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Luja Coudé is indicated for use by patients with urine retention and patients with 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 product is for male patients only (adults and pediatric above the age of 1 years).

The Luja Coude is a single-use, sterile, hydrophilic coated catheter for intermittent urinary catheterization. The catheter has a flexible tip which contains several small holes (micro holes) by the tip creating a drainage zone which allows the urine to flow from the bladder through the catheter. The drainage end of the device has an outlet to which a urine bag with a suitable connector can be connected. The catheter also contains a hydrophilic-coating and is sterilized by irradiation.

The primary packaging provides the sterile barrier and contains a proof of seal for identification of opened products.

The Luja Coude is available in one length (33cm) with a flexible tip and diameters of 8 Fr, 10 Fr, 12 Fr, 14 Fr, 16 Fr, and 18 Fr.

The provided FDA 510(k) clearance letter and supporting Traditional 510(k) summary pertain to a urological catheter (Luja Coudé) and its substantial equivalence to a predicate device. This document focuses on the mechanical and material properties of the catheter, not on an AI/software as a medical device (SaMD) or diagnostic imaging device.

Therefore, many of the requested details, such as MRMC comparative effectiveness studies, standalone algorithm performance, AI training/test sets, expert ground truth establishment, and complex adjudication methods, are not applicable to this type of medical device submission. These elements are typically required for AI/ML-based diagnostic devices where performance is measured in terms of diagnostic accuracy (e.g., sensitivity, specificity, AUC) and reader improvement.

The provided information focuses on bench testing (non-clinical performance) to demonstrate the device's physical and biological properties meet established standards and are equivalent to the predicate.

Here's an analysis of the provided text in relation to your questions, highlighting what is available and what is not:

Analysis of Acceptance Criteria and Study Proof for Luja Coudé Catheter

Based on the provided FDA 510(k) clearance letter and Traditional 510(k) summary, the Luja Coudé catheter demonstrates its performance through non-clinical (bench) testing and biocompatibility assessments, rather than clinical studies or AI/ML performance evaluations involving human readers.

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "Biocompatibility and bench performance testing were conducted to verify the proposed subject devices with modified hydrophilic coating met the pre-determined acceptance criteria per specified requirements." It also states, "The subject devices met the pre-determined acceptance criteria after simulated shipping distribution and aging cycle per specified performance requirements."

However, the specific numerical acceptance criteria or the exact reported performance values are not detailed in this public summary. Instead, the summary lists the tests conducted and confirms that the device met the criteria.

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

• Sample Size for Test Set: The document does not specify exact sample sizes for each non-clinical test (e.g., number of catheters tested for friction, kink, etc.). It only states that "Testing was performed on final, finished, and sterilized devices." This is typical for bench testing where the number of units tested is governed by standard protocols (e.g., ISO, ASTM, internal methods) to achieve statistical confidence for manufacturing and design verification, but individual numbers are not usually disclosed in 510(k) summaries unless a specific, novel statistical method for performance testing is employed.
• Data Provenance: The studies are "non-clinical" (bench testing). Therefore, concepts like "country of origin of the data" or "retrospective/prospective" studies do not apply in the context of human subject data. The device is manufactured by Coloplast A/S in Humlebæk, Denmark, and the tests would have been performed in a controlled laboratory environment.

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

• Not Applicable. For this type of device (a physical urological catheter), "ground truth" is established through physical measurements, chemical analysis, and standardized biological assessments in a lab setting, not by human experts interpreting clinical data (like radiologists interpreting images). The "experts" involved would be engineers, material scientists, and microbiologists conducting the tests.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication methods (e.g., 2+1, 3+1) are used to resolve discrepancies among human readers/experts in diagnostic studies, typically for AI/ML device validation. This is not relevant for the bench testing of a physical catheter.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

• No. An MRMC study is relevant for AI/ML-driven diagnostic devices where the AI assists human readers. This device is a physical medical instrument, not an AI diagnostic tool.

