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The SimulCare II™ is intended for the temporary relief of minor muscle and joint pain, promoting the relaxation of muscle tissue, temporarily increasing local blood circulation, symptomatic relief and management of chronic intractable pain, and adjunctive relief of post-surgical or post-traumatic pain.

The SimulCare II Multi-function Therapeutic Device is modified from the SimulCare and ComboCare 2000 devices previously cleared under 510(k)s K083202 & K081141 and includes improved interface features, EMI filters, additional audible alarm and battery monitoring circuit drain prevention.
Portable, lightweight, rechargeable unit consisting of a hand-held controller with digital control of stimulation parameters and an attached flexible pad that produces battery-charged therapy consisting of red light emitting diodes, infrared light emitting diodes, micro current, macro current (E-stim), permanent magnets and vibratory massage.

The document provided is a 510(k) premarket notification for a medical device called SimulCare II™. It asserts substantial equivalence to existing predicate devices rather than proving the device meets specific acceptance criteria through a study. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert ground truth, and comparative effectiveness studies is not applicable to this type of submission.

Here's a breakdown of what can be extracted based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: The document describes the SimulCare II™ device and compares it to two predicate devices (SimulCare™ K083202 and ComboCare 2000™ K081141) to establish substantial equivalence. It does not present explicit "acceptance criteria" in the traditional sense of performance targets that the device itself must meet independently through a clinical trial. Instead, the "acceptance" is based on demonstrating that the new device is as safe and effective as existing legally marketed devices for the same intended use. The comparison tables highlight the similarities and differences in technological characteristics and electrical parameters.

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

• Not applicable (N/A). The submission states "Clinical tests submitted or relied upon: None" (page 3). The evaluation is based on a comparison to predicate devices, not on a new clinical study with a test set. Non-clinical tests included "Safety & EMC Testing" (page 3), but details on sample size or data provenance for these engineering tests are not provided in the summary.

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

• N/A. No test set or ground truth established by experts is mentioned, as no clinical study was conducted for this 510(k) submission.

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

• N/A. No test set or adjudication process is mentioned, as no clinical study was conducted.

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 an electrical nerve stimulator, not an AI-powered diagnostic or interpretive device. No MRMC study or AI assistance is relevant here.

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

• N/A. This device does not involve an algorithm or AI that would have standalone performance.

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

• N/A. No ground truth was established, as no clinical study was conducted. The basis for clearance is substantial equivalence to legally marketed predicate devices, meaning their safety and effectiveness (previously established) are considered the "ground truth" for comparison.

8. The sample size for the training set:

• N/A. The device is not an AI/machine learning model, so there is no training set.

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

• N/A. No training set or ground truth for a training set exists for this device.

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The ComboCare 2000 is intended for the temporary relief of minor muscle and joint pain, promoting the relaxation of muscle tissue, temporarily increasing local blood circulation, symptomatic relief and management of chronic intractable pain, and adjunctive relief of post-surgical or post-traumatic acute pain.

This device, modified from the ComboCare 2000 device previously cleared under 510(k) K081141, includes the addition of permanent magnets to the flexible pads to create a static magnetic field and increased Infrared light strength for therapeutic heating.

The provided text is a 510(k) summary for the ComboCare 2000 device, which is a Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief.

The document explicitly states that no clinical testing was performed. Instead, the submission relies on non-clinical testing to validate the design against specified requirements and assure conformance with voluntary design standards (EN 60601-1, EN 60601-1-2, EN 60601-2-10). The basis for substantial equivalence is primarily the technological characteristics similar to predicate devices (K081141 Xanacare Technologies LLC ComboCare 2000 and K071445 Escada International, Inc. TerraQuant MQ2000 v.5 with TQ-ITENS).

Given this information, it is not possible to provide the requested details regarding acceptance criteria, device performance, sample sizes, ground truth, expert qualifications, adjudication, or MRMC studies, as these typically relate to clinical evaluations that were not conducted for this device's 510(k) submission.

Therefore, the response will reflect the absence of such information from the provided document.

1. Table of acceptance criteria and the reported device performance:

Since no clinical testing was performed and the submission relies on non-clinical testing for design validation and conformance to voluntary standards, there are no reported acceptance criteria or device performance metrics related to clinical efficacy. The device performance was assessed against design requirements and safety standards, but specific quantitative acceptance criteria or clinical performance data are not provided in this document.

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

Not applicable. No clinical test set was used for an effectiveness study. Non-clinical testing was performed, but details on sample sizes or data provenance for these non-clinical tests are not provided in the summary.

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

Not applicable. No clinical test set requiring expert-established ground truth was reported.

4. Adjudication method for the test set:

Not applicable. No clinical test set requiring adjudication was reported.

