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CRYOcheck Factor VIII Deficient Plasma with VWF is for clinical laboratory use as a deficient substrate in the quantitative determination of Factor VIII activity in 3.2% citrated human plasma based on the activated partial thromboplastin time (APTT) assay. It is intended to be used in identifying factor VIII deficiency and as an aid in the management of hemophilia A in individuals aged 2 years and older. For in vitro diagnostic use

CRYOcheck Factor VIII Deficient Plasma with VWF is normal human citrated plasma which has been immunodepleted of factor VIII and to which an exogenous source of human von Willebrand Factor (vWF) has been added and buffered with HEPES. Factor VIII has been assayed at less than 1% of normal activity levels and vWF antigen and activity are >50%. It will be provided to users frozen in small-volume aliquots (25 vials of 1.0 mL, and 25 vials of 1.5 mL). Vials will be packaged into boxes; these will be frozen during the manufacturing process and will be shipped and stored frozen until use to preserve the integrity of the components

The provided FDA 510(k) summary for the "CRYOcheck Factor VIII Deficient Plasma with VWF" describes various performance studies and their results. Based on the document, here's a structured breakdown of the acceptance criteria and the study details:

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

The document does not explicitly present a table of pre-defined acceptance criteria for each performance characteristic in a pass/fail format. Instead, it presents the results of various studies and implies that these results met internal or regulatory expectations for substantial equivalence to the predicate device. However, we can infer performance targets based on the documented results and common regulatory expectations for in vitro diagnostic devices.

Here's a table summarizing the reported device performance, with inferred acceptance "criteria" based on the conclusions drawn in the report:

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HemosIL Factor XII Deficient Plasma immunodepleted of factor XII and intended for the in vitro diagnostic quantitative determination of factor XII activity in citrated plasma, based on the activated partial thromboplastin time (APTT) assay, on IL Coagulation Systems.

Factor XII activity in a patient's plasma is determined by performing a modified activated partial thromboplastin time test (APTT). Patient plasma is diluted and added to plasma deficient in factor XII. Correction of the clotting time of the deficient plasma is proportional to the concentration (% activity) of that factor in the patient plasma, interpolated from a calibration curve.

The provided text describes a 510(k) submission for a medical device called "HemosIL Factor XII Deficient Plasma." This submission is a "Special 510(k)" because the changes are limited to an updated on-board instrument stability claim, which means only specific performance characteristics related to this change were tested.

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

Key Takeaway from the Document: This is not a study proving the overall efficacy or safety of a new diagnostic algorithm or AI system. Instead, it's a regulatory submission for a minor modification to an existing reagent used in a diagnostic test. The study described focuses solely on validating a change in the reagent's "on-board instrument stability" claim, meaning how long the reagent is stable once placed on the testing instrument. Therefore, many of the typical acceptance criteria and study aspects found in AI/algorithm submissions (like MRMC studies, expert consensus on images, etc.) are not applicable here.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by standard laboratory validation practices for a changed stability claim, specifically referencing CLSI EP25-A. The performance is the outcome of this validation.

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

• Sample Size: The document does not explicitly state the sample size (number of patient samples, runs, or measurements) used for the stability testing. It only mentions "additional testing done to current CLSI EP25-A requirements" and that "verification testing to establish the modified on-board instrument stability claim... was conducted under design control."
• Data Provenance: The document does not specify the country of origin of the data or whether the testing was retrospective or prospective. It implies the testing was conducted by Instrumentation Laboratory Co. as part of their design control process. Given it's a stability study for a reagent, it would inherently be a prospective study conducted in a laboratory setting.

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

• Not Applicable. This is not a study involving expert readers interpreting medical images or data where "ground truth" is established by human consensus. The "ground truth" for a reagent's stability is determined by laboratory measurements and adherence to pre-defined acceptance limits for analytical performance (e.g., maintaining accuracy, precision within a certain range over time).

4. Adjudication Method for the Test Set

• Not Applicable. As this is a laboratory stability study for a reagent, there is no "adjudication" of human interpretations involved. The "adjudication" would be based on objective analytical measurements compared against pre-defined statistical criteria (e.g., drift, bias within acceptable limits according to CLSI EP25-A).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No. An MRMC study is relevant for evaluating human performance (e.g., diagnostic accuracy of radiologists) with and without AI assistance. This submission is for a reagent, not an AI system or diagnostic algorithm that interacts with human readers.

