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510(k) Data Aggregation
(903 days)
Medica Corporation
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(592 days)
Medica corporation
The EasyStat 300 is designed for clinical laboratory use, making quantitative measurements of potassium (K+), ionized calcium (Ca++), and chloride (Cl-) in whole blood (arterial/venous) samples from Li-Heparinized Syringes. This Analyzer should only be used by trained technical laboratories to aid in the dagnosis and treatment of patients with electrolyte and/or acid-base disturbances.
Potassium (K+) measurements are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.
Calcium (Ca++) (ionized) measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).
Chloride (Cl-) measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
The EasyStat 300 is a system for use by health care professionalsto rapidly analyze venous and arterial whole blood samples in a clinical laboratory setting. The analyzer incorporates a Reagent Module containing the "calibrating" solutions A2, B2, and a "conditioning" solution C2. Calibrations are performed automatically or on-demand by the user to establish the "slope" of each sensor, used in the calculation of the patient sample.
The analyzer employs "Ion Selective Electrode" (ISE) sensors for K*, Ca**, Cl¯.
The EasyStat 300 uses 175µL of whole blood in the "Syringe" mode to analyze patient samples. The EasyStat 300 reports results for Potassium (K+), Calcium (Ca++), Chloride (Cl-). Additionally, it provides a number of calculated parameters based on the reported results and a number of input parameters as described in the Operator's Manual.
Medica's EasyQC materials (REF 8315/8316/8317) are specifically formulated for the EasyStat 300. Medica requires the use of quality controls every day patient samples are analyzed and after any troubleshooting is performed, as instructed in the Operator's Manual, to validate the performance of the analyzer. The analyzer stores QC results and provides a statistical analysis of its performance using Levey-Jennings plots for the last 30 consecutive days.
The Reagent Module (REF 8101) has a twelve-month shelf-life when stored at 4º-25ºC.
The electrolyte sensors (K, Ca, Cl) have one-year shelf-life when stored at 4º-25ºC. Use-Life of the sensors is determined from their calibration profiles and from the reported results during the EasyQC analysis. Sensors are replaced by the operator as described in the Operator's Manual. An automatic calibration is performed after installation to qualify the new sensor(s) and the operator is instructed to use the EasyQC multi-level QC materials to validate the EasyStat 300 performance.
The EasyStat 300 may be equipped with a Medica provided barcode scanner (REF 8420) via a USB port to automatically enter patient sample and EasyQC material information. Details are provided in the operator's Manual.
To maintain the performance of the analyzer Medica provides a cleaning solution (REF 8305) and a troubleshooting kit (REF 8250). Their proper uses are described also in the operator's Manual.
Here's an analysis of the provided text to extract the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document details various performance studies (Precision, Linearity, Method Comparison, Sensitivity, Selectivity) and lists specifications or desired outcomes that serve as acceptance criteria. The actual performance is described within each study's results.
Note: The document does not explicitly present a "table of acceptance criteria and reported device performance" as a single, consolidated table. I will construct it based on the details provided in different sections.
