Search Results

The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter are indicated to sample blood or administer fluids intravenously. The MedSource TrueSafe Blood Control I.V. Safety Catheter and the MedSource ClearSafe Blood Control I.V. Safety Catheter may be used for any patient population with consideration given to adequacy for the vascular anatomy, appropriateness for the solution being administered and duration of the therapy.

The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheters are a safety medical device used for inserting a catheter into a patient's body for the delivery of fluids or drainage of fluids from a patient's body. This device is engineered to protect healthcare workers using it against accidental needle stick injury. In addition, this device also secures the needle (used to insert the catheter) within the catheter body with either a push button or slide safety mechanism, thus protecting healthcare and other personnel from accidental needle sticks.

The MedSource TrueSafe Blood Control I.V. Safety Catheter is comprised of a sharp needle attached to a needle hub with a catheter attached to a catheter hub. In the catheter hub there is a valve that, when activated, allows for the movement of fluids. In the 'inactivated' state prior to insertion of a male Luer, the movement of fluids is restricted. When the needle is retracted with the push button from the catheter the needle retracts into the body of the catheter and the needle is fully encapsulated.

The MedSource ClearSafe Blood Control I.V. Safety Catheter blood control mechanism is identical to the MedSource TrueSafe Blood Control I.V. Safety Catheter. The only difference in design features is the ClearSafe Blood Control has a slide safety mechanism that retracts the needle into the catheter body. The needle is also fully encapsulated to prevent accidental needlesticks. There is no difference in clinical use between the two models and the use of one over the other depends on user preference.

The MedSource TrueSafe and ClearSafe Blood Control Safety I.V. Catheter gauges are color coded for positive identification and range from 14G to 24G.

The provided text does not contain information about acceptance criteria and a study that proves a device meets those criteria. Instead, it describes a medical device, its intended use, comparison with a predicate device, and the various performance and biocompatibility tests it underwent to achieve substantial equivalence for FDA clearance.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample size and data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for the test set.
5. MRMC study information.
6. Standalone performance information.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device through engineering and performance testing, rather than a clinical study evaluating diagnostic or therapeutic efficacy against specific acceptance criteria in a human population.

The performance testing listed (ISO standards, simulated clinical use study) are applied to the device itself to ensure it functions as intended and safely, not typically to evaluate its effectiveness in a diagnostic or treatment context against a clinical ground truth. For example, ISO 10555-5 relates to "Intravascular catheters Sterile and single-use catheters Part 5: One-needle peripheral catheters" to ensure the device meets the physical and functional requirements for such catheters.

The document states: "In summary, based on the indication for use, technological characteristics and performance testing, the differences between The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter and the predicate did not raise new or different questions of safety and effectiveness." This is the conclusion of the 510(k) process, indicating that the device is deemed safe and effective based on its similarity to existing devices and its adherence to relevant performance standards.

Ask a specific question about this device

The MedSource TrueSafe Safety IV Catheter and the MedSource TrueSafety IV Catheter is indicated to sample blood or administer fluids intravenously. The MedSource TrueSafe Safety IV Catheter and the MedSource TrueSafe Comfort Safety IV Catheter may be used for any patient population with consideration given to adequacy for the vascular anatomy appropriateness for the solution being administered and duration of the therapy.

The MedSource TrueSafe Safety IV Catheter and the MedSource TrueSafe Comfort Safety IV Catheter are safety medical devices used for inserting a catheter into a patient's body for purpose of delivery of fluids or drainage of fluids from the patient. The MedSource TrueSafe Safety IV Catheter and the MedSource TrueSafe Comfort Safety IV Catheter are comprised of the following components: protective needle cover, color-coded catheter hub, radiopaque catheter tube, catheter holder, needle guide, medical grade stainless steel needle hub, porous plug and gauge chamber. The components combine for an ergonomic design that incorporate a safety feature that when the device is withdrawn, the needle is completely enclosed within the chamber protecting healthcare and other personnel from exposure to patient body fluids after the device has been discarded post-use. The retraction mechanism is activated by the push of a button.

This document describes the safety and performance testing for the MedSource TrueSafe Safety IV Catheter and MedSource TrueSafe Comfort Safety IV Catheter.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document mentions several types of testing:

• Nonclinical Bench Performance testing: The specific sample sizes for each of the listed bench tests (e.g., flow rate, corrosion, tensile strength) are not explicitly provided in the summary. However, these are generally performed on a sufficient number of units to demonstrate compliance with the referenced ISO standards.
• Simulated Clinical Use Testing: This test used a sample size of 500 units.
• Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given that it's a 510(k) submission and the tests are bench and simulated clinical use, they are inherently prospective in nature, performed specifically for regulatory submission.

