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SteriChek® Bicarb pH Reagent Strips provide a quick convenient means of checking the pH of bicarbonate solution used to prepare dialysate and concentrated bicarbonate solutions used in the preparation of dialysate.

The device is made up of a 0.20 inch square off-white reagent pad that has been chemically treated and affixed to one end of a 3.25 inch by 0.20 inch white opaque polystyrene strip. The reagent pad is activated by exposing it to the sample. The color of the pad is visually compared to a color chart to determine the pH of the bicarbonate solution.

I am sorry, but the provided text does not contain a detailed study proving the device meets acceptance criteria. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a comprehensive study with specific acceptance criteria and detailed performance metrics.

However, based on the information provided, here's what I can extract and infer:

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

The document implicitly uses performance equivalence to the predicate device as its acceptance criteria.

2. 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 explicitly stated. The document mentions "acid/bicarbonate solutions" and "concentrated bicarbonate solutions" were "prepared," implying a laboratory setting, but the number of samples or data points is not provided.
• Data Provenance: Not explicitly stated. It's safe to assume a laboratory setting for the preparation of solutions, likely within the United States given the submitter's address, but this is an inference. The study appears to be prospective as it involves preparing specific solutions for testing.

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)

Not applicable. The ground truth was established by instrumental measurement.

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

Not applicable. The ground truth was established by instrumental measurement rather than 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

Not applicable. This device is a reagent strip for visual comparison, not an AI or imaging device involving human readers.

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

This concept is not directly applicable to a reagent strip. The "performance" of the device is its ability to produce a color change accurately reflecting pH, which is then visually interpreted by a human against a color chart. The "algorithm" here is the chemical reaction on the strip. The testing was of this chemical reaction's accuracy against a standard reference method.

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

The ground truth was established using a "standard reference method with calibration based on NIST traceable standard reference material" to determine reference pH values. This is an objective instrumental ground truth.

8. The sample size for the training set

Not applicable. This device is a chemical reagent strip, not a machine learning model that requires a training set.

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

Not applicable, as there is no training set for this type of device.

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SteriChek ™ Total Chlorine Reagent Strips provide a quick convenient means of testing for low levels of total chlorine (i.e. total chloramines plus free chlorine) in water used to prepare dialysate. The color that develops in the pad after exposure to the sample according to the directions is compared to a color chart to determine the concentration of total chlorine present in the sample.

The device is made up of a 0.20 inch square off-white reagent pad that has been chemically treated and affixed to one end of a 3.25 inch by 0.20 inch white opaque polystyrene strip. The reagent pad is activated by exposing it to the sample. The color of the pad is visually compared to a color chart to determine the amount of total chlorine present in the sample.

The provided text describes the SteriChek™ Total Chlorine Reagent Strips, a device for testing total chlorine levels in water for dialysate preparation. Here's a breakdown of the requested information based on the provided document:

Acceptance Criteria and Reported Device Performance

Study Information

1. Sample sizes used for the test set and the data provenance:

   • Test Set Sample Size: The document states "water samples in which either sodium hypochlorite or chloramines were added to give a range of free chlorine or combined chlorine levels." However, it does not specify the exact number of samples or the range of concentrations tested beyond 0-3 ppm and 0.1 ppm low-level detection.
   • Data Provenance: The document does not explicitly state the country of origin. Given the submission is to the FDA (USA), it's highly probable the testing was conducted in the USA. It's a retrospective analysis of the device's performance against controlled samples.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • The document does not mention the use of human experts to establish ground truth for visual comparison. The "color blocks are calibrated in terms of chlorine concentration," implying a predefined standard. The "color of the pad is visually compared to a color chart" by the user.

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

   • None is explicitly stated. The device relies on a direct visual comparison by the user to a color chart.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No, an MRMC study was not done. This device is a simple reagent strip with visual comparison, not an AI-powered system or one that requires human readers in the traditional sense of medical image interpretation.

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

   • Yes, a standalone performance assessment was done. The performance of the SteriChek™ strips was directly compared to the predicate device's performance using water samples with known chlorine concentrations. The "algorithm" here is the chemical reaction on the strip leading to a color change, which is then interpreted by visual comparison. The study assesses the inherent ability of the strip to accurately reflect chlorine concentration.

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

   • The ground truth was established by known, precisely prepared chemical concentrations of free chlorine and chloramines in water samples. These were "water samples in which either sodium hypochlorite or chloramines were added to give a range of free chlorine or combined chlorine levels."

7. The sample size for the training set:

   • The document does not specify a separate training set. This is a chemical reagent strip, not a machine learning model that typically involves training data. The "calibration" of the color chart would have been done during the device's development, but details on that process or sample sizes are not provided within this summary.