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

• No. This is not an algorithm or AI system. It's a laboratory reagent. The "performance" being evaluated is the chemical stability of the reagent on an automated instrument.

7. The Type of Ground Truth Used

• Analytical Performance Data / Reference Method. The "ground truth" for reagent stability in this context would be defined by the reagent's ability to produce accurate and precise results when tested immediately after reconstitution (time zero) and then over the claimed stability period (e.g., 6 hours). This would be compared against a reliable reference method or pre-established acceptable analytical performance ranges. The CLSI EP25-A guideline would specify how this analytical "ground truth" is established and evaluated.

8. The Sample Size for the Training Set

• Not Applicable. There is no "training set" as this is not a machine learning model or AI algorithm. This is a chemical reagent.

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

• Not Applicable. As there is no training set, this question is not relevant.

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NoFact VIII Deficient Plasma is a human plasma immunodepleted of Factor VIII and intended for the quantitative determination of Factor VIII activity in citrated plasma from patients suspected of FVIII deficiency. FVIII activity is based on the activated partial thromboplastin time. For in vitro diagnostic use.

NoFact VIII Deficient Plasma is a human plasma immunodepleted of Factor VIII and intended for the quantitative determination of Factor VIII activity in citrated plasma from patients suspected of FVIII deficiency. FVIII activity is based on the activated partial thromboplastin time. For in vitro diagnostic use.

Here's a breakdown of the acceptance criteria and the study details for the NoFact VIII Deficient Plasma device, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary for NoFact VIII Deficient Plasma focuses on demonstrating substantial equivalence to a predicate device (Stago VIII Deficient Plasma) through performance comparison and precision evaluation. While explicit "acceptance criteria" for each metric are not stated numerically, the narrative implies that the performance must be comparable to the predicate device and demonstrate acceptable precision.

Note: The document states "NoFact VIII Deficient Plasma provided acceptable precision" without numerical thresholds, implying adherence to general CLSI guidelines for precision for such assays.

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

• Sample Size: 233 frozen plasma samples.
• Data Provenance: The samples were analyzed across three different laboratories. The document does not specify the country of origin but implies a multi-site study within a regulatory context that often points to domestic (US) or internationally recognized sites. The data is retrospective as it refers to "frozen plasma samples."

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

This type of in vitro diagnostic device (IVD) for factor deficiency measurement typically does not use human experts to establish "ground truth" for individual samples in the way a diagnostic imaging AI might. Instead, the "ground truth" for the test set is established by the measurement of Factor VIII activity using the predicate device's reagent (Stago FVIII deficient plasma) coupled with the Stago PTT-A FVIII assay. The comparison is between the new device's performance and the established performance of the legally marketed predicate. Therefore, no experts were specifically used to establish ground truth in the context of interpretation or diagnosis for each sample.

4. Adjudication Method for the Test Set

As explained above, this study design compares the new device’s performance to an existing, validated method (the predicate device). There is no "adjudication" in the sense of resolving discrepancies between multiple human readers or between an AI and a human. The "ground truth" is the result obtained with the predicate device, and the new device's results are compared directly to those values.

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 Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is an in vitro diagnostic reagent, not an AI-powered diagnostic system that assists human readers in interpreting complex data like medical images. Therefore, the concept of "human readers improving with AI assistance" does not apply here.

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

Yes, in spirit, a standalone performance was done. The "NoFact VIII Deficient Plasma" is a reagent. Its performance is evaluated directly in an assay (Stago PTT-A FVIII assay) on an automated analyzer (STA Compact). The results (Factor VIII activity) are generated solely by the interaction of the sample, the reagent, and the analyzer, and then compared to the results obtained with the predicate reagent on the same analyzer using the same assay. There is no human "loop" involved in generating the primary measurement data, only in setting up the assay and validating the results.

7. The Type of Ground Truth Used

The ground truth used for performance comparison was the quantitative Factor VIII activity values obtained from the predicate device (Stago VIII Deficient Plasma) using the Stago PTT-A FVIII assay. This represents a "reference standard" established by an already legally marketed and validated assay.

