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The Esophageal TTS Stent is intended for use in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors and occlusion of concurrent esophageal fistulas.

The Esophageal TTS Stents that are the subject of this 510(k) are identical to the devices cleared in K221482, with the exception of the modification to its introducer system. The Esophageal TTS Stents consist of an implantable metallic stent and a disposable, flexible introducer system for placement of the stent. The stent is a flexible and expandable tubular device made of Nitinol wire that is intended to be implanted to restore the structure and/or function of the esophagus. The introducer is a disposable system for delivery and deployment of the stent at the target position. Upon deployment, the stent imparts an outward radial force on the luminal surface of the esophagus to establish patency.

This document is a 510(k) premarket notification for a medical device called the "Esophageal TTS Stent." It explains that the new device is substantially equivalent to a previously cleared device (K221482) manufactured by the same company, Taewoong Medical.

The core of the document focuses on demonstrating this substantial equivalence, noting that the stent itself is identical to the predicate device, with modifications only to the introducer system (the delivery mechanism). Therefore, much of the testing performed is related to the performance and biocompatibility of this modified introducer system.

Based on the provided document, here's a breakdown of the requested information:

This document is a marketing submission for a medical device (Esophageal Stent) that does not involve AI or software. Therefore, many of the requested criteria related to AI/software performance validation, such as "acceptance criteria for an AI model," "MRMC study," "standalone algorithm performance," "ground truth establishment for training set," are not applicable to this submission.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the standard non-clinical performance and biocompatibility testing for a physical medical device, not an AI or software component.

Here's a detailed response to the applicable sections of your request:

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

The document does not provide a formal table with specific numerical acceptance criteria and reported numerical performance for each test. Instead, it lists the types of performance tests conducted and then states a general conclusion that the device "meets its design requirements and performs as intended" and is "as safe and effective as the predicate device."

However, we can infer the types of tests and the general outcome:

Notes on Acceptance Criteria:

• For biocompatibility tests, the acceptance criteria would be defined by the ISO standards, e.g., "non-cytotoxic," "not a sensitizer," etc.
• For performance tests (Deployment, Deployment Force, Dimensional, Tensile Strength), the acceptance criteria would be specific to the device's engineering specifications, such as "deployment within X seconds," "deployment force less than Y Newtons," "dimensions within Z tolerance," "tensile strength greater than W," etc. These specific numerical criteria and results are not provided in this summary document. The document only states that the testing was conducted and found to demonstrate substantial equivalence.

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

• Sample Size:
  • The document does not specify the sample sizes used for the non-clinical performance tests (Deployment, Deployment Force, Dimensional, Tensile Strength).
  • For biocompatibility, the sample sizes would be typical for the specific ISO test methods (e.g., a certain number of mice for acute systemic toxicity, guinea pigs for sensitization), but these are not explicitly detailed.
• Data Provenance:
  • This is a submission for a medical device (stent and introducer), not data related to a clinical study or AI model.
  • The testing pertains to the physical characteristics and interaction of the device components.
  • The manufacturer is Taewoong Medical Co., Ltd., based in the Republic of Korea. It's highly probable the testing was conducted there or at subcontracted labs.
  • The tests are prospective in nature, as they are performed on newly manufactured devices or materials to demonstrate compliance for premarket submission.

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. This device is a physical medical device (stent and introducer system) and does not involve a diagnostic AI or imaging interpretation. Therefore, there is no "ground truth" derived from expert interpretation of images or clinical data in the context of an AI model.
• The "ground truth" for this device's performance is established by engineering specifications, physical measurements, and standardized biological safety tests. The "experts" involved would be engineers, material scientists, and toxicologists/biologists conducting and interpreting the non-clinical tests.

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

• Not Applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or for establishing ground truth in machine learning contexts (e.g., for radiology readings) where there might be disagreement among human readers. Since this is a submission for a physical device based on non-clinical performance and biocompatibility testing, such adjudication methods are not relevant.

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 submission is for a physical medical device (esophageal stent) and its introducer system. It does not involve AI or software, and therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted or would be relevant.

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

• Not Applicable. This device does not have an "algorithm" component. It is a physical medical device.

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

• The "ground truth" for this device is based on engineering specifications and established test methodologies.
  • For performance tests (Deployment, Deployment Force, Dimensional, Tensile Strength), the ground truth is defined by the pre-defined design requirements and specifications (e.g., a stent must deploy within a certain time, or a certain force is required for deployment).
  • For biocompatibility tests, the ground truth is defined by the results of standardized in vitro and in vivo biological tests as per ISO 10993 series, indicating the material's safety for contact with the body.
• It is not based on expert consensus, pathology, or outcomes data in the way these terms are typically used for diagnostic or AI-related devices.

