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The Medtronic, Inc. RACER Biliary Stent System is indicated for use in the palliation of malignant neoplasms in the biliary tree.

The RACER Biliary Stent System consists of a MP35N (Cobalt, Nickel, Chromium, Molybdenum Alloy) stent mounted on an over-the-wire delivery system. The device is equipped with an AV100 balloon mounted on the distal portion of the catheter. Diameters of the device include 4.0, 5.0, 6.0, and 7.0mm and the lengths are either 12mm or 18mm, all premounted on 80cm or 130cm catheters.

The Medtronic, Inc. RACER Biliary Stent System received 510(k) clearance based on substantial equivalence to a predicate device, the Bridge Constant Biliary Stent System (K030633). This type of clearance typically relies on a comparison of device characteristics and performance to a legally marketed device rather than a comprehensive study with pre-defined acceptance criteria for a new clinical endpoint.

However, based on the provided text, here's a breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission based on substantial equivalence, there are no explicit "acceptance criteria" for a new clinical outcome study as might be found for a PMA (Pre-Market Approval). Instead, the "acceptance criteria" are implied by demonstrating that the new device is as safe and effective as the predicate device. The "performance" is therefore measured against the predicate.

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

The document does not describe a clinical "test set" in the context of human subjects or patient data. The basis for clearance is preclinical testing and comparison to an existing device.

• Sample Size for Test Set: Not applicable in the context of a human clinical test set for this 510(k) submission. Preclinical testing was mentioned but no sample sizes for those tests are provided.
• Data Provenance: Not applicable in the context of a human clinical test set for this 510(k) submission.

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

Not applicable. This 510(k) submission relies on preclinical testing and comparison to a predicate device, not on expert-adjudicated ground truth from a clinical test set.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical test set requiring adjudication in the context described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No. This document describes a 510(k) submission for a medical device based on substantial equivalence, not an MRMC study comparing human reader performance.

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

No. This device is a physical medical device (stent system), not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for this 510(k) submission is established by:

• The performance and safety profile of the predicate device (Bridge Constant Biliary Stent System, K030633) which has already been deemed safe and effective.
• Preclinical testing results demonstrating the device's safe and effective mechanical and biological performance (e.g., biocompatibility, mechanical integrity).

8. The Sample Size for the Training Set

No "training set" in the context of AI/ML or a clinical study is mentioned. The device's design and manufacturing are based on established engineering principles and materials.

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

Not applicable, as there is no "training set" in the described context. The performance and safety of the device are benchmarked against an existing, cleared predicate device and supported by standard preclinical engineering and biocompatibility tests.

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The Bridge Constant Biliary Stent System is indicated for use in the palliation of malignant neoplasm in the biliary tree.

The subject device is a single use only device with a stent mounted on an over-the-wire delivery system. The device is equipped with an A V100 balloon mounted on the distal portion of the catheter to facilitate the percutaneous delivery of the stent.

This is a 510(k) summary for a medical device that does not use AI, therefore, much of the requested information regarding AI-specific studies and performance metrics is not applicable.

Here's the information based on the provided text, with clarifications where direct AI-related data is absent:

Acceptance Criteria and Device Performance for Medtronic AVE Bridge Constant Biliary Stent System

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary focuses on demonstrating substantial equivalence to existing predicate devices (Bridge Extra Support (K991533) and Bridge Assurant (K011817)) rather than specific quantitative acceptance criteria for this device. The core acceptance criterion for this submission is that the device is substantially equivalent to the predicate devices and meets their established performance and safety profiles.

2. Sample Size for the Test Set and Data Provenance

This 510(k) summary describes preclinical/in-vitro testing. It does not involve a "test set" of patient data or data provenance in the context of an AI study. The testing would have been conducted on the device itself.

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

Not applicable. This is a medical device submission based on physical device testing and substantial equivalence, not an AI model requiring expert-established ground truth from a test set.

4. Adjudication Method for the Test Set

Not applicable for the reasons stated in point 3.

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

Not applicable. This device is not an AI algorithm designed to assist human readers or perform diagnostic tasks. It is a physical medical device (biliary stent system).

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

Not applicable. This is not an AI algorithm.

7. Type of Ground Truth Used

For the preclinical/in-vitro testing, the "ground truth" would be established through engineering specifications, material standards, and validated testing protocols. For instance, burst pressure, tensile strength, radial force, and biocompatibility standards would serve as the ground truth against which the device performance is measured. It's not based on expert consensus, pathology, or outcomes data in the human patient context for this specific submission, but rather on physical and chemical performance standards.

