(48 days)
The XRES Blood Collection Reservoir is an accessory to an autotransfusion device and is intended for the sterile collection and filtration of recovered blood for subsequent processing for autotransfusion.
The XRES 120pm Blood Collection Reservoir is an accessory to an autotransfusion device and is intended for the sterile collection and filtration of recovered blood for subsequent processing for autotransfusion.
The XRES and XRES 120µm Blood Collection Reservoirs are modified versions of the currently marketed XRES reservoir. The XRES contains both a 40um and a 120µm filtering material whereas the XRES 120um only contains a 120um filtering material.
The XRES and XRES 120µm reservoirs are sterile, non-pyrogenic device used to collect and filter blood salvaged during surgical procedures. Both reservoirs have an intering system designed to filter and remove aggregates from the recovered blood.
During surgical procedures the devices operate by means of an external vacuum source to suction and filter blood from the operating field prior to subsequent processing by an autotransfusion device. Entrained air is removed from blood by the defoamer.
The provided text describes a 510(k) premarket notification for two medical devices, the XRES Blood Collection Reservoir and the XRES 120µm Blood Collection Reservoir. This submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving that an AI-driven device meets specific acceptance criteria through a clinical study.
Therefore, many of the requested elements (e.g., sample sizes for test sets, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, training set details) are not applicable to this document, as it concerns a physical medical device and its performance, not an AI or digital health product.
Here's a breakdown of the information that is available based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria. Instead, it refers to "performance specifications" and concludes that the modified devices "successfully met all acceptance criteria for each test" and "perform in a manner substantially equivalent to the unmodified device with respect to the relevant functional parameters." The performance is reported in a qualitative manner, affirming compliance.
| Test Title | Test Classification | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Break-through time and volume | Functional/Performance | Not explicitly stated, implicitly met performance specifications and substantial equivalence | Successfully met all acceptance criteria, substantially equivalent to unmodified device. |
| Defoaming efficiency | Functional/Performance | Not explicitly stated, implicitly met performance specifications and substantial equivalence | Successfully met all acceptance criteria, substantially equivalent to unmodified device. |
| Filtration efficiency | Functional/Performance | Not explicitly stated, implicitly met performance specifications and substantial equivalence | Successfully met all acceptance criteria, substantially equivalent to unmodified device. |
| Graduated scale accuracy/residual volume | Functional/Performance | Not explicitly stated, implicitly met performance specifications and substantial equivalence | Successfully met all acceptance criteria, substantially equivalent to unmodified device. |
| Hemolysis | Functional/Performance | Not explicitly stated, implicitly met performance specifications and substantial equivalence | Successfully met all acceptance criteria, substantially equivalent to unmodified device. |
Note: The acceptance criteria are implied to be "meeting the product's performance specifications" and demonstrating "substantial equivalency" to the predicate device.
2. Sample size used for the test set and the data provenance
The document indicates "In vitro testing was conducted," comparing the XRES 120µm (which included all modifications) to the unmodified XRES device. However, it does not specify the sample size for this in vitro testing (e.g., number of devices tested, number of runs).
- Sample Size: Not specified for test set.
- Data Provenance: The tests are in vitro, meaning they were conducted in a laboratory setting. No country of origin is explicitly stated for the testing data, but the submitter is "Sorin Group Italia" and the contact person is from Italy. The context suggests the testing was likely conducted or overseen by the manufacturer. It is a prospective evaluation of the new device designs against established performance metrics.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as the document describes performance testing of a physical medical device (blood collection reservoir), not an AI or digital health product that requires expert-established ground truth for a test set. The "ground truth" for this device would be objective measurements of its physical and functional performance characteristics.
4. Adjudication method for the test set
This is not applicable for the same reasons as #3.
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 not applicable as the document describes a physical medical device, not an AI-assisted diagnostic or therapeutic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable as the document describes a physical medical device, not an algorithm.
7. The type of ground truth used
The ground truth used for this device would be based on objective measurements and laboratory analyses of the device's functional performance, such as:
- Fluid dynamics measurements (e.g., break-through time and volume)
- Microscopic analysis of filtered contents for filtration efficiency
- Precision measurements for graduated scale accuracy
- Biochemical analysis for hemolysis levels
8. The sample size for the training set
This is not applicable as the document describes a physical medical device. There is no concept of a "training set" in the context of this 510(k) submission.
9. How the ground truth for the training set was established
This is not applicable as there is no training set for this type of device submission.
§ 870.4400 Cardiopulmonary bypass blood reservoir.
(a)
Identification. A cardiopulmonary bypass blood reservoir is a device used in conjunction with short-term extracorporeal circulation devices to hold a reserve supply of blood in the bypass circulation.(b)
Classification. Class II (special controls), except that a reservoir that contains a defoamer or filter is classified into the same class as the defoamer or filter. The device, when it is a cardiopulmonary bypass blood reservoir that does not contain defoamers or blood filters, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.