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V-Loc™ 90 Absorbable Wound Closure Device is indicated for soft tissue approximation where use of an absorbable suture is appropriate.

The V-Loc™ 90 Absorbable Wound Closure Device is a suture prepared from a synthetic polyester (Glycomer™ 631) composed of glycolide, dioxanone and trimethylene carbonate. Each device has unidirectional barbs along the axis of the monofilament. The V-Loc™ 90 Absorbable Wound Closure Device will be offered both Undyed (clear) and Dyed with D&C Violet No. 2 at a level not exceeding 0.2% by weight of the suture in sizes U.S.P. (EP) 4-0 (Metric 2.0) 3-0 (Metric 3), 2-0 (Metric 3.5) and 0 (Metric 4). They will be supplied in pre-cut lengths affixed to various needle types.

Here's a breakdown of the acceptance criteria and study information for the V-Loc™ 90 Absorbable Wound Closure Device, based on the provided text:

Acceptance Criteria and Device Performance

The provided text details performance evaluations rather than explicitly stating pre-defined "acceptance criteria" with numerical targets. However, the "Results" section indicates the device passed these evaluations by performing comparably to predicate devices or meeting specific standards.

Table 1: Acceptance Criteria and Reported Device Performance

Study Details

2. Sample Size and Data Provenance

• Test Set Sample Size: Not explicitly stated as a number of devices or animals.
  • For in-vitro tests, the sample size is also not specified.
  • For the porcine model, it states "Chronic 21 day study." The number of animals used is not provided.
  • For the rat model, it states "degradation over 2 weeks." The number of animals used is not provided.
• Data Provenance: The studies were conducted by Surgical Devices, a global business unit of Tyco Healthcare Group LP (d/b/a Covidien) based in North Haven, CT, USA. The studies themselves are likely proprietary data generated specifically for this 510(k) submission. Therefore, it is prospective data for the purpose of demonstrating device performance. The country of origin of the data generation is implied to be within the US or a facility controlled by the US-based company.

3. Number of Experts and Qualifications for Ground Truth

• The document does not mention the use of external experts to establish ground truth for the test set. Performance data appears to be derived from direct physical testing (bench) and biological observation/measurement (animal models) rather than expert interpretation of images or other qualitative data requiring consensus.

4. Adjudication Method for the Test Set

• None explicitly stated. The evaluations are quantitative (e.g., tensile strength, pull force, degradation percentage) based on direct measurement, not on a subjective assessment that would typically require adjudication.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices where human interpretation is a key component. This device is a surgical suture, and its performance is evaluated through physical and biological property testing.

6. Standalone (Algorithm Only) Performance

• No, a standalone (algorithm only) performance study was not done. This device is a physical medical device (suture), not an AI algorithm.

7. Type of Ground Truth Used

• The ground truth used is primarily based on:
  • Direct Physical Measurements/Specifications: For in-vitro tests such as needle attachment (USP/EP specification), diameter (USP/EP), tensile strength, and barb holding strength.
  • Biomechanical Measurements: For in-vivo studies, such as pull force (to assess strength) in the porcine model and knot pull strength in the rat model. This involves objective quantitative data.
  • Comparison to Predicate Devices: Performance is often assessed relative to the behavior of established predicate devices (e.g., Quill™ SRS MONODERM, Biosyn™ suture).

8. Sample Size for the Training Set

• Not Applicable. The V-Loc™ 90 Absorbable Wound Closure Device is a physical medical device, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The device design and manufacturing process would be informed by general engineering principles and material science, not a data-driven training set.

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

• Not Applicable. As there is no training set for an AI/ML algorithm, there is no ground truth established for it. The device's characteristics are inherent to its design, materials, and manufacturing, which are validated through the performance tests described.

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The Auto Suture™ ENDO CLIP™ III 5mm Clip Applier is primarily indicated for patients undergoing laparoscopic surgical procedures involving dissection and occlusion of blood vessels, ducts and other tubular structures, and for radiographic marking.

The Auto Suture™ ENDO CLIP™ III 5mm Clip Applier contains 16 titanium clips. The applier is designed for introduction and use through an appropriately sized trocar sleeve, or larger with the use of a converter. The ENDO CLIP™ III 5mm Clip Applier consists of a trigger handle, shaft rotation knob, clip counter window and a 33 cm shaft with jaws at its distal end. Squeezing the handle places a titanium clip in the jaws and closes the jaws to close the clip on the vessel or structure.