8. Sample Size for the Training Set

Not applicable. This is not an AI device trained on a dataset.

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

Not applicable. This is not an AI device.

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The Aurora is indicated for use in the palliation of malignant neoplasm in the biliary tree.

The subject device is a system consisting of a single-lumen, tubular, self-expanding nickel-titanium ("nitinol") stent pre-loaded onto a sheathed delivery catheter. The stent design and catheter incorporate radiopaque markers to aid in stent placement during fluoroscopy. The delivery system is designed to deliver the stent to the stricture site. Once positioned at the stricture site, the sheath is withdrawn and the stent is released. Upon release, the stent's expansion results in the opening of the constructed lumen within the biliary tree.

The provided text is a 510(k) summary for the Medtronic AVE Bridge Aurora Biliary Stent System. It details the device's description, indications for use, and a claim of substantial equivalence to a predicate device. However, it does not contain information about explicit acceptance criteria or a formal study proving the device meets specific performance criteria.

Instead of a study proving performance against acceptance criteria, the document focuses on substantial equivalence (SE) to a previously marketed device. This is a common pathway for medical device clearance in the US, where a new device is shown to be as safe and effective as a legally marketed predicate device.

Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is absent:

1. Table of Acceptance Criteria and Reported Device Performance

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

• No information about a "test set" in the context of a performance study is provided.
• The justification for clearance is based on substantial equivalence and preclinical testing, not a clinical trial or a specific test set.

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

• Not applicable, as no external "test set" and ground truth establishment by experts is described for performance evaluation.

4. Adjudication method for the test set

• Not applicable, as no external "test set" and adjudication by experts is described.

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 medical implant (a stent), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI-related effectiveness metrics are irrelevant.

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

• Not applicable, as this is a physical medical device, not an algorithm.

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

• The primary "ground truth" or basis for clearance is the performance and safety record of the predicate device.
• For the preclinical testing mentioned, the "ground truth" would be established through engineering specifications, material science standards, and biocompatibility assays, often referencing recognized standards (e.g., ISO for biocompatibility). Specific details are not provided.

8. The sample size for the training set

• Not applicable, as this is a physical medical device, not a machine learning algorithm.

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

• Not applicable, as this is a physical medical device, not a machine learning algorithm.

Summary of the "Study" that Proves the Device Meets Acceptance Criteria:

The "study" or evidence provided is primarily a demonstration of substantial equivalence to an already legally marketed device – the Medtronic AVE Bridge Aurora. The key elements for this demonstration include:

• Technological Characteristics Comparison: The submission highlights that the "Aurora" (subject device) and "Bridge Aurora" (predicate device) are technologically similar, constructed of biocompatible materials, deployed similarly, and have the same intended use (palliation of malignant neoplasms in the biliary tree). The only noted difference ("lower crossing profile") is deemed minor and not relevant to the ability to palliate malignant neoplasms.
• Nonclinical Performance Testing: The summary states that "Preclinical testing was conducted to confirm the safe and effective performance of this device as well as the biocompatibility of the device." However, no specific details about the nature of these tests, their protocols, sample sizes, or the results are provided in this summary. This preclinical testing, along with the substantial equivalence claim, forms the basis for demonstrating safety and effectiveness.
• Regulatory Conclusion: The FDA's review concludes that the device is "substantially equivalent" to the predicate, permitting its marketing with specific labeling limitations regarding vascular use.

In essence, for this 510(k) clearance, the primary "proof" is the analogy to an existing, cleared device and general statements about preclinical testing, rather than a detailed report of a specific study against predefined quantitative performance criteria.

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The Aurora is indicated for use in the palliation of malignant neoplasm in the biliary tree.

The subject device is a system consisting of a single-lumen, tubular, self-expanding nickel-titanium (“nitinol”) stent pre-loaded onto a sheathed delivery catheter. The stent design incorporates radiopaque markers to aid in stent placement during fluoroscopy. The delivery system is designed to deliver the stent to the stricture site. Once positioned at the stricture site, the sheath is withdrawn and the stent is released. Upon release, the stent expands and conforms to the inner lumen of the biliary duct. Two catheter mounted radiopaque markers aid in visibility during fluoroscopy.

The provided text describes a 510(k) summary for the Medtronic AVE Bridge Aurora Biliary Stent System, focusing on its substantial equivalence to a predicate device rather than presenting detailed acceptance criteria and a study to prove meeting those criteria.

