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UltraBio, as an in vivo biocompatible and bioexcretable sterile couplant, is intended to replace sterilized transcutaneous scanning gels that are not in vivo biocompatible or in vivo bioeliminated in surgical procedures, biopsies and similar sterile applications.

UltraBio will be used to couple sound waves between the patient and medical imaging electronic transducers during transcutaneous and intracavitary medical diagnostic ultrasound imaging procedures. It will be used with transcutaneous and intracavity ultrasound imaging.

UltraBio is unit dose packaged, sterilized and intended for use in all diagnostic ultrasound procedures that currently use an ultrasound coupling gel or fluid alone or in combination with a latex sheath where sterility and bioelimination are required.

UltraBio - In Vivo Biocompatible, Bioeliminated Sterile Ultrasound Imaging Couplant

The provided text is a 510(k) premarket notification letter from the FDA regarding a device called "UltraBio - In Vivo Biocompatible Bioeliminated Sterile Ultrasound Imaging Couplant". This document is an approval letter for a medical device and does not contain information about acceptance criteria, device performance studies, or clinical trial details as requested in your prompt.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices". This indicates that the device's approval is based on its substantial equivalence to existing predicate devices, rather than a new study proving specific performance against acceptance criteria.

Therefore, I cannot fulfill your request for the following information based on the provided text:

1. A table of acceptance criteria and the reported device performance
2. Sample sized used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
5. If a multi reader multi case (MRMC) comparative effectiveness study was done
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

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UltraBio, as an in vivo biocompatible and bioexcretable sterile couplant, is intended to replace UltraBlo, as an in Wo bloompatible and brookers on in vivo bioshested on vivo biosxcretable, but sterilized transculaneous sounting gold transmilar sterile applications.

UltraBio will be used to couple sound waves between the patient and medical imaging electronic UltraBlo will be used to couple sound waves between in the material consisted on the consective transducers during intraoperative and intraction in and aspiration, intraoperative ultrasound imaging, and intracavity ultrasound imaging.

UltraBio is unit dose packaged, sterilized and intended for use in all diagnostic ultrasound Ultration is unlift use packaged, sichiles and interess for fluid alone or in combination with a latex, and procedures that canently use an undaound beaping get in the biocompatibility and bioelimination are required.

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I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, study details, sample sizes, expert qualifications, or ground truth establishment. The document is an FDA 510(k) clearance letter for a device named "Ultrabio - InVivo Biocompatible, Bioeliminated Sterile Ultrasound Imaging Couplant," primarily discussing its regulatory classification and indications for use. It does not contain the kind of technical performance study details requested in your prompt.

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ScanLube is an in vivo biocompatible and biodegradable sterile ultrasound couplant that will be used in coniunction with hydrogel pads, such as Sonotech's ScanTac Pad, during medical diagnostic ultrasound imaging to couple ultrasound waves between the patient and medical imaging electronics.

ScanLube converts an adhesive hydrogel surface into a lubricous surface by hydrogen bonding with the ScanTac Pad, which then facilitates scanning with an ultrasound transducer.

ScanLube is intended for use with the ScanTac Strip and ScanTac Pad in conjunction with transcutaneous ultrasound image guided biopsy and aspiration, and within a protective sheath (probe cover) for intraoperative and endocavity ultrasound imaging.

ScanLube, when swabbed or similarly applied to the exposed surface of a hydrogel strip, such as the ScanTac Strip, when attached to the face of a transducer, converts the exposed hydrogel adhesive surface to lubricous, thus enabling the easy insertion of the hydrogel covered transducer into a transducer cover or sheath, or for scanning the patient using direct contact of the lubricous hydrogel surface.

ScanLube is unit dose packaged, sterilized and intended for use as a couplant and lubricant in all diagnostic ultrasound procedures which currently use an ultrasound coupling gel or fluid alone or in combination with a latex, polyurethane or polyethylene transducer cover where sterility and in vivo biocompatibility are required.

