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The BacT/ALERT SV Culture Bottles are used with the BacT/ALERT Microbial Detection Systems in qualitative procedures for enhanced recovery and detection of aerobic and facultative anaerobic microorganisms (bacteria and fungi) from blood and other normally sterile body fluids.

The BacT/ALERT SV Culture Bottle was developed for the same intended use as the current BacT/Alert Standard Aerobic Culture Bottle, to provide suitable nutritional and environmental conditions for organisms commonly encountered in blood infections and normally sterile body fluids. An inoculated bottle is placed into the BacT/ALERT Microbial Detection Instruments where it is incubated and continuously monitored for the presence of microorganisms that will grow in the BacT/ALERT SV Bottle.

The provided text describes the 510(k) Premarket Notification for the BacT/ALERT SV Culture Bottle. Here's a breakdown of the acceptance criteria and the study that proves the device meets them:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

The core acceptance criterion for the BacT/ALERT SV Culture Bottle was substantial equivalence to its predicate device, the BacT/Alert Standard Aerobic Culture Bottle. This was primarily assessed based on the ability to recover equivalent levels of microorganisms and comparable detection times.

It's important to note that the document emphasizes the equivalence to a legally marketed predicate device rather than defining numerical targets for sensitivity, specificity, or time to detection. The acceptance criteria are implicitly met if the new device performs "as well or better than" the predicate.

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

• Sample Size:
  • 23 organisms were used for the seeded studies.
  • For each organism, the study involved a dilution in human blood inoculated into both the BacT/ALERT SV bottle and the BacT/Alert Standard Aerobic bottle. The exact number of samples (bottles) per organism per dilution is not specified, but it implies multiple samples for each of the 23 organisms to assess "recovery of low levels" and "detection times."
• Data Provenance: The organism studies were conducted using "human blood." The country of origin is not specified, but it's likely within the USA, given the FDA submission. The study type was non-clinical testing, specifically seeded studies, meaning known organisms were introduced into samples. This is a form of prospective, controlled laboratory testing.

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

The document does not explicitly state the number or qualifications of experts used to establish ground truth. For seeded studies, the "ground truth" is inherently known by the experiment design (i.e., the specific organisms and their concentrations that are deliberately introduced). Therefore, external experts to establish ground truth are typically not required in such studies. Laboratory personnel with expertise in microbiology and instrument operation would have conducted the tests and interpreted the raw detection results.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are typically used for interpreting ambiguous results, often with human interpretation (e.g., radiology images). In this context of automated microbial detection using seeded samples, the assessment of "detection" is generally clear-cut based on the instrument's output. Therefore, an explicit adjudication method as described for interpretive tasks is not applicable or mentioned. The "detection times" and "recovery" would be objectively measured by the BacT/ALERT Microbial Detection Systems.

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

No, an MRMC comparative effectiveness study was not done. MRMC studies are relevant for devices that involve human interpretation (e.g., AI-assisted diagnosis in imaging). This device is an automated in vitro diagnostic instrument for microbial detection, where the direct output is from the instrument rather than a human interpretation.

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

This device is a standalone device in terms of its detection capability. The BacT/ALERT SV Culture Bottle, in conjunction with the BacT/ALERT Microbial Detection Instruments, performs the detection autonomously. Human involvement is in sample preparation, loading, and interpreting the instrument's objective detection signal (e.g., positive or negative for growth, and time to detection). The performance described in the document (recovery and detection times) is the standalone performance of the combined bottle and instrument system.

7. The Type of Ground Truth Used

The ground truth used was known microbial presence and concentration established through seeded studies. Specific organisms were diluted in human blood and intentionally inoculated into the culture bottles, allowing for a direct comparison of the device's ability to detect these known organisms against the predicate device.

8. The Sample Size for the Training Set

The document does not mention a training set because this submission is for a device that relies on a well-established detection technology (reflectance) rather than a novel algorithm requiring extensive data-driven training (like machine learning models). The technology of the new device is stated to be the same as the predicate, with minor physical differences in the sensor. The studies described are validation/verification studies, not training.

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

As no training set is mentioned or implied, the question of how its ground truth was established is not applicable.

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BacT/ALERT SA Culture Bottles are used with the BacT/ALERT Microbial Detection Systems in qualitative procedures for the recovery and detection of aerobic microorganisms (bacteria and fungi) from blood and other normally sterile body fluids.

