device manual illustrates in detail the suggested treatment protocols for the desired results. The unit features a portable battery powered base module that features a large LCD display and various buttons for easy navigation through the different treatment settings. Ultra Beauty utilizes two different types of probes and to enhance the ease of use and the maneuverability, each probe is attached to the two separate hand pieces. Stimulations generated by the base unit are delivered to the hand pieces through conductive cables.

The provided text is a 510(k) summary for the "Ultra Beauty" device, a Transcutaneous Electrical Nerve Stimulator (TENS) for aesthetic purposes. It focuses on demonstrating substantial equivalence to legally marketed predicate devices rather than proving performance against specific acceptance criteria through clinical studies.

Therefore, many of the requested sections (e.g., acceptance criteria table, sample sizes, expert qualifications, MRMC studies, standalone performance, training set details) cannot be extracted from this document because it outlines a non-clinical evaluation path.

Here's what can be gleaned from the provided text, aligning with the format requested:

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

This document does not include a table of acceptance criteria and reported device performance in the manner typically seen for clinical efficacy studies. Instead, the "acceptance criteria" for 510(k) clearance are based on demonstrating substantial equivalence to predicate devices. The reported "performance" is that it meets applicable safety and EMC standards and has similar technological characteristics to the predicates.

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

• Sample Size for Test Set: Not applicable. This 510(k) relies on non-clinical testing and comparison to predicate devices, not a test set of patient data.
• Data Provenance: Not applicable. The data is from non-clinical engineering and safety testing performed by Johari Digital Healthcare Ltd., located in Jodhpur, India.

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 ground truth was established by experts from a test set of data as this was a non-clinical submission.

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

• Not applicable. No test set requiring adjudication 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

• No. An MRMC comparative effectiveness study was not performed. This device is a transcutaneous electrical nerve stimulator, not an AI-powered diagnostic aide.

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

• Not applicable. This device does not involve an algorithm with standalone performance in the context of diagnostic or interpretive tasks.

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

• Not applicable. No clinical ground truth was established for this 510(k) submission. The ground truth for device safety and performance was based on compliance with recognized consensus standards and engineering verification.

8. The sample size for the training set

• Not applicable. No machine learning training set was used for this device.

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

• Not applicable. No machine learning training set was used for this device.

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Tone-A-Maticis indicated to be used for
L Russian and EMS for:

• . Relaxation of muscle spasms
• Prevention or retardation of disuse atrophy .
• . Increase local blood circulation
• Muscle re-education .
• . Maintaining or increasing range of motion
• Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis.
  TENS for:
  ロ
• Symptomatic relief of chronic, intractable pain.
• · Management of pain associated with post-traumatic or post-operative conditions.

The Tone-A-Matic is a Tone-A-Matic Device is Non-TRANSIT-OPERABLE and PORTABLE micro-controller operated device not to be Worn by patient. It generates electrical impulses and effectively transfers your desired choice of these pre-programmed electrical impulses directly through the electrode adhesive pads to the suggested area of the body where the electrodes are placed. Tone-A-Matic was developed based on physics, electro biology and modern micro-electronic technology. You will be more than pleased with this state-of-the-art device.
The Tone-A-Matic is very user friendly with a large liguid crystal display (LCD) screen that displays the treatment mode in use, a countdown timer and battery indicator. The intensity of the treatment can be increased or decreased by Keypads. User can set the time of the treatment from available choice of 1 min. to 60 min.
It is a clinical model with easy user interface and versatility to treat different body areas simultaneously. This aesthetically designed clinical model has 3 selectable modes(Russian, TENS, EMS) and treatment parameters. The state of the art Tone-A-Matic is light weight (1.78 Kg), small in size (10.3" X 7.5" X 3.5", LxWxH) and battery powered which allows it to be easily moved to any location for immediate use.

This descriptive study compares the Tone-A-Matic device to a predicate device, Winstim (K102190). It does not present a standalone clinical study with an acceptance criterion and reported device performance in the traditional sense of a diagnostic or therapeutic efficacy trial. Instead, it relies on demonstrating substantial equivalence to a legally marketed device through non-clinical testing and comparison of technical specifications and intended uses.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission focused on substantial equivalence rather than a clinical performance study with predefined acceptance criteria for a specific outcome, a direct "acceptance criteria" table for device performance (e.g., sensitivity, specificity, accuracy) is not applicable or provided. Instead, the acceptance criteria for a 510(k) are typically met by demonstrating that the new device has "the same intended use" and "similar technological characteristics" as a predicate device and raises "no new questions of safety or effectiveness."