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

• No. This question applies to AI algorithms. The Luja Coudé is a physical catheter designed for direct patient use via insertion, not an algorithm.

7. The Type of Ground Truth Used

• For this device, the "ground truth" is based on:
  • Standardized Bench Test Measurements: Objective physical properties (e.g., friction coefficients, kink resistance, dimensions, pH, osmolality) measured against international and proprietary Coloplast standards (ISO 20696, Coloplast TMs).
  • Biocompatibility Testing: Laboratory assays and in-vivo animal models (for systemic toxicity, irritation, sensitization) that demonstrate the material's safety in a biological environment, conforming to ISO 10993 standards.
  • Sterility Assurance Level (SAL): Defined by microbial inactivation standards (SAL 10⁻⁶).

8. The Sample Size for the Training Set

• Not Applicable. The concept of a "training set" is for AI/ML models. This device does not use an AI/ML model. The design and manufacturing process for the catheter would involve extensive development and testing, but not in the sense of an "AI training set."

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

• Not Applicable. As there is no AI training set, there is no ground truth to establish for it. The development of the catheter relies on established engineering principles, material science, and manufacturing quality control.

Summary: The provided document is a 510(k) summary for a physical medical device (catheter) that relies on non-clinical bench testing and biocompatibility assessments to demonstrate substantial equivalence and safety/effectiveness. It does not involve AI/ML technology or human reader studies. Therefore, many of the questions related to AI/ML device validation are not applicable.

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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 a sterile, single use device that is inserted over a guidewire into the upper or lower urinary tract of patients requiring ureteroscopic procedure sin a hospital environment. The ReTrace Ureteral Access Sheath consists of:

• 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 is fitted on the proximal end of the sheath and an orange connector is on the proximal end of the introducer to allow the two components to be attached.

The dilator 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. The dilator protrudes out the distal end and allows for a gradual enlargement of the passage if needed and improves trackability along the guidewire. Once in the desired location, the dilator is removed to establish a hollow conduit for insertion of endoscopes and other instruments into and out of the urinary tract.

The ReTrace Ureteral Access Sheaths are available in two diameters 10/12 Fr and 12/14 Fr. Lengths range between 28 and 55 cm.

This submission is for modifications to device materials, labeling, packaging, and connector design.

Here's a breakdown of the acceptance criteria and study information based solely on the provided text.

Crucial Note: The provided document is a 510(k) summary for a medical device (Ureteral Access Sheath) that underwent modifications. This means the primary argument for clearance is substantial equivalence to a previously cleared predicate device, rather than proving efficacy from scratch with a new device. Therefore, the details requested in your prompt regarding AI/ML models (e.g., training/test sets, human reader studies, ground truth establishment by experts) are generally not applicable to this type of device clearance. The performance data focuses on demonstrating that the modifications do not negatively impact the device's basic safety and function compared to the original cleared version.

Acceptance Criteria and Reported Device Performance

Given this is a 510(k) for a modified device, the "acceptance criteria" are implicitly that the modified device performs comparably to the predicate device in relevant mechanical, biocompatibility, and sterilization tests, and the modifications do not raise new questions of safety or effectiveness. The reported performance is that the device met these criteria.

Study Details (Based on Provided Text)

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

   • Sample Size: Not explicitly stated as a number of devices for each test. The document lists types of mechanical tests performed (e.g., tensile strength, friction tests) which implicitly involve testing multiple samples, but the exact quantity is not given.
   • Data Provenance: Not specified regarding country of origin. The studies are non-clinical testing (mechanical, biocompatibility, sterilization, packaging) and not human subject data. Thus, the concept of "retrospective or prospective" human data does not apply here.

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

   • Not Applicable. This document describes the clearance of a physical medical device (Ureteral Access Sheath) through non-clinical performance testing for substantial equivalence after modifications. It is not an AI/ML device that requires expert-established ground truth for a test set. The "ground truth" for these tests is defined by the technical specifications, standards (like ISO 10993-1), and acceptable performance parameters for the device.

