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Use of Synercid, 15 µg, BBL™ Sensi-Disc™ for in vitro agar diffusion susceptibility testing is indicated when there is a need to determine the susceptibility of bacteria to Synercid. Synercid indication whown to be active in vito against most strains of microorganisms listed below, as described in the Rhone Poulenc-Rorer package insert for this antimicrobic.

Active In Vitro Against:

Aerobic Gram Positive Microorganisms

Enterococcus facium (Vancomycin-resistant and multi-drug resistant strains only) Staphylococcus aureus (methiclilin-susceptible strains only) Straptococcus pyoganes

Antimicrobial Susceptibility Test Discs are used for semi-quantitative in vitro susceptibility testing by standardized agar diffusion test procedures. Synercid BBL® Sensi-Disc™ are intended for use in determining the susceptibility to Synercid of a wide range of bacteria, as described under Indications For Use below. Zone sizes used for interpretation of tests, including control organism limits, were determined by the antimicrobic manufacturer, Rhone Poulenc-Rorer, and received FDA approval under NDA Nos. 50-747 and 50-748.

Synercid Susceptibility Test Discs are prepared by impregnating high quality paper with accurately determined amounts of Synercid supplied by the manufacturer, Rhone Poulenc-Rorer. Each Synercid disc is clearly marked on both sides with the agent and content. Synercid discs are furnished in cartridges of 50 discs each. Synercid cartridges are packed as either a single cartridge in a single box, or in a package containing ten cartridges.

Agar diffusion methods employing dried filter paper discs impregnated with specific concentrations of antimicrobial agents were developed in the 1940's. In order to eliminate or minimize variability in the testing, Bauer et al. developed a standardized procedure in which Mueller Hinton Agar was selected as the test medium.

Various regulatory agencies and standards-writing organizations subsequently published standardized reference procedures based on the Bauer-Kirby method. Among the earliest and most widely accepted of these standardized procedures were those published by the U.S. Food and Drug Administration (FDA) and the World Health Organization (WHO). The procedure was adopted as a consensus standard by the National Committee for Clinical Laboratory Standards (NCCLS) and is periodically updated. The latest NCCLS documents are M2-A6 (1/97) and M100=S9 (1/99).

Discs containing a wide variety of antimicrobial agents are applied to the surface of Mueller Hinton Agar plates for Haemophilus Test Medium Agar for Haemophilus influenzae or Mueller Hinton Agar with 5% Sheep Blood for Streptococcus pneumoniae] inoculated with pure cultures of clinical isolates. Following incubation, the plates are examined and the zones of inhibition surrounding the discs are measured and compared with established zone size ranges for individual antimicrobial agents in order to determine the agent(s) most suitable for use in antimicrobial therapy. The determination as to whether the organism in question is susceptible (S), intermediate (I), or resistant (R) to an antimicrobial agent is made by comparing zone sizes to those found in the respective organism tables of NCCLS Document M2-A6 ("Performance Standards for Antimicrobial Disk Susceptibility Tests - Sixth Edition, Approved Standard", 1/97) and of NCCLS Document M100-S9 ("Performance Standards for Antimicrobial Susceptibility Testing", Ninth Informational Supplement, 1/99).

The acceptance criteria for the Synercid 15 µg, BBL™ Sensi-Disc™ are not explicitly stated as distinct "acceptance criteria" but are implicitly derived from the standardized procedures and interpretations of antimicrobial susceptibility testing. The performance of the device is assessed by comparing zone sizes of inhibition with established ranges.

Here's an attempt to structure the information based on your request, inferring where specific details are not directly provided in the text.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states, "See Rhone Poulenc-Rorer labeling on Susceptibility Testing - Diffusion Techniques for Synercid" for Performance Data. This indicates that the specific details regarding the test set's sample size, and data provenance (e.g., country of origin, retrospective or prospective) for the studies establishing the zone size interpretations for Synercid are located within the Rhone Poulenc-Rorer labeling, which is not provided in this 510(k) summary.

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

This information is not provided in the 510(k) summary. The document refers to "established zone size ranges" and "control organism limits" determined by Rhone Poulenc-Rorer and approved by the FDA under NDA Nos. 50-747 and 50-748. The NCCLS documents are also cited as the basis for interpretation. This suggests that the ground truth was established through a rigorous process involving expert consensus and clinical studies, but the specific number and qualifications of individuals involved in establishing those reference standards are not detailed here.

4. Adjudication method for the test set

The document does not describe an adjudication method for the test set. The methodology relies on comparing measured zones of inhibition to pre-established, standardized zone size tables from NCCLS documents (M2-A6 and M100-S9). This implies a direct comparison to a reference standard rather than an adjudication process between multiple readers.

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

No, an MRMC comparative effectiveness study involving AI assistance is not mentioned. This device is a traditional antimicrobial susceptibility test disc, not an AI-powered diagnostic tool. The "readers" in this context would be laboratory technicians or microbiologists measuring zone sizes, and the "improvement" would be their accuracy in interpreting those measurements against standardized charts.