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

For the nonclinical bench tests and simulated clinical use testing described, there is no mention of "experts" in the sense of medical professionals establishing a ground truth. These tests rely on predefined engineering and scientific criteria (e.g., ISO standards, physical measurements). The "ground truth" for these tests is the objective measurement against the specified criteria.

4. Adjudication Method for the Test Set:

Not applicable. The tests described are objective, quantitative measurements or visual assessments against predefined criteria from standards (e.g., ISO standards). There is no "adjudication" necessary between multiple observers or experts.

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

No, an MRMC comparative effectiveness study was not conducted or reported in this document. This submission focuses on the substantial equivalence of the device through bench and simulated use testing, not on comparative effectiveness with human readers.

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

Not applicable. This device is a physical medical device (an IV catheter), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used:

The ground truth for the performance tests is based on:

• Established engineering and performance standards: Primarily ISO 10555-1 and ISO 10555-5 for mechanical and functional aspects, and ISO 10993 series for biocompatibility.
• Objective physical measurements: For parameters like flow rate, tensile force, needle stick force, distance measurements, etc.
• Visual inspection criteria: For aspects like needle point defects, corrosion, and resistance to disinfection.
• Pre-defined pass/fail criteria: For all tests, specific thresholds or observations determine a "Pass" or "Fail."

8. The Sample Size for the Training Set:

Not applicable. This device is a physical product and not an AI/ML algorithm 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 physical device.

Ask a specific question about this device

The MedSource Sharps Datt is a non-sterile single-use disposable sharps container with a permanent closure system for a contaminated 1 ml or smaller syringe. Its intended use is by health care professionals in a setting where standard sharps containers are not accessible such as EMS, home healthcare, and laboratories. Its permanent closure system protects the user prior to disposal by incineration or decontamination by autoclave.

The MedSource Sharps Dart (MSD) sharps container consists of two injected molded parts-a tubular tapered cone and a polypropylene closure. Its small size of 0.6 L qualifies it as a pocket sharps container as defined by ISO 23907 First Edition 2012-09-01, Sharps injury protection-Requirements and test methods-Sharps containers. It is designed for the storage, such sharps as small syringes, blood needles, lancets, and angio-caths prior to disposal consideration. It's intended to be used in remote settings for sharps containers are not convenient and accessible such as EMS, home healthcare, etc. It is a single use device.

This document describes the MedSource Sharps Dart, a non-sterile, single-use disposable sharps container. The acceptance criteria and the study proving the device meets these criteria are detailed below.

1. Table of Acceptance Criteria and Reported Device Performance

Study Details:

The provided document is a 510(k) summary for a medical device (MedSource Sharps Dart), which primarily demonstrates substantial equivalence to predicate devices rather than independent clinical study results for novel technology. Therefore, many of the requested details about typical AI/software studies are not applicable or not provided in this regulatory submission.

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

The document describes performance testing of a physical medical device (sharps container) against established engineering standards (ISO 23907, ASTM F2132-01). It does not involve a "test set" in the context of AI/machine learning data.
The testing was conducted on samples of the MedSource Sharps Dart. The exact number of units tested is not specified in the summary, but it would involve a sufficient sample size to demonstrate compliance with the referenced standards. The provenance of this "data" is the manufactured MedSource Sharps Dart devices. The testing is prospective in the sense that newly manufactured devices were tested against existing standards.

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

This is not applicable as the "ground truth" is defined by the technical specifications and performance criteria within the international and national standards (ISO 23907, ASTM F2132-01). These standards are developed by expert committees, but there is no explicit mention of experts establishing ground truth for a test set in the context of this device's performance testing.

4. Adjudication Method for the Test Set:

Not applicable. Device performance was assessed against defined criteria in the standards rather than human adjudication of results.

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 physical sharps container, not an AI or software device that would involve 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 a physical device, not an algorithm.

7. The Type of Ground Truth Used:

The ground truth is based on the objective performance criteria and test methods specified in the recognized international and national standards: ISO 23907 and ASTM F2132-01. These standards define the acceptable physical and mechanical properties for sharps containers, such as puncture resistance and leak resistance.

8. The Sample Size for the Training Set:

Not applicable. This is a physical device, not an AI/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 physical device.

Ask a specific question about this device

The MedSource IV Set is designed to administer parenteral fluids from a container to a vascular system through a needle or catheter inserted into a vein

Not Found

The provided text is a 510(k) premarket notification letter from the FDA regarding a medical device called "MedSource Selectable IV Set." This document confirms the device's substantial equivalence to legally marketed predicate devices.

