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510(k) Data Aggregation
(236 days)
The Liquid Assayed Chemistry Control Premium Plus Levels 1, 2 and 3 are assayed quality control materials intended for in vitro diagnostic use in the quality control of diagnostic assays. This material can be used to monitor the accuracy or reproducibility of analytes listed in the package insert. This device is for prescription use only.
The Liquid Assayed Chemistry Control Premium Plus is human liquid sera to which purified biochemical material, chemicals, drugs, preservatives and stabilizers have been added. The material is supplied at levels 1, 2 and 3. Each 5 ml vial of liquid serum is stored at -20°C to -70°C. Each level is supplied in a 12 by 5ml vials.
I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that a device meets those criteria.
The document is a 510(k) premarket notification for a medical device called "Liquid Assayed Chemistry Control Premium Plus Level 1, 2 and 3". It describes the device, its intended use, compares it to a predicate device, and includes summaries of stability studies (thawed open vial stability and shelf-life study) and value assignment.
Here's what I can extract, focusing on "acceptance criteria" as applied in the context of the control material stability studies:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance (Summary) |
|---|---|---|
| Thawed Open Vial Stability | All acceptance criteria for all analytes | All acceptance criteria were met for all analytes. |
| Shelf-life Study (Real Time Testing) | All acceptance criteria for all analytes | All acceptance criteria were met for all analytes. |
Important Note: The document states that "All acceptance criteria were met for all the analytes" for both stability studies, but it does not explicitly list the specific numerical or qualitative acceptance criteria themselves. It only mentions that the percentage deviation was calculated for the shelf-life study.
Regarding the other requested information, there is no data in the provided text:
2. 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 the sample size for the stability studies or value assignment process.
- It does not mention the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This information is not applicable as the device is a quality control material, not an AI or diagnostic imaging device that requires interpretation by experts for ground truth establishment in a test set.
- For value assignment, it mentions "a number of external laboratories" and "in-house testing," but does not specify the number or qualifications of personnel involved.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not applicable. Adjudication methods are typically used in studies involving human interpretation or subjective data, which is not the primary focus of testing a quality control material.
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
- This information is not applicable. The device is a quality control material, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This information is not applicable. The device is a quality control material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the stability studies, the "ground truth" or reference is assumed to be the established values or expected performance of the control material under specific conditions, compared to its performance over time. The document mentions "statistical analysis including the mean, SD and % CV were calculated" and that "an assigned value is calculated from the target mean specific value." This implies a reference standard derived from analytical measurements rather than expert consensus or pathology.
8. The sample size for the training set
- This information is not applicable as the device is a quality control material, not an AI model requiring a training set.
9. How the ground truth for the training set was established
- This information is not applicable.
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(37 days)
Liquid Assayed Multiqual Premium is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
This product is prepared from human serum to which purified biochemical (tissue extracts of human and animal origin), chemicals, drugs, preservatives and stabilizers have been added. The control is provided in liquid form for convenience.
This document is a 510(k) summary for the Bio-Rad Laboratories Liquid Assayed Multiqual Premium. It describes a quality control material intended to monitor the precision of laboratory testing procedures.
The study presented focuses solely on the stability of the device itself, as its intended use is to serve as a quality control material. Therefore, typical acceptance criteria and study designs for diagnostic or AI-powered devices (e.g., sensitivity, specificity, MRMC studies, ground truth established by experts/pathology) are not applicable to this type of device.
