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The OSOM C. difficile Toxin A/B Test is an immunochromatographic assay intended for the qualitative detection of Clostridium difficile toxins A and/or B in human stool samples. This test is intended as an aid in the diagnosis of C. difficile-associated disease (CDAD) in patients with symptoms of CDAD.

The OSOM C. difficile Toxin A/B Test is a rapid test which can detect the presence of Clostridium difficile toxins A and B in human stool samples. A test kit contains 25 OSOM test stick devices and 25 disposable pipettes. The OSOM C. difficile Toxin A/B Test is a qualitative assay that employs immunochromatographic, dipstick technology. The test format is a sandwich immunoassay, with a single test zone on the nitrocellulose dipstick to detect Toxin A and/or Toxin B ("blue/gray" line) and a single control line zone to indicate proper sample flow ("red" line). The test procedure involves binding of C. difficile Toxin A and/or Toxin B from a patient stool sample to blue colored latex particles conjugated to a monoclonal antibody against Toxin B or a polyclonal antibody against Toxin A. When Toxin A and/or B is present in the sample, it will form a partial immune complex with the antibody-conjugated colored particles. The OSOM C. difficile Toxin A/B Test stick, when placed in the sample mixture, initiates sample migration along the nitrocellulose membrane. If C. difficile toxin A or toxin B is present, a blue/gray line will appear in the test line region indicating a positive result. A red control line must appear for the results to be valid. If C. difficile toxins are not present, only the red control line will appear. An invalid test occurs when no control line appears.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

Study Details

1. Sample sizes used for the test set and the data provenance:

   • Clinical Study 1 (Overall performance): 1274 de-identified excess loose or watery stool specimens.
     • Provenanc: Obtained from patients at five sites in the United States.
     • Nature: Retrospective (specimens submitted for CDAD testing).
   • Clinical Study 2 (Comparison to Predicate): 250 paired sample results (OSOM and Predicate Device).
     • Provenance: Not explicitly stated, but implies from a clinical trial site, likely within the US given the overall study context.
     • Nature: Retrospective (using existing clinical trial samples).
   • Analytical Sensitivity: Not reported as a sample size, but involved serial dilutions prepared from purified toxins.
   • Cross-Reactivity: Not reported as a numerical sample size, but tested against a panel of 28 bacterial isolates and 6 viral isolates.
   • Interfering Substances: Not reported as a numerical sample size, but tested against 11 potential interferents.
   • Reproducibility: 360 total test results (12 samples x 2 operators/day x 5 days x 3 sites = 360)

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

   • The ground truth for the clinical studies was established using a cytotoxicity assay. The text does not specify the number of experts or their qualifications for performing this assay, beyond stating it was "performed at Genzyme using a standard C. difficile toxin cytotoxicity assay." It notes that "Those performing the cytotoxicity assay testing were blinded to the OSOM test results," which indicates an effort to reduce bias.

3. Adjudication method for the test set:

   • No explicit adjudication method is described for the primary clinical study. The cytotoxicity assay served as the direct reference standard.
   • Discrepant testing was performed for some cases:
     • 12 cytotoxin positive, OSOM negative cases were tested with PCR for tcdB gene.
     • 37 cytotoxin negative, OSOM positive cases were tested with PCR for tcdB gene (one sample not available).
     • This suggests a form of post-hoc analysis for discordant results, but not a formal adjudication process to establish the initial ground truth for all samples.

4. 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 study is not an MRMC comparative effectiveness study involving human readers and AI. It is a study comparing an immunoassay device (OSOM C. difficile Toxin A/B Test) to a laboratory reference method (cytotoxicity assay) and a predicate device.

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

   • Yes, for the OSOM C. difficile Toxin A/B Test. The study evaluates the performance of the OSOM C. difficile Toxin A/B Test, which is a rapid immunochromatographic assay device, as a standalone diagnostic tool. Its performance is assessed directly against the ground truth (cytotoxicity assay) without human interpretation in a human-in-the-loop scenario. The device itself produces the qualitative "positive" or "negative" result.

6. The type of ground truth used:

   • The primary ground truth used for the clinical studies was a cytotoxicity assay, which detects biologically active C. difficile toxins.
   • For discrepant analysis, a PCR-based molecular method (tcdB gene detection) was used as a secondary reference.

7. The sample size for the training set:

   • The document does not report a separate training set size. This is common for traditional in vitro diagnostic (IVD) devices like this immunochromatographic assay, which are based on biochemical reactions and antibody binding, rather than machine learning algorithms that typically require extensive training data. The "training" in this context would be the development and optimization of the assay itself.

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

   • As there is no explicit "training set" in the context of machine learning, there's no ground truth established for it. The assay's performance characteristics (e.g., analytical sensitivity, cross-reactivity) are established using purified toxins or cultured microorganisms, which serve as known positive and negative controls during the assay development and validation phases.

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The OSOM® Influenza A&B Test is an in vitro diagnostic immunochromatographic assay intended for the qualitative detection of influenza A and influenza B viral nucleoprotein antigens from nasal swab specimens in symptomatic patients. It is intended to aid in the rapid differential diagnosis of influenza A and/or B viral infections.

