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510(k) Data Aggregation
(256 days)
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.
| Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance (Ova+) | Predicate Livia (K183110) Performance | Predicate Perfect EMS (K200694) Performance | Comparison Outcome (Implicit Acceptance) |
|---|---|---|---|---|---|
| Indications for Use | Substantially equivalent to predicate(s) | Mode 0: Dysmenorrhea (w/ OTC pain med); Modes 1,2,3: Sore/aching muscles (shoulder, waist, back, neck, arm, leg) | Same (including dysmenorrhea and general pain) | TENS for sore/aching muscles | Substantially Equivalent (with Livia) |
| Intended Users | Substantially equivalent to predicate(s), home use, 18+ women | Home use, women aged 18 and above | Women aged 18 and above | Keep away from children | Substantially Equivalent (with Livia) |
| Power Source | Safe and effective; similar to predicate | 3.7V Lithium ion battery (rechargeable) | 3.7V Lithium ion battery (rechargeable) | 2 x AA alkaline battery | Substantially Equivalent |
| Method of Line Current Isolation | Safe and effective; similar to predicate | Not possible to connect patient lead and charger at same time; uses same socket | Electrically disabled output when connected to charger | No connection to Line Current | Substantially Equivalent |
| Patient Leakage Current - Normal Condition | < 10µA (battery powered) | < 10µA (Battery powered) | < 10µA (Battery powered) | < 10µA (Battery powered) | Identical |
| Patient Leakage Current - Single Fault Condition | < 50µA (battery powered) | < 50µA (Battery powered) | < 50µA (Battery powered) | < 50µA (Battery powered) | Identical |
| Average DC current through Electrodes (no pulses) | 0 µA | 0 µA | 0 µA | 0 µA | Identical |
| Number of Output Modes | Similar functionality to predicates | 4 (1 Dysmenorrhea & 3 Pain) | 1 (Dysmenorrhea) | 1 (Pain) | Substantially Equivalent |
| Number of Output Channels | Similar functionality to predicates | 1 | 1 | 2 | Identical (with primary predicate) |
| Regulated Current or Voltage | Safe and effective output control | Voltage | Current | Voltage | Substantially Equivalent |
| Software/Firmware/Microprocessor Control | Safe and effective control | Yes | Yes | Yes | Identical |
| Automatic No-Load Trip | Safety features are adequate even if different from predicates | No | Yes | Yes | Substantially Equivalent (due to intrinsic safety) |
| Automatic Overload Trip | Safety features are adequate even if different from predicates | No | Yes | Yes | Substantially Equivalent (due to intrinsic safety) |
| Automatic Shut Off | Safe operation | No | No | Yes | Identical |
| User Override Control | User control for effectiveness | Yes | Yes | Yes | Substantially Equivalent |
| Indicator Display | Provides necessary user information | Yes (On/Off, Low Bat, V/C level, Time to cut-off) | Yes | Yes | Identical |
| Timer Range | Similar to predicate | No Timer | No internal timer | 20-40 minutes | Identical (with primary predicate) |
| Waveform | Biphasic, Equal duration | Biphasic, Equal duration | Bi-phasic, Symmetrical | Biphasic, Equal duration | Substantially Equivalent |
| Shape | Rectangular | Rectangular | Rectangular | Rectangular | Identical |
| Max Output Voltage (V) @ 500 ohm | Within safe operating parameters, similar to predicates | 26V | 50V | 50V | Substantially Equivalent |
| Max Output Voltage (V) @ 2k ohm | Within safe operating parameters, similar to predicates | 28V | 64V | 90V | Substantially Equivalent |
| Max Output Voltage (V) @ 10k ohm | Within safe operating parameters, similar to predicates | 29V | Not specified | 125V | Substantially Equivalent |
| Max Output Current (mA) @ 500 ohm | Within safe operating parameters, similar to predicates | 52mA | 50mA | 100mA | Substantially Equivalent |
| Max Output Current (mA) @ 2k ohm | Within safe operating parameters, similar to predicates | 28mA | 31mA | 45mA | Substantially Equivalent |
| Max Output Current (mA) @ 10k ohm | Within safe operating parameters, similar to predicates | 3mA | 6.4mA | 12.5mA | Substantially Equivalent |
| Dysmenorrhea Mode Pulse Width (μs) | Similar to primary predicate | 100μs | 100μs | Not applicable | Substantially Equivalent |
| Dysmenorrhea Mode Frequency (Hz) | Similar to primary predicate | 110Hz | 100Hz | Not applicable | Substantially Equivalent |
| General Pain Modes Pulse Width (μs) | Within range of secondary predicate | 50μs, 100μs, 150μs, 200μs | Not applicable | 50-250μs, in steps of 50μs | Substantially Equivalent |
| General Pain Modes Frequency (Hz) | Within range of secondary predicate | 10 Hz, 100Hz, 110Hz | Not applicable | From 1Hz to 120Hz | Substantially Equivalent |
| Net Charge (μC per pulse) at 500Ω | Similar to predicates | 2.24μC | 0 | 1 μC | Similar |
| Maximum Phase Charge (μC) | Within safe operating parameters, similar to predicates | 9.6μC | 6.4μC | 20.5μC | Substantially Equivalent |
| Maximum Current Density (mA/cm²) | Within safe operating parameters, similar to predicates | 0.175 (Surface=45cm²) | 0.38 | 0.01013 (Surface=25cm²) | Substantially Equivalent |
| Maximum Power Density (mW/cm²) | Within safe operating parameters, similar to predicates | 0.693 (Surface=45cm²) | 2.05 | 0.53 (Surface=25cm²) | Substantially Equivalent |
| Compliance with Voluntary Standards | Compliance with relevant electrical safety, EMC, nerve stimulator, home use standards | IEC 60601-1, -1-2, -2-10, -1-11, -6, IEC 62304, IEC 62366-1, ISO 14971 | IEC 60601-1, -1-2, -2-10, ISO 10993-1, -5, -10 | Most of the above + IEC 60601-1:2005 | Substantially Equivalent |
| Compliance with 21 CFR 898 | Yes | Yes | Yes | Yes | Identical |
| Weight | Similar to predicates (not a specific performance criterion, but a characteristic) | 19.5g | 37g | 146.5g | Similar |
| Dimensions | Similar to predicates (not a specific performance criterion, but a characteristic) | 65 x 38 x 10mm | 55 x 55 x 20mm | 66 x 136 x 30.7mm | Similar |
| Housing Materials | Biocompatible and durable | Silicone, ABS plastics | ABS plastics | ABS plastics | Substantially Equivalent |
| Electrode Biocompatibility | Compliant with ISO 10993 | Biocompatibility testing conducted on identical skin-contacting materials (hydro-gel) under K210448. | ISO 10993-1, -5, and -10 | Not explicitly detailed for this point | Substantially Equivalent |
| Software Verification | Meets specifications | 10 OVA+ prototypes tested for software verification. | Not explicitly detailed for this point | Not explicitly detailed for this point | Confirmed |
| Usability | OTC users can adequately understand and use the device | Usability Study according to ISO 62366. Lay operator requires limited training for basic safety and essential performance. | Not explicitly detailed for this point | Not explicitly detailed for this point | Shown acceptable |
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.
- Sample Size:
- 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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