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

   • Not Applicable. Again, this pertains to expert review of data, typically in AI/ML performance studies. Here, the "adjudication" is whether the device passed specific engineering and performance tests, which would be determined by laboratory results and quality system procedures, not expert consensus on ambiguous data.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No. This type of study (MRMC, human readers with/without AI) is specifically for AI-powered diagnostic/interpretive devices. The Retrace Ureteral Access Sheath is a physical, mechanical medical device.

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

   • Not Applicable. This is a physical medical device, not an algorithm.

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

   • The "ground truth" for this device's performance testing is defined by engineering specifications, industry standards (e.g., ISO 10993-1), and established test methodologies to ensure the device's physical and functional properties meet design requirements and maintain equivalency to the predicate device.

7. The sample size for the training set:

   • Not Applicable. This is not an AI/ML device with a training set.

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

   • Not Applicable. As above, no training set for an AI/ML model.

Summary of why AI/ML related questions are not addressed:

The provided text is a 510(k) summary for a physical, mechanical medical device (a Ureteral Access Sheath) that underwent modifications. The FDA clearance pathway for such devices, especially when arguing substantial equivalence, relies heavily on non-clinical performance testing (biocompatibility, mechanical integrity, sterilization validation, packaging) to demonstrate that the device is as safe and effective as a legally marketed predicate device. It does not involve AI/ML components, diagnostic interpretation, or human reader studies. Therefore, many of the questions asked in your prompt are not relevant to the content of this specific FDA submission.

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The product is indicated for use on moderate to highly exuding acute and chronic wounds such as:

• · Diabetic ulcers
• · Leg ulcers (arterial ulcers, venous ulcers and leg ulcers of mixed etiology)
• · Pressure injuries (stage 2-4)
• Traumatic wounds
• · Partial thickness (second degree) burns
• · Donor sites
• · Post-operative surgical wounds
• · Exudate absorption in oncology wounds, such as fungoides-cutaneous tumors, fungating carcinoma, cutaneous metastasis, Kaposi's sarcoma, and angiosarcoma

Biatain Fiber Ag is a soft, sterile, primary wound dressing made mainly from non-woven gelling carboxymethyl cellulose (CMC) fibers. In addition, non-gelling bicomponent (BiCo) fibers are incorporated to obtain strength and integrity of the products both in dry and gelled condition. Ionic silver (Ag+) is added for antimicrobial efficacy within the dressing, and ethyl lauroyl arginate (LAE) is added as combined surfactant and chelator within the dressing.

The provided text is a 510(k) summary for the Biatain Fiber Ag wound dressing. This document describes the device, its indications for use, comparison with a predicate device, and performance data to support its substantial equivalence. However, it does not contain information about an AI/ML-enabled medical device study, nor does it describe acceptance criteria and performance in the context of AI/ML algorithms.

Therefore, I cannot provide details on the following, as they are not present in the document:

• A table of acceptance criteria and reported device performance related to AI/ML.
• Sample size used for the test set and data provenance.
• Number of experts and their qualifications for ground truth.
• Adjudication method for the test set.
• MRMC comparative effectiveness study or human reader improvement with AI.
• Standalone algorithm performance.
• Type of ground truth used for AI/ML.
• Sample size for the training set.
• How ground truth for the training set was established.

Instead, the document details the performance data for a traditional wound dressing:

1. Performance Data Provided (Related to a traditional wound dressing):

Summary of Device and Study Type:

The document describes performance data for the Biatain Fiber Ag, which is a wound dressing, not an AI/ML device. The studies listed are standard performance tests for such a product to demonstrate its safety and effectiveness in its intended use, particularly for absorbency, wet strength, and antimicrobial properties.

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The catheter 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 product is for male patients only.