| Study Type | Analyte | Acceptance Criteria / Performance Specification | Reported Device Performance (Summary from text) |
|---|---|---|---|
| 20-Day Precision (Aqueous Controls) | Cl- (Repeatability) | Level 1: SD 2.0 | Level 1: SD ~0.04-0.05 |
| Cl- (Repeatability) | Level 2: 1.5% CV | Level 2: CV ~0.0% | |
| Cl- (Repeatability) | Level 3: 1.7% CV | Level 3: CV ~0.1% | |
| Cl- (Within-Device Total) | Level 1: SD 2.5 | Level 1: SD ~0.13-0.24 | |
| Cl- (Within-Device Total) | Level 2: 1.8% CV | Level 2: CV ~0.1% | |
| Cl- (Within-Device Total) | Level 3: 2.0% CV | Level 3: CV ~0.1% | |
| Ca++ (Repeatability) | Level 1: 2.0% CV | Level 1: CV ~0.1-0.2% | |
| Ca++ (Repeatability) | Level 2: 2.0% CV | Level 2: CV ~0.0-0.4% | |
| Ca++ (Repeatability) | Level 3: SD 0.02 | Level 3: SD ~0.00 | |
| Ca++ (Within-Device Total) | Level 1: 2.5% CV | Level 1: CV ~0.1-0.3% | |
| Ca++ (Within-Device Total) | Level 2: 2.5% CV | Level 2: CV ~0.0-0.5% | |
| Ca++ (Within-Device Total) | Level 3: SD 0.03 | Level 3: SD ~0.00 | |
| K+ (Repeatability) | Level 1: SD 0.07 | Level 1: SD ~0.00 | |
| K+ (Repeatability) | Level 2: 1.5% CV | Level 2: CV ~0.1-0.2% | |
| K+ (Repeatability) | Level 3: 2.0% CV | Level 3: CV ~0.1-0.3% | |
| K+ (Within-Device Total) | Level 1: SD 0.10 | Level 1: SD ~0.00-0.01 | |
| K+ (Within-Device Total) | Level 2: 2.0% CV | Level 2: CV ~0.1-0.3% | |
| K+ (Within-Device Total) | Level 3: 2.5% CV | Level 3: CV ~0.1-0.4% | |
| 5-Day Repeatability (Whole Blood) | Cl- | All results within specification (implied from 20-day aqueous specs, though not explicitly restated for whole blood) | CVs generally 0.1-0.5% |
| Ca++ | All results within specification | CVs generally 0.2-1.0% (SDs 0.000-0.024) | |
| K+ | All results within specification | CVs generally 0.3-1.2% (SDs 0.006-0.093) | |
| Linearity Study | Cl-, Ca++, K+ | All analytes linear within the advertised reportable range (PASS in table) | All analytes demonstrated linearity with R2 values close to 1.000 (e.g., K+ 0.999-1.000, Ca++ 0.999-1.000, Cl- 0.999-1.000) |
| Method Comparison Study | K+ (e.g. at 3.00 MDL) | Predicted Bias within 95% Confidence Interval and within 100% Total Allowable Error | Bias 0.016 (CI 3.01-3.02), Total Allowable Error 2.50-3.50. Status: PASS |
| Cl- (e.g. at 90.0 MDL) | Predicted Bias within 95% Confidence Interval and within 100% Total Allowable Error | Bias 0.25 (CI 90.1-90.4), Total Allowable Error 85.5-94.5. Status: PASS | |
| Ca++ (e.g. at 0.37 MDL) | Predicted Bias within 95% Confidence Interval and within 100% Total Allowable Error | Bias -0.022 (CI 0.34-0.35), Total Allowable Error 0.27-0.47. Status: PASS | |
| Sensitivity Study | K+ | LoQ |
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(617 days)
Medica Corporation
The EasyStat 300 is designed for clinical laboratory use, making quantitative measurements of pO2 (partial pressure of oxygen), pCO2 (partial pressure of carbon dioxide), and pH (hydrogen ion activity) in whole blood (arterial/venous) samples from Li-Heparinized Syringes or Capillary Tubes. This Analyzer should only be used by trained technicians in clinical laboratories to aid in the diagnosis and treatment of patients with blood gas and/or acid-base disturbances.
Blood gases (p02, pCO2) and pH measurements in blood are used in the diagnosis and treatment of life-threatening acidbase disturbances.