The provided text is a 510(k) summary for the "Auto Suture™ ENDO CLIP™ III 5mm Clip Applier," a surgical device. It does not describe a study involving an algorithm or AI. Therefore, I cannot extract information related to acceptance criteria and device performance in the context of an AI/algorithm-based device.

The document discusses:

• The device's intended use (occlusion of blood vessels, ducts, and other tubular structures during laparoscopic surgery).
• Its technological characteristics (identical to predicate devices).
• Materials used (biocompatible).
• Performance data states that "In-vitro and in-vivo tests were performed to verify that the ENDO CLIP™ III 5mm Clip Applier was substantially equivalent to the predicate devices in occluding vessels and other tubular structures and to validate that the ENDO CLIP™ III 5mm Clip Applier performed as intended."

However, this paragraph does not provide any specific acceptance criteria (numerical thresholds) or reported device performance metrics (e.g., success rates, occlusion strength, or specific measurements) that could be tabulated. It only broadly states that tests were performed to demonstrate substantial equivalence and intended performance.

Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance, nor can I answer the questions about sample sizes, ground truth establishment, expert involvement, or MRMC studies, as these relate to the evaluation of an AI/algorithm, which is not the subject of this document.

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V-Loc™ 180 absorbable wound closure devices are indicated for soft tissue approximation where use of an absorbable suture is appropriate.

The V-Loc™ 180 absorbable wound closure device (Size 4-0) is prepared from a copolymer of glycolic acid and trimethylene carbonate. The absorbable wound closure device is available clear or green. The device is sterile, inert, noncollagenous and nonantigenic.

The provided text is a 510(k) summary for the V-Loc™ 180 Absorbable Wound Closure Device. This type of submission is for medical devices and typically does not involve studies with human readers, AI assistance, or complex ground truth establishment as seen in diagnostic imaging AI/ML device submissions. Instead, it focuses on demonstrating substantial equivalence to a predicate device through performance testing (in vitro and in vivo), material characterization, and compliance with standards.

Therefore, many of the requested fields (2, 3, 4, 5, 6, 7, 8, 9) are not applicable to the information provided in this 510(k) summary.

Here's an analysis based on the provided document:

Acceptance Criteria and Reported Device Performance

The document states that "Performance testing (in vitro and in vivo) was conducted to verify that the V-Loc™ 180 Absorbable Wound Closure Device (Size 4-0) is safe and effective and performs as intended." However, it does not explicitly list specific numerical acceptance criteria or the detailed reported device performance in a table format. For 510(k) submissions, the “acceptance criteria” are generally met by demonstrating that the new device is substantially equivalent to a legally marketed predicate device, and the performance testing supports this claim of equivalence.

Table 1: Acceptance Criteria and Reported Device Performance (Inferred)

Study Details

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

   • The document mentions "Performance testing (in vitro and in vivo)" but does not specify sample sizes for these tests, nor does it provide details on data provenance (country, retrospective/prospective). For this type of device, "in vivo" testing typically refers to animal studies rather than human clinical trials for a 510(k).

2. 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. This is a medical device (suture) submission, not an AI/ML diagnostic device requiring expert interpretation for ground truth.

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

   • Not applicable.

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:

   • Not applicable. This device is an absorbable suture, not an AI-assisted diagnostic tool.

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

   • Not applicable. This is not an AI/ML algorithm.

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

   • For a suture device, "ground truth" would be established through physical and mechanical characterization (e.g., tensile strength, degradation rates) and biological response studies (e.g., biocompatibility) rather than expert consensus on images or pathology. The document indicates that materials were evaluated per ISO 10993-1, which provides standards for biological evaluation.

7. The sample size for the training set:

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

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

   • Not applicable.

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The Autosuture™ Endo GIA™ Staplers with Endo GIA™ Single Use Reloads have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures.

This 510(k) shall describe a new Reload cartridge with Tri-Staple™ technology for use with the currently marketed Autosuture™ Endo GIA™ Stapler as described in the predicate submission K083519. The black Reload bears the identical design characteristics as the Reloads with Tri-Staple™ Technology described in the predicate submission with the exception that the staples sizes shall be 4.0, 4.5, and 5.0 mm for use in extra thick tissue. The black Reloads shall be made available in 45 mm and 60 mm lengths.

