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510(k) Data Aggregation
(107 days)
ABBVIE INC.
The AbbVie J is intended to provide long-term enteral access for administration to the small intestine. The AbbVie J is indicated for the administration of the medication DUOPA (carbidopa enteral suspension).
The AbbVie J (List Number 62918) is a 9 FR intestinal (J) tube, 120 cm in length. The kit includes: AbbVie J intestinal tube (polyurethane), Guide Wire (Teflon™-coated stainless steel), Y-Connector, Click Adaptor. The kit is supplied sterile (ethylene oxide). The AbbVie J is inserted through the AbbVie PEG with the aid of the guide wire. The guide wire is used to aid insertion and is removed once the tube is in place. The intestinal tube's tip is placed in the small intestine for the administration of medication in a home and/or healthcare facility environment. A Y-Connector and Click Adaptor are included in the AbbVie J kit to connect the AbbVie PEG and intestinal tubes.
Here's an analysis of the provided text regarding the device AbbVie J, focusing on acceptance criteria and study details.
Crucial Note: Based on the provided document, the device described (AbbVie J, K142816) is a Gastrointestinal Tube and Accessories (Product Code KNT). This is a physical medical device, not an AI/Software as a Medical Device (SaMD). Therefore, the questions related to AI performance metrics (like sensitivity, specificity, F1 score, effect size of AI assistance for human readers, standalone algorithm performance) are not applicable to this submission. The "performance data" section for this type of device focuses on biocompatibility and physical integrity/functionality, not diagnostic or predictive accuracy.
Acceptance Criteria and Study to Prove Device Meets Criteria (for AbbVie J, K142816)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance |
|---|---|---|
| Biocompatibility | Cytotoxicity | Passed |
| Sensitization | Passed | |
| Irritation (intracutaneous reactivity) | Passed | |
| Systemic toxicity (acute) | Passed | |
| Subchronic Toxicity (subacute toxicity) | Passed | |
| Pyrogen Testing | Passed | |
| Genotoxicity | Passed | |
| Implantation | Passed | |
| Non-Clinical Performance | Conformance to EN 1615:2000 (Enteral feeding catheters) | Acceptable |
| Conformance to ISO 80369-1:2010 (Small-bore Connectors) | Acceptable | |
| Food Contact Testing (21 CFR 177.2600) | Materials acceptable for food contact use (per extractable limits) | |
| Guide Wire Performance (ISO 11070) | Evaluated and deemed acceptable | |
| MR Compatibility (FDA Guidance) | Passed compatibility testing | |
| Compatibility with DUOPA medication | Passed compatibility testing | |
| Clinical Performance | No clinical evaluations performed or relied upon | N/A (Substantial equivalence demonstrated without clinical data) |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable. For this physical device, "test set" primarily refers to the samples used in laboratory-based performance and biocompatibility testing. The document doesn't specify the number of individual units or test repetitions for each specific test, but it indicates the tests were conducted according to relevant standards.
- Data Provenance: Not explicitly stated regarding country of origin, but the tests were conducted according to FDA-recognized international (ISO, EN) and US (FDA Blue Book, CFR) standards. All testing appears to be retrospective, typically conducted during the device development and validation phase.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Number of Experts/Qualifications: Not applicable in the context of diagnostic accuracy. For the performance and biocompatibility testing, ground truth is established by the results of standardized laboratory assays and physical tests interpreted by qualified personnel in accredited labs. The document does not specify the number or qualifications of these individuals, which is standard for this type of submission.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. This concept pertains to resolving discrepancies in expert interpretations, which is not relevant for the objective, laboratory-based testing of a physical medical device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Reader Improvement with AI vs. Without AI Assistance
- MRMC Study: No. This device is not an AI/SaMD.
- Effect Size: Not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: No. This device is not an AI/SaMD.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth for this device is established through objective, validated laboratory testing methods described in the referenced international standards (ISO, EN) and US regulations (21 CFR). For example:
- Biocompatibility: Standardized cell culture assays, animal models, and analytical chemistry.
- Physical Performance: Measurements of physical properties like tensile strength, flow rate, connector integrity, and material extractables, compared against established pass/fail criteria in the referenced standards.
- MR Compatibility: Measurement of induced heating, artifact, and force/torque in an MR environment following standardized protocols.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This device does not use machine learning or AI that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable. This device does not use machine learning or AI.
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(110 days)
ABBVIE INC.
