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The Altis® Single Incision Sling System is indicated for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD).

The Coloplast Altis Single Incision Sling (SIS) System includes an implantable, non-absorbable, single incision mid-urethral sling and disposable introducer needles for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). The Altis sling is knitted to 1.1 cm width using a 0.08mm (nominal) diameter polypropylene filament and is 7.75 cm long. The Altis sling and Altis introducers are provided sterile (ethylene oxide sterilization) and are for single-use only.

The provided text is related to a 510(k) premarket notification for the "Altis® Single Incision Sling." It focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance data for a new or modified device. As such, the document explicitly states:

"Performance data was not necessary for the substantial equivalence determination as the subject device and the predicate device have identical intended use, target population, sterilization technique, biocompatibility features, overall device design features, and duration of use."

Therefore, I cannot extract the information required to answer your questions about acceptance criteria and the study that proves the device meets them from this document. The document primarily discusses regulatory aspects of the device, specifically its substantial equivalence to a previously cleared predicate device due to identical technical characteristics and intended use. The only change mentioned is revised labeling to include information from a completed 522 study, but details of that study are not provided here.

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The Saffron™ Fixation System is indicated for attaching suture to ligaments of the pelvic floor.

The Saffron Fixation System consists of a single-use disposable Saffron Fixation Tool (delivery tool) and implantable tissue fixation Saffron Anchors (packaged and sold separately) made of polysulfone that are intended to be compatible with commercially available sutures up to size 0 (not provided as a part of the system). The delivery tool facilitates anchor placement with or without direct visualization and may be used to implant multiple anchors in a single patient as needed by the surgeon. The fixation anchors are multi-barbed hooks that provide permanent fixation points for suture attachment to the sacrospinous ligament.

The provided text describes the Saffron™ Fixation System, a medical device for attaching sutures to pelvic floor ligaments. The document does not contain information about acceptance criteria for a study or a study proving the device meets these criteria in the context of an AI/ML powered device.

Instead, the document details a 510(k) premarket notification for a traditional medical device, focusing on demonstrating substantial equivalence to a predicate device based on non-clinical performance data (biocompatibility, mechanical/performance testing, sterilization, and packaging).

Therefore, I cannot provide the requested information regarding acceptance criteria and a study that proves the device meets these criteria, as the input document does not pertain to an AI/ML powered device or a clinical study with detailed acceptance criteria of that nature.

Here's why the provided text cannot answer your questions and what it does contain:

• No mention of AI or ML: The Saffron™ Fixation System is a mechanical device, not an AI/ML powered device. Therefore, questions about "human readers improve with AI vs without AI assistance" or "standalone (algorithm only without human-in-the-loop performance)" are irrelevant.
• No clinical study for effectiveness: The document explicitly states: "No animal studies or clinical testing were provided to support substantial equivalence between the subject and predicate devices." This means there's no clinical trial data to establish effectiveness in a human population.
• Focus on Substantial Equivalence via Non-Clinical Data: The FDA clearance for this device is based on demonstrating that it is "substantially equivalent" to an existing legally marketed device (predicate device). This is primarily achieved through showing similar technological characteristics and non-clinical performance data (e.g., strength, material safety, sterility) rather than a clinical effectiveness study against predefined acceptance criteria.
• "Acceptance Criteria" in this context refers to regulatory compliance: The "acceptance criteria" for this device are broadly the standards and test results that show it meets its intended function safely and effectively, and is comparable to the predicate device, as outlined in the various ISO standards and FDA guidances cited. They are not framed as specific performance metrics from a clinical study.
• Ground Truth: For a traditional mechanical device like this, "ground truth" for training or testing isn't applicable in the same way it is for AI. Performance is assessed through engineering tests (e.g., tensile strength, penetration force).

If you were expecting information on an AI/ML powered device, please provide a different document.

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Biatain® Silicone Ag is intended to provide a moist wound environment and exudate management of acute and chronic wounds.

Biatain® Silicone Ag is indicated for the management of exuding leg and foot ulcers, diabetic foot ulcers, superficial and partial thickness burns, donor sites, and, traumatic and post-operative wounds.

The device is available as sterile, single use only. The device is intended to provide a moist environment and exudate management of acute and chronic wounds. The device maintains a moist wound providing the optimal environment for wound healing.

