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510(k) Data Aggregation
(302 days)
TPE is performed using the Haemonetics MCS/MCS+ system to remove a significant quantity of platelet poor plasma and replace it with a solution as determined by the attending physician.
The MCS and MCS+ systems have not been physically modified in any significant manner from the systems reviewed by the FDA under 510(k) BK900027 and BK930013. respectively. relative to standard pumps, centrifuge, electromechanical systems and donor safety monitoring systems.
Sterile Single-Use Disposable Sets:
- List No. 780 Therapeutic Plasma Exchange Set (225 ml Latham bowl)
- List No. 781 Therapeutic Plasma Exchange Set (125 ml Latham bowl)
- List No. 980 Therapeutic Plasma Exchange Set (225 ml Latham bowl)
- List No. 981 Therapeutic Plasma Exchange Set (125 ml Latham bowl)
These sets consist of a patient harness, a centrifuge blood separation chamber (Latham bowl), and a collection harness. A detached 5 liter plasma bag is also included.
The provided text describes a 510(k) summary for new Therapeutic Plasma Exchange (TPE) disposable sets for use with the Haemonetics MCS/MCS+ system, claiming substantial equivalence to predicate devices. However, it does not contain the level of detail typically found in a study for device performance acceptance criteria as a standalone algorithm. Instead, it focuses on the safety and effectiveness of the new disposable sets in the context of TPE procedures.
Therefore, for the requested components of your prompt, some information will be absent or inferred based on the context of a 510(k) submission for disposable medical devices and the nature of therapeutic plasma exchange. This is not a study of an AI algorithm or a diagnostic device.
Here's an attempt to answer your questions based on the provided text, highlighting where information is not available:
Acceptance Criteria and Reported Device Performance
The document describes the intended use and performance within the context of a therapeutic procedure rather than typical "device performance metrics" for an algorithm. The "acceptance criteria" can be inferred as the demonstration of safety and effectiveness of the new disposable sets for TPE, comparable to existing methods.
Table 1: Acceptance Criteria (Inferred) and Reported Device Performance
| Acceptance Criteria (Inferred from 510(k) Submission) | Reported Device Performance |
|---|---|
| Safety: No undue adverse events related to the disposable sets or the TPE protocol. | Patient vital signs, fluid intake/output, and extracorporeal volumes were monitored. Blood samples collected pre-, post-, and 18-30 hours post-procedure showed measurements of hemoglobin, hematocrit, platelet counts, LDH, IgA, IgG, and IgM levels, and haptoglobins. The data indicates the "protocol and the associated disposables can be performed safely." |
| Effectiveness: Ability to successfully remove a significant quantity of platelet-poor plasma as intended, without compromising patient health. | TPE was performed to remove a significant quantity of platelet poor plasma. The study measured pre- and post-therapy platelet counts and other blood parameters, and the data indicates the "protocol and the associated disposables can be performed... effectively." |
| Substantial Equivalence: Performance comparable to predicate devices. | The conclusion states: "TPE performed using the MCS+ system with the associated disposable set is substantially equivalent to TPE as performed using marketed devices." No specific direct comparisons of performance metrics to predicate devices are provided in this summary, but this is the ultimate claim for 510(k) clearance. |
Study Details
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size (Test Set):
- 30 subjects were evaluated for TPE using the MCS with associated disposable sets.
- 3 of these subjects were excluded from data analysis (transplant patients outside protocol). So, 27 subjects were included in the primary data analysis for the MCS.
- A "smaller study" was conducted on healthy donors using the MCS+ (LN9000), but the exact number of subjects is not specified.
- Data Provenance:
- Country of Origin: Not specified in the summary, but given the sponsor (Haemonetics Corporation, Braintree, MA) and the FDA submission, it's highly likely to be United States.
- Retrospective or Prospective: The studies were prospective as TPE was "performed on 30 subjects" and "a similar, but smaller study was conducted on healthy donors."
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 is not applicable in the context of this device. This is a submission for disposable medical devices used in a therapeutic procedure (plasma exchange), not an AI algorithm or a diagnostic device where "ground truth" is established by expert review of data (e.g., medical images). The "ground truth" here is the clinical outcome of the TPE procedure on the patient, monitored by the attending physician and clinical staff.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As this is not an AI algorithm or a diagnostic imaging study requiring expert adjudication of findings, there was no adjudication method as understood in these contexts. Clinical monitoring and physician discretion guided the procedure and assessment.
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 submission is for disposable medical devices (TPE sets) for use with an existing apheresis machine. It is not an AI-assisted diagnostic or therapeutic device, and therefore, an MRMC study related to human readers and AI assistance was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This relates to disposable medical devices for a therapeutic procedure, not a standalone algorithm. The device performance is inherently "with human-in-the-loop" as an operator (healthcare professional) performs the procedure using the system and the disposable sets, and an attending physician determines the course of treatment.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this type of device and study relates to the clinical outcomes and physical parameters of the TPE procedure. This includes:
- Physiological Parameters: Patient vital signs, fluid intake/output, extracorporeal volumes (monitored during the procedure).
- Laboratory Data: Pre- and post-procedure measurements of blood components (platelets, hemoglobin, hematocrit, LDH, IgA, IgG, IgM, haptoglobins) to assess the impact and effectiveness of plasma removal and replacement.
- Safety Outcomes: Absence of undue adverse events, and demonstration that the procedure can be performed safely.
- Clinical Effectiveness: The successful removal of platelet-poor plasma as prescribed by the attending physician.
The "ground truth" here is multi-faceted clinical data, not a single definitive "diagnosis" established by experts or pathology alone.
8. The sample size for the training set
Not applicable. This appears to be a clinical validation study for a physical medical device (disposable sets), not a machine learning model that requires a training set. The existing MCS/MCS+ systems were already cleared, and the clinical tests focused on the new disposable sets in the context of the TPE protocol.
9. How the ground truth for the training set was established
Not applicable. As there is no "training set" for an AI algorithm in this context, this question is not relevant.
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