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I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study design, or ground truth establishment. The document is an FDA 510(k) clearance letter for the BioSign Flu A+B device, which indicates that the device has been deemed substantially equivalent to a legally marketed predicate device. It discusses regulatory information, but not the technical data from performance studies.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.

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The BioSign Flu A+B test is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly from nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash specimens obtained from patients with signs and symptoms of respiratory infection. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. Negative test results are presumptive and it is recommended these results be confirmed by viral culture. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions. The test is intended for professional and laboratory use. Performance characteristics for influenza were established during the 2007-2009 influenza seasons when influenza A viruses A/New Caledonia/20/99 (H1N1), A/Solomon Islands/3/2006 (H1N1), A/Brisbane/59/2007 (H1N1), A/California/07/2009 (H1N1), A/Wisconsin/67/2005 (H3N2), A/Brisbane/10/2007 (H3N2), and influenza B viruses B/Ohio/01/2005, B/Florida/4/2006, B/Brisbane/60/2008 were the predominant influenza viruses in circulation according to the Flu Activity & Surveillance report by CDC. Performance characteristics may vary against other emerging influenza viruses. If infection with a novel influenza virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent Influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL+3 facility is available to receive and culture specimens.

The modification presented in this 510(k) is the addition of influenza A/Vietnam/1194/2004 (H5N1) and influenza A/Anhui/01/2005 (H5N1) along with their respective analytical sensitivity concentrations, to the Analytical Inclusivity section of the package insert. The avian influenza A (H5N1) viruses, A/Vietnam/1194/2004 (H5N1) and A/Anhui/01/2005 (H5N1) were obtained from CDC as a non-infectious form with known titer. Analytical sensitivity is reported as the lowest dilution/concentration of the virus that the BioSign Flu A+B Test is able to detect.

The provided text describes a 510(k) summary for a modification to an existing influenza test device, the BioSign Flu A+B. The modification involves adding two specific avian influenza A (H5N1) strains and their analytical sensitivity concentrations to the package insert.

Here's an analysis based on your request:

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

The document does not explicitly state acceptance criteria in the typical sense of numerical thresholds (e.g., sensitivity > X%, specificity > Y%). Instead, the acceptance criteria for this specific modification are implicit: the device must be able to detect the new H5N1 strains at a certain analytical sensitivity, and this information needs to be added to the product labeling.

The reported device performance for the new H5N1 strains is their "analytical sensitivity concentrations," which are reported as "the lowest dilution/concentration of the virus that the BioSign Flu A+B Test is able to detect." However, the exact numerical concentrations for A/Vietnam/1194/2004 (H5N1) and A/Anhui/01/2005 (H5N1) are not provided in this specific 510(k) summary, only that they were determined.

Since explicit acceptance criteria are not given, and only the type of performance metric is mentioned for the modification, a direct table comparing explicit acceptance criteria to reported performance for the modification cannot be fully generated from this text. The underlying assumption is that demonstrating any detectable analytical sensitivity for the new strains is sufficient for their inclusion in the labeling, given this is primarily an information update rather than a redesign or a change to the core diagnostic performance for general influenza A/B.

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

For the specific modification concerning the H5N1 strains:

• Sample size: Not explicitly stated. The text mentions that the viruses were obtained in a non-infectious form with a known titer, and "analytical sensitivity is reported as the lowest dilution/concentration of the virus that the BioSign Flu A+B Test is able to detect." This implies a series of dilutions were tested, but the number of replicates or different samples tested at each dilution is not specified.
• Data provenance:
  • Country of origin: The H5N1 viruses were obtained from the CDC (Centers for Disease Control and Prevention), which is a US-based agency. The viruses themselves are A/Vietnam/1194/2004 and A/Anhui/01/2005.
  • Retrospective or prospective: This study is best described as an analytical study or in-vitro technical validation using prepared samples, rather than a clinical study with retrospective or prospective patient data. The viruses were obtained and then tested in a controlled laboratory setting.