This test is not intended for the detection of influenza C viruses. A negative test is presumptive and it is recommended these results be confirmed by cell 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 OSOM Influenza A&B Test consists of a test stick that separately detects influenza A and B. The test procedure requires the solubilization of the nucleoproteins from a swab by mixing the swab in Extraction Buffer. The test stick is then placed in the sample mixture, which then migrates along the membrane surface. If influenza A and/or B viral antigens are present in the sample, it will form a complex with mouse monoclonal IgG antibodies to influenza A and/or B nucleoproteins conjugated to colloidal gold. The complex will then be bound by another mouse anti-influenza A and/or B antibody coated on the nitrocellulose membrane. A pink to purple control line must appear in the control region of the stick for results to be valid. The appearance of a second and possibly a third light pink to purple line will appear in the test line region indicating an A, B or A and B positive result.

The provided text describes a 510(k) summary for the OSOM® Influenza A&B Test, primarily focusing on updating the package insert with additional analytical reactivity information for the H1N1 Influenza A strain Mexico/4108/2009.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" for clinical performance. Instead, it demonstrates the device's analytical reactivity with a specific strain of influenza. The acceptance is based on the device showing reactivity to the H1N1 strain.

2. Sample Sizes and Data Provenance

• Test Set Sample Size: The document refers to testing with a "cultured strain" (A/Mexico/4108/2009) of the 2009 H1N1 Influenza A virus. It does not specify a "sample size" in terms of number of patient samples, but rather indicates a single viral strain was used for this analytical reactivity test.
• Data Provenance: The data is analytical reactivity information, presumably from a laboratory setting. Specific country of origin is not mentioned for this particular test, but the strain name "Mexico/4108/2009" indicates the origin of the virus strain. The study is a prospective analytical study, not a retrospective clinical study.

3. Number of Experts and Qualifications

Not applicable. This was an analytical reactivity study, not a study requiring expert interpretation of results. The determination of whether the test "reacts" is a direct laboratory observable.

4. Adjudication Method

Not applicable. There was no need for adjudication as this was an analytical reactivity study, not a clinical study involving multiple interpreters.

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

No. The document describes an analytical reactivity study, not a clinical effectiveness study. There is no mention of human readers or AI assistance.

6. Standalone Performance Study

Yes. The study described is a standalone analytical performance study, demonstrating the device's ability to detect the H1N1 strain in a cultured sample without human intervention in the result interpretation (beyond observing the test line).

7. Type of Ground Truth Used

The ground truth used was the cultured presence of the specific H1N1 Influenza A virus strain (A/Mexico/4108/2009). This is a laboratory-established ground truth.

8. Sample Size for the Training Set

Not applicable. This device is an immunochromatographic assay, not an AI/machine learning algorithm, so 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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Reagents: For the quantitative measurement of cystatin C concentration in human serum, heparinized plasma and EDTA plasma. Cystatin C measurements are used as an aid to the diagnosis and treatment of renal diseases. For In Vitro Diagnostic Use. Calibrator: For the calibration of Genzyme Cystatin C assay. For In Vitro Diagnostic Use.

Genzymc Cystatin C assay reagent is based on the sol particle turbidimetric immunoassay principle. It contains colloidal gold particles coated with anticystatin C specific polyclonal antibodies. The reaction between the particles and any cystatin C in samples results in the formation of agglutinates and an associated change in absorbance signal. The change in absorbance signal is proportional to the amount of cystatin C in the sample. Cystatin C concentration in the sample is determined by comparison with a standard curve. Genzyme Cystatin C calibrators consist of a bovine serum albumin liquid matrix with assigned concentrations of cystatin C. The calibrators are preserved with sodium azide and are ready to use.

The provided text describes a 510(k) summary for a medical device called "Genzyme Cystatin C Reagent and Calibrator." It details the device's intended use, comparison to a predicate device, and performance characteristics to establish substantial equivalence. However, it does not explicitly define "acceptance criteria" in a quantitative manner as typically expected in a scientific study. Instead, it refers to "Performance characteristics" and states that these "support a determination of substantial equivalence."

Here's an attempt to extract and infer the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" with specific thresholds for parameters like sensitivity, specificity, or accuracy. Instead, it indicates that the device's performance was compared to a legally marketed predicate device (Dade Behring N Latex Cystatin C). The "acceptance" is implicitly tied to demonstrating "comparable performance and accuracy, good correlation, and substantial equivalence" to the predicate device.

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

The document states: "Method comparison studies performed with clinical specimens demonstrate comparable performance and accuracy, good correlation, and substantial equivalence." However:

• Sample size: The exact sample size for the test set (clinical specimens) used in the method comparison studies is not provided.
• Data provenance: The country of origin of the data is not specified. It can be inferred that the samples are human serum, heparinized plasma, and EDTA plasma, but whether they are retrospective or prospective is not stated.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This type of information is not applicable or not provided for this device. The device is an in vitro diagnostic (IVD) assay that quantifies cystatin C directly. The "ground truth" for method comparison studies in IVDs typically relies on the performance of a meticulously validated reference method or the predicate device itself, not on expert consensus from radiologists or similar clinical experts.

4. Adjudication Method for the Test Set

Since the "ground truth" is likely established by a reference method or the predicate assay itself, an adjudication method (like 2+1, 3+1) involving human experts is not applicable or not described for this type of IVD performance study.