The "reported device performance" in this context is the technical specifications and safety/EMC compliance, which are compared to the predicate device to justify substantial equivalence.

The study (the 510(k) submission) "proves" the device meets acceptance criteria by presenting a detailed comparison of its technical specifications and intended use against a legally marketed predicate device (Winstim, K102190). The conclusion states: "The electrical stimulation provided by the Tone-A-Matic device is similar to that of Predicate Device Winstim... Tone-A-Matic has same intended use and similar technological characteristics... and the verification and validation tests contained in this submission demonstrate that the differences... still maintain the same safety and effectiveness as that of the cleared predicate."

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

This is not a clinical study involving human or animal subjects for performance testing in the sense of a "test set." The "test set" here refers to the data generated from non-clinical bench testing of the device's electrical characteristics and compliance with standards. Therefore:

• Sample size: Not applicable in the context of a clinical test set. The submission refers to non-clinical tests performed on the Tone-A-Matic device itself to verify its specifications and compliance with standards. The number of individual devices tested or the extent of that testing is not specified, but it would typically involve one or more production units subjected to comprehensive engineering tests.
• Data provenance: The data would be generated in a laboratory setting by the manufacturer, Tone-A-Matic International Inc., during the design, development, and verification stages of the device. It is retrospective in the sense that these tests were performed to support the premarket submission. The country of origin for the data generation would be where the manufacturer conducted these tests (likely Canada or the manufacturing location, if different).

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

Not applicable. This is a non-clinical submission. Ground truth, in the context of clinical studies, refers to definitive diagnoses or outcomes. For this type of submission, "ground truth" for the device's performance is established by engineering measurements and compliance with established international standards (e.g., IEC 60601 series). The "experts" involved would be the engineers and quality assurance professionals performing and reviewing these tests, ensuring they align with the device's design specifications and regulatory requirements. Their qualifications would be in electrical engineering, biomedical engineering, and regulatory compliance.

4. Adjudication Method for the Test Set

Not applicable. As no human readers or clinical interpretations are involved in establishing performance or ground truth for this non-clinical submission, there is no adjudication method. The outcome is determined by direct measurement and comparison to predefined technical standards.

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/TENS unit, not an AI-assisted diagnostic or therapeutic technology that would typically be evaluated with MRMC studies comparing human reader performance.

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

Not applicable in the typical sense of AI algorithm performance. This device is an electrotherapy device. Its "performance" is its ability to generate specific electrical waveforms and outputs as designed and comply with safety standards. The non-clinical tests performed (electrical safety, EMC, software verification) represent the standalone assessment of the device against its specifications and applicable standards.

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

The "ground truth" used for this submission is based on:

• Engineering specifications and measurements: The device is designed to produce specific electrical parameters (voltage, current, waveforms, phase charge, etc.). The non-clinical tests verify that the device's actual output matches these design specifications within acceptable tolerances.
• International safety and performance standards: Compliance with standards like IEC 60601 series, ISO 14971, and FDA software guidance serves as a "ground truth" for safe and effective design and manufacturing.
• Predicate device characteristics: The ground truth for demonstrating substantial equivalence is the established safety and effectiveness of the legally marketed predicate device (Winstim, K102190). The new device is compared directly to these known characteristics.

8. The Sample Size for the Training Set

Not applicable. As this device does not involve machine learning or AI algorithms, there is no "training set."

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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FM 10/C is indicated to be used for:

• CES for the treatment of insomnia, depression, or anxiety. .
• TNS for Symptomatic relief and management of chronic intractable pain and/or . as an adjunctive treatment in the management of post-traumatic and postsurgical acute pain.

