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A non-radiometric automated blood culturing system which is designed for the monitoring and detection of clinical cultures of blood for the presence of microorganisms.

BACTEC® 9050 System is a non-radiometric automated blood culturing system. It has a capacity of 50 specimens, uses Positivity Algorithms by Media Type for culture analysis, has agitation on during testing, uses a Florescence Detector (LED) for detection optics, incubates at 35°C ± 1.5°C, has a protocol length of 4 to 7 Days, uses Florescent Series Media, tests specimens every 10 Minutes, uses Low Voltage DC power supplies, and displays 1 rack (Rotor). Its dimensions are 24"W x 28.5"H x 25.5"D.

Here's an analysis of the provided text, focusing on the acceptance criteria and study details:

Acceptance Criteria and Device Performance

The provided text focuses on demonstrating substantial equivalence to a predicate device rather than defining specific numerical acceptance criteria for a novel performance threshold. The core acceptance criterion appears to be that the BACTEC 9050 performs "equivalent" to the BACTEC 9240.

Study Details

• Sample Size for Test Set: 485 paired seeded vials.
• Data Provenance: Not explicitly stated, but given it's a non-clinical test using "seeded vials" (likely laboratory-prepared cultures), it's a controlled laboratory setting rather than patient-derived data. The country of origin is not mentioned. It is a prospective, non-clinical test.
• Number of Experts Used to Establish Ground Truth for Test Set and Qualifications: Not applicable. The "ground truth" for these non-clinical tests would have been the known quantity and type of microorganisms seeded into the vials. There's no mention of expert consensus or interpretation required for this.
• Adjudication Method: Not applicable. As the ground truth is based on known seeded organisms, no expert adjudication process is described or needed.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No. This study is a technical performance comparison between two automated blood culture instruments in a non-clinical setting, not an evaluation of human reader performance with or without AI assistance.
• Standalone Performance (Algorithm Only): Yes, this study evaluates the standalone performance of the BACTEC 9050 system's ability to detect microbial growth compared to the BACTEC 9240. There isn't a human-in-the-loop component described.
• Type of Ground Truth Used: "Known seeded organisms." The study involved using 23 specific organisms chosen for clinical relevance, implying that the presence and identity of these organisms in the seeded vials constituted the ground truth.
• Sample Size for Training Set: Not applicable. This document describes a non-clinical validation study comparing a new device to a predicate, not the development or training of an AI algorithm.
• How Ground Truth for Training Set was Established: Not applicable. (See above).

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