Search Results

The HANAROSTENT® Esophagus Asymmetric (CCC) is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistula.

This self-expanding tubular prosthesis is designed to maintain patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas. It consists of a self-expandable metal stent and a delivery device. The self-expandable metal stent is made of nickel titanium alloy (Nitinol) wire with fully covered silicone membrane, and the delivery device is made of polymeric materials. The stent is loaded into the distal part of the delivery device, and expanded in the body by pulling the outer sheath of the delivery device. The HANAROSTENT® Esophagus Asymmetric (CCC) is intended for single use only.

The provided document is a 510(k) summary for the HANAROSTENT® Esophagus Asymmetric (CCC), a device intended for maintaining esophageal luminal patency in esophageal strictures and occlusion of concurrent esophageal fistula. This type of device approval (510(k)) focuses on demonstrating substantial equivalence to a predicate device, rather than proving absolute safety and effectiveness through extensive clinical trials as would be required for a Premarket Approval (PMA).

Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the bench testing performed to demonstrate that the new device is substantially equivalent to existing, legally marketed devices.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for a 510(k) device are generally established by comparison to a predicate device and relevant industry standards. For this device, the "acceptance criteria" are implied by the performance tests conducted, with the underlying assumption that the device's performance in these tests is comparable to or acceptable relative to the predicate device. The document does not explicitly state numerical acceptance criteria, but rather lists the types of tests performed to demonstrate substantial equivalence.

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

The document explicitly states: "No animal and clinical performance data is submitted in this 510(k)." The testing performed was "Bench testing." The sample sizes for each specific bench test (e.g., number of stents tested for foreshortening) are not specified in the provided text.

• Sample Size for Test Set: Not specified for individual bench tests.
• Data Provenance: The bench testing was performed by M.I.Tech Co., Ltd., which is based in the Republic of Korea. The testing is described as "performance testing was performed as per the design control system," suggesting it was conducted under controlled, in-house laboratory conditions (retrospective in the sense that the data already existed at the time of submission).

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

This information is not applicable and not provided in the document. For a 510(k) reliant on bench testing and substantial equivalence, there isn't a "ground truth" established by external medical experts in the same way there would be for a diagnostic AI study. The "ground truth" for the performance tests would be the established engineering specifications and the performance characteristics of the predicate device.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are typical for clinical studies involving interpretation by multiple human readers, not for bench testing of medical devices. The "adjudication" for bench test results would be based on comparison to engineering specifications and predicate device data.

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

There was no MRMC comparative effectiveness study done. This study is for a physical medical device (esophageal stent), not an AI-assisted diagnostic tool.

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

There was no standalone (algorithm only) performance study done. This study is for a physical medical device (esophageal stent), not an algorithm or AI.

7. The Type of Ground Truth Used

The "ground truth" for this submission is based on the engineering specifications and performance characteristics derived from bench testing, as compared to the predicate device and relevant standards. It is not based on expert consensus, pathology, or outcomes data. The goal is to demonstrate that the new device performs comparably to the predicate device in key functional aspects.

8. The Sample Size for the Training Set

This information is not applicable and not provided. There is no "training set" in the context of a 510(k) submission for a physical medical device like an esophageal stent. Training sets are relevant for machine learning or AI models.

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

This information is not applicable and not provided for the reasons stated above.

Ask a specific question about this device

The HANAROSTENT® Esophagus (CCC) and HANAROSTENT® Esophagus (NCN) are intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic malignant tumors, and occlusion of concurrent esophageal fistulas.

This self-expanding tubular prosthesis is designed to maintain patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas. It consists of a self-expandable metal stent and an over the wire (OTW) delivery device. The self-expandable metal stent is made of nickel titanium alloy (Nitinol) wire, radiopaque markers made of gold wire, fully or partially covered silicone membrane, and one repositioning lasso at each end of the stent made of polymeric materials. The delivery device is made of polymeric materials. The stent is loaded into the distal part of the delivery device, and expanded in the body by pulling the outer sheath of the delivery device. The HANAROSTENT® Esophagus (CCC) and the HANAROSTENT® Esophagus (NCN) are intended for single use only.

The provided text is a 510(k) summary for the HANAROSTENT® Esophagus (CCC) and HANAROSTENT® Esophagus (NCN) devices. This document focuses on demonstrating substantial equivalence to a predicate device through bench testing rather than presenting a clinical study with acceptance criteria for device performance.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth, and expert involvement for a study proving device performance against acceptance criteria cannot be fully extracted from the provided text. The document explicitly states:

• "No animal performance data is submitted in this 510(k)."
• "No clinical performance data is submitted in this 510(k)."

Instead, the submission relies on bench testing to demonstrate performance and substantial equivalence.

