The Macroduct Advanced Model 3710 Sweat Collection System is intended only for clinical laboratory use by qualified medical personnel for stimulation of sweat from humans for analysis for the diagnosis of cystic fibrosis.

The Macroduct Advanced Model 3710 Sweat Collection System is intended only for clinical laboratory use by qualified medical personnel for stimulation and collection of sweat from humans for analysis for the diagnosis of cystic fibrosis.

The Macroduct Advanced Sweat Collection System consists of the Macroduct Advanced Model 3710, which is a microprocessor-controlled device powered from a rechargeable lithium-ion battery, battery charging power supply and cord for charging the battery, electrode cable assembly, and a kit of single-use supplies (Pilogel discs, collectors, and straps). The system safely and efficiently accomplishes the stimulation of human sweat through pilocarpine iontophoresis using the Macroduct Advanced Model 3710. The Macroduct Advanced Sweat Collector collects a sample of the stimulated sweat. Markings on the collection tube of the collector indicate if a sufficient sweat rate is achieved during the collection of sweat. The sample can then be analyzed for indications of cystic fibrosis with the Sweat-Chek™ Sweat Conductivity Analyzer using the principle of total electrolyte concentration in the sweat sample; or with the ChloroChek® Chloridometer® using the principle of coulometric titration.

The provided document is an FDA 510(k) Premarket Notification for the Macroduct Advanced Model 3710 Sweat Collection System. This device is an iontophoresis device intended for the stimulation and collection of sweat for the diagnosis of cystic fibrosis.

The document focuses on demonstrating substantial equivalence to a predicate device (Macroduct Model 3700-SYS) rather than presenting a study proving a specific performance claim against established acceptance criteria using a novel algorithm or AI. Therefore, many of the requested elements for an AI/algorithm-based study (like MRMC studies, training/test set sample sizes, ground truth establishment for AI, etc.) are not applicable to this type of submission.

The "acceptance criteria" in this context refer to the device meeting the requirements for substantial equivalence, primarily by demonstrating that modifications do not introduce new safety or effectiveness concerns and that the device performs like the predicate.

Here's a breakdown of what can be extracted and what is not applicable:

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

For a substantial equivalence submission like this, "acceptance criteria" are typically related to maintaining the same fundamental function, safety, and effectiveness as the predicate device. The performance is demonstrated by showing that the modifications do not negatively impact these aspects.

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Iontophoretic drug delivery electrodes are indicated for the administration of soluble salts or other drugs into the body for medical purposes as an alternative to hypodermic injections. They are also indicated for iontophoretic dermal administration of IONTOCAINE® (Lidocaine HCl 2% and Epinephrine 1:100,000 Topical Solution).

An iontophoresis device is intended to use a direct current to introduce ions of soluble salts or other drugs into the body for medical purposes. Iontophoresis technology is based on the principle that an electric potential will cause ions in solution to migrate according to their electrical charges. The quantity and distribution of a drug delivered into and across the skin by iontophoresis is dependent on the charge and molecular wcight of the ion, the strength of the electrical current applied, electrode composition, duration of current flow, and numerous other factors.

The IOMED, Inc. RH-950 iontophoresis electrode patch consists of an active delivery electrode and a passive return electrode. These electrodes are designed for a singlepatient, one-application use.

This electrode is powered by an on-board 1.5-volt button-cell battery. The maximum allowable electrical current is controlled by means of a fixed in-series resistor included in the device, while the treatment duration is pre-defined and controlled by a printed conductive ink limit switch.

The RH-950 iontophoresis electrode consists of dry, monolithic, impregnated polyester nonwoven fabric drug and clectrolyte containment pads designed to be hydrated with aqueous solutions of the drug and electrolyte immediately prior to use. It features a Silver-based metallic conductive current distribution component and a medical-grade pressure sensitive adhesive tape border for skin attachment. All components in contact with the skin are known GRAS materials and/or are listed in the National Formulary.

The provided text describes the IOMED, Inc. RH-950 iontophoresis electrode. However, it does not contain specific acceptance criteria, performance metrics, or study details in the format requested. The document focuses on establishing substantial equivalence to predicate devices for regulatory clearance.

Therefore, many of the requested fields cannot be filled directly from the provided text. I will extract what is available and note what is missing.

