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The HYDRAGEL 3 CSF ISOFOCUSING and HYDRAGEL 9 CSF ISOFOCUSING kits are designed for the qualitative detection of oligoclonal bands in the electrophoretic patterns of cerebrospinal fluid (CSF) and confirmation of their immunoglobulin character. The use of anti-IgG antisera permits to prove or disprove the "true" IgG character of oligoclonal banding. Visual, comparative interpretation of immunofixation patterns of IgG in high resolution isoelectric separations of CSF and serum proteins from the same patient allows detection of oligoclonal banding that represents intrathecal synthesis of immunoglobulins.

The HYDRAGEL 3 CSF ISOFOCUSING and HYDRAGEL 9 CSF ISOFOCUSING kits are indicated when certain diseases of the central nervous system (CNS), such as multiple sclerosis, are suspected and the detection of oligoclonal banding and inflammatory processes (intrathecal synthesis of immunoglobulins) can aid to the diagnosis.

The use of enzyme labeled antibodies increases the sensitivity of detection so that the analysis can be generally performed on unconcentrated CSF.

The only difference between the 3 CSF and 6 CSF kits is in the intended number of samples per gel: 3 and 9 CSF/serum sample pairs, respectively.

Not Found

This 510(k) summary does not contain the detailed study information regarding acceptance criteria and performance as it is a premarket notification for substantial equivalence, not a clinical study report. The document states that the device is substantially equivalent to legally marketed predicate devices without providing explicit acceptance criteria or a dedicated study demonstrating performance against specific metrics as would be found in a clinical trial report.

However, based on the provided text, we can infer some general information about the device's intended use and the nature of its performance.

Inferences from the document:

• Device Function: The HYDRAGEL 3 CSF ISOFOCUSING and HYDRAGEL 9 CSF ISOFOCUSING kits are designed for the qualitative detection of oligoclonal bands in cerebrospinal fluid (CSF) and confirmation of their immunoglobulin character for aiding in the diagnosis of certain CNS diseases like multiple sclerosis.
• Performance Claim: The use of enzyme-labeled antibodies increases sensitivity, allowing analysis on unconcentrated CSF.
• Substantial Equivalence: The FDA's review determined substantial equivalence to predicate devices marketed prior to May 28, 1976. This implies that the device's performance is considered comparable to existing, legally marketed devices.

Missing Information (not found in the provided document):

The document does not provide the following information:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance.
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication method for the test set.
5. Information on a Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
6. Information on a standalone (algorithm only) performance study.
7. The type of ground truth used (e.g., pathology, outcomes data).
8. The sample size for the training set.
9. How the ground truth for the training set was established.

Conclusion:

This document is a regulatory approval letter based on a 510(k) submission, which focuses on demonstrating substantial equivalence to a predicate device. It typically does not include the detailed performance study results, acceptance criteria, ground truth establishment, or expert involvement that would be found in a comprehensive clinical study report. The FDA concluded that the device is substantially equivalent to existing devices based on the information provided in Sebia's 510(k) submission (K033277).

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HYDRAGEL LDLIHDL CHOL Direct K20, HYDRAGEL 7 LDLIHDL CHOL Direct and HYDRAGEL LDLHDL CHOL Direct 15/30 kits are designed for quantification of the cholesterol canied by the Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL) fractions of human serum. The analysis is performed in two stages:

· electrophoresis on agarose get to separate the VLDL, LDL and HDL as well as chylomicrons,

· visualization of lipoprotein fractions based on a sensitive and cholesterol-specific enzymatic procedure involving the cholesterol esterase / cholesterol dehydrogenase system coupled with nitro blue tetrazolium chromogen.

The stained electrophoregrams are intended for visual interpretation to confirm identification of the individual fractions and for densitometry to obtain relative concentrations of cholesterol in the individual lipoprotein fractions. When the sample's total cholesterol value is known, cholesterol distribution in a/dL or mol/L concentrations can be calculated.

