(55 days)
CryoCheck Weak Lupus Positive Control is prepared from human source plasma and is recommended for use as a positive control in assays for lupus anticoagulant.
CryoCheck Weak Lupus Positive Control contains citrated human plasma collected from donors that have tested positive in accordance with the revised criteria of the SSC Subcommittee for the Standardization of Lupus Anticoagulants. Source plasmas are processed in a manner that yields platelet-poor plasmas. Plasma is then buffered, aliquoted and rapidly frozen.
The provided text describes a 510(k) premarket notification for a medical device called "CryoCheck Weak Lupus Positive Control." The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance data for the new device. Therefore, many of the requested sections regarding a study cannot be directly extracted as such a study with detailed performance metrics is not included.
Here's an analysis based on the available information:
1. A table of acceptance criteria and the reported device performance
This information is not explicitly provided in the document. The document's purpose is to establish substantial equivalence, not to demonstrate performance against specific quantitative acceptance criteria for the new device itself. The "performance" described is in terms of its characteristics being similar to the predicate device.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided. The document does not describe a clinical study or a test set in the traditional sense for evaluating the new device's performance. It states that the device "contains citrated human plasma collected from donors that have tested positive in accordance with the revised criteria of the SSC Subcommittee for the Standardization of Lupus Anticoagulants." This indicates the source material, but not a separate "test set" for performance evaluation, nor its provenance details.
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 information is not provided. As there's no described "test set" for performance evaluation, there's no mention of experts establishing ground truth for such a set. The "ground truth" for the source plasma is implicitly the results of the tests performed on the donors to determine their lupus anticoagulant status, following the SSC Subcommittee's criteria.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided. There is no described test set or adjudication method.
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 information is not applicable/not provided. The device is a "Lupus Positive Control" (a biological reagent), not an AI-powered diagnostic tool for human readers. Therefore, an MRMC study or AI assistance is not relevant to this device.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done
This information is not applicable/not provided. The device is a biological control, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the source plasma used in the device is based on "donors that have tested positive in accordance with the revised criteria of the SSC Subcommittee for the Standardization of Lupus Anticoagulants." This implies a set of established laboratory test results and clinical criteria for diagnosing lupus anticoagulant status.
8. The sample size for the training set
This information is not provided. The concept of a "training set" as understood in machine learning/AI is not applicable to this biological control device.
9. How the ground truth for the training set was established
This information is not provided. As above, the concept of a training set is not applicable. The "ground truth" for the source material refers to the diagnostic criteria for lupus anticoagulants used to select the plasma donors.
Summary of Device and Substantial Equivalence Claim:
The "CryoCheck Weak Lupus Positive Control" is a biological control designed for use in assays for lupus anticoagulant. It is composed of citrated human plasma from donors who have tested positive for lupus anticoagulant according to specific scientific guidelines (SSC Subcommittee criteria). The manufacturer, Precision BioLogic Inc., is seeking 510(k) clearance by demonstrating substantial equivalence to their previously cleared device, the "CryoCheck Lupus Positive Control (K952623)."
The claim of substantial equivalence is based on the following similarities:
- Intended Use: Both devices are recommended as positive controls in assays for lupus anticoagulant.
- Matrix: Both consist of citrated human plasma from donors testing positive for lupus anticoagulant based on the same SSC Subcommittee criteria.
- Format: Both are provided in a frozen format.
- Volume: Both are available in 0.5 mL and 1.0 mL vial sizes.
The FDA reviewed these similarities and concluded that the new device is substantially equivalent to the predicate device. This means that the new device does not require new efficacy or performance studies to prove its safety and effectiveness, as its characteristics are considered sufficiently similar to an already approved device. The regulatory approval is for the device itself as a control material, not for a diagnostic test utilizing the control, nor an AI algorithm.
§ 864.5425 Multipurpose system for in vitro coagulation studies.
(a)
Identification. A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.(b)
Classification. Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.