The AbbVie NJ is intended to provide short-term enteral access for administration of medication to the small intestine. The AbbVie NJ is indicated for the administration of the medication DUOPA (carbidopa and levodopa enteral suspension).
The AbbVie NJ (List Number 62903) is a 10 FR, 152 cm, naso-jejunal (NJ) tube made of white radiopaque polyurethane. The distal coiled end region and bolus tip are coated with a water activated lubricant. The AbbVie NJ includes a silicone coated stainless steel Stylet. The kit is supplied sterile (ethylene oxide). The AbbVie NJ is inserted through the nose and advanced into the small intestine for administration of medication in a home and/or healthcare facility environment. The Stylet is used to aid insertion and is removed once the tube is in place.
The provided text describes a 510(k) submission for the AbbVie NJ device, a naso-jejunal tube. This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria for a novel device. Therefore, much of the requested information about device performance, study design, and ground truth establishment is not available in the provided text.
Based on the information given:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as numerical performance criteria for the device itself. Instead, the focus is on demonstrating conformance to standards and biocompatibility. | Biocompatibility: Passed Cytotoxicity, Sensitization, Irritation (intracutaneous reactivity), Systemic toxicity (acute), Pyrogen Testing, and Implantation tests. |
| Product Specific Performance: Conformance to BS EN 1615:2000 for enteral feeding catheters and enteral giving sets. | Found to be acceptable per ISO 80369-1:2010. |
| Material Compatibility: Compatibility with DUOPA medication. | Passed compatibility testing with the medication DUOPA. |
| Substantial Equivalence: Device is identical to the predicate device (AbbVie NJ, K133129) and the new indication does not alter intended use or impact safety/effectiveness. | Demonstrated by stating identity to predicate device and no change in intended use or safety/effectiveness due to the new indication. |
2. Sample size used for the test set and the data provenance:
- The document states, "No animal or clinical evaluations were performed or relied upon for the determination of substantial equivalence." This implies that there was no specific test set or clinical data of human subjects to evaluate the device's performance in a clinical setting against acceptance criteria.
- The "test set" for performance evaluation consisted of the physical device undergoing various laboratory tests (biocompatibility, product-specific performance, material compatibility). The sample size for these laboratory tests is not specified in the provided text, nor is the data provenance in terms of country of origin or retrospective/prospective nature.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. As no clinical or animal studies were conducted, there were no human subjects or cases requiring expert consensus for ground truth. The "ground truth" for the laboratory tests would be the accepted standards and methods for those tests.
4. Adjudication method for the test set:
- Not applicable. No clinical data requiring adjudication was generated or relied upon.
5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done:
- No. The document explicitly states, "No animal or clinical evaluations were performed or relied upon for the determination of substantial equivalence." Therefore, no MRMC study was conducted.
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 (naso-jejunal tube), not a software algorithm or AI model.
7. The type of ground truth used:
- The "ground truth" implicitly used for this submission is based on established international and FDA-recognized standards and test methods for biocompatibility (ISO 10993 series), product-specific performance (BS EN 1615:2000, ISO 80369-1:2010), and material compatibility. The successful completion of these tests serves as the "ground truth" for meeting the regulatory requirements for substantial equivalence.
8. The sample size for the training set:
- Not applicable. This device is a physical medical device, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. (See point 8).
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(110 days)
AbbVie Inc.
The AbbVie PEG is intended to provide long-term enteral access for administration of medication to the small intestine when used in conjunction with the AbbVie J, intestinal tube. As needed, enteral nutrition may be administered directly to the stomach in parallel with medication delivery to the intestine. The AbbVie PEG is indicated for the administration of the medication DUOPA (carbidopa and levodopa enteral suspension).
The AbbVie PEG is a percutaneous endoscopic gastrostomy (PEG or gastric) tube, either 15 FR (List Number 62910) or 20 FR (List Number 62912) and 35 cm in length.
The product components include the following:
- AbbVie PEG Tube (polyurethane) .
- External Fixation Plate (silicone, radio-opaque) with integrated Tube Clip and ●
- Tube Clamp. ●
Additionally, the kit includes the following components: - Reel of thread .
- Introducer device ●
- Puncture cannula with safety (air) valve and ●
- Disposable scalpel. ●
The kit is supplied sterile (ethylene oxide).
The AbbVie PEG is intended to allow the introduction of the AbbVie J intestinal tube for administration of medication in a home and/or healthcare facility environment. The AbbVie PEG is inserted through an incision in the abdominal wall over the stomach. The AbbVie J intestinal tube is placed through the PEG in order to deliver medication to the small intestine.
