The AMT Low-Profile Suprapubic Catheter & Drainage Set is indicated for patients 7 years of age and older with lower urinary tract dysfunctions such as neurogenic bladder dysfunction or urethral obstruction or who are severely disabled or requiring constant care. The AMT Low-Profile Suprapubic Catheter & Drainage Set is indicated to be used for temporary suprapubic urinary diversion and drainage for less than or equal to four weeks. The AMT Low- Profile Suprapubic Catheter is intended to be placed directly into the bladder through a secured (initial placement) or formed (replacement) stoma.

The Applied Medical Technology, Inc. (AMT) Low-Profile Suprapubic Catheter & Drainage Set (LPSPC) consists of two primary assemblies. The LPSPC is identical in materials and manufacturing processes to the Low-Profile Balloon Feeding Device cleared in K161413 for a different indication.

The Suprapubic Catheter is used to provide urinary diversion and drainage through the lower abdomen, placed and maintained in a percutaneously prepared cystostomy opening. The Drainage Set is intended to allow a connection between the suprapubic catheter device and a urinary collection bag system. The device is designed for bladder drainage by way of a secured (initial placement) or formed (replacement) cystostomy tract and may be used for irrigation. Patients may include: any user with urethral trauma, those who require long-term catheterization and urethral catheterization is intolerable, or those with a spinal cord injury and an inability to self-catheterize who may find the suprapubic method simpler to manage.

The LPSPC is a urinary drainage device made principally of silicone elastomer. The device consists of an internal retention balloon and a flexible external bolster with a balloon fill-valve, interlocking irrigation port, and safety plug. The catheter is inserted through the stoma and into the urinary bladder and is secured by the internal retention balloon. The device is offered in various sizes to accommodate different stoma diameters and lengths. On the shaft near the end is located a balloon which, when properly inflated, acts as an internal stabilizer preventing outward displacement through the stoma in the abdominal wall. The balloon is inflated through a separate inflation valve located in the external portion of the device.

The external profile of the device acts as a stabilizer to prevent inward migration and affords the user the ability to connect a provided Drainage Set.

The Drainage Set is identical in material and manufacturing process to certain configurations of the Irrigation Set included with the AMT Bowel Management Device previously cleared in K180026. The right-angle connector of the Drainage Set is compatible with the interlock on the LPSPC and is used to direct fluids drained from the bladder, through the catheter, and into a separate urinary collection bag.

The AMT Low-Profile Suprapubic Catheter & Drainage Set may optionally be marketed with a Foley Insertion Tray accessory. If included, the accessory would be a legally marketed Foley Insertion Tray, such as:

• AMSure Foley Insertion Tray (previously cleared Class II, Product Code FCM, K030664)
• Bardia Foley Insertion Tray (registered Class II, Product Code OHR, 510(k) exempt)
• Dynarex Foley insertion Tray without Catheter (registered Class II, Product Code OHR, 510(k) exempt)

The device is sold as sterile and can be initially placed in an outpatient-setting by a health care professional. The device may be replaced in an outpatient-setting or home setting by a health care professional or care giver.

The provided text describes a 510(k) premarket notification for the "AMT Low-Profile Suprapubic Catheter & Drainage Set." This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a standalone study with specific acceptance criteria and performance metrics in the format requested.

Therefore, much of the requested information cannot be extracted directly from this document. The document primarily describes the types of testing performed and concludes that the device met acceptance criteria, but generally does not specify these criteria or report quantitative performance results against them.

Here's an attempt to answer the questions based on the available information:

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

The document states that the device "met or exceeded all the acceptance criteria and does not raise new questions of safety or effectiveness when compared to the predicate/reference devices." However, specific numerical acceptance criteria and precise performance data are not detailed in this summary. The performance is generally stated as meeting standards.

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

• Sample Size:
  • Bench Testing: Not specified. The document lists the types of tests but not numbers of samples.
  • Clinical Performance (Literature Review): Clinical experience was reported on 34 adults and 188 pediatric patients across 22 published articles.
• Data Provenance: The clinical data is from a systematic literature review (retrospective). The countries of origin are not specified, only that the literature from "independent organizations" was reviewed.

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. This was a systematic literature review, not a study where experts established ground truth for newly collected patient data. The "ground truth" for the clinical performance was derived from the findings reported in the published literature.

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

Not applicable. The clinical evidence was gathered through a systematic literature review. The "reporting of this systematic review was guided by the standards of the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) Statement, as well as the Cochrane Handbook for Systematic Reviews of Interventions. Assessment of the included literature was completed using the critical appraisal tools published by the Joanna Brigges Institute." This describes the methodology for reviewing existing literature, not an adjudication process for a new test set.

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 suprapubic catheter, not an AI-assisted diagnostic or therapeutic device. The submission does not mention any AI components or MRMC studies.

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

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

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

For the clinical performance aspects, the "ground truth" was derived from "clinical experience... reported on 34 adults and 188 pediatric patients" across published literature, guidelines from organizations like the Pediatric Urologists of Canada and the Canadian Urological Association, operative textbooks, and information from the International Continence Society (ICS). This can be broadly categorized as published clinical outcomes data and expert-derived guidelines/clinical experience.

