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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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XSTAT 30 is a hemostatic device for the control of severe, life-threatening bleeding from wounds in the groin or axilla that are not amenable to tourniquet application in adults and adolescents.

XSTAT 30 is a hemostatic device for the control of severe, life-threatening bleeding from narrow entrance extremity wounds in the arms or legs in adults and adolescents.

XSTAT 30 is a temporary device for use up to four (4) hours until surgical care is acquired. It should only be used for patients at high risk from, immediate life-threatening hemodynamically significant (Advanced Trauma Life Support class 3 or 4 hemorrhagic shock), non-compressible junctional wounds or narrow entrance extremity wounds, and when definitive care at an emergency care facility cannot be achieved within minutes.

XSTAT 30 is NOT indicated for use in the thorax, the pleural cavity, the mediastinum, the abdomen, the retroperitoneal space, the sacral space, tissues above the inguinal ligament; or tissues above the clavicle.

XSTAT 12 is a hemostatic device for the control of severe, life-threatening bleeding from wounds in the groin or axilla that are not amenable to tourniquet application in adults and adolescents.

XSTAT 12 is a hemostatic device for the control of severe, life-threatening bleeding from narrow entrance extremity wounds in the arms or legs in adults and adolescents.

XSTAT 12 is a temporary device for use up to four (4) hours until surgical care is acquired. It should only be used for patients at high risk from immediate life-threatening hemodynamically significant (Advanced Trauma Life Support class 3 or 4 hemorrhagic shock), non-compressible junctional wounds or narrow entrance extremity wounds, and when definitive care at an emergency care facility cannot be achieved within minutes.

XSTAT 12 is NOT indicated for use in the thorax; the pleural cavity; the mediastinum; the retroperitoneal space; the sacral space; tissues above the inguinal ligament, or tissues above the clavicle.

The XSTAT 30 device consists of an applicator that facilitates delivery of minisponges to external bleeding wounds. The applicator with a telescoping handle is filled with ~ 92 minisponges and packaged in a vacuum-sealed foil pouch and terminally sterilized by gamma radiation to a sterility assurance level of 10°. The XSTAT 30 3-pack consists of three (3) applicators in an individually sealed foil pouch and terminally sterilized by gamma radiation. The Instructions for Use ("FU") are printed on the outside of the sterile packaging. One (1) product insert summarizing preclinical testing and one (1) casualty card is included with the packaging. The XSTAT 30 1-pack consists of one (1) applicator in an individually sealed foil pouch and terminally sterilized by gamma irradiation. The Instructions for Use (IFU) are printed on the outside of the sterile packaging. One (1) product insert summarizing preclinical testing and one (1) casualty card is included with the packaging.

The XSTAT 12 device consists of an applicator and plunger that facilitate delivery of minisponges to external bleeding wounds. Individual applicators are filled with minisponges and are packaged in a vacuum-sealed foil pouch with one (1) plunger, and terminally sterilized by gamma radiation to a sterility assurance level of 10 °. The XSTAT 12 device consists of vacuum-sealed, gamma radiated, inner pouches which are packaged inside a larger outer pouch as a three (3) pack or one (1) pack configuration. Each outer pouch also contains one (1) casualty card and one (1) package insert. The Instructions for Use (IFU) are affixed to the outer pouch.

The XSTAT devices comprise standard, regenerated cellulose medical sponge that is compressed and formed into minisponges. Each minisponge has a height of 4-5 mm and a circular surface diameter of 9.8 mm. The minisponges absorb blood upon contact, and within approximately 20 seconds expand to their pre-compressed height of 40-50 mm. Each minisponge contains a radiopaque marker for easy detection via X-ray.

This document is a 510(k) summary for medical devices (XSTAT 30 and XSTAT 12), primarily focusing on demonstrating substantial equivalence to existing predicate devices rather than proving performance against specific acceptance criteria for an AI/ML algorithm. Therefore, many of the requested details about acceptance criteria, study design for AI/ML, human expert involvement, and ground truth establishment are not present in this document.

However, I can extract the information relevant to the device's performance and the studies conducted to support its safety and effectiveness, interpreting them in the context of device approval rather than AI/ML model validation.

Here's a breakdown of the available information:

Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of predetermined acceptance criteria with corresponding performance metrics for the XSTAT devices in the way one would for an AI/ML algorithm. Instead, the "acceptance" is based on demonstrating substantial equivalence to predicate devices. This means the new devices (XSTAT 30 and XSTAT 12) must be shown to be as safe and effective as previously cleared devices.