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

An MRMC study is typically performed for image-based diagnostic aids or interpretations where human readers are involved. This device is an automated in vitro diagnostic assay for quantitative measurement. Therefore, an MRMC comparative effectiveness study is not applicable and not mentioned in the document.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The Genzyme Cystatin C assay is designed as an automated, standalone diagnostic test. Its performance characteristics (precision, linearity, specificity, analytical sensitivity, etc.) are inherently "algorithm only" in the sense that the device directly measures the analyte without human interpretation loops at the point of result generation. The "method comparison studies" essentially serve as a standalone performance assessment against a predicate method.

However, the term "standalone study" often implies a comparison to a clinical outcome or gold standard in the absence of human interpretation. While the method comparison evaluates the device's inherent analytical performance, the document doesn't use the term "standalone study" in a way that suggests a separate evaluation against a clinical gold standard beyond comparing it to the predicate device.

7. Type of Ground Truth Used

The primary ground truth used for demonstrating substantial equivalence is the performance of the legally marketed predicate device (Dade Behring N Latex Cystatin C). The method comparison studies compare the Genzyme Cystatin C assay with the results obtained from the predicate device on clinical specimens. There is no mention of pathology, outcomes data, or expert consensus in this context.

8. Sample Size for the Training Set

The document is a 510(k) summary for an IVD reagent and calibrator kit, not an AI/ML algorithm. Therefore, the concept of a "training set" in the context of machine learning is not applicable. The device's underlying principle is a turbidimetric immunoassay, not a learning algorithm that requires a training set.

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

As mentioned in point 8, the concept of a "training set" is not applicable to this device.

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Sepramesh™ IP Bioresorbable Coating/Permanent Mesh is indicated for use in the reconstruction of soft tissue deficiencies such as for the repair of hernias.

Sepramesh™ IP Bioresorbable Coating/Permanent Mesh (Sepramesh™ IP) is a dualcomponent (absorbable and non-absorbable), sterile prosthesis designed for the reconstruction of soft tissue deficiencies. Sepramesh™ IP is co-knitted using polypropylene and polyglycolic acid (PGA) fibers to result in a two-sided mesh with a polypropylene surface and PGA surface. Genzyme will offer two versions of the device. The first version utilizes violet dyed PGA fibers. The second version utilizes natural beige PGA fibers instead of the original violet version. The mesh is coated on the PGA surface with a bioresorbable coating of chemically modified sodium hyaluronate (HA), carboxymethylcellulose (CMC) and a polyethylene glycol (PEG) based hydrogel.

The uncoated side of the mesh allows a prompt fibroblastic response through the interstices of the mesh, encouraging tissue ingrowth, similar to polypropylene mesh alone. The coated side of the mesh provides a hydrophilic bioresorbable layer, separating the mesh from underlying tissue and organ surfaces during the critical wound-healing period resulting in minimal tissue attachment and visceral adhesions to the mesh. Shortly after placement, the biopolymer coating becomes a hydrated gel that is resorbed from the site in less than 30 days. The absorption of the PGA fibers is essentially complete between 50 and 80 days. The polypropylene mesh is permanent and allows for tissue ingrowth.

The provided text is a 510(k) summary for a medical device called Sepramesh™ IP Bioresorbable Coating - Permanent Mesh. This document is a premarket notification to the FDA to demonstrate that the new device is substantially equivalent to a legally marketed predicate device.

The 510(k) summary does not contain a study proving the device meets acceptance criteria in the way described in your request. A 510(k) submission typically focuses on demonstrating substantial equivalence to a predicate device, often through a comparison of technological characteristics, materials, and intended use, rather than presenting a new clinical study with specific performance metrics against pre-defined acceptance criteria.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment are not present in this type of regulatory submission. The document explicitly states: "Per Section 12, Part (a)(i)(3A) of the Safe Medical Devices Act of 1990, Genzyme Corporation is providing a summary of the safety and effectiveness information available for Sepramesh™M IP Bioresorbable Coating - Permanent Mesh (Sepramesh™ IP)." This indicates a review of existing information and a comparison, not a de novo clinical trial with new performance data.

Here's a breakdown of what can be extracted from the provided text, and what is not available:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not provided in the 510(k) summary. The document does not describe specific acceptance criteria (e.g., a certain percentage reduction in adhesions, a specific tensile strength after implantation) or present new performance data from a clinical study to meet such criteria. Instead, it justifies substantial equivalence by comparing the Sepramesh™ IP with a predicate device (K053066) based on broad characteristics like classification, indication, labeling claims, product design, materials, and sizes.

The "Performance" of the device is described qualitatively:

• "The uncoated side of the mesh allows a prompt fibroblastic response through the interstices of the mesh, encouraging tissue ingrowth, similar to polypropylene mesh alone."
• "The coated side of the mesh provides a hydrophilic bioresorbable layer, separating the mesh from underlying tissue and organ surfaces during the critical wound-healing period resulting in minimal tissue attachment and visceral adhesions to the mesh."
• "Shortly after placement, the biopolymer coating becomes a hydrated gel that is resorbed from the site in less than 30 days."
• "The absorption of the PGA fibers is essentially complete between 50 and 80 days."
• "The polypropylene mesh is permanent and allows for tissue ingrowth."

These are descriptive statements about the device's function, not quantitative performance metrics against acceptance criteria from a specific study.