8. The Sample Size for the Training Set

The document does not provide information on a "training set." This is typical for an in vitro diagnostic reagent. Reagents are generally developed and then their performance is validated against predicate devices or established methods. There isn't an "AI model" that requires a distinct training phase with labeled data in the same way an imaging algorithm would. The development (analogous to training) would involve optimizing the reagent's formulation and manufacturing processes, but this isn't detailed as a "training set" in the context of performance studies.

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

Since no specific "training set" is mentioned for an AI model, the concept of establishing ground truth for it is not applicable here. The focus is on validating the performance of the final reagent product against a recognized standard (the predicate device).

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NoFact IX Deficient Plasma is a human plasma immunodepleted of Factor IX and intended for the quantitative determination of Factor IX activity in citrated plasma from patients suspected of FIX deficiency. FIX activity is based on the activated partial thromboplastin time. For in vitro diagnostic use.

NoFact IX Deficient Plasma is a human plasma immunodepleted of Factor IX and intended for the quantitative determination of Factor IX activity in citrated plasma from patients suspected of FIX deficiency. FIX activity is based on the activated partial thromboplast time. For in vitro diagnostic use.

Here's an analysis of the acceptance criteria and study detailed in the provided 510(k) summary for the NoFact IX Deficient Plasma device:

Important Note: The provided document is a 510(k) summary for an in vitro diagnostic device, specifically a deficient plasma product used in laboratory tests. It is not an AI or imaging device, and therefore many sections of your request (like "Number of experts used to establish the ground truth," "Adjudication method," "MRMC comparative effectiveness study," and "Standalone performance") are not applicable to this type of medical device submission. I will address only the relevant information from the document.

Acceptance Criteria and Device Performance for NoFact IX Deficient Plasma

The device, NoFact IX Deficient Plasma, is an in vitro diagnostic intended for the quantitative determination of Factor IX activity. Its performance is demonstrated through a comparison study with a legally marketed predicate device (STA Deficient IX) and precision testing.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) for an in vitro diagnostic, the "acceptance criteria" are not explicitly stated with numerical thresholds in the provided summary in the same way they might be for an AI model. Instead, the acceptance is based on demonstrating "substantial equivalence" to a predicate device through a strong correlation in quantitative measurements and acceptable precision. The reported performance metrics are derived from this equivalence study and precision assessment.

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HemosIL Factor VIII deficient plasma is human plasma, depleted of Factor VIII, which is intended for the in vitro diagnostic quantitative determination of Factor VIII activity in citrated plasma, based on the activated partial thromboplastin time (APTT) assay, on the ACL TOP® Family analyzers. HemosIL Factor VIII deficient plasma is indicated for use on patients who are suspected of congenital or acquired deficiency based on the activated partial thromboplastin time (APTT) assay results.

The assay determines the functional activity of Factor VIII by measuring the degree of prolongation of activated partial thromboplastin time in the presence of a contact activator, thromboplastin, phospholipids and calcium ions. Factor VIII activity is correlated with the prolongation of the clotting time of the Factor VIII deficient plasma to which diluted patient sample has been added.

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

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

The provided document primarily details performance characteristics rather than explicit "acceptance criteria" for regulatory approval in every instance. However, it implicitly defines satisfactory performance through comparisons to the predicate device and established linearity/precision targets. Due to the nature of the submission (Reagent formulation change), the primary acceptance criterion is demonstrating comparable performance to the predicate device.

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

• Precision Study:

  • Sample Size: 80 replicates per instrument/lot per control level (e.g., 4 control levels x 3 lots x 3 instruments x 80 = 2880 individual measurements if all were run, but data is shown for one representative instrument/reagent/lot).
  • Data Provenance: Not explicitly stated, but clinical laboratory samples (normal and abnormal types) were used. Implied to be prospective within the context of the study design (20 days, 2 runs/day, 2 replicates/run). Country of origin is not specified, but the applicant is US-based.

• Linearity Study:

  • Sample Size: 4 replicates for each Factor VIII sample level.
  • Data Provenance: Not explicitly stated, but generated in-house using prepared Factor VIII samples ranging from 150%. Implied prospective within the study.

• Interference Study:

  • Sample Size: Not specified, but involved testing samples spiked with various interferents.
  • Data Provenance: Not specified, likely in-house laboratory testing, prospective.