FM 10/C is portable Cranial Electrical Nerve Stimulator. FM 10/C combines uniquely two proven therapies CES for the treatment of insomnia, depression, or anxiety and TENS for symptomatic relief of chronic intractable pain, post-traumatic and post-surgical pain. Thus FM 10/C offers a partnership between Transcutaneous Electrical Nerve Stimulation (TENS) and Cranial Electrotherapy Stimulation (CES). FM 10/C has three modes viz. (i) TENS Burst (ii) TENS Conventional and (iii) CES mode. It provides easy mode selection through slide switch and user can select any one of the available modes through it. TENS and CES modes will not operate simultaneously so, if CES Leads are inserted then TENS modes are automatically blocked for the user and vice versa. TENS mode is programmable and user will have the option to select pulse width and pulse rate using analog pots. In addition treatment time is also selectable using a slide switch options available are 30 minutes or continuous treatment time. FM 10/c is only battery operated, with low battery indication.

The provided document does not contain information about acceptance criteria or a study that proves the device meets those criteria. Instead, it is a 510(k) premarket notification summary for a medical device (Cranial Electrical Nerve Stimulator, Model FM 10/C).

This document mainly describes the device, its intended use, and compares its technical specifications to two legally marketed predicate devices (CES Ultra and ELECTRONIC PAIN RELIEVERS) to claim substantial equivalence. The FDA letter confirms the substantial equivalence determination.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and the reported device performance: This information is not present. The document focuses on technical specifications of the new device and predicate devices.
2. Sample size used for the test set and the data provenance: No clinical testing or data is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no test set or ground truth establishment is described.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No such study is mentioned.
6. If a standalone performance (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is an electrotherapy device, not an AI algorithm.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable, as no AI model or training data is discussed.
9. How the ground truth for the training set was established: Not applicable.

The document serves to demonstrate that the FM 10/C device is substantially equivalent to existing devices in terms of its technology and intended use, primarily through technical specification comparison and safety considerations (e.g., battery operation). It does not present results from performance studies or clinical trials to meet specific acceptance criteria.

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POWERTONE PT-11 is intended to be used for:

• Improvement of abdominal tone, for strengthening of the abdominal muscles, for development of a firmer abdomen.
• Strengthening, toning and firming of buttocks & thigh .

Powertone is a Muscle stimulator with two different outputs. This battery powered unit is designed for men & women to provide exercise technology anytime-whether relaxing at home or to use as a part of exercise routine . The stimulation is the most comfortable & this technology makes it easier to combine active & passive exercise.
PT-11 stimulator provides selections of different programs through one output to treat Abdominal muscles (ABS) & through two outputs Bottom /Thighs muscles (BTS). Four body areas can be treated. LCD shows the selected program & balance treatment time.
The MKB panel with the LCD simplifies the selections. This unit is ergonomically designed, being portable it is easy and simple to use, yet works as a Clinical model (two output channels) rechargeable batteries power it. The unit can perform anytime & anywhere. Powertone is suitable for use by all healthy adults. However as with other form of exercise, some care is needed when using them. The electrical muscle stimulator (Powertone) contracts muscles rhythmically to achieve muscle tone and strength. This unit contains six self-adhesive electrodes, which can be fixed to the belt with buttons.

This document is a 510(k) premarket notification for the Powertone PT-11 muscle stimulator. It does not contain information about acceptance criteria or a study proving device performance against such criteria. Instead, it describes the device, its intended use, and establishes its substantial equivalence to previously marketed devices.

Therefore, I cannot provide the requested information from the provided text. The document focuses on regulatory approval based on equivalence rather than clinical study results demonstrating performance against specific acceptance criteria.

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INFREX is indicated to be used for: -

• Symptomatic relief and management of chronic intractable pain.
• Adjunctive treatment in the management of post surgical and post-traumatic, Acute pain condition.

INFREX is a Microcomputer controlled portable two channel electrical stimulator. It allows the treatment specifically tailored to the precise needs of the patient. The unique feature of this unit is that it is supplied with two removable packs of rechargeable batteries and an external charger. The user can put one battery pack in the unit for reatment and another spare pack can be charged outside the unit using the supplied external charger. This system facilitates the user to have charged batteries always available and the treatment can be aak any time. Often the units available in the market consume lot of power and batteries die fast. The Rubber Key Pad operation and LCD protocols makes the use and programming easy and simple. All the parameters remain in the system control except the amplitude & time selectable, which can be set by the patient himself. The ergonomic design makes this unit very comfortable to worn and carry.

The provided document is a 510(k) summary for the INFREX device, a Transcutaneous Electrical Nerve Stimulator (TENS) and Interferential Stimulator. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a clinical study with detailed acceptance criteria and performance metrics in the way a new, high-risk device might.

