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Controlled, elective, subcricoid percutaneous insertion of a tracheostomy tube for airway management using a Seldinger guidewire dilation technique.
Controlled, elective subcricoid percutaneous insertion of a tracheostomy tube for airway management using a Seldinger technique to guide the specially designed Guidewire Dilating Forceps into trachea, which are then used to dilate the trachea.

The BLUperc® and BLUgriggs® Percutaneous Dilation Tracheostomy Tube Kits or Trays aid in the tracheostomy tube surgical procedure for adult patients; designed to aid adult patients requiring an artificial breathing airway due to trauma, medical condition and/or for airway maintenance. The tracheostomy tubes (kits or trays) maximum recommended period of use is 29 days. The kit or tray contains all the proprietary procedural components to support tracheostomy insertion, including the BLUselect tracheostomy tube for physician's ease during the clinical procedure flow.

The provided document is a 510(k) premarket notification summary for medical devices (tracheostomy kits). It focuses on establishing substantial equivalence to previously cleared predicate devices rather than proving a device meets specific acceptance criteria through a clinical study. Therefore, most of the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth types, training set details) is not applicable or cannot be extracted from this type of document.

The document primarily demonstrates that the BLUperc® and BLUgriggs® Percutaneous Dilation Tracheostomy Procedural Kits or Trays are substantially equivalent to existing predicate devices (UltraPerc Percutaneous Dilation Kit and Portex Percutaneous Tracheostomy Kit).

Here's a breakdown of the available information:

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

This document does not present a table of specific performance acceptance criteria in the way it would for a new AI/software device or a device requiring new clinical performance data to demonstrate effectiveness. Instead, the "acceptance criteria" are implied by establishing substantial equivalence to predicate devices. The performance testing conducted (bench testing, packaging validation, design validation/human factors, sterilization/microbiology validation, biocompatibility assessment) ensures the device meets its own specifications and is safe and performs as intended, thereby being equivalent to the predicates.

The study proves the device meets the "acceptance criteria" of substantial equivalence to the predicate device.

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

• Sample Size: Not specified for individual tests. The document refers to "applicable components" for bench testing and mentions that tests were "conducted" without providing specific sample numbers for each test.
• Data Provenance: The studies are described as "Non-clinical testing" and include bench testing, packaging validation, design validation/human factors, sterilization/microbiology validation, and biocompatibility assessment. These are laboratory/engineering tests rather than clinical studies with patient data. Therefore, concepts like "country of origin of the data" or "retrospective/prospective" do not apply.

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

This information is not provided. The testing described (bench, packaging, sterilization, biocompatibility, and human factors) relies on engineering and scientific principles and product specifications, not on expert consensus for "ground truth" as might be seen in diagnostic imaging studies. Human factors testing involves users, but their qualifications are not detailed beyond "physician (healthcare staff)".

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

Not applicable. Adjudication methods are typically used in clinical studies where multiple reviewers assess outcomes, which is not the type of study described here.

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 premarket notification for a physical medical device (tracheostomy kit), not an AI/software device. No MRMC study was conducted or mentioned.

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

Not applicable. This is not an algorithm or AI device.

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

The "ground truth" for the performance testing is adherence to predefined engineering specifications, performance standards (e.g., fluid flow, material strength), and regulatory standards (e.g., ISO for packaging, sterilization, biocompatibility). It is based on objective measurements and compliance with recognized standards, rather than clinical expert consensus or pathology.

8. The sample size for the training set:

Not applicable. This is not a study involving machine learning or AI models, so there is no "training set."

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

Not applicable (no training set).

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The Kimberly-Clark* KimVent* BAL Cath* Bronchial Aspirate Sampling Catheter is used in the diagnosis of diffuse lung disease by allowing collection of bronchoalveolar lavage (BAL) specimens from deep within the lung. The use of a bronchoscope is not necessary. This catheter is used in adult intubated patients.

Sterile, single use, catheter kit for performing non-bronchoscopic Brochoalveolar Lavage (BAL) in adult patients undergoing mechanical ventilation. (also known as mini-BAL)

The document provided is a 510(k) summary for a medical device called the "Kimberly-Clark* KimVent* BAL Cath* Bronchial Aspirate Sampling Catheter." This type of submission is for demonstrating substantial equivalence to a predicate device, rather than proving efficacy through clinical trials with specific performance criteria for AI/ML systems.