8. How the ground truth for the training set was established:

   • As there's no explicitly mentioned training set in the context of machine learning, this question is not fully applicable. However, the ground truth for calibrating the color chart (which informs the "training" aspect of the device's functionality) would have been established through controlled laboratory experiments using precisely measured concentrations of chlorine to correlate color intensity with ppm values. This process is implied by the statement "The color blocks are calibrated in terms of chlorine concentration."

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SteriChek™ Total Chlorine Test Kit provides a quick convenient means of testing for low levels of total chlorine (i.e. total chloramines plus free chlorine) in water used to prepare dialysate. The water sample changes color relative to the amount of total chlorine in the water sample.

The device consists of utilizing a fixed sample size of powdered reagent with a predetermined water sample volume in a test tube to effect a color reaction in the water sample. The color of the sample is then visually compared to a colormetric comparator to determine the total chlorine level in the sample. The device utilizes a recognized standard method of analysis for determining levels of total chlorine in water according to the Association for the Advancement of Medical Instrumentation (1993 Association for the Advancement of Medical Instrumentation-ANSI/AAMI;RD5-1992).

The provided text describes a medical device, the SteriChek™ Total Chlorine Test Kit, and its 510(k) submission for market clearance. However, the document primarily focuses on the device's description, intended use, and a comparison of its performance to a predicate device. It does not explicitly state specific acceptance criteria (performance targets/thresholds) or a detailed study plan that demonstrates the device meets those criteria.

Instead, it states that the "Performance of both devices was equivalent," referring to the SteriChek™ kit and its predicate device (Serim™ HiSense Test Strips). This implies that the acceptance criteria for the SteriChek™ kit were to show performance equivalent to the legally marketed predicate device.

Therefore, many of the requested details about the study are not explicitly available or are not applicable in the typical sense for a substantial equivalence submission relying on a predicate device.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: Not explicitly stated. The document mentions "water samples in which either sodium hypochlorite or monochloramines were added to give a range of free chlorine or combined chlorine levels." The number of these samples is not provided.
• Data Provenance: Not explicitly stated, but the submission is from Environmental Test Systems, Inc. in Elkhart, IN, USA. It's likely the testing was conducted in the USA, but this is not explicitly confirmed. The study appears to be prospective in the sense that the SteriChek™ kit was analyzed with new samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Number of Experts: Not mentioned.
• Qualifications of Experts: Not mentioned.

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

• Adjudication Method: Not mentioned. The device involves visual comparison to a colorimetric comparator. It's possible that a single operator/technician compared the colors, but details are not provided.

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 device is a chemical test kit, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study and AI-related effect sizes are not applicable.

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

• Standalone Performance: The device itself is a "standalone" chemical test kit. Its performance is based on the chemical reaction and visual comparison, not an algorithm. The description implies human-in-the-loop for visual comparison, as the color of the sample is "visually compared to a colormetric comparator."

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

• Type of Ground Truth: The ground truth was established by adding known concentrations of "sodium hypochlorite or monochloramines" to water samples. This creates a synthetic but precisely known (reference) concentration of free or combined chlorine, against which the device's readings are compared.

8. The sample size for the training set:

• Sample Size for Training Set: Not applicable. The device is a chemical test kit, not a machine learning algorithm that requires a "training set."

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

• Ground Truth for Training Set: Not applicable, as there is no "training set" for this type of device.

Summary of the Study:

The study performed was a comparison study where the SteriChek™ Total Chlorine Test Kit was evaluated against a predicate device, Serim™ HiSense Test Strips. Both devices were tested with water samples prepared with known concentrations of either sodium hypochlorite (for free chlorine) or monochloramines (for combined chlorine). The objective was to demonstrate that the SteriChek™ kit's performance was "equivalent" to the predicate device. Details on the specific number of samples, how the comparison was quantified (e.g., specific accuracy metrics), or who performed the readings are not provided in this summary. The ground truth was based on the precisely prepared known concentrations of chlorine in the water samples.

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SteriChek™ Peracetic Acid Reagent Strips provide a convenient means for determining the effective levels of peracetic acid in dialyzer reprocessing in hemodialysis.

The device is made up of a 0.20 inch square faint-yellow reagent pad that has been chemically treated to detect peracetic acid in dialyzer reprocessing mix. The pad is affixed to one end of a 3.25 inch by 0.20 inch white opaque polystyrene strip.

The provided text describes a 510(k) submission for a medical device called "SteriChek™ Peracetic Acid Reagent Strips." This device is a reagent strip designed to detect peracetic acid levels in dialyzer reprocessing. The submission focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study with detailed acceptance criteria and performance metrics for a novel technology.

