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The MicroScan Prompt® Inoculation System-D is used to standardize inocula for microdilution antimicrobial susceptibility tests.

The MicroScan Prompt Inoculation System-D is an accessory to the MicroScan Gram Negative and Gram Positive MIC/Combo Panels. Indications for use organisms are specific for each antimicrobial agent on the panel.

The MicroScan Prompt Inoculation System-D is a method for obtaining standardized bacterial inoculum while eliminating the need for incubation and turbidity adjustment with inocula prepared according to the CLSI procedure. It consists of an inoculation wand and a bottle of diluent. The wand is a polypropylene rod with a breakaway collar that serves as a wiping mechanism. The rod is attached to a stopper. At the tip of the wand is a groove designed to hold a specific amount of bacteria equivalent to a 0.5 McFarland standard. Thirty (30) ml of diluent (Pluronic is used as the surfactant) are provided in the plastic bottle. Each kit contains 60 plastic bottles, each containing 30 ml of stabilized aqueous Pluronic surfactants and 62 inoculation wands.

The provided text is a 510(k) Premarket Notification from the FDA for the Beckman Coulter MicroScan Prompt Inoculation System-D. While it discusses the device's intended use, description, and comparison to a predicate device, it does not contain the detailed study results, acceptance criteria, or specific performance metrics (like sensitivity, specificity, accuracy, or effect sizes) that would typically be found in a study report proving a device meets acceptance criteria.

The document states that "Clinical performance data obtained with the Prompt Inoculation System-D were evaluated in previously conducted studies described in recent 510(k) decision summaries for the MicroScan Dried Gram negative and Gram positive MIC/Combo panels for each antimicrobial agent." It further notes that "Performance of the MicroScan MIC/Combo panels were evaluated using the Prompt inoculation method and the turbidity method against the CLSI broth microdilution reference method and results were analyzed based on the recommended guidelines in the AST Class II Special Controls Guidance Document issued on August 28, 2009."

Therefore, I cannot extract the specific information requested in your prompt based on the provided text. The document refers to other 510(k) decision summaries and a guidance document for the actual performance data and acceptance criteria.

To answer your request thoroughly, I would need access to those referenced documents, specifically the "recent 510(k) decision summaries for the MicroScan Dried Gram negative and Gram positive MIC/Combo panels" and the "AST Class II Special Controls Guidance Document issued on August 28, 2009."

Without those, the most I can infer is that the acceptance criteria are based on the CLSI broth microdilution reference method, and the performance analysis follows the AST Class II Special Controls Guidance Document. The device's performance is likely evaluated in terms of its ability to standardize bacterial inocula for Antimicrobial Susceptibility Tests (AST) such that the AST results are consistent and accurate compared to the reference method.

Regarding your specific points, here's what the provided text does not contain:

1. A table of acceptance criteria and the reported device performance: Not present.
2. Sample sized used for the test set and the data provenance: Not present. It mentions "previously conducted studies" but no details on sample size or origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
4. Adjudication method: Not present.
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, as this is an inoculation system, not an AI-assisted diagnostic device for human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is an inoculation system; its "performance" is in consistently producing a standardized inoculum, which then feeds into a downstream AST process (MicroScan MIC/Combo panels). The text mentions results were read both manually and with instruments, but doesn't detail a "standalone" algorithm performance study in the way it might for an AI diagnostic.
7. The type of ground truth used: It references the "CLSI broth microdilution reference method" as the comparative standard, which serves as the ground truth for AST results.
8. The sample size for the training set: Not applicable/not present. This is a physical device/reagent system, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established: Not applicable/not present.

In summary, the provided document describes the regulatory submission for an inoculation system, outlining its purpose and comparison to a predicate device. It specifically references other documents where the detailed performance data and acceptance criteria would be found, rather than including them directly.

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The Sensititre® AIM™ is intended for use with the Sensititre® MIC or BP Susceptibility Test System. The Sensititre® AIM™ 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 gram positive and fastidious organisms comprising of Haemophilus influenzae, Streptococci pneumoniae, other Streptococci spp. and Candida spp.

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.

I am sorry, but the provided text from the FDA 510(k) K103456 document does not contain the detailed information necessary to answer the questions about acceptance criteria and study results for a device that uses AI or machine learning.

The document describes the Sensititre AIM™, an instrument for inoculating Sensititre MIC or BP Susceptibility plates, which falls under the category of Antimicrobial Susceptibility Test Powder. The 510(k) is primarily for the addition of this "AIM" instrument to an existing system.

The content focuses on regulatory approval, substantial equivalence, and general controls, rather than performance studies with acceptance criteria typically associated with advanced algorithmic or AI-driven medical devices. Therefore, I cannot extract the following information from the provided text:

• A table of acceptance criteria and reported device performance.
• Sample size and data provenance for a test set.
• Number and qualifications of experts for ground truth establishment.
• Adjudication method for the test set.
• Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
• Results of a standalone (algorithm only) performance study.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for performance validation.
• Sample size for the training set.
• How ground truth for the training set was established.

This document predates the widespread regulatory submissions for AI/ML devices and therefore does not contain the type of data requested.

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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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