Therefore, much of the requested information (such as AI/ML specific metrics, expert adjudication, MRMC studies, training set details, etc.) is not applicable and cannot be extracted from this document, as the device is a physical catheter, not an AI/ML system.

However, I can provide the available information regarding the device's acceptance criteria and how it was proven to meet them, based on the provided text.

Here's a summary of the available information:

1. Acceptance Criteria and Reported Device Performance

The device is a physical catheter, and its performance was evaluated through bench testing against established standards, not through specific clinical performance metrics like sensitivity or specificity typically associated with AI/ML systems.

• ISO 594-2:1998 (Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment — Part 2: Lock fittings)
• ISO 10993-5:2009 (Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity)
• ISO 10993-7:2008 (Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals)
• ISO 10993-10:2010 (Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization)
• ISO 11135-1:2007 (Sterilization of health care products — Ethylene oxide — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices)
• ISO 5356-1:2004 (Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets) |
  | Overall Outcome | All results of testing met acceptance criteria. |

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

Not applicable for a physical device being evaluated through bench testing. The "test set" here refers to the samples or units of the physical device subjected to the bench tests. The document does not specify the number of units tested.

Data provenance (country of origin, retrospective/prospective) is also not applicable as this is not a study involving human data or AI/ML model evaluation.

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

Not applicable. Ground truth, in the context of AI/ML, refers to validated classifications or outcomes. For a physical device's performance, the "ground truth" is typically defined by the objective measurements and pass/fail criteria specified by the benchmarking standards (e.g., specific force, flow rate, or biocompatibility limits). These are set by the standard-setting bodies, not by human experts adjudicating individual cases.

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

Not applicable for physical device testing against technical standards.

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 catheter, not an AI/ML system, and no human reader studies with or without AI assistance were conducted or are relevant.

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

Not applicable. This is not an algorithm. The "standalone performance" refers to the device's ability to meet the specified physical and material criteria through bench testing, as summarized in Section 1.

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

For this physical device, the "ground truth" for proving acceptance criteria was based on objective measurements and conformance to established international standards (ISO standards listed above) for physical properties, biocompatibility, and sterilization.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI/ML model that requires training data.

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

Not applicable. No training set was used.

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This closed suction system is indicated for endotracheal / tracheostomy suction of adult and pediatric intubated patients (including neonates). This device is intended for single use only.

Ty-Care is a suction catheter system that is designed to connect to the endotracheal tube or tracheostomy tube of the patient and remains in place up to 48 hours ("fixed" version). Ty-Care exel is a detachable system and features a suction catheter that must be replaced after 24 hours while the angled connector (elbow) may be replaced after 72 hours of use. If the patient is on mechanical ventilation, this device allows the attending health professional to suction the patient's tracheobronchial secretions without disconnecting the ventilator. Ty-Care exel offers all the advantages of Ty-Care system with the added feature of a rotating patient-access valve.

The provided text describes the 510(k) summary for the MALLINCKRODT DAR Ty-Care™ / Ty-Care™ exel Closed Suction System, claiming substantial equivalence to predicate devices. However, it does not contain the detailed information required to fill out a table of acceptance criteria and a study that proves the device meets those criteria, specifically regarding performance metrics, sample sizes, expert involvement, or comparative effectiveness studies.

The document primarily focuses on establishing substantial equivalence based on intended use, design, operational characteristics, and materials of construction compared to predicate devices. It briefly mentions "Biocompatibility and performance testing demonstrate that MALLINCKRODT DAR Ty-Care™ / Ty-Care Closed Suction System complies with designated voluntary standards and fulfills product specifications. Verification and validation testing demonstrates that the increased duration of use raises no new issues of safety or effectiveness." This is a general statement and lacks the specific details requested in your prompt.

Therefore, most of the requested information cannot be extracted from this document.

Here's how much of your request can be answered based solely on the provided text:

1. Table of acceptance criteria and the reported device performance

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

• Sample size for test set: Not specified.
• Data provenance: Not specified (e.g., country of origin, retrospective/prospective).

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

• Not specified. The document does not mention experts involved in establishing ground truth for performance testing.

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

• Not specified.

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 medical device (closed suction system), not an AI-powered diagnostic or imaging device for which MRMC studies comparing human readers with and without AI assistance would be 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, not an algorithm.

