(49 days)
The GPS™ Platelet Separation kit is designed for use in the clinical laboratory or intraoperatively at point of care, for the safe and effective preparation of platelet poor plasma and platelet concentrate from a small sample (50-60 ml) of whole blood. The plasma and concentrated platelets can be used for diagnostic tests.
The GPSTM separation kit aids separation of the patient's own blood components by density through the use of the GPS™-Thermo International Equipment Company (IEC) centrifuge. The GPS™ separation kit permits platelet rich plasma to be rapidly prepared from a small volume of the patient's blood that is drawn at the time of treatment.
Kit Components: 18 gauge x 1" x 12" apheresis needle, 16 gauge centesis needle 1 1/4" catheter, 60 ml piston syringe, 30 ml piston syringe, 1 ml piston syringe, petri dish, rubber tubing tourniquet, gauze pad, alcohol pad, adhesive tape, silicone tube, volume gauge, PETG tray with sealed Tyvek® lid, 50 ml bottle of anticoagulant citrate dextrose solution, U.S.P., Solution A (ACD-A).
The provided document is a 510(k) clearance letter for a medical device called the GPS™ Platelet Separation Kit with Anticoagulant ACD-A. This document describes the device, its intended use, and the basis for its clearance, which is substantial equivalence to a predicate device.
It is crucial to understand that a 510(k) clearance does not necessarily involve a study with acceptance criteria in the same way a de novo or PMA submission might, especially for diagnostic AI/ML devices. Instead, it focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device. The "acceptance criteria" here are implicitly tied to the performance of the predicate device.
The request for information (table format, sample sizes, experts, adjudication, MRMC, standalone, ground truth type and training set details) is typically applicable to the validation of AI/ML-driven diagnostic devices. This 510(k) document is for a physical medical device for preparing blood components, not an AI/ML diagnostic system. Therefore, most of the requested information regarding AI/ML device validation is not present in this document.
However, I can extract the relevant information from the provided text as accurately as possible given the context of a 510(k) for a non-AI/ML device.
Here's an analysis based on the provided document:
Acceptance Criteria and Device Performance
Since this is a substantial equivalence claim for a physical kit (not an AI/ML diagnostic), the "acceptance criteria" are implied by demonstrating that the device performs comparably to its predicate device in its intended function: separating blood components to produce platelet-rich plasma (PRP).
| Acceptance Criteria (Implied by Predicate Performance) | Reported Device Performance (as tested for predicate) |
|---|---|
| Produce platelet-rich plasma (PRP) | Produced platelet rich plasma at a concentration that was equal to or greater than other devices cleared for market. |
| Safe preparation of platelet poor plasma and platelet concentrate from whole blood | Kit is "designed for safe and effective preparation of platelet poor plasma and platelet concentrate." |
| Functional testing on human and bovine blood | Functional testing on bovine and human blood was performed. |
| Anticoagulant functionality | Original manufacturer performed relevant testing for the anticoagulant. |
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets the acceptance criteria is detailed under "Non-Clinical Testing" within the 510(k) submission for the predicate device (K021927). The current 510(k) (K030555) references these earlier tests to support its substantial equivalence claim, particularly for the physical separation kit components. The anticoagulant (ACD-A) specifically had relevant testing performed by its original manufacturer, Cytosol Laboratories, Inc.
Detailed Information Request (where applicable to this type of device):
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Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not explicitly stated in terms of a specific "test set" size. The document mentions "small sample (50-60 ml) of whole blood" as the input for the device, and "functional testing on bovine and human blood." The number of subjects or samples used in the predicate device's testing is not provided in this summary.
- Data Provenance: Not specified (e.g., country of origin). The testing was "functional testing on bovine and human blood," indicating some human samples were likely involved, but specifics are absent in this summary. The anticoagulant testing was done by "Cytosol Laboratories, Inc."
- Retrospective or Prospective: Not specified.
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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):
- Not applicable/Not provided. This device is a component separation kit. Its performance is assessed by quantitative measurements (e.g., platelet count, separation efficiency), not by expert interpretation of diagnostic images or data. Therefore, the concept of "experts establishing ground truth" in the diagnostic AI/ML sense is not relevant here.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not provided. As above, this is not an AI/ML diagnostic device requiring adjudication of interpretations.
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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 is not an AI-assisted diagnostic device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm-only device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For this type of device, the "ground truth" would be quantitative laboratory measurements of blood component concentrations (e.g., platelet count, plasma volume, purity of separation) compared against expected or established values for effective PRP preparation. It is based on analytical and functional performance criteria, not expert interpretation of pathology or outcomes data in the usual sense.
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The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set.
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How the ground truth for the training set was established:
- Not applicable. This is not an AI/ML device that requires a training set.
§ 862.2050 General purpose laboratory equipment labeled or promoted for a specific medical use.
(a)
Identification. General purpose laboratory equipment labeled or promoted for a specific medical use is a device that is intended to prepare or examine specimens from the human body and that is labeled or promoted for a specific medical use.(b)
Classification. Class I (general controls). The device is identified in paragraph (a) of this section and is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.