The EasyStat 300 is a system for use by health care professionals to rapidly analyze whole blood samples. The analyzer incorporates a Reagent Module containing the "calibrating" solutions A2, B2, and a "conditioning" solution C2, which is also use a calibrant for the Oxygen sensor. Calibrations are performed automatically or on-demand by the user to establish the "slope" of each sensor used in the calculation of the patient sample. The EasyStat 300 uses 175μL of whole blood in the "Syringe" mode and 100μL of whole blood in the "Capillary" mode to analyze patient samples. The EasyStat 300 reports results for blood Gases (PCO2, PO2), and pH. Additionally, it provides a number of calculated parameters based on the reported results and a number of input parameters as described in the Operator's Manual. The EasyStat 300 is a microprocessor-controlled device with a touch sensitive screen that guides the operator through the different menu options and proper operation. It also incorporates a thermal printer to record all reported results and patient information as described in the Operator's Manual. The device software has incorporated routines to assist the end-user with maintenance, cleaning, and troubleshooting activities also outlined in the manual. The incorporated USB port may be used to download data and also to update the software version based on detailed instructions by Medica Corporation. The blood gas and pH sensors require calibration and cleaning after a predefined number of samples are analyzed as described in the Operator's Manual. The pH and PCO2 sensors are based on potentiometric sensor design, generating a small voltage that is dependent on the concentrations of these analytes in the patient sample. The PO2 sensor is based on amperometric sensor design that generates a small current that is dependent on the concentration of oxygen in the patient sample. Medica's EasyQC materials are specifically formulated for the EasyStat 300. The EasyStat 300 may be equipped with a Medica provided barcode scanner via a USB port to automatically enter patient sample and EasyQC material info. To maintain the performance of the analyzer Medica provides a cleaning solution and a troubleshooting kit.
Here's a breakdown of the acceptance criteria and the study that proves the EasyStat 300 device meets these criteria, based on the provided FDA 510(k) summary.
Key Findings from the Document:
- Device: EasyStat 300 Blood Gas Analyzer
- Purpose: Measures pO2, pCO2, and pH in whole blood.
- Comparison: Substantially equivalent to its predicate device, the EasyStat Blood Gas Analyzer (K021515).
- Studies Conducted: Precision (Repeatability, Reproducibility), Linearity, Method Comparison, Sensitivity, and Selectivity (Interference).
- Ground Truth for Analytical Studies: Primarily based on pre-assayed whole blood samples, aqueous QC materials, and tonometered whole blood, with comparisons against results from the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a single table labeled "Acceptance Criteria," but rather presents "Performance Specs" within the precision studies and "Status" (PASS) for linearity and method comparison, indicating adherence to pre-defined criteria. The interference study uses a "Conclusion" column based on a predefined percentage change. Based on the data provided, the acceptance criteria are inferred from the "Performance Specs" headers and the overall "PASS" status for each test.
| Assay Category | Acceptance Criteria (Performance Specs) | Reported Device Performance (Summary) |
|---|---|---|
| Precision | ||
| Repeatability | pO2: Level 1: 2.5 SD; Level 2: 2.5 SD; Level 3: 2.5% CV | Aqueous Controls (Syringe Mode): All results "within specification." Examples: |
- System 1 PO2 Level 1: 1.39 SD (vs 2.5 SD)
- System 1 PCO2 Level 1: 0.9 CV (vs 5.0% CV)
- System 1 pH Level 1: 0.002 SD (vs 0.020 SD)
Aqueous Controls (Capillary Mode): All results "within specification." Examples:
- Unit 1 PO2 Level 1: 2.70 SD (vs 3 SD)
- Unit 1 PCO2 Level 1: 1.5 CV (vs 5.0% CV)
- Unit 1 pH Level 1: 0.004 SD (vs 0.020 SD) |
| Reproducibility | pO2: Level 1: 2.5mmHg; Level 2: 2.5mmHg; Level 3: 3.0% CV | 5-day w. Blood Study (Syringe Mode): All results "within specification." Examples: - PO2 Level 1: 0.6 SD (vs 2.5mmHg)
- PCO2 Level 1: 0.5 SD (vs 2.0% CV, implied from table structure)
- pH Level 1: 0.007 SD (vs 0.015 units)
5-day w. Blood Study (Capillary Mode): All results "within specification." Examples:
- PO2 Level 1: 0.9 SD (vs 2.4mmHg)
- PCO2 Level 1: 2.5 CV (vs 4.0% CV)
- pH Level 1: 0.008 SD (vs 0.015 units) |
| Linearity | "met all device specifications" (implied criteria typically high R^2 values, slope ~1) | Data shown (e.g., for ES300-P7): - PO2 (Syringe): R² 0.999, Slope 1.016 (PASS)
- PCO2 (Syringe): R² 0.999, Slope 1.066 (PASS)
- pH (Syringe): R² 0.996, Slope 1.008 (PASS)
Conclusion: "all analytes... are linear within the advertised reportable range." |
| Method Comparison | "linear regression slope, the coefficient of variation, and the calculated predicted bias at the decision levels for each analyte were within specifications." (implied) | Exemplified by PO2 Syringe Mode: - n=272, Slope=1.001, R²=0.999
- Predicted Bias for PO2 (30.0, 45.0, 60.0): All PASS ("within specifications," typically close to 0 bias and CI within allowable error).