Therefore, many of the requested points cannot be answered directly from the provided text, as it does not contain information about:

• Specific quantitative acceptance criteria for device performance.
• A detailed study protocol (sample sizes for test sets, training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for specific performance metrics).

However, I can extract information related to the overall regulatory approval process and the type of evidence submitted.

Here's what can be inferred or directly stated based on the given documents:

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

• Acceptance Criteria (Inferred): The primary "acceptance criteria" for 510(k) clearance is demonstrating substantial equivalence to a legally marketed predicate device. This means the new device is as safe and effective as the predicate. The document states: "The Aurora is substantially equivalent to the currently cleared and marketed device and meets the clinical needs of the physicians."
• Reported Device Performance: The document explicitly states: "Preclinical testing was conducted to confirm the safe and effective performance of this device as well as the biocompatibility of the device." However, specific quantitative results of this preclinical testing are not provided in this summary. The device's technological characteristics are mentioned as being similar to the predicate, with the improvement of "increased visibility under fluoroscopy."

• "The subject and predicate stents are technologically similar and are intended for palliation of malignant neoplasms in the biliary tree."
• "Constructed of biocompatible materials."
• "Delivered via a sheathed delivery system."
• "The subject device offers increased visibility under fluoroscopy."
• "Preclinical testing was conducted to confirm the safe and effective performance of this device as well as the biocompatibility of the device." |
  | Meeting clinical needs of physicians. | - "The Aurora... meets the clinical needs of the physicians." |
  | Device safety and effective performance. | - "Preclinical testing was conducted to confirm the safe and effective performance of this device as well as the biocompatibility of the device." (No specific metrics or quantitative data provided in this summary). |
  | Biocompatibility. | - "The subject and predicate stents are constructed of biocompatible materials."
• "Preclinical testing was conducted to confirm the... biocompatibility of the device." |

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 provided in the given 510(k) summary. The document mentions "Preclinical testing" but does not detail the nature, size, or provenance of any test sets. This summary focuses on substantial equivalence and device description.

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 provided in the given 510(k) summary. There is no mention of a "test set" in the context of expert review for performance evaluation.

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

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

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

• This is not applicable as the device is a Biliary Stent System, not an AI-powered diagnostic device designed to assist human readers. The provided documentation does not suggest any MRMC study was conducted.

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

• This is not applicable as the device is a Biliary Stent System. It is an implantable medical device, not a standalone diagnostic algorithm.

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

• This information is not explicitly stated as the details of "preclinical testing" are not elaborated. For an implantable stent, "ground truth" for performance would typically be based on established engineering benchmarks, material science properties, biocompatibility testing (in vitro/in vivo), and potentially animal studies or historical clinical data from predicate devices. It is not framed in terms of expert consensus on diagnostic images.

8. The sample size for the training set

• This information is not provided in the given 510(k) summary. (Moreover, "training set" is typically associated with machine learning or AI models, which is not the nature of this device.)

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

• This information is not provided in the given 510(k) summary (and again, the concept of a "training set" as commonly understood in AI/ML is not applicable here).

Summary of what is known:

The provided documents are a 510(k) summary for a medical device (a biliary stent), not an AI/ML device. Therefore, the questions related to AI/ML specific rigorous study designs (like MRMC, training/test sets, expert ground truth, adjudication) are not addressed in this type of regulatory submission. The clearance is based on substantial equivalence to existing predicate devices and general "preclinical testing" demonstrating safe and effective performance and biocompatibility, without disclosing specific quantitative results or study methodologies in this public summary.

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The Bridge SE Biliary Self-Expanding Stent Delivery System is indicated for use in the palliation of malignant neoplasm in the biliary tree.

The subject device is a system consisting of a single-lumen, tubular, self-expanding nickel-titanium ("nitinol") stent pre-loaded onto a sheathed delivery catheter. The delivery system is designed to deliver the stent to the stricture site via transhepatic access. Once positioned at the stricture site, the sheath is withdrawn and the stent is released. Upon release, the stent expands and conforms to the inner lumen of the biliary duct. The device has two radiopaque markers to aid in stent placement during fluoroscopy.

The provided document is a 510(k) summary for the Bridge SE Biliary Self-Expanding Stent Delivery System. This type of regulatory submission establishes substantial equivalence to a predicate device, rather than performing a de novo clinical study with specific acceptance criteria or an MRMC study. Therefore, the information requested about acceptance criteria, specific study details, and AI-related metrics is not directly applicable or available in this document.