• In-House Method Comparison Study:

  • Sample Size: Not explicitly stated for the regression analysis. The table shows 'N' for the ACL TOP 500 CTS as 90 (likely 90 samples tested).
  • Data Provenance: "In-House Study," likely prospective laboratory testing.

• Field Site Study:

  • Sample Size:
    • OUS site: n = 109
    • US #1 site: n = 125
    • US #2 site: n = 102
  • Data Provenance: Conducted at "2 US sites and one OUS site." The document states "Both normal and abnormal samples were tested." Implied prospective testing at these sites.

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

This device is an in vitro diagnostic reagent kit for quantitative determination of Factor VIII activity. The "ground truth" for Factor VIII activity in the test samples is typically established by assigned values from reference materials or by established laboratory methods using calibrated instruments, not by expert human interpretation like in imaging or pathology. The document mentions "assigned values" for the HemosIL Calibration plasma (for calibration curves) and "assigned values" for samples in the linearity study, but does not detail how these assignments were made in terms of human experts. It's a quantitative chemical assay, where "ground truth" is analytical, not based on expert consensus for a "reading."

4. Adjudication Method for the Test Set

Not applicable. This is a quantitative diagnostic assay, not a diagnostic imaging or pathology device where human interpretation and adjudication would be typically required for a "test set" in the sense of establishing truth for diagnostic accuracy. The performance is assessed against known or assigned values for Factor VIII activity.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a diagnostic reagent, not an AI-powered diagnostic aid for human readers. It functions as a standalone laboratory test.

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

Yes. This device (HemosIL Factor VIII deficient plasma) is a reagent used in an automated assay on ACL TOP Family analyzers. Its performance characteristics (precision, linearity, interference, method comparison) are evaluated as a standalone component of the in vitro diagnostic system, independent of direct human interpretive "reading" of the results in the same way an imaging device would be read. The "performance" described is the analytical performance of the reagent used with the specified instruments.

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

For the analytical studies (precision, linearity, method comparison), the "ground truth" is based on:

• Reference materials/assigned values: HemosIL Calibration plasma values are assigned for Factor VIII Activity and used to calibrate the standard curve. In the linearity study, samples had "assigned values."
• Established methods: The predicate device itself serves as the "truth" for comparative purposes in the method comparison studies.
• Known concentrations: For interference studies, samples are spiked with known concentrations of interferents.

This is primarily an analytical ground truth derived from laboratory standards, calibrated materials, and established predicate device performance.

8. The Sample Size for the Training Set

Not applicable. This is an IVD reagent, not a machine learning or AI-based device that requires a "training set" in the context of algorithm development. The reagent itself does not learn or get "trained."

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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HemosIL Factor II Deficient Plasma is human plasma immunodepleted of factor II and intended for the in vitro diagnostic quantitative determination of factor II activity in citrated plasma, based on the prothrombin time (PT) assay, on IL Coagulation and ELECTRA Systems.

HemosIL Factor II Deficient Plasma is human plasma immunodepleted of factor II and intended for the in vitro diagnostic quantitative determination of factor II activity in citrated plasma, based on the prothrombin time (PT) assay, on IL Coagulation and ELECTRA Systems.

Abnormalities of the extrinsic pathway factors are determined by performing a modified prothrombin time (PT) test. Patient plasma is diluted and added to a plasma deficient in factor II. Correction of the clotting time of the deficient plasma is proportional to the concentration (% activity) of the factor II in the patient plasma, interpolated from a calibration curve.

The provided 510(k) summary for the HemosIL Factor II Deficient Plasma does not explicitly state acceptance criteria in the form of pre-defined thresholds that the device had to meet. Instead, the study demonstrates that the new device is "substantially equivalent" to predicate devices by showing comparable performance.

However, we can infer performance metrics that were deemed acceptable for substantial equivalence based on the presented data. The study primarily relies on method comparison and precision data.

Here's a breakdown of the information requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, explicit "acceptance criteria" are not given. The study aims to demonstrate substantial equivalence to predicate devices. We can infer that correlation coefficients (r) close to 1.0, slopes close to 1.0, and small intercepts compared to predicate devices, along with acceptable precision (%CV), were considered evidence of substantial equivalence.