The provided document is a 510(k) summary for the AbbVie PEG device. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not necessarily for proving novel clinical effectiveness or for providing acceptance criteria tables and detailed study designs that are common in PMAs or clinical trials for new medical devices.
Based on the document, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria with corresponding performance metrics in the way one would expect for a diagnostic or interventional device with specific quantitative endpoints. Instead, the "performance data" section focuses on demonstrating the device's conformance to established biocompatibility and product-specific standards, as well as its substantial equivalence to a predicate device.
The performance data reported are more qualitative confirmations of compliance:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Biocompatibility Testing | |
| Cytotoxicity | Compliant with ISO-10993 and FDA Guidance |
| Sensitization | Compliant with ISO-10993 and FDA Guidance |
| Irritation (intracutaneous reactivity) | Compliant with ISO-10993 and FDA Guidance |
| Systemic toxicity (acute) | Compliant with ISO-10993 and FDA Guidance |
| Subchronic Toxicity (subacute toxicity) | Compliant with ISO-10993 and FDA Guidance |
| Pyrogen Testing | Compliant with ISO-10993 and FDA Guidance |
| Genotoxicity | Compliant with ISO-10993 and FDA Guidance |
| Implantation | Compliant with ISO-10993 and FDA Guidance |
| Product Specific Performance Testing | |
| Conformance to EN 1615:2000 | Assessment completed and shown to be acceptable |
| Conformance to ISO 80369-1:2010 | Assessment completed and shown to be acceptable |
| Food contact testing (21 CFR 177.2600) | Materials acceptable for food contact use, per extractable limits |
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 document for the performance tests mentioned (biocompatibility, product-specific). These tests are typically conducted on device materials or components rather than clinical subject cohorts. No clinical "test set" in the traditional sense was used because no animal or clinical studies were performed or relied upon for substantial equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not applicable as no clinical studies with "ground truth" established by experts were conducted or presented. The submission relies on laboratory testing and comparison to standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable as no clinical studies requiring expert adjudication were conducted.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable. The device is a physical medical tube (Percutaneous Endoscopic Gastrostomy tube) and not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies are not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical medical tube, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not applicable as no clinical ground truth was established for the performance evaluation presented. The "ground truth" for the performance data in this submission is compliance with recognized standards and regulations (e.g., ISO, EN, CFR).
8. The sample size for the training set
This information is not applicable as this device is a physical medical device, not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as point 8.
In summary: The provided document is a 510(k) summary for a physical medical device (AbbVie PEG) seeking substantial equivalence to a predicate. The "acceptance criteria" and "study" described are primarily focused on biocompatibility testing and conformance to engineering/safety standards for the device materials and design, rather than clinical performance metrics or AI algorithm validation. Therefore, many of the requested details about clinical studies, expert-established ground truth, and AI training/testing are not present in this type of submission. The key claim is that the device is identical to the predicate device with the exception of the proposed indication for use with DUOPA, and this new indication does not alter the intended use or impact safety/effectiveness.
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(262 days)
ABBVIE INC.
The AbbVie PEG is intended to provide long-term enteral access for administration of medication to the small intestine when used in conjunction with the AbbVie J, intestinal tube. As needed, enteral nutrition may be administered directly to the stomach in parallel with medication delivery to the intestine.
The AbbVie™ PEG is a percutaneous endoscopic gastrostomy (PEG or gastric) tube, either 15 FR or 20 FR and 35 cm in length. The kit includes the following: AbbVie PEG Tube (polyurethane), Reel of Thread with double thread and Introducer Device, Puncture Cannula with safety (air) valve, Disposable Scalpel, Silicone external Fixation Plate (radio-opaque) with integrated Tube Clip, and Tube Clamp.
The provided document does not contain information regarding a study that proves the device meets specific acceptance criteria related to its performance in a clinical setting with human subjects or an AI component.
Instead, this 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (EndoVive™ Initial Placement PEG Kit, K030855) through non-clinical performance data.