However, I can extract information regarding the device description, indications for use, and technological characteristics to explain how the device is considered to meet substantial equivalence criteria without the detailed study information you requested.

Here's an analysis based on the provided text, addressing only the applicable points:

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

The concept of explicit "acceptance criteria" and "reported device performance" in the context of a de novo clinical trial is not present here because this is a 510(k) submission. Instead, the "acceptance criteria" for a 510(k) submission are met by demonstrating substantial equivalence to a legally marketed predicate device. The "performance" is demonstrated through nonclinical testing and comparison to the predicate.

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 provided in the 510(k) summary. A 510(k) summary primarily focuses on demonstrating substantial equivalence through comparison to a predicate device and often relies on bench testing and existing knowledge of similar devices, rather than a prospective clinical trial with a defined test set of patients.

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 provided as this document does not describe a clinical study involving human readers or expert-established ground truth in the way a diagnostic algorithm study would.

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

This information is not provided as there is no described clinical study in the document that would require an adjudication method for a test set.

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

An MRMC comparative effectiveness study was not performed or described in this 510(k) summary. This document pertains to a medical device (stent and delivery system), not an AI-assisted diagnostic tool or an imaging modality requiring a reader study.

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

This concept is not applicable to the Bridge SE Biliary Self-Expanding Stent Delivery System, as it is a physical medical device (stent) and not an algorithm or AI system.

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

The concept of "ground truth" in the context of diagnostic accuracy for an algorithm is not applicable here. The assessment for this device relies on preclinical testing to confirm performance and biocompatibility, and the comparison to an already cleared predicate device. For stent efficacy, "outcomes data" or clinical follow-up would typically be part of a full clinical trial, but this 510(k) relies on the established safety and efficacy of the predicate device for its substantial equivalence claim.

8. The sample size for the training set

This information is not provided as this is not a study involving a training set for an algorithm.

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

This information is not provided as this is not a study involving a training set for an algorithm.

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The Medtronic AVE Bridge™ FX Biliary Stent Delivery System is intended to maintain patency of a bile duct, which is occluded by a malignant tumor.

The Bridge FX Stent Delivery System consists of a balloon-expandable intralumenal, 316L stainless steel stent pre-mounted onto the balloon of an over-the-wire delivery catheter. The device is available in diameters ranging from 6-10 mm and in several lengths including 20, 30, 40, and 60 mm. The delivery system has two radiopaque marker bands to aid in the placement of the stent during fluoroscopy. The delivery system is compatible with 0.035" guidewires and has useable lengths of 80 and 130 cm. The device is provided in a sterile package.

The provided text is a 510(k) summary for the Medtronic AVE Bridge FX Stent Delivery System. It describes the device, its intended use, and states that preclinical testing was conducted to confirm its safe and effective performance. However, this document does not contain information about acceptance criteria or a detailed study proving the device meets specific performance criteria in the way typically expected for an AI/CADe device.

The 510(k) process for a device like this stent typically relies on demonstrating "substantial equivalence" to a legally marketed predicate device rather than presenting extensive clinical performance studies with acceptance criteria in the format requested. The "performance" section mentions "Preclinical testing was conducted to confirm the safe and effective performance of the Bridge FX. The device passed biocompatibility testing." This is a high-level summary and doesn't provide the granular detail needed for the requested table and study information.

Therefore, many sections of your request cannot be fulfilled based on the provided text. I will indicate where information is "Not provided in the text."

Here's a breakdown of the available information:

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

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

• Sample size for test set: Not provided in the text. The term "preclinical testing" suggests laboratory or animal studies, not human clinical trials with a test set in the traditional sense for evaluating diagnostic performance.
• Data provenance: Not provided in the text.
• Retrospective or prospective: Not provided in the text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable as the text describes preclinical testing of a physical medical device (stent), not an AI/CADe system requiring expert-established ground truth for image interpretation.

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

• Not applicable for the type of preclinical testing described.

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. This is a physical medical device (stent), not an AI/CADe system, so an MRMC study is not relevant.

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

• Not applicable. This is a physical medical device.

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

• For "preclinical testing," ground truth would be established through laboratory measurements, engineering specifications, and potentially animal model outcomes (e.g., successful stent deployment, patency in a simulated vessel, biocompatibility assessment using standard assays). The specific details are not provided in the summary.