The SpeediCath Flex Coudé catheter is a sterile single use hydrophilic coated polyurethane catheter for men. The catheter is to be used for intermittent drainage of the bladder through the urethra by males with missing or reduced bladder control. The catheter has a flexible bendable tip that facilitates passage through the urethra to the bladder. The catheter is shielded by a sleeve, which serves as protection from the user's touch during insertion.

Here is an analysis of the provided FDA document regarding the SpeediCath Flex Coudé device, focusing on acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

   Acceptance Criteria / Performance Aspect	Reported Device Performance
   Bench Testing
   Flow rate	Passed (according to EN1616/EN1618 & ASTM F623-99:2013)
   Coefficient of friction	Passed (according to ASTM D1894:2014)
   Tensile strength	Passed (according to EN1616/EN1618)
   Connector security	Passed (according to EN1616)
   Biocompatibility	Passed (according to ISO 10993-1 and applicable parts of FDA Blue Book Memorandum #G95-1)
   Clinical Performance (Cadaver Study)
   Insertion & navigation in difficult male urethral anatomies	Comparable to a standard coudé catheter in terms of insertion and navigation through difficult male anatomies (enlarged prostate and strictures). Implies meeting performance equivalent to established devices for these challenging cases.
   Clinical Performance (Clinical Evaluation of Published Data)	Safety and efficacy profile equivalent to the predicate and reference devices.

   Note: The document states "All tests passed" for the bench performance data, implying that the acceptance criteria for each of these tests were met.

2. Sample Size and Data Provenance

   • Test set (cadaver study): The document mentions "male cadavers with difficult urethral anatomies." It does not specify the exact number of cadavers used.
   • Data Provenance (cadaver study): Not explicitly stated, but implies a laboratory setting for the "pre-clinical study." It is a prospective observational study in a pre-clinical setting.
   • Clinical Evaluation: Based on "available published data," which would be retrospective analysis of existing clinical literature. No specific sample size mentioned for this review beyond the studies themselves.

3. Number of Experts and Qualifications for Ground Truth

   • Cadaver Study: The document does not specify the number of experts or their qualifications involved in establishing "ground truth" or evaluating insertion/navigation in the cadaver study. It only states the device "was comparable to a standard coudé catheter." This comparison would likely have been made by experienced individuals, but their number and specific qualifications are not detailed.
   • Clinical Evaluation: For the "clinical evaluation of available published data," the "experts" would be the authors of the published studies being reviewed. The document does not state how many individuals conducted this literature review or their qualifications.

4. Adjudication Method for the Test Set

   • The document does not describe any formal adjudication method (like 2+1 or 3+1) for the cadaver study or the clinical evaluation. The comparison in the cadaver study ("comparable to a standard coudé catheter") implies a direct observation and assessment, but multi-reader adjudication is not mentioned.

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

   • No MRMC comparative effectiveness study involving human readers with and without AI assistance was performed. This device is a medical device (catheter) for physical use, not an AI diagnostic/interpretive tool.

6. Standalone Performance (Algorithm Only)

   • Not applicable. This is a physical medical device, not a software algorithm.

7. Type of Ground Truth Used

   • Bench Testing: Engineering measurements and adherence to specified standards (e.g., ASTM, EN, ISO).
   • Cadaver Study: Direct observation and assessment of the device's physical performance (insertion and navigation) in anatomical models (cadavers) with known difficult anatomies (enlarged prostate and strictures). The "ground truth" is the physical reality of successful navigation and the comparative ease with a predicate.
   • Clinical Evaluation: Clinical outcomes and safety profiles reported in existing published literature for predicate and reference devices.

8. Sample Size for the Training Set

   • Not applicable as this is a physical medical device, not a machine learning algorithm. The "development" or "training" would refer to design iterations and engineering evaluations, not a data-driven training set in the AI sense.

