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The BD Preset™ Syringe & BD A-Line™ Syringe are sterile, single use medical devices specifically intended to be used for the collection of whole blood specimens for the purpose of in vitro diagnostic testing which may include: pH, blood gases, electrolytes (including ionized calcium), metabolytes, co-oximetry. The device is intended to be used by trained healthcare professionals.

The BD Preset™ Syringe & BD A-Line™ Syringe is a sterile, single use device designed to collect whole blood specimens for diagnostic testing. The BD A-Line™ Syringe is specifically designed for aspiration of blood samples from arterial lines. The BD Preset™ Syringe is offered with and without a pre-attached Eclipse™ needle and is specifically designed to preset a desired volume but permits aspiration when necessary. It also includes a venting system that expels residual air through the self-venting membrane (as blood fills the syringe), which ensures rapid filling. The syringe is individually packaged, and Gamma sterilized with an SAL of 10-6.

The provided text describes a Special 510(k) premarket notification for the BD Preset™ Syringe & BD A-Line™ Syringe. This submission focuses on demonstrating substantial equivalence to a predicate device after minor modifications.

Here's a breakdown of the acceptance criteria and the study conducted, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly present a table of acceptance criteria defined as numerical thresholds alongside reported device performance for blood gas measurements or similar clinical metrics. This submission focuses on bench, biocompatibility, and sterilization testing to demonstrate that the modified device performs equivalently to the predicate, and that the changes introduce no new safety or effectiveness issues.

Instead, the "acceptance criteria" are implied to be meeting the performance of the predicate device and relevant international standards. The "reported device performance" is a general statement that the device functioned as intended and demonstrated acceptable performance.

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

• Sample Size for Test Set: The document does not specify exact sample sizes for each of the bench, biocompatibility, or sterilization tests. It only lists the types of tests conducted.
• Data Provenance: The data are internal company testing results ("BD performed the following bench, biocompatibility, and sterilization testing"). The document does not specify country of origin for the data (e.g., US, Europe, etc.) or whether it was retrospective or prospective, though performance testing of a new/modified device would generally be prospective.

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

This type of submission (510(k) for a medical device like a syringe) does not involve establishing ground truth through expert review in the way a diagnostic AI submission would. The "ground truth" for the performance tests listed (e.g., tip cap leak, heparin activity) would be established by the physical and chemical properties of the materials and the manufacturing process, verified by standard laboratory testing procedures. There's no interpretive component requiring multiple human experts.

4. Adjudication Method for the Test Set

Not applicable, as this is not a diagnostic interpretation study. The tests performed are objective measurements.

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

No. An MRMC study is relevant for diagnostic devices where human reader performance (e.g., radiologists interpreting images) is being evaluated for improvement with or without AI assistance. This submission is for a blood collection syringe, a physical medical device, not a diagnostic interpretation system. Therefore, this type of study was not conducted.

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

Not applicable. This is not an algorithmic or AI device. The "performance data" refers to the physical and chemical performance of the syringe.

7. The Type of Ground Truth Used

The "ground truth" for the performance "studies" (which are laboratory tests rather than clinical trials with patient outcomes) is based on:

• Established physical and chemical test methods (e.g., ASTM, ISO standards).
• Functional specifications for the device (e.g., desired plunger force, leak-free operation).
• The performance of the legally marketed predicate device (demonstrating equivalence).

Essentially, the "ground truth" is that the device must function safely and effectively according to engineering and material science principles, and meet the performance standards of its predicate.

8. The Sample Size for the Training Set

Not applicable. This is a physical device, not a machine learning algorithm. Therefore, there is no "training set."

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

Not applicable, as there is no training set for this type of device.

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The BD SoloShot™ Mini Syringe/ BD Auto Disable Syringe is intended for aspiration and injection of fluids.