ScanLube may be used to lubricate the exterior surface of endocavity transducer sheaths or covers prior to insertion into the vagina or rectum. In this application, ScanLube serves both as an ultrasound couplant and instrument lubricant.

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This document is a 510(k) clearance letter from the FDA for a device named ScanLubeTM. It primarily focuses on the regulatory approval for this device as a substantially equivalent product to existing ones, rather than providing a detailed study report with specific acceptance criteria and performance data.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, and expert involvement is not available in the provided text.

Here's what can be inferred or stated based on the document's content:

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

   • Not available. The document is a clearance letter, not a study report. It states that the device is "substantially equivalent" to legally marketed predicate devices, implying it met certain regulatory requirements, but it does not detail specific performance metrics or acceptance criteria for those metrics.

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

   • Not available. The document does not describe any specific test set or clinical study details.

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 available. Ground truth establishment related to a test set is not discussed.

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

   • Not available. Adjudication methods are not mentioned as no test set details are 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/Not available. ScanLubeTM is an ultrasonic couplant and lubricant, not an AI-powered diagnostic device. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this product.

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

   • Not applicable/Not available. As above, this device is not an algorithm.

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

   • Not available. The document does not describe clinical study ground truth. The basis for substantial equivalence would likely rely on physical/chemical properties and biocompatibility testing, not diagnostic ground truth as understood for imaging algorithms.

8. The sample size for the training set:

   • Not applicable/Not available. This device is not an AI algorithm requiring a training set.

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

   • Not applicable/Not available. This device is not an AI algorithm requiring a training set.

Summary of available information related to equivalence:

• Device Name: ScanLubeTM
• Regulation Number: 21 CFR 892.1570
• Regulation Name: Diagnostic ultrasonic transducer (ScanLube is an accessory to this)
• Regulatory Class: II
• Product Code: 90 MUI
• Indication For Use: ScanLube is an in vivo biocompatible and biodegradable sterile ultrasound couplant and lubricant. It is used in conjunction with hydrogel pads (e.g., Sonotech's ScanTac Pad) during medical diagnostic ultrasound imaging to couple ultrasound waves, convert adhesive hydrogel surfaces to lubricous surfaces for easier scanning with an ultrasound transducer, and facilitate insertion of hydrogel-covered transducers into sheaths or for direct contact scanning. It is unit-dose packaged, sterilized, and intended for use in diagnostic ultrasound procedures where sterility and in vivo biocompatibility are required, including lubricating the exterior surface of endocavity transducer sheaths.
• Predicate Device: The letter states the device is substantially equivalent to "legally marketed predicate devices." Specific predicate device names are not provided in this excerpt.
• Basis for Approval: Substantial equivalence to existing predicate devices. This implies that the properties, indications for use, and performance characteristics (e.g., acoustical coupling, lubrication, sterility, biocompatibility) were demonstrated to be acceptable and similar to those of previously cleared devices. However, the exact tests and their acceptance criteria are not detailed here.

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The biocompatible ScanTac Membrane or Pad will be used during medical diagnostic ultrasound imaging to couple sound waves between the patient's body and medical imaging electronics by being affixed to the active element of the transducer. The pad is biocompatible, sterile, and, being solid, leaves no residue. It will be used for transcutaneous ultrasound imaging over surgical wounds, during transcutaneous biopsy and to enhance acoustic coupling to difficult geometries. The pad is sufficiently adherent to remain in place during the procedure. The pad is placed onto the patient, and is a hydrogel. The exposed side of the hydrogel pad will be rendered lubricous with an application of ultrasound coupling sterile fluid, including ScanLube™, water or saline.

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The provided text is an FDA 510(k) clearance letter for a device called "ScanTacTM Pad." This document does not contain the information requested about acceptance criteria and the study proving device performance.

The letter is a notification of substantial equivalence for marketing the device. It focuses on regulatory classifications, general controls, and compliance requirements, rather than detailed performance study results.

Therefore, I cannot provide the requested table and information based on the given input.

