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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.

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