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

   • Not applicable for the same reason as point 8. The "ground truth" for the device's design would stem from engineering principles, user needs, and clinical requirements for urinary catheterization.

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Restorelle M and XL Polypropylene Mesh devices are indicated for use as bridging material for sacrocolposuspension / sacrocolpopexy (laparotomy, laparoscopic, or robotic approach) where surgical treatment for vaginal vault prolapse is warranted.

Restorelle M and Restorelle XL Polypropylene Mesh are provided as sterile mesh constructed of knitted non-absorbable monofilaments of polypropylene, a synthetic polymer. Restorelle M is a flat mesh measuring 10cm x 15cm. Restorelle XL is a flat mesh measuring 30cm. Both are designed for the treatment of apical vaginal prolapse.

The provided document is a 510(k) summary for a medical device (surgical mesh), which focuses on demonstrating substantial equivalence to a predicate device. This type of regulatory submission does not typically contain the detailed information requested regarding acceptance criteria and a study proving a device meets those criteria in the way a clinical trial or performance study report would.

510(k) submissions, especially for devices claiming substantial equivalence based on material and design similarities, often rely on non-clinical data (e.g., material properties, dimensions) and comparison to a legally marketed predicate. They don't usually involve acceptance criteria related to AI/algorithm performance, human reader studies, or detailed ground truth establishment as would be present for AI/ML-based medical devices or devices with novel performance claims requiring rigorous clinical validation.

Therefore, many of your requested points cannot be answered from the provided text.

Here's an analysis of what can be extracted and what cannot:

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

• Acceptance Criteria: The document implies that the acceptance criteria for the subject devices (Restorelle M & XL) are that they are "substantially equivalent" to the predicate device (Restorelle L) in terms of indications, materials, and technological characteristics. The specific metrics for "performance" are based on physical properties, not clinical outcomes in a comparative study.
• Reported Device Performance: The document reports the physical characteristics of both the subject and predicate devices. The "performance" is demonstrated by the equivalence of these characteristics.

The overarching "acceptance criterion" as explicitly stated in the Conclusions: "The performance and non-clinical referenced demonstrate that the Restorelle M and XL Polypropylene Mesh devices are substantially equivalent to Restorelle L Polypropylene Mesh."

The following information cannot be found in the provided 510(k) summary:

• 2. Sample size used for the test set and the data provenance: Not applicable here as this is a physical device comparison, not a data-based algorithm.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• 4. Adjudication method for the test set: Not applicable.
• 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, as this is not an AI/ML device or an imaging device requiring human reader 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: Not applicable as this is not an AI/ML device requiring clinical ground truth for performance. The "ground truth" for this submission is the established properties and safety of the predicate device.
• 8. The sample size for the training set: Not applicable (no AI/ML model).
• 9. How the ground truth for the training set was established: Not applicable (no AI/ML model).

Summary of the Study/Evidence Provided:

The "study" in this context is the submission for a 510(k) premarket notification. The company Coloplast A/S is seeking clearance for two new mesh sizes (Restorelle M and XL) by demonstrating their substantial equivalence to a previously cleared predicate device, Restorelle L (K122440).

The core of the study is a comparison of technological characteristics. The "performance" is proven by showing that the new devices share the "same materials, features, intended use, and technological characteristics" as the predicate device, with the only difference being the mesh size.

This is a non-clinical comparison study, relying on the established safety and effectiveness of the predicate device rather than new clinical trials on the subject devices themselves.

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NovaSilk Mesh is indicated for use as a bridging material for sacrocolposuspension/sacrocolpopexy (laparotomy, laparoscopic, or robotic approach) where surgical treatment for vaginal vault prolapse is warranted.

NovaSilk Mesh is an implantable, permanent, non-resorbable, synthetic support mesh manufactured from knitted, monofilament polypropylene. It is square in shape, measuring 150mm x 150mm, and 0.25mm thick.