However, the letter does not contain any information about acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/ML powered medical device. It is a regulatory clearance document for a physical medical product (an IV set), not a software or AI product.

Therefore, I cannot provide the requested information based on the given input. The categories in your request (e.g., "effect size of how much human readers improve with AI vs without AI assistance," "standalone performance") are typically associated with performance studies for AI/ML diagnostic or assistive technologies, which are not described in this document.

Ask a specific question about this device

The MedSource IV Set is designed to administer parenteral fluids from a container to a vascular system through a needle or catheter inserted into a vein.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA regarding a MedSource IV Administration Set. This document is a regulatory approval notice for a medical device and does not contain information about software or AI-powered devices, nor does it detail acceptance criteria, study designs, or performance metrics in the way requested for an AI/ML device.

Therefore, I cannot extract the requested information regarding:

• A table of acceptance criteria and reported device performance.
• Sample size and data provenance for a test set.
• Number and qualifications of experts for ground truth.
• Adjudication method.
• Multi-reader multi-case (MRMC) comparative effectiveness study results.
• Standalone performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

This document is solely focused on the regulatory approval of a physical medical device (an IV administration set) based on substantial equivalence to a predicate device, not on the performance evaluation of an AI/ML algorithm.

Ask a specific question about this device

The MedSource IV Safety Catheter is indicated to sample blood or administer fluids intravenously. The MedSource IV Safety Catheter may be used for any patient population with consideration given to adequacy for the vascular anatomy appropriateness for the solution being administered and duration of the therapy.

The MedSource IV Safety Catheter is a safety medical device used for inserting a catheter into a patient's body for purpose of delivery of fluids or drainage of fluids from the patient's body. This device is engineered to protect healthcare workers using it against accidental needle stick injury and exposure to parts of the device that have come in contact with patient's blood or other body fluids, and have hence been potentially contaminated with infectious agents. In addition this device also secures the needle (used to insert the catheter) in an enclosed chamber, thus protecting healthcare and other personnel from exposure to patient body fluids after the device has been discarded postuse.

The device comprises a sharp needle attached to a hub which projects into a chamber. In the 'unactivated' state prior to insertion, the needle and hub are 'locked' in position. There exists a retraction mechanism for 'unlocking' the needle such that on activation of this mechanism it is withdrawn and completely enclosed within the chamber. This mechanism for retracting the needle preferably includes a coiled spring or other elastic components. The retraction mechanism is activated by the user using only one hand by means of a lever or 'switch'.

The provided text is a 510(k) Summary for the MedSource IV Safety Catheter, which is a medical device and not an AI/ML product. Therefore, many of the requested elements pertaining to AI/ML device studies (such as sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable to this document.

However, I can extract the acceptance criteria and performance data as presented for this traditional medical device.

1. Table of Acceptance Criteria and Reported Device Performance:

The document performs a comparison to a predicate device (Becton Dickinson Angiocath Autogaurd, K984059) to demonstrate substantial equivalence. The "acceptance criteria" for the MedSource IV Safety Catheter are implied by its performance being equivalent to or better than the predicate device's established performance, as well as compliance with specific ISO and ASTM standards.

Ask a specific question about this device

The MedSource IV Administration Set is designed to administer parenteral fluids from a container to a vascular system through a needle or catheter inserted into a vein.

The MedSource IV Administration Set is a sterile, single use intravascular administration set used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device includes: 1. Guard for Closure 2. Closure Piercing Device (spike)- Vented with Drip flow rate (either 10, 15, or 60 drops/mL 3. Housing for air-vent with filter 4. Drip Chamber 5. Fluid Filter 6. Tubing 7. Flow Regulator 8. Injection Site (Y-site, Needleless) 9. Male Luer Lock Fitting 10. Protective Cap for Male Fitting

The MedSource IV Administration Set is a medical device designed to administer parenteral fluids. The submission focuses on demonstrating substantial equivalence to a predicate device, the Angletouch IV Administration Set (K012189), through various performance tests.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

Study Proving Acceptance Criteria:

The study proving the MedSource IV Administration Set meets the acceptance criteria is a substantial equivalence comparison study against a legally marketed predicate device, the Angletouch IV Administration Set (K012189). This type of study is common for Class II medical devices seeking 510(k) clearance, where the primary goal is to demonstrate that the new device is as safe and effective as a previously cleared device.

