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510(k) Data Aggregation
(126 days)
HYPHEN BIOMED
ZYMUTEST HIA IgG and IgGAM kits are designed as a solid phase enzyme- linked immunosorbent assay (ELISA). These products are intended to be used as an in vitro diagnostics kit by Hematology, coagulation or other pathology laboratories to assist in screening patients samples for the presence of heparin- associated antibodies commonly found in patients with heparin induced thrombocytopenia or thrombosis (HIT).
The ZYMUTEST HIA is solid phase enzyme linked immunosorbent assay (ELISA) designed to detect antibodies. These antibodies are found in some patients undergoing heparin therapy.
The provided 510(k) summary describes the ZYMUTEST HIA IgG and ZYMUTEST HIA IgGAM devices, which are ELISA kits designed to detect heparin-associated antibodies related to Heparin Induced Thrombocytopenia (HIT). The submission establishes substantial equivalence to existing predicate devices (ASSERACHROM ®HPIA Test Kit and PF4 ENHANCED Solid Phase ELISA).
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly based on establishing substantial equivalence with the predicate devices. The primary performance metrics reported are agreement, co-positivity, and co-negativity with the predicate devices, along with intra- and inter-assay reproducibility. Specific numerical acceptance criteria are not explicitly stated as target percentages for agreement, co-positivity, or co-negativity, but the general conclusion implies that the observed values meet the FDA's criteria for substantial equivalence.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Agreement (vs. Predicate) | Sufficient agreement to demonstrate substantial equivalence | Zymutest IgGAM vs. Asserachrom (n=243): 76% |
| Zymutest IgGAM vs. GTI PF4 Enhanced (n=345): 74% | ||
| Zymutest IgG vs. Asserachrom (n=243): 76% | ||
| Co-positivity (vs. Predicate) | Sufficient co-positivity to demonstrate substantial equivalence | Zymutest IgGAM vs. Asserachrom (n=243): 64% |
| Zymutest IgGAM vs. GTI PF4 Enhanced (n=345): 58% | ||
| Zymutest IgG vs. Asserachrom (n=243): 44% | ||
| Co-negativity (vs. Predicate) | Sufficient co-negativity to demonstrate substantial equivalence | Zymutest IgGAM vs. Asserachrom (n=243): 81% |
| Zymutest IgGAM vs. GTI PF4 Enhanced (n=345): 90% | ||
| Zymutest IgG vs. Asserachrom (n=243): 90% | ||
| Intra-assay Reproducibility | CV below 10% | CVs below 10% (for positive control) |
| Inter-assay Reproducibility | CV below 10% | CVs below 10% (for positive control) |
2. Sample Size for the Test Set and Data Provenance
- Zymutest IgGAM vs. Asserachrom (internal study): 44 plasma samples. Provenance not specified, but stated as an "internal study," suggesting it was conducted by Hyphen BioMed. Retrospective or prospective nature is not specified.
- Zymutest IgGAM vs. Asserachrom (clinical studies): 243 plasma samples. Provenance from "Combined Site 1 & 2." Specific country of origin or whether retrospective/prospective is not specified.
- Zymutest IgGAM vs. GTI PF4 Enhanced (clinical studies): 345 plasma samples. Provenance from "Combined Sites 1,2,3." Specific country of origin or whether retrospective/prospective is not specified.
- Zymutest IgG vs. Serotonin Release Assay (SRA) (clinical studies): 174 samples. Provenance not specified. This appears to be a reference method rather than a predicate.
- Zymutest IgG vs. Asserachrom (clinical studies): 243 samples. Provenance from "Combined Sites 1 & 2." Specific country of origin or whether retrospective/prospective is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
The ground truth for the comparison studies was established by the predicate devices (ASSERACHROM ®HPIA and PF4 ENHANCED) and the Serotonin Release Assay (SRA). There is no mention of human experts being used to establish ground truth for the test set; instead, the results of existing, legally marketed diagnostic tests are used as the reference.
4. Adjudication Method for the Test Set
Not applicable. The comparisons are directly against the results of the predicate devices or the SRA, not against expert consensus.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This is an in vitro diagnostic device, and the evaluation focuses on its performance compared to other diagnostic assays, not on human reader performance with or without AI assistance.