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 TENS unit for pain relief, not an AI-assisted diagnostic tool involving human readers. No MRMC study was conducted or referenced.

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

Not applicable. This device is a medical device for physical therapy, not an algorithm or AI system.

7. The type of ground truth used:

Not applicable. No clinical data requiring "ground truth" (e.g., from pathology, expert consensus, or outcomes data) was used for this 510(k) submission. Non-clinical testing focused on design validation against company specifications and compliance with safety and performance standards.

8. The sample size for the training set:

Not applicable. This device did not involve machine learning algorithms requiring a training set.

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

Not applicable. This device did not involve machine learning algorithms requiring a training set with established ground truth.

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The ComboCare 2000 is intended for the temporary relief of minor muscle and joint pain, promoting relaxation of muscle tissue, symptomatic relief and management of chronic intractable pain, and adjunctive relief of post-surgical or post-traumatic acute pain.

The ComboCare 2000 is intended for the temporary relief of minor muscle and joint pain, promoting relaxation of muscle tissue, symptomatic relief and management of chronic intractable pain, and adjunctive relief of post-surgical or post-traumatic acute pain.

The provided 510(k) summary for the ComboCare 2000 does not describe a study that establishes acceptance criteria through clinical evidence or performance metrics like accuracy, sensitivity, or specificity. Instead, it focuses on demonstrating substantial equivalence to predicate devices through technological characteristics and conformance to voluntary design standards.

Here's an analysis based on the provided text, addressing your points:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not present in the provided document. The submission is for a device based on "non-heating lamps for adjunctive use in pain therapy" and TENS technology, which typically relies on established safety and performance profiles of equivalent predicate devices rather than novel performance criteria requiring a new clinical study with specific acceptance metrics.

The document discusses "design requirements" and "conformance with voluntary design standards" instead of measurable performance acceptance criteria for diagnostic or treatment effectiveness.

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

• Test Set Sample Size: Not applicable/Not provided. No clinical or performance test set (in terms of patient data) is mentioned.
• Data Provenance: Not applicable/Not provided. The submission explicitly states: "Xanacare did not conduct, nor rely upon, clinical tests to determine substantial equivalence." Non-clinical testing for safety and design validation was performed.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

• Number of Experts: Not applicable/Not provided. Since no clinical performance study was conducted on patient data, there was no need for experts to establish ground truth for a test set.

4. Adjudication Method

• Adjudication Method: Not applicable/Not provided. No clinical performance study on patient data, hence no adjudication method.

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

• MRMC Study: No. The document explicitly states: "Xanacare did not conduct, nor rely upon, clinical tests to determine substantial equivalence." Therefore, no MRMC study, and no effect size for human readers with and without AI assistance (as this is not an AI device).

6. If a Standalone (Algorithm Only) Performance Study Was Done

• Standalone Performance Study: No. This is not an algorithm-only device. The submission relies on substantial equivalence to predicate devices based on technological characteristics and safety standards.

7. The Type of Ground Truth Used

• Type of Ground Truth: Not applicable/Not provided in the context of clinical performance. The "ground truth" for this submission revolves around demonstrating that the device's technical specifications and safety features are equivalent to legally marketed predicate devices and conform to relevant electrical safety and medical device standards.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable/Not provided. This is not an AI/machine learning device that would require a training set.

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

• Ground Truth for Training Set: Not applicable/Not provided.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The provided 510(k) summary indicates that the ComboCare 2000's acceptance for market clearance is not based on a clinical study demonstrating specific performance criteria (like accuracy or effectiveness compared to a ground truth) directly for its intended use.

Instead, the "study" that proves the device meets the criteria for market clearance (i.e., substantial equivalence) is:

• Non-clinical testing: Performed to "validate the design against the company's specified design requirements."
• Conformance to voluntary design standards: EN 60601-1 (General safety), EN 60601-1-2 (Electromagnetic compatibility), and EN 60601-2-10 (Nerve and muscle stimulators safety).
• Risk Management Program: Application of ISO 14971 to eliminate or mitigate known health hazards.
• Comparison of Technical Characteristics: A detailed comparison table (provided in the document) demonstrates that the ComboCare 2000's electrical power source, battery type, light characteristics (IR and Red LED), vibratory massage, and E-Stim/Micro-Current TENS parameters (max output current/voltage, pulse frequency/width, waveform) are either equivalent to or within the ranges of legally marketed predicate devices.

The FDA's decision to clear the device is based on this demonstration of substantial equivalence to existing predicate devices already on the market, rather than a de novo clinical trial proving efficacy or specific performance metrics. The underlying assumption is that if the new device is technologically similar and meets the same safety standards as cleared predicate devices, it is equally safe and effective for its stated indications for use.

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