Here's an analysis of the provided text regarding the NovaSilk Mesh device, specifically addressing the acceptance criteria and study information:

Based on the provided K122968 510(k) summary, the device is NovaSilk Mesh, and this submission is for a "Traditional 510(k) with Narrowed Indications." This type of submission relies heavily on demonstrating substantial equivalence to a previously cleared predicate device, rather than new extensive clinical trials for performance. Therefore, many of the typical "acceptance criteria" and "study" details you'd find for a new, novel AI or diagnostic device will not be present.

Acceptance Criteria and Reported Device Performance

The provided documentation does not define specific quantitative "acceptance criteria" in terms of performance metrics (e.g., sensitivity, specificity, accuracy) or numerical efficacy targets that the NovaSilk Mesh needs to meet. This is characteristic of a 510(k) submission for a surgical mesh, where the primary focus is on demonstrating substantial equivalence to a predicate device.

Table of Acceptance Criteria and Reported Device Performance (as inferred from the 510(k) process):

Study Details:

Given that this is a 510(k) for substantial equivalence of a surgical mesh, the "study" is primarily a non-clinical comparison and verification of physical and material properties against predicate devices. There is no mention of a clinical study or performance study in the context of diagnostic accuracy, AI performance, or human reader improvement, as these types of studies are generally not required for this class and type of device in a 510(k).

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

   • Test Set Sample Size: Not applicable in the context of a clinical performance study as might be expected for an AI device. The testing refers to non-clinical bench testing.
   • Data Provenance: Not specified, but the testing was likely conducted in a lab setting by the manufacturer or contracted labs. Retrospective/prospective terms do not apply here.

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

   • Not applicable. Ground truth, in the sense of clinical annotations by experts, is not established for this type of device submission. The "ground truth" for the non-clinical testing is compliance with established engineering and safety standards.

3. Adjudication method for the test set:

   • Not applicable. There is no expert adjudication process for this type of non-clinical testing.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No MRMC study was done. This is not an AI device or a diagnostic device where human reader performance would be a relevant metric.

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

   • Not applicable. This is not an algorithm or AI device.

6. The type of ground truth used:

   • For the non-clinical performance data mentioned ("Design verification, biocompatibility, sterilization, and shelf life testing"), the "ground truth" is adherence to established industry standards, regulatory guidelines (e.g., ISO standards for biocompatibility), and internal design specifications for surgical meshes.

7. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device that requires a training set.

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

   • Not applicable.

Summary of Approach:

The provided document describes a 510(k) submission for a surgical mesh device. The regulatory strategy is based on demonstrating substantial equivalence to previously cleared predicate devices (NovaSilk Mesh K053414 and Vertessa K120327). This involves showing that the subject device has identical or similar technological characteristics (materials, design, fundamental scientific technology) and identical or narrower indications for use compared to the predicates.

The "performance data summary" refers to non-clinical testing (design verification, biocompatibility, sterilization, and shelf life testing) that was previously completed on the predicate NovaSilk Mesh, which then supports the substantial equivalence claim for the new NovaSilk Mesh (subject device) because the subject device is technologically identical. No new clinical performance data or studies defining specific acceptance criteria in terms of clinical outcomes or reader performance are presented in this 510(k) summary.

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Restorelle L Polypropylene Mesh is indicated for use as a bridging material for sacrocolposuspension / sacrocolpopexy (laparotomy, laparoscopic or robotic approach) where surgical treatment for vaginal vault prolapse is warranted.

Restorelle L Polypropylene Mesh is provided as a sterile mesh that is constructed of knitted non-absorbable monofilaments of polypropylene, a synthetic polymer. It consists of a flat mesh measuring 24cm x 8cm and is designed for the treatment of apical vaginal prolapse.

This 510(k) summary for the Coloplast Restorelle® L surgical mesh does not describe a study that involves analyzing device performance based on acceptance criteria in the manner typically seen for AI/ML or diagnostic devices. Instead, this submission focuses on demonstrating substantial equivalence to existing predicate devices.