The device consists of:

• Polyurethane (PU) top film - a 25 um semi-permeable barrier, printed with grey dots.
• . Absorbing pad - composed of a 3.0 mm PU foam containing an anti-bacterial silver complex (silver sodium hydrogen zirconium phosphate).
• Silicone adhesive bi-layer composed of a middle PU film . with a silicone adhesive gel. The PU top film and the middle PU film are laminated together at the border.
• . Protective film - composed of three or five parts; the center part and the remaining side parts.

The device:

• . contains a silver compound (silver sodium hydrogen zirconium phosphate). In vitro testing demonstrated that Biatain® Silicone Ag has an antimicrobial effect in the dressing against the following strains of 3 gram positive bacteria, 3 gram negative bacteria, 1 yeast, and 1 mold: Staphylococcus aureus, Enterococcus faecalis, Streptococcus pyogenes, Proteus mirabilis, Klebsiella pneumoniae, Escherichia coli, Aspergillus brasiliensis and Meyerozyma guilliermondii. The dressing sustains antimicrobial activity for up to 7 days.
  The device may be used in hospitals, healthcare facilities, and home care.

Sterilized using ethylene oxide (EO).

Prescription Use Only.

The provided document is a 510(k) Premarket Notification from the FDA for a wound dressing called Biatain® Silicone Ag. This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than performing clinical studies to prove effectiveness.

Therefore, the document does not contain information about acceptance criteria for an AI/CADe device, nor does it describe a study proving the device meets such criteria. The acceptance criteria table, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment are all relevant to the evaluation of AI/CADe systems, but are not applicable to the information contained within this 510(k) submission for a wound dressing.

The document describes material properties, sterilization methods, and antimicrobial effectiveness of the wound dressing itself, not an AI system.

However, I can extract the performance data and "acceptance criteria" (which are actually performance specifications) relevant to the wound dressing as described in the document, and then explain why this information doesn't fit the template for an AI/CADe device.

Based on the provided document, here's information related to the Biatain® Silicone Ag wound dressing, organized to address your request as much as possible, while clarifying its irrelevance to AI/CADe devices:

This device is a wound dressing, not an AI/CADe system. Therefore, the questions related to AI/CADe device performance (e.g., sample size for test/training sets, expert involvement, MRMC studies, standalone algorithm performance) are not applicable to this 510(k) submission.

The acceptance criteria listed below are for the physical and biological properties of the wound dressing and its components, not for the performance of an artificial intelligence algorithm in diagnosing or detecting medical conditions.

1. Table of Acceptance Criteria and the Reported Device Performance (for the Biatain® Silicone Ag Wound Dressing):

Statement from the document: "All tests passed the pre-determined acceptance criteria."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
This information is not applicable as the document describes performance testing of a physical medical device (wound dressing), not an AI/CADe system. The performance tests were likely conducted on specific numbers of dressing samples in a laboratory setting, but this is not equivalent to a "test set" for an AI model.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable. Ground truth, in the context of an AI/CADe system, refers to definitive labels or diagnoses provided by experts (e.g., radiologists interpreting images, pathologists analyzing tissue). For a wound dressing, "ground truth" would refer to the accurate measurement of physical properties, adhesion, or microbiological action in a lab, not expert consensus on interpretations.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable. Adjudication methods are used to resolve discrepancies in expert interpretations for AI ground truth labeling.

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:
This information is not applicable. MRMC studies are designed to evaluate the impact of AI on human reader performance in diagnostic tasks. This document concerns a wound dressing, not a diagnostic AI tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable. This refers to the performance of an AI algorithm intrinsically, without human intervention.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the wound dressing, the "ground truth" for these tests are laboratory measurements and adherence to established international and national standards (e.g., ASTM, EN, ISO) for material properties, sterility, and antimicrobial effectiveness. This is based on objective scientific measurement rather than clinical outcomes or expert interpretation of diagnostic data.

8. The sample size for the training set:
This information is not applicable. This device is a physical product, not an AI model requiring a training set.

9. How the ground truth for the training set was established:
This information is not applicable. No training set exists for this type of device.