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

Not applicable for this type of analytical validation study. The "ground truth" for the H5N1 strains was their known presence and concentration (titer) as determined by the CDC. This is a technical standard rather than an expert interpretation.

4. Adjudication method for the test set

Not applicable. This was an analytical sensitivity study, not a clinical study involving human interpretation or adjudication of diagnostic results. The "result" (detection or non-detection) at various dilutions would be objectively observed, not adjudicated by a panel.

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 is not an AI/CAD device. It is an in vitro diagnostic (IVD) rapid test for influenza. There are no human readers in the context of an MRMC study and no AI assistance involved.

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

Not applicable. This is not an algorithm or AI device. The device itself performs the detection. The analytical sensitivity study evaluates the device's inherent ability to detect the target analytes.

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

The ground truth for the H5N1 strains was defined by the known titer/concentration of the non-infectious viral material provided by the CDC. This is essentially a "reference standard" or "analytical standard" rather than a clinical ground truth like pathology or expert consensus.

8. The sample size for the training set

Not applicable. This device is an IVD rapid test. There is no machine learning or AI model involved that would require a "training set." The device's performance is based on its biochemical reactions.

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 BioSign Flu A+B test is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly from nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash specimens obtained from patients with signs and symptoms of respiratory infection. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. Negative test results are presumptive and it is recommended these results be confirmed by viral culture. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions. The test is intended for professional and laboratory use. Performance characteristics for influenza were established during the 2007-2009 influenza seasons when influenza A viruses A/New Caledonia/20/99 (H1N1), A/Solomon Islands/3/2006 (H1N1), A/Brisbane/59/2007 (H1N1), A/California/07/2009 (H1N1), A/Wisconsin/67/2005 (H3N2), A/Brisbane/10/2007 (H3N2), and influenza B viruses B/Ohio/01/2005, B/Florida/4/2006, B/Brisbane/60/2008 were the predominant influenza viruses in circulation according to the Flu Activity & Surveillance report by CDC. Performance characteristics may vary against other emerging influenza viruses. If infection with a novel Influenza virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent Influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL+3 facility is available to receive and culture specimens.

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This document is a 510(k) clearance letter for the BioSign® Flu A+B immediate from the FDA to Princeton Biomeditech Corporation. It confirms the device's substantial equivalence to legally marketed predicate devices. The document also includes the device's intended use. However, it does not contain the detailed information about acceptance criteria, study design, or performance metrics requested in the prompt.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria from the provided text. The document is primarily a regulatory approval notice, not a performance study report.

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The BioSign® Flu A+B test is an in vitro rapid qualitative test that detects influenza type A and type B antigens directly from nasal swab, nasopharyngeal swab, and nasopharyngcal aspirate/wash specimens obtained from patient with signs and symptoms of respiratory infection. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. A negative test result is presumptive and it is recommended these results be confirmed by viral culture. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions. The test is intended for professional and laboratory use.

BioSign® Flu A+B is an immuno-chromatographic test for the rapid, qualitative detection of influenza A and B. The test device has two test lines, thereby allowing the separate identification of type A and/or type B viral antigens from the same specimen.

In the test procedure, a specimen is collected and placed into the Extraction Well of the test device containing extraction solution for one minute, during which time antigen is extracted from disrupted virus particles. The test device is then raised, tapped and laid back down onto a level surface to allow the solution in the Extraction Well to migrate through the pads containing lyophilized detector antibodies conjugated to gold dye and then through the test membrane. If influenza antigens are present in the specimen, they will react with anti-influenza antibody coupled to gold dye particles, migrate through the membrane as antigen-antibody-dye complexes, bind to the immobilized anti-influenza antibody on the membrane, and generate a colored line in the Test line position (A and/or B). The rest of the sample and unbound/bound dye complexes continue to migrate to the Control line position, where antibody to the antiinfluenza antibody is immobilized, and anti-influenza antibody-unbound/bound dye complexes form the Control line (internal procedural control).

