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The Sensititre® OptiRead™ is intended for use with the Sensititre® MIC or BP Susceptibility Test System. The Sensititre® OptiRead™ is a fluorescence based detection instrument used to read Sensititre® MIC or BP Susceptibility plates.

The Sensititre MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of non-fastidious Gram negative organisms.

The Sensititre OptiRead is used to read fluorescence values from the Sensititre MIC or BP Susceptibility Test System for non-fastidious Gram negative organisms. The plate reading on the OptiRead is initiated via SWIN software and the fluorescence values from the OptiRead are then transferred back to the SWIN software where the results are generated.

The Sensititre® OptiRead™ is a fluorescence based detection instrument used to read Sensititre® MIC or BP Susceptibility plates.

This document is a 510(k) clearance letter for the Sensititre® OptiRead™, an antimicrobial susceptibility test powder reader. It does not contain the detailed study information required to answer your questions. The letter simply states that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide:

1. A table of acceptance criteria and the reported device performance: This information is not present in the provided text.
2. Sample sizes used for the test set and the data provenance: This information is not present.
3. Number of experts used to establish the ground truth for the test set and their qualifications: This information is not present.
4. Adjudication method: This information is not present.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: This information is not present.
6. If a standalone performance study was done: This information is not present.
7. The type of ground truth used: This information is not present.
8. The sample size for the training set: This information is not present.
9. How the ground truth for the training set was established: This information is not present.

The document focuses on the regulatory clearance and the device's indications for use, not the specifics of its validation studies.

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The Sensititre HP MIC Susceptibility plate is an in vitro diagnostic product for clinical susceptibility testing of fastidious isolates.

The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of nonfastidious isolates.

This 510(k) is for the addition of Ceftaroline in the dilution range of 0.004-8ug/ml to the Sensititre HP MIC Susceptibility plate for testing Streptococcus spp. and the Sensititre 18 - 24 hour MIC panel in the dilution range of 0.06-64ug/ml for testing gram positive isolates. The organisms which may be used for Ceftaroline susceptibility testing in this panel are:

Facultative Gram-Positive Microorganisms: Staphylococcus aureus (including methicillin-resistant isolates) Streptococcus pyogenes Streptococcus agalactiae Streptococcus pneumoniae

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The provided text is a 510(k) premarket notification letter from the FDA regarding an antimicrobial susceptibility test (AST) device. It does not contain information about acceptance criteria, device performance tables, study designs (sample sizes, data provenance, expert adjudication, MRMC studies, standalone performance), or ground truth establishment methods in the depth requested.

The document primarily focuses on:

• Device Identification: Sensititre HP MIC Susceptibility Plate with Ceftaroline (0.004-8ug/ml) and The Sensititre® 18-24 Hour MIC Susceptibility System Test Panel with Ceftaroline (0.06-64ug/ml).
• Regulatory Classification: Class II, Product Code JWY, LRG.
• Indications for Use: Clinical susceptibility testing of fastidious (Sensititre HP) and nonfastidious (Sensititre 18-24 hour MIC) isolates. Specifically for Ceftaroline susceptibility testing of Staphylococcus aureus (including methicillin-resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, and Streptococcus pneumoniae.
• FDA Clearance: A determination of substantial equivalence to predicate devices, allowing the device to be marketed.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, or study details, as it is not present in the provided text.

To answer your questions, I would need a detailed study report, a summary of safety and effectiveness, or a more comprehensive technical document from the manufacturer or FDA submission.

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The Sensititre® AIM™ is intended for use with the Sensititre® MIC or BP Susceptibility Test System. The Sensititre® AIMTM is an instrument used to inoculate Sensititre® MIC or BP Susceptibility plates.

The Sensititre MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of non fastidious gram negative organisms.

The Sensititre AIM™ is a microprocessor controlled instrument that delivers inoculum in 50ul multiples to the Sensititre 96 well micro-titre plate. The user prepares the inoculum suspension in accordance with the package insert. A Sensititre disposable dosehead is affixed to the glass tube containing the final inoculum density which is placed into the AIM's pump assembly. The inoculum is then dispensed into the microtitre plates.

This appears to be a 510(k) clearance letter for the Sensititre AIM™ device, which is an instrument used to inoculate Sensititre MIC or BP Susceptibility plates for antimicrobial susceptibility testing. The provided document itself does not contain the detailed study information, acceptance criteria, or performance data that would be typically found in a clinical study report or a summary of safety and effectiveness.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."

