(44 days)
The Thermo Forma CryoMed ® Controlled Rate Freezers are intended to be used to freeze gametes and/or embryos at a user determined rate. This device is not intended for long-term storage.
The intended use of these freezers is to freeze gametes and/or embryos. The freezer is designed to allow the user to select the desired cooling rate and temperature, for the purpose of improved viability.
The CryoMed controlled rate freezers are bench top units. They control temperature and temperature rate through the use of liquid nitrogen (LN2), an electric heater and an air-circulating fan. Freezing parameters and alarm functions are controlled by a microprocessor built into the controlled rate freezer itself. The freezer is supplied with several preloaded freezing profiles as well as allowing the user to define their own profiles. Optional PC resident software, supplied with each unit, allows user defined programs to be written on a personal computer and downloaded to the freezer. The freezer then stores these parameters in its memory and takes over control of the run.
The provided text describes a 510(k) summary for the Thermo Forma CryoMed® IVF Controlled Rate Freezer. It outlines the device, its intended use, and substantial equivalence to a predicate device based on the Final Rule on reclassification of Medical Devices Used for In Vitro Fertilization.
However, the provided document does not contain the specific details required to fully address your request regarding acceptance criteria and the study that proves the device meets those criteria. The document states that "Thermo Forma's CryoMed ® Controlled Rate Freezers were subjected to electrical safety, electromagnetic compatibility and operating performance tests. The freezers passed all these tests." but does not provide:
- A table of specific acceptance criteria values.
- Reported device performance against those criteria.
- Sample sizes, data provenance, number of experts, adjudication methods, multi-reader multi-case study results, standalone performance, type of ground truth, or details on the training set.
Therefore, I can only provide a partial answer based on the information present in the document and highlight what is missing.
Acceptance Criteria and Device Performance Study Details:
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Table of Acceptance Criteria and Reported Device Performance:
Acceptance Criteria Category Specific Acceptance Criteria Reported Device Performance Electrical Safety (Not specified in document) Passed Electromagnetic Compatibility (Not specified in document) Passed Operating Performance (Not specified in document) Passed Note: The document only states that the freezers "passed all these tests" without detailing the specific criteria for each category or providing quantitative performance metrics.
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Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified.
- Data Provenance: Not specified. It's an engineering test for a physical device, so it would likely be conducted in a laboratory setting by the manufacturer, but the location or whether it was internal testing, an independent lab, etc., is not mentioned.
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Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Number of Experts: Not applicable/not specified. The tests mentioned (electrical safety, EMC, operating performance) typically rely on engineering standards and measurement equipment rather than expert human interpretation for ground truth.
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Adjudication Method for the Test Set:
- Not applicable/not specified.
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If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. This is a hardware device (controlled rate freezer), not an AI/software diagnostic tool. MRMC studies are not relevant for this type of product.
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If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a hardware device. The concept of "standalone performance" for an algorithm is not applicable. The device itself is standalone in terms of its function as a freezer.
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The Type of Ground Truth Used:
- Engineering Standards and Specifications: For electrical safety and electromagnetic compatibility, the ground truth would be defined by relevant national and international electrical and EMC standards. For operating performance, it would be based on the device's design specifications for temperature control, cooling rates, and accuracy. The document does not specify which standards or what operating performance specifications were used.
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The Sample Size for the Training Set:
- Not applicable. This is a manufactured hardware device. It does not use machine learning or AI models that require a "training set" in the conventional sense.
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How the Ground Truth for the Training Set was Established:
- Not applicable, as there is no training set for this type of device.
Summary of Missing Information:
To fully answer your request, the following specific details would be needed, which are not present in the provided 510(k) summary:
- Specific numerical acceptance criteria for electrical safety (e.g., leakage current limits, dielectric strength), electromagnetic compatibility (e.g., emissions limits, immunity levels), and operating performance (e.g., temperature control accuracy, cooling rate precision, uniformity within the chamber).
- Quantitative results demonstrating the device's performance against each of those specific criteria.
- Details about the test protocols, the number of units tested, and where the testing was performed.
§ 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.