Here's an analysis of the provided 510(k) summary, extracting the requested information:

The device under review is the BioSign® Flu A+B / Status™ Flu A & B, an immuno-chromatographic test for the rapid, qualitative detection of influenza A and B antigens.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implicitly set by the reported performance (sensitivity and specificity) when compared against viral culture as the reference method. The document presents performance for different sample types (nasopharyngeal aspirate, nasopharyngeal swab, nasal swab).

Table of Acceptance Criteria and Reported Device Performance:

Note: The document does not explicitly state numerical "acceptance criteria" thresholds, but rather reports the observed performance and implies these values were sufficient for regulatory clearance. The wide confidence intervals in some cases suggest that the performance might vary.

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

• Sample Size for Test Set:
  • Total Patients: 862
  • Nasopharyngeal Aspirate: 253 cases
  • Nasopharyngeal Sample: 251 cases
  • Nasal Swab Sample: 358 cases
    (Note: The sum of individual sample types is 862, matching the total number of patients, indicating these might be overlapping or distinct subsets of samples from the same patient pool, or simply different sample types evaluated from the overall patient population.)
  • Archived Samples: 80 samples for both Flu A and Flu B verification (Columbia NY Presbyterian Hospital).
• Data Provenance:
  • Country of Origin: USA (samples collected at 5 sites in the USA).
  • Retrospective or Prospective: Prospective clinical study, with additional testing on "Archived Samples" which would be considered retrospective.

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

The document does not specify the number of experts used to establish the ground truth or their qualifications. The ground truth method was viral culture, and it's common for laboratory professionals to perform and interpret viral cultures, but no details on their expertise are provided.

4. Adjudication Method for the Test Set

The primary reference method for initial comparison was viral culture. For samples that produced discrepant results between the BioSign® Flu A+B test and viral culture, a third, more definitive method was used for resolution: proFLU plus by Prodesse (real-time RT-PCR, or PCR). This constitutes an adjudication method, where ambiguous cases are resolved by a higher-tier test. The document refers to the results from the PCR as "further analyzed" or used to identify cases that were "positive by both BioSign and PCR" or "negative by both BioSign and PCR".

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This study design is typically used for image-based diagnostic aids where human readers interpret results with and without AI assistance to assess the impact of AI on reader performance. The BioSign® Flu A+B is a rapid diagnostic test, not an AI-powered diagnostic imaging device.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance study was done for the device. The reported sensitivity and specificity values directly reflect the performance of the BioSign® Flu A+B device itself, without any human interpretation adjustments beyond standard operation and reading of a rapid diagnostic test. The entire clinical study section, including the performance tables, represents the standalone performance of the device against the ground truth.

7. Type of Ground Truth Used

The type of ground truth used was primarily viral culture, which is a laboratory-based method for identifying and growing viruses. For discrepant results, real-time RT-PCR (proFLU plus by Prodesse) was used as a confirmatory or adjudicating ground truth.

8. Sample Size for the Training Set

The document does not explicitly mention a "training set" or its sample size. This type of device (rapid diagnostic test) is typically developed and optimized during its R&D phase using various sample sets, but the clinical study described is primarily for validation/testing of the finalized device.

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

As no explicit training set is described, the method for establishing ground truth for a training set (if one existed in the R&D phase) is not provided. The ground truth for the clinical test set was established by viral culture (and PCR for discrepants), as described in point 7.

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The BioSign™ Central Station is an accessory to nulti-parameter patient monitors (bedside or ambulatory) or clinical information system and is indicated for use by health care professionals with those non-pediatric high dependency care patients for whom multi-parameter patient monitoring has been routine.

The BioSign 146 Central Station provides the clinician with a patient status index (BioSign™ Index) based on a weighted average of five vital signs namely heart rate, respiration rate, temperature, oxygen saturation and blood pressure. The BioSign™ index is a single measure of the patient's condition and represents how different the patient's vital signs are with respect to normality. BioSign™ is an adjunct to and is not intended to replace vital signs monitoring.