The test system is intended for the measurement of the LDL cholesterol and HDL cholesterol. The cholesterol values of only these two fractions are indicated as an aid in the diagnosis and treatment of lipid disorders.

The procedure is indicated for the general population for a direct measurement of:

• . the LDL cholestero! level regardless the triglyceride levels
• the HDL cholesterol level .
• the ratio LDL/HDL cholesterol .

The HYDRAGEL LDUHDL CHOL Direct K20 kit is designed for use with a manual electrophoresis apparatus, K20. The kit is intended to run up to 7 samples per gel.

The HYDRAGEL 7 LDL/HDL CHOL Direct and HYDRAGEL LDL/HDL CHOL Direct 15/30 kits are designed for use with the semi-automated Hydrasys electrophoresis apparatus. These kits are intended to run up to 7, 15 and 30 samples per gel, respectively.

Not Found

This document is a 510(k) premarket notification from the FDA, granting clearance for a medical device. It does not contain the detailed acceptance criteria and study information typically found in a clinical study report or a detailed validation document.

The document states that the FDA has reviewed the 510(k) and determined the device is "substantially equivalent" to legally marketed predicate devices. This means the manufacturer demonstrated that their device is as safe and effective as a device already on the market, but it does not typically involve the rigorous clinical study details you're asking for.

Therefore, I cannot provide the requested information from this document. The document refers to the device's "indications for use" and states that "The analysis is performed in two stages," but does not provide performance metrics, acceptance criteria, sample sizes, ground truth methodology, or expert qualifications.

The information you are requesting would usually be found in the 510(k) submission itself (which is not fully provided here) or in a separate validation report prepared by the manufacturer.

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All Sebia's Hydragel ISO-CK kits are intended for the identification and quantitation of the three creatine kinase (CK) isoenzymes. MM. MB and BB. by electrophoresis on alkaline buffered agarose gels followed by a densitometry.

The creatine kinase (CK) isoenzyme, CK-MB, is primarily released from a damaged heart muscle. It is one of the earliest markers for distinguishing patients with acute myocardial infarction o(AMI) from those with other coronary syndromes and episodes with similar symptoms.

Biochemical assays have been, and remain so, the most reliable means of detecting myocardial injury. However, no single biochemical marker can alone give a complete picture of myocardial injury and its extent. Therefore, the assay of CK isoenzymes is often used in tandem with the assay of LD isoenzymes, which are released slower from the injured heart muscle and remain. Ionger in circulation, to confirm or rule out the diagnosis of MI, assess its severity and , monitor patient's condition.

The principles of HYDRAGEL ISO-CK assays are: the electrophoretic separation of the CK isoenzymes, the use of a specific chromogenic substrate for the CK catalyzed visualization reaction, and densitometric quantitation of the electrophoregrams.

Not Found

I apologize, but the provided text from the FDA 510(k) summary for the HYDRAGEL ISO-CK Kits does not contain the detailed study information required to answer your request.

The document is a letter from the FDA to the manufacturer, confirming the substantial equivalence of the device to a predicate device. It briefly describes the intended use and principles of the assay but does not present any specific acceptance criteria, performance data, or study methodologies.

Therefore, I cannot provide:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and their qualifications.
4. Adjudication method.
5. Information on whether an MRMC comparative effectiveness study was done or its effect size.
6. Information on whether a standalone performance study was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

To obtain this information, you would typically need to refer to the full 510(k) submission, which usually includes detailed performance studies and clinical data. This document only presents the FDA's decision based on the submitted information.