Additional Information Required by the Prompt (not explicitly detailed in the provided text):

Since this is a submission for a physical medical device (IV administration set) and not an AI/software device, many of the requested points related to AI/software evaluation (e.g., ground truth, experts, MRMC studies) are not applicable. The information provided focuses on the physical and chemical properties and general performance of the device.

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

• Sample Size for Test Set: The document does not explicitly state the numerical sample size for each specific test (e.g., how many IV sets were tested for flow rate, tensile strength, etc.). It describes the criteria and results of the tests.
• Data Provenance: The data provenance is from bench testing conducted on the MedSource IV Administration Set itself and comparative analysis against the specifications and performance of the predicate device (Angletouch IV Administration Set, K012189). This is a prospective evaluation of the new device's performance based on established standards and predicate device data. The country of origin for the testing is not specified, but the submitter is Medsource International, LLC, located in Mound, MN, USA.

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

• Not Applicable: This request is typically relevant for studies involving subjective human interpretation (e.g., image analysis, diagnosis). For a physical medical device like an IV administration set, the "ground truth" for chemical, biological, and physical properties is established by adherence to recognized consensus standards (e.g., ISO 8536-4, ASTM F1982-07, ISO 954-1/2, etc.) and objective laboratory measurements, rather than expert consensus on subjective interpretations. There's no mention of experts establishing a "ground truth" in this context.

4. Adjudication Method for the Test Set:

• Not Applicable: Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among multiple human readers or annotators when establishing ground truth for subjective tasks. This is not relevant for the objective physical and chemical testing performed on an IV administration set. The tests performed yield objective, measurable results that either meet or do not meet the predefined specifications.

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

• Not Done: An MRMC comparative effectiveness study is used to evaluate the performance of human readers with and without AI assistance for interpretative tasks. This is not applicable to the evaluation of a physical IV administration set.

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

• Not Applicable: This also refers to AI/software performance. The device is a physical IV administration set, not an algorithm.

7. Type of Ground Truth Used:

• The "ground truth" for the performance evaluation of the MedSource IV Administration Set is based on:
  • Defined Standards and Specifications: Adherence to recognized international consensus standards (e.g., ISO 8536-4, ASTM F1982-07, ISO 954-1/2, EN 980, ISO 11138, BS EM 556-1, ISO 11135).
  • Predicate Device Performance: Comparison against the known performance characteristics and materials of the legally marketed predicate device (Angletouch IV Administration Set, K012189).
  • Objective Laboratory Measurements: Chemical, biological, and physical tests yielding quantifiable results that are compared against predefined acceptance thresholds derived from these standards and predicate device data.

8. Sample Size for the Training Set:

• Not Applicable: This concept of a "training set" is relevant for machine learning algorithms. For a physical device, there isn't a "training set" in the common AI sense. The design and manufacturing process are refined through engineering, testing, and adherence to quality systems and standards, not through "training data."

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

• Not Applicable: As there is no "training set" in the AI sense, this question is not relevant to the evaluation of this physical medical device.

Ask a specific question about this device

Indications for Use: MedSource Endotracheal Tube: The device is intended for oral or nasal intubation and for airway management.

Indications for Use: MedSource Pre-Loaded Endotracheal Tube and Stylet: The device is intended for oral or nasal intubation and for airway management.

MedSource Pre-Loaded Endotracheal Tube (Cuffed & Uncuffed) with and without Stylet:
• Constructed of Polyvinylchloride
• Single lumen tube with or without a cuff;
• Tapered tip with Murphy Eye;
• Clear medical-grade tubing(polyvinyl) with graduations;
• Connector with check valve;
• Pre-loaded with Stylet having a low friction coating;
• Various sizes
• Sterile Single-Use Device

The provided document is a 510(k) Summary for a medical device called "MedSource Endotracheal Tube" and "MedSource Pre-Loaded Endotracheal Tube and Stylet." This type of document is a premarket notification to the FDA to demonstrate that the new device is substantially equivalent to a legally marketed predicate device, and thus does not include extensive clinical study details like acceptance criteria or device performance data in the way a PMA (Pre-Market Approval) or clinical trial report would.

Therefore, the document explicitly states that "No clinical studies were conducted for safety or effectiveness." This means that the information requested about acceptance criteria, device performance, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, and ground truth for a study is not available in this submission.