The BioSign™ Central Station displays BioSign indices for multiple patients.

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician

BioSign™ Central Station is a software accessory to standard multiple parameter physiological patient monitors (bedside or ambulatory) or clinical information systems. It operates on a standard PC, or personal computer.

BioSign™ is a software device that through advanced signal processing can combine physiological signals in order to produce a single index (BioSign index) representation of patient condition.

BioSign™ is a computerized analysis system that can accept multiple channels of physiological data (for example heart rate, respiratory rate, temperature, blood pressure and oxygen saturation as inputs). Through advanced signal processing, BioSign can identify changes in patient status.

The provided 510(k) summary for the BioSign™ Central Station discusses design verification and design validation but does not provide specific acceptance criteria or a detailed study report that proves the device meets those criteria.

Here's an analysis based on the provided text, highlighting what's present and what's missing:

Acceptance Criteria and Device Performance

The document states:

• "Design verification testing of the BioSign™ Central Station hardware and software against the specified requirements has been conducted and the BioSign™ device has been found to meet the specifications."
• "Design validation testing of the BioSign™ index model has been conducted and concluded that device specifications conformed with user needs and intended use."

However, the specific acceptance criteria (e.g., performance metrics, thresholds for accuracy, sensitivity, specificity, or correlation) and the reported device performance metrics are NOT provided in this summary. The document broadly states that the device "meets the specifications" and "conformed with user needs," but offers no quantitative data.

Detailed Analysis of Study Information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified in the provided text.
• Data Provenance: Not specified in the provided text. The device is said to be based on a "model derived from historic clinical data" (referring to the predicate device, BioSign™ K053112), but no specifics are given for the BioSign™ Central Station's validation.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication method for the test set

• Not specified.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

• No, a multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned in the provided summary. This device is an accessory that provides an index; it doesn't involve human readers interpreting images, so an MRMC study would be out of scope for its function.

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

• The document states "Design validation testing of the BioSign™ index model has been conducted and concluded that device specifications conformed with user needs and intended use." This implies an assessment of the algorithm's performance. However, no specific details of this standalone performance, metrics, or study design are provided. The device calculates a "BioSign™ index" as a "single measure of a patient's condition."

7. The type of ground truth used

• The summary mentions the BioSign™ Index is based on "a model derived from historic clinical data." This suggests that the ground truth for establishing the "normality" model was based on historic clinical data and potentially clinical outcomes or expert labels within that data. However, how the ground truth for the validation test set was established is not explicitly stated.

8. The sample size for the training set

• Sample Size: Not specified. The predicate device's model was "derived from historic clinical data," but no numbers are given for the volume of this data.

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

• The ground truth for the model is described as being "derived from historic clinical data." This implies that the 'normality' model and the weighting of the five vital signs were established by analyzing historical patient data, presumably labeled with patient states or outcomes. The precise method of how ground truth was established within this "historic clinical data" (e.g., physician diagnosis, pathology, specific vital sign thresholds indicating certain states) is not detailed.

Summary of Missing Information:

The 510(k) summary provides a high-level overview of design verification and validation, but it significantly lacks specific, quantitative details regarding:

• Acceptance criteria: What performance metrics (e.g., accuracy, reliability measures) did the device need to achieve?
• Device performance results: What were the quantitative results from the verification and validation studies?
• Study design details: Sample sizes for test and training sets, data provenance, ground truth establishment specifics, and expert qualifications.

This level of detail is typically found in more comprehensive study reports submitted to the FDA, rather than the summary provided here.

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BioSign™ is an accessory to a multi-parameter patient monitor (bedside or ambulatory) or clinical information system and is indicated for use by health care professionals with those non-pediatric high dependency care patients for whom multi-parameter patient monitoring has been routine.