Therefore, the document does not contain a traditional "study that proves the device meets the acceptance criteria" in the sense of a clinical trial with statistical endpoints for AI performance. Instead, it relies on demonstrating that the new device has the same intended use and similar technological characteristics as predicate devices, and that any differences do not raise new questions of safety or effectiveness.

However, I can extract information related to the acceptance criteria (defined by the substantial equivalence comparison) and the device's technical specifications as its "reported performance" in a comparative context.

Here's an analysis based on the provided text, addressing your points where data is available:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) for substantial equivalence, "acceptance criteria" are implicitly defined by the technical specifications and performance characteristics of the predicate devices. The new device (INFREX) must demonstrate similar performance or that any differences do not raise new safety/effectiveness concerns.

Here's a comparison of key technical specifications, where INFREX's performance is implicitly "accepted" if it is similar to or an improvement upon the predicate devices, or if the differences are justified as safe and effective.

Study Information (Based on 510(k) Submission Type)

This is a Traditional 510(k) submission (K060246) for medical device clearance, not a clinical trial report for an AI algorithm. The "study" here refers to the engineering, design controls, and comparison to predicate devices, rather than a clinical performance study with human subjects validating specific metrics like sensitivity or specificity.

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

• Sample Size for Test Set: Not applicable in the context of this 510(k). The document describes technical specifications and design verification, not a clinical test set from patient data.
• Data Provenance: Not applicable. The data presented is engineering specifications and comparisons to predicate devices, not clinical data sets.

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. This device is an electrical stimulator, not an AI diagnostic tool requiring expert ground truth for interpretation of images or other complex data.

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

• Not applicable. No "test set" in the context of expert adjudication is mentioned. The device's technical specifications are verified through engineering tests and comparison to recognized standards (e.g., ANSI 3.2.3.2, 1985).

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

• Not applicable. This is not an AI-assisted diagnostic or interpretive device. It is a physical electrical stimulator.

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

• Not applicable. This is not an AI algorithm. It's a medical device with fixed operational parameters and control by the patient (for amplitude & time) or clinician. The "microcontroller" discussed enhances precision, but it's not an AI performing clinical tasks.

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

• The "ground truth" for this submission is adherence to recognized electrical and safety standards (e.g., ANSI 3.2.3.2, 1985 for channel isolation) and demonstration of similar or improved technical performance characteristics compared to legally marketed predicate devices, verifying that the device functions as intended and safely delivers the specified electrical stimulation. This is validated through engineering design and testing, as described implicitly by the "design control activities, verification and validation activities" mentioned in the "Safety" section.

8. The sample size for the training set

• Not applicable. There is no AI model being trained with a dataset.

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

• Not applicable. There is no AI model being trained with a dataset.

Summary of what the document does describe for acceptance and proof:

Instead of clinical study data for AI, the document focuses on:

• Substantial Equivalence: The primary "acceptance criteria" for a 510(k) is demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is proven by showing:
  • Identical Indications for Use: INFREX has the exact same Indications for Use as its predicate devices.
  • Similar Technological Characteristics: A detailed comparison of technical specifications (output current, voltage, waveform, pulse width, frequency, etc.) is provided to show that INFREX is technologically similar to the predicate devices.
  • Resolution of Differences: Where there are differences (e.g., power source - rechargeable batteries; microcontroller for precision; specific parameter ranges), the submitter argues these differences do not raise new questions of safety or effectiveness, and in some cases, are presented as improvements (e.g., rechargeable batteries for portability, microcontroller for precision over analog).
• Safety and Performance Testing: The document mentions "design control activities, verification and validation activities" and specifically notes open/short circuit performance testing ("This INFREX functions normally after open and short circuited conditions between output jacks, with the device operating for maximum of 15 minutes, in each condition at the maximum available setting of pulse width, pulse rate and pulse amplitude"). This confirms the device's electrical safety and functional integrity under specific fault conditions. Compliance with standards like ANSI 3.2.3.2, 1985 for channel isolation is also stated.

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INTENDED USE

• Interferential Current Stimulation is indicated for : A)
• 1. Symptomatic relief and management of chronic and intractable pain.
• Adjunctive treatment in the management of post-surgical and post-traumatic, acute pain 2. conditions.
• B) Electrical Muscle Stimulation (EMS or Russian) is indicated for:
• 1 . Relaxation of Muscle spasm.
• 2. Prevention or Retardation of disuse atrophy.
• 3. Increasing local blood circulation.
• 4. Muscle re-education.
• న్. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
• 6. Maintaining or increasing range of motion.

