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The device is intended for manual insufflation of medical grade talc into the pleurodesis. The device is indicated for use according to the approved indication for use of the medical grade talc.

NOVATECH® TALCAIR™ is a powder blower comprised of an insufflation cannula, an insufflation bulb and its connecting pieces (a coupling, and a luer connector). The coupling, which is made of polypropylene, is used to attach the device to a vial.

The device is a sterile, single use medical device which is sterilized by gamma sterilization.

The coupling will be inserted into the glass vial. The cannula, made of polyethylene, is attached to the exit of the coupling. The insufflation bulb has two valves and a tube. The bulb and the tube are made of Soft-PVC. The luer connector, made of radiation grade polycarbonate, is attached to the insufflation bulb. The luer connector is to be attached to the coupling. When ready for use, the coupling is to be firmly pressed onto the vial until the coupling "clicks" on the vial top. Attach the balloon to the coupling with the luer connector. For administration, the cannula is introduced into the body cavity and pulverization is started.

The device is intended for manual insufflation of medical grade talc into the pleural cavity during pleurodesis. The device is indicated for use according to the approved indication for use of the medical grade talc.

The provided text describes a 510(k) submission for the NOVATECH® TALCAIR™ device, which is a powder blower for manual insufflation of medical grade talc into the pleural cavity during pleurodesis. The submission primarily seeks to add a new indication for use to an already approved device (K151832), and thus leverages the previous performance data.

Here's an analysis of the acceptance criteria and study data based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a table format with numerical targets. Instead, it demonstrates substantial equivalence to a predicate device (the previously approved NOVATECH® TALCAIR™) by showing that the proposed device maintains the same technological characteristics and meets established safety and performance benchmarks (primarily focused on biocompatibility and physical performance for a talc insufflator).

However, based on the performance data section, we can infer the tested aspects and their outcomes:

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

• Sample Size for Bench Performance Tests: Not explicitly stated for each test (e.g., number of devices tested for ejection volume, distribution, pressure). The phrasing "The results show that NOVATECH® TALCAIR™ has an equal or better performance..." implies quantitative testing was performed.
• Data Provenance: The benchmark performance tests (ejection volume, distribution pattern, pressure/volume changes) referenced are from the K151832 submission for the same device, which serves as the predicate. This suggests these were likely retrospective data for the current submission, originally collected for the initial clearance of the device. The country of origin of the data is not specified, but the applicant (NOVATECH S.A.) is based in France.
• Biocompatibility Testing: Not specified for sample size. These tests are typically conducted on material samples rather than whole devices.
• Transport Validation: Not specified for sample size (e.g., number of packages tested).

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

This section is not applicable as the studies described are primarily analytical performance tests (biocompatibility, physical performance of the insufflator, sterilization, shelf life, sterile barrier integrity) rather than clinical studies requiring expert interpretation of medical images or patient outcomes. The "ground truth" for these tests is based on objective measurements and adherence to international standards.

4. Adjudication Method for the Test Set:

This is not applicable for the same reason as point 3.

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. The device is a manual medical instrument (powder blower), not an AI-powered diagnostic or assistive tool. There is no AI component or human-in-the-loop scenario described here.

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, manual medical instrument and does not involve an algorithm.

7. The Type of Ground Truth Used:

• Biocompatibility: Ground truth is established by adherence to international standards (EN ISO 10993 series) and acceptance criteria defined within those standards (e.g., no cytotoxicity, no irritation).
• Bench Performance Tests (Talc Ejection, Distribution, Pressure): Ground truth is based on quantitative measurements and comparison to a legally marketed predicate device (KARL STORZ ENDOSCOPY POWDER BLOWER) to demonstrate equivalence or superiority in functional performance.
• Sterile Barrier & Shelf Life: Ground truth is established by standardized testing protocols (ISTA, EN 868-10, ASTM F1929) and demonstrating that the product meets pre-defined physical and sterility performance metrics over time and under simulated stress.