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The ReTrace Ureteral Access Sheath is used to establish a continuous conduit during urological endoscopic procedures facilitating the in and out passage of endoscopes and other instruments into the urinary tract.

The ReTrace Ureteral Access Sheath is comprised of the following components: Reinforced tube/sheath, Introducer/dilator, Connector, Clip. The reinforced polymeric introducer sheath includes a hydrophilic coating on the exterior and a lubricious inner surface. The sheath is reinforced to provide kink resistance. The distal tip of the sheath is fitted with a radiopaque ring. A white connector and orange clip is fitted on the proximal end of the sheath. The introducer is fitted with a Luer connector on the proximal end and has a hydrophilic coating on the distal end. A guidewire entry and exit eye and exit holes for fluid delivery are located at the distal end of the introducer. This submission expands the product line to include 28 cm long and 55 cm long sheaths with inner diameters of 10 and 12 Fr.

The provided text describes a 510(k) premarket notification for a medical device, the ReTrace Ureteral Access Sheath. This specific submission is for an expansion of the product line, including new lengths and diameters of the existing device.

Based on the information provided, this document does not contain the details of a study that proves the device meets specific acceptance criteria in the manner requested by the prompt. The submission is a "Special 510(k) Summary" which aims to demonstrate substantial equivalence to previously cleared predicate devices (K140523 and K123675) for new sizes of the ReTrace Ureteral Access Sheath, rather than presenting a de novo clinical study with specific acceptance criteria related to accuracy, sensitivity, or specificity.

Therefore, many of the requested sections about acceptance criteria, device performance, sample sizes, ground truth establishment, expert involvement, and MRMC studies are not applicable to the content of this document.

However, I can extract the information related to the device's mechanical and sterilization testing which serves as "performance data" in the context of this 510(k) submission for demonstrating substantial equivalence.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in the format of a clinical trial (e.g., sensitivity > X%, specificity > Y%). Instead, it lists mechanical tests performed to ensure the new device variations maintain equivalence to the predicate devices. The "reported device performance" is essentially that these tests were completed successfully and support substantial equivalence.

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

• The document does not specify sample sizes for the mechanical or sterilization testing. These types of tests typically involve a defined number of units per batch or configuration, but the specific numbers are not disclosed.
• Data Provenance: The tests are conducted internally by the manufacturer (Coloplast A/S, based in Denmark, with a US contact in Minneapolis) as part of their design control and quality system. It is laboratory-based testing, not clinical data from patients.

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

• This is not applicable as the document describes mechanical and sterilization testing, not studies requiring expert review of patient data to establish "ground truth." The "ground truth" for these tests are objective measurements against engineering specifications.

4. Adjudication Method for the Test Set:

• This is not applicable for mechanical and sterilization testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

• No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No animal studies or clinical testing were provided to support substantial equivalence between the subject and predicate devices." This is a regulatory pathway (510(k)) that, for this specific device and modification, relies on non-clinical data to demonstrate substantial equivalence, not comparative effectiveness.

6. If a Standalone (Algorithm Only Without Human-in-the-loop Performance) Was Done:

• This is not applicable. The device is a physical medical instrument (ureteral access sheath), not an algorithm or AI software. Therefore, there's no "standalone algorithm" performance to assess.

7. The Type of Ground Truth Used:

• The "ground truth" for the mechanical and sterilization testing referenced is based on engineering specifications, international standards, and validated methods for device performance and sterility. For example, a "guidewire pullout force" test would have an engineering specification for the minimum acceptable force, and the test result confirms it meets that specification.

8. The Sample Size for the Training Set:

• This is not applicable as there is no "training set" in the context of an AI/algorithm. The device is a physical medical instrument.

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

• This is not applicable as there is no "training set."

Summary of Key Findings from the Document:

The document is a regulatory submission demonstrating substantial equivalence for new sizes of an existing medical device. It relies on non-clinical (mechanical and sterilization) testing to show that the new sizes perform similarly to the predicate devices and do not raise new questions of safety or effectiveness. It explicitly states that no animal or clinical studies were conducted for this specific submission to support substantial equivalence.

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The Digitex Delivery Device is a single-use device intended for use as an aid in suturing transvaginal pelvic organ prolapse procedures with surgical mesh.