Here's the information gleaned from the submission regarding its acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance
| Stability Type | Acceptance Criteria (Stated Claim) | Reported Device Performance (Confirmed by Study) |
|---|---|---|
| Shelf Life Stability | "3 Years at -20 to -70 ℃" | "Acceptance criteria were met to support product as claimed." (Based on Accelerated Stability studies) |
| Thawed & Unopened Vial Stability | "All analytes will be stable for 30 days when the control material is thawed and stored unopened at 2 to 8°C, with the following exceptions: Direct Bilirubin will be stable for 11 days, Triglycerides, HDL, Cholinesterase, and Phosphorus will be stable for 7 days." (From Table 1, Predicate) | |
| Note: The new device claims "All analytes will be stable for 14 days...exceptions: Direct Bilirubin, Triglycerides, HDL, Cholinesterase, and Phosphorus will be stable for 7 days." and the text in Section 8 repeats the 14-day claim. | "All analytes will be stable for 14 days when stored tightly capped at 2 to 8°C, with the following exceptions: Direct Bilirubin, Triglycerides, HDL, Cholinesterase, and Phosphorus will be stable for 7 days." (Based on Real Time Stability studies; there is a discrepancy between the text in Section 8 and the table for the general stability period claim) | |
| Thawed & Opened Vial Stability | "Once the product stopper is punctured, all analytes will be stable for 5 days when stored at 2 to 8°C." (From Table 1, Predicate) | |
| Note: The new device claims "all analytes will be stable for 14 days...exceptions: Direct Bilirubin, Triglycerides, HDL, Cholinesterase, and Phosphorus will be stable for 7 days." | "All analytes will be stable for 14 days when stored tightly capped at 2 to 8℃, with the following exceptions: Direct Bilirubin, Triglycerides, HDL, Cholinesterase, and Phosphorus will be stable for 7 days." (Based on Real Time Stability studies) | |
| Frozen Aliquot Stability | "No claims made." (From Table 1, Predicate) | "AST/SGOT, Direct Bilirubin, HDL, Phosphorus, LDL, and Triglycerides will be stable for 14 days when stored in tightly capped aliquot amber vials at -20 to -70°C." (Based on Real Time Stability studies) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document mentions "replicate analyses" and "a representative sampling of this lot of product" for value assignment, and "Real Time Stability studies" and "Accelerated Stability studies" for stability claims. However, specific numbers of samples or batches tested are not provided.
- Data Provenance: The studies were conducted by Bio-Rad Laboratories or "independent laboratories." The data appears to be prospective as it's generated specifically for the stability claims being made for this new device. The country of origin for the data is not specified, but Bio-Rad Laboratories is located in Irvine, California, USA, implying the studies were likely conducted there or overseen by their US operations.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. This device is a quality control material, not a diagnostic or AI device that requires expert interpretation for its "ground truth" performance in a clinical setting. The "ground truth" in this context pertains to the stability of the analytes within the control material, which is determined by analytical measurements against established reference methods, not expert consensus.
- The "Value Assignment" section states that "The mean values and the corresponding ±3SD ranges printed in this Insert were derived from replicate analyses and are specific for this lot of product. Data from Unity™ Interlaboratory Program are included in the determination of some ranges." This indicates analytical testing and interlaboratory data were used to assign values, not expert opinions.
4. Adjudication Method for the Test Set
- Not Applicable. As this is a quality control material stability study, there is no "adjudication method" in the sense of resolving discrepancies in expert interpretations. The stability is determined by meeting pre-defined analytical criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No. This is not applicable to a quality control material. MRMC studies are used for evaluating diagnostic performance (e.g., image interpretation) where human readers are involved.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Not Applicable. This is a chemical control material, not an algorithm or AI device.
7. The Type of Ground Truth Used
- The "ground truth" for this device is the analytical stability of the constituents (analytes) over time and under various storage conditions. This is established through analytical testing using manufacturer-supported reagents and representative samples of the product. The acceptance criteria for stability (e.g., within certain limits or recovery percentages relative to initial measurements) likely guide the determination of whether the analytes are "stable."
8. The Sample Size for the Training Set
- Not Applicable. This is not an AI or machine learning device that requires a "training set." The product's characteristics are determined through analytical chemistry and stability testing.
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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(183 days)
Liquid Assayed Multiqual is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in this package insert.
Liquid Assayed Multiqual is prepared from human serum to which purified biochemical material (tissue extracts of human and animal origin), chemicals, drugs, preservatives, and stabilizers have been added.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the "Liquid Assayed Multiqual" device:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a "table of acceptance criteria" in the format of pass/fail thresholds for a device, as one might find for a diagnostic test's sensitivity or specificity. Instead, it describes product claims related to stability, which serve as performance characteristics that the device is intended to meet. The study's purpose is to demonstrate that the new device meets these claims, and establishes substantial equivalence to a predicate device.