Conclusion: "all analytes... are favorably correlated to the predicate/reference device... within specifications." |
| Sensitivity | LoQ
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(471 days)
Medica Corporation
The EasyLyte Na/K/C/Ca Analyzer is intended for in-vitro diagnostic testing of sodium (Na), Potassium (K), Chloride (CL), and lonized Calcium (Ca++) without pH correction.
The ionized calcium test on the EasyLyte Na/K/C//Ca analyzer is intended for the quantitative determination of calcium ions (Ca++) in human serum, plasma and whole Blood in clinical laboratories. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone disease and tetany finternittent muscular contractions or spasms).
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The provided text is a 510(k) premarket notification letter from the FDA to MEDICA CORPORATION for their EasyLyte Na/K/Cl/Ca Analyzer. This document primarily focuses on the regulatory aspects of the device, stating that the FDA has determined it is "substantially equivalent" to legally marketed predicate devices.
However, the letter does not contain the detailed study information required to answer your specific questions regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, or MRMC studies. This type of information would typically be found in the device's 510(k) submission itself, which is a much larger and more technical document than the FDA's regulatory response letter.
Therefore,Based on the provided document, I cannot accurately describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is an FDA 510(k) clearance letter, which confirms substantial equivalence but does not detail the specific performance studies, acceptance criteria, or their results.
To answer your questions, I would need access to the actual 510(k) submission for K152327, which contains the detailed technical and clinical performance data.
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(484 days)
MEDICA CORPORATION
The EasyRA Creatine Kinase-MB (CK-MB) Reagent is intended for the quantitative determination of CK-MB activity in human serum and plasma, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. Measurements of CK-MB activity are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy. For in vitro diagnostic use only. For prescription use only.
Medica's EasyRA C-Reactive Protein (CRP) Reagent is intended for use in the quantitative in-vitro diagnostic determination of C-reactive protein in human serum or plasma using the EasyRA clinical chemistry analyzer. Measurements of C-reactive protein aids in evaluation of the amount of injury to body tissues. For in-vitro diagnostic use only. For prescription use only.
The EasyCAL C-Reactive Protein (CRP) Calibrator Kit is used for calibrating the CRP assay on the EasyRA clinical chemistry analyzer when used in conjunction with EasyRA CRP Reagent. The CRP calibrators are used to establish points of reference that are used in the determination of values in the measurement of CRP in human serum and plasma. For in-vitro diagnostic use only. For prescription use only.
The EasyQC C-Reactive Protein (CRP) Quality Control Materials are intended for use as quality control material for the CRP turbidimetric assay, using the EasyRA CRP Reagent and calibrator kit on the EasyRA clinical chemistry analyzer. For in-vitro diagnostic use only. For prescription use only.
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This document is a letter from the FDA regarding the 510(k) premarket notification for several diagnostic reagents and related calibrator/control materials. It does not contain information about the acceptance criteria or a study proving the device meets those criteria.
Therefore, I cannot provide the requested information. The document focuses on regulatory approval and indications for use, not performance studies.
