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The Orbus LifeStent LP SDS Biliary Endoprosthesis is indicated for the palliation of malignant neoplasms in the biliary tree.

The LifeStent LP SDS Biliary Endoprosthesis consists of a balloon expandable stent which is mounted onto a transluminal angioplasty (PTA) balloon catheter which acts as the delivery system. The permanently implanted device used to maintain patency of a lumen compromised by tissue of an impinging tumor. The flexible, balloon expandable stent is made by laser cutting an open lattice design into a 316L stainless steel tube. The stent is supplied mounted onto a PTA balloon catheter, inserted percutaneously to the diseased site, and expanded by balloon. The systems are available with an expanded diameter of 5.0 mm at stent lengths of 18, 36 and 56mm.

The provided 510(k) notification for the Orbus LifeStent LP SDS Biliary Endoprosthesis focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel performance criteria through a dedicated clinical study with defined acceptance criteria. Therefore, several of the requested sections (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, training set details) are not applicable or cannot be extracted from this specific document.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not applicable. This submission relies on in vitro testing and comparison to predicate devices, not a clinical test set with human data.
• Data Provenance: Not applicable. The performance data described is from "Orbus protocols" for "in vitro tests."

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

• Not applicable. No ground truth was established by experts for a test set in the context of this submission. The "ground truth" here is the performance of the predicate devices.

4. Adjudication Method for the Test Set

• Not applicable. No test set requiring expert 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 stent, not an AI diagnostic tool. 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 medical stent, not an algorithm.

7. The Type of Ground Truth Used

• The "ground truth" in this context is the established performance and safety profile of the predicate devices, as demonstrated through their prior FDA clearance and the company's internal in vitro testing protocols. There is no external "ground truth" (e.g., pathology, outcomes data) generated for this specific submission; rather, the device is considered substantially equivalent to already-cleared devices that presumably have such data supporting their original clearances.

8. The Sample Size for the Training Set

• Not applicable. This submission does not involve a training set for an algorithm.

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

• Not applicable. This submission does not involve a training set for an algorithm.

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The Orbus LifeStent XL SDS Biliary Endoprosthesis is indicated for the palliation of malignant neoplasms in the biliary tree.

The LifeStent XL SDS Biliary Endoprosthesis consists of a balloon expandable stent which is I ne Enehein AL SDD Dipercutaneous transluminal angioplasty (PTA) balloon catheter which acts as the delivery system. The stent is a permanently implanted device used to maintain patency of a major bile duct obstructed by tissue of an impinging tumor. The flexible, balloon expandable stent is made by laser cutting an open lattice design into a 316L stainless steel tube. The stent is supplied mounted onto a PTA balloon catheter, inserted percutaneously to the diseased site, and expanded by balloon inflation. The systems are available with expanded diameter of 100mm at stent lengths of 17, 27, 37mm.

The provided text describes a 510(k) premarket notification for a medical device, the LifeStent XL SDS Biliary Endoprosthesis. This submission focuses on demonstrating substantial equivalence to a predicate device rather than a new clinical study involving AI or human readers. Therefore, many of the requested categories (e.g., sample size for test set, number of experts, MRMC study, training set details) are not applicable to this type of submission.

Here's an analysis based on the available information:

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

Since this is a substantial equivalence submission, the "acceptance criteria" are implied to be substantial equivalence to the predicate device in terms of design, materials, performance, and intended use. The "reported device performance" refers to the results of in vitro tests comparing the new device to the predicate.

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

• Sample Size for Test Set: Not applicable. The submission relies on in vitro testing for substantial equivalence, not a clinical test set from patients.
• Data Provenance: Not applicable. The data is from internal in vitro testing performed by Orbus Medical Technologies, Inc.

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

• Number of Experts: Not applicable. Ground truth from experts is not relevant for this type of in vitro substantial equivalence testing.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

• Adjudication Method: Not applicable. There was no clinical test set requiring adjudication.

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

• MRMC Study: No. This is a medical device submission focused on in vitro performance and substantial equivalence to a predicate device, not an AI-assisted diagnostic tool.

