(145 days)
To maintain the temperature of human reproductive tissue such as occytes and embryos through an assisted reproduction (AR) cycle.
The RI Witness Embryology Heated Plate is designed to maintain the temperature of embryos and other reproductive tissues placed in dishes on the surface of the device. It is typically installed in a flow hood or on a work bench and comprises of a central clear window within a solid baseplate containing the temperature controller. There are 5 heating circuits, one for the window that uses ITO coated glass and the other 4 use power resistors screwed in thermal contact to the aluminium base plate.
The provided text describes the RI Witness Embryology Heated Plate, a device designed to maintain the temperature of human reproductive tissues. However, the document does not contain information about a study that measures the device's performance against detailed acceptance criteria in the manner requested (e.g., in a clinical trial with human subjects, or a detailed analytical study with a specified sample size, ground truth, and expert involvement).
The document is a 510(k) summary for the device, focusing on demonstrating substantial equivalence to a predicate device. It details non-clinical performance data related to electrical safety, EMC, wireless technology, software verification, and bench testing. These tests are primarily focused on safety and engineering performance, rather than clinical efficacy or accuracy in the context of an AI/algorithm-driven device as implied by the request's structure.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's a summary of what can be extracted and what cannot:
1. Table of acceptance criteria and reported device performance:
The document lists some technical specifications and mentions various types of bench testing performed. From this, we can infer some internal acceptance criteria related to these technical specifications and tests.
| Acceptance Criteria (Inferred from Technical Specifications & Bench Tests) | Reported Device Performance (Summary from text) |
|---|---|
| Electrical Safety Standards | Compliance with IEC 60601-1:2012 (safety standards). |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2:2014 for EMC. |
| Wireless Technology (RFID) | Tested per FDA guidance document "Radio Frequency Wireless Technology in Medical Devices - Guidance for Industry and Food and Drug Administration Staff" (January 3, 2007). Performance characteristics like "RFID Read Range and Read Reliability" were evaluated. |
| Software Verification & Validation | Documentation provided as recommended by FDA guidance. Software considered a "minor" level of concern. |
| Temperature Accuracy | +/- 0.2 °C (This is listed as a specification, implying it was met). |
| Heating Range | 30-45 °C (This is listed as a specification, implying it was met). |
| Bench Testing (Operational Performance) | Satisfactory operating performance for: |
- Time to reach temperature set point
- Maximum temperature
- Stability of temperature control
- Uniform distribution of temperature across the device
- Liquid ingress
- Volatile organic compound emissions
- Cable integrity up to 84°C
- Thermal Cycling Life Test
- Packaging Verification |
| Biological Effect of Radiofrequency Exposure | Mouse embryo assay performed to measure the effects of exposure to radiofrequency. (The text states the test was done, implies acceptable results as it concludes substantial equivalence). |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified for any of the tests. The "mouse embryo assay" implies a biological sample, but the number of embryos or replicates is not mentioned.
- Data Provenance: The device is manufactured in the United Kingdom by Research Instruments Ltd. All testing appears to be non-clinical bench testing conducted by or for the manufacturer. The "mouse embryo assay" is the only test that could be considered biological, but specific details are absent.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The tests performed are primarily engineering and safety assessments, not evaluations requiring expert human interpretation of images or clinical data.
4. Adjudication method for the test set:
- Not applicable. No expert adjudication process is described for the types of tests 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:
- Not applicable. This device is not an AI/algorithm-driven diagnostic tool that assists human readers. It is a heated plate for medical samples.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is not an algorithm.
7. The type of ground truth used:
- For the engineering/safety tests: Standards (e.g., IEC 60601-1:2012, IEC 60601-1-2:2014, FDA guidance for wireless technology) and defined performance specifications (e.g., temperature accuracy, heating range).
- For the mouse embryo assay: Biological outcomes in mouse embryos, implicitly compared against a control or expected norm for viability/development. Specific details are not provided.
8. The sample size for the training set:
- Not applicable. The device is not an AI/machine learning algorithm requiring a training set in this context.
9. How the ground truth for the training set was established:
- Not applicable.
In conclusion, the provided document is a regulatory submission focused on substantial equivalence of a medical device (a heated plate). It describes engineering and safety tests rather than performance against acceptance criteria for an AI or imaging diagnostic device. As such, most of the requested information regarding study design, sample sizes, expert involvement, and ground truth in a clinical or AI context is not present.
§ 884.6120 Assisted reproduction accessories.
(a)
Identification. Assisted reproduction accessories are a group of devices used during assisted reproduction procedures, in conjunction with assisted reproduction needles and/or assisted reproduction catheters, to aspirate, incubate, infuse, and/or maintain temperature. This generic type of device may include:(1) Powered aspiration pumps used to provide low flow, intermittent vacuum for the aspiration of eggs (ova).
(2) Syringe pumps (powered or manual) used to activate a syringe to infuse or aspirate small volumes of fluid during assisted reproduction procedures.
(3) Collection tube warmers, used to maintain the temperature of egg (oocyte) collection tubes at or near body temperature. A dish/plate/microscope stage warmer is a device used to maintain the temperature of the egg (oocyte) during manipulation.
(4) Embryo incubators, used to store and preserve gametes and/or embryos at or near body temperature.
(5) Cryopreservation instrumentation and devices, used to contain, freeze, and maintain gametes and/or embryos at an appropriate freezing temperature.
(b)
Classification. Class II (special controls) (design specifications, labeling requirements, and clinical testing). The device, when it is a simple embryo incubator with only temperature, gas, and humidity control; a syringe pump; a collection tube warmer; a dish/plate/microscope stage warmer; a controlled-rate cryopreservation freezer; or an assisted reproduction laminar flow workstation is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.