(30 days)
The Platelet Concentrate Separation kit is designed for use in the clinical laboratory or intra-operatively 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 platelet concentrate separation kit aids separation of the patient's own blood components by density through the use of a centrifuge. The platelet concentration kit permits platelet rich plasma to be rapidly prepared from a small volume of the patient blood that is drawn at the time of treatment.
Kit Components: 18 gauge x 1" x 12" apheresis needle, 16 gauge centesis needle 1 ¼" 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
The provided document (K021927) is a 510(k) premarket notification for a medical device. It does not describe acceptance criteria and a study that proves the device meets those criteria in the typical sense of a clinical trial for diagnostic performance. Instead, it details a non-clinical study for substantial equivalence to a predicate device.
Here's an analysis based on the information provided, tailored to your request:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not specify formal "acceptance criteria" with numerical thresholds for performance. The non-clinical testing focused on demonstrating functional equivalence.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Produces platelet rich plasma (PRP) from whole blood. | Met: The device aids separation of blood components to prepare PRP. |
| Produces PRP at a concentration equal to or greater than the predicate device. | Met: Platelet count results verified the modified device produced platelet rich plasma at a concentration that was equal to or greater than the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions "bovine and human blood" but does not quantify the number of samples or individuals studied.
- Data Provenance: The study was a "Non-Clinical Testing" and "Laboratory testing" performed to compare efficiency.
- Country of Origin: Not specified, but likely in the US as the applicant is Biomet, Inc. in Indiana.
- Retrospective or Prospective: Not explicitly stated, but typically these types of laboratory comparison studies are prospective, conducted for the purpose of the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This was a laboratory comparison study of a device's mechanical function (blood component separation and concentration), not an interpretive diagnostic device requiring expert human review to establish ground truth for a test set. The "ground truth" here would be the measured platelet concentration.
4. Adjudication Method for the Test Set
Not applicable, as there was no subjective interpretation or diagnostic outcome requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The study was a non-clinical laboratory test comparing the functional output (platelet concentration) of the new device to a predicate device. The document explicitly states "Clinical Testing: Not Applicable."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This device is a physical kit for blood processing, not an algorithm. Therefore, "standalone" algorithm performance is not relevant. The device itself operates autonomously once initiated to separate blood components. Its performance was tested directly by measuring platelet concentration.
7. The Type of Ground Truth Used
The ground truth used was measured platelet count/concentration. This is an objective laboratory measurement, not expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
Not applicable. This device is a physical kit, not an AI/ML algorithm that requires a "training set." The engineering and design of the kit would be based on scientific principles of centrifugation and blood component density, rather than an iteratively trained model.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
§ 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.