Here's an analysis based on the information provided, specifically addressing your points where possible:

Analysis of Acceptance Criteria and Device Performance Study for Restorelle® L (K122440)

The provided document describes a 510(k) submission for substantial equivalence of the Restorelle® L surgical mesh. This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, and often doesn't involve the same kind of performance study with defined quantifiable acceptance criteria as might be expected for an AI/ML or diagnostic device.

The core argument for equivalence is that the Restorelle® L is identical in materials and design to a predicate device (Restorelle® Y), with the only difference being its size, which falls within the range of existing predicate devices. For this reason, the submission states that "Non-clinical performance testing, biocompatibility testing, shelf life and sterilization validations were not required for the Restorelle L since the proposed mesh is identical in materials and design as that used in the predicate Restorelle Y device. The results and data from these studies are applicable to the Restorelle L device."

Therefore, many of the typical acceptance criteria and study details you'd expect are not explicitly present for the subject device itself in this document, as its performance is inferred from predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

As noted, this submission primarily focuses on comparative characteristics for substantial equivalence, rather than a standalone performance study against specific acceptance criteria for the Restorelle® L itself. The "performance" for Restorelle® L is essentially that it matches the properties of its predicate devices, implying equivalent safety and effectiveness.

The study that "proves" the device meets the acceptance criteria is the substantial equivalence comparison to predicate devices. The primary proof is the identical nature of its materials and manufacturing processes to the Restorelle Y, and its size falling within the acceptable range of established meshes.

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

Not applicable for this type of submission. There is no "test set" in the sense of patient data or clinical imagery evaluated against ground truth. The submission relies on comparative physical and material characteristics and the established safety and performance of predicate devices.

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. No expert review for ground truth was performed for the Restorelle® L in this context. The "ground truth" for its equivalence is based on engineering and material specifications matching predicate devices.

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

Not applicable. See point 3.

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/ML or diagnostic device.

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

Not applicable. This is a medical device (surgical mesh), not an algorithm.

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

The "ground truth" for this substantial equivalence determination is the physical and material specifications and established safety/efficacy profiles of its predicate devices (Restorelle® Y and Vertessa™ Polypropylene Mesh), as previously cleared by the FDA. Specifically, the material composition, pore size, sterilization method, and indications for use being identical to Restorelle® Y, and the dimensions being within an acceptable range.

8. The sample size for the training set

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

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

Not applicable. See point 8.

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

The SpeediCath Compact Set (Female) is a sterile, single use, disposable polyurethane catheter for females with a pre-attached urine collection bag. The catheter is pre-lubricated with a hydrophilic coating and immersed in saline solution. In use, the cover is removed, the bag is unfolded and the catheter is pulled out of the packaging. The catheter with attached bag is then ready to use allowing easy drainage and collection of urine.

This document appears to be a 510(k) summary for a medical device called "SpeediCath Compact Set." It describes the device, its intended use, and claims substantial equivalence to a previously cleared device. However, it does not contain the detailed acceptance criteria and study results typically found in an AI/ML device submission.

The "Summary of Testing" section is very brief and only mentions compliance with general standards for medical devices and biological evaluations. It does not provide specific performance metrics, sample sizes, ground truth establishment, or details about comparative effectiveness studies that would be relevant to an AI/ML device.

Therefore, based on the provided text, I cannot extract the information you've requested about acceptance criteria and a study that proves the device meets them, especially in the context of an AI/ML device. The SpeediCath Compact Set appears to be a physical medical device (a urinary catheter), not an AI/ML algorithm.

If you have a document pertaining to an AI/ML medical device, please provide that.

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The Coloplast Exair Anterior and Posterior Prolapse Repair Systems are indicated for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.