8. The Sample Size for the Training Set:

This is not applicable as the device is a physical medical instrument, not a machine learning model requiring a training set.

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

This is not applicable as there is no training set for a physical device.

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Treatment of malignant pleural effusion by insufflation of medical grade talc following drainage of pleural fluid.

NOVATECH® TALCAIR™ is a powder blower comprised of an insufflation cannula, an insufflation bulb and its connecting pieces (a coupling, and a luer connector). The coupling, which is made of polypropylene, is used to attach the device to a vial. The device is a sterile, single use medical device which is sterilized by gamma sterilization. The coupling will be inserted into the glass vial. The cannula, made of polyethylene, is attached to the exit of the coupling. The insufflation bulb has two valves and a tube. The bulb and the tube are made of Soft-PVC. The luer connector, made of radiation grade polycarbonate, is attached to the tube of the insufflation bulb. The luer connector is to be attached to the coupling. When ready for use, the coupling is to be firmly pressed onto the vial until the coupling "clicks" on the vial top. Attach the balloon to the coupling with the luer connector. For administration, the cannula is introduced into the body cavity and pulverization is started. The medical device is intended for the administration of medical grade talc via thoracoscopy. The device is intended to treat patients with malignant pleural effusion.

The provided document is a 510(k) summary for the Novatech® Talcair™ device, which is a powder blower used for the administration of medical grade talc to treat malignant pleural effusion. The document focuses on demonstrating substantial equivalence to a predicate device rather than providing a stand-alone study with acceptance criteria and device performance as typically understood for diagnostic AI/ML devices.

Therefore, much of the requested information regarding acceptance criteria, sample sizes for test and training sets, expert involvement, and ground truth establishment, which are standard for AI/ML device studies, is not present in this regulatory submission. This submission does not describe a clinical study of an AI/ML device.

However, based on the provided text, I can extract information related to the device's technical performance and comparison with its predicate.

Here's an attempt to answer the questions based on the available information:

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

The document does not explicitly present a table of "acceptance criteria" with corresponding "reported device performance" in the typical sense of a clinical study for a diagnostic device. Instead, it details benchmark performance tests comparing the Novatech® Talcair™ to its predicate device. The implicit acceptance criterion for these tests is "equal or better performance" than the predicate.

2. Sample sizes 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 document describes benchmark performance tests and biocompatibility testing of the device itself, not a clinical study involving patient data. The "test sets" refer to the physical devices or materials used in laboratory/engineering tests, not 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)

This information is not applicable as this is not a study assessing AI/ML diagnostic performance. The "ground truth" here relates to the objective measurements of the device's physical performance characteristics, which would be established through engineering and laboratory testing protocols, not expert consensus on medical images or diagnoses.

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

This information is not applicable. Adjudication methods are relevant for studies where human expert disagreement on interpretation needs to be resolved to establish ground truth for a diagnostic task. This document concerns a physical medical device's performance characteristics.

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 MRMC study was done, as this submission is for a physical medical device (powder blower), not an AI/ML diagnostic software. Therefore, there is no information on human reader improvement with AI assistance.

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

This information is not applicable. This device is a physical medical instrument, not a standalone algorithm.

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

The "ground truth" in this context is based on objective engineering measurements and standardized test methods for physical and biological properties. For example:

• Benchmark Performance Tests: Quantitative measurements of ejection volume, observation of talc distribution patterns, and pressure monitoring.
• Biocompatibility Testing: Laboratory assay results aligned with ISO 10993 standards.
• Sterile Barrier Testing: Physical tests like seal strength (EN 868-10) and dye penetration (ASTM F1929-12) with defined pass/fail criteria.
• Sterilization: Validation of a specific Sterility Assurance Level through microbiological testing and dosimetry.

8. The sample size for the training set

This information is not applicable. There is no "training set" as this is not an AI/ML device study.

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

This information is not applicable. There is no "training set" or "ground truth for a training set" in the context of this device submission.