The BD SoloShot™ Mini Syringe/ BD Auto Disable Syringe device is a sterile two-piece piston syringe designed to deliver a single fixed dose. It features a permanently attached hypodermic needle and auto-disable feature that prevents reuse of the syringe by locking the plunger rod in place after injection. The SoloShot™ Mini Syringe consists of a syringe barrel, a one-piece plunger rod (without rubber stopper), a clip affixed to the plunger rod and a integral needle is protected with a shield cover. The clip activates the auto-disabled feature, preventing re-use of the syringe is individually blister packaged and ETO sterilized to SAL of 10-6 .

The provided document is a 510(k) summary for the BD SoloShot™ Mini Syringe/ BD Auto Disable Syringe, which is a medical device. This type of document is used to demonstrate substantial equivalence to a predicate device, not to prove the device meets specific performance criteria in a clinical setting in the way a diagnostic AI device might.

Therefore, many of the requested details about acceptance criteria, study design, expert involvement, and ground truth are not applicable to this type of device and submission. This is a syringe, and its performance is evaluated through bench testing, biocompatibility, and sterilization, not through clinical trials where human readers or AI algorithms analyze data for diagnostic purposes.

Here's an attempt to answer the questions based on the provided document, highlighting what is applicable and what isn't:

1. A table of acceptance criteria and the reported device performance

The document states that "In all instances, the BD SoloShot™ Mini Syringe functioned as intended and results observed met the predefined acceptance criteria." However, the exact numerical acceptance criteria for each test and the precise numerical results are not provided in this summary. The summary only lists the types of tests performed.

2. Sample size 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 510(k) summary. These tests are "bench performance" tests, not clinical studies involving patient data. The "sample size" would refer to the number of syringes tested for each performance characteristic, which is typically standard practice for device validation but not detailed here.

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 is not applicable to this type of device. "Ground truth" in the context of expert consensus is relevant for diagnostic devices that interpret images or other patient data. For a syringe, performance is measured against objective physical and chemical standards, not expert interpretation of patient-related data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable. Adjudication methods are used in studies where there is subjective interpretation (e.g., by experts) to resolve disagreements. Here, the performance is measured objectively.

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 is not applicable. An MRMC study is relevant for diagnostic devices, particularly those involving human readers and AI assistance. This device is a syringe, not an AI diagnostic tool.

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

This is not applicable. This is a physical medical device (syringe), not an algorithm or AI system.

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

For this device, "ground truth" refers to established engineering, chemical, and biological standards (e.g., ISO standards for sterility, biocompatibility, and physical performance). The device's performance is measured against these objective standards.

8. The sample size for the training set

This is not applicable. There is no "training set" in the context of a syringe's performance evaluation. Training sets are used in machine learning for AI algorithms.

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

This is not applicable. As there is no training set for a syringe, there is no ground truth to establish for it.

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The BD Intelliport™ system is an automated record keeping system that incorporates patient safety features that are aligned with hospital patient records and protocols. The system is comprised of an injection port and software that enables the identification, measurement, alerting and documentation of the administration of medications to patients.

The BD Intelliport™ system allows the clinician to record anesthesia-related, medication administration events in the pre-op, intra-op, and PACU. The system is indicated for use by healthcare professionals in a hospital or medical center setting with patients who are receiving manually administered bolus intravenous injections as part of their care to facilitate documentation of the medications.

The BD Intelliport™ system is intended for patients whose body weights are >20kg.

The BD Intelliport™ system is not intended for use with blood, blood products, biologics, or chemotherapeutics.

The BD Intelliport™ system is not intended for use with refrigerated medications (excluding cefazolin)

Like the cited predicate device, the BD Intelliport Medication Management System, Version 1.2 is a system of hardware and software components that measures the delivered volume of intravenous (IV) bolus medications associated with anesthesiarelated, medication administration events in the pre-op, intra-op, and PACU, and provides automated documentation of medication identity, concentration, dose, delivered volume, and delivery timestamp to the hospital electronic medical record (EMR) system. There are two modes: EMR mode and Standalone mode. Standalone mode allows for printing dose history reports, but is not connected to an EMR

The device is organized by three subsystems, each of which includes several physical/software components:

• . Injection Site subsystem
• . Tablet subsystem
• . Gateway subsystem

The Injection Site subsystem is composed of two physical components (the Base and the ultrasonic Sensor) and the software residing inside the Base. The Tablet subsystem is composed of one physical component (the Tablet) and the software residing inside the Tablet. The Gateway subsystem consists of the Gateway software and the hospital server hardware on which the Gateway software resides. The device also includes an accessory for charging up to five Bases simultaneously.

