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Indications for Use: Polyurethane probe covers are indicated during diagnostic ultrasound procedures in cases where patient sensitivity to latex is speculative.

The Sheathing Technologies, Inc Ultrasound Probe Cover provides a thin, conformal covering to fit various and specific ultrasound transducer shapes. The cover is made in a general cylindrical shape. It is closed at the proximal end and open at the distal end for insertion of the ultrasound transducer. This device is an accessory used on diagnostic probes to help minimize cross contamination. The cover material is a polyether-based polyurethane. Various sizes and shapes of covers are offered to address the variations in Ultrasound Transducer configurations.

Product categories/models include

• General Purpose Sheathes Ultrasound 1. Probe Covers (sterile and non-sterile)
  Covers are packaged in both sterile and nonsterile, individually wrapped or in bag/box quantities.

The sole difference between this device and the predicate is a labeling change (addition of "viral barrier" to labeling, based on bench testing) to our line of seamless and seamlesstipped ultrasound probe covers. Please see section 13, labeling, for full wording. Please note that seamless and seamless-tipped probe covers are only a subset of the product line. The labeling for the remaining products would remain unchanged.

The provided text is a 510(k) summary for the "Sheathes Ultrasound Probe Covers" by Sheathing Technologies, Inc. This document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study to prove a device meets specific acceptance criteria based on performance metrics such as sensitivity, specificity, or accuracy for a medical AI device.

Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or how ground truth was established, as this document does not contain that type of data.

This document describes a medical device (ultrasound probe covers) and highlights non-clinical bench testing to demonstrate a viral barrier and mechanical properties, not the diagnostic performance of an AI algorithm.

Here's a breakdown of what the document does discuss in relation to testing:

• Acceptance Criteria and Reported Device Performance: This information is not present in the context of an AI device's performance metrics. The document instead discusses non-clinical tests and their conclusions.
  • Bench Testing:
    • Viral Penetration Testing using Minute Mouse Virus
    • Burst Testing
    • Tensile Testing
    • Tear Propagation and Tear Resistance testing
    • Leak testing
  • Conclusion from Non-Clinical Tests: "The seamless probe cover device provides a viral barrier to viruses of the size of Minute Mouse Virus (20 nm) or larger." "Based on bench testing, the device is substantially equivalent or superior to the predicate device, and is safe and effective for its intended use."

The device in question is an ultrasound probe cover, which is a physical accessory, not a diagnostic AI algorithm. Therefore, the types of studies and performance metrics requested (e.g., sensitivity, specificity, human reader improvement with AI) are not applicable to the content provided.

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Sterile ultrasound couplant for use with medical diagnostic ultrasound. It is intended for non-invasive use in medical diagnostic ultrasound procedures to couple sound waves between a patient and the medical imaging electronics. The gel is intended for use in all diagnostic ultrasound procedures which require ultrasound coupling gel or fluid.

Sheathing Technologies, Inc Ultrasound Gel is a water-based coupling agent for diagnostic ultrasonic procedures. This device is an accessory used on diagnostic ultrasound probes. The material is a water-based gel. Gel will be sold in sterile packets for single patient/procedure, disposable use.

This sterile ultrasound gel 510(k) submission describes testing to support substantial equivalence to predicate devices. The acceptance criteria and supporting studies are outlined below:

1. Acceptance Criteria and Reported Device Performance

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

The document does not specify exact sample sizes for each test in the non-clinical studies (biocompatibility, bench testing, physical measurements). The data provenance is derived from laboratory testing of the device and comparison to predicate devices, rather than clinical patient data. Therefore, concepts like country of origin for patient data (as in medical image analysis) or retrospective/prospective clinical studies do not apply here.

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

This submission pertains to a sterile ultrasound gel, an accessory, and its substantial equivalence is demonstrated through non-clinical laboratory testing and comparison to predicate devices, not through human interpretation of medical data. Therefore, the concept of "experts" to establish ground truth in the context of diagnostic interpretation is not applicable here. The experts involved would be laboratory technicians, engineers, and quality assurance personnel performing and verifying the tests according to established international standards (like ISO 10993-1:2009). Their qualifications are typically in biomedical engineering, chemistry, biology, or related scientific fields, with expertise in laboratory testing and regulatory compliance.

4. Adjudication Method for the Test Set

The concept of an adjudication method (like 2+1, 3+1) is relevant for studies where multiple expert readers assess the same cases and a consensus is needed to establish ground truth. As this submission focuses on objective laboratory and physical tests of a medical device accessory, such an adjudication method is not applicable. The "ground truth" for each test is established by the validated measurement methods and comparison against the characteristics of the legally marketed predicate devices.