Johari 'Combo Stimulator' is a Neuromuscular Electrical Stimulation System, consists of programmable controller just like the predicate device Analgesic Pulsar AP-439. This unit Combo Stimulator allows the treatment specifically tailored to the precise needs of the patient in the clinic and for subsequent treatment off site. The clinicians can set the treatment parameters and lock it, so patient can repeatedly use the unit as prescribed by the clinician. The stimulation is most comfortable and the waveforms are unique.

It has been the clinician requirement many a times where they wanted to have a unit that can perform for muscle stimulation followed by interferential, so that, the painful muscle condition can be treated. Usually they have to turn the machine On and Off for different stimulation waveforms. The unique feature of Combo Stimulator is that in such above conditions, the clinicians can set the unit to perform in such a way that desired muscle stimulation can be followed by desired Interferential stimulation just by pressing one key "Combo", otherwise in itself the unit can perform muscle stimulation through all the outputs or Interferential stimulation through all the output.

The ease and simplicity by which the programming can be done is not more than touch of the key on the panel and LCD display. All the parameters remain in the system control except the amplitude & time which can be set by the patient himself. This unit is ergonomically designed, so that, it is comfortable to hold in hands.

It is portable and has two output channels, four channels works on rechargeable battery system. The unit can perform offsite wherein the hospital room, clinic or home while the predict device Analgesic Pulsar could not run on rechargeable battery system and so limited its use near to the AC outlet. This has always limited the clinicians to perform on their patient. Also many times, the patient may be in need to have a repeated treatment and this modified device "Combo Stimulator" can work in such cases. The Combo Stimulator can provide True Interferential with desired frequency, sweep selection and muscle stimulation of desired mode similar to Analgesic Pulsar.

The provided document is a 510(k) Special Summary for the "Combo Stimulator IF-5000". It describes the device, its intended use, and compares its technical specifications and technological characteristics to an already legally marketed predicate device, the "Analgesic Pulsar AP-439".

Based on the information provided, here's a description of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Combo Stimulator IF-5000 are implicitly defined by its substantial equivalence to the predicate device, Analgesic Pulsar AP-439. The study demonstrates that the modified device has technical characteristics that are either identical, improved (e.g., portable, battery-operated), or within acceptable ranges compared to the predicate, and serves the same intended use.

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

The document describes a comparison to a predicate device (Analgesic Pulsar AP-439) rather than a clinical trial with a specific test set of patients/data. Therefore, there is no explicit sample size or data provenance provided for a test set in the traditional sense of a clinical study. The evaluation focuses on engineering and performance specifications.

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

This is a regulatory submission for a device modification, relying on technical specifications and functional equivalence. No experts are mentioned as establishing ground truth for a test set, as this is not a study assessing diagnostic accuracy or clinical outcomes based on interpretation. The "ground truth" for the device's acceptable performance is its compliance with recognized standards (ANSI 3.2.3.2, 1985 for channel isolation) and demonstration of equivalent (or improved) technical characteristics to a legally marketed predicate device.

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

Not applicable. As noted above, this is a technical comparison for regulatory clearance, not a clinical study involving human judgment or interpretation requiring an adjudication method.

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

No MRMC comparative effectiveness study was done. This is a medical device for physical medicine applications, not an AI or imaging device where such a study would typically be performed.

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

Not applicable. This device is an electrical stimulator, not an algorithm. Its performance is inherent in its hardware and firmware function, which is designed to be user-controlled ("human-in-the-loop" in the sense of a clinician/patient operating it). The "standalone" performance here refers to its electrical and functional characteristics as presented in the technical specifications.

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

The "ground truth" for this submission is the documented technical specifications and safety standards compliance of the predicate device (Analgesic Pulsar AP-439), as well as general engineering principles and safety regulations for electrical medical devices. The manufacturer demonstrates that the modified device's specifications and functionality are substantially equivalent to or improved upon the predicate device's established performance, which was already accepted by the FDA.

8. The sample size for the training set

Not applicable. This is a hardware medical device submission, not a machine learning or AI context that would involve training sets.

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

Not applicable. As per point 8, there is no training set for this type of device submission.

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