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

• Standalone Performance: No. This device is a physical medical implant (stent) and a delivery system, not an algorithm.

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

• Type of Ground Truth: Not applicable in the clinical sense. For in vitro testing, the "ground truth" would be established engineering specifications and measurement standards.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

• Ground Truth for Training Set: Not applicable.

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The Orbus LifeStent XL SDS Biliary Endoprosthesis is indicated for the palliation of malignant neoplasms in the biliary tree.

The LifeStent XL SDS Biliary Endoprosthesis consists of a balloon expandable stent which is provided mounted onto a percutaneous transluminal angioplasty (PTA) balloon catheter that acts as the delivery system. The stent is a permanently implanted device used to maintain patency of a major bile duct obstructed by tissue of an impinging tumor. The flexible, balloon expandable stent is made by laser cutting an open lattice design into a 316L stainless steel tube. The stent is inserted percutaneously to the diseased site, and supplied mounted onto a PTA balloon catheter, available with expanded diameters of 8.0 and 9.0mm at stent lengths of 17, 27, 37mm.

Here's a breakdown of the acceptance criteria and study information for the Orbus LifeStent XL SDS Biliary Endoprosthesis, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text focuses on demonstrating substantial equivalence to predicate devices rather than establishing specific quantitative performance acceptance criteria for the new device itself. The "performance data" section primarily lists types of in vitro tests conducted to show equivalence. Therefore, the table below reflects what can be inferred from the document regarding "acceptance" in the context of a 510(k) submission, which is often about demonstrating equivalence rather than meeting pre-defined numerical thresholds for novel performance claims.

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

• Test Set Sample Size: The document does not specify the sample size used for any of the in vitro tests.
• Data Provenance: The data provenance is not explicitly stated as retrospective or prospective, nor is the country of origin mentioned. However, since these are described as "in vitro tests" conducted by "Orbus protocols," it implies laboratory testing rather than human clinical trials.

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

• Number of Experts: This information is not provided as the document discusses in vitro tests rather than expert-adjudicated clinical data.
• Qualifications of Experts: Not applicable, as expert ground truth establishment for a test set is not described.

4. Adjudication Method for the Test Set

• Adjudication Method: None described. The evaluation appears to be based on the direct results of in vitro engineering and materials tests, rather than a process requiring expert adjudication.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. The submission is a 510(k) for a medical device (stent), not an AI/software device that would typically involve a multi-reader study. The focus is on physical and performance characteristics compared to predicate devices.

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

• Standalone Performance: Not applicable. This device is a physical medical device (stent), not a software algorithm.

7. The Type of Ground Truth Used

• Type of Ground Truth: For the in vitro tests mentioned, the "ground truth" would be established by engineering specifications, material standards, and experimental measurements compared against pre-defined acceptance criteria or performance of predicate devices. This is not "expert consensus," "pathology," or "outcomes data" in the typical clinical sense, but rather objective measurement and comparison.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This document describes a medical device, not a machine learning model, so there is no concept of a "training set."

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

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

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The Orbus LifeStent SDS Biliary Endoprosthesis is indicated for the palliation of malignant neoplasms in the biliary tree.

The LifeStent SDS Biliary Endoprosthesis consists of a balloon expandable stent which is provided mounted onto a percutaneous transluminal angioplasty (PTA) balloon catheter which acts as the delivery system. The stent is a permanently implanted device used to maintain patency of a major bile duct obstructed by tissue of an impinging tumor. The flexible, balloon expandable stent is made by laser cutting an open lattice design into a 316L stainless steel tube. The stent is supplied mounted onto a PTA balloon catheter, inserted percutaneously to the diseased site, and expanded by balloon inflation. The systems are available with an expanded diameter of 8.0 mm at stent lengths of 18 mm.

This document describes a 510(k) submission for the Orbus Medical Technologies LifeStent SDS Biliary Endoprosthesis, specifically an 8 x 18/20 mm size, as a line extension to a previously cleared device. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving specific acceptance criteria in a clinical study.