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HemosIL Factor XII Deficient Plasma is human plasma immunodepleted of factor XII and intended for the in vitro diagnostic quantitative determination of factor XII activity in citrated plasma, based on the activated partial thromboplastin time (APTT) assay, on IL Coagulation and ELECTRA Systems.

HemosIL Factor XII Deficient Plasma is human plasma immunodepleted of factor XII and intended for the in vitro diagnostic quantitative determination of factor XII activity in citrated plasma, based on the activated partial thromboplastin time (APTT) assay, on IL Coagulation and ELECTRA Systems. Abnormalities of the intrinsic pathway factors are determined by performing a modified activated partial thromboplastin time (APTT) test. Patient plasma is diluted and added to a plasma deficient in factor XII. Correction of the clotting time of the deficient plasma is proportional to the concentration (% activity) of the factor XII in the patient plasma, interpolated from a calibration curve.

Here's a breakdown of the acceptance criteria and study information for the HemosIL Factor XII Deficient Plasma, based on the provided text:

Acceptance Criteria and Reported Device Performance

For this specific device, the acceptance criteria are not explicitly stated as numerical cutoffs. Instead, the study aims to demonstrate substantial equivalence to predicate devices. This means that the new device's performance, as measured by method comparison and precision, should be comparable to the legally marketed predicates.

The summary highlights:

• Method Comparison: Consistency in results (slope and correlation coefficients) when compared to predicate devices across different IL systems. A slope close to 1 and a correlation coefficient (r) close to 1 indicate strong agreement.
• Precision: Acceptably low variability (Within run %CV and Between Run %CV) for both normal and abnormal controls.

Study Information

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

   • Sample Size (Method Comparison): Approximately 70-73 citrated plasma samples per comparison (e.g., 71 for ACL 3000, 70 for ACL Advance, 73 for ELECTRA 1600C).
   • Sample Size (Precision): Not explicitly stated how many unique samples were used to create the controls, but precision was assessed over multiple runs (n=80) for each instrument and control type.
   • Data Provenance: "In-house method comparison study." This suggests the data was generated by the manufacturer, likely in a controlled laboratory setting. The country of origin is not specified, but the manufacturer is based in Lexington, MA, USA. The study appears to be prospective for the new device as it's being compared to established predicates.

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

   • Not applicable. This device is an in vitro diagnostic (IVD) for quantitative determination of factor XII activity, not an image-based diagnostic or clinical decision support system that relies on expert human interpretation for ground truth. The "ground truth" (or reference standard) in this context is the measurement obtained from the predicate devices.

3. Adjudication method for the test set:

   • Not applicable. As above, this is an IVD device measuring a quantitative value, not subject to expert adjudication in the way an imaging study or qualitative diagnostic might be. The comparison is objective, based on measured values.

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:

   • Not applicable. This is an IVD device, not an AI-assisted diagnostic tool that involves human readers interpreting results.

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

   • Yes, this is a standalone device. Its performance is evaluated directly on patient samples (or controls) by comparing its measurements to those of predicate devices. The "algorithm" here is the biochemical assay and the instrument's processing of the reaction, without human interpretation as a performance variable.

6. The type of ground truth used:

   • For the method comparison, the "ground truth" or reference standard for comparison was the measurements obtained from the predicate devices (HemosIL Factor XII Deficient Plasma on ACL Family and Hemoliance Factor XII Deficient Plasma on ELECTRA). These are established, legally marketed devices.
   • For precision, the ground truth is against the statistical mean of the measurements themselves, for "Normal Control" and "Special Test Control Level 2" materials.

7. The sample size for the training set:

   • Not applicable in the typical sense of machine learning. This device functions as a biochemical assay, not an AI/ML model that requires a "training set" to learn from data. Its performance is based on the inherent chemical and biological principles of the assay and its manufacturing quality, not a learned algorithm.

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

   • Not applicable for the reasons stated above.

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The DiaPharma Factor X Kit is an in vitro diagnostic test kit for the quantitative determination of Factor X activity in human citrated plasma.

Factor X activity is useful for monitoring patients on oral anticoagulant therapy (warfarin) where baseline PT values may be prolonged and INR results are not reliable, such as in OAC patients with lupus inhibitors. The DiaPharma FX kit provides health care providers with a tool for with Tapac Innovelor The DiaPharma Factor X Kit is also useful for screening for factor X deficiencies.