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

No MRMC comparative effectiveness study was conducted. This type of study is relevant for evaluating the performance of AI-powered diagnostic devices where human reader performance is a key metric, and improvement with AI assistance is assessed. This submission is for an ultrasound gel, which is not an AI-powered diagnostic device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No standalone study (in the context of an algorithm's performance without human interaction) was conducted. The device is a physical product (ultrasound gel), not an algorithm. Its performance is entirely standalone in the sense that it functions as a coupling agent for ultrasound, and its physical and acoustic properties are measured directly.

7. Type of Ground Truth Used

The ground truth used for this submission is based on:

• Established International Standards: For biocompatibility, the ISO 10993-1:2009 standard serves as the benchmark.
• Predicate Device Characteristics: For acoustic performance and physical measurements (density, viscosity), the characteristics of legally marketed predicate devices (Sonotech Clear Image™ Sterile Scanning Gel, K931909; Sheathing Technologies Ultrasound Gel, K112827; Sonotech UltraBio™ Sterile Ultrasound Imaging Couplant, K042619) serve as the "ground truth" or reference for substantial equivalence. The new device's performance is compared directly to these established products.

8. Sample Size for the Training Set

The concept of a "training set" is relevant for machine learning algorithms. This submission is for a physical medical device accessory and does not involve AI or machine learning. Therefore, there is no training set.

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

Since there is no training set for an AI/machine learning algorithm, this question is not applicable.

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Non-sterile ultrasound couplant for use with medical diagnostic ultrasound. It is intended to be used during non-invasive medical diagnostic ultrasound procedures to couple sound waves between a patient and the medical imaging electronics. The gel is intended for use in all diagnostic ultrasound procedures which require ultrasound coupling gel or fluid.

Sheathing Technologies, Inc Ultrasound Gel is a water-based coupling agent for diagnostic ultrasonic procedures. This device is an accessory used on diagnostic ultrasound probes. The material is a water-based gel. Product categories/models include Individual packets (non-sterile) and Bulk bottles (non-sterile). Gel is for single patient/procedure, disposable use.

The provided text describes the 510(k) premarket notification for "Sheathes™ Ultrasound Gel," an ultrasound couplant. The submission primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical bench testing and biocompatibility assessments. It does not involve studies related to device performance in an imaging context that would require ground truth, expert review, or human reader studies.

Therefore, many of the requested sections (2 through 9) related to clinical study design, ground truth, expert involvement, and reader studies are not applicable or cannot be extracted from this document, as this is a non-clinical device that does not perform diagnostic functions.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Device Name: Sheathes™ Ultrasound Gel
Predicate Devices:

• Sonotech Natural Image Ultrasound Couplant (510K#K883917)
• Konix Ultrasound Gel (510K#K101952)

Regarding the other requested information:

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

   • Not applicable. The provided document describes non-clinical bench testing and biocompatibility assessments, not a clinical test set with patient data.

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

   • Not applicable. No ground truth was established by experts for a clinical test set.

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

   • Not applicable. No clinical test set requiring adjudication was performed.

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 an ultrasound couplant, not an AI-powered diagnostic tool, and therefore 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 physical device (ultrasound gel), not an algorithm.

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

   • Not applicable. The "ground truth" for this device's performance is based on established ISO standards for biocompatibility and technical specifications (e.g., acoustical properties, density, viscosity) compared against legally marketed predicate devices.

8. The sample size for the training set:

   • Not applicable. This device does not involve a training set as it is not an AI/machine learning algorithm.

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

   • Not applicable. No training set or associated ground truth was established for this device.

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Colonoscope/Sigmoidoscope Sheaths are meant for use in non-sterile colonoscopy or sigmoidoscopy procedures to help reduce gross contamination of the endoscope, reducing the exposure of staff to gross contamination during the cleaning procedure.

The Sheathing Technologies, Inc. Polyurethane Colonoscope/Sigmoidoscope Sheath provides a conformal covering to fit various lengths and widths of colonoscopes and sigmoidoscopes (hereafter referred to as 'endoscopes'). The cover is open at the proximal end to allow free use of the endoscope's channels, and open at the distal end for insertion of the endoscope. Various sizes and shapes of Sheaths are offered to address the variations in size of the endoscopes.

This device is an accessory for use in nonsterile colonoscopy or sigmoidoscopy procedures to help reduce gross contamination of the endoscope, reducing the exposure of staff to gross contamination during the cleaning procedure.

The cover material is a polyether-blend polyurethane, which is the same blend currently used for Sheathing Technologies probe covers (510(K) K963831 for Sheathes Non-Latex, Non-Sterile and 510(K) K990175 for Sheathes Non-Latex, Sterile).