The Digitex® Suture Delivery System is composed of a delivery device and suture cartridge and is designed for use by the physician to facilitate the consistent placement of suture when direct visualization is not possible and/or the anatomical location is difficult to reach. The shaft of the device has been designed to allow for adjusting the angle of the needle housing to further facilitate suture placement in the desired location.

This document (K173527) is a 510(k) Premarket Notification for the Digitex Delivery Device, a specialized surgical instrument. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with acceptance criteria for an AI/algorithm.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, ground truth, and MRMC studies for an AI device is NOT available in this document. The document describes non-clinical performance testing for a physical medical device.

However, I can extract the information relevant to the device's non-clinical performance testing and its acceptance (as stated in the document), though it's not structured in the way you asked for an AI/algorithm study.

Here's what can be extracted based on the provided text, rephrased to fit your prompt as much as possible, while clarifying that this is for a physical device, not an AI:

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

The document mentions that "The results of all performance testing met pre-defined acceptance criteria as applicable and are acceptable." However, the specific quantitative acceptance criteria or the raw performance data for each test are not detailed in this summary. It only states that the results met the criteria.

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

This document describes non-clinical physical device testing. Sample sizes for these engineering tests and data provenance in terms of country of origin or retrospective/prospective nature are not specified in this 510(k) summary. These types of details would typically be found in the full test reports submitted to the FDA, not in the public 510(k) summary.

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)

This is not applicable to the non-clinical physical device testing described. The "ground truth" for these tests relates to engineering specifications and material standards, not expert medical consensus on diagnostic images.

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

Not applicable. This is not a study involving human readers or expert adjudication of medical cases.

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 document is for a physical surgical device, not an AI or imaging diagnostic tool. No MRMC study was performed or is relevant.

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

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

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

The "ground truth" for the non-clinical performance tests is based on engineering specifications, material standards (e.g., ISO 10993-1 for biocompatibility), and pre-defined acceptance criteria for physical device performance (e.g., sterilization efficacy, package integrity, mechanical strength).

8. The sample size for the training set

Not applicable, as this is not an AI/machine learning device. No training set was used.

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

Not applicable.

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The Peristeen™ Anal Irrigation System is intended to instill water into the colon through a rectal catheter - which incorporates an inflatable balloon - inserted into the rectum to promote evacuation of the contents of the lower colon. The Peristeen Anal Irrigation System is indicated for use by children (2 years -

The Peristeen™ Anal Irrigation (PAI) System is a Class II device intended for intermittent use that facilitates emptying of the colon/bowel in patients with neurogenic bowel dysfunction. The PAI system consists of a single-use irrigation catheter that incorporates an inflatable balloon to keep the catheter in place during the procedure and retain the water that flows into the colon. The rectal catheter is non-sterile, intended for single-use, and packaged and labeled accordingly. The other components may be used multiple times; usage guidelines are detailed in the labeling. All System components are also provided separately in various accessory packages.

The provided document is a 510(k) premarket notification for the Peristeen™ Anal Irrigation System. It states that no changes have been made to the device design, materials, components, technological characteristics or manufacturing processes of the subject device compared to the predicate. The only change being effected is the release of an updated Instructions For Use (IFU).

Therefore, the document explicitly states: "As such, testing for Performance, Shelf Life and Biocompatibility was not deemed necessary to support substantial equivalence. No clinical testing was performed, referenced, or relied on in the 510(k) for a determination of substantial equivalence."

Because no new performance testing was conducted for this submission, the document does not contain the information required to answer the questions about acceptance criteria and a study proving the device meets those criteria.

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SpeediCath Compact Eve is indicated for use by patients with chronic urine retention and patients with a post void residual volume (PVR) due to neurogenic and non-neurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing urine to drain.

The catheter is for female patients only.

The SpeediCath Compact Eve is a sterile, single use, disposable polyurethane catheter for females. The catheter is pre-lubricated with a hydrophilic coating and immersed in saline solution. In use, the handle is turned to break the packaging, connect a urine bag to the end of the handle, if required, and the catheter is pulled out of the packaging. The catheter is then ready to use allowing easy handling and urine to flow through the catheter and handle.