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Sebia's HYDRAGEL HEMOGLOBIN(E) and HYDRAGEL ACID(E) HEMOGLOBIN(E) lines of devices are intended as an aid in the detection and identification of human hemoglobin abnormalities, namely hemoglobinopathies (structural hemoglobin abnormalities) and thalassemias (regulation abnormalities). The uses are indicated as follows:

The HYDRAGEL HEMOGLOBIN(E) and HYDRAGEL MINI HEMOGLOBIN(E) Kits are designed for use in conjunction with a manual electrophoretic apparatus. The HYDRAGEL 7/15 HEMOGLOBIN(E) Kits are designed for use with the semi-automated HYDRASYS electrophoretic apparatus. All these kits utilize alkaline agarose gels for electrophoretic separation of human hemoglobins. The electrophoregrams are interpreted visually for pattern abnormalities. Densitometry can serve as an aid in the interpretation by providing relative concentrations of individual fractions. The kits are intended for the normal hemoglobins (A and A2) and the major hemoglobin variants S or D and C or E. They are indicated for screening for clinically important abnormal hemoglobins. Electrophoresis on acidic gel, e.g., HYDRAGEL ACID(E) HEMOGLOBIN(E), should follow to confirm the identification of hemoglobin variants, in particular, to differentiate hemoglobins S from D and E from C.

The HYDRAGEL ACID(E) HEMOGLOBIN(E) and HYDRAGEL MINI ACID(E) HEMOGLOBIN(E) Kits are designed for use in conjunction with a manual electrophoretic apparatus. The HYDRAGEL 7/15 ACID(E) HEMOGLOBIN(E) Kits are designed for use with the semi-automated HYDRASYS electrophoretic apparatus. All these kits utilize acid buffered agarose gels for electrophoretic separation of human hemoglobins. The electrophoregrams serve for qualitative, visual interpretation of the patterns. The kits are indicated for confirming the identity of clinically important abnormal hemoglobins that have been previously detected on alkaline buffered HYDRAGEL HEMOGLOBIN(E) gels. Primarily, they serve for differentiation of hemoglobins S from D and E from C.

Not Found

This document is a 510(k) premarket notification from the FDA for a device called HYDRAGEL Hemoglobin (E). It does not contain the detailed information necessary to answer all aspects of your request. The document describes the device's intended use and FDA's determination of substantial equivalence to predicate devices, but it does not detail a study conducted to establish acceptance criteria or demonstrate performance in the way a clinical trial report would.

However, I can extract some information based on the typical regulatory context of such devices.

Here's what can be inferred or directly stated from the provided text, along with what cannot be answered:

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

This information is not present in the provided 510(k) summary. A 510(k) often focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and performance data from a new, standalone study for the device itself. The document mentions "electrophoregrams are interpreted visually for pattern abnormalities" and "Densitometry can serve as an aid in the interpretation by providing relative concentrations of individual fractions," which are methods of interpretation, but not performance metrics or acceptance criteria.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not present in the provided 510(k) summary.

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 present in the provided 510(k) summary. The document states that "electrophoregrams are interpreted visually for pattern abnormalities," implying human interpretation, but does not specify the number or qualifications of interpreters.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not present in the provided 510(k) summary.

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 present in the provided 510(k) summary. The device described (HYDRAGEL Hemoglobin (E)) is an in vitro diagnostic electrophoresis kit, and as such, it predates widespread AI assistance in this specific application. The document describes visual interpretation and densitometry, which are human-centric methods.

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

This information is not present in the provided 510(k) summary. Given the nature of the device as an electrophoresis kit with visual interpretation, it's highly unlikely that a standalone algorithm-only performance study was conducted or would even be relevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

This information is not explicitly stated in the provided 510(k) summary. However, for a device intended to aid in the detection and identification of hemoglobin abnormalities, the ground truth would typically be established by:

• Reference methods: Other established, highly accurate laboratory tests for hemoglobin variants.
• Clinical diagnosis: Confirmation through patient clinical presentation and other diagnostic findings.
• Expert interpretation: Consensual agreement among experienced laboratory professionals specializing in hemoglobinopathies.
  The document states the device is intended for "screening for clinically important abnormal hemoglobins" and "confirming the identity of clinically important abnormal hemoglobins," implying that the outcome of these tests would need to align with established clinical knowledge.

8. The sample size for the training set

This information is not present in the provided 510(k) summary. This type of device (electrophoresis kit) is not "trained" in the machine learning sense. Its performance relies on the biochemical principles of electrophoresis and the reagents provided.

