(64 days)
The Summit Medical CellTrans™ Postoperative Autotransfusion Set is intended for the collection, filtration and reinfusion of blood lost postoperatively following surgery, particularly orthopaedic joint replacement. The device is indicated for autologous blood transfusion.
The CellTrans™ Postoperative Autotransfusion Set consists of two individually sterilized packages, containing the Summit Medical CellTrans™ Postoperative Autotransfusion System (K022489) and the Summit Medical Transfusion Filter (K022477) respectively, presented for ease of handling and reordering in a non-sterile. polvethylene slide lock transit bag. Inside the transit bag the CellTrans™ device is double-wrapped, whilst the Transfusion Filter is single wrapped, both using Tyvek & Film packaging. The transit bag also contains an additional copy of the CellTrans™ Instructions For Use to facilitate use of the Transfusion Filter.
The provided text describes a 510(k) premarket notification for the CellTrans™ Postoperative Autotransfusion Set. This is a medical device for blood collection and reinfusion, and the submission focuses on demonstrating substantial equivalence to previously cleared predicate devices. Therefore, the information typically found in a study proving a device meets acceptance criteria for an AI/ML product (such as performance metrics, sample sizes, expert involvement, and ground truth establishment) is not present in this document.
The document states that "No safety or effectiveness issues are raised when the Summit Medical CellTrans™ Postoperative Autotransfusion Set is compared to the predicate products and therefore the CellTrans™ Postoperative Autotransfusion Set is substantially equivalent to the Summit Medical CellTrans™ Postoperative Autotransfusion System and the Summit Medical Transfusion Filter." This indicates that the primary "acceptance criterion" for this 510(k) submission was demonstrated substantial equivalence to existing predicate devices, rather than meeting specific performance metrics from a new clinical study.
Therefore, I cannot fulfill your request for the following sections based on the provided text:
- A table of acceptance criteria and the reported device performance
- Sample sizes used for the test set and data provenance
- Number of experts and their qualifications
- Adjudication method
- Multi-reader multi-case (MRMC) comparative effectiveness study information
- Standalone performance information
- Type of ground truth used
- Sample size for the training set
- How the ground truth for the training set was established
§ 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).