8. The sample size for the training set

• Not applicable for the type of preclinical testing described. The device is a physical stent, not an AI model requiring a training set of data.

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

• Not applicable for the type of preclinical testing described.

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The Medtronic AVE Solstice™ Solstice Balloon Temporary Occlusion System is intended to be used for temporary vascular occlusion in selectively stopping or controlling blood flow in the peripheral, cerebral, and visceral vasculature.

The Solstice is a single lumen balloon catheter that uses the QS 10 guidewire to occlude the central lumen and allow inflation of the balloon. This is accomplished by advancing any part of the QS 10 through the catheter. The single lumen then becomes occluded allowing fluid to fill the balloon.

The Medtronic AVE Solstice™ Temporary Occlusion Balloon System (K994141) is a medical device designed for temporary vascular occlusion. This document summarizes the acceptance criteria and the study used to establish its substantial equivalence to a predicate device.

1. Acceptance Criteria and Reported Device Performance

The provided text, a Summary of Safety and Effectiveness for a 510(k) submission, describes the general approach to demonstrating safety and effectiveness rather than a specific table of acceptance criteria with numerical performance targets. The overall acceptance criteria are implied to be achieving equivalence in intended use, design, and physical characteristics to the predicate device, the MTI Equinox™ Occlusion Balloon System (K990487).

The reported device performance is stated broadly: "Based on in-vitro and in vivo testing results, Medtronic AVE believes the Solstice and QS 10 are safe and effective for their intended use."

To provide a structured table, we can infer the categories of acceptance criteria based on the testing performed.

2. Sample Size and Data Provenance

The provided text does not specify the exact sample sizes used for the "physical bench testing," "biocompatibility," and "animal studies." It states that "Testing was conducted on final, testing, mounted catheters and QS 10 Guidewires."

The data provenance is not explicitly stated in terms of country of origin. The studies are described as "animal studies" and "in-vitro testing," suggesting laboratory and preclinical environments. The nature of the submission (510(k)) implies the data is retrospective, as it was gathered prior to the submission for regulatory clearance.

3. Number of Experts and Qualifications for Ground Truth

The provided text does not mention the use of experts to establish a "ground truth" in the context of human-readable data (e.g., image interpretation). The evaluation focuses on the physical and biological performance of the device through bench and animal testing. Therefore, this section is not applicable in the context of the provided information. If this were a clinical study with human outcomes data requiring expert interpretation, then such information would be relevant.

4. Adjudication Method

Since the assessment is based on physical bench testing, biocompatibility, and animal studies, and not on human-interpreted data, an "adjudication method" as typically understood in clinical trials (e.g., 2+1 reading) is not applicable. The assessment would have been based on pre-defined test protocols and measurable outcomes from the various tests.

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

An MRMC comparative effectiveness study is not applicable to this device. This type of study is typically used for diagnostic or screening devices where human readers interpret images or other data, and the focus is on how an AI system might improve human performance. The Medtronic AVE Solstice™ is an interventional device, and its evaluation is based on its physical properties and in-vivo performance, not human interpretive accuracy.

6. Standalone (Algorithm Only) Performance

A standalone performance evaluation (algorithm only, without human-in-the-loop) is not applicable for this device. The device itself is a physical medical instrument, not an AI algorithm. Its performance is inherent to its design and manufacturing, evaluated through physical, chemical, and biological testing, not through algorithmic output.

7. Type of Ground Truth Used

For the safety and effectiveness studies, the "ground truth" was established through:

• Bench Test Results: Measurable physical and mechanical properties of the device (e.g., balloon inflation/deflation times, material strength, integrity under stress).
• Biocompatibility Standards: Compliance with established biological safety standards for medical devices (e.g., lack of cytotoxicity, sensitization, irritation).
• Physiological Outcomes in Animal Models: Direct observable and measurable effects in living animal models (e.g., successful vascular occlusion, no adverse tissue reactions, patency after occlusion removal).

These are objective, direct measurements and observations, not expert consensus on an interpretation of data.

8. Sample Size for the Training Set

The concept of a "training set" is primarily relevant for AI/ML algorithms. Since this is a physical medical device and not an AI solution, there is no training set in the traditional sense. The manufacturing process and quality control would involve statistical sampling during production and validation, but this is distinct from an AI training set.

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

As there is no "training set" for an AI algorithm, this question is not applicable. The "ground truth" for the device's performance was established through rigorous physical, chemical, and biological testing according to established medical device standards and protocols, as outlined in earlier sections.

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