BioSign™ provides the clinician with a trend graph of the patient status index based on a weighted average of five vital signs namely heart rate, respiration rate, temperature, oxygen saturation and blood pressure. The patient status index is a single measure of the patient's condition and represents how different the patient's vital signs are with respect to normality. BioSign™ is an adjunct to and is not intended to replace vital signs monitoring.

BioSign™ is a software accessory to standard multiple parameter physiological patient monitors (bedside or ambulatory) or clinical information systems. It operates on a standard medical grade computer.

BioSign™ is a software device embedded in a standard medical grade computer that through advanced signal processing can combine physiological signals in order to produce a single graph representation of patient condition.

BioSign™ is a computerized analysis system that can accept multiple channels of physiological data (for example heart rate, respiratory rate, temple viauncis of pressure and oxygen saturation as inputs). Through advanced signal procession, BioSign can identify changes in patient status.

The provided document describes the BioSign™ device, its indications for use, and its substantial equivalence to other devices. However, the document does not contain specific acceptance criteria, detailed study designs, or performance metrics from a formal clinical study that would allow for a comprehensive description of acceptance criteria and how a study proves the device meets those criteria.

The document mentions "Design verification" and "Design validation" but only provides generic statements about their conclusions. It does not provide the quantitative performance criteria or the results of studies against those criteria.

Therefore, many of the requested details cannot be extracted from the provided text.

Here's an analysis of what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information in the Document: The document does not provide specific acceptance criteria in terms of quantitative performance metrics (e.g., accuracy, precision, sensitivity, specificity, agreement with a gold standard) for the BioSign™ patient status index. It only states that design validation and verification were performed and concluded positively.

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

• Sample Size for Test Set: Not specified.
• Data Provenance (e.g., country of origin, retrospective/prospective): Not specified. The document vaguely refers to "historic clinical data" in the context of substantial equivalence to another device (Sonicaid System 8002) but does not link this directly to the BioSign™ device's own performance testing.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

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

• Adjudication Method: Not specified.

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

• The document does not describe an MRMC comparative effectiveness study where human readers' performance with and without AI assistance was evaluated. The BioSign™ is described as "decision support" and an "adjunct," but no study is detailed to quantify its assistance to clinicians.

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

• The document mentions "Design validation testing of the BioSign™ patient status index model has been conducted..." which implies an evaluation of the algorithm's performance. However, no specific metrics or study details for this standalone performance are provided. It states the system "can identify changes in patient status" and produces an "index and associated trend graph indicative of the patient's state," but without quantification.

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

• Type of Ground Truth: Not explicitly stated for performance testing. The description of how the BioSign™ model is derived (similar to Sonicaid System 8002) references "a model derived from historic clinical data" and "examination of historical clinical data." This suggests that a form of historical clinical data was used as a basis for establishing "normality" for the patient status index, which could imply expert-defined normal ranges or outcomes from those historical cases. However, no specific ground truth methodology for its own validation study is detailed.

8. The sample size for the training set

• Sample Size for Training Set: Not specified. The document refers to a "model derived from historic clinical data" but does not provide details on the size or characteristics of this data.

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

• How Ground Truth was Established: Not explicitly detailed. The statement "provides decision support to a clinician in the determination of normality based on a model derived from historic clinical data" (in comparison to Sonicaid System 8002 which had criteria established by "examination of historical clinical data") suggests that the "normality" concept for the patient status index was established through analysis of historical physiological data and likely included clinical interpretation or consensus within that historical dataset. No specific methodology (e.g., expert review, outcome correlation for each case) is provided.

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The Getinge Biosign Steam-24 Biological Indicator is a steam sterilization monitor designed specifically for biological testing of 121°C, 134°C gravity and pre-vacuum and flash gravity and prevacuum steam sterilization cycles with results available after 24 hours incubation.

