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The Catheter Introducer Sheath is indicated for use in patients requiring access of the venous system or to facilitate catheter insertion (e.g. pulmonary artery or infusion catheter). It is intended to be used for ≤ 72 hours.

Edwards Lifesciences' Catheter Introducer Sheath is an 11 Fr. sterile, non-pyrogenic, single-use introducer made of flexible and non-flexible polymeric materials. It consists of a single lumen shaft and a hemostasis valve with a side-arm extension tube with a female luer and clamp.

The provided text describes a 510(k) premarket notification for a Catheter Introducer Sheath and does not contain information about studies proving the device meets specific acceptance criteria in the manner of a clinical trial or AI/ML performance evaluation. The document focuses on demonstrating substantial equivalence to a predicate device through functional and safety testing.

Here's an analysis based on the provided text, addressing your questions where possible:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for each test performed, nor does it provide specific numerical results of device performance. Instead, it concludes: "The functional data indicate that the Catheter Introducer Sheath performs in a substantially equivalent manner when compared to the predicate device." and "All data met acceptance criteria." This implies that for each test listed below, there were pre-defined acceptance criteria, and the device successfully met them.

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

The document does not specify the sample sizes used for any of the functional or safety tests. It also does not mention any test sets in the context of clinical data, or the provenance (country of origin, retrospective/prospective) of any data beyond the physical device testing. The "tests" described are laboratory-based, not patient-based clinical trials.

3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts

This information is not applicable to the provided document. The "ground truth" here is established by engineering and material standards, and the results of laboratory tests are presumably interpreted by qualified engineers and scientists involved in the testing and regulatory submission, not by medical experts establishing diagnostic ground truth.

4. Adjudication Method

Not applicable. The tests performed are laboratory-based and would involve measurements against established standards, not interpretation by multiple human readers requiring adjudication.

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

Not applicable. This is a 510(k) submission for a physical medical device (catheter introducer sheath), not an AI/ML-driven diagnostic or assistive technology. Therefore, no MRMC study, human reader improvement effect size, or human-in-the-loop performance is relevant or discussed.

6. Standalone (Algorithm Only) Performance Study

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

7. Type of Ground Truth Used

The "ground truth" for the tests described is based on established engineering standards for medical device performance, material science specifications, biocompatibility guidelines (e.g., ISO standards), and internal performance specifications derived from the predicate device characteristics. For example, "Valve leak" would have a maximum allowable leakage rate, which is the ground truth for that test.

8. Sample Size for the Training Set

Not applicable. This document describes a physical medical device, not a machine learning model, so there is no concept of a "training set" in this context.

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

Not applicable, as there is no training set mentioned.

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The Sheath Introducer system is indicated for use in percutaneous introduction of catheters and other intravascular devices into the vasculature.

The materials of construction are consistent with introducers presently in Device Description. The product is available in 4 French to 9 French. The sheath lengths are 5cm to 110cm.

This document describes a 510(k) premarket notification for a Catheter Introducer. The information provided heavily focuses on substantial equivalence to predicate devices rather than a direct performance study with acceptance criteria.

The acceptance criteria described in the document are implicitly based on demonstrating that the Galt Medical Catheter Introducer is "substantially equivalent" to predicate devices. This means that its functionality and performance should be comparable to these existing, legally marketed devices.

Based on the provided text, there is no explicit statement of numerical acceptance criteria (e.g., minimum accuracy, sensitivity, or specificity thresholds) that would typically be seen for a device that relies on a direct performance evaluation against a defined ground truth. Instead, the "acceptance criteria" are met by demonstrating equivalence through non-clinical testing and shared technological characteristics and indications for use.

Here's an attempt to structure the information based on the request, acknowledging the limitations of the provided text for certain categories:

Acceptance Criteria and Device Performance

Study Proving Acceptance Criteria:

The study that proves the device meets the (implicit) acceptance criteria is a non-clinical comparative testing program and a review of technological characteristics against predicate devices.

Detailed Breakdown of Study Information:

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

   • Test Set Sample Size: Not explicitly stated. The tests mentioned are "tensile strength, and valve leakage," which would involve a certain number of manufactured units of the Galt Medical Catheter Introducer. However, the specific quantity is not reported.
   • Data Provenance: The tests were performed on the Galt Medical Catheter Introducer itself. There is no mention of external data or specific countries of origin beyond the company's location (Garland, TX). These were likely prospective tests performed on newly manufactured devices.