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

This question is not applicable to the device described. The BBL™ Sensi-Disc™ is a physical diagnostic tool that requires human involvement for application, incubation, measurement of inhibition zones, and interpretation against reference standards. It is not an algorithm-only device.

7. The type of ground truth used

The ground truth used for interpreting the device's performance is expert consensus and established reference standards. Specifically:

• Zone sizes and interpretive criteria (S, I, R) were determined by the antimicrobic manufacturer, Rhone Poulenc-Rorer, and received FDA approval under NDA Nos. 50-747 and 50-748.
• These interpretations are aligned with the consensus standards published by the National Committee for Clinical Laboratory Standards (NCCLS), specifically M2-A6 and M100-S9.
• The Bauer-Kirby method, a widely accepted standardized procedure, forms the basis.

This type of ground truth is analogous to a "reference standard" established through extensive clinical validation and expert agreement in the field of microbiology.

8. The sample size for the training set

The document does not explicitly mention a "training set" in the context of an algorithm. However, the development of the standardized zone size interpretations (which could be considered analogous to the "training" for the interpretation system) would have involved extensive testing by Rhone Poulenc-Rorer and the NCCLS with a large number of bacterial isolates and clinical correlations. The specific sample sizes for these historical "training" studies are not provided in this 510(k) summary but would be found in the foundational documents for Synercid and the NCCLS standards.

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

The ground truth for establishing the interpretive criteria (zone sizes for S, I, R) was established through extensive microbiological studies and clinical correlation.

• The antimicrobic manufacturer (Rhone Poulenc-Rorer) conducted studies for Synercid to correlate minimum inhibitory concentrations (MICs) with zone diameters, and clinical outcomes. This process involved determining the breakpoints that differentiate susceptible, intermediate, and resistant organisms based on pharmacokinetic/pharmacodynamic data and clinical efficacy. These results were submitted to the FDA for approval under the New Drug Applications (NDAs).
• The NCCLS (now CLSI) then develops and updates its "Performance Standards for Antimicrobial Disk Susceptibility Tests" (M2-A6) and "Performance Standards for Antimicrobial Susceptibility Testing" (M100-S9) based on a comprehensive review of data, including that from drug manufacturers, academic institutions, and public health laboratories. This involves expert committees reviewing vast amounts of microbiological data, epidemiological cut-off values, and clinical outcome data to establish the universally accepted zone size breakpoints.

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The Becton Dickinson SafetyGlide™ Syringes are used for a variety of injections and aspirations of fluid from vials, ampules and parts of the body below the surface of the skin. The insulin syringe has scale lines in insulin units and is typically used for insulin injections. The allergy syringes come in test and treatment versions. The allergy test syringe has an intra-dermal bevel for intradermal injections. The allergy treatment syringe has a regular bevel which is typically used for subcutaneous injections. The tuberculin syringe has a regular bevel which can be used for any of the 3 types of common injections (intradermal, intra-muscular or subcutaneous).

The SafetyGlide™ Syringe contains a mechanism that covers the needle point after use. In the activated position the needle cover guards against accidental needle sticks during normal handling and disposal of the used needle/syringe combination.

Single-use syringe with needle protection system. Syringes sizes: .3, .5, & 1 ml.

Function: Syringes are used for aspiration/injection of fluids. The device contains a mechanism that covers the needle point after use. In the activated position the needle cover guards against accidental needle sticks during normal handling and disposal of the used need as syringe combination.

This document describes the safety and effectiveness of the Becton Dickinson SafetyGlide™ Syringe, comparing it to predicate devices. The syringe includes a needle protection system designed to prevent accidental needle sticks after use.

Here's an analysis of the provided text based on your requested criteria:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only states that the "sharps injury prevention feature was compared to the predicate devices."

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth. The comparison appears to be based on physical performance parameters rather than expert clinical assessment.

4. Adjudication Method for the Test Set:

The document does not describe any adjudication method. The comparison appears to be based on direct testing of performance parameters.

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

No, an MRMC comparative effectiveness study was not done. The device is a syringe, and the study focuses on physical performance characteristics, not on the interpretation of medical images or data by multiple readers. The prompt mentions "human readers improve with AI vs without AI assistance," which is not applicable to a device like a syringe.

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

This question is not applicable. The device is a physical syringe, not an AI algorithm. Therefore, no standalone algorithm performance study was conducted.

7. The Type of Ground Truth Used:

The ground truth used for this study appears to be performance metrics against established engineering standards or the performance of legally marketed predicate devices. The criteria (activation forces, security of assembly, safety barrier resistance, impact resistance) are measurable physical properties, not clinical outcomes, pathology, or expert consensus in a diagnostic sense.

8. The Sample Size for the Training Set:

The concept of a "training set" is not applicable here as this is a physical medical device and not an AI or machine learning model. Therefore, no training set size is mentioned.

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

This question is not applicable as there is no training set for a physical device.