Acceptance Criteria and Study Details for IOMED, Inc. RH-950 Iontophoresis Electrode

The provided document, a 510(k) summary for the IOMED, Inc. RH-950 iontophoresis electrode, primarily focuses on demonstrating substantial equivalence to predicate devices (IOMED RH-900 and Birch Point IontoPatch). It describes the device, its intended use, and comparative testing for drug delivery and biocompatibility. However, it does not define specific numerical acceptance criteria for performance or explicitly detail a "study that proves the device meets the acceptance criteria" in a typical clinical trial or rigorous performance study format. Instead, it presents comparative data against a predicate device.

Below is an attempt to structure the available information according to your request, with significant caveats about missing data.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state numerical "acceptance criteria" for performance. The "performance" is largely demonstrated through comparability to a predicate device.

• 0.1 (negligible) when operated from negative polarity.
• 0.3 (negligible) when operated from positive polarity.
  These scores are "comparable to the IOMED, Inc. RH-900 electrode" (which is self-referential but implies meeting the negligible category). Scores for the Birch Point predicate were not available for comparison. |
  | Biocompatibility - Cytotoxicity | Meeting USP and ISO 10993-10 requirements, indicating 'mild' reactivity (e.g., Grade 2 on a 0-4 scale). | RH-950 (materials identical to RH-900): Not directly tested, but the RH-900 showed a cytotoxic grade of 2 (on a 0 to 4 scale), indicating 'mild' reactivity. This "meets USP and ISO 10993-10 requirements and shows that all the materials used in the RH-950 are safe to come in limited contact with intact patient skin." |

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

• Drug Delivery Test Set: Not explicitly stated. The study involved "hairless mouse skin in vitro." The number of samples (e.g., number of skin pieces, number of repetitions) is not provided.
• Biocompatibility - Primary Dermal Irritation Test Set: "Rabbits." The specific number of animals is not provided.
• Biocompatibility - Cytotoxicity Test Set: Not explicitly stated, as direct testing was not done on RH-950. The RH-900 results are referenced. Specific sample size for RH-900 cytotoxicity is not provided.
• Data Provenance: The drug delivery study was in vitro. The dermal irritation study involved "rabbits." No country of origin is specified for these studies, but the regulatory submission is to the US FDA. The studies appear to be prospective in nature, conducted for the purpose of demonstrating equivalence.

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

• Not applicable in the context of the provided information. "Ground truth" in this document refers to analytical measurements (drug transport) and standardized biological response assessments (irritation, cytotoxicity) rather than expert interpretation of images or clinical outcomes. The studies were conducted according to established scientific protocols (e.g., Petelenz et al., J Controlled Release 20 (1992), 55-56 for drug delivery; ISO 10993-10:2002 and GLP for biocompatibility).

4. Adjudication Method for the Test Set

• Not applicable. This is not a study relying on subjective adjudication of results. Measurements and observations were made according to scientific protocols.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically associated with diagnostic imaging devices where multiple human readers assess cases with and without AI assistance. The RH-950 is an iontophoresis electrode, and its evaluation relies on drug delivery kinetics and biocompatibility, not reader performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

• Not applicable. This device is a passive electrode, not an algorithm. Its performance is evaluated intrinsically through its physical and chemical properties and interaction with biological systems, not as an "algorithm only" component.

7. The Type of Ground Truth Used

• Drug Delivery: Quantitative measurements of drug transport (e.g., amount of drug delivered across the skin) in an in vitro model. This is an objective, measured outcome.
• Biocompatibility (Dermal Irritation): Standardized scoring of observed biological reactions in animal models (rabbits) according to ISO 10993-10:2002 guidelines. These scores are objective based on a predefined scale.
• Biocompatibility (Cytotoxicity): Standardized scoring of cellular reactions (grade 0-4) according to USP and ISO 10993-10 requirements. This is an objective, measured outcome.

8. The Sample Size for the Training Set

• Not applicable. This device is not an AI/ML algorithm that requires a "training set." The materials and design are based on established principles and manufacturing processes.

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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Northstar System is indicated for the administration of lidocaine hydrochloride to provide local dermal anesthesia on normal intact skin. This system is an alternative to hypodermic injection or topical application of lidocaine hydrochloride.

Northstar System is indicated for use on patients 5 years of age and older.

The Northstar Lidocaine Iontophoretic Drug Delivery System (Northstar System) is composed of the Controller and the pre-medicated Patch. The Controller is fitted with a unique interconnect device, mating only with the Northstar Patch.

The Northstar System delivers drugs through a process known as iontophoresis. It is based on the principle that a soluble salt or drug can be transported across the skin barrier as a part of an electric current induced in the skin.

The quantity and distribution of delivered drug(s) is dependent on; ion charge, molecular weight, the intensity of the electric current and the time the current is present. In most iontophoretic systems the delivery is measured in terms of milliampere-minutes (mA-min).