8. The sample size for the training set

• Not Applicable. This is not an AI or machine learning device. Therefore, there is no "training set." The device's design is based on engineering principles and knowledge gained from previous device iterations (the predicate device).

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

• Not Applicable. As there is no training set (being a physical medical device, not an AI), there is no ground truth establishment for a training set.

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The Esophageal TTS Stent is intended for use in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors and occlusion of concurrent esophageal fistulas.

The Esophageal TTS Stents consists of an implantable metallic stent and a disposable, flexible introducer system for placement of the stent is a flexible and expandable tubular device made of Nitinol wire that is intended to be implanted to restore the structure and/or function of the esophagus. The introducer is a disposable system for delivery and deployment of the stent at the target position. Upon deployment, the stent imparts an outward radial force on the luminal surface of the esophagus to establish patency.

The provided document is a 510(k) premarket notification for the Taewoong Medical Co., Ltd. Esophageal TTS Stent. It states that the device is "substantially equivalent" to previously cleared predicate devices (K211706, K123205, K113551) with the "exception of a modification to the Indications for Use statement."

As such, this document does not contain acceptance criteria for this specific submission with new performance data to prove the device meets these criteria. Instead, it relies on the previous clearances and argues that the change in indication does not affect safety and efficacy, therefore no additional performance data is required for this 510(k).

Therefore, I cannot provide the requested information regarding acceptance criteria and performance study details from this document. The document explicitly states:

• No additional biocompatibility information is required.
• Not applicable for Electrical safety and electromagnetic compatibility (EMC) as it contains no electrical components.
• Not applicable for Software Verification and Validation Testing as it contains no software.
• No additional performance data is required for Bench Testing because no design modifications were made.
• Not applicable for Animal Testing.
• Not applicable for Clinical Data.

The 510(k) submission relies on the substantial equivalence principle, asserting that since the new device is identical in design and materials to previously cleared devices, and the change in indication does not introduce new risks, the prior performance data of the predicate devices is sufficient.

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The Esophageal TTS Stent is intended for use in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors.

The Esophageal TTS Stent consists of the implantable metallic stent and introducer system. The stent is made of Nitinol wire. It is a flexible, fine mesh tubular prosthesis that has 10 radiopaque markers; 4 in each end and 2 in the center. It has a body diameter of 18, 20 and 22mm, and a total length from 60 to 150mm. The surface of the body portion of the stent is covered with silicone. The Esophageal TTS Stent is provided in two configurations, either fully covered with silicone or with both heads not covered in silicone (bare). The introducer system accepts a 0.035 in (0.89 mm) or 0.038 in (0.97 mm) guidewire. The stent introducer system is passed over the guidewire and through an endoscope into the esophagus. The stent may be positioned appropriately using the X-ray markers for guidance under fluoroscopy.

The provided text is a 510(k) summary for the Esophageal TTS Stent. It describes the device, its intended use, and a comparison to predicate devices, along with performance data. However, it explicitly states that no clinical data or animal testing were performed to establish substantial equivalence.

Therefore, the study that proves the device meets acceptance criteria is not a clinical study involving human or animal subjects, but rather bench testing.

Here's a breakdown of the requested information based on the provided text:

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

The document states: "All samples met their acceptance criteria, demonstrating that when manufactured to specification, the device functions as intended and can be found substantially equivalent to the predicate device." However, the specific acceptance criteria for each test (e.g., a specific force range for the Deployment Force Test) are not detailed within this document. Only the types of tests conducted are listed.

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

• Sample size: The document states that bench testing was conducted on "both the 22mm diameter size and the 220cm length" of the device. It does not provide a specific number of units tested for each test.
• Data provenance: Not explicitly stated, but assumed to be internal testing conducted by the manufacturer, Taewoong Medical Co., Ltd., which is based in Korea. This is a retrospective evaluation of the device performance during its development and prior to submission.

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

Not applicable. This device's substantial equivalence was established through bench testing, not a clinical study requiring expert assessment of patient data.

4. Adjudication method for the test set

Not applicable, as this was not a clinical study involving human judgment. The outcome of the bench tests would have been objective measurements against predetermined (but not specified in this document) specifications.

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 (stent) and not an AI/software product, so an MRMC study and AI assistance are not relevant to its performance evaluation as described.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used

The "ground truth" for the bench testing would be the engineering specifications and design requirements for the device. The tests validated that the manufactured device performed in accordance with these established technical criteria.

8. The sample size for the training set

Not applicable. This is a physical medical device and does not involve machine learning or a "training set" in the context of AI.

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

Not applicable, as no training set was used.

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For use in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors.