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Lubricate the insertion and passage of imaging devices and surgical instrumentation, such as endoscopes, ultrasound transducers, cransesponias instrumentation, Such as Chaoseoped, catheters and surgical instrumentation.

Endo-Glide™ is a lubricant that is biocompatible with all hollow viscera, is in vivo biocompatible with tissue and body fluids, is in vivo biodegradable and is recognized as safe for oral administration'. Endo-Glide is an excellent film former, requiring a thin coating to adequately lubricate an instrument, thus using less material. A thin film of Endo-Glide has excellent adherence and will not "snowplow" when inserted into an orifice, which can create dry spots on an instrument, and most particularly on an endoscope. Endo-Glide will be offered in sterile and non-sterile packaging for endoscopic, transurethral and surgical instrumentation lubrication.

I am sorry but this document does not contain the information you are requesting. This document is a 510(k) premarket notification for a medical device called "Endo-Glide Lubricant." It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting detailed study data or acceptance criteria.

Therefore, I cannot provide:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for test sets, data provenance, or the number and qualifications of experts for ground truth establishment.
• Adjudication methods, MRMC comparative effectiveness study details, or standalone algorithm performance.
• The type of ground truth used, sample size for the training set, or how its ground truth was established.

The document states that Endo-Glide is "equivalent in formula" to VivoSonic and "equivalent in use" to K-Y Jelly and Surgilube. This approach, prevalent in 510(k) submissions, relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device without necessarily requiring extensive new clinical studies.

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The biocompatible ScanTac Strips will be used in diagnostic ultrasound imaging to couple sound waves between the patient's body and medical imaging electronics. ScanTac Strips are biocompatible, sterile, and, being solid, leave no residue. They are single use and disposable. ScanTac Strips are intended for use in sterile fields substituting for an ultrasound coupling gel or fluid, as currently used, in combination with a latex, polyurethane, polypropylene or other polymeric protective transducer cover.

The ScanTac Membrane is used for transcutaneous ultrasound imaging over wounds and to enhance imaging contact over difficult geometries. The ScanTac Membrane has a backing on one side that is removed prior to transcutaneous scanning. The Membrane is placed onto the patient, and is sufficiently adherent to remain in place during the scan due to the adhesive nature of the hydrogel. Either water or ultrasound scanning gel is used on the other side of the Membrane between the transducer and the Membrane.

ScanTacTM Membrane and ScanTac™ Strip

This document is a 510(k) premarket notification letter from the FDA regarding the "ScanTacTM Membrane and ScanTac™ Strip". It approves the devices for marketing, stating they are substantially equivalent to legally marketed devices. It also outlines the intended use of the devices.

Based on the provided text, there is no study described that proves the device meets acceptance criteria. The document is an FDA clearance letter, which indicates that the FDA has reviewed the submission and found the device substantially equivalent to an existing device, thus permitting its marketing. It does not contain details of a specific study performed by the manufacturer to establish acceptance criteria or device performance in the manner requested.

However, based on the information provided, we can infer some aspects related to what would be considered in such a submission, particularly for the "Acceptance Criteria" and "Reported Device Performance" for biocompatibility and sterility as these are explicitly mentioned in the "Indications For Use" section.

Here's an attempt to answer the questions based on the available text, along with explanations for unavailable information:

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

   The document does not contain a table of acceptance criteria or specific reported device performance metrics in the way one might expect from a clinical or performance study summary. However, it does state key characteristics of the devices that would have been evaluated as part of the substantial equivalence determination.