It has been shown that the efficacious delivery of anesthetic levels of lidocaine hydrochloride can be made to local dermal areas through iontophoresis.

The Northstar Controller-D uses a combination of discrete analog circuitry to control the delivery current and an embedded microprocessor to monitor the delivery.

The Northstar System utilizes a solid-state electronic controller and a pre-medicated drug delivery patch to form a simplified iontophoretic drug delivery system. As a result of this product design coordination, the Northstar System requires no special patch preparation or delivery parameter selection in the controller. An ON button actuation turns on an LCD (Liquid Crystal Display) indicating the number of deliveries available, starts the delivery and two LED's (Light Emitting Diodes) on the controller indicate the delivery status to the user.

The Northstar System has been specifically designed for the delivery of a proprietary preparation containing 10.0% Lidocaine hydrochloride and 1.0% Epinepherine packaged in a pre-filled patch. The delivery is done over a 10 minute interval. The user simply applies the patch to the patient, connects the controller and patch then depresses the ON button to start the delivery.

The provided text describes the Northstar Lidocaine Iontophoretic Drug Delivery System (Northstar System), which gained 510(k) clearance. The focus of the provided document is on the device itself (the controller) and its substantial equivalence to a predicate device, rather than a detailed clinical study report with acceptance criteria and specific performance metrics.

Therefore, the following information is extracted and inferred from the given text.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for the device performance but rather focuses on its ability to deliver the electrical current required for the intended use and its safety and efficacy as a system.

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

The document states that Phase III clinical studies were conducted, but does not specify the sample size for these studies.

• Data Provenance: The studies were prospective Phase III clinical studies conducted to provide safety and efficacy data for a New Drug Application (NDA) (N21-504) to CDER at the FDA. The country of origin of the data is not specified in this document.

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

The document does not provide information regarding the number of experts or their qualifications used to establish ground truth for the test set. Given that it's a drug delivery system for local anesthesia, ground truth would likely be based on objective measures of pain reduction or numbness, potentially reported by patients and assessed by clinicians.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method for the test set.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or reported in this document. The study described focuses on the efficacy of the device-drug system itself, not on human readers interpreting outputs or improving with AI assistance, as there is no AI component mentioned.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This is not applicable as the described device is an iontophoretic drug delivery system, not an algorithm or AI system. The "performance" refers to the system delivering the drug and achieving local anesthesia in patients.

7. Type of Ground Truth Used

The ground truth for the clinical studies would be related to the patient's response to local dermal anesthesia, likely assessed through clinical observations, patient-reported pain scales, or objective measures of numbness. The document refers to "safety and efficacy data" from the Phase III clinical studies supporting the indication of local dermal anesthesia.

8. Sample Size for the Training Set

The document does not specify a training set in the context of an algorithm. The term "training set" is typically used in machine learning. For a medical device, there would be development and testing phases, but not a "training set" in the AI sense.

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

This is not applicable as there is no mention of an algorithm training set. The clinical studies establish the safety and efficacy of the system as a whole.

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Iontophoretic drug delivery electrodes are indicated for the administration of soluble salts or other drugs into the body for medical purposes as an alternative to hypodermic injections. They are also indicated for iontophoretic dermal administration of IONTOCAINE® (Lidocaine HCl 2% and Epinephrine 1:100,000 Topical Solution).

An iontophoresis device is a device that is intended to use a direct current to introduce ions of soluble salts or other drugs into the body for medical purposes. Iontophoresis technology is based on the principle that an electric potential will cause ions in solution to migrate according to their electrical charges. The quantity and distribution of a drug delivered into and across the skin by iontophoresis is dependent on the charge and molecular weight of the ion, the strength of the electrical current applied, electrode composition, duration of current flow, and numerous other factors.

The RH-900 consists of an active delivery electrode and a passive return electrode. Both electrodes have buffering capability for up to an 80mA-min treatment. These electrodes are designed for a single-patient, one-application use.

This electrode is recommended for use with the Phoresor® Iontophoretic Drug Delivery Systems (Iomed, Inc., Salt Lake City, UT 84120). This system is a 9-volt battery powered, solid state, microprocessor-controlled device that controls current levels and duration, calculates total charge delivered and monitors current flow and electrode/skin impedance.

The RH-900 electrode consists of a dry, monolithic, impregnated nonwoven polyester fabric liquid containment element designed to be hydrated with an aqueous solution immediately prior to use. It also has a carbon conductive element and an adhesive tape border for skin fixation. All components in contact with the skin are known GRAS materials and/or are listed in the National Formulary.