The reported "performance" is qualitative, asserting that based on the conducted studies, the devices meet the bar for substantial equivalence.

Qualitative Performance Claims based on Studies:

• Hemostatic Efficacy: Demonstrated effectiveness in controlling severe, life-threatening bleeding.
• Radiopacity: Minisponges contain a radiopaque marker for easy detection via X-ray (a critical safety feature).
• Expansion Properties: Minisponges absorb blood and expand rapidly (within ~20 seconds) to fill the wound.
• Sterility: Terminally sterilized by gamma radiation to a sterility assurance level of 10⁻⁶.
• Biocompatibility: Demonstrated per ISO 10993.
• Mechanical Integrity (Applicator): Shown to be identical to predicate devices and thus assumed to perform similarly.
• Safety/Effectiveness: Overall claim that the devices are "as safe and effective" as predicate devices.

Summary of Studies and Data Provenance:

The document describes the following types of studies:

1. Bench Testing:

   • Applicator: Mechanical testing was not repeated because the applicators are identical to the predicate devices (K152624 for XSTAT 30, K161020 for XSTAT 12).
   • Minisponges: Performed to verify properties like:
     • Radiopacity and Radiopaque Marker Durability
     • Immunogenicity
     • Absorption Capacity
     • Extent of Swelling
     • Expansion Force/Pressure
   • Data Provenance: Not explicitly stated, but typically these are internal lab tests conducted by the manufacturer.

2. Biocompatibility Testing:

   • Conducted: Per ISO 10993 for the minisponges. Applicator biocompatibility was also demonstrated via predicate device clearance.
   • Data Provenance: Not explicitly stated, but likely conducted by the manufacturer or a contract research organization.

3. Animal Study:

   • Type of Study: GLP (Good Laboratory Practice) animal studies.
   • Purpose: To demonstrate safety and effectiveness, specifically for the hemostatic function.
   • Applicability: The animal testing of the minisponges using the XSTAT 30 applicator was considered "fully applicable" to the XSTAT 12 device because they use the same minisponges.
   • Data Provenance: Not explicitly stated, but usually conducted in a controlled laboratory setting (e.g., animal research facility).

This document is a regulatory submission for a medical device (hemostatic sponges), not an AI/ML algorithm. Therefore, the following sections are not applicable to the provided text.

2. Sample Size used for the test set and the data provenance: Not applicable. The studies are described in terms of "bench tests," "biocompatibility testing," and an "animal study," not AI/ML test sets. There are no explicit sample sizes provided for these tests, other than the general statement that they were conducted. Data provenance is implied to be from the manufacturer's internal testing or contracted labs.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no mention of human experts establishing ground truth for a test set, as this is not an AI/ML study.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No human adjudication is mentioned, as this is not an AI/ML study.

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/ML device; therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.

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.): The "ground truth" for this device's performance is established through direct physical and biological testing:

   • Bench Testing: Engineering specifications, material science properties, physical measurements (e.g., expansion time, absorption).
   • Biocompatibility Testing: ISO standards for biological safety.
   • Animal Study: Direct observation of hemostatic efficacy in a live animal model (a form of "outcomes data" in a pre-clinical setting).

8. The sample size for the training set: Not applicable. This is a physical medical device, not an AI/ML algorithm requiring a training set.

9. How the ground truth for the training set was established: Not applicable.

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SafetyMate® Talking First Aid, SM200 Series is an electronic device intended for use to provide verbal information from established sources to refresh how to handle common medical emergencies through utilization of button options, voice queries and prompts which remind the user of important points in the management of identified emergency situations for infant, child, and adult emergencies.

SafetyMate® Talking First Aid, SM200 Series is a hand-held, interactive talking first aid guide for adult, child or infant emergencies. It includes eight themed first aid categories including CPR/Unconscious, Choking/Breathing, Allergic Reaction, Bleeding, Burns, Falls/Bone Injury, Poison/Bites/Stings, and Seizures. Besides providing guidance for what to do in case of an emergency, SafetyMate also highlights what not to do to prevent further injury. SafetyMate is designed to reinforce and remind users of the correct steps and procedures to provide established first aid care.

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: SafetyMate® Talking First Aid, SM200 Series

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the specific sample size used for the clinical usability and human factors studies (test set). It is referred to as "users" and "subjects" in the plural, but no number is given.