The provided text describes a 510(k) submission for a surgical stapler reload, the "Autosuture™ Endo GIA™ Single Use Black Reload with Tri-Staple™ Technology." The submission focuses on demonstrating substantial equivalence to predicate devices, rather than a clinical study evaluating AI performance. Therefore, many of the requested elements for AI model evaluation are not present in this document.

However, I can extract information related to the acceptance criteria and the general study type from the provided text for this medical device (not an AI device).

Acceptance Criteria and Device Performance

The document does not explicitly state quantitative acceptance criteria in a table format common for AI models (e.g., specific sensitivity, specificity, or AUC thresholds). Instead, for this surgical device, the acceptance criteria are implicitly tied to demonstrating substantial equivalence to predicate devices and acceptable performance in bench and in-vivo evaluations. The primary performance goals are safety and effectiveness when used as intended, and functional equivalence to the predicate.

The table below summarizes the closest information available regarding acceptance aspects and reported performance, framed within the context of a medical device submission:

Study Information (Based on provided text)

Given that this is a 510(k) summary for a surgical stapler reload and not an AI device, the following points address the requested information as much as possible, or explain why it is not applicable or available in the provided document:

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

   • The document states "Bench and in-vivo performance evaluations were conducted."
   • Bench Test Sample Size: Not specified in the summary document. Bench tests typically involve a controlled number of samples to assess mechanical properties and function.
   • In-vivo Test Sample Size: Not specified in the summary document. In-vivo studies typically involve animal models or, less commonly for 510(k)s, human subjects. The details of these studies are not provided.
   • Data Provenance: Not specified in the summary document. Such details (country, retrospective/prospective) are not typically included in a 510(k) summary for bench or in-vivo non-human studies.

2. 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):

   • N/A. For this type of surgical device performance study, "ground truth" is typically established through direct measurement (e.g., staple formation, tissue integrity) in bench testing and observational outcomes in in-vivo studies, rather than expert consensus on diagnostic images. No information on experts establishing ground truth is provided.

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

   • N/A. This concept is primarily relevant for studies involving human interpretation (e.g., radiology reads) where disagreements need resolution. It is not applicable to the bench and in-vivo performance evaluations described for this surgical stapler reload.

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:

   • N/A. This is a medical device, not an AI device. No MRMC study was conducted, as there is no AI component or human reader interpretation involved in its intended use.

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

   • N/A. This is a physical surgical device, not an algorithm. Its performance is inherent to its mechanical function, not an algorithm.

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

   • For Bench Tests: Ground truth would likely be based on engineering specifications, mechanical measurements (e.g., staple leg formation, closure height, bursting pressure for anastomoses), and visual inspection for proper function.
   • For In-vivo Tests: Ground truth would include direct observation of surgical outcomes, tissue healing, absence of leaks or bleeding, and potentially histological analysis of stapled tissue, as applicable to animal models.
   • The document does not detail the specific ground truth metrics beyond generally stating "safe and effective and performs as intended."

7. The sample size for the training set:

   • N/A. This is a medical device, not an AI model. There is no concept of a "training set" in the context of this 510(k) submission.

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

   • N/A. Not an AI model; thus, no training set or associated ground truth establishment process for a training set.

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V-Loc™ 180 absorbable wound closure devices are indicated for soft tissue approximation where use of an absorbable suture is appropriate.

The V-Loc™ 180 absorbable wound closure device is prepared from a copolymer of glycolic acid and trimethylene carbonate. The absorbable wound closure device is available clear or green. The device is sterile, inert, noncollagenous and nonantigenic.

This document is a 510(k) summary for a medical device called the "V-Loc™ 180 Absorbable Wound Closure Device." It outlines the device's description, intended use, and its substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

The 510(k) summary explicitly states: "Performance testing is not applicable as there has been no change to the V-Loc™ 180 absorbable wound closure device." This means there was no new performance study conducted with a test set for this 510(k) submission. The device's approval is based on its substantial equivalence to a predicate device (K082662 - V-loc™ 180 Absorbable Wound). Therefore, information on sample size, test set data provenance, and ground truth for a new test set is not provided in this document.

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

Not applicable, as no new performance study with a test set was conducted for this 510(k). The device's performance relies on the previous evaluation of the identical predicate device.

4. Adjudication Method for the Test Set

Not applicable, as no new performance study with a test set was conducted for this 510(k).

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

No, an MRMC comparative effectiveness study was not done as part of this 510(k) submission. The FDA clearance is based on substantial equivalence, not a comparative effectiveness study showing improvement with AI.