The BacT/ALERT SA Culture Bottle was developed for the same intended use as the current BacT/Alert Standard Aerobic Culture Bottle, to provide suitable nutritional and environmental conditions for organisms commonly encountered in blood infections and normally sterile body fluids. An inoculated bottle is placed into the BacT/ALERT Microbial Detection Instruments where it is incubated and continuously monitored for the presence of microorganisms that will grow in the BacT/ALERT SA Bottle.

Here's a breakdown of the acceptance criteria and the study details for the BacT/ALERT SA Culture Bottle, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The submission focuses on demonstrating substantial equivalence to a predicate device rather than setting explicit numerical acceptance criteria for a new mode of operation. The primary "acceptance criteria" can be inferred as "recovery of low levels of 23 microorganisms and equivalent detection times" compared to the predicate device.

2. Sample Size and Data Provenance

• Sample Size for Test Set: Seeds studies were performed on 23 organisms. The document doesn't specify the number of individual tests or bottles used per organism, but refers to "seeded studies."
• Data Provenance:
  • Country of Origin: Not explicitly stated, but the submission is from Organon Teknika Corporation in Durham, North Carolina, USA, suggesting the study was likely conducted in the US.
  • Retrospective or Prospective: The description "Seeded studies were performed" indicates a prospective study design where the researchers inoculated samples under controlled conditions.

3. Number, Qualifications, and Adjudication of Experts for Ground Truth

This type of device (microbial culture bottle) does not typically involve human experts for establishing ground truth in the same way an imaging AI device would. The "ground truth" is determined by the objective growth and detection of microorganisms, which is inherent to the function of the culture bottles themselves.

• Number of Experts: Not applicable.
• Qualifications of Experts: Not applicable.
• Adjudication Method: Not applicable.

4. MRMC Comparative Effectiveness Study

• Was an MRMC study done? No. This type of study is not relevant for a microbial culture bottle, as it does not involve human readers interpreting output.

5. Standalone Performance

• Was a standalone (algorithm only without human-in-the-loop performance) study done? Yes, in essence. The comparison between the new device and the predicate device is a standalone performance comparison, where the "performance" is the ability of the bottle (and the associated instrument) to detect microbial growth. There is no human involved in the detection process itself; the instrument continuously monitors and flags growth.

6. Type of Ground Truth Used

• Ground Truth: The ground truth for this device is the actual growth of the seeded microorganisms within the culture bottle. This is an objective biological outcome. The success of the device is its ability to accurately detect this growth.

7. Sample Size for Training Set

• The document does not specify a separate training set or details on how the training data was collected. For this type of device, which is a physical consumable for microbial detection rather than a machine learning algorithm, the concept of a "training set" for an AI model is not applicable. The development would involve optimizing the medium and sensor through laboratory testing, likely a continuous process rather than a distinct "training set" as understood in AI/ML contexts.

8. How Ground Truth for Training Set Was Established

• As a training set (in the AI/ML sense) is not applicable here, the method of establishing ground truth for it is also not applicable. The design and validation of the device components (e.g., culture medium, sensor) would have relied on standard microbiological techniques to confirm microbial growth and detection capabilities during product development.

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The BacT/ALERT SN Culture Bottles are used with the BacT/ALERT Microbial Detection Systems in qualitative procedures for recovery and detection of anaerobic microorganisms (bacteria) from blood and other normally sterile body fluids.

The BacT/ALERT SN Culture Bottle was developed for the same intended use as the current BacT/Alert Standard Anaerobic Culture Bottle, to provide suitable nutritional and environmental conditions for organisms commonly encountered in blood infections and normally sterile body fluids. An inoculated bottle is placed into the BacT/ALERT Microbial Detection Instruments where it is incubated and continuously monitored for the presence of microorganisms that will grow in the BacT/ALERT SN Bottle.

Here's a breakdown of the acceptance criteria and study information for the BacT/ALERT SN Culture Bottle, based on the provided text:

Acceptance Criteria and Device Performance

The core of the acceptance criteria for the BacT/ALERT SN Culture Bottle revolved around demonstrating substantial equivalence to its predicate device, the BacT/Alert Standard Anaerobic Culture Bottle. This was primarily assessed by comparing the recovery and detection times of various microorganisms.

Study Details

This document describes a 510(k) Premarket Notification, which typically relies on demonstrating substantial equivalence rather than a full-scale clinical trial with acceptance criteria defined by specific clinical endpoints like sensitivity or specificity percentages. The study performed here is a comparative non-clinical study.