Here's a breakdown based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

This 510(k) summary does not present specific quantitative acceptance criteria or reported device performance in the format of a table as it pertains to clinical outcomes. Instead, it relies on demonstrating substantial equivalence to predicate devices. The performance data mentioned are primarily from in-vitro tests designed to show that the new device performs "in a manner substantially equivalent to the predicate devices."

In-vitro tests performed (as listed in "11. Performance Data"):

• Deployment
• Expansion force
• Compression force
• Dimensions
• Corrosion susceptibility
• Visual appearance
• Balloon performance
• Expansion damage
• Balloon tensile strength

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

The provided document does not describe a clinical study with a "test set" of patient data. The performance data mentioned are from in-vitro tests (laboratory tests) of the device itself, not from human subjects. Therefore, information on sample size for a test set, country of origin, or retrospective/prospective nature of data is not applicable to this 510(k) summary.

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

This is not applicable. The submission focuses on substantial equivalence based on technical comparisons and in-vitro performance, not on establishing ground truth for a test set of clinical cases.

4. Adjudication Method for the Test Set

This is not applicable as no clinical test set is described.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This submission relies on demonstrating substantial equivalence through non-clinical data.

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

This question is typically relevant for AI/software devices. The LifeStent SDS Biliary Endoprosthesis is a physical medical device (a stent and delivery system). Therefore, the concept of "standalone performance" in the context of an algorithm is not applicable here. The performance evaluated relates to the physical and mechanical properties of the device itself.

7. The Type of Ground Truth Used

The concept of "ground truth" (expert consensus, pathology, outcomes data) typically applies to diagnostic or treatment effect studies involving patient data. For this 510(k) submission, the "ground truth" for demonstrating substantial equivalence is based on:

• Engineering specifications and design documents of the predicate devices.
• Measurement results from in-vitro tests of the new device and, presumably, comparative data or established ranges from the predicate devices.
• Established material properties of 316L stainless steel.

8. The Sample Size for the Training Set

The provided document does not describe a "training set" as would be used for machine learning or AI. The development and testing of this device are based on engineering principles and in-vitro testing, not statistical training on a data set.

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

This is not applicable as there is no "training set" in the context of an AI/ML algorithm.

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The Orbus LifeStent SDS Biliary Endoprosthesis is indicated for use in the palliation of malignant neoplasms in the biliary tree.

The LifeStent SDS Biliary Endoprosthesis consists of a balloon expandable stent which is provided mounted onto a percutaneous transluminal angioplasty (PTA) balloon catheter which acts as the delivery system. The stent is a permanently implanted device used to maintain patency of a major bile duct obstructed by tissue of an impinging tumor. The flexible, balloon expandable stent is made by laser cutting an open lattice design into a 316L stainless steel tube. The stent is supplied mounted onto a PTA balloon catheter, inserted percutaneously to the diseased site, and expanded by balloon inflation. The systems are available with expanded diameters of 6.0, 7.0, and 8.0 mm at stent lengths of 18, 26, 36, and 56 mm.

The provided text describes a 510(k) submission for the "LifeStent SDS Biliary Endoprosthesis." This is a medical device submission seeking clearance to market, demonstrating substantial equivalence to existing devices. It is not a study that proves the device meets acceptance criteria in the way described by the request, particularly for AI/machine learning models.

The information provided focuses on comparative technological characteristics (materials, performance properties, biocompatibility, sterilization, packaging) and in vitro tests to establish substantial equivalence to predicate devices, rather than a clinical study with acceptance criteria for device performance based on patient outcomes or expert evaluations.

Therefore, many of the requested fields cannot be directly answered from the provided document.

Here's a breakdown of what can be inferred or directly stated, and what cannot:

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

The document does not specify quantitative acceptance criteria with corresponding performance results. Instead, it states: "Orbus protocols ensure that the LifeStent SDS Biliary Endoprosthesis performs in a manner substantially equivalent to the predicate devices during in vitro tests such as deployment, expansion force, compression force, dimensions, corrosion susceptibility, visual appearance, balloon performance, expansion damage, and balloon tensile strength." This implies that the device met internal performance specifications designed to demonstrate equivalence, but the specific metrics and targets are not disclosed.