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(175 days)
MEDICA CORPORATION
The EasyRA Creatinine (CREA) Reagent is for the measurement of creatinine in serum and plasma using the "EasyRA chemistry analyzer". Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis. For in vitro diagnostic use only.
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The provided document is an FDA 510(k) clearance letter for the EasyRA Creatinine Reagent. It states that the device is substantially equivalent to a predicate device for measuring creatinine in serum and plasma.
However, this document does not contain the specific information required to answer your request about acceptance criteria and study details. The 510(k) clearance letter itself is a summary of the FDA's decision, not the full submission that would detail the performance studies and acceptance criteria.
To answer your questions, one would need access to the actual 510(k) premarket notification submission for K123586, which would include the performance data and the study design.
Therefore, I cannot provide the requested table and study details based solely on the provided text. The document confirms the device's indications for use: "The EasyRA Creatinine (CREA) Reagent is for the measurement of creatinine in serum and plasma using the "EasyRA chemistry analyzer". Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis." but does not elaborate on the performance characteristics or the studies conducted to establish substantial equivalence.
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(370 days)
Z-MEDICA CORPORATION
QuikClot Interventional-A Hemostatic Bandage is applied topically as an adjunct to manual compression and is indicated for the local management and control of surface bleeding from vascular access sites, percutaneous catheters or tubes utilizing introducer sheaths up to 7 Fr. in patients on drug/induced anti-coagulation treatment.
The QuikClot Interventional-A Hemostatic Bandage that is the subject of this submission is described in detail in K090620 in that it is made of a soft, white, kaolin-impregnated gauze. QuikClot® Interventional-A Hemostatic Bandage may be provided in a kit form that consists of a hemostatic pad and an adhesive bandage. The adhesive bandage is a 3M Tegaderm® bandage (K973036) or equivalent. The hemostatic pad is a hemostatic dressing made of soft, white, kaolin impregnated gauze, configured in a 1 ½" long by l 1/2"wide by 1/2" thick multi-layer pad.
Here's an analysis of the acceptance criteria and supporting studies for the QuikClot Interventional-A Hemostatic Bandage, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" in a quantitative format typical for regulatory submissions (e.g., "sensitivity must be > X%", "specificity must be > Y%"). Instead, it presents performance metrics from pre-clinical animal studies and clinical studies. The implicit acceptance criterion is that the device demonstrates efficacy in controlling bleeding in anticoagulated patients, comparable to or superior to control methods, with an acceptable safety profile.
| Metric/Study Objective | Implicit Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Pre-Clinical Swine Model | ||
| Efficacy in Coumadin-treated pigs | Effective control of bleeding | 94.5% successful control of bleeding (vs 24% for control gauze) |
| Efficacy in Plavix-treated pigs | Effective control of bleeding | 91.2% successful control of bleeding (vs 29.7% for control gauze) |
| Safety in animal model | Safe use in anticoagulated model | No animal deaths due to bleeding. Wounds not fully controlled required additional manual compression. |
| Trabattoni D, et al. (2010) - Single Arm Pilot Study | ||
| Complete bleeding cessation at 5 min | High rate of cessation | Mean cumulative hemostasis time 4.9 ± 1.05 min (diagnostic: 4.2 ± 0.9 min, interventional: 5.3 ± 0.95 min) |
| Safe ambulation at 4 hours | All patients achieve safe ambulation | All patients achieved ambulation at 4 hours |
| Serious Adverse Events | Low incidence of adverse events | One patient required extra compression and developed a small hematoma ( 5cm |
| Politi L, et al. (2011) - Randomized Clinical Trial (Radial) | ||
| Radial Artery Occlusion (RAO) | Low to no RAO | Group 1 (QuikClot): 0% RAO; Group 2 (control short time): 5% RAO; Group 3 (control 2 hours): 10% RAO (p = 0.05) |
| Active bleeding after compression removal | Lower incidence than control | Group 1 (QuikClot): 10 patients (20%); Group 2 (control short time): 18 patients (90%); Group 3 (control 2 hours): 1 patient (2%) (p |
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(89 days)
MEDICA CORPORATION
The EasyRA HDL Cholesterol reagent is intended for the quantitative determination of High Density Lipoprotein Cholesterol in human serum and plasma on the Medica EasyRA Chemistry Analyzer. The Medica EasyRA HDL-Cholesterol reagent can assist in the diagnosis and treatment of patients at risk of developing coronary heart disease. For in vitro diagnostic use only.