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

This question is not applicable as there is no "training set" in the context of this device. The device itself (the kit and electrophoretic method) is the "system," and its performance is evaluated against established diagnostic accuracy, not by training an algorithm.

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HYDRAGEL LDL/HDL CHOL DIRECT, HYDRAGEL 7 LDL/HDL CHOL DIRECT and HYDRAGEL LDL/HDL CHOL DIRECT 15/30 kits are designed for quantification of the cholesterol carried by the LDL and HDL lipoprotein fractions of human plasma or serum. The analysis is performed in two stages:

· electrophoresis on agarose gel to separate the VLDL, LDL and HDL as well as chylomicrons and Lp (a) when present,

· visualization of lipoprotein fractions based on a sensitive and cholesterol-specific enzymatic method involving cholesterol esterase and cholesterol oxidase, and a chromogenic system with reduced AEC (amino ethyl carbazole) and peroxidase.

The stained electrophoregrams are intended for visual interpretation to confirm identification of the individual fractions and for densitometry to obtain accurate, relative concentrations of cholesterol in the individual lipoprotein fractions If the sample's total cholesterol value is known, cholesterol distribution in g/dL or mol/L concentrations can be calculated. Since the LDL cholesterol and HDL cholesterol assays are of primary interest, laboratories may chose to measure the relative concentration of cholesterol only in the HDL and LDL fractions.

The procedure is indicated for the general population for a direct measurement of:

• the LDL cholesterol level regardless the triglyceride levels ◆
• . the HDL cholesterol level
• the ratio LDL/HDL cholesterol .

The HYDRAGEL LDL/HDL CHOL Direct kit is designed for use with a manual electrophoresis apparatus. The kit is intended to run up to 8 samples per gel.

The HYDRAGEL 7 LDL/HDL CHOL Direct and HYDRAGEL LDL/HDL CHOL Direct 15/30 kits are designed for use with the semi-automated Hydrasys electrophoresis apparatus. These kits are intended to run up to 7, 15 and 30 samples per gel, respectively.

Not Found

The document assesses the substantial equivalence of the HYDRAGEL LDL/HDL CHOL DIRECT devices to legally marketed predicate devices, focusing on their use for quantifying cholesterol carried by LDL and HDL lipoprotein fractions. While the document details the device's indications for use and the FDA's regulatory approval, it does not explicitly provide acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot provide the requested table, sample sizes, expert details, adjudication methods, MRMC study information, standalone performance, ground truth types, or training set details as this information is not present in the provided text.

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The HYDRAGEL 6 CSF kit is designed for the qualitative detection of "oligocional" bands in the electrophoretic patterns of cerebrospinal fluid (CSF). and confirmation of their immunoglobulin character. The use of anti-immunoglobulin antisera permits to prove or disprove the "true", Ig character of oligoclonal banding. Visual, comparative interpretation of immunofixation patterns of immunodobulins in high resolution separations of CSF and serum proteins from the same patient allows detection of intrathecal synthesis of immunoglobulins.

The HYDRAGEL 6 CSF kit is indicated when certain diseases of the central nervous system (CNS), such as multiple sclerosis, are suspected and the detection of oligoclonal banding and inflammatory processes (intrathecal synthesis of immunoglobulins) can aid to the diagnosis.

Depending on the selection of detecting antisera (anti-IgA and/or anti-IgM) two to six CSF - serum sample pairs can be run on each gel.

The use of enzyme labeled antibodies increases the sensitivity of detection so that the analysis can be generally performed on unconcentrated CSF.

Not Found

This document is a 510(k) clearance letter for the HYDRAGEL 6 CSF Kit and does not contain the detailed study information regarding acceptance criteria and performance of the device. The letter simply states that the FDA has determined the device to be "substantially equivalent" to legally marketed predicate devices, allowing it to proceed to market.

Therefore, I cannot provide the requested information based on the provided text. To answer your questions, I would need to review the original 510(k) submission document or a separate clinical study report from the manufacturer.

