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The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of non fastidious isolates. This 510(k) is for the newly approved Oritavancin in the dilution range of 0.0005-8 ug/ml for testing non-fastidious gram positive organisms on the Sensititre 18 - 24 hour MIC panel. The approved primary "Indications for Use" and clinical significance for non-fastidious Gram positive isolates: Staphylococcus aureus (including methicillin-resistant (MRSA) and methicillin susceptible (MSSA) isolates) Enterococcus faecalis(vancomycin-susceptible isolates only)

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The provided document is a 510(k) clearance letter from the FDA for the Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Oritavancin. It does not contain information about the acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot provide the requested information based on the given input. The document primarily focuses on regulatory clearance and indications for use.

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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 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.

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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 Breakpoints for Telavancin, utilizing the 0.002% Polysorbate 80 for the reference method in 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 Streptococcus spp. is for the following species: Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus anginosus.

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I am sorry, but the provided text does not contain the detailed information necessary to answer your request about the acceptance criteria and the study proving the device meets those criteria.

The document is a 510(k) clearance letter from the FDA for a medical device called "Sensititre HP MIC Susceptibility Plate with Telavancin". While it states the device has been reviewed and determined substantially equivalent to a predicate device, it does not include:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes for test or training sets, or data provenance.
• Information on a study to prove the device meets acceptance criteria, including the number and qualifications of experts, adjudication methods, or MRMC studies.
• Specification of ground truth type or how it was established.

The provided text is primarily a regulatory approval document and not a scientific study report.

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The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of non fastidious isolates. This 5 IV(k) is for the newly approved Breakpoints for Telavancin, utilizing the 0.002% Polysorbate 80 for the reference method in the dilution range of 0.0005-2ug/ml to the Sensititee 18 - 24 hour MCC panel for terfeirences of on positive isolates. The approved primary "Indications for Use" and clinical significance for non-fastidious Gram positive isolates; Staphylococcus aureus (including methicillin-resistant isolates) Enterococcus faecalis

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The provided FDA 510(k) clearance letter does not contain the detailed study information required to answer your request in full. It primarily focuses on the regulatory aspects of the device's clearance. However, I can extract the acceptance criteria and a general overview of what the study was for from the document.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "This 510(k) is for the newly approved Breakpoints for Telavancin, utilizing the 0.002% Polysorbate 80 for the reference method in the dilution range of 0.0005-2ug/ml to the Sensititre 18 - 24 hour MCC panel for terfeirences of on positive isolates."

This phrasing indicates that the acceptance criteria are tied to the concept of "newly approved Breakpoints for Telavancin." The study would have aimed to demonstrate that the Sensititre system's results align with these established breakpoints. The specific quantitative acceptance criteria (e.g., Categorical Agreement, Essential Agreement percentages) and the reported device performance (actual values achieved) are not detailed within this document. These would typically be found in the full 510(k) submission or associated clinical study reports, which are not provided here.

However, based on typical Antimicrobial Susceptibility Test (AST) device submissions, the acceptance criteria would generally revolve around:

• Essential Agreement (EA): The percentage of isolates for which the MIC (Minimum Inhibitory Concentration) value obtained by the test device is within plus or minus one doubling dilution of the reference method MIC.
• Categorical Agreement (CA): The percentage of isolates for which the interpretive category (Susceptible, Intermediate, or Resistant) obtained by the test device agrees with the interpretive category of the reference method.
• Major Errors (ME): Instances where the test device classifies an isolate as Susceptible when the reference method classifies it as Resistant.
• Very Major Errors (VME): Instances where the test device classifies an isolate as Resistant when the reference method classifies it as Susceptible.
• Minor Errors (mE): Instances where the test device classifies an isolate as Intermediate when the reference method classifies it as Susceptible or Resistant, or vice versa.

Without the actual study report, I cannot provide numerical values for the reported device performance against specific acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not specify the sample size (number of isolates) used in the test set.
• Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. Typically, clinical studies for AST devices involve prospective collection of isolates from various clinical sites.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• This information is not provided in the document. For AST devices, the "ground truth" is typically established by a recognized reference method performed by trained microbiologists, rather than a panel of "experts" in the way it might be for image-based diagnostic AI.

4. Adjudication Method for the Test Set

• This information is not provided in the document. For AST devices, the reference method's result is generally considered the "gold standard," and complex adjudication methods like 2+1 or 3+1 are not typically used to establish ground truth for MIC values.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• An MRMC study is not applicable to this type of device. The Sensititre system is an automated or semi-automated system that provides an MIC value and interpretive category, not an image-based diagnostic that requires human interpretation. Therefore, a study comparing Human Readers with and without AI assistance is not relevant here.

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

• The Sensititre system itself is the "standalone" device in this context. The study evaluates the performance of the system (including its reagents and methodology) against a recognized reference method. It's not an "algorithm only" in the sense of an AI model, but rather a complete diagnostic test system. The clearance is based on its standalone performance relative to the reference method.

7. The Type of Ground Truth Used

• The ground truth used is implicitly stated as the "reference method in the dilution range of 0.0005-2ug/ml". For AST devices, this typically refers to a standardized broth microdilution method (e.g., CLSI broth microdilution reference method) for determining the MIC.

8. The Sample Size for the Training Set

• This information is not applicable/not provided in the context of this device. The Sensititre system is not an AI/ML device that requires a "training set" in the conventional sense. Its performance is based on its established methodology and reagents, which are validated during manufacturing and clinical studies.

9. How the Ground Truth for the Training Set was Established

• This information is not applicable/not provided as there is no "training set" for this type of device.

In summary, the provided document offers limited details regarding the specifics of the performance study. It broadly indicates that the device was evaluated against reference methods to support the "newly approved Breakpoints for Telavancin." Comprehensive details on sample sizes, specific performance metrics (EA, CA, ME, VME), and the exact study methodology would be found in the complete 510(k) submission, which is not included here.

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