The provided document is a 510(k) premarket notification letter and summary for the SpeediCath Compact Eve urinary catheter. This document does not contain information related to software or AI/ML device performance, acceptance criteria, or studies involving human readers or ground truth establishment in the context of AI/ML.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. The document describes a physical medical device (catheter) and its testing for substantial equivalence to a predicate device, focusing on material, design, and regulatory compliance through physical and biological evaluations, not AI/ML performance.

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The hydrophilic guidewire is intended to facilitate the placement of devices through the urinary tract during endourologic procedures.

The Orchestra® Hydrophilic Guidewire is a guidewire consisting of a metallic core wire with a polymer coating. A hydrophilic coating is applied over the radiopaque polymer jacket. The guidewire is supplied sterile and non-pyrogenic.

The provided text describes a 510(k) premarket notification for the Orchestra Hydrophilic Guidewire. The document states that the device is substantially equivalent to a previously cleared device (K131072) and details the nonclinical tests performed to support this claim, specifically focusing on a modification to the hydrogel coating. However, the document does not contain acceptance criteria or performance metrics that would typically be reported as "reported device performance." It also does not detail a specific "study" in the sense of a standalone algorithm or a comparative effectiveness study with human readers.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or information about a study proving the device meets those criteria, as this information is not present in the provided text.

Based on the information available, here are the details related to the nonclinical testing mentioned:

• 1. Table of acceptance criteria and the reported device performance:

  • Not provided. The document states that "all current product requirements and specifications were met" for the modified coating. However, the specific requirements and their numerical acceptance criteria are not detailed, nor are the specific performance results for each criterion.

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

  • Not provided. The document states "Bench testing was also performed by Coloplast to evaluate performance of the modified hydrophilic coating."
  • The nature of the tests (e.g., durability, reliability) suggests laboratory testing, not human patient data.

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

  • Not applicable. This was bench testing, not a clinical study requiring expert ground truth for interpretation of medical data.

• 4. Adjudication method for the test set:

  • Not applicable. This was bench testing.

• 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 (guidewire), not an AI/imaging diagnostic device.

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

  • No. This is a medical device (guidewire), not an algorithm.

• 7. The type of ground truth used:

  • Not applicable. The "ground truth" for bench testing would be the physical/chemical properties and functional performance measured against predefined specifications.

• 8. The sample size for the training set:

  • Not applicable. This is bench testing for a physical device, not a machine learning model.

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

  • Not applicable. This is bench testing for a physical device, not a machine learning model.

In summary, the provided document focuses on a change to a medical guidewire's coating and confirms that the modified device continues to meet existing product requirements through bench testing. It does not provide the specific details of a study with acceptance criteria and performance data as requested in the format of a clinical or AI diagnostic study.

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SpeediCath Compact Male is indicated for use by patients with urine retention and patients with a post void residual volume (PVR) due to neurogenic and non-neurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing urine to drain. The catheter is for male patients.

The SpeediCath Compact Male is a sterile, single use, disposable polyurethane catheter for males. The catheter is pre-lubricated with a hydrophilic coating and immersed in saline solution. To prepare the catheter for use, the cover is removed and the catheter is pulled out of the packaging thereby extending and locking it to its full length. The catheter is then ready to use allowing easy drainage.

This document is a 510(k) Summary for the SpeediCath Compact Male urinary catheter. It describes the device, its intended use, and substantial equivalence to a predicate device. It also summarizes the testing performed to demonstrate its safety and effectiveness.

However, the provided text does not contain acceptance criteria or a detailed study description that presents the device's performance against specific acceptance criteria.

The document states:

• "SpeediCath Compact Male has been tested and complies with relevant sections of ASTM F 623-99, ASTM D1894-11, EN 1616, EN 1617 and EN 1618."
• "Performance Testing included: Flow Rate, Coefficient of Friction, Tensile Strength."
• "SpeediCath Compact Male has been tested and complies with relevant sections of ISO 10993, Biological Evaluation of Medical Devices."
• "Biocompatibility Testing included: Cytotoxicity, Irritation, Sensitization, Colorant Leachable Study."

While these statements indicate that testing was performed and the device complied with standards, they do not provide the specific acceptance criteria (e.g., "flow rate must be > X mL/min") or the reported device performance values (e.g., "observed flow rate was Y mL/min"). Therefore, I cannot construct the requested table or answer the specific questions about sample size, ground truth, expert involvement, or MRMC studies for performance metrics.