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

Not applicable. This was an in vitro (laboratory) testing comparison against predicate devices, not a clinical study involving a test set of patient data.

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. Ground truth for clinical data is not relevant to this in vitro device comparison.

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

Not applicable.

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 not an AI-assisted diagnostic device, nor was an MRMC study described.

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

Not applicable. This is not an algorithm.

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

For the in vitro tests, the "ground truth" would be the engineering specifications and performance characteristics of the predicate devices and the physical measurements/observations during testing of the LifeStent SDS Biliary Endoprosthesis. This is not clinical ground truth.

8. The sample size for the training set

Not applicable. No training set is mentioned as this device clearance is not based on a machine learning model.

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

Not applicable.

Summary of what can be extracted based on the nature of the submission:

• Device Type: Biliary stent (LifeStent SDS Biliary Endoprosthesis) mounted on a balloon catheter.
• Intended Use: Palliation of malignant neoplasms in the biliary tree.
• Regulatory Pathway: 510(k) premarket notification, demonstrating substantial equivalence.
• Performance Evaluation: Primarily in vitro testing.
• Comparison Basis: Substantial equivalence to predicate devices based on:
  • Identical intended use.
  • Identical material properties.
  • Similar performance properties (deployment, expansion force, compression force, dimensions, corrosion susceptibility, visual appearance, balloon performance, expansion damage, balloon tensile strength).
  • Similar packaging and sterilization methods.
• Key Finding: The device was deemed substantially equivalent to predicate devices, allowing it to be marketed.

Conclusion: The provided document is a 510(k) clearance letter and associated summary information. It describes regulatory clearance based on substantial equivalence demonstrated through in vitro testing, not a clinical study with detailed acceptance criteria and performance data as would be typically expected for AI/ML device validation or a human clinical trial. As such, the specific metrics for patient-centric acceptance criteria, sample sizes for medical data, and expert ground truth establishment are not present in this document.

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The LifeStent Biliary Endoprosthesis is intended for the palliation of malignant neoplasms in the biliary tree.

The LifeStent Biliary Endoprosthesis is a permanently implanted device used to maintain patency of a major bile duct obstructed by tissue of an impinging tumor. The device is a balloon expandable stent made by laser cutting an open lattice design into a 316L stainless steel tube. The stent is designed to be manually crimped onto a PTA balloon catheter, inserted percutaneously to the diseased site, and deployed by balloon inflation. The stents are available with an expansion range of 4.0-7.0 mm at lengths of 13, 18, 26, 36, and 56 mm.

The provided document is a 510(k) summary for the LifeStent Biliary Endoprosthesis, which is a medical device. This type of document is for demonstrating substantial equivalence to a predicate device, not typically a study proving the device meets specific acceptance criteria in the way a clinical trial for a novel drug or high-risk device would. Therefore, the requested information, particularly regarding AI performance, ground truth, expert adjudication, and detailed statistical results, is not present in this type of regulatory submission for this device.

Based on the provided text, here's what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance:

The document states that "Orbus protocols ensure that the LifeStent Biliary Endoprosthesis performs in a manner substantially equivalent to the predicate devices during in vitro tests such as deployment, expansion force testing, compression force testing, dimensions, expansion damage, and corrosion testing."

This implies that the "acceptance criteria" are related to achieving substantial equivalence in these in-vitro performance characteristics compared to the predicate devices. However, the exact numerical acceptance criteria (e.g., "expansion force must be within X% of predicate") and the specific reported performance values are not detailed in this summary. It only states that the device performs in a manner substantially equivalent.

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

This document describes in-vitro performance tests on the device itself, not a clinical study on patient data. Therefore, there is no information about patient sample sizes or data provenance in the context of clinical data. The "test set" would refer to the number of devices tested for each in-vitro parameter, which is not specified.

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

This is irrelevant for an in-vitro device performance study. "Ground truth" in this context would be objective physical measurements of the stent's properties. No experts are mentioned for establishing ground truth on physical properties.

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

Not applicable for in-vitro device performance testing.