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

Not applicable. This device is a physical wound closure device, not an AI algorithm, so the concept of standalone performance for an algorithm is irrelevant here.

7. Type of Ground Truth Used

Not explicitly stated for this 510(k). The device's performance is established by its identity to a predicate device, which would have undergone its own testing and established its efficacy through appropriate methods (e.g., in vitro, in vivo, or clinical studies) prior to its own approval. The biocompatibility for the materials was evaluated against ISO 10993-1:2003.

8. Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI algorithm requiring a training set.

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

Not applicable, as this is a physical medical device, not an AI algorithm.

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V-Loc™ 180 Absorbable Wound Closure Device is indicated for soft tissue approximation in where use of an absorbable suture is appropriate.

The V-Loc ™ 180 Absorbable Wound Closure Device is a suture prepared from a copolymer of glycolic acid and trimethylene carbonate. Each device has unidirectional barbs along the axis of the monofilament. The V-Loc ™ 180 Absorbable Wound Closure Device will be offered dyed with D&C Green No. 6 (21 CFR 74.3206) or clear (undyed) in sizes USP (EP) 2-0 (Metric 3), 0 (Metric 3.5) and 1 (Metric 4). They will be supplied in pre-cut lengths affixed to various needle types.

The input document is a 510(k) summary for the V-Loc™ 180 Absorbable Wound Closure Device. This document does not describe the acceptance criteria or results of a study in the format requested. It is a regulatory submission outlining the device description, indications, and substantial equivalence to predicate devices, but lacks detailed performance data with specific acceptance criteria and study results. Therefore, I cannot generate the requested table and answer the study-related questions based on the provided text.

Specifically, the "Performance Data" section merely states: "Performance testing was conducted to verify that the V-Loc™ 180 Absorbable Wound Closure Device is safe and effective and performs as intended." This general statement does not provide the specific metrics, criteria, or study outcomes needed to answer your request.

To fulfill your request, I would need a document that includes:

• A table or section explicitly listing acceptance criteria for various performance metrics (e.g., tensile strength, absorption rate, knot security, biocompatibility).
• Detailed results of the studies performed to demonstrate compliance with these criteria.
• Information on sample sizes, data provenance, ground truth establishment, expert qualifications, and study designs (e.g., standalone, MRMC) if applicable.

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The Autosuture™ ENDO GIA™ Staplers with ENDO GIA™ Single Use Loading Units with Staple Line Reinforcement have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and billary structures.

The Autosuture™ ENDO GIA™ Staplers with ENDO GIA™ Single Use Loading Units with Staple Line Reinforcement place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples is determined by the selection of the 3.5 mm or 4.8 mm Single Use Loading Unit (SULU). The ENDO GIA™ UNIVERSAL Single Use Loading Units (SULUs) with Staple Line Reinforcement are only available in the straight and articulating 45 mm and 60 mm length cartridges with the 3.5 mm or 4.8 mm staples. The staple line reinforcement material is a synthetic absorbable film prepared from synthetic polyester composed of glycolide, dioxanone, and trimethylene carbonate. The staple line reinforcement material is supplied on each SULU undyed (natural) and is secured to the anvil and cartridge with BIOSYN™ synthetic absorbable suture. Studies indicate that the staple line reinforcement material can be expected to retain measurable mechanical strength through 14 days and absorption should be complete between 90 and 110 days.

The provided text describes a 510(k) summary for the Autosuture™ ENDO GIA™ Surgical Staplers with ENDO GIA™ Single Use Loading Units with Staple Line Reinforcement. However, it does not include information about specific acceptance criteria or an explicit study that proves the device meets those criteria in the context of a typical AI/software device evaluation.

The document mainly focuses on the device description, intended use, technological characteristics, and material safety. It states: "Performance evaluations were completed to verify that the Autosuture™ ENDO GIA™ Staplers with ENDO GIA™ Single Use Loading Units with Staple Line Reinforcement are safe and effective and perform as intended." This is a general statement and does not provide the detailed information requested regarding specific acceptance criteria, study design, sample sizes, ground truth establishment, or expert involvement, which are typical for studies assessing AI device performance.