6. Standalone Performance Study
Yes, the studies presented are standalone performance studies of the ZYMUTEST HIA IgG and IgGAM devices, comparing their results directly with established predicate devices and a reference method (SRA). The performance metrics (agreement, co-positivity, co-negativity, reproducibility) characterize the algorithm's (device's) performance.
7. Type of Ground Truth Used
The ground truth used for the comparison studies was the results obtained from legally marketed predicate in vitro diagnostic devices (ASSERACHROM ®HPIA and PF4 ENHANCED) and a reference assay (Serotonin Release Assay - SRA). This falls under the category of using established, validated diagnostic tests as the reference standard.
8. Sample Size for the Training Set
The document does not provide information about a "training set" in the context of machine learning or AI. This device is an ELISA kit, not an AI-powered diagnostic system. The validation studies instead compare the device's performance against existing methods.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no mention of a training set for machine learning or AI in this 510(k) submission.
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(464 days)
HYPHEN BIOMED
Biophen Heparin is an in vitro diagnostic test for the quantitative determination of unfractionated heparin (UFH) activity in human citrated plasma using automated or manual methods. The nopant of UFH is determined from the Anti factor Xa (anti-FXa) activity expressed by the [AT* Heparin] complex formed in plasma. Heparin is used for curative or preventive indications. Measuring Heparin concentration in patient's plasma allows monitoring therapy and adjusting drug dosage.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA for a heparin assay device. It does not contain the detailed study information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or multi-reader multi-case studies typically associated with AI/ML device evaluations. Such information is usually found in the 510(k) summary or full submission, not in the FDA's decision letter.
Therefore, I cannot fulfill your request for a table of acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details from the given text.
The document primarily states that the device is substantially equivalent to a predicate device for the quantitative determination of unfractionated heparin (UFH) activity in human citrated plasma.
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(316 days)
HYPHEN BIOMED
Biophen Protein C 5 & 2.5 kit is a Chromogenic assay for measuring the Protein C Activity in human citrated plasma using a manual or an automated method. Biophen Protein C 5 & 2.5 Kit is a Chromogenic assay for measuring the Protein C Activity in human citrated plasma using a manual or an automated method.
Biophen Protein C is a chromogenic assay consisting of chromogenic substrate and Protein C activator.
This document describes a 510(k) submission for the "Biophen Protein C 5 & 2.5" device, a chromogenic assay for the quantitative determination of Protein C activity in human plasma. The submission focuses on demonstrating substantial equivalence to a predicate device, the "Coamatic Protein C".
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" for the Biophen Protein C device. Instead, it presents performance data for "Intra-Assay CV%" and "Inter-Assay CV%", which are common metrics for assay precision. The implication is that these performance characteristics are considered acceptable due to their similarity to the predicate device, which is already legally marketed.
| Metric | Acceptance Criteria (Implied by Predicate Performance) | Reported Device Performance (Biophen Protein C 5 & 2.5) |
|---|---|---|
| Intra-Assay CV% | Not explicitly stated; likely |
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(203 days)
HYPHEN BIOMED
Biophen Low Molecular Weight Heparin (LMWH), Low Molecular Weight Heparin Low (LMWH Low) and Unfractionated Heparin (UFH) control are set of control plasmas for the quality control of Low Molecular weight Heparin(LMWH) and Unfractionated Heparin(UFH) measurements using anti Xa colorimetric assays (Biophen Heparin 3 & 6) . These control plasmas are within the usual therapeutic range recommended for the low molecular weight heparin (LMWH) and Unfractionated Heparin (UFH).
Biophen Heparin & Unfractionated heparin (UFH) Calibrators are set of calibration plasmas for the calibration of Low molecular weight heparin (LMWH) and Unfractionated heparin, using anti-Xa colorimetric assays.
Biophen LMWH, LMWH Low and UFH Control Plasma is an in vitro diagnostic quality control intended for use with chromogenic assays to assess precision and accuracy at Heparin low and high levels (in the usual recommended therapeutic range).