Based on the provided text, the following information is either not available or cannot be fully extracted:

1. A table of acceptance criteria and the reported device performance: Information about specific acceptance criteria (e.g., numerical thresholds for flow rate, friction, tensile strength) and the actual performance values obtained is not provided. The document only states compliance with standards.
2. Sample sizes used for the test set and the data provenance: This information is not provided in the summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not relevant for the type of device (urinary catheter) and the performance tests described (physical and biocompatibility). These tests do not involve expert interpretation of images or clinical data for ground truth establishment.
4. Adjudication method for the test set: Not applicable for empirical physical and biocompatibility testing.
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: This is not applicable as this is a medical device (urinary catheter), not an AI/software as a medical device for interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For physical and biological tests, "ground truth" would typically be established by validated test methods and reference standards, not expert consensus or pathology in the context of this device.
8. The sample size for the training set: Not applicable as this is not an AI/machine learning device requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) summary for a physical medical device (urinary catheter) and focuses on demonstrating substantial equivalence through compliance with recognized standards for physical and biocompatibility properties. It does not contain the detailed performance study results, acceptance criteria, or ground truth establishment relevant for AI-based or diagnostic devices.

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The Re-Trace Ureteral Access Sheath is used to establish a continuous conduit during urological endoscopic procedures facilitating the passage of endoscopes and other instruments into the urinary tract.

The Re-Trace Ureteral Access Sheath is comprised of the following components: Reinforced tube/sheath, Introducer/dilator, Connector, Clip. The reinforced introducer sheath is composed of a polyether block amide (PEBA) outer surface with a hydrophilic coating. The inner surface of the sheath is polytetralluoroethylene (PTFF). The sheath is reinforced with a stainless steel coil between the PEBA and PTFE materials. The distal tip of the sheath is fitted with a radiopaque ring. A white connector and orange clip is fitted on the proximal end of the sheath. The introducer/dilator is a radiopaque polyvinyl chloride (PVC). The introducer is fitted with a luer connector on the proximal end and has a hydrophilic coating on the distal end. A guidewire entry and exit eye and three exit holes for fluid delivery are located at the distal end of the introducer. A 4cm length Nitinol tube is inserted in the injection channel of the introducer to stiffen the guide wire exit eye section of this introducer.

The request concerns a 510(k) submission for the "Re-Trace Ureteral Access Sheath," focusing on modifications made to a previously cleared device. The provided text, however, details nonclinical (bench) testing and biocompatibility assessments, not a study evaluating device performance with human interaction or AI assistance. Therefore, many of the requested details about acceptance criteria, human study design, and AI elements are not present in the provided document.

Here's a breakdown of the information that can be extracted or inferred, and what cannot:

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

The document states that biocompatibility and performance testing were conducted, and the conclusions state that the modified device "is as safe and effective and performs as well as the predicate device." However, specific quantitative acceptance criteria or reported performance values for each test are not provided in the given text. The tests performed are listed as:

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

This information is not provided in the document, as the tests described are nonclinical (bench testing) and biocompatibility studies, not human clinical trials.

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)

This information is not applicable as the document describes nonclinical testing, not studies requiring expert interpretation or ground truth establishment.

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

This information is not applicable as the document describes nonclinical testing.

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

This information is not applicable. The device is a ureteral access sheath, a physical medical device, not an AI-powered diagnostic tool or system that would involve human readers or AI assistance.

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

This information is not applicable as the device is not an algorithm.

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

For the nonclinical tests described, the "ground truth" would be established by objective physical and chemical measurements and standard protocols for biocompatibility testing, rather than expert consensus, pathology, or outcomes data typically associated with clinical studies of diagnostic or prognostic devices.

8. The sample size for the training set

This information is not applicable as the device is not an AI algorithm requiring a training set.

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

This information is not applicable as the device is not an AI algorithm requiring a training set.

In summary, the provided document details a 510(k) submission for a modified physical medical device (Ureteral Access Sheath). The "study" referenced is a series of nonclinical bench tests and biocompatibility tests designed to demonstrate substantial equivalence to a predicate device. It does not involve human subjects, AI, or expert adjudication in the context of the requested questions.

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