(42 days)
The Sensitire® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC Susceptibility plate is an in vitro diagnostic product for clinical susceptibility testing of Haemophilus influenzae; Streptococcus pneumoniae and Streptococcus species.
This 510(k) is for the addition of Streptococcus spps to Meropenem (0.25 -2 ug/mL), Moxifloxacin (0.25-8 ug/mL), Penicillin (0.03-8 ug/mL) for use with the Sensititle® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC Susceptibility Plates .
The approved primary "indications for use" and clinical significance of Meropenem is for: Streptococcus pneumoniae (penicillin-susceptible isolates only) Streptococcus agalactiae Streptococcus pyogenes Viridans group streptococci The approved primary "indications for use" and clinical significance of Moxifloxacin is for Streptococcus pneumoniae, (including penicillin-resistant strains) Streptococcus pyogenes The following in vitro data are available but their clinical significance is unknown; Streptococcus agalactiae Viridans group streptococci The approved primary "indications for use" and clinical significance of Penicillin is for: Streptococcus pneumoniae
Streptococcus pyogenes
Viridans group streptococci
Streptococcus agalactiae
Streptococcus (beta-hemolytic group )
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The provided text describes a 510(k) premarket notification for Sensititre® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC susceptibility plates for Meropenem, Moxifloxacin, and Penicillin, specifically for the addition of Streptococcus spps to these antimicrobial agents.
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria and reported device performance. It is a regulatory clearance letter, not a study report. Regulatory clearances often refer to "substantial equivalence" to predicate devices and state that specific data were reviewed. Details of acceptance criteria and performance would typically be found in the 510(k) submission itself, which is not fully provided here.
However, based on the nature of antimicrobial susceptibility testing (AST) devices, the acceptance criteria generally revolve around the agreement between the new device's results and a reference method (often broth microdilution or agar dilution as defined by CLSI standards). The performance metrics typically include:
- Essential Agreement (EA): The percentage of isolates for which the MIC (Minimum Inhibitory Concentration) value reported by the device is within one doubling dilution of the reference method's MIC value.
- Category Agreement (CA): The percentage of isolates for which the categorization (Susceptible, Intermediate, Resistant) reported by the device matches the categorization determined by the reference method.
- Minor Errors (mER): Occur when the device reports an isolate as Susceptible or Resistant, but the reference method reports it as Intermediate (or vice-versa, depending on specific definitions).
- Major Errors (MER): Occur when the device reports an isolate as Susceptible, but the reference method reports it as Resistant.
- Very Major Errors (VMER): Occur when the device reports an isolate as Resistant, but the reference method reports it as Susceptible.
Typical Acceptance Criteria for AST devices (based on common FDA guidance, not explicitly stated in this document):
- EA: ≥ 90%
- CA: ≥ 90%
- mER: ≤ 10%
- MER: ≤ 3%
- VMER: ≤ 1.5%
Reported Device Performance: The document does not include a table of reported device performance. It states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent...". This implies that the data submitted in the 510(k) met the FDA's requirements for substantial equivalence, which would include performance data against established acceptance criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not state the sample size used for the test set or the data provenance. These details would be in the full 510(k) submission documents. For AST devices, test sets typically include a significant number of recent clinical isolates, often augmented with challenge strains to ensure a range of MIC values and resistance mechanisms.
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 provided in the document. For AST devices, "ground truth" is typically established by a reference laboratory method (e.g., CLSI broth microdilution or agar dilution) performed by trained microbiologists, rather than multiple human experts in the same way imaging studies might.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This concept is not directly applicable to the type of device described (an in vitro diagnostic for antimicrobial susceptibility testing). Adjudication methods like 2+1 or 3+1 are typically used in studies where human readers (e.g., radiologists) interpret images and their consensus establishes ground truth. For AST, the ground truth is instrumental, derived from a reference laboratory method.
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
An MRMC comparative effectiveness study is not relevant here. This document pertains to an in vitro diagnostic susceptibility plate, which is a laboratory test, not an AI-assisted diagnostic imaging device meant to improve human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This device is inherently a "standalone" or "algorithm-only" performance measurement in the sense that the test results (MICs and interpretations) are generated by the device based on microbial growth. Human readers interpret these results, but the initial measurement is automated or semi-automated. The performance study would compare the device's output directly to the reference method's output. There isn't a "human-in-the-loop" concept in the same way as with an AI-powered diagnostic tool assisting a clinician.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this type of device, the ground truth is established using a reference laboratory method, typically broth microdilution or agar dilution, performed according to recognized standard guidelines (e.g., Clinical and Laboratory Standards Institute - CLSI). This reference method is considered the "gold standard" for determining the true MIC and susceptibility category of an isolate to an antimicrobial agent.
8. The sample size for the training set
The document does not mention a training set. Modern AST devices, while sometimes incorporating some level of automation or expert rules, are generally not "trained" in the same way a machine learning algorithm is. Their performance is based on the chemical and biological interactions within the wells and the accuracy of the MIC reading method. If there were any computational components (e.g., for automated interpretation), details about their development (which might involve a "training set" of sorts) would be in the full submission, but this is unlikely to be a primary concern for a susceptibility plate.
9. How the ground truth for the training set was established
As there is no mention of a "training set" in the context of an AI/ML algorithm, this question is not directly applicable. If any internal validation or development of the interpretation algorithms occurred, it would have used ground truth established by the same reference laboratory methods as the main test set.
§ 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).