The provided document describes the RH-900 Iontophoresis Electrode and its comparison to predicate devices, focusing on drug delivery capabilities and biocompatibility. The document does not describe a clinical study in the typical sense with patient outcomes, nor does it involve an AI/ML device. Therefore, it does not contain information about acceptance criteria in the context of clinical performance metrics like sensitivity, specificity, or accuracy, and does not provide details like sample sizes for test sets, expert qualifications, or MRMC studies for AI/ML devices.

However, I can extract the acceptance criteria (or rather, performance benchmarks) and the study (technical testing) used to demonstrate the device meets those benchmarks based on the information provided for this medical device (an iontophoresis electrode).

Here's the information structured to best fit your request, with strong caveats that this is not an AI/ML device study:

Acceptance Criteria and Study for Iomed RH-900 Iontophoresis Electrode

This document describes the safety and effectiveness of the RH-900 Iontophoresis Electrode by comparing its drug delivery and biocompatibility to predicate devices. It establishes performance through in vitro drug transport studies and in vivo dermal irritation studies.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Drug Delivery: The sample size for the in vitro hairless mouse skin model is not explicitly stated. The provenance is from a laboratory study ("in vitro by methods described by Petelenz et al., J Controlled Release 20 (1992), 55-56"). No country of origin is specified for the lab or samples.
• Biocompatibility (Primary Dermal Irritation): Rabbits were used. The specific number of rabbits is not provided. The study was conducted in accordance with FDA regulations for Good Laboratory Practices (GLP) and ISO 10993-10:2002.
• Biocompatibility (Cytotoxicity): The sample size for the in vitro cytotoxicity testing of the hydratable non-woven material is not specified. The testing followed GLP procedures and referenced USP and ISO 10993-10 requirements.

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

This type of information is not applicable as this is not a study assessing diagnostic performance by human experts. The "ground truth" for drug delivery was established by quantitative measurement of radiolabeled drug transport. The "ground truth" for dermal irritation and cytotoxicity was established by standardized laboratory testing protocols (GLP, ISO 10993-10) with objective scoring criteria, not by human expert consensus on images or interpretations.

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring adjudication of expert opinions.

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 not an AI/ML product and does not involve human readers interpreting output.

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

Not applicable. This is a non-AI medical device. The "standalone" performance here refers to the device's inherent physical and chemical properties and interaction with biological systems, as tested in the laboratory.

7. The Type of Ground Truth Used

• Drug Delivery: Quantitative measurement of radiolabeled drug transport across hairless mouse skin (in vitro model).
• Biocompatibility (Primary Dermal Irritation): Objective scoring of dermal reactions in rabbits based on predefined scales (0.0 to 8.0), as per ISO 10993-10:2002 and GLP.
• Biocompatibility (Cytotoxicity): Standardized in vitro cytotoxicity assays yielding a grade on a 0-4 scale, as per USP and ISO 10993-10.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device, so there is no training set.

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

Not applicable. As there is no training set for an AI/ML algorithm, this question is irrelevant to the provided document.

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The Q-Sweat™ Quantitative Sweat Measurement System is designed to measure the sweat output of the skin of humans. This device does not make a diagnosis or indicate by itself that any disease state exists; it simply documents sweat output. This device is to be used in scientific studies of the anatomy, physiology, and biochemistry of the skin & associated structures.

The O-Sweat device is measurement-only device which is designed to measure the rate & volume of sweating by capturing a sample of sweat (water) inside a small measuring chamber which is affixed to the skin. It does not measure any other parameters of the sweat sample. The measurement made is simply a calculation of moisture given off by the skin.

Here's an analysis of the provided text regarding the Q-Sweat Quantitative Sweat Measurement System, focusing on acceptance criteria and study details.

Based on the provided text, there is no specific study described that proves the device meets explicitly stated acceptance criteria. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance study results against predefined metrics.

The document primarily states that the device is substantially equivalent to other sweat measuring devices. This is a claim made by the applicant, and the FDA's letter indicates their agreement with this claim for market clearance, not necessarily a detailed performance validation against specific criteria.

Therefore, many of the requested sections (1, 2, 3, 4, 5, 6, 7, 8, 9) cannot be fully populated as the information is not present in the provided text.

However, I can extract the relevant available information:

1. Table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance

• Sample Size (Test Set): Not specified in the provided text.
• Data Provenance: Not specified in the provided text.