Therefore, many of the requested categories in your prompt are not applicable or cannot be extracted from this type of regulatory document. This document is a premarket notification for a Class II device, where the primary goal is to show equivalence to an already marketed device, not to present a de novo study with strict performance criteria.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

This information is not explicitly stated in the provided text. The document refers to "identical in performance" to the predicate device, but no specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy against a gold standard) for the SteriChek device itself are given. The performance description is qualitative:

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 available in the provided text. The document does not describe a new clinical or laboratory study with a separate test set. The claim is based on manufacturing an identical product to a predicate.

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 available in the provided text. No specific ground truth establishment process for a new test set is described.

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

This information is not available in the provided text. No adjudication method is mentioned as a new study was not conducted on this new device.

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/available. This device is a simple chemical reagent strip, not an AI-powered diagnostic tool, so an MRMC study related to AI assistance is irrelevant.

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

This information is not applicable/available. The device is a reagent strip that changes color, which is read by a human. There is no algorithm involved.

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

For the SteriChek device, the "ground truth" implicitly relies on the established performance and chemical properties of the predicate device, Serim™ Peracetic Acid Reagent Strips. The underlying chemical reaction (iodide oxidation to iodine forming a color with starch) is the scientific basis. No new independent 'ground truth' study is discussed for this specific submission as it relies on equivalence.

8. The sample size for the training set

This information is not applicable/available. This is a chemical reagent strip, not a machine learning model, so there is no "training set."

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

This information is not applicable/available. As explained above, there is no training set for this type of device.

Study Proving Device Meets Acceptance Criteria:

The document states: "The predicate device has been manufactured by Environmental Test Assessment of Performance: Systems, Inc. since its introduction by Serim Research Corporation. ETS will manufacture the SteriChek™ Peracetic Acid Strips using the same manufacturing and quality assurance procedures to produce a product identical in performance to the marketed device, but with a new name. The change in formulation provides for different color development but follow the same test principles as the predicate device."

Conclusion regarding the "study":

The "study" or justification for meeting acceptance criteria is essentially the claim of manufacturing identity and adherence to the same quality assurance procedures as the predicate device. The regulatory approach here is Substantial Equivalence (SE), meaning the device is considered safe and effective because it is essentially the same as a legally marketed predicate device. No new standalone performance study (as would be typical for novel devices or AI) is presented or required for this 510(k) submission. The "proof" is the assertion of identical manufacturing processes and shared underlying chemical principles with an already approved device.

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SteriChek™ Residual Peroxide Reagent Strips provide a convenient means for measuring the concentration of peroxide remaining in water being used to rinse out dialysate lines and dialyzers following disinfection with peroxide/peracetic acid.

The device is made up of a 0.20 square inch off-white reagent pad that is chemically treated to detect peroxide in water. The pad is affixed to one end of a 3.25 inch by 0.20 inch white opaque polystyrene strip.

The provided text does not contain detailed information about specific acceptance criteria or a dedicated study with performance metrics in the way a typical medical device study would describe. The document is a 510(k) Safety and Effectiveness Summary for the SteriChek™ Residual Peroxide Reagent Strips.

This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a de novo performance study against defined acceptance criteria.

However, based on the information provided, we can infer some aspects and highlight what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Missing Information:

• Specific numerical acceptance thresholds for accuracy, precision, sensitivity, or specificity.
• Quantitative data from direct comparison studies where the SteriChek™ strip's readings are compared against a gold standard or the predicate device at various concentrations.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified. The document states that the new device will be manufactured using the same manufacturing and quality assurance procedures as the predicate and will be identical in performance. This implies that no new, extensive test set was generated for direct comparison within this submission.
• Data Provenance: Not explicitly stated as a separate test set. The claim of "identical in performance" suggests reliance on the predicate device's established performance data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable/Not specified. There is no mention of human experts interpreting the results of the device for a test set, nor of defining a "ground truth" through expert consensus for a new study. The device itself produces a readily interpretable color change.

4. Adjudication method for the test set:

• Not applicable/Not specified. There is no mention of human interpretation requiring adjudication for a test set.

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 device is a chemical reagent strip, not an AI-powered diagnostic tool. MRMC studies are not relevant here.

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

• Not applicable. This is a chemical reagent strip, not an algorithm. The "standalone" performance is the color development and its proportional intensity to peroxide concentration.

7. The type of ground truth used:

• For the device's function: The "ground truth" for the device's function (color change proportional to peroxide concentration) would be established by analytical chemistry methods (e.g., spectrophotometry, titration) to accurately determine peroxide concentrations in reference solutions. The document implies that the color blocks on the label are "calibrated" against such a ground truth.
• For the submission: The "ground truth" for this 510(k) submission is the established performance and safety record of the predicate device (Serim™ Peroxide Reagent Strips). The new device aims to be substantially equivalent to this predicate.

8. The sample size for the training set:

• Not applicable. This is a chemical reagent strip, not a machine learning model. There is no "training set" in the context of AI.