This means the FDA granted clearance based on the device being substantially equivalent to a predicate device, rather than requiring extensive new clinical trial data that would be presented in the format you're requesting. The detailed performance data would have been submitted by the manufacturer as part of their 510(k) submission, but it's not included in this public-facing clearance letter.

Therefore, I cannot extract the following information from the provided text:

• A table of acceptance criteria and the reported device performance: This information is not present.
• Sample sizes used for the test set and the data provenance: This information is not present.
• Number of experts used to establish the ground truth for the test set and their qualifications: This information is not present.
• Adjudication method for the test set: This information is not present.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: This information is not present.
• If a standalone (algorithm only) performance study was done: This information is not present. The Sensititre AIM™ is an instrument for inoculation, not an algorithm in the sense of AI/ML.
• The type of ground truth used: This information is not present.
• The sample size for the training set: This information is not present.
• How the ground truth for the training set was established: This information is not present.

What the document does tell us:

• Device Name: Sensititre® AIM™
• Intended Use: The Sensititre® AIM™ is intended for use with the Sensititre® MIC or BP Susceptibility Test System. It is an instrument used to inoculate Sensititre® MIC or BP Susceptibility plates. The Sensititre MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of non-fastidious gram-negative organisms.
• Device Function: It is a microprocessor-controlled instrument that delivers inoculum in 50ul multiples to the Sensititre 96 well micro-titre plate. The user prepares the inoculum suspension, affixes a disposable dosehead to the glass tube containing the final inoculum density, and places it into the AIM's pump assembly for dispensing into microtitre plates.
• Regulatory Pathway: 510(k) substantial equivalence. This means the device was found to be as safe and effective as a legally marketed predicate device. The performance data justifying this equivalence would have been submitted to the FDA in the original 510(k) application.
• Product Code: LIE, JWY, LRG
• Regulation Number/Name: 21 CFR 866.1640, Antimicrobial Susceptibility Test Powder (Note: This regulation name seems to refer to the reagents, not directly to the instrument itself, highlighting that the AIM is part of a larger system.)

To obtain the detailed acceptance criteria and study data for the Sensititre AIM™, one would typically need to review the original 510(k) submission summary (often called the 510(k) Summary or 510(k) Statement) which is usually publicly accessible on the FDA website for cleared devices, or directly from the manufacturer.

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The Sensititre® Haemophilus influenza/Streptococcus pneumoniae (HP) MIC susceptibility plates and Justone are in vitro diagnostic products for quantitatively and or qualitative susceptibility testing of isolated colonies of Haemophilus influenzae, Streptococcus pneumoniae and Streptococcus species from clinical specimens.

Plates can either be read manually or automatically on the Sensititre Autoreader and/or ARIS with Streptococcus pneumoniae and Streptococcus species and manually with H. influenzae. The JustOne® strip can only be read manually.

This 510(k) is for the addition of Tigecycline in the dilution range of 0.004 - 8 µg/ml for testing Streptococcus pneumoniae isolates on the Sensititre® (HP) MIC susceptibility system. The additional approved primary "Indications for Use" and clinical significance of Tigecycline is for:

Aerobic facultative Gram-positive microorganisms Streptococcus pneumoniae (Penicillin susceptible stains only)

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The information provided is a 510(k) premarket notification letter from the FDA, approving the Sensititre® Haemophilus influenza/Streptococcus pneumoniae (HP) MIC susceptibility plates, Tigecycline (0.004 - 8ug/mL). This document primarily contains the regulatory approval status and indications for use. Key information about the device's performance study and acceptance criteria is not explicitly detailed in the provided text.

Specifically, the document states:

• The device is an in vitro diagnostic product for susceptibility testing.
• The 510(k) is for the addition of Tigecycline in the dilution range of 0.004 - 8 µg/ml for testing Streptococcus pneumoniae isolates.
• The additional approved primary "Indications for Use" and clinical significance of Tigecycline is for Streptococcus pneumoniae (Penicillin susceptible stains only).

To address your request, I will outline the typical information that would be found in a study report for such a device, and explicitly state what is missing from this FDA letter.

Missing Information:

The provided text does not contain any details about the acceptance criteria, the specific study conducted, sample sizes, data provenance, ground truth establishment, or any comparative effectiveness studies. These details would typically be found in the 510(k) submission itself or a separate study report, which is not included here.