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Open Vial Stability | 5 days at 2 to 8°C (This is the claim the device intends to meet and thus serves as the implicit acceptance criterion for this characteristic.) | "Open vial 5 days at 2 to 8°C" (The study performed stability studies to determine this claim, implying it was met.) |
| Thawed and Unopened | 30 days at 2 to 8°C, with exceptions: Direct Bilirubin 11 days, Triglycerides, HDL, Cholinesterase, Phosphorus 7 days. Total Bilirubin and Direct Bilirubin values may decrease, Alkaline Phosphatase activity may rise. (This is the claim the device intends to meet and thus serves as the implicit acceptance criterion for this characteristic.) | "Thawed and Unopened: 30 days at 2 to 8°C, with the following exceptions: Direct Bilirubin 11 days, Triglycerides, HDL, Cholinesterase, Phosphorus 7 days. Total Bilirubin and Direct Bilirubin values may decrease, Alkaline Phosphatase activity may rise." (The study performed stability studies to determine this claim, implying it was met.) |
| Shelf Life Stability | 3 Years at -20°C to -50°C (This is the claim the device intends to meet and thus serves as the implicit acceptance criterion for this characteristic.) | "Shelf Life Stability 3 Years at -20°C to -50°C" (The study performed stability studies to determine this claim, implying it was met.) |
| Substantial Equivalence | The new device performs "similarly" to the predicate device (K043208) as outlined by their identical intended use, physical form, matrix, and comparable stability claims, with noted differences in specific analyte stability and fill volume. | The report concludes: "Liquid Assayed Multiqual (new device) is intended to be used for the same purposes as the predicate device, it has the same human serum matrix and performs similarly as the predicate device." (This confirms the finding of substantial equivalence based on the comparison provided.) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document states, "The assigned values were derived from replicate analyses and are specific for each lot of product. The tests listed were performed by the manufacturer and/or independent laboratories using manufacturer supported reagents and a representative sampling of the product lot."
- This indicates that a "representative sampling of the product lot" was used for testing, but the exact number of samples or the sample size (n) for the stability studies is not specified in this summary.
- Data Provenance: The studies were performed by the manufacturer (Bio-Rad Laboratories) and/or independent laboratories. The country of origin for the data is not explicitly stated, but Bio-Rad Laboratories is based in Irvine, California, suggesting the studies were likely conducted in the USA or by labs commissioned from the USA. The studies appear to be prospective in nature, as they were conducted to determine the stability claims for a new product.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This document describes a quality control material used to monitor the precision of laboratory testing procedures. The concept of "ground truth" established by experts, as required for diagnostic devices (e.g., radiologists interpreting images), is not applicable here.
Instead, the "ground truth" for this type of device (Assayed Quality Control Material) is the assigned values for the analytes within the control. These are established through:
- Method: "replicate analyses"
- Personnel: Tests were "performed by the manufacturer and/or independent laboratories"
- Qualifications: While not explicitly detailed, these laboratories would employ trained personnel (e.g., clinical chemists, laboratory scientists) proficient in the analytical methods for each analyte.
4. Adjudication Method for the Test Set
Again, the concept of "adjudication" in the sense of resolving discrepancies among expert readers (e.g., 2+1, 3+1) is not applicable to this type of device. The "ground truth" (assigned values) is established through rigorous laboratory testing using replicate analyses, not through human interpretation of complex data that might require adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI
No, an MRMC comparative effectiveness study was not done. This device is a quality control material, not a diagnostic imaging or screening tool that would involve AI assistance for human readers. Therefore, the effect size of AI improvement is not relevant or reported.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone (algorithm only) performance study was not done. This device is a biochemical control material, not an algorithm or AI system. Its performance is evaluated based on its stability and the accuracy of its assigned values when measured by laboratory instruments, not as a standalone algorithmic output.
7. The Type of Ground Truth Used
The ground truth used for this type of quality control device is the assigned values for the various analytes it contains. These values are established through:
- Expert Consensus / Reference Methods: While not explicitly stated as "expert consensus," the "replicate analyses" performed by the manufacturer and independent laboratories using "manufacturer supported reagents" are indicative of adherence to established, scientifically sound analytical methodologies that are considered the reference or "true" values for the analytes. The ±3SD ranges reported are statistical measures around this empirically determined true value.