During treatment, the clinician connects an intelligent injection port (the Injection Site) to a patient's fluid-delivery line and performs standard drug-delivery activities. The clinician injects the druq using BD Luer Lok, 1-60ml size syringes only, and then flushes with a separate normal, saline syringe. Flushing after each administration ensures all medication is administered to patient since there is a 0.334 ml dead space.

The device can be used with both encoded and non-coded syringes. If an encoded syringe is used, the device reads the two-dimensional barcode adhered to the syringe. The barcode contains information about the content in the syringe including the drug name and concentration. If a noncoded syringe is used, then the end user is prompted by the Tablet software to pick the drug name and concentration from the Encoded Drug List (EDL). When an encoded syringe is first connected to the device, the name of the drug is read back to the clinician and an allergy alert will trigger on the Injection Site base if the patient is allergic to the medication based on the patient's allergies record in their EHR (electronic health record). As the drug is injected, the device measures the volume of the injected drug via an ultrasonic sensor and records the time the drug was administered. Drug delivery information is stored and inserted into the patient's EHR by way of the Tablet and Gateway software in the EMR mode and available for printing in the Standalone mode.

Please find the requested information regarding the acceptance criteria and the study that proves the device meets the acceptance criteria for the BD Intelliport System, Version 1.2.

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the sample size for the test set in quantitative terms for the identified performance criteria. For volume measurement accuracy, it states "Testing was conducted on a set of drugs commonly used in Anesthesia, bracketed based upon speed of sound and solvent/dissolved solids composition," implying multiple drugs were tested.

The document does not provide information on the country of origin of the data or whether the data was retrospective or prospective. The study appears to be bench and simulated human use testing, rather than clinical data from human patients.

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)

The document does not specify the number of experts or their qualifications for establishing ground truth within the context of the technical performance testing (e.g., volume accuracy). For human factors testing, it refers to "intended device users" and "clinicians," but does not detail their number or specific qualifications for establishing ground truth beyond their role as users.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not describe any specific adjudication method for establishing ground truth for the technical performance test sets. For human factors testing, it implies evaluation by human factors experts (though not explicitly stated as '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

There is no indication that a multi-reader multi-case (MRMC) comparative effectiveness study was performed. The device is described as an "automated record keeping system" and the studies reported are primarily non-clinical performance testing and simulated human use testing, not studies 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, standalone (algorithm only) performance was assessed for aspects like volume measurement accuracy. The "Modification of the volume measurement algorithm to improve accuracy and precision" implies testing of the algorithm itself. The system also has a "Standalone mode" which allows for printing dose history reports without EMR connection, suggesting functionality independent of real-time human interaction for certain tasks.

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

For volume measurement accuracy, the ground truth would likely be established through precise, laboratory-grade measurements of administered fluid volumes using calibrated equipment, comparing these to the device's reported measurements. The document mentions "Testing was performed to ensure that the device volume measurements meet the volume accuracy specification with real drugs," which supports this interpretation. For software functionalities like error messages and drug tables, the ground truth would be based on predefined software requirements and verification of their correct implementation.

8. The sample size for the training set

The document does not provide information about a "training set" or its sample size. The studies described are primarily verification and validation testing of the device's performance against specifications, rather than development or training of a machine learning model.

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

As no training set is described in the provided text, there is no information on how its ground truth was established.

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The BD Phoenix™ Automated Microbiology System is intended for in vitro quantitative determination of antimicrobial susceptibility by minimal inhibitory concentration (MIC) of most Gram-negative aerobic and facultative anaerobic bacteria isolates from pure culture for Enterobacteriaceae and Non-Enteriaceae and most Gram-positive bacteria isolates from pure culture belonging to the genera Staphylococcus, Enterococcus and Streptococcus.