The Getinge Biosign Steam-24 Biological Indicator is a self-contained biological indicator designed for biological testing of steam 121°C and 134°C pre-vacuum and gravity and flash steam sterilization cycles. When used to monitor steam cycles, the product is intended to give the user results after 24 hours incubation. The Biosign Steam-24 Biological Indicator contains 10^6 Geobacillus stearothermophilus (nee Bacillus stearothermophilus) spores/carrier. The Biological Indicator is selfcontained with an ampule containing culture medium in the same vial as the spore strip.

Here's an analysis of the provided text, focusing on acceptance criteria and the study details:

Acceptance Criteria and Device Performance Study

The Getinge Biosign Steam-24 Biological Indicator is intended to show results after 24 hours of incubation. The primary acceptance criterion for this modified device over its predicate is improved incubation time while maintaining sterilization effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set Sample Size: The document states that "different lots of Biosign Steam-24 were tested." However, no specific number of lots or individual Biological Indicators (BIs) tested is provided.
• Data Provenance: The study was likely conducted internally by Getinge USA, Inc. The data is retrospective in the sense that the testing was performed, and the results were then compiled for the 510(k) submission. The country of origin for the data is implicitly the USA, where Getinge USA, Inc. is located.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not applicable. This type of device relies on a physicochemical reaction (spore inactivation) for its function, not subjective expert interpretation. The ground truth is intrinsically linked to the biological viability of the Geobacillus stearothermophilus spores and their known resistance to steam sterilization, coupled with objective observation of growth in the culture medium.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The assessment of spore growth/no growth (which determines positive/negative results) is an objective biological outcome based on a color change or turbidity in the culture medium. There is no mention of subjective interpretation or a need for expert adjudication.

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

• MRMC Study Done: No. An MRMC study is not relevant for this type of device. Biological indicators do not involve human readers interpreting complex imaging or data. Their function is to provide a clear, objective biological result (growth or no growth) indicating successful or failed sterilization.

6. Standalone Performance (Algorithm Only) Study

• Standalone Study Done: Yes, in effect. The evaluation of the Biosign Steam-24 Biological Indicator's performance (incubation time and steam resistance) is a standalone assessment of the device itself. It operates independently of human interpretation beyond observing the final growth result. There is no "human-in-the-loop" interaction in the function of the BI; it is a direct measurement of sterility conditions.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth is based on biological viability and spore inactivation kinetics. For sterilization, the ground truth is whether the Geobacillus stearothermophilus spores, known to be highly resistant to steam, were successfully killed. This is objectively determined by the absence of growth (no color change/turbidity) in the culture medium after incubation. The D-value (Decimal Reduction Time) also represents a quantitative measure of resistance used to establish ground truth for effectiveness.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. Biological indicators are not machine learning algorithms that require a "training set." Their performance is based on established biological principles and physical testing, not data-driven model training.

9. How Ground Truth for the Training Set Was Established

• Ground Truth for Training Set: Not applicable. As there is no training set for a biological indicator in the machine learning sense, there is no ground truth established for a training set. The performance characteristics (spore count, resistance, incubation time) are inherent properties of the biological system and its design, verified through standardized laboratory testing procedures as outlined by the CDRH Guidelines.

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The Getinge Biosign SSI Test Pack with Instant Readout Integrator is a steam sterilization monitor designed specifically for biological testing of pre-vacuum steam sterilizers operating at 132°C. The instant readout integrator card gives the operator a prediction of the biological test outcome. When the chemical integrator "PASS" changes from purple to green, it indicates correct exposure conditions of temperature, time and steam.

The Getinge Biosign SSI Test Pack with Instant Readout Integrator is a test pack designed specifically for biological testing of steam 132°C pre-vacuum sterilization cycles. When used to monitor steam 132°C pre-vacuum cycles, the product is intended to give the user an instant reassurance based on a result from a steam integrator card, and after biological indicator incubation, even greater assurance that the sterilizer operated at proper sterilization parameters.