   Acceptance Criteria (Implied from Indications for Use)	Reported Device Performance (Implied from Device Description/Clearance)
   Biocompatibility	ScanTac Strips are biocompatible. (Stated in Indications For Use)
   Sterility	ScanTac Strips are sterile. (Stated in Indications For Use)
   Non-residue forming	ScanTac Strips, being solid, leave no residue. (Stated in Indications For Use)
   Single-use and disposable	ScanTac Strips are single use and disposable. (Stated in Indications For Use)
   Effective coupling for ultrasound imaging	Intended for use in coupling sound waves between patient's body and medical imaging electronics. (Stated in Indications For Use)
   Adherence during scanning (Membrane)	ScanTac Membrane is sufficiently adherent to remain in place during the scan. (Stated in Indications For Use)
   Transcutaneous imaging over wounds (Membrane)	ScanTac Membrane is used for transcutaneous ultrasound imaging over wounds. (Stated in Indications For Use)
   Enhanced imaging contact over difficult geometries (Membrane)	ScanTac Membrane is used to enhance imaging contact over difficult geometries. (Stated in Indications For Use)

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

   Not provided in the document. This is an FDA clearance letter and typically does not include the detailed test data or study design.

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 provided in the document. This information would be part of the detailed submission, not the clearance letter.

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

   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

   Not applicable. The device is an ultrasound coupling agent/membrane, not an AI diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this 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 (membrane/strip), not an algorithm or software.

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

   Not explicitly stated for performance, but for biocompatibility and sterility, the ground truth would likely be based on established international standards (e.g., ISO 10993 for biocompatibility, ISO 11137/11737 for sterility) and laboratory testing results.

8. The sample size for the training set

   Not applicable. This device is not an AI/machine learning model, so there is no "training set."

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

   Not applicable, as there is no training set for this type of device.

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Used during invasive medical diagnostic ultrasound imaging to couple sound waves between the patient and the medical imaging electronics, and to lubricate the insertion and passage of imaging devices.

Used in conjunction with transcutaneous ultrasound image guided biopsy and aspiration, intraoperative ultrasound imaging, endocavity ultrasound imaging and ophthalmic ultrasound imaging.

Intended for use in all diagnostic ultrasound procedures which currently use an ultrasound coupling gel or fluid alone or in combination with a latex, polyurethane or polyethylene transducer cover where sterility and in vivo biocompatibility are required.

VivoSonic - In Vivo Biocompatible Sterile Ultrasound Imaging Couplant

This document is a 510(k) premarket notification for a medical device called VivoSonic (Diagnostic Ultrasound Imaging Coupling Media). It does not contain information about acceptance criteria or a study proving that the device meets such criteria.

The purpose of a 510(k) submission is to demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and technological characteristics as a legally marketed device that does not require premarket approval (PMA). This is a regulatory clearance process, not a performance study.

Therefore, I cannot provide the requested information based on the provided text, as it does not include:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and data provenance
3. Number of experts used to establish ground truth and their qualifications
4. Adjudication method
5. MRMC comparative effectiveness study results
6. Standalone (algorithm only) performance
7. Type of ground truth used
8. Sample size for the training set
9. How ground truth for the training set was established

The document primarily focuses on the regulatory aspects of the device, its intended use, and its substantial equivalence to other devices already on the market.

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ScanFlex Solid Couplant Membranes is intended for use during transcutaneous (external) and invasive (intraoperative and/or endocavity) medical diagnostic ultrasound imaging to couple sound waves between the patient's body and medical imaging electronics. ScanFlex Solid Couplant Membranes are intended for use in sterile fields, including intraoperative, endocavity or transcutaneous ultrasound imaging procedures which currently use an ultrasound coupling gel or fluid in combination with a latex, polyurethane or polypropylene protective transducer cover. ScanFlex is intended for use in non-sterile transcutaneous applications where a solid couplant would be advantageous.

ScanFlex Solid Couplant Membrane

The provided text is an FDA 510(k) clearance letter and an Indications for Use statement for the "ScanFlex Solid Couplant Membrane." It addresses regulatory classification and intended use but does not contain information about device performance, acceptance criteria, or details of a study that proves the device meets such criteria.

Therefore, I cannot provide the requested table and study information based on the input.

To answer your request, I would need a different document, such as a summary of safety and effectiveness, or the full 510(k) submission, which would typically describe the testing and performance of the device.