The Esophageal TTS Stent consists of an implantable metallic stent and a flexible introducer system. The stent is a flexible, expandable tubular device made of Nitinol wire and are either fully silicone covered or partially silicone covered (the body is covered but both heads remains uncovered). This device also includes a disposable introducer. Upon deployment, the stent imparts an outward radial force on the luminal surface esophagus to establish patency.

The provided text describes the regulatory clearance for the Esophageal TTS Stent but does not contain information about a study proving the device meets acceptance criteria in the context of AI/ML or diagnostic performance metrics.

The document is a 510(k) summary for a medical device (an esophageal stent), which focuses on demonstrating substantial equivalence to a predicate device based on engineering and mechanical performance tests, rather than clinical efficacy studies with human subjects that would typically involve acceptance criteria for diagnostic accuracy, sensitivity, or specificity.

Therefore, most of the requested information cannot be extracted from this document, as it pertains to a different type of device evaluation (e.g., AI/ML-driven diagnostic tools).

Information Based on the Provided Text:

Here's what can be inferred or directly stated from the document, acknowledging that most of the requested fields are not applicable to this type of device clearance:

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

   Acceptance Criteria (Type of Test)	Reported Device Performance (Summary)
   Expansion Force Testing	Demonstrated safety and effectiveness.
   Compression Force Testing	Demonstrated safety and effectiveness.
   Dimensional Testing	Demonstrated safety and effectiveness.
   Deployment Testing	Demonstrated safety and effectiveness.
   Deployment Force Testing	Demonstrated safety and effectiveness.
   Tensile Strength Testing	Demonstrated safety and effectiveness.
   Packaging Adhesive Strength Testing	Demonstrated safety and effectiveness.
   MR Compatibility	Demonstrated safety and effectiveness.
   Overall Conclusion	"The performance testing showed that the Esophageal TTS Stent with a larger body diameter of 20mm is as safe, as effective, and performs as well as or better than the predicate device."

2. Sample sized 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 document. The performance data section refers to engineering tests on the device, not a human reader or image-based test set.

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 and is not applicable to the type of device (a medical implant) and the type of testing described (engineering performance tests).

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

   • This information is not provided and is not applicable to the type of 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, an MRMC study was not done. This document describes the clearance of an esophageal stent, not an AI/ML diagnostic tool.

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 physical medical implant, not an algorithm.

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

   • The "ground truth" for the engineering performance tests would be the established engineering specifications and physical properties benchmarks. This is not explicitly detailed in the document beyond stating that "Performance Data" was collected per FDA "Guidance for Industry - Guidance for the Content of Premarket Notifications for Esophageal and Tracheal Prostheses."

8. The sample size for the training set

   • This is not applicable as the document describes the clearance of a physical medical device, not an AI/ML algorithm that requires a training set.

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

   • This is not applicable as the document describes the clearance of a physical medical device.

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For use in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors.

The Esophageal TTS Stent consists of an implantable metallic stent and a flexible introducer system. The stent is a flexible, expandable tubular device made of Nitinol wire and covered with silicone. This device also includes a disposable introducer. Upon deployment, the stent imparts an outward radial force on the luminal surface esophagus to establish patency.

This document describes the premarket notification (510(k)) for the Taewoong Medical Esophageal TTS Stent. However, it does not contain information about the acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML powered medical device. The information provided is for a traditional medical device (esophageal stent).

Therefore, I cannot fulfill your request as it pertains to AI/ML device performance and testing. The document focuses on the substantial equivalence of the Esophageal TTS Stent to previously cleared predicate devices based on physical and mechanical properties, not on an algorithm's performance.

Here's why I cannot provide the requested information from the given text:

• No AI/ML Component: The device described, the Esophageal TTS Stent, is an implantable metallic stent. It does not appear to have any artificial intelligence or machine learning components.
• Performance Data Type: The "Performance Data" section lists physical and mechanical tests like Deployment Testing, Expansion Force Testing, Compression Force Testing, Dimensional Testing, Tensile Strength Testing, Packaging Adhesive Testing, and MR Compatibility. These are standard tests for physical medical devices and do not involve evaluating an algorithm's accuracy, sensitivity, or specificity.
• Absence of Specific Metrics: There are no mentions of metrics like sensitivity, specificity, AUC, F1-score, or any other performance indicators typically associated with AI/ML devices.
• No Reference to Ground Truth or Expert Adjudication: The concept of "ground truth," expert consensus, or adjudication methods is irrelevant for the type of device and testing described in this document.

In summary, the provided text describes a medical device clearance process for a physical esophageal stent and does not contain the information requested about acceptance criteria and studies for an AI/ML-powered device.

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