The Biosign SSI Test Pack with Instant Readout Integrator is constructed using a self-contained Geobacillus stearothermophilus biological indicator (10"spores/strip), placed inside a small package of porous and nonporous materials, and includes a steam integrator card. The package simulates the biological indicator 16-towel test pack as defined by ANSI/AAMI ST46-1993. The instant readout integrator card provides immediate verification that the test pack was exposed to sterilization parameters, when the word "PASS" imprinted with a purple indicator ink, changes to green. The biological indicator gives an even greater assurance that sterilization occurred, when the incubated spores display no growth, as indicated by no color change (red) in the growth media.

The shelflife of the new Biosign SSI Test Pack with Instant Readout Integrator is the same as the predicate Biosign EZ-VU Test pack (18 months). The biological indicator is the generally limiting factor and the shelflife of the product can never go beyond the shelflife of the biological indicator, or the shelflife of the integrator card, whichever is shortest.

The Getinge Biosign SSI Test Pack with Instant Readout Integrator is the same size as, utilizes the same materials and is constructed the same as the Biosign EZ-VU Test pack, only with the addition of the instant readout indicator card printed with the integrator ink utilized in the SteriTec Biological Test Pack with Instant Readout Integrator. Since the integrator card was designed to function inside a test pack, its placement in the biological test pack offers no difference in functional environment. The same Biosign biological indicator with Geobacillus stearothermophilus is utilized in the Biosign SSI Test Pack with Instant Readout Integrator, as is used in the Biosign EZ-VU Test pack.

Here's a breakdown of the acceptance criteria and the study details for the Biosign SSI Test Pack with Instant Readout Integrator, based on the provided 510(k) summary:

1. Acceptance Criteria and Reported Device Performance

The core acceptance criteria for this device revolve around demonstrating substantial equivalence to its predicate devices in terms of function and performance, specifically for monitoring 132°C pre-vacuum steam sterilization cycles. The performance is assessed for both the instant readout integrator card and the biological indicator.

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

• Sample Size: "Samples from 3 different lots of Biosign SSI Test Pack with Instant Readout Integrator" were used. In addition, "different lots of Biosign EZ-VU Test Pack and SteriTec Biological Test Pack with Instant Readout Integrator were also run." While the specific number of packs per lot is not stated, the use of multiple lots for both the new device and predicates suggests a reasonable attempt at demonstrating consistency.
• Data Provenance: The testing was conducted internally by Getinge USA, Inc. The nature of the testing (running samples in sterilization equipment) means it's a prospective study of the device's performance under controlled conditions. The country of origin for the data is implicitly the USA, where Getinge USA, Inc. is located.

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

• Not Applicable. This device is a biological indicator and chemical integrator for sterilization processes. The "ground truth" is not established by human experts interpreting images or complex data. Instead, it's established by the physical and biological processes of sterilization itself. The outcome (sterilization achieved vs. not achieved) is determined by the environmental parameters of the sterilizer (temperature, time, steam presence) and the viability of the biological spores.

4. Adjudication Method for the Test Set

• Not Applicable. As the ground truth is not expert-derived, there is no human adjudication process involved in determining the test set's outcome. The "readout" is built into the device: a color change for the integrator, or lack of growth for the biological indicator.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

• No. An MRMC study is not relevant for this type of device. MRMC studies are typically used to evaluate diagnostic imaging devices where human readers interpret and make decisions based on complex visual information, and the AI's role is to assist or augment that interpretation. This device's function is a direct, objective chemical/biological response to sterilization parameters.

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

• Yes, effectively. The performance of the instant readout integrator card and the biological indicator can be considered "standalone" in that their function is an objective, automated response to the sterilization cycle.
  • The integrator card changes color (purple to green) if sterilization parameters are met, without human interpretation of nuanced data.
  • The biological indicator shows no growth if sterilization is achieved, which is an objective biological outcome based on spore viability.
  • While humans visually inspect the color change or growth, the "algorithm" (the device's chemical/biological mechanism) itself provides the direct output. The study described tests this standalone performance against predicate devices.

