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For Mode 0, Ova+ is indicated for temporary relief of pain associated with dysmenorrhea (menstrual cramps) when used with over-the-counter pain medication.

For Modes 1, 2& 3 Ova+ is indicated 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.

The Ova+ is a non-invasive small and convenient unit that can be worn under clothing to provide safe, continuous, drug-free period pain relief whilst maintaining a normal, active lifestyle.

The device is battery powered, single channel home using Transcutaneous Electrical Nerve Stimulation (TENS).

The device is supplied with self-adhesive electrodes which connect to the control unit by cable and plug and are placed on patients' intact skin by the end user. Electrical stimulation is delivered via these self-adhesive electrodes to superficial nerves.

The unit is intended for home use by the patient and is designed with simplicity and ease of use in mind. It has four preset treatment Modes. The level of electrical stimulation of Ova+ is easily controlled by the end user using manual, push-button controls.

The new device Ova+ uses the same technical principle and substantially equivalent stimulation parameters to the marketed device Livia (K183110) and/or reference predicate device Perfect EMS (K200694)

The Ova+ uses a rechargeable Li-Ion polymer battery and a custom TENS connecting lead with 2mm connecting pins.

The Ova+ is supplied with adhesive electrodes that are similar to those of the predicate devices.

The provided text is a U.S. FDA 510(k) summary for the TensCare Ova+ device, a transcutaneous electrical nerve stimulator (TENS). The document describes the device, its intended use, and a comparison to predicate devices to establish substantial equivalence.

Based on the provided text, the TensCare Ova+ device is not a device that uses AI/ML or requires a complex study for its acceptance criteria. It is a TENS device that relies on established technology and regulatory pathways for electrical medical devices.

Therefore, many of the requested elements (e.g., acceptance criteria for AI performance, sample sizes for AI test/training sets, expert adjudication for ground truth, MRMC studies, standalone AI performance) are not applicable to this specific device submission.

The acceptance criteria for this device are based on its electrical performance, safety, and functional equivalence to legally marketed predicate TENS devices, as demonstrated through non-clinical bench testing and adherence to recognized consensus standards.

Here's an attempt to answer the relevant questions based on the provided document:

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

The document does not present explicit "acceptance criteria" in a table format with pass/fail results for each criterion. Instead, it compares the performance characteristics of the Ova+ device to its predicate devices to demonstrate substantial equivalence. The implication is that if the Ova+ device's performance characteristics are similar enough to the cleared predicate devices and meet relevant safety standards, it is considered acceptable.

Below is a summary of the comparative performance from the document (mostly from "Table 3: Comparison of output specifications" and "Table 2: Basic Unit Characteristics Comparison Table" but also other sections). The "Acceptance Criteria" here are implicitly "Substantially Equivalent to Predicate Device(s)" and "Compliance with relevant standards". The "Reported Device Performance" is the stated characteristic of the Ova+ device.

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

• Test Set (Non-clinical Bench Testing): The document mentions "A current production model of the Livia was also tested using the same test instruments for a direct comparison." and "Softrware verification testing on 10 OVA+ prototypes demonstrated that the software of Ova+ meets the requirements of the specifications."
  • Sample Size:
    • For the Livia predicate comparison: "A current production model" (suggests N=1).
    • For Ova+ software verification: "10 OVA+ prototypes".
  • Data Provenance: The testing was "bench testing," meaning physical performance measurements. The location of the testing is not specified, but the manufacturer is based in the UK, and the manufacturing facility is in China. The data would be prospective data from lab tests.
• Clinical Data (from Predicate): The document states that the primary predicate device Livia (K183110) obtained clearance based on clinical performance data. It explicitly states: "The predicate device's manufacturer (LifeCare Ltd.) conducted a clinical trial designed to show the safety and effectiveness of the Livia device for the indication of temporary relief of pain associated with dysmenorrhea (menstrual cramps) when used with over-the-counter pain medication."
  • Sample Size: Not specified in this 510(k) summary, as it refers to the predicate's original submission.
  • Data Provenance: Not specified for the predicate's clinical trial in this document (e.g., country, retrospective/prospective). However, clinical trials for FDA submissions are typically prospective.

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 not applicable for this device. Ground truth established by experts is typically for diagnostic devices, especially those using AI/ML where human interpretation is the gold standard. For a TENS device, the "ground truth" for performance is based on electrical measurements, adherence to standards, and user usability, not expert interpretation of outputs.

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

This is not applicable. Adjudication methods are used in studies where there is subjective interpretation (e.g., medical image reading) to establish consensus or resolve discrepancies in ground truth. The "test set" for this device involved bench testing and software verification, which are objective measurements.

