(193 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 newly approved Tedizolid for the dilution range of 0.002-4ug/ml to the Sensititre HP MIC Susceptibility plate for testing Streptococcus spp. The approved primary "Indications for Use" and clinical significance for Streptococcus spp. is for the following species: Streptococcus pyogenes Streptococcus agalactiae Streptococcus anginosus
Sensititre Haemophilus / Streptococcus pneumoniae (HP) MIC plates with Tedizolid in the dilution range of 0.002-4ug/ml
Summary of Acceptance Criteria and Device Performance for K142338:
Device Name: Sensititre Haemophilus / Streptococcus pneumoniae (HP) MIC Plates with Tedizolid in the dilution range of 0.002-4ug/ml
Device Description:
The Sensititre HP MIC Susceptibility plate is an in vitro diagnostic product designed for clinical susceptibility testing of fastidious isolates, specifically for Streptococcus spp. This 510(k) approval expands its use to include Tedizolid in the dilution range of 0.002-4ug/ml for testing Streptococcus pyogenes, Streptococcus agalactiae, and Streptococcus anginosus.
Study Overview:
This document is a 510(k) premarket notification approval letter, not a detailed study report. Therefore, it does not contain the specific performance data, sample sizes, or ground truth establishment methods typically found in a clinical study description. The letter confirms the device's substantial equivalence to legally marketed predicate devices, implying that the submitted data met the FDA's requirements for demonstrating equivalent performance.
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is an FDA approval letter, specific acceptance criteria and detailed device performance are not explicitly stated in a table format within the provided text. However, for antimicrobial susceptibility testing (AST) devices, typical acceptance criteria relate to:
- Essential Agreement (EA): The percentage of isolates for which the MIC of the new device is within one doubling dilution of the reference method's MIC.
- Categorical Agreement (CA): The percentage of isolates for which the new device assigns the same susceptibility category (Susceptible, Intermediate, Resistant) as the reference method.
- Minor Errors: Discrepancies where the new device classifies an isolate as Intermediate when the reference is Susceptible or Resistant, or vice versa.
- Major Errors (ME): Discrepancies where the new device classifies an isolate as Susceptible when the reference is Resistant.
- Very Major Errors (VME): Discrepancies where the new device classifies an isolate as Resistant when the reference is Susceptible.
Based on the typical requirements for 510(k) clearances for AST devices, the implied acceptance criteria would involve meeting specific thresholds for EA, CA, and acceptable rates of ME and VME against a reference method (e.g., CLSI broth microdilution). The fact that the device received 510(k) clearance indicates that these criteria were met.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not specified in the provided document.
- Data Provenance: Not specified in the provided document. For 510(k) submissions, data often comes from multi-site clinical trials, which could include various countries. The retrospective or prospective nature of the data is also not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. For AST, the "ground truth" is typically established by laboratory testing using a recognized reference method (e.g., CLSI broth microdilution) performed by trained microbiologists, rather than clinical experts like radiologists.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable/not specified. For AST devices, discrepancies are usually resolved by re-testing or by a pre-defined algorithm comparing results to a gold standard reference method, not typically by expert adjudication in the same way as an imaging diagnosis.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Was an MRMC study done? No. This type of study is not relevant for an antimicrobial susceptibility test device, as there are no "readers" in the context found in imaging or diagnostic pathology.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Was a standalone study done? Yes, in essence. An AST device like the Sensititre HP MIC plate provides a direct result (MIC value) from the laboratory assay. The performance data submitted for 510(k) clearance would represent this "standalone" performance against a reference method. Human interpretation is involved in reading the MIC endpoint on the plate, but the performance evaluation is based on the device's ability to produce accurate MIC values.
7. Type of Ground Truth Used:
- Type of Ground Truth: The ground truth for AST devices is typically established through a reference method (e.g., Clinical and Laboratory Standards Institute (CLSI) recommended broth microdilution method). This method is considered the gold standard for determining the minimum inhibitory concentration (MIC) of an antimicrobial agent against an isolate.
8. Sample Size for the Training Set:
- Sample Size for Training Set: Not applicable/not specified. AST devices are usually based on a direct measurement of bacterial growth inhibition at various concentrations, not on machine learning algorithms trained on large datasets. Therefore, a "training set" in the AI sense is not relevant. The device development would involve optimizing the assay itself.
9. How the Ground Truth for the Training Set Was Established:
- How Ground Truth for Training Set was Established: Not applicable. As explained above, there isn't a "training set" in the conventional AI sense for this type of device. The development process would involve extensive laboratory work to ensure the accuracy and reliability of the MIC readings across a range of bacterial isolates and Tedizolid concentrations, using CLSI or similar reference methods to confirm results.
§ 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).