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

Not applicable/Not provided. This document does not describe a "test set" in the context of an AI/algorithm performance study. It's a regulatory submission for a physical medical device (surgical mesh).

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

Not applicable/Not provided. This document does not involve expert review or ground truth establishment for a test set.

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

Not applicable/Not provided.

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/Not provided. This is not an AI/software device.

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

Not applicable/Not provided. This is not an AI/software device.

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

Not applicable/Not provided.

8. The sample size for the training set:

Not applicable/Not provided. This is not a machine learning device, so there is no "training set."

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

Not applicable/Not provided.

In summary: The provided document is a 510(k) premarket notification for a surgical mesh, demonstrating substantial equivalence to a previously cleared device. It does not contain the details of a study with acceptance criteria, sample sizes, expert involvement, or ground truth establishment as would be found in a performance study for, for example, a diagnostic AI device. The comparison provided (Table 5) focuses on the device's features, intended use, and materials to argue for equivalence, not on quantitative performance metrics.

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The OSOM Influenza A&B Test is an in vitro diagnostic immunochromatographic assay intended for the qualitative detection of influenza A and influenza B viral nucleoprotein antigens from nasal swab specimens in symptomatic patients. It is intended to aid in the rapid differential diagnosis of influenza A and/or B viral infections. This test is not intended for the detection of influenza C viruses. A negative test is presumptive and it is recommended these results be confirmed by cell 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 OSOM Influenza A&B Test consists of a test stick that separately detects influenza A and B. The test procedure requires the solubilization of the nucleoproteins from a swab by mixing the swab in Extraction Buffer. The test stick is then placed in the sample mixture, which then migrates along the membrane surface. If influenza A and/or B viral antigens are present in the sample, it will form a complex with mouse monoclonal IgG antibodies to influenza A and/or B nucleoproteins conjugated to colloidal gold. The complex will then be bound by another mouse anti-influenza A and/or B antibody coated on the nitrocellulose membrane. A pink to purple control line must appear in the control region of the stick for results to be valid. The appearance of a second and possibly a third light pink to purple line will appear in the test line region indicating an A, B or A and B positive result.

This document is a 510(k) summary for the OSOM® Influenza A&B Test. It describes the device, its intended use, and compares it to a legally marketed predicate device (OSOM Influenza A&B Test K051244). The information provided focuses on the device's characteristics and its equivalence to the predicate, rather than a detailed study proving it meets specific acceptance criteria with performance metrics.

Therefore, much of the requested information regarding acceptance criteria, reported performance, and study details (sample sizes, ground truth establishment, expert involvement, MRMC studies) is not present in the provided text. The document is primarily a regulatory submission for substantial equivalence.

Here's an analysis of what can be extracted from the provided text based on your request:

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

The provided text does not include explicit acceptance criteria or detailed reported device performance (e.g., sensitivity, specificity, accuracy) from a clinical study. It focuses on comparing the new device's technological characteristics to a predicate device. The cross-reactivity data table shows potential interfering substances that were tested and found to have "no affect on the performance," but it doesn't quantify performance metrics.

2. Sample sized 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 document. The text describes the device and its intended use but does not detail any clinical study or the sample size used for a test set, nor the provenance of such data.

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 information is not provided in the document. There is no mention of a test set, ground truth establishment, or experts involved in such a process.

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

This information is not provided in the document. There is no mention of a test set or any adjudication method.

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

A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned. This device is an in vitro diagnostic immunochromatographic assay, not an AI-assisted diagnostic tool, so the concept of human readers improving with AI assistance is not applicable.

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

This device is a lateral flow immunoassay. Its performance is inherent to the chemical reaction and visual interpretation of the test stick, not an algorithm. Therefore, the concept of "standalone (algorithm only)" performance is not applicable. The test provides a direct result (pink to purple line) that is interpreted by the user.

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

The document states under "Intended Use": "A negative test is presumptive and it is recommended these results be confirmed by cell culture." This implies that cell culture is considered the gold standard or ground truth for confirming negative results of influenza infection. However, it does not explicitly state what was used as ground truth for any performance evaluation in this 510(k) submission.

8. The sample size for the training set

This information is not provided in the document. As a lateral flow immunoassay, there wouldn't typically be a "training set" in the machine learning sense. The device's formulation and antibodies are developed through a different process.

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

This information is not provided and is again not applicable in the context of this type of device.

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The OSOM Influenza A&B Test is an in vitro diagnostic immunochromatographic assay intended for the qualitative detection of influenza A and influenza B viral nucleoprotein antigens from nasal swab specimens in symptomatic patients. It is intended to aid in the rapid differential diagnosis of influenza A and/or B viral infections. This test is not intended for the detection of influenza C viruses. A negative test is presumptive and it is recommended these results be confirmed by cell culture.

Cross-reactivity with respiratory viruses other than influenza viruses has not been evaluated. The user is responsible for determining the cross-reactivity of other respiratory viruses with this test.