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 device is a physical medical implant (stent), not an AI-based diagnostic or prognostic tool. Therefore, an MRMC study and AI performance metrics are not applicable and not mentioned.

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

Not applicable as this is not an AI algorithm.

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

For the in-vitro performance tests, the 'ground truth' would be the objective measurements of the physical and mechanical properties of the stent, compared against established engineering and material standards, or directly against the predicate device's measured properties. No expert consensus, pathology, or outcomes data is mentioned for establishing this.

8. The sample size for the training set:

Not applicable, as this is not an AI model.

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

Not applicable, as this is not an AI model.

Summary of what is available from the document:

The 510(k) summary focuses on demonstrating substantial equivalence of the LifeStent Biliary Endoprosthesis to previously marketed predicate devices. This demonstration is primarily based on:

• Identical Intended Use: Palliation of malignant neoplasms in the biliary tree.
• Identical Material Properties: Made from 316L stainless steel.
• Similar Performance Properties: Assessed through in-vitro tests (deployment, expansion force, compression force, dimensions, expansion damage, corrosion testing) the summary claims the device performs in a manner substantially equivalent to predicates.
• Similar Packaging and Sterilization Methods.

The FDA's review confirms this substantial equivalence, allowing the device to be marketed, with specific labeling limitations regarding its use in the vascular system. The document pertains to a physical device approval, not an AI or software device, hence many of the requested criteria are not relevant or discussed.

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The Orbus LifeStent LP SDS Biliary Endoprosthesis is indicated for use for the palliation of malignant neoplasms in the biliary tree.

The LifeStent LP SDS Biliary Endoprosthesis consists of a balloon expandable stent which is provided mounted onto a percutaneous transluminal angioplasty (PTA) balloon catheter which acts as the delivery system. The stent is a permanently implanted device used to maintain patency of a major bile duct obstructed by tissue of an impinging tumor. This flexible, balloon expandable stent is made by laser cutting an open lattice design into a 316L stainless steel tube. The stent is supplied mounted onto a PTA balloon catheter, inserted percutaneously to the diseased site, and expanded by balloon inflation. The systems are available with expanded diameters of 4.0, 5.0, 6.0 mm at stent lengths of 18, 36, and 56 mm.

The provided text describes the 510(k) summary for the LifeStent LP SDS Biliary Endoprosthesis, outlining its characteristics, intended use, and substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria, device performance metrics, or any specific study results as would be typically found in clinical trials or performance testing reports for AI/ML devices.

The document is a regulatory submission demonstrating substantial equivalence of a medical device (a biliary stent) to previously approved predicate devices, not an AI/ML product. Therefore, many of the requested categories for AI/ML device studies (such as sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set information) are not applicable or present in this context.

Here's an attempt to answer the questions based on the available information, noting where the information is not present or not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

The submission focuses on demonstrating substantial equivalence based on in vitro tests and comparison to predicate devices, rather than predefined acceptance criteria for clinical efficacy or AI performance metrics.

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

This information is not provided in the document. The submission references "in vitro tests" but does not specify the sample sizes (e.g., number of stents tested), the specific test protocols, or the origin of any data (as it's in vitro, geographic provenance is less relevant than for patient data).

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

This information is not applicable as the document describes a physical medical device and in vitro performance testing, not an AI/ML device requiring expert-established ground truth from medical images or patient data.

4. Adjudication Method Used for the Test Set

This information is not applicable as the document describes in vitro performance testing of a physical medical device, not an AI/ML device with an adjudicated test set.

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

This information is not applicable. An MRMC study is typically for evaluating the impact of an AI/ML device on human reader performance. This document concerns a physical device (stent) and its in vitro performance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This information is not applicable. This document evaluates a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

For the in vitro performance tests, the "ground truth" would be established by the measurement standards and specifications for the physical properties of the stent and its delivery system (e.g., precise dimensions, force measurements, materials analysis). This is inherent to engineering and material science testing, rather than medical ground truth like pathology or expert consensus.

8. The Sample Size for the Training Set

This information is not applicable as this is not an AI/ML device that requires a training set.

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

This information is not applicable as this is not an AI/ML device that requires a training set.

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