Therefore, I cannot provide the requested information from the given text. The text does not contain:

1. A table of acceptance criteria and reported device performance: No specific performance metrics or acceptance thresholds are listed.
2. Sample size used for the test set and data provenance: No information on the number of cases or the origin of data used for performance evaluation.
3. Number of experts used to establish ground truth and their qualifications: No mention of expert involvement in establishing ground truth.
4. Adjudication method for the test set: Not applicable as no ground truth creation process is described.
5. MRMC comparative effectiveness study: The document does not describe a study involving human readers with or without AI assistance.
6. Standalone (algorithm only) performance: This device is a surgical stapler, not an AI algorithm, so standalone algorithm performance is not applicable in the usual sense. Its performance is inherent to its mechanical function and material properties.
7. Type of ground truth used: Not applicable as it's a physical device and not an AI interpreting data. The "ground truth" for a physical device would relate to its mechanical integrity and biological interaction, which is assessed through various engineering and biocompatibility tests.
8. Sample size for the training set: Not applicable as this is a physical device, not an AI system that requires a training set.
9. How the ground truth for the training set was established: Not applicable for the same reason.

The "performance evaluations" mentioned in the document likely refer to laboratory testing, mechanical robustness tests, biocompatibility assessments, and potentially animal studies, which are standard for surgical devices, rather than clinical studies involving human readers or AI algorithms that would generate the kind of data you're asking for.

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COPA AMD dressings are indicated for use in management of post-surgical incisions, pressure sores, venous stasis ulcers, diabetic ulcers, donor sites, abrasions, 1st and 200 degree burns, dermatologic disorders, other wounds inflicted by trauma and, as a secondary dressing or cover dressing for packed wounds.

COPA AMD is a hydrophilic polyurethane foam that is impregnated with Polyhexamethylene Biguanide Hydrochloride (PHMB), an antimicrobial agent that protects the dressing from bacterial penetration and colonization.

The provided text from the 510(k) Premarket Notification for the COPA AMD Antimicrobial Wound Dressing describes performance data related to its antimicrobial properties. The information pertains to the device's ability to prevent bacterial penetration and colonization.

Here's a breakdown of the requested information based on the provided text:

1. Table of acceptance criteria and the reported device performance

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

• Sample size: Not explicitly stated in terms of the number of unique dressings or tests. The tests were performed in-vitro and an animal testing was also mentioned.
• Data provenance: The tests were described as "in-vitro and animal testing," indicating laboratory and possibly animal model experiments. The country of origin for these tests is not specified, but the submission is to the US FDA.

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

Not applicable. The performance data is based on laboratory (in-vitro) and animal testing, which typically relies on established microbiological and scientific protocols rather than expert consensus on subjective observations.

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

Not applicable. This type of adjudication is relevant for studies involving human interpretation (e.g., image reading), not for laboratory or animal testing results.

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 a wound dressing, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.

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

Not applicable. This device is a physical wound dressing and does not involve an algorithm or AI.

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

The ground truth was established through microbiological assays (quantifying bacterial kill) for the in-vitro tests and likely biological endpoints related to infection or wound healing for the animal testing.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a training set. The "testing" referred to is for device performance, not algorithm training.

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

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

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The proposed catheters are intended for use in the drainage/collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgical or post-surgical intervals. General drainage is accomplished by inserting the catheter through the urethra and into the urine bladder. The catheter is retained in the bladder by inflation of balloon. Drainage is sometimes accomplished by suprapubic or other placement of the catheter, such as a nephrostomy tract.

Not Found

Please note that the provided document is a 510(k) clearance letter from the FDA for a medical device (a Foley catheter with a temperature sensor). This type of document does not contain the detailed study information, acceptance criteria, or performance metrics that would be generated by a clinical or performance study.

The FDA 510(k) process is primarily about demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel performance against specific acceptance criteria. Therefore, most of the requested information regarding study details, ground truth, and sample sizes will not be present in this document.

However, I can extract the following relevant information and explain why other requested details are not available:

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

This document does not specify quantitative acceptance criteria or detailed reported device performance in this format. The FDA 510(k) clearance process focuses on demonstrating substantial equivalence to a predicate device. This typically involves showing that the new device has the same design, materials, and intended use, and performs as safely and effectively as the predicate. Performance data, if submitted, would be intended to support this equivalence, not necessarily to meet pre-defined, publicly disclosed acceptance criteria in the manner one might find for a novel drug or a high-risk device requiring a PMA.

The closest to "performance" mentioned is in the "Indications for Use" section (Page 3), which states: "The proposed catheters are intended for use in the drainage/collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgical or post-surgical intervals." This is a statement of intended function, not a quantitative performance metric.