Here's an analysis of what can be extracted or inferred based on the scope of the document:

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

The document does not explicitly present a table of acceptance criteria with corresponding performance values in the way you've requested for a device proving study. It lists various bench tests performed and states:

• "Bench testing was performed to confirm the safety and effectiveness of the proposed subject devices as compared to the predicate devices."
• "Performance testing was performed as per the design control system."
• "The subject and predicate devices have equivalent expansion forces."
• "The subject and predicate devices have equivalent compression forces."
• "The subject delivery device in both 6mm (18Fr) and 8mm (24Fr) diameters have lower deployment forces than the predicate delivery device when deploying the HANAROSTENT® Esophagus (CCC)."
• "The subject delivery device in 6mm (18Fr) diameter has lower deployment force than the predicate delivery device when deploying the HANAROSTENT® Esophagus (NCN). The subject delivery device in 8mm (24Fr) diameter has equivalent deployment force to the predicate delivery device when deploying the HANAROSTENT® Esophagus (NCN)."

From this, we can infer that the acceptance criterion for many of these bench tests was "equivalence to the predicate device" or "lower than the predicate device" (for deployment force, which is a positive outcome). However, specific numerical acceptance thresholds or detailed performance metrics are not provided.

Inferred Table of Performance and Criteria (Based on Bench Testing for Substantial Equivalence):

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

The document does not specify sample sizes used for the bench tests. Since no clinical data was submitted, there is no "test set" in the context of patient data. The bench tests were presumably conducted internally by M.I.Tech Co., Ltd., based in the Republic of Korea. Therefore, the data provenance for these bench tests would be the Republic of Korea. It's not applicable to categorize bench testing as retrospective or prospective.

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. The submission relies entirely on bench testing for substantial equivalence, not on a clinical test set requiring expert interpretation or ground truth establishment in a medical context.

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

Not applicable, as there is 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

Not applicable. This is not an AI/software device and no MRMC study was conducted.

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

Not applicable. This is a medical device (stent and delivery system), not an algorithm.

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

Not applicable. For the bench tests, the "ground truth" would be the engineering specifications and established standards for material and device performance, against which the physical properties of the stent were tested.

8. The sample size for the training set

Not applicable, as no clinical study (and thus no training set) was conducted or submitted.

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

Not applicable, as there is no training set.

Ask a specific question about this device

The Ultraflex™ Tracheobronchial Stent System is intended for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.

The Ultraflex Tracheobronchial Stent Systems are permanently implanted expandable metal stents designed to serve as an intralumenal support to keep open the inner of the tracheobronchial tree. They consist of a flexible delivery catheter preloaded with an expandable metallic stent.

The stent is an open-ended cylindrical mesh constructed from a single strand of nitinol wire. The wire is configured into a series of circumferential interwoven loops, with the number of loops being dependent on the diameter of the stent. The stent is elongated and compressed onto a plastic delivery catheter. The stent is held onto the delivery catheter by nylon suture wrapped around the stent. The delivery catheter has a flush taper tip at the distal end, and a round hub handle at the proximal end.

The covered stent has a single layer of translucent polyurethane that covers the midsection of the stent.

Covered stents are available with a distal release system only. The distal release system begins stent deployment from the lower (distal) end of the delivery catheter.

The radiopaque (RO) markers on the delivery system and stent facilitate fluoroscopic placement.

The covered stent has four RO markers. The outer two (2) RO markers indicate the estimated final position of the ends of the deployed stent. The inner two (2) RO markers indicate the estimated final position of the margins of the deployed stent cover (Figure 1B).

The delivery system accepts a 0.035 in (0.89 mm) or 0.038 in (0.97 mm) guidewire. The delivery system is passed over the guidewire into the tracheobronchial lumen. The stent is positioned appropriately using the RO markers for guidance under fluoroscopy and by bronchoscopic visualization of the stent.

The stent is deployed by holding the handle hub in the palm of one hand, and grasping the finger ring with the other hand. By retracting the finger ring the suture crochet knots are unraveled in a circular manner along the length of the stent, gradually deploying the stent. When using the proximal release system, stent deployment begins from the upper (proximal) end of the delivery system, and continues to release toward the tip of the delivery system (distally) as the entire suture unravels. When using the distal release system, stent deployment begins from the lower (distal) end of delivery system, and continues to release towards the operator (proximally) as the entire suture unravels.

After the stent is completely released, and the nylon suture has been completely removed, the delivery system catheter can be removed.

The provided document is a 510(k) premarket notification for a medical device (Ultraflex™ Tracheobronchial Partially Covered Stent System). It describes the device, its intended use, and its substantial equivalence to previously cleared predicate devices.

However, this document does not contain information about a study based on statistical performance metrics (like accuracy, sensitivity, specificity, or AUC) or human reader performance. The "Performance Data" section (Section 7) on page 5 details in-vitro testing and compliance with various standards for aspects like dimensions, fatigue, compression, deployment accuracy, magnetic resonance, corrosion, sterility, pyrogenicity, and biocompatibility.

Therefore, I cannot provide a table of acceptance criteria and reported device performance related to a statistical study, nor can I answer questions 2 through 9, as these pertain to information that is not present in the provided text.

The information provided only demonstrates that the device ("Ultraflex™ Tracheobronchial Partially Covered Stent System") met required specifications for a series of in-vitro tests and complies with various safety and material standards. This is the basis for its substantial equivalence determination by the FDA for market clearance.

Ask a specific question about this device