(56 days)
The Sensititre® 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 species to azithromycin (0.25 - 2 ug/mL), amoxicillin/clavulanic acid (2/1 -- 16/8 ug/mL), cefotaxime (0.12 - 4 ug/mL) for use with the Sensititre® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC Susceptibility Plates.
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Here's an analysis of the provided text to extract the requested information about acceptance criteria and a study:
Based on the provided text, the device is the Sensititre® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC susceptibility plates with specific antimicrobial agents. The 510(k) submission (K062022) is for the addition of Streptococcus species to the existing indications for azithromycin, amoxicillin/clavulanic acid, and cefotaxime when used with these plates.
The document primarily focuses on the regulatory approval for an expanded indication and does not contain detailed information about a specific study proving the device meets acceptance criteria in terms of analytical performance metrics like accuracy, essential agreement, or categorical agreement against a gold standard. Instead, it refers to "in vitro data," likely meaning internal validation studies the manufacturer performed to demonstrate substantial equivalence to a predicate device.
Therefore, many of the requested fields cannot be directly populated from the provided submission. However, an attempt has been made to infer or state what information is missing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance | Comments |
|---|---|---|
| Antimicrobial Agent: Azithromycin | Clinical Significance: | The document states "The approved primary 'indications for use' and clinical significance of azithromycin is for: Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes with activity against: Streptococci (Groups C, F, G), Viridans group streptococci." No specific performance metrics (e.g., % agreement with a reference method) are provided in this regulatory letter. The acceptance criteria would typically involve demonstrating a high level of agreement (e.g., >90-95% Essential Agreement and Categorical Agreement) with a recognized reference method like broth microdilution or agar dilution. |
| Antimicrobial Agent: Amoxicillin/clavulanic acid 2:1 ratio | Clinical Significance: | The document states "The approved primary 'indications for use' and clinical significance of amoxicillin/clavulanic acid 2:1 ratio is for: Streptococcus pneumoniae ** (non beta lactamase producing organisms), with in vitro data available for Streptococcus pyogenes ** (clinical significance unknown)." No specific performance metrics are provided. Similar to azithromycin, acceptance criteria would be based on agreement with a reference method. |
| Antimicrobial Agent: Cefotaxime | Clinical Significance: | The document states "The approved primary 'indications for use' and clinical significance of cefotaxime is for: Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus spp." No specific performance metrics are provided. Similar to the other antibiotics, acceptance criteria would be based on agreement with a reference method. |
| Device Purpose: In vitro diagnostic product for clinical susceptibility testing | Successfully demonstrated substantial equivalence for expanded Streptococcus species indication. | The FDA letter grants market clearance based on substantial equivalence to a legally marketed predicate device, implying that the manufacturer's internal studies met the necessary regulatory thresholds for performance, which generally include agreement with a reference method. However, the specific acceptance thresholds and reported performance metrics are not detailed in this public regulatory letter. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in the provided documents. The general requirement for antimicrobial susceptibility test (AST) devices during FDA clearance would typically involve a statistically significant number of isolates for each species and drug combination, often in the hundreds of isolates for clinical trials and potentially hundreds more for challenge isolates.
- Data Provenance: Not specified. It's highly likely to be prospective clinical isolates and possibly retrospective challenge isolates, often collected from various geographical locations (e.g., across the US or internationally) to ensure diversity.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not specified. For AST devices, ground truth is typically established by a reference method like broth microdilution or agar dilution, performed by trained microbiologists, rather than experts establishing a "ground truth" diagnosis. If any expert review were involved (e.g., for interpreting discordant results), their numbers and qualifications are not mentioned.
4. Adjudication Method for the Test Set
- Not specified. For AST devices, adjudication would typically involve revisiting isolates with discordant results between the investigational device and the reference method. This often involves retesting by both methods or using a third, confirmatory method. The method for resolving these discrepancies (e.g., a "2+1" rule where two out of three agree, or expert consensus) is not detailed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
- No. This document describes an antimicrobial susceptibility test (AST) plate, which is a laboratory device for determining bacterial resistance to antibiotics. It is not an AI-assisted diagnostic imaging or interpretation tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No, not directly applicable in the AI sense. The device itself is a phenotypic test that produces a result (MIC value, susceptible/intermediate/resistant category). While it might be read by an automated reader, the device itself is not an "algorithm" in the context of AI. The performance evaluation would be of the device's ability to accurately determine susceptibility, not an AI algorithm's standalone performance.
7. The Type of Ground Truth Used
- Reference Method (e.g., Broth Microdilution or Agar Dilution): For antimicrobial susceptibility testing, the universally accepted "ground truth" is a standardized reference method, such as broth microdilution or agar dilution, often performed according to CLSI (Clinical and Laboratory Standards Institute) guidelines. This is the standard against which new AST devices are compared.
- Pathology/Outcomes Data: Not typically used as ground truth for AST device performance, which focuses on the in-vitro bacterial response to antibiotics.
8. The Sample Size for the Training Set
- Not specified. For AST devices, the "training set" concept is less directly applicable than in machine learning. Instead, product development involves extensive internal validation and optimization using a large collection of isolates (likely thousands) to ensure accurate growth and antimicrobial activity across different strains and concentrations. This "internal validation" serves a similar purpose to a training set in optimizing the device's design.
9. How the Ground Truth for the Training Set Was Established
- Not specified directly. Similar to the test set, the "ground truth" during the development and optimization (analogous to training) of an AST plate would be established using a standardized reference method (e.g., broth microdilution or agar dilution) on a large bank of characterized bacterial isolates.
§ 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).