Ceftolozane/tazobactam has been shown to be active in vitro against most strains of microorganisms listed below, as described in the FDA-approved package insert for this antimicrobial agent.

Active In Vitro and in Clinical Infections Against: Gram-negative bacteria Enterobacter cloacae Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa

Active In Vitro but clinical significance is unknown: Gram-negative bacteria Citrobacter koseri Morganella morganii Proteus vulgaris Providencia stuartii Serratia liquefaciens Serratia marcescens

The BD Phoenix™ Automated Microbiology System (Phoenix System) is an automated system for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically relevant bacterial isolates. The system includes the following components:

• . BD Phoenix instrument and software.
• . BD Phoenix panels containing biochemicals for organism ID testing and antimicrobial agents for AST determinations.
• . BD Phoenix ID Broth used for performing ID tests and preparing AST Broth inoculum.
• . BD Phoenix AST Broth used for performing AST tests only.
• . BD Phoenix AST Indicator solution added to the AST Broth to aid in bacterial growth determination.

The Phoenix panel is a sealed and self-inoculating molded polystyrene tray with 136 micro-wells containing dried reagents. Organisms for susceptibility testing must be a pure culture and preliminarily identified as a Gram-negative or Gram-positive isolate. Phoenix panels are inoculated with a specified organism density and placed into the instrument. Inoculum for use with the Phoenix system may be prepared either manually or may be automated using the BD PhoenixTM AP System.

The Phoenix AST method is a broth based microdilution test. The Phoenix System utilizes a redox indicator for the detection of organism growth in the presence of an antimicrobial agent. Measurements of changes to the indicator as well as bacterial turbidity are used in the determination of bacterial growth. Each AST panel configuration contains several antimicrobial agents with a wide range of two-fold doubling dilution concentrations.

The instrument houses the panels where they are continuously incubated at a nominal temperature of 35 ℃ ± 1 °C. The instrument takes readings of the panels every 20 minutes. The readings are interpreted to give an identification of the isolate, minimum inhibitory concentration (MIC) values and category interpretations, S, I, R or N (susceptible, intermediate, resistant or not susceptible).

1. Acceptance Criteria and Reported Device Performance

Note on Vmj Error: While a significant initial Vmj error rate was noted for E. coli, the submission indicates that additional testing and replicate analysis demonstrated no Vmj errors, suggesting the device ultimately met an acceptable standard for this metric.

2. Sample Size and Data Provenance (Test Set)

• Sample Size:
  • Clinical and Challenge Isolates: 1179 isolates in total ("All Organisms" in the performance table).
    • Specifically, 1034 Enterobacteriaceae isolates.
    • Specifically, 145 Pseudomonas aeruginosa isolates.
    • An "additional comparative study" included 66 resistant E. coli isolates to further investigate very major errors.
  • Reproducibility Test: A "panel of Gram-negative isolates" was used, tested in triplicate on three different days. The exact number of isolates is not specified.
• Data Provenance: The isolates were tested "across multiple geographically diverse sites across the United States." Whether the data was purely retrospective or involved prospective collection is not explicitly stated, but "clinical, stock and challenge isolates" suggests a mix, possibly including isolates collected for the purpose of the study (prospective) and pre-existing isolates (retrospective/stock).

3. Number of Experts and Qualifications (Ground Truth for Test Set)

The document does not explicitly state the number or qualifications of experts used to establish the ground truth for the test set.

4. Adjudication Method (Test Set)

The document does not explicitly describe an adjudication method for the test set. The "ground truth" was established by comparing the device's results to the CLSI reference broth microdilution method or to "expected results" for challenge isolates. This implies a direct comparison rather than a human expert adjudication process for the final MIC values.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The study described is a standalone performance evaluation of an automated antimicrobial susceptibility testing (AST) system compared to a reference method, not a comparative effectiveness study involving human readers with and without AI assistance. Therefore, there is no effect size reported for human readers' improvement with AI.