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Couplant: HybriSonic Sheaths will be used during invasive medical diagnostic ultrasound imaging to couple sound waves between the patient's body and medical imaging electronics, intended for use in sterile and non-sterile fields, including intraoperative, endocavity or transcutaneous ultrasound imaging procedures when used alone or in combination with an ultrasound coupling gel or fluid alone or in combination with a latex, polypropylene protective transducer cover. The Combination are intended to be used without additional lubrication for typically ultrasound such as ultrasound guided biopsy and aspiration.

Microbial barrier: HybriSonic Sheaths are also intended for use as ultrasound transducer Microbial barriers that are in vivo biocompatible with tissue and body fluids and leave no residue with the transducer, are single use and disposable.

Device lubricant: In addition to coupling ultrasound, the HybriSonic Sheath is intended for use as a device lubricant and microbial barrier during transcutaneous ultrasound exams and with ultrasound imaging and transcutaneous ultrasound guided biopsy or aspiration.

HybriSonic Sheath

The provided text describes a 510(k) premarket notification for the "HybriSonic Sheath" but does not contain information regarding acceptance criteria, study details, or performance results.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them, nor can I provide information on:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set and data provenance.
• Number and qualifications of experts for ground truth.
• Adjudication method.
• MRMC comparative effectiveness study results or effect size.
• Standalone performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

The document is a clearance letter from the FDA, confirming the device's substantial equivalence to a predicate device for its stated indications for use, without detailing the specific studies or performance metrics used to reach that conclusion.

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Sono Image and Ultra Glide are coupling gels and will be used in conjunction with ultrasound transducers during medical diagnostic ultrasound to couple sound waves into the patient's body.

Sono Image is a high viscosity scanning gel suitable for echocardiography, vascular sonography and general ultrasound scanning procedures.

Ultra Glide is a low viscosity scanning gel suitable for abdominal, OB/GYN and general ultrasound scanning procedures.

Sono Image and Ultra Glide are medical diagnostic ultrasound scanning gels that transmit sound waves into the body through the skin and whose formulas are identical except for the polymer (thickener) content. Sono Image and Ultra Glide do not contain silicon, mineral oil, surfactants or any chemicals which are considered harmful to ultrasound transducer material (see Sono Image and Ultra Glide product formulation).

This 510(k) submission for "Sono Image and Ultra Glide" is for medical diagnostic ultrasound scanning gels, not an AI-powered device. Therefore, the requested information regarding acceptance criteria, study data, ground truth establishment, expert involvement, and MRMC studies, which are typically relevant for AI/ML device evaluations, is not applicable in this context.

The document primarily focuses on establishing substantial equivalence to previously cleared predicate devices for the intended use as coupling gels in ultrasound procedures. The core argument for acceptance is based on the identical formulation (except for thickener content which does not affect safety or performance), and the general understanding that viscosity preference is a user-dependent factor.

Here's an attempt to address the prompts based on the provided information, noting the limitations due to the nature of the device:

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

Based on the provided document, there are no specific quantified acceptance criteria for performance for these gels, as their primary function is sound wave transmission, which is inherent to their chemical composition as aqueous gels designed for ultrasound. The "performance" is primarily described as their ability to "transmit sound waves into the body through the skin" and to "couple sound waves into the patient's body," which is a fundamental requirement of such gels.

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

Not applicable. The submission does not detail any clinical studies or "test sets" in the context of performance metrics that would require sample sizes. The "data" provided is primarily related to the chemical composition and intended use.

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. There is no mention of a "test set" requiring ground truth establishment by experts for performance evaluation.

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

Not applicable. No "test set" or adjudication method 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

Not applicable. This is not an AI-powered device.

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

Not applicable. This is not an AI-powered device.

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

Not applicable. No specific ground truth related to performance evaluation is mentioned for this type of device. The "truth" lies in the chemical composition meeting the requirements for a coupling gel.

8. The sample size for the training set

Not applicable. This is not an AI-powered device and therefore does not have a "training set."

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

Not applicable. As above, no training set.

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