Instead of clinical studies, the submission relies on demonstrating substantial equivalence to existing predicate devices based on:

1. Intended Use: The MedSource devices have the same intended use (oral or nasal intubation and airway management) as the predicate devices.
2. Materials of Construction: The materials (Polyvinyl Chloride) are the same or equivalent to the predicate devices.
3. Product Features: Both MedSource and predicate devices have features like a Murphy's Eye and Pilot balloon (where applicable).
4. Instructions for Use: The instructions for use are the same or similar.
5. Technological Characteristics: A table comparing characteristics shows direct equivalence for materials, sizes, manual method of use, Murphy's Eye, Pilot Balloon, and the option with/without Stylet.
6. Compliance with Standards: The device complies with applicable sections of ISO 5361:1999 (Anaesthetic and respiratory equipment - Tracheal tubes and connectors) and ISO10993-1 edition-1997-12-15 (Biological Evaluation Of Medical Devices—Part 1: Evaluation and Testing).

The FDA's letter (Page 4 of the document) confirms that the device was deemed "substantially equivalent" to legally marketed predicate devices, allowing it to be marketed without the need for a new premarket approval or clinical trials.

Ask a specific question about this device

The MedSource CPR Mask is designed to assist in providing immediate life support (mouth to mask ventilation) to health emergency victims requiring oxygen support (inhalation) or cardiopulmonary resuscitation (CPR) rescue techniques.

The CPR Mask with Oxygen Port is for prescription use.

A one piece, single use, full-size, light-weight PVC mask system which includes:

• A Universal breathing tube.
• A One-way filtered valve.
• A Head strap.
• With Oxygen Port or Without Oxygen Port.
• Packaged for easy portability and quick access.

Here's a breakdown of the acceptance criteria and the study details for the MedSource CPR Mask, based on the provided text:

MedSource CPR Mask: Acceptance Criteria and Study Details

The provided document describes a 510(k) premarket notification for the MedSource CPR Mask, which focuses on demonstrating substantial equivalence to predicate devices rather than proving novel clinical efficacy. Therefore, the "acceptance criteria" are related to performance standards and biocompatibility, not clinical outcomes for patients. The "study" refers to the performance testing and biocompatibility assessments conducted.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily derived from the performance expected of similar devices and recognized consensus standards, particularly AS-4259-1995 for respiratory resistance and ISO 10993 for biocompatibility.

Discussion of Results: The MedSource CPR Mask showed better performance (lower resistance) than the predicate device (Spiracle CPR Mask) for both inspiratory and expiratory resistance. The difference was stated as 5%, deemed to demonstrate "substantially the same performance" given inherent variations in test methods. All required and extra biocompatibility tests were passed.

2. Sample Size and Data Provenance

• Test Set Sample Size: For the respiratory resistance testing, the exact number of individual devices or tests performed is not specified, but the results are presented as single values for "MedSource CPR Mask" and "Spiracle CPR Mask," implying a representative sample was tested and reported.
• Data Provenance: The testing was presumably conducted by or for MedSource International, LLC as part of their submission to the FDA. The specific country of origin for the data is not stated, but the manufacturer is based in Minnesota, USA. The testing is prospective as it was specifically performed to support the 510(k) submission.

3. Number of Experts and Qualifications for Ground Truth

• Not Applicable. This type of device (CPR mask) and submission (510(k) for substantial equivalence) typically relies on objective performance measurements (like resistance) and standardized biocompatibility tests, not subjective expert assessment of images or clinical outcomes that require establishing a "ground truth" through expert consensus.

4. Adjudication Method for the Test Set

• Not Applicable. As mentioned above, there was no expert assessment or adjudication process involved in performance or biocompatibility testing. The results are objective measurements.

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

• No. An MRMC study is relevant for diagnostic devices where human readers interpret results, often with and without AI assistance, to assess changes in accuracy or efficiency. This type of study is not applicable to a CPR mask, which is a physical medical device for mechanical assistance, not a diagnostic tool requiring interpretation.

6. Standalone (Algorithm Only) Performance Study

• Not Applicable. This is not an AI-powered device or algorithm. The performance testing was for the physical device itself.

7. Type of Ground Truth Used

• Objective Measurements and Standardized Test Results:
  • For respiratory resistance: The "ground truth" is the measured physical property of the device (pressure drop at a given flow rate) as determined by methods outlined in AS-4259-1995.
  • For biocompatibility: The "ground truth" is determined by standardized laboratory assays (e.g., cell culture for cytotoxicity, animal models for sensitization/irritation) that assess biological responses to the materials, against passing criteria defined by ISO 10993.

8. Sample Size for the Training Set

• Not Applicable. There is no "training set" as this is not an AI/machine learning device. The design, materials, and manufacturing processes are developed through traditional engineering methods, not data-driven machine learning training.

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

• Not Applicable. As there is no training set, this question is not relevant.

Ask a specific question about this device