Biophen Heparin Calibrator is a set of calibration plasmas for Heparin (UFH and LMWH) measurements, using anti-Xa colorimetric assays (BIOPHEN HEPARIN 3 and 6). Biophen Heparin Calibrator allows calibrating the assays of Low Molecular Weight Heparin (LMWH) using chromogenic anti-Xa methods. It can be also used for calibrating the measurements of Unfractionated Heparin (UFH) when the BIOPHEN Heparin kit is used. Biophen heparin is a chromogenic anti-Xa method developed for measuring homogeneously heparin (UFH) and Low Molecular Weight Heparin (LMWH), using the same calibration curve.
BIOPHEN UFH Calibrator is a set of calibration plasmas for Unfractionated Heparin (UFH) measurements, using anti-Xa colorimetric assays (BIOPHEN HEPARIN 3 and 6). BIOPHEN UFH Calibrator allows calibrating the measurements of Unfractionated Heparin (UFH) when the BIOPHEN Heparin kit is used.
The provided text describes two separate devices: "Biophen LMWH and UFH Control Plasma" and "Biophen Heparin Calibrator/Biophen UFH Calibrator." I will address the acceptance criteria and study information for each.
Device 1: Biophen LMWH and UFH Control Plasma
This device is an in vitro diagnostic quality control intended for use with chromogenic assays to assess precision and accuracy at Heparin low and high levels in the usual recommended therapeutic range.
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that the device is "substantially equivalent in performance" to its predicate devices. The performance data provided focuses on reproducibility. The acceptance criteria are defined by the "Acceptable Range" within which the measured concentration of LMWH or UFH should fall. The device performance is indicated by the reported LMWH/UFH Concentration and the Standard Deviation (SD).
| Biophen LMWH Control | LMWH Concentration (IU/ml) | Acceptable Range (IU/ml) | N | SD |
|---|---|---|---|---|
| Level 3 | 0.79 | 0.69 - 0.89 | 69 | 0.03 |
| Level 4 | 1.25 | 1.10 - 1.40 | 69 | 0.05 |
| Biophen LMWH Control Low | LMWH Low Concentration (IU/ml) | Acceptable Range (IU/ml) | N | SD |
|---|---|---|---|---|
| Level I | 0.25 | 0.17 - 0.33 | 43 | 0.02 |
| Level II | 0.50 | 0.40 - 0.60 | 43 | 0.03 |
| Biophen UFH Control | UFH Concentration (IU/ml) | Acceptable Range (IU/ml) | N | SD |
|---|---|---|---|---|
| Level 1 | 0.21 | 0.11 - 0.31 | 30 | 0.01 |
| Level 2 | 0.51 | 0.36 - 0.66 | 30 | 0.02 |
2. Sample size used for the test set and the data provenance:
- Sample sizes (N):
- Biophen LMWH Control (Level 3 & 4): 69 samples each
- Biophen LMWH Control Low (Level I & II): 43 samples each
- Biophen UFH Control (Level 1 & 2): 30 samples each
- Data Provenance: The document does not explicitly state the country of origin or whether the data is retrospective or prospective. Hyphen BioMed is based in France.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is a quality control plasma, and the "ground truth" (target concentration and acceptable range) is established by the manufacturer through multiple determinations and validated through reproducibility studies, not by clinical experts in the same way imaging or diagnostic studies requiring expert review would.
4. Adjudication method for the test set:
Not applicable. The performance is based on quantitative measurements and statistical analysis (mean, standard deviation), not subjective expert judgment requiring adjudication.
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 quality control plasma, 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 an in vitro diagnostic quality control plasma.
7. The type of ground truth used:
The ground truth used is the target concentration of LMWH or UFH, established by the manufacturer through multiple determinations (implied by the reporting of mean concentrations and standard deviations). The "Acceptable Range" serves as the clinical or analytical tolerance around this ground truth.
8. The sample size for the training set:
Not applicable. This is not an AI/ML device; therefore, there is no "training set" in the context of machine learning. The "N" values in the table refer to the number of measurements taken for the reproducibility study.
9. How the ground truth for the training set was established:
Not applicable.
Device 2: Biophen Heparin Calibrator & Biophen UFH Calibrator
This device is a set of calibration plasmas for Heparin (UFH and LMWH) measurements, using anti-Xa colorimetric assays. Its intended use is to calibrate assays for LMWH and UFH.