Product categories/models include

• Rigid sigmoidoscope Sheaths (sterile and non-sterile)
• Flexible sigmoidoscope Sheaths (sterile and non-sterile)
• Colonoscope Sheaths (sterile and nonsterile)

Sheaths are packaged in both sterile and nonsterile, individually wrapped or in bag/box quantities. All are intended for non-sterile procedures, and all are for single patient/procedure, disposable use.

The provided text describes a 510(k) submission for a Colonoscope/Sigmoidoscope Sheath. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials with strict acceptance criteria often seen with novel high-risk devices.

Therefore, the information regarding acceptance criteria and a study proving the device meets those criteria, as typically understood in a clinical efficacy context, is not present in the provided document. The submission relies on non-clinical bench testing and biocompatibility assessments to support equivalence.

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

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

No explicit "acceptance criteria" table with corresponding device performance values for clinical efficacy is provided. The non-clinical tests' conclusions state: "Sheathing Technologies's Polyurethane sigmoidoscope/colonoscope Sheath has sufficient strength and elasticity for the intended application. It is biocompatible according to the ISO 10993-1:2003 biocompatibility standard for contact with skin and mucous membranes for a limited (

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Synthetic polyisoprene probe covers are indicated for use during diagnostic ultrasound procedures in cases where patient sensitivity to natural rubber latex is speculative.

The Sheathing Technologies, Inc CIS-Isoprene Ultrasound Transducer Cover provides a thin, conformal covering to fit various and specific ultrasound transducer shapes. The cover is made by dipping to form a general cylindrical shape. It is closed at the proximal end and open at the distal end for insertion of the ultrasound transducer. This device is an accessory used on diagnostic probes to help minimize cross contamination. The cover material is a Cis-1,4-polyisoprene, a synthetic version of natural rubber latex made without using natural rubber latex in the formulation. Various sizes and shapes of covers are offered to address the variations in Ultrasound Transducer configurations. Product categories/models include General Purpose SheathesISO Ultrasound Transducer Covers (sterile and non-sterile). Covers are packaged in both sterile and nonsterile, individually wrapped or in bag/box quantities, as well as in "procedure kit" form for single patient/procedure, disposable use. The "procedure kit" may include elastic fasteners, with or without coupling gel packets. Transducer covers are also combined with disposable needle guide devices into kits.

This document is a 510(k) premarket notification for a Synthetic Polyisoprene Ultrasound Transducer Cover. The information provided does not describe a study involving AI or complex statistical analysis for diagnostic accuracy. Instead, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical bench testing and biocompatibility assessments. Therefore, many of the requested categories related to AI performance, expert ground truth, and comparative effectiveness studies are not applicable.

Here's an analysis of the provided text based on your request:

Acceptance Criteria and Reported Device Performance

The document describes the device's characteristics and the non-clinical tests performed to demonstrate its safety and effectiveness relative to predicate devices. The "acceptance criteria" here are implied by successful completion of these tests in comparison to established standards and the predicate device's performance.

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The Sheathes Needle Guide provides guidance for a needle, catheter, biopsy apparatus, or other interventional device by positioning it relative to the ultrasound apparatus, of other moreman as aring a diagnostic ultrasound procedure in order to perform a biopsy or precise needle placement.

The Sheathes Needle Guide system consists of 4 primary components which are used to provide interventional tool in relation to the ultrasound image. Three components (a transducer cover, a guide clip, and retainer clip) are single use disposable, while the fourth component, the adapter, is a reusable component, providing a system interface to various transducers.

I am sorry, but the provided text does not contain the acceptance criteria or a study proving the device meets acceptance criteria for the "Sheathes Needle Guide System."

The document is a 510(k) premarket notification for the Sheathes Needle Guide System, aiming to demonstrate substantial equivalence to legally marketed predicate devices. It lists the trade name, common name, classification, product equivalence, and intended use of the device.

However, it does not provide:

• A table of acceptance criteria and reported device performance.
• Details on sample sizes or data provenance for any studies.
• Information on experts, ground truth establishment, or adjudication methods.
• Any mention of a multi-reader multi-case (MRMC) comparative effectiveness study or standalone algorithm performance.
• Sample size or ground truth establishment for a training set.

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STERILE NON-LATEX PROBE COVERS ARE INDICATET) DURING DIAGNOSTIC ULTRASOUND PROCEDURES in CASES WHERE.. PATIENT SENSITIVITY TO LATEX is SPECULATIVE.

Sheathes (Non-Latex), Sterile

The provided text is a 510(k) clearance letter from the FDA for a non-latex sterile sheath, not a study report or clinical trial. Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, study details, or performance data for a device.

The clearance letter simply states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices. It does not provide any specific quantitative acceptance criteria or the results of any performance studies.

To answer your questions, I would need a different document, such as a summary of safety and effectiveness data (SSE) or a clinical study report that was part of the 510(k) submission.

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