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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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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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