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

This is not applicable. MRMC studies are specific to diagnostic devices, particularly those involving human readers (e.g., radiologists) interpreting cases, often with and without AI assistance, to assess diagnostic performance. This device is a therapeutic TENS device, not a diagnostic one, and does not involve human "readers" or AI assistance in interpretation.

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

This is not applicable. This question pertains to AI/ML software performance. The Ova+ device is a physical TENS unit; while it contains software for control, it's not a standalone AI algorithm in the context of diagnostic performance evaluation. Its "standalone" performance would be its electrical output and safety characteristics, which were assessed via bench testing as described in Section 1.

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

• For the Ova+ device itself: The "ground truth" for its performance and safety is its adherence to electrical safety standards (e.g., IEC 60601 series), electromagnetic compatibility (EMC) standards, biocompatibility (ISO 10993), and functional specifications measured via bench testing. For usability, it's performance against ISO 62366 usability standards, demonstrated through a usability study.
• For the predicate device Livia's clinical clearance: The ground truth for its effectiveness was clinical outcomes data from a clinical trial, demonstrating temporary pain relief for dysmenorrhea.

8. The sample size for the training set

This is not applicable. This question relates to AI/ML models. The Ova+ device is a hardware TENS unit. It has no "training set" in the context of machine learning.

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

This is not applicable, as there is no "training set" for this type of device.

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The FT610-B is designed for symptomatic relief and management of chronic pain, and for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities and lower extremities due to strain from exercise or normal household work activities. It is also indicated for temporary relief of pain associated with dysmenorrhea (menstrual cramps) when used with over-the-counter pain medication, it also provides a heat function intended to temporarily relieve minor aches and pains.

The subject device is a self-adhesive TENS device with 15 adjustable intensity levels for pain relief. Moreover, it also provides a heat function which can be used alone, or in conjunction with the TENS function simultaneously. TENS, Transcutaneous Electrical Nerve Stimulation, refers to the electrical stimulation of nerves through the skin which is an effective method of pain relief. It can be used for self-treatment. Any symptoms that could be relieved using TENS must be checked by your general practitioner who will also give you instruction on how to carry out a TENS selftreatment regime.

TENS device works by passing electrical currents over the skin via a set of gel pads. As a transfer medium, the gel pads are subject to natural wear and tear, and must be replaced when they stop providing sufficient contact or the main unit no longer sticks to the skin completely. Failure to replace the gel pad may lead to skin irritation as a result of heightened current density in particular areas.

This device is only compatible with the 50 mm x 56 mm gel pads which are the OTC medical device cleared by FDA under K132588, and come with the device.

The provided document is a 510(k) Premarket Notification from the FDA for a medical device. It does not contain information about acceptance criteria and studies in the context of AI/ML device performance or clinical trials with human readers. Instead, it describes a substantial equivalence determination for a physical medical device (HIVOX OTC Electrical Stimulator, FT610-B) based on non-clinical testing and comparison to predicate devices.

Therefore, I cannot extract the requested information regarding:

• A table of acceptance criteria and reported device performance for an AI/ML device.
• Sample sizes, data provenance, or number/qualifications of experts for a test set.
• Adjudication methods for a test set.
• MRMC comparative effectiveness studies or human reader improvement with AI.
• Standalone algorithm performance.
• Type of ground truth used (expert consensus, pathology, outcomes data).
• Sample size for the training set or how its ground truth was established.

The document explicitly states: "No clinical test data was used to support the decision of substantial equivalence."

Instead, I can provide information based on the non-clinical testing for the physical device:

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

The document states that "All the test results demonstrate the subject device, HIVOX OTC Electrical Stimulator (FT610-B), meets the requirements of its pre-defined acceptance criteria and intended use". Specific numerical acceptance criteria are not detailed in the provided text, but the device performance was measured against recognized consensus standards and guidance documents.

Regarding the other points, the document explicitly states or implies they are not applicable:

• 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for this type of non-clinical device testing for substantial equivalence.
• 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. "Ground truth" in the context of expert consensus for AI/ML performance is not relevant here. Non-clinical tests typically involve engineers and technicians evaluating against technical standards.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for non-clinical testing.
• 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 device is a physical Transcutaneous Electrical Nerve Stimulator, not an AI/ML diagnostic or assistive tool.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-only device.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For non-clinical tests, "ground truth" is typically defined by the specifications in the standards themselves (e.g., specific electrical output values, temperature limits, material properties).
• 8. The sample size for the training set: Not applicable. This device does not use a "training set" in the context of machine learning.
• 9. How the ground truth for the training set was established: Not applicable.

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