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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 Oritavancin in the dilution range of 0.0005-8ug/ml to the Sensitire 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 dysgalactia Streptococcus anginosus

The Sensititre HP MIC Susceptibility plate with Oritavancin in the dilution range of 0.0005-8ug/mL

This is a 510(k) premarket notification for "The Sensititre HP MIC Susceptibility plate with Oritavancin in the dilution range of 0.0005-8ug/ml." This device is an in vitro diagnostic product for clinical susceptibility testing of fastidious isolates, specifically for testing Streptococcus spp. The document you provided is an FDA clearance letter and an Indications for Use statement, not a detailed study report. Therefore, much of the requested information regarding the study design and acceptance criteria specifically for the device's performance is not available in these documents.

However, based on the information provided and general knowledge of FDA clearances for antimicrobial susceptibility testing (AST) devices, I can construct a partial answer.

Please note: The provided documents are limited. A full study report, often found in the 510(k) summary or detailed submission, would contain the complete information. The following response is an interpretation based on the given text and common practices for AST device clearance.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly list the acceptance criteria or reported device performance in a table format. However, for AST devices, FDA typically expects specific agreement rates between the investigational device and a reference method. The Indications for Use states that the device is for susceptibility testing of Streptococcus spp., and the clearance implies that the device met the FDA's criteria for substantial equivalence to a predicate device.

Typical Acceptance Criteria for AST Devices (Based on FDA Guidance for 510(k)s):

Study Proving Acceptance Criteria:

The document states, "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices..." This implies that Thermo Fisher Scientific submitted a study comparing the performance of the Sensititre HP MIC Susceptibility plate with Oritavancin to a recognized reference method (e.g., broth microdilution or agar dilution as described by CLSI standards) for the specified Streptococcus species. The results of this study demonstrated that the device met the FDA's acceptance criteria for Essential Agreement, Category Agreement, and acceptable rates of Major and Very Major Discrepancies.

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not explicitly stated in the provided documents. For AST devices, FDA typically requires a significant number of isolates (e.g., hundreds) for each drug-bug combination, including a diverse representation of susceptible, intermediate, and resistant strains.
• Data Provenance: Not explicitly stated in the provided documents. Data for clinical studies for FDA clearance usually comes from multiple clinical laboratories, often in the US, to ensure representativeness. It would typically be prospective or a combination of retrospective and prospective isolates depending on the availability of strains and the clearance pathway.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable in the context of this device. For AST devices, the "ground truth" (reference method) is typically a standardized laboratory method (e.g., broth microdilution or agar dilution) performed by trained microbiologists, not a panel of experts reviewing cases.

4. Adjudication method for the test set

Not applicable. Adjudication methods (like 2+1, 3+1) are typically used for subjective assessments (e.g., image interpretation). For AST, discrepancies between the investigational device and the reference method are usually resolved by re-testing or thorough investigation, not by an expert panel adjudication.

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

Not applicable. This device is an in vitro diagnostic (IVD) antimicrobial susceptibility test, not an AI-based diagnostic tool that assists human readers. Therefore, an MRMC study and analysis of human reader improvement with AI assistance are not relevant to this type of device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This concept doesn't directly apply. The device itself (the Sensititre plate) produces results (MIC values and categorical interpretations). The "standalone performance" is the device's accuracy in determining MICs and categories compared to the reference method. The device is standalone in the sense that its primary function is to provide an objective measurement. Clinical microbiologists then interpret these results in the context of patient care.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for AST devices is almost universally established by a standardized reference method, typically:

• Broth Microdilution (BMD): The most common reference method, performed according to CLSI (Clinical and Laboratory Standards Institute) guidelines.
• Agar Dilution: Another recognized reference method.

These methods involve precise measurements of the minimum concentration of an antimicrobial agent that inhibits visible growth of a microorganism (Minimum Inhibitory Concentration - MIC).

8. The sample size for the training set

Not explicitly stated in the provided documents. For AST devices, "training set" doesn't apply in the common machine learning sense. Instead, product development involves extensive internal testing and optimization (sometimes called internal validation or verification) using numerous isolates before formal clinical studies for regulatory submission. The number of isolates used in this developmental phase would be considerably larger than the submission test set.

9. How the ground truth for the training set was established

Similar to the ground truth for the test set, the ground truth for any internal optimization or "training" phases would be established using standardized reference methods (e.g., Broth Microdilution) according to CLSI guidelines.

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