Here's a breakdown based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Conformance to ISO 10993-1:2009 Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process. | "The material composition of the AbbVie PEG shows acceptable performance across all protocols tested for biocompatibility per ISO 10993-1:2009..." (Stated as acceptable, no specific values or thresholds reported in this summary). |
| Enteral Feeding Catheters | Conformance to EN 1615:2000 Enteral feeding catheters and enteral giving sets for single use and their connectors - Design and testing. | "The AbbVie PEG was assessed for conformance to standard EN 1615:2000...and shown to be acceptable." (Stated as acceptable, no specific values or thresholds reported in this summary). |
| Small-bore Connectors | Conformance to ISO 80369-1:2010 Small-bore Connectors for Liquids and Gases in Healthcare Applications- Part 1: General requirements. | "An assessment of the AbbVie PEG has been completed and shown to be acceptable per ISO 80369-1:2010..." (Stated as acceptable, no specific values or thresholds reported in this summary). |
| Food Contact Safety | Conformance to 21 CFR 177.2600 Indirect Food Additives: Polymers, Rubber articles intended for repeated use per the extractable limits. (This implies specific extractable limits for various substances). | "Food contact testing was conducted on the AbbVie PEG and demonstrated that the materials that constitute the AbbVie PEG are acceptable for food contact use. The study was conducted as described in 21 CFR 177.2600...per the extractable limits." (Stated as acceptable, no specific values or thresholds reported in this summary, but implies compliance with regulatory extractable limits). |
| Safety and Effectiveness | Overall substantial equivalence to the predicate device, meaning no differences that would affect the safety or effectiveness of the device as compared to the predicate device, and no new issues of safety or effectiveness are raised. (This is a cumulative qualitative assessment rather than a specific numeric criterion). | "The information provided within this pre-market notification demonstrates that the AbbVie PEG has no differences that would affect the safety or effectiveness of the device as compared to the predicate device, EndoVive Initial Placement PEG Kit. The differences between the two devices do not raise new issues of safety or effectiveness." (This is the overarching conclusion of the 510(k) submission based on comparison and non-clinical testing). |
2. Sample size used for the test set and the data provenance:
- No clinical test set was used. The document explicitly states: "No clinical evaluations were performed or relied upon for the determination of substantial equivalence."
- The non-clinical tests (biocompatibility, standards conformance, food contact) would have involved material samples and device prototypes, but specific sample sizes for these tests are not provided in this summary. The provenance would be the test labs where these non-clinical tests were conducted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable, as no clinical test set requiring expert ground truth establishment was used.
4. Adjudication method for the test set:
- Not applicable, as no clinical test set requiring adjudication was used.
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 medical tube, not an AI-assisted diagnostic or imaging device. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a medical tube, not an algorithm.
7. The type of ground truth used:
- For the non-clinical tests, the "ground truth" was established by conformance to established international and national standards (ISO 10993-1, EN 1615, ISO 80369-1) and regulatory requirements (21 CFR 177.2600).
- For the overall substantial equivalence claim, the ground truth was the characteristics and performance of the legally marketed predicate device (EndoVive™ Initial Placement PEG Kit).
8. The sample size for the training set:
- Not applicable, as this device is not an AI/machine learning product and does not have a "training set."
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set.
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(262 days)
ABBVIE INC.
The AbbVie NJ is intended to provide short-term enteral access for administration of medication to the small intestine.
The AbbVie™ NJ is a 10 FR, 152 cm, naso-jejunal (NJ) tube made of white radiopaque polyurethane. The distal coiled end region and bolus tip are coated with a water activated lubricant. The AbbVie NJ includes a silicone coated Stylet.
This document describes the pre-market notification for the AbbVie™ NJ device, a naso-jejunal tube. It explicitly states that "No clinical evaluations were performed or relied upon for the determination of substantial equivalence." This means that the device's performance was assessed through non-clinical data and comparison to a predicate device, rather than through a clinical study that would generate the kind of data you're asking for regarding acceptance criteria, sample sizes, and expert review.
Therefore, I cannot provide the requested information, including a table of acceptance criteria and reported device performance based on a human study, sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or details about training sets.