The provenance of the data (country of origin, retrospective/prospective) is not specified in the provided text. However, given the context of a 510(k) submission to the FDA, it's highly likely to be prospective studies conducted in the USA.

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

The document does not specify the number of experts used or their qualifications to establish ground truth for the usability and human factors studies. The ground truth for correct first aid procedures would likely be based on established medical guidelines, but the method for assessing subject performance against this ground truth (e.g., observation by medical professionals or trained evaluators) is not detailed.

4. Adjudication Method for the Test Set:

The document does not describe a specific adjudication method (e.g., 2+1, 3+1). It states "Clinical usability and human factors studies were conducted to assess..." and "Conclusions indicated that overall, no significant delays in treatment were noted." This implies an assessment and conclusion were made, but the exact process of reaching consensus on "appropriateness of care" and "speed to treat" is not detailed.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly done in the traditional sense of comparing multiple human readers' diagnostic accuracy. The studies focused on human factors and usability of the device for first aid assistance, specifically comparing performance with the device versus without a prompting device to assess delays in treatment and appropriateness of care.

The "effect size" mentioned, while not a standard MRMC metric, indicates that the device did not cause significant delays and did not lead to inappropriate care, with 100% of users able to use the device correctly without prompting.

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

No, a standalone performance study in the sense of an "algorithm only" without human interaction was not relevant or performed for this device. The SafetyMate® is an interactive, talking first aid guide that by its nature requires human interaction (selection of categories, response to voice prompts) to function. Its performance is inextricable from human-in-the-loop use.

7. The Type of Ground Truth Used:

The ground truth for the clinical usability and human factors studies implicitly relied on established best practices and protocols for first aid and common medical emergencies. The device itself "provides verbal information from established sources" and "reminds the user of important points in the management of identified emergency situations." The studies assessed whether users could correctly follow these established procedures with the device's assistance.

8. The Sample Size for the Training Set:

The document describes non-clinical tests for electromagnetic compatibility (EMC) and clinical usability/human factors studies for performance. It does not mention a "training set" in the context of machine learning. The device is an electronic talking first aid guide, not an AI/ML algorithm that requires a training set in the typical sense.

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

As there is no mention of a "training set" for an AI/ML algorithm, this question is not applicable. The information provided by the device (first aid instructions) is stated to be from "established sources."

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The Bovie Suture Remover is used to perform suture removal procedures in health care facilities and veterinary offices. The suture removal procedures in which the sutures are located externally on the surface of the skin.

The Suture Remover consists of a rechargeable power handle, charging stand, and a sterile, single-use kit distributed in a multipack. The single-use kit includes three components, two of which are Class I devices (forceps and gauze) commonly used in predicate suture removal kits. The forceps and gauze components are substantially equivalent to those included in other Class I, Premarket notification-exempt devices. The single-use tip component is included in the sterile kit. After the handle is charged, the tip is attached to the power handle. The bottom of the tip is placed flat against the sutured skin surface so that the tip filament only touches the suture. The button is pressed, delivering heat to the filament for about 0.5 second prior to deactivating. This process is completed for all sutures, after which the suture threads are easily removed using the supplied forceps. Using a heated filament to cut the suture provides an advantage over the use of scissors to cut the suture because pulling of the suture prior to the cut is minimized.

This document is a 510(k) premarket notification for the Bovie inaFlash™ Suture Remover. It does not contain information about specific acceptance criteria, a study proving the device meets said criteria, or detailed performance metrics.

The document primarily focuses on demonstrating substantial equivalence to predicate devices, which is the basis for 510(k) clearance, rather than presenting a performance study with detailed acceptance criteria and results.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth methods from the provided text. The document states that "Electromagnetic Compatibility testing in accordance with EN 60601-1-2 was successfully performed" and "Hazard analysis evaluations were also performed," but it does not provide the specific acceptance criteria or results of these tests, nor does it detail a clinical performance study.

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Use of the Subdural Evacuating Port System Cranial Access Kit is indicated when access to and evacuation of a cranial subacute or chronic hematoma or hygroma is necessary. The Subdural Evacuating Port System Cranial Access Kit is intended for drainage of subdural fluid accumulations such as hygromas and chronic or subacute hematomas to an external suction reservoir. The Subdural Evacuating Port System Cranial Access Kit is also intended for draining air and fluids from the subdural space immediately following craniotomy procedures performed to remove a chronic or subacute subdural hematoma.