The Exair Anterior and Posterior Prolapse Repair System is composed of NovaSilk mesh precut into shape with an enlarged or elongated body with four appendages extending out from the main body. The mesh arms for both Exair Anterior and Posterior Prolapse Repair Systems are sleeved in 2-mil thick polypropylene to facilitate arm implantation and positioning: sleeves are removed after proper placement of the implant is achieved. The system instrumentation includes a hollow introducer used to create a passage through the tissues and facilitate placement of the mesh arms, and four (4) anterior or two (2) posterior retrievers used to guide the mesh arms in place the tissues for positioning and fixating the mesh body. The system provided sterile and for single use only.

This is a 510(k) summary for a surgical mesh device (K112386). It does not contain information about acceptance criteria or a study proving the device meets those criteria. The document states that the proposed changes described in the submission do not affect the materials, design, components, or technological features of the device, implying that no new performance studies were conducted for this specific submission to demonstrate compliance with new acceptance criteria. The submission is focused on demonstrating substantial equivalence to a predicate device (K083499) based on existing characteristics.

Therefore, I cannot provide the requested information from the provided text.

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SpeediCath Compact 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.

SpeediCath Compact is a sterile, single use, disposable polyurethane catheter for females. The catheter is pre-lubricated with a hydrophilic coating and immersed in saline solution. The packaging of SpeediCath Compact is an integrated part of the product functioning partly as an insertion handle. In use, the inner tube is extended and removed from the handle as the catheter is locked in place with the handle. The catheter is then ready to use allowing easy handling and urine to flow through the catheter and handle.

The provided text describes a 510(k) summary for the SpeediCath Compact device, a urinary catheter. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

Key takeaway regarding your request: The provided text does not contain information about acceptance criteria or a study proving device performance against such criteria in the manner typically associated with clinical trials for AI/ML medical devices (e.g., performance metrics like sensitivity, specificity, F1-score, AUC).*

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Coloplast's SpeediCath) through:

• Material and functional similarity: Both are ready-to-use intermittent catheters with hydrophilic coatings, made of the same material, immersed in the same saline solution, sterile, and single-use.
• Minor differences in packaging and intended user group: SpeediCath Compact has a modified packaging for ease of use and is specifically for female use, while the predicate is for both males and females.
• Compliance with relevant standards: The device has been tested against ASTM 623, ASTM D1894, EN 1616, EN 1618, and relevant sections of ISO 10993 (Biological Evaluation of Medical Devices). These standards generally relate to physical properties, biocompatibility, and intended use characteristics of catheters, not diagnostic performance of an AI/ML algorithm.

Therefore, I cannot populate the table or answer most of your specific questions related to AI/ML device performance criteria, sample sizes for test/training sets, expert ground truth, or MRMC studies, as this information is not present in the provided 510(k) summary for this device.

Below is a table reflecting the type of "acceptance criteria" (compliance with standards) and "reported performance" (compliance achieved) as derived from the document, but it's crucial to understand this is not the typical performance evaluation for AI/ML.

1. Table of Acceptance Criteria and the Reported Device Performance

Regarding the study that proves the device meets the acceptance criteria:

The study that proves the device meets these "acceptance criteria" is a series of tests demonstrating compliance with the relevant sections of the listed national and international standards (ASTM, EN, ISO). These tests would typically assess physical properties, sterility, biocompatibility, and other performance characteristics specific to urinary catheters. The document states, "SpeediCath Compact has been tested and complies with relevant sections..." which serves as the "proof" within this regulatory submission. The specifics of these tests (e.g., sample sizes, methodology) are not detailed in this summary.

The following information is NOT available in the provided text as it pertains to AI/ML device evaluation, which this document does not cover:

2. Sample sizes used for the test set and the data provenance: Not applicable/Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not provided.
4. Adjudication method for the test set: Not applicable/Not 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 provided.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable/Not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable/Not provided.
8. The sample size for the training set: Not applicable/Not provided.
9. How the ground truth for the training set was established: Not applicable/Not provided.

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