6. Standalone Performance Study

Yes. The study described is a standalone performance study. The "BD Phoenix™ Automated Microbiology System" (the algorithm/device) was directly compared to the CLSI reference broth microdilution method, which served as the gold standard for establishing ground truth for antimicrobial susceptibility.

7. Type of Ground Truth Used (Test Set)

The primary type of ground truth used was:

• Reference Method Comparison: For clinical isolates, the BD Phoenix System results were compared to the results obtained from the CLSI reference broth microdilution method (AST panels prepared according to CLSI M07). This is a recognized laboratory standard.
• Expected Results: For challenge isolates, the BD Phoenix System results were compared to "expected results." These expected results are typically derived from extensive prior characterization of these specific isolates, often using reference methods or phenotypic/genotypic analysis.

8. Sample Size for the Training Set

The document does not provide information on the sample size for a training set. This is typical for an AST device evaluation, where the "training" (if it occurs) is usually part of the initial development and validation of the instrument's growth detection and MIC interpretation algorithms, and not explicitly detailed in a 510(k) submission focused on the performance of a new antimicrobial agent on an existing system. The collected data represents the test set for evaluating the performance of the system with the new drug.

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

As no training set is explicitly mentioned or detailed, the method for establishing its ground truth is not provided. The entire submission focuses on the performance of the device against a defined test set where the CLSI reference method served as the ground truth.

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The BD MAX CT/GC/TV assay, as performed using the BD MAX System incorporates automated DNA extraction and real-time polymerase chain reaction (PCR) for the direct, qualitative detection of DNA from Chlamydia (CT), Neisseria gonorrhoeae (GC) and/or Trichomonas vaginalis (TV). The assay may be used for detection of CT and/or GC DNA in male urine specimens, and the detection of CT, GC and/or TV DNA in female urine specimens, cliniciancollected female endocervical swab speciment-collected vaginal swab specimens (in a clinical setting). The assay is indicated for use to aid in the diagnosis of chlamydial urogenital disease, gonococcal urogenital disease and/or trichomoniasis in asymptomatic and symptomatic individuals.

The BD MAX System and the BD MAX CT/GC/TV are comprised of an instrument with associated hardware and accessories, disposable microfluidic cartridges, master mixes, unitized reagent strips, and extraction reagents. The instrument automates sample preparation including target lysis, DNA extraction and concentration, reagent rehydration, and target nucleic acid amplification and detection using real-time PCR. The assay includes a Sample Processing Control (SPC) that is present in the Extraction Tube. The SPC monitors DNA extraction steps, thermal cycling steps, reagent integrity and the presence of inhibitory substances. The BD MAX System software automatically interprets test results. A test result may be called as POS, NEG or UNR for each of the assay's targets, based on the amplification status of the target and of the Sample Processing Control. IND (Indeterminate) or INC (Incomplete) results are due to BD MAX System failure.

The BD MAX CT/GC/TV assay, performed using the BD MAX System, is an in vitro diagnostic device for the direct, qualitative detection of DNA from Chlamydia trachomatis (CT), Neisseria gonorrhoeae (GC), and Trichomonas vaginalis (TV).

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics. However, the "Clinical Performance Studies" section implicitly establishes the performance expectations through its reported sensitivity and specificity values. The acceptance criteria can be inferred as the achieved sensitivity and specificity values for each pathogen across different specimen types and patient populations (asymptomatic and symptomatic).

For the purpose of this response, I will present the key performance metrics from the "Clinical Performance Studies" (Table 18) as the reported device performance, which are implicitly the performance targets the device met. The clinical performance is compared against a "Patient Infected Status (PIS)," which is a composite reference method.

Table: Acceptance Criteria (Inferred from Achieved Performance) and Reported Device Performance

Note: The "Acceptance Criteria" values are inferred as the lower bounds of the reported 95% Confidence Intervals for Sensitivity and Specificity, representing the minimum performance demonstrated to be acceptable.