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

• Not specified. The document only generally mentions "biocompatibility and performance testing" and "verification and validation testing" against "designated voluntary standards and product specifications." It does not detail how the "truth" or success of these tests was established.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device that would have a "training set."

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

• Not applicable.

Summary:
The provided 510(k) summary is designed to demonstrate substantial equivalence to predicate devices based on design and intended use, rather than presenting a detailed performance study with specific acceptance criteria and results in the format requested. Information regarding specific testing methodologies, sample sizes, ground truth establishment, or expert involvement in performance criteria is absent from this document.

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The Spirit Medical Systems, Inc. DUAL PURPOSE CLOSED CATHETER is a disposable sterile dual purpose catheter designed to provide both the functions of suctioning and supplying oxygen into the patient's trachea through an endotracheal tube. The first function provides maximum suction efficiency into the airway without compromising sterility and patient safety. The second function provides additional gas flow into the airway for the purpose of improving alveolar ventilation prior to and immediately following suctioning.

The Spirit Medical Systems, Inc. DUAL PURPOSE CLOSED CATHETER is a disposable sterile dual purpose catheter designed to provide both the functions of suctioning and supplying oxygen into the patient's trachea through an endotracheal tube. The first function provides maximum suction efficiency into the airway without compromising sterility and patient safety. The second function provides additional gas flow into the airway for the purpose of improving alveolar ventilation prior to and immediately following suctioning.

The provided 510(k) summary for the "DUAL PURPOSE CLOSED CATHETER" does not include specific acceptance criteria or detailed results from the performance testing. Instead, it makes a general statement about substantial equivalence.

Here's a breakdown of the information that is available and what is missing for your specific questions:

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

• Acceptance Criteria: Not explicitly stated in the provided text.
• Reported Device Performance: Not explicitly enumerated in the provided text beyond the general statement of "substantially equivalent."

The document states: "Based on the results of performance testing conducted at HAUSER Laboratories the Spirit Medical Systems. Inc. DUAL PURPOSE CLOSED CATHETER is substantially equivalent to the Jinotti™ Closed Suction/Oxygen Catheter Systems manufactured and distributed by MedCare Medical Group, Inc." This indicates that performance testing was done, but the details of what was tested, the specific metrics, and the acceptance thresholds are not included in this summary.

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

• Sample Size: Not specified.
• Data Provenance: The testing was "conducted at HAUSER Laboratories," but details regarding the type of samples (e.g., in vitro, animal, human), their origin, or whether the study was retrospective or prospective are not provided. Given the nature of a catheter, it's highly likely this involved in-vitro and/or animal studies rather than human clinical trials for a 510(k) submission, especially from this era.

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

• This question is largely irrelevant for a device of this type (a physical catheter) undergoing performance testing for substantial equivalence. The "ground truth" would likely be objective measurements from laboratory tests, rather than expert interpretation of images or other diagnostic data. Therefore, no information is provided.

4. Adjudication method for the test set

• Not applicable/provided for the reasons stated in 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

• MRMC Study: No.
• Effect Size: Not applicable. This device is a physical catheter, not an AI-assisted diagnostic tool.

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

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

7. The type of ground truth used

• While not explicitly stated, for a physical medical device like a catheter seeking substantial equivalence, the "ground truth" for performance testing (likely flow rates, suction efficiency, material compatibility, strength, etc.) would be established through objective laboratory measurements and engineering standards, not expert consensus, pathology, or outcomes data in the way these terms are typically used for diagnostic or AI devices. The comparison is made against the predicate device's established performance characteristics.

8. The sample size for the training set

• Not applicable/provided. This refers to a physical device, not an AI model requiring a training set.

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

• Not applicable/provided.

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As with the great majority of other ET suction catheters, the indication for endotracheal suctioning is to provide a patent airway by removing excess fluids, secretions, exudate and transudate through the artificial airway. These include patients with indwelling oral or nasal endotracheal tubes, and tracheostomy tubes. This system applies to intubated patients requiring a full range of respiration and ventilatory support. They may be spontaneously breathing, on mechanical ventilation, or partially supported by mechanical devices. The TRACH CARE® closed suction system, as well as other suction catheters, can also be used for saline lavage and surfactant delivery to the distal airway. The closed system device allows for multiple suction episodes utilizing the same catheter. The protective sleeve of the closed system isolates the flora from the patient's secretions, thus reducing the risk of cross-contamination to health care providers and other patients.