8. The Sample Size for the Training Set
This document describes a quality control material, not a machine learning model. Therefore, the concept of a "training set" for an algorithm is not applicable. The device itself is the "product," and its stability and assigned values are characterized through direct experimentation.
9. How the Ground Truth for the Training Set Was Established
As explained above, there is no "training set" or "ground truth for a training set" in the context of this device. The "assigned values" for the control material are established through "replicate analyses" by the manufacturer and/or independent laboratories.
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(49 days)
Liquid Assayed Multiqual is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in this package insert.
Liquid Assayed Multiqual is prepared from human serum to which purified biochemical material (tissue extracts of human and animal origin), chemicals, drugs, preservatives, and stabilizers have been added.
The provided documentation describes the Liquid Assayed Multiqual device, a quality control serum. However, it does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or details regarding sample sizes for test/training sets, expert involvement, or adjudication methods in the way typically expected for a diagnostic or AI-driven device.
This document is a Summary of Safety and Effectiveness (part of a 510(k) submission) for a quality control material. Its primary purpose is to establish substantial equivalence to a predicate device, not to present a detailed performance study with discrete acceptance criteria for a diagnostic tool.
Therefore, many of the requested items cannot be extracted from this document. Here's a breakdown of what can be inferred or directly stated, and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
No explicit "acceptance criteria" are stated in the document in terms of performance metrics (e.g., sensitivity, specificity, accuracy, precision ranges for analytes). The document focuses on demonstrating that the new device is substantially equivalent to a predicate by having similar intended use, form, matrix, storage conditions, and open vial claims, with the primary difference being the addition of Lactic Acid as an analyte.
The "performance" reported is primarily related to stability:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Open Vial Stability | 14 days at 2 to 8°C (LAP Arylamidase stable for 3 days) |
| Thawed and Unopened Stability | 30 days at 2 to 8°C (with exceptions for Total Bilirubin and Alkaline Phosphatase) |
| Shelf Life Stability | 3 Years at -20°C or colder |
Explanation: The "acceptance criteria" here are implied by the stability claims made for the device. The study demonstrating these is referred to generally as "Stability studies."
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not specified. The document refers to "Stability studies" but does not detail the number of samples or batches used for these studies.
- Data Provenance: Not specified. The country of origin for the data or whether it was retrospective or prospective is not mentioned.
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 material, not a diagnostic device requiring expert interpretation for ground truth. The "ground truth" for a quality control material is its chemical stability and stated analyte values, which are determined through laboratory testing procedures, not expert consensus.
4. Adjudication method for the test set
Not applicable. See point 3.
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 not an AI-driven or diagnostic device that involves human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for a quality control device like this would be the analytically determined values and stability characteristics of the biochemical components within the control material, established through validated laboratory methods. It's based on chemical and physical testing rather than clinical outcomes or expert interpretation of images/data.
8. The sample size for the training set
Not applicable. This device does not involve a training set as it is not an AI/ML algorithm.
9. How the ground truth for the training set was established
Not applicable. See point 8.
Summary of the Study:
The document states that "Stability studies have been performed to determine the open vial stability and shelf life for the Liquid Assayed Multiqual." These studies resulted in the product claims listed under section 7.0 and 7.1, 7.2, and 7.3. The type of study conducted was a stability study to determine how long the control material retains its specified characteristics under various conditions (open vial, thawed and unopened, and frozen shelf life). All supporting data is stated to be "retained on file at Bio-Rad Laboratories."
Without access to those detailed studies, further specifics on methodology, sample sizes, or exact performance data beyond the claims made cannot be provided from this public summary.
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(28 days)
Liquid Assayed Multiqual® Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for analytes listed in the package insert.
Liquid Assayed Multiqual® Control is prepared from human serum to which purified biochemical material (tissue extracts of human and animal origin) chemicals, drugs, preservatives and stabilizers have been added. The control is provided in liquid form for convenience.