The Subdural Evacuating Port System Cranial Access Kit is indicated when access to the subdural space and evacuation of a cranial subacute or chronic hematoma or hygroma is necessary. The Subdural Evacuating Port System Cranial Access Kit consists of surgical instruments and accessories used for draining subdural fluid accumulations such as hygromas and liquid-state subdural hematomas to an external suction reservoir without touching the brain. Utilizing a minimally invasive technique, the Subdural Evacuating Port System Cranial Access Kit's "SEPS Components" are designed to promote gradual brain reexpansion by creating a low homogeneous negative pressure throughout the subdural space as fluid is drained to an external suction reservoir. The completeness of the Subdural Evacuating Port System Cranial Access Kit saves time and eliminates the need to gather supplies; this convenience can be critical in an emergency situation.

The Subdural Evacuating Port System Cranial Access Kit is available in three (3) kit configurations:

1. SEPS-CA, Catalog # 11-0401-CA (Standard Kit)
2. SEPS-CAL, Catalog # 11-0401-CAL (Standard Kit with Lidocaine w/epinephrine)
3. SEPS-CAND, Catalog # 11-0401-CAND (Standard Kit without Lidocaine, ChloraPrep® One-Step, or PVP (Povidone-Iodine) ointment -- no drugs).

The provided text describes a 510(k) submission for the Subdural Evacuating Port System Cranial Access Kit (SEPS Cranial Access Kit). This is a medical device, not an AI/ML algorithm or software that would typically have acceptance criteria based on performance metrics like sensitivity, specificity, or AUC.

Therefore, many of the requested categories in the prompt are not applicable to this type of traditional medical device submission. The 510(k) process focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving performance against specific quantitative acceptance criteria through a study with clearly defined statistical endpoints for sensitivity/specificity.

Here's an attempt to answer the questions based on the provided text, indicating "Not Applicable" or "Not Provided" where the information is not present or relevant to this type of device submission:

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 explicitly stated for the current device. The submission refers to "successful performance testing and clinical data presented and accepted for the predicate device (510(k) # K002970)." This implies that the data relied upon was from studies previously conducted for the predicate device.
• Data Provenance (country of origin, retrospective/prospective): Not provided in this summary. The data provenance would relate to the predicate device's studies.

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

• Number of Experts: Not applicable/Not provided. The 510(k) submission for this device type does not involve establishing ground truth through expert reads of images for performance evaluation in the way an AI diagnostic device would. Performance is demonstrated through substantial equivalence to existing devices.
• Qualifications of Experts: Not applicable/Not provided.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable/Not provided. Adjudication is typically used in studies involving human readers or AI output where discrepancies need resolution, which is not the primary assessment method described for this device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study Done: No. This type of study is specifically designed for evaluating the impact of AI assistance on human reader performance, which is not relevant for this physical medical device.
• Effect Size of Human Readers with/without AI: Not applicable.

6. Standalone (Algorithm Only) Performance Study

• Standalone Study Done: No. This device is a physical surgical kit, not a software algorithm.

7. Type of Ground Truth Used

• Type of Ground Truth: Not applicable/Not provided in the context of typical AI performance evaluation. For this device, the "ground truth" for demonstrating safety and effectiveness is primarily established through the regulatory approval of the predicate device(s) and their associated clinical performance data. The current submission relies on the established safety and performance of the predicate.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device is a physical medical kit and does not involve AI model training.

9. How Ground Truth for the Training Set Was Established

• How Ground Truth for Training Set Was Established: Not applicable.

Summary of Performance Testing (as per document):

The manufacturer (Medical Designs, LLC) states that the Subdural Evacuating Port System Cranial Access Kit is "substantially equivalent to the Subdural Evacuating Port System Kit (Predicate Device #1) based on the successful performance testing and clinical data presented and accepted for the predicate device (510(k) # K002970)."

This means that the current device's safety and effectiveness were demonstrated by showing that it is essentially the same as a device already approved by the FDA, which had its own performance testing and clinical data submitted previously. No new specific clinical trials or performance studies unique to the "SEPS Cranial Access Kit" itself (as described in the 510(k) summary) were conducted beyond demonstrating its equivalence to the predicate. Biocompatibility was also confirmed by noting that components are FDA approved or substantially equivalent to approved components.

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