1. Table of Acceptance Criteria and Reported Device Performance:
Similar to the control plasma, the "ground truth" for the calibrators is their established concentration. The performance is assessed by reproducibility, specifically Intra-Assay and Inter-Assay %CV (Coefficient of Variation) or SD. The acceptance criteria are implicitly that the CV/SD values demonstrate "good reproducibility" as stated in the summary.
Biophen Heparin Calibrator (LMWH)
| Calibrator | Concentration in LMWH (IU/ml) | Intra Assay N | Intra Assay CV | Inter Assay N | Inter Assay SD |
|---|---|---|---|---|---|
| Calibrator 1 | 0 | 10 | NA | 50 | 0.01 |
| Calibrator 2 | 0.38 | 10 | 2.3 | 50 | 0.02 |
| Calibrator 3 | 0.77 | 10 | 0.5 | 50 | 0.03 |
| Calibrator 4 | 1.14 | 10 | 1.0 | 50 | 0.05 |
| Calibrator 5 | 1.5 | 10 | 0.5 | 50 | 0.06 |
Biophen UFH Calibrator (Unfractionated Heparin)
| Calibrator | Concentration in Unfractionated Heparin (IU/ml) | Intra Assay N | Intra Assay CV | Inter Assay N | Inter Assay SD |
|---|---|---|---|---|---|
| Calibrator 1 | 0 | 10 | NA | 28 | 0 |
| Calibrator 2 | 0.36 | 10 | 1.4 | 28 | 0.02 |
| Calibrator 3 | 0.74 | 10 | 1.0 | 28 | 0.04 |
| Calibrator 4 | 1.08 | 10 | 0.5 | 28 | 0.06 |
| Calibrator 5 | 1.42 | 10 | 0.5 | 28 | 0.08 |
2. Sample size used for the test set and the data provenance:
- Sample sizes (N): The tables provide the number of measurements for "Intra Assay" (N=10 for all levels) and "Inter Assay" (N=50 for LMWH calibrators, N=28 for UFH calibrators).
- Data Provenance: The document does not explicitly state the country of origin or whether the data is retrospective or prospective. Hyphen BioMed is based in France.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Similar to the control plasma, the "ground truth" (concentration) is established by the manufacturer through multiple determinations and validated through reproducibility studies.
4. Adjudication method for the test set:
Not applicable. Performance is based on quantitative measurements and statistical analysis (CV, SD).
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 calibrator, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable.
7. The type of ground truth used:
The ground truth used is the target concentration of LMWH or UFH in the calibrator plasma, determined by the manufacturer from "multiple determinations."
8. The sample size for the training set:
Not applicable. This is not an AI/ML device; therefore, there is no "training set." The "N" values in the table refer to the number of measurements taken for the reproducibility study.
9. How the ground truth for the training set was established:
Not applicable. The document states that "The concentration of the calibrators is determined from the multiple determinations." This is how the ground truth for these calibrators was established.
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(371 days)
HYPHEN BIOMED
BIOPHEN Antithrombin 2.5 and 5 kit, is an in vitro diagnostic test for the quantitative determination of Antithrombin in human plasma, as an aid in the diagnosis of thrombophilia (a congenital deficiency of Antithrombin).
Biophen Antithrombin 2.5 and 5 kit, an in vitro diagnostic test for the quantitative determination of Antithrombin in human plasma to monitor the Antithrombin concentration in human plasma, in instances of recurrent thrombosis resulting from a congenital or acquired deficiency of Antithrombin.
The provided text describes the Biophen Antithrombin device and its performance relative to a predicate device, Coamatic® Antithrombin. The study presented here is focused on demonstrating substantial equivalence to the predicate device, not on establishing de novo clinical utility or a standalone performance against a clinical ground truth.