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

• Sample Size: "Seeded studies were performed on 11 organisms diluted in human blood and inoculated into the BacT/ALERT SN bottle and the BacT/Alert Standard Anaerobic bottle." The exact number of replicates or individual test instances for each organism is not specified.
• Data Provenance:
  • Country of Origin: Not explicitly stated, but the submission is to the U.S. FDA, suggesting the study was likely conducted in the U.S. or by a company with operations there.
  • Retrospective or Prospective: The description "Seeded studies were performed" implies a prospective experimental design, where samples were created and tested specifically for the study.

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

• This type of study (comparative performance of culture bottles) does not typically involve human experts establishing a "ground truth" in the same way an imaging AI algorithm might. The ground truth in this context is the confirmed presence and growth rate of the seeded microorganisms, which is measured by the BacT/ALERT system itself. The expertise would lie in the microbiological techniques used for organism preparation, inoculation, and confirmation, rather than diagnostic interpretation. The document does not specify the number or qualifications of these microbiological experts.

4. Adjudication method for the test set:

• No adjudication method is described, as the "outcome" is a direct measurement by the BacT/ALERT instrument (detection of growth and time to detection). The comparison is between the new device and the predicate device's performance, not human interpretations.

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. This was a non-clinical, in-vitro diagnostic (IVD) device study comparing the performance of two culture bottles. MRMC studies are typically used for imaging AI algorithms where human interpretation is a key component.

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

• Yes, effectively. The BacT/ALERT system (both with the new SN bottle and the predicate bottle) operates as an automated, standalone system for detecting microbial growth. The study assessed the performance of the new bottle within this automated context. There isn't a "human-in-the-loop" for interpreting the primary outcome of microbial growth detection; the instrument provides a positive/negative result and a time to detection.

7. The type of ground truth used:

• The ground truth was established by seeded microorganisms of known species and concentrations, diluted in human blood. The expected outcome was the growth of these specific microorganisms. The "truth" is the fact of microbial presence and their growth characteristics.

8. The sample size for the training set:

• This document does not describe a training set. This is not an AI/machine learning device that requires a training set. It's a medical device (culture bottle) that undergoes performance testing.

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

• As there is no training set for this device, this question is not applicable.

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The BacT/ALERT MP Process Bottle is designed for use with the MB/BacT and the The DacT/ALERT 3D Mycobacteria Detection Systems, for recovery and detection of mycobacteria from sterile body specimens other than blood, and from digested-decontaminated clinical specimens.

The BacT/ALERT MP Process Bottle was developed for the same intended use as the current MB/BacT Process Bottle, provide suitable nutritional and environmental conditions for mycobacterial organisms commonly encountered in body fluids. An inoculated bottle is placed into the MB/ BacT Detection Instrument or the BacT/ALERT 3D Instrument where it is incubated and continuously monitored for the presence of mycobacteria that will grow in the BacT/ALERT MP Process Bottle.

Here's a breakdown of the acceptance criteria and study information for the BacT/ALERT MP Process Bottle, based on the provided K993576 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The submission doesn't explicitly state numerical acceptance criteria (e.g., "sensitivity must be > X"). Instead, the acceptance criterion is implied as substantial equivalence to the predicate device (MB/BacT Process Bottles) in terms of recovery and detection times for mycobacterial organisms.

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

• Sample Size (Test Set): 12 organisms were used. The document does not specify the number of replicate bottles per organism or the total number of individual tests performed.
• Data Provenance: The document does not specify the country of origin. The studies appear to be prospective seeded studies as organisms were inoculated into bottles for testing.

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

The document does not mention the use of experts to establish ground truth for the seeded studies. For seeded studies in microbiology, the "ground truth" is typically the known presence and identity of the inoculated organism.

4. Adjudication Method for the Test Set

Not applicable. The study involved a direct comparison of the new device's performance against a predicate device using known inoculated organisms (ground truth). There was no mention of human interpretation requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This device is a microbial growth monitor, and performance is based on automated detection by instrumentation, not human reader interpretation.

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

Yes, a standalone performance study was done. The device's performance (recovery and detection time) was evaluated directly by the BacT/ALERT 3D System or MB/BacT Mycobacterial Detection Systems after inoculation and incubation, without human intervention for result interpretation.

7. The Type of Ground Truth Used

The ground truth used was the known inoculation of specific mycobacterial organisms into the test bottles. This provides a definitive "positive" control for the presence of the target organisms.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning or algorithm development. The studies described are performance validation tests for the physical bottle. If there was any internal algorithm development for the detection systems themselves, that information is not provided in this 510(k) summary. The 12 organisms tested were part of the test set to demonstrate equivalence.

