(86 days)
The Sensititre HP MIC Susceptibility plate is an in vitro diagnostic product for clinical susceptibility testing of fastidious isolates. This 510(k) is for the addition of newly approved Dalbavancin for the dilution range of 0.0005-2ug/ml to the Sensititre HP MIC Susceptibility plate for testing Streptococcus spp. The approved primary "Indications for Use" and clinical significance for Streptococus spp. is for the following species: Streptococcus pyogenes Streptococcus agalactiae Streptococcus anginosus
Sensititre Haemophilus / Streptococcus pneumoniae (HP) MIC plates with Dalbavancin at a concentration of 0.0005-2ug/ml
This document is a 510(k) clearance letter from the FDA for a specific antimicrobial susceptibility test. It does not contain information about acceptance criteria or a study proving device performance in the way typically expected for a medical imaging AI/ML device.
The provided text pertains to a Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC plate with Dalbavancin used for in vitro diagnostic clinical susceptibility testing of fastidious isolates. This is a laboratory diagnostic product, not a medical imaging or AI/ML device.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set size, ground truth for training set) are not applicable to the type of device described in this FDA clearance.
However, I can extract the following relevant information based on the context of an in vitro diagnostic device:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly list a table of acceptance criteria and reported device performance in the way a clinical study report would. For antimicrobial susceptibility tests, performance is typically evaluated through Essential Agreement (EA) and Categorical Agreement (CA) with a reference method, which are standard metrics for these devices. The clearance indicates that the device has been deemed "substantially equivalent" to a legally marketed predicate device, implying its performance met the necessary criteria for this type of in vitro diagnostic device. The "Indications for Use" section specifies the species for which the device is intended.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the clearance letter. For an in vitro diagnostic, this would typically refer to the number of bacterial isolates tested.
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 information is not applicable in the context of an antimicrobial susceptibility test. "Ground truth" for these devices is established by a reference method (e.g., broth microdilution or agar dilution according to CLSI standards), not by human expert interpretation in the same way as medical imaging.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. See point 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 information is not applicable as this is not an AI/ML-driven medical imaging device that uses human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable as this is not an AI/ML device. The device itself performs the susceptibility testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For an antimicrobial susceptibility test, the "ground truth" (or reference method) is typically the CLSI (Clinical and Laboratory Standards Institute) broth microdilution or agar dilution method. This is an objective, standardized laboratory test, not an interpretive one like expert consensus or pathology in a medical imaging context.
8. The sample size for the training set
This information is not applicable as this is not an AI/ML device which requires a training set.
9. How the ground truth for the training set was established
This information is not applicable as this is not an AI/ML device.
§ 866.1640 Antimicrobial susceptibility test powder.
(a)
Identification. An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.(b)
Classification. Class II (performance standards).