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

• Not applicable (as above).

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SteriChek™ Chlorine Reagent Strips provide. a convenient means for measuring the concentration of chlorine bleach remaining in water being used to rinse out dialysate lines following disinfection of hemodialysis equipment.

The device is made up of a 0.20 inch square off-white reagent pad that has been chemically treated and affixed to one end of a 3.25 inch by 0.20 inch white opaque polystyrene strip.

SteriChek™ Chlorine Reagent Strips contain syringaldazine, a colorless compound which serves as an indicator, potassium iodide, and a pH buffer.

The reagent strips react with both free chlorine and combined chlorine (monochloramines). Free chlorine oxidizes syringaldazine to form a colored oxidation product. Combined chlorine in the form of monochloramines oxidize potassium iodide to iodine which in turn oxidizes syringaldazine to the colored form.

The SteriChek™ Chlorine Reagent Strips are intended for measuring the concentration of chlorine bleach in water used to rinse dialysate lines after disinfecting hemodialysis equipment. This device is a new brand name for an existing product, the Serim™ Chlorine Reagent Strips, manufactured by the same company. The submission states that the new device is identical in performance to the predicate device because it uses the same materials and manufacturing processes. Therefore, specific acceptance criteria and detailed study results as typically seen for new device performance validation are not explicitly provided in this summary. Instead, the focus is on demonstrating substantial equivalence to the existing, already-marketed device.

Here's an attempt to extract and synthesize the requested information based on the provided text, acknowledging that many fields will be "Not Applicable" or "Not Provided" due to the nature of this 510(k) submission as a rebranding:

1. Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state quantitative acceptance criteria or detailed device performance metrics in the format of a table. Instead, the core assertion is that the "SteriChek™ Chlorine Reagent Strips have no technological characteristics that raise new types of safety or effectiveness questions" and are "identical in performance to the marketed device" (Serim™ Chlorine Reagent Strips).

Given this, the implicit acceptance criterion is demonstration of identical performance to the predicate device, the Serim™ Chlorine Reagent Strips.

Table: Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not specified. The submission indicates that the new device is identical to the predicate device due to manufacturing consistency, implying no new performance studies with a distinct test set were conducted.
• Data Provenance: Not explicitly stated for performance testing. The claim of identical performance is based on manufacturing processes, not new testing data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Number of Experts: Not applicable/Not provided. New performance studies requiring expert-established ground truth for a test set are not described.
• Qualifications of Experts: Not applicable/Not provided.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable/Not provided.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study Done: No. The device is a diagnostic reagent strip for chemical detection, not an image-reading or human-interpretation-dependent device that would typically involve an MRMC study.
• Effect Size of Human Readers Improvement: Not applicable.

6. Standalone Performance Study (Algorithm Only)

• Standalone Study Done: Not explicitly described as a new study for the SteriChek™ strips. The "performance" assessment relies on the established performance of the predicate device, which is considered identical. The device itself is a chemical reagent, not an algorithm in the typical sense.

7. Type of Ground Truth Used

• Type of Ground Truth: For the predicate device's original validation (which is being leveraged here), the ground truth for chlorine concentration would typically be established using laboratory reference methods (e.g., titrimetric methods, spectrophotometry) known to accurately measure free and combined chlorine. This is inferred, as direct ground truth establishment for the new device is not documented.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable/Not provided. This type of chemical test strip does not involve a "training set" in the context of machine learning or complex algorithmic development. Its "training" is in its chemical formulation and manufacturing processes.

9. How the Ground Truth for the Training Set Was Established

• How Ground Truth for Training Set Was Established: Not applicable/Not provided.

Summary of the Study Proving Acceptance Criteria:

The "study" proving the device meets its (implicit) acceptance criteria is the assertion of manufacturing identicality to the predicate device. The submitter states:

• "The predicate device has been manufactured by Environmental Test Systems, Inc. since its introduction by Serim Research Corporation."
• "ETS will manufacture the SteriChek™ Chlorine Reagent Strips using the same bill of materials and the same manufacturing and quality assurance procedures to produce a product identical in performance to the marketed device, but with a new name."
• "The SteriChek™ Chlorine Reagent Strips have the same intended use as the predicate device. There will be no changes in the design, materials, or other features compared to the predicate device, other than a change in the trade or proprietary name of the device."
• "The SteriChek™ Chlorine Reagent Strips have no technological characteristics that raise new types of safety or effectiveness questions."

This approach fundamentally relies on the FDA's "substantial equivalence" pathway, where if a new device is shown to be identical or very similar to a legally marketed predicate device, extensive new performance studies may not be required beyond demonstrating that similarity. In this case, identical manufacturing processes and materials are presented as sufficient evidence for identical performance.

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