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The HYDRAGEL-MINI LIPO, HYDRAGEL LIPO, HYDRAGEL LIPO MAXI, HYDRAGEL, 7 LIPO, and HYDRAGEL 15/30 LIPO kits are designed for determination of lipoprotein profiles in human serum.

All HYDRAGEL LIPO kits utilize the same composition of alkaline buffered HYDRAGEL LIPO agarose gels, same reagents and the same procedure. The only differences among the individual kits are the number of samples per gel and that some kits are for the manual and some for the automated format:

The HYDRAGEL-MINI LIPO , HYDRAGEL LIPO and HYDRAGEL LIPO MAXI kits are designed for use with a manual electrophoresis apparatus. These kits are intended to run up to 5, 8 and 10 samples per gel, respectively.

The HYDRAGEL 7 LIPO and HYDRAGEL 15/30 LIPO kits are designed for use with the semiautomated Hydrasys electrophoresis apparatus. These kits are intended to run up to 7, 15 and 30 samples per gel, respectively,

The resulting electrophoregrams can be evaluated visually for pattern abnormalities or by densitometry to obtain approximate, relative quantification of individual zones. Fredrickson classification of lipoproteins aids in the interpretation of lipoprotein patterns. Indication of the qualitative (presence of abnormal or absence of normal fractions) or semi-quantitative (relative increase or decrease of fractions) abnormalities necessitates further lipoprotein analyses.

I am sorry, but based on the provided document, I cannot answer your request. The document is a 510(k) clearance letter for the HYDRAGEL LIPO Kits from the FDA in 1998. This type of document declares substantial equivalence to a predicate device but does not typically include detailed information about specific acceptance criteria or a comprehensive study report with the level of detail you are requesting, especially regarding AI algorithms, multi-reader multi-case studies, and ground truth establishment, which are more relevant to modern AI/ML medical device submissions.

The document mainly focuses on:

• The product names and their indications for use.
• Confirmation of substantial equivalence.
• Regulatory classifications and requirements.
• Contact information for various FDA offices.

There is no mention of acceptance criteria, device performance metrics, sample sizes for test or training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or the ground truth types in the context of an AI/ML device. The device described appears to be a laboratory kit for manual or semi-automated electrophoresis, not an AI-powered diagnostic tool.

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HYDRAGEL BENCE JONES, MAXI KIT HYDRAGEL BENCE JONES, HYDRAGEL 2 BENCE JONES and HYDRAGEL 4 BENCE JONES kits are designed for qualitative detection and identification of Bence Jones proteins (monoclonal free light chains) in urine and serum. The detection of Bence Jones proteins serves as a qualitative aid in the identification of monoclonal gammopathies.

The analysis is generally performed on unconcentrated urine or on diluted serum. All these kits utilize the same composition of alkaline buffered HYDRAGEL BENCE JONES agarose gels and the same procedure which is carried out in two stages:

· electrophoresis of the sample on multi-track agarose gel to separate the individual urinary or serum proteins.

· the separated proteins in the reference track are fixed, the remaining tracks are subjected to respective immunofixation with anti aloha, gamma & mu heavy chain trivalent anti kappa and anti lambda free & bound light chains antisera; anti kappa and anti lambda free light chains antisera. The fixed and immunoprecipitated proteins are then stained with acid violet. The electrophoregrams are evaluated visually. The suspect band (in the reference track) is identified from the positive reaction, or lack of, with the individual antisera.

The HYDRAGEL BENCE JONES kit and MAXI KIT HYDRAGEL BENCE JONES are designed for use with a manual electrophoresis apparatus. The only difference between these two kits is the total number of tests which can be performed with i.e., 10 and 100, respectively. Each agarose gel in the HYDRAGEL BENCE JONES kit and MAXI-KIT HYDRAGEL BENCE JONES is intended to run one sample.

The HYDRAGEL 2 BENCE JONES and HYDRAGEL 4 BENCE JONES kits are designed for use with the semi-automated Hydrasys electrophoresis apparatus.