Therefore, the following sections will indicate where the requested information would normally be found or what typical approaches are used for such devices, and will explicitly state that the specific details are not available in the provided document.

Acceptance Criteria and Reported Device Performance

Specific data for acceptance criteria and reported device performance are NOT available in the provided text.

For an antimicrobial susceptibility test (AST) device like the Sensititre® plates, the acceptance criteria would typically focus on agreement rates with a predicate method (e.g., broth microdilution) for categorical agreement (Sensitive, Intermediate, Resistant) and essential agreement (within +/- 1 dilution).

A hypothetical table showing typical acceptance criteria and what would be reported for an AST device:

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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 gram positive and gram negative organisms. This 510(k) is for addition of Minocycline in the dilution range of 0.03 - 32μg/ml for testing gram negative and gram positive isolates on the Sensititre® 18 - 24 hour Susceptibility system. The approved primary "Indications for Use" and clinical significance of Minocycline is for: Aerobic and facultative Gram-negative and Gram-positive microorganisms: Escherichia coll Klebsiella spp. Enterobacter aerogenes Acinetobacter spp. Staphylococcus aureus* *Minocycline is not the drug of choice in the treatment of any type of staphylococcal infection.

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The provided text is an FDA 510(k) clearance letter and an "Indications for Use" statement for a medical device. It does not include information about acceptance criteria, study design, or performance metrics. Therefore, I cannot extract the requested information from the provided text.

The document states that the Sensititre 18-24 hour Susceptibility Plates with Minocycline are "substantially equivalent" to legally marketed predicate devices, meaning it has been deemed safe and effective for its stated indications for use based on comparison to existing devices, not necessarily a new clinical study.

To provide the requested details, I would need a different document, such as a summary of safety and effectiveness data, a clinical study report, or a regulatory submission detailing the validation of the device.

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The Sensititre® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC Susceptibility plate is and I he Sellstitle= Huemophilus influence&oldid=918888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888 Streptococcus species.

This 510(k) is for the addition of Streptococcus spps to cefepime (0.12 - 8 ug/mL), ceftrianone (0.06-2 I I IIIS SIV(K) is for the addition of Shippoooooal vipps Sensitite® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC Susceptibility Plates .

oneumonde (HF) MIC Susceptionity Frates -

Viridans group streptococci. Streptococcus pneumoniae, Streptococcus pyogenes With activity against: Streptococcus agalactiae " " Sheptococcas agatachas for use" and clinical significance of ceftriaxone is for

Viridans group streptococci.

Streptococcus pneumoniae,

Streptococcus pyogenes

The following in vitro data are available but their clinical significance is unknown:

Streptococcus agalactiae

" "Streptococcas ugadestions for use" and clinical significance of chloramphenicol is for: Streptococcus pneumoniae

Streptococcus spp.

Not Found

The provided text describes a 510(k) premarket notification for a medical device called "Sensititre® Haemophilus inflenzae/Streptococcus pneumoniae (HP) MIC susceptibility plates." This device is used for determining the antimicrobial susceptibility of various Haemophilus and Streptococcus species to specific antibiotics (Cefepime, Chloramphenicol, and Ceftriaxone). However, the document does not contain the acceptance criteria or the study details proving the device meets those criteria.

The text is a communication from the FDA indicating that the device has been found substantially equivalent to a legally marketed predicate device, thus allowing it to proceed to market. It outlines regulatory information, product codes, and class designation. The "Indications for Use" section lists the specific bacterial species and antibiotics for which the device is intended.

Therefore, based solely on the provided text, I cannot complete the table or answer the questions regarding acceptance criteria and study details. The document is a regulatory approval letter, not a scientific study report.

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The Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility plate is an in vitro diagnostic product for clinical susceptibility testing of Haemophilus/Streptococcus pneumoniae.

The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of gram positive organisms.

This 510(k) is for the addition of Telithromycin in the dilution range of 0.002-16µg/ml to the Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility plate for testing Haemophilus/Streptococcusion pneumoniae and the Sensititre 18 - 24 hour MIC panel for testing gram positive isolates. The approved primary "Indications for Use" and clinical significance for Telithromycin is for: Streptococcus_pneumoniae (including multi-drug resistant isolates [MDRSP]), Haemophilus influenzae, and Staphylococcus aureus (methicillin and erythromycin susceptible isolates only). In vitro data, without clinical correlation is provided for: Streptococcus pyogenes(erythromycin susceptible isolates only).