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

As no specific training set is mentioned for an algorithm, this question is not directly applicable. For the performance studies described, the ground truth was inherently established by the controlled inoculation of known organisms.

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The BacT/ALERT FN Culture Bottles are used with the BacT/ALERT Microbial Detection Systems in qualitative procedures for enhanced recovery and detection of anaerobic microorganisms from blood and other normally sterile body fluids.

The BacT/ALERT FN Culture Bottle was developed for the same intended use as the current BacT/Alert FAN Anaerobic Culture Bottle, to provide suitable nutritional and environmental conditions for organisms commonly encountered in blood infections and normally sterile body fluids. An inoculated bottle is placed into the BacT/ALERT Microbial Detection Instrument where it is incubated and continously monitored for the presence of microorganisms that will grow in the BacT/ALERT FN Culture Bottle.

Here's an analysis of the provided text to extract the requested information regarding the acceptance criteria and the study that proves the device meets them:

1. Table of acceptance criteria and the reported device performance

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

• Sample Size: Not explicitly stated, but the study involved "low levels of eleven anaerobic organisms diluted in human blood." The number of samples (bottles) per organism or per blood sample is not provided.
• Data Provenance: The data was generated through "seeded studies" using "human blood." The country of origin is not specified, but the submission is to the FDA in the USA. Given this, it's a prospective study conducted specifically for this submission.

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

Not applicable. This device is a diagnostic tool for microbial growth. The "ground truth" for the test set would be the confirmed presence and identity of the seeded anaerobic organisms, which is determined by standard microbiological culture and identification methods, not expert reader consensus.

4. Adjudication method for the test set

Not applicable. As described above, the ground truth for microbial growth detection is based on the inherent biology and laboratory confirmation of the seeded organisms, not expert adjudication of images or diagnoses.

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. This device is a fully automated microbial detection system, not an AI-assisted diagnostic tool that aids human readers.

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

Yes, a standalone study was performed. The BacT/ALERT FN Culture Bottle, in conjunction with the BacT/ALERT Microbial Detection Instrument, operates automatically to detect microbial growth. The study compared the performance of this system (BacT/ALERT FN Culture Bottle + Instrument) directly against the predicate device's system (BacT/Alert FAN Anaerobic Culture Bottle + Instrument).

7. The type of ground truth used

The ground truth was established by seeding known anaerobic organisms into human blood at "low levels" and then measuring their recovery and time to detection. This is essentially a controlled laboratory setup where the presence and type of microorganism are known beforehand.

8. The sample size for the training set

Not applicable. This document describes a new iteration of an existing diagnostic culture bottle, not a machine learning algorithm that requires a training set in the conventional sense. The "training" for the device would have been its design and development based on established microbiological principles.

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

Not applicable. See point 8.

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The NucliSens® CMV pp67 assay is a nucleic acid amplification-based qualitative assay to be used in conjunction with the NucliSens® Reader for the detection of human cytomegalovirus (HCMV) pp67 mRNA in EDTA anticoagulated whole blood from adult transplant donors and HIV infected individuals. It is intended as an aid in the diagnosis of active (acute or reactivated) HCMV infection. This product is not intended for use in screening of blood or plasma donors.

The NucliSens® CMV pp67 assay is a nucleic acid amplification-based qualitative assay to be used in conjunction with the NucliSens®™ Reader for the detection of human cytomegalovirus (HCMV) pp67 mRNA in EDTA anticoagulated whole blood from adult transplant donors and HIV infected individuals. It is intended as an aid in the diagnosis of active (acute or reactivated) HCMV infection. This product is not intended for use in screening of blood or plasma donors.

The NucliSens® CMV pp67 assay is comprised of four separate stages:

• Nucleic acid release
• Nucleic acid isolation
• Nucleic acid amplification
• Nucleic acid detection

The provided text describes the NucliSens® CMV pp67 assay and its performance, primarily in comparison to existing methods (CMV pp65 antigenemia assay and cell culture) for diagnosing active HCMV infection in transplant and HIV-infected populations. However, it does not explicitly state "acceptance criteria" in the format of defined thresholds that the device had to meet. Instead, the study provides performance metrics (sensitivity, specificity, agreement) and concludes that the device performed "as well as" the predicate device.

Let's extract the relevant information based on your request, inferring "acceptance criteria" from the comparative performance.