Here's an analysis based on your questions:
1. Table of Acceptance Criteria and Reported Device Performance
The core acceptance criterion for substantial equivalence in this context is a strong correlation with the predicate device and acceptable reproducibility (intra-assay and inter-assay variability).
| Acceptance Criteria | Reported Device Performance (Biophen® Antithrombin) |
|---|---|
| Correlation with Predicate Device (Coamatic® Antithrombin) | 0.99 |
| Intra-Assay Reproducibility | Sample 1: 0.73% CV |
| Sample 2: 0.66% CV | |
| Sample 3: 0.92% CV | |
| Inter-Assay Reproducibility | Sample 1: 2.57% CV |
| Sample 2: 2.49% CV | |
| Sample 3: 3.72% CV |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 21 samples
- Data Provenance: The plasma samples were "received from hospital," implying they are clinical samples. The country of origin is not explicitly stated, but the submission is from Hyphen Biomed, France, and the FDA review process is for the US market. It is retrospective as samples were "received from hospital" and tested.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This type of study does not involve establishing ground truth by human experts in the typical sense for diagnostic imaging or subjective assessments. Instead, the performance of the new device (Biophen Antithrombin) is compared to the results obtained by a predicate device (Coamatic® Antithrombin), which serves as the "reference" or "ground truth" for the comparison of analytic performance. Therefore, no human experts were used to establish the "ground truth" for the test set in this context. The "truth" is established by the measurements of the predicate device.
4. Adjudication Method for the Test Set
Not applicable. As described in point 3, there was no expert adjudication process. The comparison was directly between the quantitative results of two laboratory devices.
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 (IVD) device for quantitative determination of Antithrombin, not an imaging AI or a device that assists human readers. Therefore, an MRMC study or assessment of human reader improvement with AI assistance is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, in a way. The "performance data" provided clearly represents the standalone analytical performance of the Biophen Antithrombin device. It measures the Antithrombin concentration directly from plasma samples. There is no human "in the loop" impacting the quantitative measurement itself, beyond handling the samples and operating the automated system (ACL, BCS). The comparison to the predicate device is also a standalone comparison of two device-generated results.
7. The Type of Ground Truth Used
The "ground truth" for this study is not a clinical outcome or pathology report, but rather the results obtained from the legally marketed predicate device, Coamatic® Antithrombin. The study aims to demonstrate that Biophen Antithrombin produces results substantially equivalent to an already approved device.
8. The Sample Size for the Training Set
The document does not provide information about a "training set" for the Biophen Antithrombin device itself. This is an IVD kit, not a machine learning algorithm that requires a training set in the conventional sense. The development of such a kit would involve internal validation and optimization, but these details are not part of this 510(k) summary.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of a training set for a machine learning algorithm. The "training" of an IVD device like this would involve internal R&D to define reagents and protocols, but this is not disclosed in the summary.
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(93 days)
HYPHEN BIOMED
Biophen Plasma Calibrator is normal citrated human plasma used as the calibrator in the assay for the coagulation factors Antithrombin III and Protein C. The Biophen Plasma Calibrator is tested for the absence of Lupus Anticoagulant and can be used for this investigation.
Biophen Normal and Abnormal Control Plasma is a set of 12 vials each of normal citrated human plasma used as quality control of some coagulation factors. The Biophen Normal and Abnormal Control Plasma are tested for the absence of Lupus Anticoagulant and can be used as a negative control for this investigation. This control plasma is also tested for the absence of Activated Protein C resistance (APCR): when tested with or without Activated Protein C (APC), the ratio obtained (APTT + APC/APTT) is ≥ 2.00 for the Normal Control Plasma.
BIOPHEN Plasma Calibrator reagent is composed of citrated normal human plasma, lyophilised in the presence of additives and preservatives. It contains 12 vials of lyophilised reagent to be reconstituted with 1 ml distilled water.
Biophen Normal and Abnormal Control Plasma is a set of 12 vials each of normal citrated human plasma used as quality control of some coagulation factors.
The provided text describes three medical devices: the Biophen Plasma Calibrator, Biophen Normal Control Plasma, and Biophen Abnormal Control Plasma. The information provided is primarily focused on their intended use, composition, and comparison to predicate devices, rather than a detailed study evaluating their performance against specific acceptance criteria.
Therefore, I cannot fully complete all sections of your request as the document does not contain the specific details of a performance study with acceptance criteria, sample sizes, ground truth establishment, or expert involvement as you've outlined.
However, I can extract information related to the device's characteristics and its intended use, which indirectly serve as a form of "acceptance criteria" in the context of substantial equivalence to predicate devices.