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

This information is not available in the provided document. The 510(k) clearance letter itself does not include details about specific test set sample sizes or data provenance. Such information would be part of the predicate device's historical data or a new device's performance testing reports, which are part of the full 510(k) submission, but not typically summarized in the clearance letter.

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 and therefore not available in the provided document. This device is a physical medical device (Foley catheter with temperature sensor), not an AI or diagnostic imaging device that would require expert-established ground truth for a test set. Its performance relies on physical specifications, material compatibility, and temperature sensing accuracy, not on interpretations of complex data by experts.

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

This information is not applicable and therefore not available. Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective interpretation, often in diagnostic imaging or clinical trials where multiple experts assess the same cases. This is not relevant for a physical device like a Foley catheter.

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 and therefore not available. An MRMC study is relevant for diagnostic performance, particularly with AI assistance, where different readers analyze cases. This device is a physical catheter, not an AI diagnostic tool.

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

This information is not applicable and therefore not available. A "standalone algorithm" is not relevant for a physical medical device like a Foley catheter.

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

Again, the concept of "ground truth" as it applies to AI diagnostics or complex clinical endpoints is not directly applicable to this device in the context of this 510(k) letter. For a Foley catheter with a temperature sensor, "ground truth" would be related to:

• Physical measurements: Accuracy of the temperature sensor against a calibrated standard.
• Biocompatibility: In vitro and in vivo testing for material safety.
• Mechanical integrity: Tensile strength, balloon inflation/deflation, tip integrity, etc.
• Sterility: Confirmation of sterility.
  These types of "ground truth" are established through engineering testing, laboratory standards, and biocompatibility assessments, not typically through expert consensus on clinical cases or pathology. The document does not detail these specific test methods or their "ground truth" establishment.

8. The sample size for the training set

This information is not available in the provided document and likely not applicable in the context of this device. Training sets are relevant for machine learning algorithms. This device is a conventional medical device, not an AI/ML product.

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

This information is not applicable and therefore not available, for the same reasons as point 8.

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The Kendall Antimicrobial Drain Dressing is intended for OTC use. It is used as a primary dressing around drains, IV sites, and tracheotomies.

The Kendall Antimicrobial Drain Dressing for OTC use is a sterile, single use wound dressing consisting of a rayon/polyester nonwoven material treated with polyhexamethylene biguanide hydrochloride (0.2%), and is available in sponge form.

I am sorry, but without a dedicated study section detailing acceptance criteria and performance results, I cannot fulfill your request for a table of acceptance criteria and reported device performance.

The provided text {0}-{4} is a 510(k) summary for a medical device (Kendall Antimicrobial Drain Dressing). It focuses on demonstrating substantial equivalence to a predicate device for OTC marketing, not on establishing specific performance criteria for the new device.

Here's what I can extract based on the provided text, and why I cannot complete most of your request:

• No specific acceptance criteria or quantitative performance measures are mentioned for the Kendall Antimicrobial Drain Dressing itself. The document primarily asserts "substantial equivalence" to a predicate device.
• No new study is described to "prove the device meets acceptance criteria." Instead, it references prior biocompatibility testing of the predicate device and states the current device "is identical to the predicate device with the exception of OTC labeling."

Therefore, I cannot provide:

1. A table of acceptance criteria and reported device performance. No such criteria or performance data for this specific device are presented.
2. Sample size used for the test set and data provenance. No new test set or study for this device's performance is detailed.
3. Number of experts used, qualifications, or adjudication method for ground truth for a test set. Not applicable, as no new performance study is described.
4. MRMC comparative effectiveness study or human reader improvement. This type of study is not relevant to a drain dressing and is not mentioned.
5. Standalone (algorithm only) performance. The device is a physical dressing, not an algorithm.
6. Type of ground truth used. Not applicable, as no new performance study is described.
7. Sample size for the training set. Not applicable, as no training set for an algorithm is involved.
8. How ground truth for the training set was established. Not applicable.

The closest information provided related to testing is in section 7:

• "Biocompatibility testing of the predicate Kendall Excilon AMD Antimicrobial Drain Sponge, (predicate device), has demonstrated that it meets the requirements of guidelines presented in the 10993 ISO Standard, Part 1, with the FDA modified matrix presented in memorandum G95-1."
  • This indicates that the predicate device met certain biocompatibility standards.
  • It does not provide specific acceptance criteria values or detailed performance results for this new device.

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