Not Found

The provided document does not contain information about acceptance criteria or a study that proves a device meets such criteria. This document is a 510(k) premarket notification letter from the FDA to DiaPharma Group, Inc. for their DiaPharma Factor X Kit. It primarily confirms the substantial equivalence of the device to a legally marketed predicate device and outlines regulatory compliance requirements.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and a study demonstrating compliance. This type of detailed performance data is typically found in a clinical study report or a more extensive technical file, not in the FDA's initial 510(k) clearance letter.

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HemosIL Factor VIII Deficient Plasma is human plasma immunodepleted of factor VIII and intended for the in vitro diagnostic quantitative determination of factor VIII activity in citrated plasma, based on the activated partial thromboplastin time (APTT) assay, on IL Coagulation and ELECTRA Systems.

HemosIL Factor VIII Deficient Plasma is human plasma immunodepleted of factor VIII and intended for the in vitro diagnostic quantitative determination of factor VIII activity in citrated plasma, based on the activated partial thromboplastin time (APTT) assay, on IL Coagulation and ELECTRA Systems.

Abnormalities of the intrinsic pathway factors are determined by performing a modified activated partial thromboplastin time (APTT) test. Patient plasma is diluted and added to a plasma deficient in factor VIII. Correction of the clotting time of the deficient plasma is proportional to the concentration (% activity) of the factor VIII in the patient plasma, interpolated from a calibration curve.

The provided text describes the 510(k) summary for the HemosIL Factor VIII Deficient Plasma device, which is an in vitro diagnostic intended for quantitative determination of factor VIII activity. The study presented focuses on demonstrating substantial equivalence to predicate devices, rather than establishing specific clinical acceptance criteria in the way an AI/ML device would.

However, I can extract the performance data provided and frame it in a table, even if explicit "acceptance criteria" are not stated as pass/fail thresholds in the document. The study's aim was to show comparable performance to predicate devices.

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

For a diagnostic device like this, "acceptance criteria" are typically met by demonstrating performance (like correlation and precision) that is comparable to or better than a legally marketed predicate device. The document states that the device is "substantially equivalent... in performance, intended use and safety and effectiveness."

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

• Test Set Sample Size:
  • Method Comparison: Approximately 60 citrated plasma samples (30 normal and 30 abnormal) were used for each predicate comparison.
  • Within-Run and Between-Run Precision: Not explicitly stated as a number of samples, but assessed over "multiple runs (n=80) on different instruments using a specific lot of APTT reagent and both normal and abnormal samples." This refers to the number of runs, not individual patient samples. Typically, controls are run multiple times.
• Data Provenance: Not specified in the document (e.g., country of origin, retrospective or prospective).

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

This type of in vitro diagnostic device study does not typically involve human expert adjudication for ground truth in the same way an AI image analysis device would. The "ground truth" for method comparison is the result obtained from the predicate device (another established diagnostic test). For precision, the "ground truth" is the expected value of the control sample. Therefore, this section is not applicable.

4. Adjudication method for the test set

Not applicable. As noted above, this study compares the device's measurements to predicate device measurements or established control values, not to adjudicated expert opinions.

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 an in vitro diagnostic reagent, not an AI-assisted diagnostic tool that would involve human readers or image interpretation.

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

Yes, this is a standalone device. The performance data presented (method comparison, precision) reflects the device's intrinsic analytical performance when run on the specified coagulation systems. It's a reagent that works with an instrument to produce a result, without direct human-in-the-loop interpretation of that result in the way an AI would assist.

7. The type of ground truth used

• For Method Comparison: The "ground truth" was the results obtained from the predicate devices (Hemoliance Factor VIII Deficient Plasma and IL Test Factor VIII Deficient Plasma) on their respective analytical systems.
• For Precision: The "ground truth" was the assigned values of normal and low abnormal control plasmas.

8. The sample size for the training set

Not applicable. This is a conventional in vitro diagnostic device, not an AI/ML device that requires a "training set" in that sense. The device's formulation and manufacturing processes are developed to achieve the intended performance characteristics.

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

Not applicable, as there is no "training set" in the context of an AI/ML algorithm for this type of device.

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HemosIL Factor IX Deficient Plasma is human plasma immunodepleted of Factor IX and intended for the in vitro diagnostic quantitative determination of Factor IX activity in citrated plasma, based on the activated partial thromboplastin time (APTT) assay, on IL Coagulation and ELECTRA Systems.