The OSOM Influenza A&B Test consists of a test stick that separately detects influenza A and B. The test procedure requires the solubilization of the nucleoproteins from a swab by mixing the swab in Extraction Buffer. The test stick is then placed in the sample mixture, which then migrates along the membrane surface. If influenza A and/or B viral antigens are present in the sample, it will form a complex with mouse monoclonal IgG antibodies to influenza A and/or B nucleoproteins conjugated to colloidal gold. The complex will then be bound by another mouse anti-influenza A and/or B antibody coated on the nitrocellulose membrane. A pink to purple control line must appear in the control region of the stick for results to be valid. The appearance of a second and possibly a third light pink to purple line will appear in the test line region indicating an A, B or A and B positive result.

Here's an analysis of the acceptance criteria and study that proves the OSOM Influenza A&B Test meets them, based on the provided text:

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

The document does not explicitly state pre-defined acceptance criteria in terms of numerical thresholds for sensitivity, specificity, and agreement. However, the study results are presented as the device's performance. For the purpose of this response, I will interpret the reported performance values as implicitly meeting the unstated acceptance criteria for substantial equivalence to the predicate device.

Additional Performance Data:

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

• Sample Size for Clinical Performance (Test Set): 383 subjects.
  • 383 total samples for comparison to viral culture for both Influenza A and B.
  • Of these, 132 samples were from pediatric subjects (2-19 years) and 251 samples were from adults (> 20 years).
• Data Provenance: The document does not explicitly state the country of origin or whether the study was retrospective or prospective. Given the context of a 510(k) submission to the FDA in the US, it is highly likely that the clinical study was conducted in the United States. The study involved enrollment of subjects, which suggests a prospective collection of samples for the clinical performance evaluation.

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 ground truth for the clinical performance study (sensitivity, specificity, agreement) was established using viral cell culture as the reference method. This is a laboratory-based method, not dependent on human expert interpretation of the final result for the ground truth. Therefore, the concept of "number of experts" and their "qualifications" for establishing the ground truth does not directly apply here in the traditional sense of image or clinical interpretation.

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

• The document does not describe any human adjudication method for the ground truth (viral culture) or for the device's results. Viral culture results are objective laboratory findings. For the OSOM test results, it is a rapid diagnostic test with visually interpreted lines, implying a single interpretation per test, though reproducibility was assessed across different operators.
• Polymerase Chain Reaction (PCR) was performed on specimens that gave inconsistent results between the OSOM test and viral culture. This was done "for information only" and PCR was not FDA approved/cleared for this purpose at the time, meaning it was not used as a primary adjudication method for the final, reported clinical performance metrics directly, but rather for investigational purposes.

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, a MRMC comparative effectiveness study was not done. This device is an in vitro diagnostic immunochromatographic assay (a rapid point-of-care test), not an AI-powered diagnostic imaging or interpretation system. It does not involve human readers interpreting complex images with or without AI assistance, so the concept of "effect size of how much human readers improve with AI" is not applicable.
• However, an Assay Reproducibility study was conducted to demonstrate that the test performs acceptably in the hands of various operators (nurses, nurse practitioners, physician's office personnel). This involved multiple operators interpreting coded and masked samples, which is a form of multi-reader evaluation for the device's interpretability. The overall accuracy was 97% for Flu A and 94% for Flu B in this reproducibility study.

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

• Yes, in essence, the primary clinical performance evaluation is a standalone study. The OSOM Influenza A&B Test is a lateral flow immunoassay that provides a visual reading (pink to purple lines). Although a human interprets these lines, the core "algorithm" (the immunochromatographic assay itself) operates independently. The sensitivity, specificity, and agreement reported in the "Agreement with Viral Culture" section represent the performance of the device on its own, with human interpretation assumed to be done according to instructions. The test is designed to be read directly by an operator, not to be an "AI algorithm" that outputs a result for a human to then validate or integrate into a diagnosis.

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

• The primary ground truth for the clinical performance (sensitivity, specificity) was viral cell culture. This is considered a gold standard for influenza virus detection.
• For the analytical specificity and cross-reactivity studies, the ground truth was the known identity of the bacterial isolates and influenza virus strains.

8. The sample size for the training set

• The document describes the clinical performance evaluation and various analytical studies. It does not describe a separate "training set" in the context of machine learning or AI models, as this is an immunoassay. The tests performed are validations of the developed assay, not training phases for an algorithm.

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

• As concluded in point 8, there isn't a "training set" for an AI model mentioned in the document. The development of an immunoassay like the OSOM test involves extensive laboratory work, including using known positive and negative samples, and samples spiked with varying concentrations of analytes, to optimize the assay's components and parameters (antibodies, reagents, flow characteristics, etc.). This iterative process would utilize known viral cultures and other characterized samples to ensure the assay functions as intended, but it's not typically referred to as a "training set" with ground truth in the same way as in AI/ML development.

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Sepramesh™ IP Bioresorbable Barrier - Permanent Mesh is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias.

Sepramesh™ IP Bioresorbable Coating/Permanent Mesh (Sepramesh™ IP) is a dualcomponent (absorbable and non-absorbable), sterile prosthesis designed for the reconstruction of soft tissue deficiencies. Sepramesh™ IP is co-knitted using polypropylene and polyglycolic acid (PGA) fibers to result in a two-sided mesh with a polypropylene surface and PGA surface. Genzyme will offer two versions of the device. The first version, previously cleared through K040868 utilizes violet dyed PGA fibers. The second version described in this submission utilizes natural beige PGA fibers. The mesh is coated on the PGA surface with a bioresorbable barrier of chemically modified sodium hyaluronate (HA), carboxymethylcellulose (CMC) and a polyethylene glycol (PEG) based hydrogel.