Not Found

Here's a breakdown of the acceptance criteria and study information for the Sensititre® Haemophilus/Streptococcus pneumoniae (HP) MIC/Susceptibility Plate and Test Panel for Telithromycin 0.002-16μg/ml, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document is a 510(k) clearance letter, which indicates the device is substantially equivalent to a legally marketed predicate device. For such submissions, the acceptance criteria are generally based on agreement rates between the new device and a reference method (often a standard broth microdilution method). The specific acceptance criteria (e.g., Categorical Agreement and Essential Agreement percentages) and the reported performance are not explicitly detailed in this clearance letter. However, the letter implies that the device successfully met these benchmarks.

As a typical example for antimicrobial susceptibility tests (ASTs) in 510(k) submissions, the acceptance criteria and performance would look something like this (actual values are usually found in the full 510(k) summary, not just the clearance letter):

Note: The document only states that the device was deemed "substantially equivalent." This means that the performance was considered comparable to the predicate device, which inherently means it met the necessary agreement criteria with a reference method. The specific numerical values for acceptance criteria and performance are not present in this clearance letter.

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

• Sample Size for Test Set: Not explicitly stated in the provided document.
• Data Provenance: Not explicitly stated. For clinical trials supporting 510(k) submissions for ASTs, data typically comes from clinical laboratories, often across multiple sites, within the US. The document does not specify if it was retrospective or prospective, but clinical test validation data for ASTs is often prospective collection and testing of isolates.

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

• This information is not applicable in the context of an antimicrobial susceptibility test (AST) device.
• For ASTs, the "ground truth" is established by a reference method (e.g., broth microdilution or agar dilution) performed by trained microbiologists following standardized protocols, not by expert interpretation of images or other subjective data. These methods are quantitative and provide the minimum inhibitory concentration (MIC) values directly.

4. Adjudication Method for the Test Set

• This is not applicable for an AST device. The ground truth for ASTs is determined by a quantitative reference method, not by expert consensus or adjudication. Discrepancies are often resolved by re-testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for devices where human readers interpret data (e.g., radiology images) and the AI's role is to assist or replace that interpretation.
• The Sensititre device is an in vitro diagnostic product designed to directly measure antimicrobial susceptibility. Its performance is evaluated against a reference method, not by comparing human reader performance with and without AI assistance.

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

• Yes, in essence, standalone performance is what is primarily evaluated for this device. The Sensititre plate is designed to provide MIC values automatically or semi-automatically. The "algorithm" here is the system's ability to accurately measure growth inhibition relative to a reference method, without significant human interpretation beyond setting up the test and reading the final result (which is often automated). The performance data cited for substantial equivalence would be the standalone performance of the device against the reference method.

7. The Type of Ground Truth Used

• Expert Consensus: Not used.
• Pathology: Not used.
• Outcomes Data: Not used.
• The ground truth for AST devices is typically established by a recognized reference method, such as CLSI (Clinical and Laboratory Standards Institute) or ISO (International Organization for Standardization) standard broth microdilution or agar dilution methods. These methods provide quantitative Minimum Inhibitory Concentration (MIC) values.

8. The Sample Size for the Training Set

• This information is not explicitly provided in the clearance letter.
• For an AST plate, the concept of a "training set" in the machine learning sense (for training an algorithm) is less direct. Instead, a large bank of characterized bacterial isolates (many of which are historical and well-studied) is used during the development and optimization phase to ensure the test system can accurately detect susceptibility and resistance across a wide range of relevant organisms and resistance mechanisms. The letter doesn't specify the size of this internal development/optimization data.

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

• Similar to the test set, the "ground truth" for any internal development or optimization of an AST device (analogous to a training set) would be established using standardized reference methods (e.g., CLSI broth microdilution) for each isolate. This involves growing the bacteria in the presence of varying concentrations of the antimicrobial and observing the lowest concentration that inhibits visible growth.

In summary, the provided document is a 510(k) clearance, which confirms substantial equivalence based on prior studies. However, it does not contain the granular details of the specific acceptance criteria, study design parameters (like sample sizes or ground truth establishment methods) that would typically be found in the full 510(k) summary or clinical study reports. The nature of the device (an in vitro diagnostic AST) means many questions related to expert interpretation or AI assistance are not directly applicable.

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