Here's a breakdown of the acceptance criteria and study information based on the provided text for the Bio-Rad Laboratories Liquid Assayed Multiqual Control:
This document is a 510(k) Pre-market Notification, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study results for novel device functions. Therefore, much of the requested information regarding detailed study design (like sample size for test sets, ground truth establishment, expert adjudication, MRMC studies, and standalone performance) is not explicitly available in this summary. The provided text primarily discusses stability studies to support product claims.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria here refer to the stability claims for the control material. The reported device performance is presented as the stability duration for various storage conditions.
| Acceptance Criteria (Claimed Stability) | Reported Device Performance (Achieved Stability) |
|---|---|
| Open Vial Stability: | |
| - General analytes: 14 days at 2-8°C | 14 days at 2-8°C (tightly capped) |
| - Total bilirubin: 10 days at 2-8°C | 10 days at 2-8°C |
| - LAP Arylamidase: 3 days at 2-8°C | 3 days at 2-8°C |
| Closed Vial Stability (Thawed): | |
| - General analytes: 30 days at 2-8°C | 30 days at 2-8°C (stored unopened) |
| - Total bilirubin values: may decrease | Values may decrease |
| - Alkaline Phosphatase activity: may rise | Activity may rise |
| - AST methods without pyridoxal-5-phosphate: must be stored frozen | Must be stored frozen |
| Shelf Life (Closed Vial, Frozen): | |
| - 3 years at -20°C or colder | 3 years at -20°C or colder |
Regarding the Study Information:
Since this is a 510(k) summary for a control material, the "study" referred to is primarily stability testing rather than a clinical effectiveness study. The intent is to demonstrate that the control material maintains its integrity and stability under specified conditions for its intended use, which is "to monitor the precision of laboratory testing procedures."
2. Sample size 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 summary.
- Data Provenance: Not specified in the provided summary. "Real time studies will be ongoing to support the shelf life of this product" suggests a prospective component, but the summary primarily describes historical data that has already been collected. The studies were performed by Bio-Rad Laboratories, located in Irvine, California, USA, so presumably the data originates there.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. For a quality control material, the "ground truth" for stability is typically determined by analytical testing methods and comparison to initial formulated values, not expert consensus as in a diagnostic imaging study.
- Qualifications of Experts: Not applicable.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. Stability studies rely on laboratory measurements and statistical analysis, not expert 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
- MRMC Study: No, this is not applicable. This device is a liquid assayed control material, not an AI or diagnostic imaging device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is a quality control material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: For stability studies of control materials, the "ground truth" is typically the initial analytical values of the components within the control at the time of manufacture, and then subsequent measurements are compared against these initial values to determine if they remain within acceptable ranges over time and under various storage conditions. This is based on analytical testing and established analytical methods, not expert consensus or pathology.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. There is no "training set" as this is not an AI or machine learning device. The studies are related to the stability of the manufactured product.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable.
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(83 days)
LIQUID A is intended to be used with Alumina Zinc Oxide Powder to set as a temporary or permanent cement, or as a base or liner in a dental restoration.
Not Found
I apologize, but the provided text only contains an FDA 510(k) clearance letter for a dental cement called "Liquid A." It does not include information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given text.
If you have a different document that contains this information, please provide it, and I will be happy to assist you.
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(30 days)
This product is to be used in a diagnostic laboratory setting, by qualified laboratory technologists, for the quantitative determination of alkaline phosphatase in serum. It is intended for in vitro diagnostic use only. The determination of alkaline phosphatase in serum is most commonly performed for the diagnosis of two groups of conditions: hepatobiliary disease and bone disease associated with increased osteoblastic activity.
Liquid Alkaline Phosphatase Reagent Set
The provided text is a 510(k) premarket notification letter from the FDA regarding a "Liquid Alkaline Phosphatase Reagent Set." It confirms the device's substantial equivalence to previously marketed devices and outlines regulatory requirements. However, this document does not contain information about acceptance criteria, device performance studies, or details relevant to a typical AI/medical imaging device submission.
The letter is for an in vitro diagnostic (IVD) reagent set, not an AI or imaging device. Therefore, the questions posed (e.g., sample size for test set, experts for ground truth, MRMC study, standalone performance) are not applicable to the content of this document.
To answer your request, I would need a different type of document, such as a summary of safety and effectiveness (SSE) for a medical device that utilizes AI, imaging, or has a performance study section.
Based on the provided document, I cannot fill out the requested table or answer the specific questions about acceptance criteria and study details.
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