The uncoated side of the mesh allows a prompt fibroblastic response through the interstices of the mesh, encouraging tissue ingrowth, similar to polypropylene mesh alone. The coated side of the mesh provides a hydrophilic bioresorbable layer, separating the mesh from underlying tissue and organ surfaces during the critical wound-healing period resulting in minimal tissue attachment and visceral adhesions to the mesh. Shortly after placement, the biopolymer coating becomes a hydrated gel that is resorbed from the site in less than 30 days. The absorption of the PGA fibers is essentially complete between 50 and 80 days. The polypropylene mesh is permanent and allows for tissue ingrowth.

Here's an analysis of the acceptance criteria and study information for the Sepramesh™ IP Bioresorbable Coating/Permanent Mesh, based on the provided text:

Important Note: The provided document is a 510(k) summary for a medical device. This type of document focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing independent clinical efficacy or presenting detailed acceptance criteria and performance data in the same way a clinical trial report would. Therefore, the information provided below will reflect this context.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) summary, explicit "acceptance criteria" for precise numerical performance metrics are not typically presented in the same way as a full clinical study with predefined endpoints. Instead, the acceptance criterion for a 510(k) is usually substantial equivalence to predicate devices. The performance is reported in terms of comparability to these predicates.

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

• Sample Size for Test Set: The document mentions an in vivo study in a rabbit hernia repair model. However, the specific number of animals (sample size) used in this animal study is not provided in the excerpt.
• Data Provenance: The study was an in vivo animal study conducted specifically for this submission to evaluate the device's performance. The country of origin is not explicitly stated, but Genzyme Corporation is based in Cambridge, MA (USA). The study is prospective in nature for the purpose of demonstrating substantial equivalence.

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

The document does not detail the number of experts or their qualifications for evaluating the in vivo rabbit study. In animal studies, assessments like adhesion formation, tissue ingrowth, and cellular response are typically performed by veterinary pathologists or other experts in tissue analysis, but this specific information is absent.

4. Adjudication Method for the Test Set

The adjudication method for the in vivo rabbit study is not specified in the provided text.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was NOT done. This document pertains to a medical device (surgical mesh), not an imaging or diagnostic AI system. MRMC studies are typically used to assess the performance of diagnostic aids (like AI algorithms) in improving human reader interpretation of images. The study described here is an in vivo animal study evaluating the physical and biological interaction of the mesh in a living system.

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

This question is not applicable as the device is a physical surgical mesh and not an algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant here. The in vivo rabbit study evaluates the device itself, not an algorithm's performance.

7. The Type of Ground Truth Used

The ground truth for the in vivo animal study appears to be based on:

• Direct Observation/Measurement: Evaluation of adhesion formation and tissue ingrowth in the rabbit hernia repair model.
• Histopathological Analysis: Assessment of cellular response.
• Standardized Physical Testing: Measurement of mesh thickness, knit characteristics, pore size, mass/area, suture retention strength, tear propagation strength, and burst strength.

8. The Sample Size for the Training Set

Not applicable. The device is a surgical mesh, not an AI algorithm that requires a "training set" of data.

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

Not applicable. This device does not involve an AI algorithm with a training set.

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Sepragel ENT packing/stent is indicated for use in patients undergoing nasal/sinus, middle ear and external ear canal surgery as a space-occupying dressing and/or stent intended to prevent adhesions in the nasal cavity, separate mucosal surfaces, help control minimal bleeding following surgery or trauma, and act as an adjunct to aid in the natural healing process. The device is indicated for use in the middle ear following canalplasty, myringoplasty, tympanoplasty, stapes and mastoid surgery. The device is indicated following nasal/sinus surgery or trauma to prevent lateralization of the middle turbinate during the post operative period.

Sepragel ENT is a sterile, non-pyrogenic, transparent, viscoelastic, bioresorbable gel composed of cross-linked molecules of hyaluronan. It is indicated for use in patients undergoing nasal/sinus, middle ear and external ear canal surgery as a space-occupying dressing and/or gel stent intended to separate and prevent adhesions between mucosal surfaces, to help control minimal bleeding following surgery or trauma, and act as an adjunct to aid in the natural healing process.

SeprageI™ ENT hylan B gel, is a sterile, non-pyrogenic, transparent, viscoelastic gel composed of cross-linked molecules of hyaluronan. This hyaluronan is a bioresorbable material that functions to fill the sinus cavity, middle ear and external ear canal following surgery and to keep mucosal surfaces separate during the healing process. During this time, the tamponade effect helps control minimal bleeding normally associated with routine Otologic surgery. Sepragel ENT leaves the site of placement by natural elimination. In nasal/sinus applications it may be aspirated from the cavity earlier at the discretion of the physician.

The provided text describes a 510(k) premarket notification for the Sepragel™ ENT Bioresorbable Packing/Stent. A 510(k) submission is primarily for demonstrating substantial equivalence to a legally marketed predicate device, not necessarily for proving that a device meets specific clinical performance acceptance criteria through the types of studies typically associated with clinical trials of AI/ML devices or novel therapies.