The EasyRA LDL Cholesterol reagent is intended for the quantitative determination of Low Density Lipoprotein Cholesterol in human serum and plasma, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. The LDL Cholesterol measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. For in vitro diagnostic use only.
The EasyRA CHOL reagent is intended for the quantitative determination of total cholesterol in human serum and plasma, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. Total cholesterol measurements are used to screen for elevated cholesterol as a risk factor in coronary artery disease. For in vitro diagnostic use only.
The EasyRA TRIG reagent is intended for the quantitative measurement of triglycerides in human serum and plasma, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. Measurements obtained by this device are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism and various endocrine disorders. For in vitro diagnostic use only.
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The provided text is a 510(k) premarket notification letter from the FDA regarding in vitro diagnostic (IVD) reagents for cholesterol and triglyceride measurements. It is not about an AI-powered medical device or an imaging device, and therefore, many of the requested criteria (e.g., sample size for test set, number of experts, MRMC studies, ground truth establishment for AI models) are not applicable to this type of device.
This document confirms substantial equivalence of Medica Corporation's EasyRA reagents to legally marketed predicate devices, meaning their performance characteristics are considered similar enough for market entry without requiring a full Premarket Approval (PMA) application. The assessment for IVD reagents typically focuses on analytical performance characteristics like accuracy, precision, linearity, and interference, rather than diagnostic accuracy studies involving human readers or AI algorithms.
Here's an attempt to address the points based on the provided document, noting where information is not applicable:
-
A table of acceptance criteria and the reported device performance
The document itself does not contain a table of acceptance criteria or reported device performance data. This information would typically be found in the manufacturer's 510(k) submission summary, which the FDA reviews. The letter only states that the FDA reviewed the submission and found the device substantially equivalent. For IVD reagents, acceptance criteria usually relate to analytical specifications (e.g., % bias vs. a reference method, coefficient of variation for precision). -
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the provided FDA letter. This would be detailed in the manufacturer's submission.
- Data Provenance: Not specified in the provided FDA letter. For IVD reagents, samples typically refer to human serum or plasma specimens used to validate the reagent's performance.
-
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)
Not Applicable. This is an in vitro diagnostic reagent. The "ground truth" for chemical measurements like cholesterol or triglycerides is typically established by using validated reference methods (e.g., CDC reference methods, certified reference materials) or by comparing to another FDA-cleared predicate device, not by expert human interpretation like in imaging. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not Applicable. As explained above, this is an IVD reagent, not an imaging device requiring human adjudication of results. -
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. No human readers or AI assistance are involved in the direct output of these IVD reagents. Their performance is measured analytically. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. This is not an AI algorithm. It's a chemical reagent for a lab analyzer. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for IVD reagents typically refers to:- Reference Methods: Highly accurate and precise laboratory methods (e.g., gas chromatography-mass spectrometry for some analytes, or established enzymatic methods traceable to reference standards).
- Certified Reference Materials (CRMs): Samples with known, certified concentrations of the analyte.
- Comparison to Predicate Devices: Performance is often compared to another legally marketed and validated device to demonstrate "substantial equivalence."
The specific method used is not detailed in this FDA letter.
-
The sample size for the training set
Not Applicable. This is not an AI device that requires a "training set" in the machine learning sense. The "training" for a chemical reagent involves its formulation and validation, which doesn't use data sets in the same way. -
How the ground truth for the training set was established
Not Applicable. As above, no training set in the AI sense.
In summary, the provided document is a regulatory clearance letter for laboratory testing reagents, not for a medical device that utilizes artificial intelligence or requires human interpretation for its primary function. Therefore, the questions related to AI models, human expert review, and related study designs (like MRMC) are not relevant to this specific product.