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The QBC STAR™ Centrifugal Hematology System provides a diagnostic hematology profile on venous or capillary blood: hematocrit, hemoglobin, mean corpuscular hemoglobin concentration (MCHC), platelet count, white blood cell count, granulocyte count (% and number) and lymphocyte/monocyte count (% and number).

The QBC STAR™ Centrifugal Hematology System is a self-contained, whole blood automated hematology system. Testing can be performed on venous or capillary samples. All tests are performed in the QBC STAR™ Blood Collection Tube. The system is powered by a universal voltage internal power supply that plugs directly into an AC power source. The instrument is factory preset and does not require user calibration. The methodology of the QBC STAR centrifugal hematology system is based on electro-optical linear measurements of the discrete layers of packed blood cells in a microhematocrit-type tube. The cell layering results from density gradients formed during high-speed centrifugation of the blood. Nine primary hematology values, including, hematocrit, hemoglobin, mean corpuscular hemoglobin concentration (MCHC), white blood cell count, platelet count, granulocyte count (% and number) and lymphocyte/monocyte count (% and number) are derived. QBC hematology tests utilize precision-bore glass tubes pre-coated with potassium oxalate, acridine orange fluorochrome stain and an agglutinating agent. During high-speed centrifugation of the blood-filled tube, the cells form in packed layers, according to their density, around the float, which has descended into the red blood cells. The buffy coat is automatically scanned and fluoresence and absorbance readings are made to identify the expanded layers of differentiated cells. Volumes of these packed cell layers are then computed to obtain quantitative values for the listed parameters. On the QBC STAR system, the hematocrit, white blood cell counts and the platelet count are direct measurements of the cell lavers. The hemoglobin measurement is directly related to the density of the red blood cells and based on the depth of penetration of the float into the red blood cell layer. Mean Corpuscular Hemoglobin Concentration (MCHC) is a function of hemoglobin and hematocrit and is electronically calculated according to the standard equation (Hab/Hct x 100).

Here's an analysis of the provided text regarding the acceptance criteria and study for the QBC STAR™ Centrifugal Hematology System, formatted as requested:

Acceptance Criteria and Study for QBC STAR™ Centrifugal Hematology System

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly state quantitative "acceptance criteria" in a typical numerical format (e.g., "accuracy must be >95%"). Instead, the acceptance criteria are implicitly defined by demonstrating equivalent performance to the predicate device, the QBC™ AUTOREAD™ Plus Hematology System, for all measured parameters. The reported device performance is therefore the demonstrated equivalence.

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

• Sample Size: Not explicitly stated. The document mentions "multiple blood and control samples" and "venous and capillary samples."
• Data Provenance: Not explicitly stated. Given the context of a 510(k) submission to the FDA, it is highly likely the studies were conducted in the USA, but this is not confirmed. The document does not specify if the data was retrospective or prospective.

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

Not applicable. This type of device (hematology analyzer) typically uses established laboratory reference methods or predicate devices for ground truth comparison, rather than human experts interpreting results. The predicate device's performance serves as the benchmark for equivalence.

4. Adjudication Method for the Test Set

Not applicable. As described above, human expert adjudication is not typically used for establishing ground truth for automated hematology analyzers. The device's measurements are directly compared against established reference methods or the predicate device's results.

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 evaluates human reader performance, typically in imaging diagnostics, and is not relevant for an automated hematology analyzer.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the study demonstrates the standalone performance of the QBC STAR™ Centrifugal Hematology System. This device is an automated hematology analyzer, meaning it operates without human intervention in the interpretation or direct measurement of results from a sample. Its performance is evaluated independently of a human operator's judgment apart from proper sample collection and loading.

7. The Type of Ground Truth Used

The ground truth was established by:

• Predicate Device Performance: The QBC™ AUTOREAD™ Plus Hematology System's performance served as the primary benchmark for demonstrating substantial equivalence.
• Established Laboratory Reference Methods: Although not explicitly detailed, "accuracy testing" usually implies comparison to well-established and validated laboratory methods for hematology parameters.

8. The Sample Size for the Training Set

Not explicitly stated. The document focuses on verification testing and comparison to a predicate device, rather than detailing a separate "training set" in the context of machine learning. The device's algorithms are pre-programmed and based on physical principles of blood separation and optical measurement, not on machine learning models that require a distinct training set in the modern sense.

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

Not applicable in the typical machine learning sense. The "ground truth" for developing the underlying algorithms and measurement principles of the QBC STAR™ (and its predicate) would have been established through:

• Known physical properties of blood cells: Density, size, and fluorescent properties.
• Extensive laboratory testing and empirical data: To refine the algorithms that convert optical measurements to cell counts and other hematology parameters.
• Clinical correlation: Ensured the device's measurements correlated with patient health status and clinical needs.

The document indicates that existing algorithms from the predicate device were likely re-used or adapted ("A series of numerical algorithms convert the volume of measured cell material in each layer to an equivalent cell count," identical description for both devices in Table 1). Therefore, the "training" (development and refinement) of these algorithms would have occurred during the development of the predicate device and potentially minor adjustments during the development of the QBC STAR system.

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