Based on the provided text, there is no information about:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for a test set or data provenance for a performance study.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication methods.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
• Standalone (algorithm only) performance studies.
• Type of ground truth used (e.g., pathology, outcomes data).
• Sample size for a training set.
• How ground truth for a training set was established.

The document demonstrates regulatory approval based on substantial equivalence to predicate devices. The key aspects of the submission are:

1. Acceptance Criteria and Device Performance:
No specific quantitative acceptance criteria or reported device performance metrics (e.g., sensitivity, specificity, accuracy) are mentioned. The approval is based on demonstrating that the Sepragel™ ENT is substantially equivalent in terms of intended use, technological characteristics, and safety to already marketed devices.

2. Study/Evidence for Substantial Equivalence:
The "study" or evidence provided is a comparison of technological characteristics to predicate devices, as detailed in Table 4. This table highlights similarities and some differences in:

• Manufacturer
• Product Classifications/Codes
• Intended Use/Indications
• Material Composition (Derivative hyaluronic acid for all)
• Bioresorbability (YES for all)
• Product matrix (Gel in a syringe for Sepragel ENT and Hylasine™, Non-woven pad for MeroGel™)

The document asserts that Sepragel™ ENT is "substantially equivalent" to these predicates because it shares material composition (hyaluronan), bioresorbability, similar intended uses (with Sepragel ENT having an expanded indication to middle and external ear applications not explicitly listed for Sepragel Sinus, but listed for MeroGel Otologic Pack), and a similar product matrix to Sepragel Sinus.

3. Other Requested Information (Not Applicable/Not Provided):
All other requested points (sample sizes, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, type of ground truth, training set size, training ground truth establishment) are not relevant or not provided in this type of 510(k) submission. These details are typically found in clinical trials or performance studies designed to evaluate the efficacy or accuracy of a device, especially for AI/ML or diagnostic tools, which is not the nature of this submission. The submission is focused on demonstrating that the device is as safe and effective as devices already on the market through comparison.

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Reagents: For the quantitative measurement of C-Reactive Protein (CRP) concentration in serum or plasma. For In Vitro Diagnostic Use. Calibrator: For the calibration of the N-geneousTM Wide Range CRP assay. For In Vitro Diagnostic Use.

The Genzyme N-geneous™ Wide Range CRP Reagent is a two-reagent method for the quantitative measurement of CRP concentration from 0.04 to 320 mg/L in serum or plasma. The test is an enhanced latex-agglutination turbidimetric immunoassay. Sample is added to a buffer solution and mixed with a suspension of mouse anti-human CRP monoclonal antibody, which is bound to latex. CRP binds to the latex-bound antibody, which agglutinates. The light scattering caused by the increase in particle size is used as a measure of CRP concentration. The amount of light scattering is proportional to the concentration of CRP in the sample. N-geneous™ Wide Range CRP Calibrator Set is a stabilized human serum designed to be used to calibrate the N-geneous™ Wide Range CRP Reagent and is sold separately.

Here's an analysis of the provided text regarding the N-geneous™ Wide Range CRP Reagent Kit, structured to answer your questions:

Acceptance Criteria and Device Performance Study for N-geneous™ Wide Range CRP Reagent Kit

The 510(k) submission for the N-geneous™ Wide Range CRP Reagent Kit demonstrates substantial equivalence to a predicate device, the Dade Behring N High Sensitive CRP method, primarily through comparative performance and precision studies.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state "acceptance criteria" for the comparative performance and precision studies in terms of pre-defined thresholds. Instead, it presents the results of these studies and concludes that the device's performance is "substantially equivalent" or "acceptable."

However, we can infer the implicit performance targets based on the evaluation presented. For devices seeking substantial equivalence, a high correlation with a legally marketed predicate device and acceptable precision (low variability) are key.

2. Sample Size and Data Provenance

• Sample Size for Test Set (Comparative Performance): 229 serum samples.
• Data Provenance: The document does not explicitly state the country of origin. It describes "comparative performance studies" and "precision studies" conducted on the Hitachi 912 clinical analyzer. Given Genzyme Diagnostics is located in Cambridge, MA, it's reasonable to infer the studies were likely conducted in the US, but this is not explicitly stated. The studies used "serum samples" and "sera that were stored frozen (-20°C) and thawed prior to use." This indicates the data is retrospective in the sense that the samples were collected prior to the full study, but they are prospectively analyzed in the context of this study.

3. Number of Experts and Qualifications for Ground Truth

• This document describes a diagnostic device (reagent and calibrator) for quantitative measurement of CRP. The "ground truth" for the comparative performance study is the measurement obtained from the predicate device, the Dade Behring N High Sensitive CRP method.
• No human experts were used to establish ground truth in the sense of a subjective interpretation or diagnosis. The ground truth is established by the measurement value from the predicate device.

4. Adjudication Method for the Test Set

• Since the "ground truth" is derived from the quantitative measurement of a predicate device, there was no adjudication method involving human experts for the test set.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for image-based diagnostic devices or tests where human interpretation is involved (e.g., radiology, pathology). This submission is for an in vitro diagnostic reagent and calibrator kit, where the output is a quantitative measure of CRP.

6. Standalone Performance Study

• Yes, a standalone performance study was done. The precision studies (within-run and total precision) directly assess the performance of the N-geneous™ Wide Range CRP Reagent Kit in isolation, without direct comparison to human interpretation or a human-in-the-loop scenario. The comparative performance study also evaluates the algorithm's (reagent's) output against the predicate device's output, essentially a standalone comparison to another device.