The relevant information from the document is as follows:
1. Acceptance Criteria and Reported Device Performance (Non-Clinical):
| Acceptance Criteria (Non-Clinical) | Reported Device Performance (Non-Clinical) |
|---|---|
| Biocompatibility: Conformance to ISO 10993-1:2009 Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process. | The material composition of the AbbVie NJ shows acceptable performance across all biocompatibility protocols tested per ISO 10993-1:2009. |
| Enteral Feeding Catheters and Giving Sets: Conformance to BS EN 1615:2000 Enteral feeding catheters and enteral giving sets for single use and their connectors - Design and testing. | An assessment of the AbbVie NJ has been completed and shown to be acceptable per BS EN 1615:2000. |
| Small-bore Connectors: Conformance to ISO 80369-1:2010 Small-bore Connectors for Liquids and Gases in Healthcare Applications- Part 1: General requirements. | An assessment of the AbbVie NJ has been completed and shown to be acceptable per ISO 80369-1:2010. |
| Substantial Equivalence to Predicate Device (Entriflex™ Feeding Tube, K833621): No differences that would affect safety or effectiveness, and no new issues of safety or effectiveness are raised. | The AbbVie NJ is substantially equivalent to the currently marketed predicate device, Entriflex Feeding Tube (K833621). Both devices are naso-enteric tubes with the same fundamental structure and function. The AbbVie NJ tube diameter (10 FR) falls within the predicate's range. Duration of use (30 days or less), stylet feature, tube material (polyurethane), and anatomical delivery are the same. Differences (tube length, distal end, proximal connector, sterility) do not raise new issues of safety or effectiveness. The indication for use (administration of medication) is within the predicate's indications. |
2. Sample size used for the test set and the data provenance: Not applicable. No clinical test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No clinical 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 is a medical device (tube), not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done: Not applicable. This is a medical device (tube).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For non-clinical studies, conformance to established industry standards and substantial equivalence to a legally marketed predicate device.
8. The sample size for the training set: Not applicable. No clinical training set.
9. How the ground truth for the training set was established: Not applicable. No clinical training set.
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(261 days)
ABBVIE INC.
The AbbVie J is intended to provide long-term enteral access for administration of medication to the small intestine.
The AbbVie™ J is a 9 FR intestinal (J) tube, 120 cm in length. The kit includes: AbbVie J tube with Teflon™-coated Guide Wire and Blue Guide Wire Lock, Y-Connector, Fixation Screw (blue or violet) with Outer Ring, Click Adaptor consisting of: Click Adaptor Cap and Click Adaptor Connector.
Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility (per ISO 10993-1:2009) | Acceptable performance across all protocols tested for biocompatibility. |
| Material Composition | Acceptable performance across all protocols tested for biocompatibility. (Implicitly tied to biocompatibility, but explicitly mentioned). |
| Conformance to EN 1615:2000 (Enteral feeding catheters and enteral giving sets for single use and their connectors - Design and testing) | Device assessed for conformance and shown to be acceptable. |
| Conformance to ISO 80369-1:2010 (Small-bore Connectors for Liquids and Gases in Healthcare Applications - Part 1: General requirements) | Assessment completed and shown to be acceptable. |
| Substantial Equivalence to Predicate Device (EndoVive™ Two-Port Through The PEG (TTP) Jejunal Feeding Tube (J-Tube) Kit, K081739) | Demonstrated no differences that would affect safety or effectiveness, and differences do not raise new issues of safety or effectiveness. |
2. Sample Size for Test Set and Data Provenance:
The document explicitly states: "No clinical evaluations were performed or relied upon for the determination of substantial equivalence." This means there was no test set in the traditional sense of patient data or clinical trials for evaluating device performance in humans. The testing was entirely non-clinical (bench testing and material assessments). Therefore, there is no information about sample size for a test set or data provenance related to human subjects.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Since no clinical evaluations were performed, there was no "ground truth" derived from patient outcomes or expert consensus on clinical data. The acceptance criteria were based on adherence to international standards and non-clinical performance characteristics. The "experts" involved would likely be the engineers, toxicologists, and regulatory specialists within AbbVie who conducted and reviewed the non-clinical testing. Their specific qualifications are not detailed.
4. Adjudication Method for the Test Set:
Not applicable, as no clinical test set requiring adjudication by experts was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. The device's approval was based on non-clinical performance and substantial equivalence to a predicate device, not on human-in-the-loop performance or comparison of human readers with and without AI assistance.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical medical device (an intestinal tube), 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 device's acceptance relied on:
- Compliance with recognized international standards: ISO 10993-1:2009, EN 1615:2000, and ISO 80369-1:2010.
- Bench test results: Demonstrating mechanical and material properties meet specified requirements.
- Biocompatibility testing: As per ISO 10993, which provides a "ground truth" for material interaction with biological systems.
- Comparison to a predicate device: Establishing substantial equivalence based on technical characteristics and intended use.
8. The Sample Size for the Training Set:
Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI. The design and manufacturing process would involve various prototypes and batch testing, but these are not considered a "training set" for an algorithm.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no "training set" for this type of device. The design specifications and performance requirements for the device would have been established through engineering principles, prior knowledge of similar devices, and regulatory standards.
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