Each agarose gel in the HYDRAGEL 2 BENCE JONES and HYDRAGEL 4 BENCE JONES kits is intended to run two and four samples, respectively.

This document is an FDA 510(k) clearance letter for the HYDRAGEL BENCE JONES Kit. It does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria in the format requested.

Specifically, the document states that the device is "substantially equivalent" to predicate devices, which means it met the regulatory requirements for clearance based on comparison to existing devices, rather than necessarily performing a specific study to meet pre-defined acceptance criteria for a novel device.

Here's what is not present in the provided document:

1. A table of acceptance criteria and the reported device performance: This document only lists the indications for use and a general description of the test procedure. It doesn't present performance metrics like sensitivity, specificity, accuracy, or any specific numerical acceptance thresholds.
2. Sample size used for the test set and the data provenance: There is no mention of a test set, its size, or the origin of any data.
3. Number of experts used to establish the ground truth for the test set and their qualifications: No information about expert review or ground truth establishment is provided.
4. Adjudication method for the test set: Not applicable as no test set or expert review is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: This type of study is not mentioned. The device is a diagnostic kit, not an AI-assisted interpretation tool, so MRMC studies are generally not applicable in this context.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The device is a lab kit requiring human interpretation, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not described.
8. The sample size for the training set: Not applicable as this is not an AI/ML device with a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary, this FDA clearance letter confirms the device's substantial equivalence to existing devices for its intended use, but it does not provide the kind of detailed study results and performance metrics that would be present in a clinical trial report or a more extensive submission for a novel device or an AI/ML product.

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HYDRAGEL CHOL-HDL, HYDRAGEL 7 CHOL-HDL, HYDRAGEL 15 CHOL-HDL and HYDRAGEL 30 CHOL-HDL kits are designed for quantification of the cholesterol carried by the HYDRAGEE 50 OFFE Friend or serum. This analysis is performed by electrophoresis on alkaline buffered (pH 9.4) agarose gels. The separated lipoproteins are visualized by a of alkaline banered (p). cholesterol-specific enzymatic reaction. The stained electrophoregrams are to be interpreted visually to confirm identification of the individual fractions and by densitometry to obtain viccurale, relative concentrations of cholesterol in the individual lipoprotein fractions if the somole's total cholesterol value is known, cholesterol distribution in g/l or mol/l concentrations can be calculated. Since the HDL cholesterol assay is of primary interest, laboratories may chose to measure the relative concentration of cholesterol only in the HDL fraction.

All HYDRAGEL CHOL-HDL kits utilize the same composition of alkaline buffered HYDRAGEL CHOL-HDL agarose gels and the same procedure. It is carried out in two stages:

· electrophoresis on agarose gel to separate the VLDL, LDL and HDL as well as chylomicrons and Lp (a) when present,

· visualization of lipoprotein fractions based on a sensitive and cholesterol-specific enzymatic method involving cholesterol esterase and cholesterol oxidase, and a chromogenic system with reduced AEC (amino ethyl carbazole) and peroxidase.

The HYDRAGEL CHOL-HDL kit is designed for use with a manual electrophoresis apparatus. The kit is intended to run up to 8 samples per gel.

The HYDRAGEL 7 CHOL-HDL, HYDRAGEL 15 CHOL-HDL and HYDRAGEL 30 CHOL-HDL kits are designed for use with the semi-automated Hydrasys electrophoresis apparatus. These kits are intended to run up to 7, 15 and 30 samples per gel, respectively.

I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria.

The document is a 510(k) clearance letter from the FDA for the HYDRAGEL CHOL-HDL Kits. It primarily states that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory information for its marketing.

Specifically, the document lacks:

• A table of acceptance criteria or reported device performance.
• Details about sample size, data provenance, or ground truth establishment for any studies.
• Information on expert panels, adjudication methods, or MRMC studies.
• Mention of standalone algorithm performance.
• Any description of specific studies conducted to demonstrate clinical or analytical performance against predefined acceptance criteria.

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