7. Type of Ground Truth Used

• The ground truth used for the comparative performance study was the quantitative measurement value obtained from the legally marketed predicate device (Dade Behring N High Sensitive CRP method).
• For the precision studies, the "ground truth" is inherent to the intrinsic variability of the device itself when measuring known concentrations, and the results are reported as mean, standard deviation, and %CV.

8. Sample Size for the Training Set

• The document does not specify a separate training set or its sample size. This is common for in vitro diagnostic device submissions where the 'algorithm' is essentially the chemical reaction and light scattering measurement, and the parameters (e.g., reagent concentrations) are established during product development, not typically through a distinct machine learning "training phase" on a separate dataset in the same way an AI/ML diagnostic would. The comparative and precision studies are validation studies, not training studies.

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

• As no explicit training set is described for an AI/ML algorithm, the concept of establishing ground truth for a training set in this context is not applicable. The underlying chemical and physical principles of the immunoassay, along with established laboratory practices and quality control, govern the development and calibration of such a device. The calibrator itself is traceable to CRM470, which serves as a widely accepted "ground truth" or reference material for CRP measurements.

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Sepramesh™ IP Bioresorbable Coating - Permanent Mesh is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias.

Sepramesh™ IP Bioresorbable Coating - Permanent Mosh (Sepramesh™ IP) is a dualcomponent (absorbable and non-absorbable), sterile prosthesis designed for the reconstruction of soft tissue deficiencies. Sepramesh™ IP is co-knitted using polypropylene and polyglycolic acid (PGA) fibers to result in a two-sided mesh with a polypropylene surface and PGA surface. The mesh is coated on the PGA surface with a bioresorbable, chemically modified sodium hyaluronate (HA), carboxymethylcellulose (CMC) and a polyethylene glycol (PEG) based hydrogel.

The fascial side of the mesh allows a prompt fibroblastic response through the interstices of the mesh, encouraging tissue ingrowth, similar to polypropylene mesh alone. The visceral side of the mesh provides a hydrophilic bioresorbable layer, separating the mesh from underlying tissue and organ surfaces during the critical wound-healing period resulting in minimal tissue attachment and visceral adhesions to the mesh. Shortly after placement, the biopolymer coating becomes a hydrated gel that is resorbed from the site in less than 30 days. The absorption of the PGA fibers is essentially complete between 50 and 80 days. The polypropylene mesh is permanent and allows for tissue ingrowth.

The provided submission describes a medical device, Sepramesh™ IP Bioresorbable Coating - Permanent Mesh, seeking 510(k) clearance. This type of submission focuses on demonstrating substantial equivalence to legally marketed predicate devices rather than proving specific performance against an acceptance criterion in a clinical study. Therefore, the information requested regarding acceptance criteria and a study proving device performance in the context of an AI/human-in-the-loop study is not applicable.

Here's a breakdown of why this information isn't present in this specific document:

• Device Type: Sepramesh™ IP is a surgical mesh for soft tissue repair, not an AI or diagnostic imaging device. Its clearance pathway is based on material properties, design, and intended use comparison to existing devices.
• 510(k) Clearance: The 510(k) process is about demonstrating "substantial equivalence," meaning that the new device is as safe and effective as a legally marketed device. It typically relies on comparisons of technological characteristics, materials, and intended use, often supported by bench testing and sometimes animal studies, rather than large-scale clinical trials with specific performance endpoints like those seen in AI device submissions.

Therefore, many of the requested categories related to AI performance, human reader studies, and large-scale test datasets do not apply to this specific 510(k) submission.

Here is the information that can be extracted from the provided text, recognizing the nature of a 510(k) for a surgical mesh:

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

This document does not present a table of specific acceptance criteria in the way one might see for an AI device (e.g., sensitivity, specificity thresholds). Instead, the "acceptance criteria" for a 510(k) of this nature involve demonstrating substantial equivalence to predicate devices, focusing on:

• Materials: Comparison of polypropylene, PGA, HA, CMC, PEG.
• Design: Dual-component mesh with two sides (fibroblastic response side and bioresorbable separation layer).
• Intended Use: Reconstruction of soft tissue deficiencies, such as hernia repair.
• Performance (General): Bioresorption profile of coating and PGA fibers, permanent nature of polypropylene mesh, tissue ingrowth, minimal tissue attachment/adhesions.

The document states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This statement from the FDA serves as the "reported device performance" in the context of the 510(k) process – that it meets the "acceptance criteria" of being substantially equivalent.

2. Sample size used for the test set and the data provenance: Not applicable. This is not an AI device or a diagnostic device; therefore, there isn't a "test set" in the sense of patient data for performance evaluation. The substantial equivalence is based on component comparison and intended use.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for the reasons stated above.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for the reasons stated above.

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. Sepramesh™ IP is a surgical implant, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithmic device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for this 510(k) submission is the established safety and effectiveness of the predicate devices and the demonstration that the new device shares similar technological characteristics and performs similarly.

8. The sample size for the training set: Not applicable. This is not a machine learning or AI device.

9. How the ground truth for the training set was established: Not applicable. This is not a machine learning or AI device.

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