Here's a breakdown based on the available information:
Acceptance Criteria and Device Performance (Based on Substantial Equivalence Claim)
The "acceptance criteria" for these devices appear to be their ability to perform equivalently to their predicate devices for their intended uses. The document states that the devices use the same principles as the predicate devices and are "substantially equivalent in performance, intended use and safety and effectiveness."
| Acceptance Criteria / Performance Claim | Reported Device Performance | Comments |
|---|---|---|
| Biophen Plasma Calibrator: | ||
| Calibrator for ATIII assays | Substantially equivalent to predicate plasma calibrators | The document implies equivalence to established calibrators, but a specific predicate for the calibrator isn't mentioned in detail beyond "legally marketed predicate devices." Its purpose is to calibrate specific coagulation factor assays. |
| Calibrator for Protein C assays | Substantially equivalent to predicate plasma calibrators | Supports the calibration of Protein C assays. |
| Calibrator for Lupus Anticoagulant investigation | Tested for absence of Lupus Anticoagulant | Used as a calibrator for Lupus Anticoagulant investigations. |
| Biophen Normal Control Plasma: | ||
| Quality control for ATIII assays | Substantially equivalent to "Control Plasma N" (K001256) | Claims equivalent performance to the predicate device for QC of ATIII. |
| Quality control for Protein C assays | Substantially equivalent to "Control Plasma N" (K001256) | Claims equivalent performance to the predicate device for QC of Protein C. |
| Negative control for Lupus Anticoagulant investigation | Tested for absence of Lupus Anticoagulant | Claims equivalent performance to the predicate device for LA control. |
| Absence of Activated Protein C resistance | Ratio (APTT + APC/APTT) ≥ 2.00 | This is a specific performance characteristic for the Normal Control Plasma. |
| Biophen Abnormal Control Plasma: | ||
| Quality control for ATIII assays | Substantially equivalent to "Lyphochek® Hemostasis Control" (K020878) | Claims equivalent performance to the predicate device for QC of ATIII. |
| Quality control for Protein C assays | Substantially equivalent to "Lyphochek® Hemostasis Control" (K020878) | Claims equivalent performance to the predicate device for QC of Protein C. |
| Negative control for Lupus Anticoagulant investigation | Tested for absence of Lupus Anticoagulant | Claims equivalent performance to the predicate device for LA control. |
Study Details Based on the Provided Information:
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document does not specify a numerical sample size for any test set.
- The data provenance is not explicitly stated as a formal "study" with a test set in the traditional sense. The submission is a 510(k) for substantial equivalence, which relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device. This often involves comparative testing, but the details of such testing (e.g., number of samples, origin) are not provided here. The manufacturer is Hyphen Biomed, based in France.
-
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 document does not provide information about experts establishing ground truth for a test set. This type of information is typically part of a detailed clinical or performance study report, which is not present here.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- The document does not provide information about an adjudication method.
-
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 MRMC study was mentioned or implied. These devices are calibrators and controls for in-vitro diagnostic assays, not AI-assisted reading tools.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- These are reagents (plasma calibrators and controls), not algorithms. Therefore, a standalone algorithm performance study is not applicable.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For "Biophen Plasma Calibrator": The "ground truth" implicitly refers to the established values of coagulation factors (ATIII, Protein C) in normal human plasma as determined by validated laboratory methods, against which the calibrator would be standardized. For Lupus Anticoagulant, the ground truth is the absence of Lupus Anticoagulant as determined by specific testing.
- For "Biophen Normal and Abnormal Control Plasma": The "ground truth" for these controls would be their expected diagnostic values for ATIII, Protein C, and the presence/absence of Lupus Anticoagulant, and APC resistance status, established through validated assays and comparison to predicate devices and potentially reference materials. The Normal Control Plasma explicitly has a ground truth for APC resistance (ratio ≥ 2.00).
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The sample size for the training set
- The document does not mention a "training set" as this is not an AI/machine learning device. The closest concept would be the pooled normal human plasma used in the manufacturing process (e.g., "Normal human citrated pooled plasma" for the calibrator, which contains >75% human plasma). The size of this pool is not specified.
-
How the ground truth for the training set was established
- Not applicable as there is no "training set" in the context of an AI device. The controls and calibrators are derived from pooled human plasma, and their characteristics are established through analytical testing against known standards and predicate devices.
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