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The main indications according to their frequency are : - 1. tracheobronchial tumors - 2. Tracheal stenosis with scarring - 3. Bronchial stenosis after surgical anastomotic, anastomoses resections or pulmonary transplantation. These stenoses have, as a common characteristic, the importance of the extrinsic compression or the collapse of the cartilingeous wall. The indication always focuses on an endoscopic therapeutic action, whether is concerns a resection or dilation. The stent insertion is indicated if the endoscopic resection is incomplete, in case of a persistent extrinsic compression, or if the lumen is insufficient. The most frequent locations are tracheal. The left main bronchus is the second location, followed by the right main bronchus.

the ENDOXANE® is an endoscopy stent made of silicone. This stent, the most fitted in the world, is presented as a silicone tube with stubs allowing to avoid any movement. The non armed polysiloxane is covered with a new coating especially designed in order to keep its' flexibility which facilitates tolerance and evacuation of secretions. A well-adapted ENDOXANE® does not move and cough reflexes are inhibited by reflex center saturation. The stubs prevent a direct contact between the stent surface and the mucus membrane and distribute the pressures among the small surfaces.

The provided document is a 510(k) premarket notification for a medical device called ENDOXANE. It describes the device, its indications for use, and claims substantial equivalence to a predicate device. However, it does not contain the detailed clinical study data, acceptance criteria, or performance metrics that would typically be required to fully answer the request.

Therefore, I can only provide the information that is available in the document and explicitly state where information is missing.

Here's an analysis based on the provided text:

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

No explicit acceptance criteria (e.g., specific thresholds for performance metrics like sensitivity, specificity, accuracy, or complication rates) are stated in the document.

The document mentions "Complications were uncommon, usually easily manage, and rarely life threatening. The main complications were emigration (9.5%)n obstruction by secretions." This is a reported observation from a study, not a pre-defined acceptance criterion.

• Oval-shaped stents regained round shape in less than two days in cases of extreme compression
• Complications: uncommon, usually easily managed, rarely life-threatening
• Main complications: emigration (9.5%), obstruction by secretions |

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

The document refers to a study: "The conclusion that one can reach concerning our stents is best stated in the study published in "The Journal of Bronchology" (3:6-10, 1996) about the placing of 1500 stents (Cavalière, Diaz, Dumon, Vergnon)."

• Sample Size for Test Set: 1500 stents were placed (implicitly, 1500 patients or cases).
• Data Provenance:
  • Country of Origin: Not explicitly stated, but the applicant (NOVATECH S.A.) is based in France, and the authors of the cited study (Cavalière, Diaz, Dumon, Vergnon) are likely affiliated with French institutions, suggesting the data is likely from France or Europe.
  • Retrospective or Prospective: Not explicitly stated. Given that it's a publication summarizing "placing of 1500 stents," it could be a retrospective analysis of a series of cases over time.

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 document. The document refers to a published study, but does not detail the methodology for establishing ground truth within that study. The "ground truth" for stent performance would likely come from clinical follow-up and physician assessment, but specifics are missing.

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

This information is not provided in the document.

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 not an AI device. The ENDOXANE® is a physical medical device (tracheal/bronchial stent). This question is not applicable.

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

• Standalone Performance: No, this is not an AI device. This question is not applicable.

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

The "ground truth" implicitly refers to clinical outcomes and physician assessment of stent performance and complications from the cited study. For example, "no single case of compression was observed" and "complications were emigration (9.5%) and obstruction by secretions" are clinical outcome data. Specifics on how individual outcomes were defined and assessed are not provided in this regulatory document, but would be expected in the full journal article.

8. The sample size for the training set

• Training Set Sample Size: This is not applicable as the ENDOXANE® is a physical medical device, not an AI or software device that undergoes a "training" process in the typical machine learning sense. The device was developed and then tested.

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

• Ground Truth for Training Set: This is not applicable for the same reasons as above.

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