1. Table of Acceptance Criteria and Reported Device Performance

As explicit acceptance criteria are not stated, the table below will summarize the comparative effectiveness results, which are analogous to demonstrating the device meets performance expectations for substantial equivalence. The predicate device's performance (or a combined reference standard) implicitly sets the bar.

Note: The document states "The conclusions drawn from the clinical tests demonstrate that the NucliSens™ CMV pp67 assay is as safe, as effective, and performed as well as the legally marketed CMV Brite™ CMV Antigenemia Detection Test Kit and typical cell culture in the diagnosis of active HCMV infection." This implies that performance comparable to these reference methods serves as the de facto acceptance criteria.

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

• Interfering Substances: 60 samples (10 unspiked negative, 10 spiked positive for each of 6 categories).
• Analytical Specificity (CMV Strains/Cross-reactivity):
  • HCMV Strains: Number not specified, but 5 laboratory strains (Towne, C87, Davis, ESP, AD169) were tested.
  • Cross-reactivity (other infections/diseases): 86 samples (various infections/diseases, tested unspiked and spiked with HCMV RNA; e.g., 10 HIV-1, 8 HTLV-I/II, 10 HSV-I, etc.)
  • Cross-reactivity (related Herpes viruses): 4 cell lines (HHV-6A, HHV-6B, HHV-7, HHV-8 infected).
  • Cross-reactivity (bacterial flora): 4 types of bacterial flora, each with 2 aliquots (unspiked and spiked).
• Analytical Specificity (Whole Blood Donors): 100 donors (50 HCMV seronegative, 50 HCMV seropositive).
• Analytical Sensitivity (CMV Infected Population): 51 clinical specimens.
• Reproducibility: 4 samples tested multiple times (repeated 8 times per lot/site/tech combination for some, 4 or 6 times for others). This involved 3 sites, with 1-3 technicians per site, and 3 lots of reagents. Total tests: (37+32+29) + (44+31+33) + (30+35+34) totals 325-334 specific tests for each specimen type (1-4).
• Limit of Detection: Based on the reproducibility data (4 samples with known RNA input, tested repeatedly).
• Clinical Performance (Transplant Population): 50 patients; multiple specimens collected over an extended period. Total valid tests considered: 368.
• Clinical Performance (HIV-1 Infected Population): 50 individuals; multiple specimens collected over an extended period. Total valid tests considered: 450.

Data Provenance:

• Analytical Specificity (CMV Strains/Cross-reactivity): North America and Europe for clinical/analytical studies; laboratory strains AD169, Towne, C87, Davis, ESP.
• Analytical Specificity (Whole Blood Donors): Not specified, but generally implies a US-based population if the study was for FDA clearance.
• Analytical Sensitivity (CMV Infected Population): United States (New England, Northeast, and West Coast regions).
• Reproducibility: 3 sites, likely in different geographical locations (internal to the company or contracted third parties).
• Clinical Performance (Transplant Population): Italy (longitudinal study).
• Clinical Performance (HIV-1 Infected Population): The Netherlands (longitudinal study).
• Overall: The data is primarily prospective (longitudinal studies) and retrospective (existing positive/negative panels) from multiple countries including the USA, Italy, and The Netherlands.

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

The document does not explicitly mention the number or specific qualifications of experts (e.g., radiologists with 10 years of experience) used to establish ground truth.

Instead, the "ground truth" (referred to as "true state of nature") for the clinical studies was established by conventional laboratory methods:

• For the analytical sensitivity and clinical performance studies, ground truth was determined by cell culture and/or an FDA-cleared CMV pp65 antigenemia assay.
• These are established diagnostic laboratory tests, and their interpretation would typically be performed by trained clinical laboratory professionals or physicians overseeing patient diagnosis.

4. Adjudication Method for the Test Set

The document describes the "ground truth" being established by either antigenemia OR culture being positive for a "CMV positive" designation, and BOTH antigenemia AND culture being negative for a "CMV negative" designation. This serves as the adjudication method for the reference standard.

• "If either antigenemia or culture were found positive for a specimen, that particular specimen was regarded as CMV positive. If both antigenemia and culture were negative, the state of nature for that specimen was considered CMV negative."

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. This device is a diagnostic assay (in vitro diagnostic device), not an imaging device or AI-assisted diagnostic tool that would involve human "readers" in the typical sense of an MRMC study assessing image interpretation. The NucliSens® CMV pp67 assay is an automated nucleic acid amplification test. It does not involve human readers interpreting AI output.