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(30 days)
Z-MEDICA CORPORATION
QuikClot® Interventional™ hemostatic bandage is applied topically as an adjunct to manual compression and is indicated for the local management and control of surface bleeding from vascular access sites, percutaneous catheters or tubes utilizing introducer sheaths up to 12 Fr.
QuikClot® Interventional™ hemostatic bandage is a kit that consists of a hemostatic pad and an adhesive bandage. The adhesive bandage is a 3M Tegaderm® 4" x 4-3/4" bandage (reference K973036). The hemostatic pad is a hemostatic dressing made of soft, white, kaolin impregnated gauze, configured in a 1 ½" long by 1 ½" wide by ½" thick multi-layer pad. The pad is held secured in place by stitching with polyester thread. QuikClot® Interventional™ hemostatic bandage is packaged in a plastic tray within a peelable foil pouch and irradiated to a SAL of 104.
The QuikClot® Interventional™ hemostatic bandage is intended for topical application as an adjunct to manual compression for the local management and control of surface bleeding from vascular access sites, percutaneous catheters, or tubes utilizing introducer sheaths up to 12 Fr.
Here's an analysis of the acceptance criteria and the study that supports the device's performance:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Objective) | Reported Device Performance |
|---|---|
| Achieve hemostasis following removal of percutaneous vascular access catheters. | The device demonstrated hemostasis in a preclinical porcine model following the removal of percutaneous vascular access catheters using either an 8 French or a 12 French tissue dilator. It successfully controlled all bleeding in all 25 vascular access procedures. |
| Performanceเทียบเท่ากับอุปกรณ์Predicate (for bleeding control) | The device controlled bleeding as effectively as the predicate devices: ChitoFlex-Surgical dressing and D-Stat Dry™ Hemostatic Bandage. |
| Biocompatibility | The device is composed of identical materials as the QuikClot® eX™ device. Therefore, the successful biocompatibility testing (MEM Elution, Kligman Maximization, and Intracutaneous Injection) for QuikClot® eX™ device applies to QuikClot® Interventional™ hemostatic bandage. |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: 25 vascular access procedures.
- Data Provenance: Pre-clinical porcine model testing (animal study). The country of origin is not specified but it is an animal-based study, not human. Given the context of a 510(k) submission, it is retrospective to the submission date.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not specify the number or qualifications of experts used to establish the ground truth for the pre-clinical porcine model testing. Given it's an animal model, the ground truth would typically be established by veterinarians, researchers, or technicians competent in animal surgery and hemostasis assessment.
4. Adjudication method for the test set:
- The document does not explicitly state an adjudication method. In a pre-clinical animal study, adjudication is often implicitly handled by the experimental design, observation protocols, and direct measurement of bleeding cessation by the researchers.
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 a hemostatic bandage, not an AI-powered diagnostic or assistive tool, so such a study would not be applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, a standalone (algorithm only) performance study was not done. This device is a physical hemostatic product, not an algorithm.
7. The type of ground truth used:
- The ground truth used was the observed cessation of bleeding (hemostasis) in the pre-clinical porcine model following vascular access procedures. This is a direct outcome measurement.
8. The sample size for the training set:
- This information is not applicable and therefore not provided. The QuikClot® Interventional™ hemostatic bandage is a physical medical device, not an AI or machine learning model that requires a "training set." The studies conducted were for performance validation.
9. How the ground truth for the training set was established:
- This information is not applicable for the same reason as point 8.
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(27 days)
Z-MEDICA CORPORATION
Not Found
Not Found
I apologize, but the document you provided is an FDA notification letter regarding an administrative change to a device's product code. It does not contain any information about acceptance criteria, device performance studies, or clinical trial details. Therefore, I cannot extract the requested information.
To answer your request, I would need a document that describes the device's performance characteristics and the studies conducted to demonstrate its effectiveness and safety.
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