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The CEFAR REHAB 2 and CEFAR REHAB 2 PRO are symmetrical biphasic neuromuscular electronic stimulators indicated for use under medical supervision for adjunctive therapy in the treatment of medical diseases and conditions. Intended uses include:

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

The CEFAR REHAB 2 and CEFAR REHAB 2 PRO are battery powered handheld Neuro-Muscular Electrical Stimulation (NMES) devices only to be used under medical supervision for adjunctive therapy of medical diseases and conditions. The devices operate with two channels and 22 preset stimulation programs. On the CEFAR REHAB 2 PRO the user also can set parameters to create user defined stimulation programs.
Program information and amplitude is displayed on a LCD. The user can set the amplitude in the range 0-100 mA for all programs.

The provided document, a 510(k) summary for the CEFAR REHAB 2 and CEFAR REHAB 2 PRO devices, does not contain information regarding specific acceptance criteria, a detailed study proving device performance against such criteria, or any of the specific points requested (sample sizes, ground truth establishment, expert qualifications, MRMC studies, or standalone algorithm performance).

The document focuses on demonstrating substantial equivalence to a predicate device based on technical specifications and general safety/EMC testing, rather than a clinical performance study with defined acceptance criteria.

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

1. Table of Acceptance Criteria and Reported Device Performance

Missing. The document does not provide a table with specific acceptance criteria or quantitative performance metrics for the device's intended uses (e.g., a specific percentage of muscle spasm reduction or improvement in range of motion).

The comparison table provided focuses on technical specifications to demonstrate equivalence:

Note: This table compares features, not performance against clinical acceptance criteria.

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

Missing. The document states "An extensive collection of tests has been conducted and successfully completed, including system validation in-house and external testing to show compliance with IEC EN 60 601-1-2 regarding EMC, IEC EN 60601-1 regarding general safety for medical equipment." However, these are general safety and electromagnetic compatibility standards, not clinical performance studies. There is no mention of a clinical test set, sample size, or data provenance (country, retrospective/prospective).

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

Missing. Since no clinical test set or ground truth establishment is described, this information is not present.

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

Missing. This information pertains to a clinical study with ground truth established by experts, which is not described.

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. The CEFAR REHAB 2 and REHAB 2 PRO are Neuro-Muscular Electrical Stimulation (NMES) devices, not AI-powered diagnostic or assistive tools. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device.

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

Not applicable. This device is an NMES device with no described AI algorithm component.

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

Missing. As no clinical performance study is detailed, no ground truth type is specified. The assessment focuses on the device's technical specifications and compliance with general medical device safety standards.

8. The sample size for the training set

Not applicable. This device does not use an AI algorithm that would require a training set.

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

Not applicable. This device does not involve a training set for an AI algorithm.

In summary: The provided 510(k) summary demonstrates substantial equivalence based on a comparison of device characteristics and compliance with general safety and EMC standards. It does not include details of a clinical performance study with specific acceptance criteria, sample sizes, ground truth establishment, or expert involvement as would be typical for a device requiring such evidence for performance claims. This is common for predicate pathway 510(k) submissions where the new device is functionally very similar to an already cleared device and does not raise new questions of safety or effectiveness.

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TENS stimulation is used for symptomatic relief and management of chronic intractable pain. It is also used as an adjunctive treatment in the management of post-surgical and post-traumatic pain. It has no curative value and should be used only in conjunction with medical supervision.

The CEFAR Primo is a handheld battery powered TENS device with two channels and nine preset stimulation programs. The two channels are separated and it is possible to stimulate with two different stimulation programs simultaneously, one on each channel. Program information and electrical current amplitude is displayed on a LCD. The user can set the amplitude in the range 0-60 mA for all programs.

Here's a breakdown of the acceptance criteria and study information for the CEFAR Primo, based on the provided document:

Acceptance Criteria and Device Performance

The document does not explicitly state formal "acceptance criteria" in terms of performance metrics (e.g., sensitivity, specificity, accuracy) that the device had to meet. Instead, the "acceptance criteria" appear to be centered on demonstrating substantial equivalence to a predicate device and compliance with relevant safety standards.

The study presented focuses on demonstrating that the CEFAR Primo performs equivalently to the predicate device and adheres to safety regulations, rather than meeting specific quantifiable performance targets.

• Indications for use
• Prescription device
• Number of channels (2)
• Open circuit detection (Yes)
• Transcutaneous current delivery (Yes)
• LCD display (showing intensity & program)
• Power supply (battery operated)
• Software controlled output (Yes)
• User control of output (push buttons)
• Pulsed output (Yes)
• Pulse form (Asymmetric biphasic, zero net DC)
• Max amplitude (60 mA)
• Max pulse width (180 µs vs 300 µs for predicate)
• Max charge per pulse (10.8 µC vs 18 µC for predicate)
  Differences noted but deemed acceptable:
• Specific preset stimulation programs/parameters (e.g., continuous, burst, modulated pulse duration, mixed frequency) offer different specific settings but are within the general functional scope of a TENS device. |
  | (Implied) No New Concerns | The device must not raise any new questions of safety or effectiveness compared to the predicate device. | Conclusion: The CEFAR Primo "presents no new concerns about safety and effectiveness." |

Study Information

The document describes a bench testing and comparison study rather than a clinical trial or a study involving human readers.

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

   • Test Set Sample Size: The document does not specify a "sample size" in the context of clinical data or image sets. The study involved in-house system validation and external testing against technical standards. It's an assessment of the device's physical and electrical properties, not its performance on patient data.
   • Data Provenance: Not applicable, as it's a technical validation of a physical device against standards, not data-driven performance.

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

   • Number of Experts: Not applicable in the sense of clinical experts establishing ground truth for diagnostic accuracy since this is a TENS device subject to technical safety and performance standards.
   • Qualifications: The "experts" involved would be the engineers and technicians at CEFAR Medical AB for in-house validation, and the testing personnel at SEMKO AB (ID 0413), a Notified Body, for external compliance testing. Their qualifications would be in electrical engineering, medical device safety, and regulatory compliance.

3. Adjudication method for the test set:

   • Not applicable. Adjudication methods like 2+1 or 3+1 are used for reconciling expert opinions on clinical ground truth. This study relies on objective measurements against engineering standards.

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

   • No MRMC study was done. This device is a Transcutaneous Electrical Nerve Stimulator (TENS), not an AI-powered diagnostic tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply.

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

   • Yes, a standalone study was done, but not in the context of an algorithm. The "standalone" performance here refers to the device's intrinsic functional and safety characteristics as measured against technical standards, independent of human interaction beyond normal operation. The device itself (the "algorithm only") was tested for its electrical output, safety features, and compliance with regulations.

6. The type of ground truth used:

   • The "ground truth" for this regulatory submission is defined by international medical device safety and performance standards (IEC EN 60601-1-2, IEC EN 60601-1, IEC EN 60601-2-10) and the functional characteristics of the predicate device (SMP-PLUS K982410 TENS-stimulator Rehabilicare). The device's measurements and functionalities were compared against these established technical benchmarks and the predicate device's specifications.

7. The sample size for the training set:

   • Not applicable. This is not a machine learning or AI device that requires a training set.

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

   • Not applicable. No training set was used.

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