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

   • Not Applicable / Not Mentioned. For a device demonstrating substantial equivalence through non-clinical testing (tensile strength, valve leakage), "experts" for ground truth in the traditional sense (e.g., clinical diagnosis) are not required. The "ground truth" would be objective measurements of physical properties compared against established benchmarks or predicate device performance.

3. Adjudication method for the test set:

   • Not Applicable / Not Mentioned. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation (e.g., imaging, pathology). For non-clinical tests measuring physical properties, the results are quantitative and do not require expert adjudication to establish a "ground truth" among differing opinions.

4. 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 not an AI/imaging device. No MRMC study was conducted.

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

   • No. This is not an AI/algorithm device.

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

   • The "ground truth" for the non-clinical tests (tensile strength, valve leakage) would be objective physical measurements and engineering specifications for the device, benchmarked against the predicate devices' known performance or industry standards. It's not a clinical "ground truth" in the sense of diagnosis or patient outcomes.

7. The sample size for the training set:

   • Not Applicable. This is a physical medical device, not a machine learning model. There is no "training set."

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

   • Not Applicable. As there is no training set, this question is not relevant.

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The StealthStation® System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation® System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT or MR based model or fluoroscopy images of the anatomy.

Example procedures include, but are not limited to:

Cranial Procedures:
Cranial Biopsies Placement Tumor Resections Craniotomies/ Craniectomies Skull Base procedures Thalamotomies/Pallidotomies Pituitary Tumor Removal CSF Leak Repair Pediatric Catheter Shunt Placement General Catheter Shunt Placement

Spinal Procedures:
Spinal Implant Procedures, such as Pedicle Screw

ENT Procedures:
Transphenoidal Procedures Intranasal Procedures Orbital Nerve Decompression Procedures Optic Nerve Decompression Procedures Polyposis Procedures Endoscopic Dacryocystorhinostomy Encephalocele Procedures Sinus procedures, such as Maxillary Antrostomies, Ethmoidectomies, Sphenoidotomies/Sphenoid Explorations, Turbinate Resections.and Frontal Sinusotomies

Orthopedic Procedures:
Total Knee Arthroplasty (Primary and Revision) Unicompartmental Knee Arthroplasty Minimally Invasive Orthopedic Procedures Pediatric Orthopedics Total Hip Replacement (Primary and Revision) Periacetabular Osteotomies Tumor Resection and Bone/Joint Reconstruction Femoral Revision Stabilization and Repair of Pelvic Fractures (Including but not Limited to Acetabular Fractures)

This submission allows a surgeon an image guided instrument to place catheter shunts. The Catheter Introducer for the StealthStation® System is technically equivalent to the StealthStation® System. All systems use either active(LED's), passive reflective markers or electromagnetic coils to track surgical instruments in relation to an image guided reference frame. This information is correlated to the patient's CT, MR or fluoroscopic images of the anatomy.

The provided text is a 510(k) summary for a Catheter Introducer for the StealthStation® System. It describes the device, its indications for use, and a determination of substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria, specific device performance metrics, or details of a study demonstrating fulfillment of such criteria.

The document primarily focuses on regulatory approval based on substantial equivalence, rather than a detailed performance study with defined acceptance criteria. Therefore, most of the requested information cannot be extracted from this text.

Here's a breakdown of what can and cannot be answered based on the provided input:

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

• Cannot be provided. The document does not define specific acceptance criteria (e.g., accuracy thresholds, failure rates) or report detailed device performance metrics from a study against such criteria. The "verification and validation activities" mentioned generally indicate testing was done but no specific results or targets are shared.

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

• Cannot be provided. The document does not describe a clinical study or a test set, hence no sample size, data provenance, or study design (retrospective/prospective) is available.

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)

• Cannot be provided. No information about ground truth establishment or experts involved is present, as no specific test set is detailed.

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

• Cannot be provided. No adjudication method is mentioned, as no test set or expert review process is 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

• Cannot be provided. This document is for a surgical navigation system, not an AI diagnostic tool. No MRMC study is mentioned, nor is there any AI component that would involve human readers improving with AI assistance.

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

• Cannot be provided. This device is an instrument for a surgical navigation system, which inherently involves human interaction (a surgeon using the instrument). The concept of "standalone" algorithm performance without human-in-the-loop is not applicable in this context.

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

• Cannot be provided. No ground truth type is mentioned as no specific performance study is detailed.

8. The sample size for the training set

• Cannot be provided. This document describes a medical device, not a machine learning model, so there is no concept of a "training set" in the context of this submission. "Verification and validation activities" were performed, but these are typically engineering tests, not machine learning model training.

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

• Cannot be provided. As there is no training set for a machine learning model, this question is not applicable.

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