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

Yes, the studies presented are for the standalone (algorithm only) performance of the NucliSens® CMV pp67 assay. It's an automated molecular diagnostic test; the "algorithm" is the entire test procedure from sample processing to result interpretation by the NucliSens® Reader. Its performance is compared directly against the established laboratory methods (antigenemia and cell culture).

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The primary ground truth used in the clinical performance studies was a composite reference standard of:

• Traditional laboratory methods: Cell culture and an FDA-cleared CMV pp65 antigenemia assay results.
• For the analytical specificity and sensitivity studies, the ground truth involved known CMV strains, known negative panels, and clinical panels confirmed by existing diagnostic tests.

8. The Sample Size for the Training Set

The document does not explicitly describe a separate "training set" for the NucliSens® CMV pp67 assay in the context of machine learning or algorithm development. This is typical for a traditional in vitro diagnostic (IVD) assay which follows a pre-defined chemical and molecular reaction protocol rather than being "trained" iteratively on data. The validation studies (analytical and clinical) serve to demonstrate the performance of the fixed assay.

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

Since there is no explicitly defined "training set" in the context of an algorithm that learns from data, this question is not directly applicable. If one were to consider any preliminary data used during the assay's development (e.g., to optimize primer design, reaction conditions), the ground truth for such internal development would typically come from well-characterized positive and negative samples, often using established methods like viral culture or PCR. However, this is not detailed in the 510(k) summary.

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The BacT/ALERT PF Culture Bottles are used with the BacT/ALERT Microbial Detection Systems in qualitative procedures for enhanced recovery and detection of aerobic and facultative anaerobic microorganisms (bacteria and yeast) from blood.

The BacT/ALERT PF Culture Bottle provides a sensitive method for detection of microorganisms when only a small volume of blood is available. An inoculated bottle is placed into the instrument where it is incubated and continuously monitored for the presence of microorganisms that will grow in the BacT/ALERT PF Culture Bottle.

Here's an analysis of the provided text to fulfill your request:

Acceptance Criteria and Study for BacT/ALERT PF Culture Bottle

The provided documentation details the submission for a 510(k) premarket notification for the BacT/ALERT PF Culture Bottle, claiming substantial equivalence to the BacT/ALERT Pedi-BacT Culture Bottle. The study primarily focuses on demonstrating that the new device performs equivalently to the predicate device in terms of microbial recovery.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document doesn't explicitly state quantitative acceptance criteria or specific numerical performance targets for the new device. Instead, the criterion is implied to be "equivalence" to the predicate device for microbial recovery and detection.

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

• Sample Size for Test Set: The "test set" consists of 23 organisms. For each organism, two concentrations were seeded into bottles of both the BacT/ALERT PF and Pedi-BacT Culture Bottles. This means a total of 23 organisms * 2 concentrations * 2 bottle types = 92 bottles were tested as a minimum, although the phrasing "utilizing 23 organisms seeded into BacT/ALERT PF and Pedi-BacT Culture Bottles" suggests a larger total number of bottles, as each organism at each concentration would need multiple replicates of each bottle type for statistical validity. However, the exact number of replicates is not specified.
• Data Provenance: The study was described as "In-house seeded studies." This indicates the data was generated within the submitter's (Organon Teknika Corporation) laboratory. The country of origin is not explicitly stated, but the company address is Durham, North Carolina, USA. The study design is an experimental, controlled study rather than retrospective or prospective clinical data.

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

The document does not mention the use of experts to establish ground truth for the test set. The ground truth (presence or absence of microbial growth and detection) would have been established by direct observation and monitoring using the BacT/ALERT systems themselves or through standard microbiological culturing techniques to confirm growth.

4. Adjudication Method for the Test Set

No adjudication method is described. As the "ground truth" is determined by the objective operation of the instruments detecting microbial growth, expert adjudication (like in image interpretation studies) is not applicable here.

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

No multi-reader multi-case (MRMC) comparative effectiveness study was conducted or mentioned. This type of study is more relevant for diagnostic devices that involve human interpretation (e.g., radiology images) rather than automated microbial detection systems. Therefore, there is no effect size reported for human readers improving with or without AI assistance.

6. Standalone Performance Study

Yes, a standalone performance study was done. The "In-house seeded studies" evaluated the performance of the BacT/ALERT PF Culture Bottle (algorithm/device only) in detecting microorganisms, comparing it directly to the predicate device. This was a direct assessment of the device's capability without human intervention in the detection process.

7. Type of Ground Truth Used

The ground truth used was the known presence and concentration of specific microorganisms (23 different organisms seeded at two specified concentrations:

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