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

• This information is not provided in the text as no specific performance study is detailed with an independent ground truth establishment.

4. Adjudication method for the test set

• This information is not provided in the text as no specific performance study is detailed.

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 information about an MRMC study or AI assistance is present. This device is a measurement-only system and does not appear to involve AI or human interpretation in the context of diagnostic decision-making that would necessitate an MRMC study.

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

• The document implies standalone performance comparison to predicate devices, but no dedicated "standalone study" with detailed metrics is described. The device is a direct measurement tool, not an algorithm.

7. The type of ground truth used

• This information is not provided in the text as no specific performance study is detailed with an independent ground truth. The basis of equivalence is implied to be through comparison with the operational principles and intended use of existing predicate devices.

8. The sample size for the training set

• Not applicable/Not provided. The text does not describe a machine learning model or a training set.

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

• Not applicable/Not provided. The text does not describe a machine learning model or a training set.

Summary of what is provided:

The document is a 510(k) summary for the Q-Sweat Quantitative Sweat Measurement System. Its primary goal is to establish substantial equivalence to existing predicate devices.

• Intended Use: "To measure the sweat output of the skin of humans. This device does not make a diagnosis or indicate by itself that any disease state exists; it simply documents sweat output. This device is to be used in scientific studies of the anatomy, physiology, and biochemistry of the skin & associated structures."
• Comparison to Predicate Devices: The applicant claims the Q-Sweat operates in "nearly exact same fashion" as predicate devices and does not raise new questions of safety or effectiveness. The FDA's letter confirms substantial equivalence, allowing the device to be marketed.
• Device Type: A "measurement-only device" designed to measure the rate and volume of sweating. It captures a sample of sweat inside a small measuring chamber affixed to the skin and calculates moisture given off by the skin.

The absence of detailed performance study data, acceptance criteria, and ground truth establishment methods is typical for 510(k) applications that rely heavily on demonstrating substantial equivalence to already cleared devices, especially for devices where the technology and intended use are well-established. The equivalence claim focuses on the device's operational similarity and lack of new safety/effectiveness concerns, rather than a quantifiable performance comparison against specific metrics.

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The Iomed, Inc. Phoresor II PM900 is indicated for production of local dermal anesthesia using Iontocaine™ (brand of lidocaine hydrochloride 2% and epinephrine 1:100,000 Topical Solution).

An iontophoresis device is a device that is intended to use a direct current to introduce ions of soluble salts or other drugs into the body for medical purposes. Iontophoresis technology is based on the principle that an electric potential will cause ions in solution to migrate according to their electrical charges. The quantity and distribution of a drug delivered into and across the skin by iontophoresis is dependent upon the charge and size (molecular weight) of the ion, the strength of the electrical current being applied, electrode composition, duration of current flow, and numerous other factors.

ThePhoresor® II, Model PM900 iontophoretic device is a 9V battery-powered, solid state, microprocessorcontrolled device which controls current strength and duration, calculates total charge delivered, and monitors current flow and electrode/tissue impedance.

I am sorry, but the provided text from the K974855 submission does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

The document is a 510(k) summary and the FDA's response letter for the Phoresor® II, Model PM900 iontophoresis device. It focuses on:

• Device Description and Intended Use: Explaining what the device is and its purpose (administration of soluble salts or other drugs into the body for medical purposes, specifically local dermal anesthesia using Iontocaine™).
• Predicate Device: Identifying the previous model (Phoresor® II, Model PM800) for substantial equivalence comparison.
• Regulatory Classification: Discussing the classification of iontophoresis devices (Class II or Class III) and the conditions under which the PM900 is considered substantially equivalent.
• FDA's Decision: Confirming the device's substantial equivalence to devices marketed prior to May 28, 1976, provided it complies with regulations, particularly regarding drug labeling and manufacturing practices. The approval specifically applies to the use with Iontocaine™.

There is no mention of:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for a test set, data provenance, or the nature of any study dataset.
3. Number or qualifications of experts for ground truth establishment.
4. Adjudication methods.
5. Multi-reader multi-case (MRMC) comparative effectiveness study.
6. Standalone (algorithm-only) performance.
7. Type of ground truth used (e.g., pathology, outcomes data).
8. Sample size for a training set.
9. How ground truth for a training set was established.

The 510(k) process primarily relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials with specific performance metrics and ground truth establishment as might be seen for novel high-risk medical devices or AI-powered diagnostics. In this case, the updated device (PM900) is being compared to its predecessor (PM800), and the focus is on its intended use for drug delivery, not diagnostic performance.

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