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

• Test Set Sample Size:

  • Female Subjects: 2,114 evaluable subjects for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC), and 1,291 of these for Trichomonas vaginalis (TV).
  • Male Subjects: 892 evaluable subjects for CT and GC.
  • Specimens for CT: 1,836 patient-collected vaginal swabs, 1,831 endocervical swabs, 1,849 female urine, and 830 male urine specimens.
  • Specimens for GC: 1,836 patient-collected vaginal swabs, 1,824 endocervical swabs, 1,849 female urine, and 840 male urine specimens.
  • Specimens for TV: 1,048 patient-collected vaginal swabs, 1,039 endocervical swabs, and 1,047 female urine specimens.
  • Total specimens initially evaluated: 6,573 specimens.

• Data Provenance: Retrospective and Prospective. The study mentions that it was a "multicenter study where clinical sites enrolled subjects and also performed testing." This suggests prospective collection of real-world samples for the clinical performance evaluation. The provenance is from "nine (9) geographically diverse clinical sites in North America."

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

The document refers to a "Patient Infected Status (PIS)" as the reference method for establishing ground truth. The PIS is described as a "composite reference method algorithm." This suggests that the ground truth was not established by a panel of individual experts directly reviewing each case. Instead, it was based on results from multiple reference methods integrated by an algorithm. The specific number of experts or their qualifications involved in developing or validating this algorithm (if any) is not specified in this document.

4. Adjudication Method for the Test Set

The ground truth was established by a "composite reference method algorithm" (PIS). This implies an algorithmic adjudication rather than human expert adjudication. The study states, "This multicenter study evaluated results obtained with the BD MAX CT/GC/TV compared to reference methods defining the Patient Infected Status (PIS)." No specific human adjudication method (e.g., 2+1, 3+1) is mentioned, as the PIS serves as the "truth."

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

No, an MRMC comparative effectiveness study was not explicitly mentioned or presented in the document. The study focuses on the standalone performance of the BD MAX CT/GC/TV assay against a defined Patient Infected Status (PIS). There is no comparison of human readers with versus without AI assistance.

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

Yes, the study primarily presents standalone performance of the BD MAX CT/GC/TV assay. The device description states, "The BD MAX System software automatically interprets test results. A test result may be called as POS, NEG or UNR for each of the assay's targets..." and "The BD MAX System performs results interpretation automatically." The clinical performance tables (Table 18) present the sensitivity and specificity of the device's automated results against the PIS, which represents a standalone evaluation of the algorithm's performance.

7. The Type of Ground Truth Used

The type of ground truth used is a "Patient Infected Status (PIS)" which is described as a "composite reference method algorithm." This indicates that the truth was derived from the results of multiple established laboratory reference methods, combined using a predefined algorithm, rather than directly from pathology, individual expert consensus, or outcomes data solely.

8. The Sample Size for the Training Set

The document does not explicitly state the sample size used for the training set for the BD MAX CT/GC/TV assay. This type of information (training set details) is often omitted in premarket notification summaries which focus on clinical validation data for regulatory approval. The "Analytical Performance" section (Precision, Reproducibility, Analytical Sensitivity, Analytical Specificity, Interfering Substances, Carryover/Cross-Contamination, Mixed Infection/Competitive Interference) describes laboratory-based studies used to characterize the assay's analytical capabilities, which might be considered part of the development and optimization process, but not a distinct "training set" in the context of machine learning model development. For in vitro diagnostic assays like this, the "training" aspect is more about optimizing reaction parameters and thresholds rather than training a machine learning model on patient data.

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

Since a distinct "training set" for a machine learning model is not explicitly mentioned, and the device is an IVD assay based on PCR and automated interpretation, the concept of "ground truth for the training set" as it applies to AI/ML devices is not directly applicable here. For the analytical studies, the "ground truth" (e.g., in LoD or analytical specificity) would have been established by precisely creating samples with known concentrations of organisms or known non-target organisms, based on established laboratory methods and controls.

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