HemosIL Factor IX Deficient Plasma is human plasma immunodepleted of Factor IX and intended for the in vitro diagnostic quantitative determination of Factor IX activity in citrated plasma, based on the activated partial thromboplastin time (APTT) assay, on IL Coagulation and ELECTRA Systems. Abnormalities of the intrinsic pathway factors are determined by performing a modified activated partial thromboplastin time (APTT) test. Patient plasma is diluted and added to a plasma deficient in factor IX. Correction of the of the deficient plasma is proportional to the concentration (% activity) of the factor IX in the patient plasma, interpolated from a calibration curve.

Here's a breakdown of the acceptance criteria and study information for the HemosIL Factor IX Deficient Plasma device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state quantitative acceptance criteria in terms of specific slope and correlation coefficient ranges. Instead, it implies that the device is acceptable if it demonstrates "substantial equivalence" to predicate devices through method comparison and satisfactory precision.

Vs. IL Test Factor IX Deficient Plasma (on ACL Family - ACL 3000):
n=76, Slope = 1.1076, r = 0.9793 |
| Precision (Within-Run) | Acceptable reproducibility of results. (No specific quantitative criteria provided). | ACL 6000: Normal 5.8% CV, Low Abnormal 8.5% CV
ACL 9000: Normal 3.0% CV, Low Abnormal 2.3% CV
ACL Futura: Normal 4.4% CV, Low Abnormal 6.0% CV
ELECTRA 1400C: Normal 8.4% CV, Low Abnormal 8.0% CV
ELECTRA 1800C: Normal 8.8% CV, Low Abnormal 8.8% CV |
| Precision (Between-Run)| Acceptable reproducibility of results across different runs. (No specific quantitative criteria provided). | ACL 6000: Normal 2.6% CV, Low Abnormal 4.1% CV
ACL 9000: Normal 3.8% CV, Low Abnormal 5.9% CV
ACL Futura: Normal 2.9% CV, Low Abnormal 2.7% CV
ELECTRA 1400C: Normal 8.3% CV, Low Abnormal 7.6% CV
ELECTRA 1800C: Normal 5.7% CV, Low Abnormal 6.4% CV |

Study Description:

The study to prove the device meets acceptance criteria involved two main parts: Method Comparison and Precision.

Method Comparison Study:

• Sample size used for the test set:
  • 65 citrated plasma samples for comparison against Hemoliance Factor IX Deficient Plasma on the E1600C.
  • 76 citrated plasma samples for comparison against IL Test Factor IX Deficient Plasma on the ACL 3000.
• Data provenance: Not explicitly stated, but "field site studies" suggest prospective collection. Country of origin not specified.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This study compares the new device's measurements against established predicate devices, which serve as the reference.
• Adjudication method for the test set: Not applicable. Direct comparison of numerical results.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this is an in-vitro diagnostic device measuring an analyte, not an imaging or diagnostic device requiring human interpretation of cases.
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Yes, the device's performance is measured in a standalone fashion, comparing its output to that of predicate devices. There is no "human-in-the-loop" component in the measurement itself.
• The type of ground truth used: The results obtained from the predicate devices (Hemoliance Factor IX Deficient Plasma and IL Test Factor IX Deficient Plasma) served as the comparative 'ground truth' or reference for demonstrating substantial equivalence.
• The sample size for the training set: Not applicable. This is not a machine learning model requiring a training set.
• How the ground truth for the training set was established: Not applicable.

Precision Study (Within-Run and Between-Run):

• Sample size used for the test set: "multiple runs (n=80)" for each instrument/control combination (40 measurements for Normal Control, 40 measurements for Low Abnormal Control on each of the 5 instruments listed, for a total of 80 measurements per instrument/control pair over the multiple runs).
• Data provenance: Not explicitly stated, but implies laboratory testing.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Precision is about the device's own consistency.
• Adjudication method for the test set: Not applicable.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, this is a standalone performance metric of the device's reproducibility.
• The type of ground truth used: Not applicable. This study assesses the consistency of the device's measurements on control samples, rather than comparing to an independent ground truth. The "control" samples themselves have established target ranges, but the study measures the device's variability around the mean.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

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