(189 days)
The Dideco electa is indicated for intraoperative and postoperative recovery of blood, washing of the processed blood, and pre-operative sequestration (with indirect and direct patient connection). Typical clinical applications of autotransfusion include the following surgical specialties: Cardiovascular, Orthopedics, Thoracic, Transplant Surgery, Emergency (Trauma), Neurosurgery, Obstetrics and Gynecology, and Urology.
The Dideco electa consists of hardware and disposables. It is the next generation of the Dideco autotransfusion device family. The main elements of the hardware include the centrifuge, blood pump, automatic clamps, control and monitoring sensors, and a user interface (display panel and keyboard). The modifications to the disposables are the addition of a bar code to the addition of a tubing cassette to simplify disposables installation.
The provided submission for the Dideco electa autotransfusion device is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance characteristics through detailed studies against acceptance criteria. Therefore, the document does not contain the specific information requested in the prompt regarding acceptance criteria, study design, sample sizes, ground truth establishment, or expert involvement in a multi-reader multi-case (MRMC) study.
The submission primarily relies on a side-by-side comparison of features and intended uses to establish equivalence.
Here's a breakdown of what the document does state in relation to your request, and where it falls short:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not present a table of quantitative acceptance criteria for the electa's performance (e.g., specific hematocrit recovery rates, wash efficiency, or red blood cell viability). Instead, it provides a "Side-by-Side Comparison of the electa and Predicate Devices" (Table I-1 in section 6 and continued in section 7). This table compares various characteristics such as:
- Intended Use: Identical to predicate devices (Pre-operative Sequestration, Intraoperative/Postoperative recovery, PPP, PRP, etc.)
- Typical Clinical Applications: Mostly identical, with some predicates "not specified" for certain surgical specialties where the electa is indicated.
- Operating Modes: All devices (electa and predicates) have Automatic, Semi-automatic, and Manual modes, and are pre-programmed and reprogrammable.
- Processing Phases: All devices perform Prime (Fill), Wash, Empty, Return, and Concentrate.
- Disposables: electa uses 55, 125, 175, and 225 mL bowl sizes, similar to Dideco ABMS, but different from COBE BRAT II (135, 250 mL). All are sterile, single-use, and disposable.
- Features: The electa has additional features compared to its direct predicate (Dideco ABMS) and some features not present in COBE BRAT II (e.g., Cardiotomy weighing system, Hematocrit sensor, Free hemoglobin sensor, Pressure occlusion sensor, Blood loss sensor, Bar code reader, Level sensor, Smart card, Continuous operation capability). It also shares features like Air bubble sensor, Buffy coat sensor, and Vacuum pump with some predicates.
- Operating Parameters:
- Centrifuge speeds (RPM): electa (1500-5600) is identical to Dideco ABMS, and wider than COBE BRAT II (4400).
- Pump speeds (mL/min): electa (25-1000) is identical to Dideco ABMS, and within the range of COBE BRAT II (25-1300).
- Blood source for PPP/PRP: All devices can use Patient or bag.
- PPP collection parameters: Similar to Dideco ABMS and COBE BRAT II (50 mL/min, 5600 RPM or 4400 RPM for COBE).
- PRP collection parameters: Similar to Dideco ABMS and COBE BRAT II (50 mL/min, 2400 RPM or 4400 RPM for COBE).
- Vacuum level: electa (0 to 300 mmHg) is comparable to COBE BRAT II (50-300 mmHg).
The document states, "Dideco S.p.A. believes that the electa is substantially equivalent to the Dideco ABMS, COBE Brat II, and other currently marketed automated autotransfusion devices, that any differences are minor, and raise no new issues of safety and effectiveness."
2. Sample size used for the test set and the data provenance:
- The document mentions "performance testing that demonstrate compliance with performance specifications" (Section 7). However, it does not provide any specific sample sizes for this testing, nor does it detail the nature of the "test set" (e.g., patient samples, simulated blood, etc.).
- There is no information on data provenance (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. As performance data itself is not presented in detail, the method of establishing ground truth for such data (if any was used for comparison) is absent.
4. Adjudication method for the test set:
- This information is not provided in the document.
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 is an autotransfusion device, not an AI diagnostic imaging or analysis tool. Therefore, an MRMC study and the concept of "human readers improving with AI assistance" are not applicable to this type of device and are not mentioned in the submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- As above, this is an autotransfusion device, not an AI algorithm. The concept of "standalone algorithm performance" is not applicable and not mentioned. The device's performance would be evaluated in the context of its function in processing blood, typically by comparing output parameters (like hematocrit) to established standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The document does not specify the type of ground truth used for any performance testing. For an autotransfusion device, ground truth would typically refer to gold standard measurements of blood components (e.g., laboratory analysis of hematocrit, red blood cell count, hemolysis) of the processed blood, and possibly clinical outcomes related to re-infusion. This level of detail is absent.
8. The sample size for the training set:
- As this is not an AI/ML device, the concept of a "training set" in that context is not applicable. The device's operation is based on established engineering principles and pre-programmed parameters, not a learned model from a training set.
9. How the ground truth for the training set was established:
- Again, not applicable as it's not an AI/ML device with a training set.
In summary:
The provided 510(k) summary for the Dideco electa focuses on demonstrating substantial equivalence to predicate devices based on design characteristics and intended use, rather than presenting detailed performance study results against specific acceptance criteria. Consequently, most of the specific questions about study design, sample sizes, ground truth, and expert involvement for a performance study are not addressed in this document. The "testing" section (Section 7) is very brief, stating only that electrical testing, electromagnetic compatibility testing, and performance testing were supplied to demonstrate compliance with performance specifications, without providing specifics of those tests or their results.
§ 868.5830 Autotransfusion apparatus.
(a)
Identification. An autotransfusion apparatus is a device used to collect and reinfuse the blood lost by a patient due to surgery or trauma.(b)
Classification. Class II (performance standards).