7. The Type of Ground Truth Used

• The ground truth is based on the physical and biological conditions of sterilization.
  • For the chemical integrator, the ground truth is whether the correct exposure conditions of temperature, time, and steam were met, as designed by the underlying chemical reaction.
  • For the biological indicator, the ground truth is whether the biological spores were killed (indicating a successful sterilization cycle), which is then verified by the absence of growth in the incubation media.
  • The predicate devices further serve as a reference for establishing "expected" ground truth performance.

8. The Sample Size for the Training Set

• Not Applicable / Not Explicitly Stated. This device is a physical/chemical/biological indicator, not an AI software algorithm that "learns" from a training set. Its design and performance are based on established scientific principles of sterilization biology and chemistry, not machine learning. Therefore, the concept of a "training set" as typically understood in AI/ML is not relevant here.

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

• Not Applicable. As there is no training set in the AI/ML sense, this question is not relevant. The device's fundamental function is based on established sterilization principles and material science, not a learned model from labeled data.

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BioSign" H. pylori WB qualitatively detects anti-H. pylori antibody in human whole blood, serum or plassua specimens. The test is intended for use in the diagnosis of Helicobacter pylori infection in parients with symptoms of gastrointestinal disorders.

Not Found

This document, a 510(k) clearance letter for the BioSign™ H. pylori WB device, primarily focuses on regulatory approval based on substantial equivalence to a predicate device. It does not contain detailed information about specific acceptance criteria, a dedicated study proving device performance against those criteria, or the methodology typically associated with such a study (like sample sizes, expert qualifications, or ground truth establishment).

Therefore, based only on the provided text, I cannot fill out the requested table or answer most of the questions about a device performance study. The letter states that the device "qualitatively detects anti-H. pylori antibody in human whole blood, serum or plasma specimens" and is "intended for use in the diagnosis of Helicobacter pylori infection in patients with symptoms of gastrointestinal disorders." This is the core 'performance' described.

If a study report or clinical data were included as an attachment to this 510(k) submission (which is common), that document would contain the requested information. However, this letter itself does not provide it.

Here's what can be inferred or stated from the provided text:

• Device Name: BioSign™ H. pylori WB New One Step anti-H. pylori antibody test
• Intended Use: Qualitatively detects anti-H. pylori antibody in human whole blood, serum or plasma specimens. Intended for use in the diagnosis of Helicobacter pylori infection in patients with symptoms of gastrointestinal disorders.
• Regulatory Status: Substantially Equivalent to legally marketed predicate devices.

Attempting to answer based on the lack of specific information in the provided document:

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

2. Sample sized used for the test set and the data provenance
* Sample Size (test set): Not mentioned in this document.
* Data Provenance: Not mentioned in this document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
* Number of Experts: Not mentioned in this document.
* Qualifications: Not mentioned in this document.

4. Adjudication method for the test set
* Adjudication Method: Not mentioned in this document.

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
* MRMC Study: Not mentioned in this document. This device appears to be an in vitro diagnostic test, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study related to human improvement with AI would not be applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
* Standalone Performance: This device is a rapid diagnostic test (implied by "One Step" and "WB" likely meaning "Whole Blood"). Its performance itself is the standalone performance. The document doesn't provide specific standalone performance metrics (e.g., sensitivity, specificity) but rather confirms its regulatory clearance.

7. The type of ground truth used
* Ground Truth Type: Not mentioned in this document. For an H. pylori test, ground truth would typically be established by culture, histology, urea breath test (UBT), or an alternative validated H. pylori test.

8. The sample size for the training set
* Sample Size (training set): Not mentioned in this document. For a rapid diagnostic test like this, the concept of a "training set" in the machine learning sense is not directly applicable. If a training phase was involved in optimizing the assay, details are not provided.

9. How the ground truth for the training set was established
* Ground Truth Establishment (training set): Not mentioned in this document.

Summary of what's provided: The document is a regulatory clearance letter acknowledging substantial equivalence. It confirms the device's intended use and regulatory pathway but does not delve into the detailed performance study data that would have been part of the underlying submission.

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