5 French through 18 French TRACH CARE® Closed Suction Endotracheal Suction Catheters with MICROBAN® and various airway connectors.

This device, the TRACH CARE® with MICROBAN®, is an Endotracheal Suction Catheter. The 510(k) summary indicates that the submission requests permission to market a device with a label change, extending the recommended use time from "24 hours" to "72 hours."

The submission explicitly states: "The device of this submission is identical in design, material, chemical composition, and all other logical characteristics as the predicate device. This submission requests permission to market a device with a label change in contraindications FROM "Do not use for more than 24 hours." TO "Do not use for more than 72 hours. Change more frequently if catheter becomes soiled or develops any other factor which reduces device efficiency.""

This implies that the acceptance criteria and study proving the device meets them are based on demonstrating that the device remains safe and effective for the extended 72-hour use period, given that its physical characteristics are otherwise identical to the previously cleared 24-hour version. However, the provided text does not contain any specific performance data, acceptance criteria, or details of a study that directly prove the device meets these extended use criteria for the 72-hour period. The clearance is based on the substantial equivalence argument of the label change.

Therefore, many of the requested details cannot be extracted from the provided text.

Here's what can be inferred or stated based on 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)

• Not provided. The document does not describe any specific test set or study conducted for the 72-hour extended use claim.

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 / Not provided. Since no specific test set or study is described, this information is not available.

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

• Not applicable / Not provided.

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 device (endotracheal suction catheter), not an AI-powered diagnostic tool. Therefore, an MRMC study or AI-related metrics are irrelevant.

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

• Not applicable. This is not an algorithmic device.

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

• Not provided. The basis for extending the use time to 72 hours is not detailed in terms of specific ground truth data or studies. The substantial equivalence argument relies on the physical identity to the predicate.

8. The sample size for the training set

• Not applicable / Not provided. This is not an AI/machine learning device that requires a training set.

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

• Not applicable / Not provided.

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The device is intended to be used in critical care units to aspirate secretions from patient airways who have endotracheal or tracheostomy tubes and require mechanical ventilation. The system allow for the insertion and withdrawal of a suction catheter into the artificial airway without disconnecting the patient from the ventilator circuit. The components of this system are sterile, single patient use, and disposable.

The Argyle® ASPR-Care™ Closed Suction System consists of three discreet components: a dual swivel T-piece, a sheathed suction catheter, and a suction control valve. When connected together, these components form a closed system suction catheter similar in form and function to the closed system catheters available from Ballard and Concord/Portex.

This document is a 510(k) summary for the Argyle® ASPR-Care™ Closed Suction System, not a study evaluating acceptance criteria against reported device performance as might be found for AI/ML-driven medical devices. Therefore, much of the requested information (e.g., sample sizes, expert qualifications, MRMC studies, training set details) is not applicable or cannot be extracted directly from this type of regulatory submission.

However, I can extract the general acceptance criteria in terms of "substantial equivalence" and the types of tests performed.

1. Table of Acceptance Criteria and Reported Aevice Performance

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

• This document does not specify a "test set" in the context of AI/ML performance evaluation. The "testing" referred to is for device performance characteristics and biocompatibility.
• For performance, "Sherwood Medical has conducted a battery of tests comparing the performance of the Argyle® ASPR-Care™ Closed Suction System and ancillary components with those devices to which we are claiming substantial equivalence." No sample sizes or data provenance (country, retrospective/prospective) are mentioned for these tests in this summary.
• For biocompatibility, the tests were conducted according to ISO 10993 Part 1. Specific sample sizes for these biological tests (e.g., number of animals for systemic toxicity, number of cell cultures for cytotoxicity) are not provided in this summary, nor is the provenance of the samples.

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

• Not applicable. This is not an AI/ML device requiring expert-established ground truth for a test set.

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 device.

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 (expert consensus, pathology, outcomes data, etc.):

• For biocompatibility: Ground truth is typically based on laboratory assay results (e.g., cell viability for cytotoxicity, skin reaction for irritation, systemic effects in animal models).
• For performance: Ground truth would be based on engineering specifications, physical measurements (e.g., airflow, pressure integrity, suction flow rates), and functional testing against design requirements and comparison to predicate devices. The summary indicates that testing was "conducted to ensure Sherwood's device provides a safe and effective conduit for ventilator qases and allows efficient tracheal and oral suctioning capabilities," implying functional validation.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device.

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

• Not applicable.

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