8. The sample size for the training set

Not applicable. This is a physical medical device submission, not a machine learning model. There is no concept of a "training set" in this context.

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

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

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To provide percutaneous drainage of abscess fluid, biliary, nephrostomy, urinary, pleural empyemas, lung abscesses, and mediastinal collection.

The vanSonnenberg™ Sump Catheter is designed for use as a percutaneously placed drain for intra-abdominal fluid collections. Such conditions include abscesses, cysts, pseudocysts, bilomas, seromas, urinomas, or any loculated fluid collection.

All Purpose Drainage catheters are designed to provide constant, unobstructed fluid drainage from various fluid accumulations to an external and/or internal collection sites and to ensure stability during treatment. These ends are met through the choice of drainage material and by incorporating a secure fixation method in the drainage site (internally by pig-tail or "J" style tips and externally, by means of suture or adhesive). Percutaneous placement is accomplished with radiological guidance.

Select Boston Scientific All Purpose Drainage catheters are coated with a hydrophilic material, Glidex™ , for the reduction of surface friction during placement.

Some of these catheters are also available with a biocompatible, distal tip (Temp-Tip™). The tip's internal diameter allows the guidewire to direct the tip for accurate catheter placement; however, soon after placement, the Temp-Tip™ material dissolves, allowing the full diameter of the catheter lumen to contribute to site drainage.

All Purpose Drainage catheters are manufactured with one of two types of resins, Flexima or Percuflex.

• Flexima is a biocompatible polyurethane (Tecoflex) known for its flexibility, strength, and kink resistance. Flexima comes in durometers ranging in Firm, Regular and Soft and uses a radiopacifier for visualization under fluoroscopy.
• Percuflex is an ELVAX™ 460, ethylene vinyl acetate (EVA) copolymer for patient comfort. This material is available in firm (white in color) and regular (blue in color) durometers. The firmer durometers provide more pushability during device placement. A radiopaque additive, bismuth subcarbonate, incorporated throughout the catheter tube also aids radiopacity and percutaneous placement.

The provided text is a 510(k) summary for the Boston Scientific APDL Drainage Catheter System and related products. It outlines the regulatory clearance process for drainage catheters and accessories. However, this document does not contain information about an AI/ML-driven device or a study assessing its performance using acceptance criteria related to AI/ML metrics (e.g., sensitivity, specificity, AUC).

Instead, the document details a traditional medical device submission, focusing on establishing substantial equivalence to existing predicate devices. The "performance testing" described refers to:

• Engineering and materials testing to support the addition of Magnetic Resonance (MR) compatibility information and to justify cumulative changes in manufacturing materials (e.g., resin types, coatings). This includes tests for radio frequency heating, force measurement, and image artifact in an MR environment, as well as packaging integrity and aging tests.
• Biological Endotoxin (BET) assessment.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies for an AI device. The document does not describe such a device or study.

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Cook-Cope Loop Nephrostomy Set: This device is used for percutaneous placement of a loop catheter in the renal pelvis for nephrostomy drainage.

Ultrathane Nephrostomy Set with Mac-Loc: This device is used for percutaneous placement of a loop catheter in the renal pelvis for nephrostomy drainage.

Ultrathane Suprapubic Set with Mac-Loc: The Ultrathane Suprapubic Set with Mac-Loc is used to provide bladder drainage by percutaneous placement of a loop catheter.

The bundled submission includes the Cook-Cope Loop Nephrostomy Set, Ultrathane® Nephrostomy Set with Mac-Loc®, and the Ultrathane® Suprapubic Set with Mac-Loc®

• . Cook-Cope Loop Nephrostomy Set and Catheter: The catheter is placed using standard percutaneous nephrostomy techniques into the kidney. The catheter is then secured in place by pulling the suture taut to create the distal retention loop, wrapping around the catheter shaft and knotting the suture. The latex is then folded over the suture and the excess suture is cut off. The catheter is kept in place within the patient using a retention disc.
• . Ultrathane Nephrostomy Set with Mac-Loc: The catheter is placed using standard percutaneous nephrostomy techniques. The catheter is then secured in place by pulling the suture taut to create the distal retention loop. While maintaining traction on the monofilament, the locking cam lever is pushed down until a distinct "snap" is felt. The catheter's distal loop is now locked into position. The excess suture is trimmed off. The catheter is then kept in place within the patient using a retention disc.
• Ultrathane Suprapubic Set with Mac-Loc: The catheter is placed using standard . suprapubic techniques. The catheter is then secured in place by pulling the suture taut to create the distal retention loop. While maintaining traction on the tether, the locking cam lever is pushed down until a distinct "snap" is felt. The catheter's distal loop is now locked into position. The excess suture is trimmed off. The catheter is then kept in place within the patient using the enclosed StatLock device.

The subject percutaneous drainage catheter sets consist of a flexible tube with an open distal tip and drainage holes. The distal end of the subject devices has either a Mac-Loc locking loop or a cope loop. A Mac-Loc locking loop mechanism secures the distal catheter loop configuration by means of a nylon monofilament. After the catheter is placed in the desired location, the nylon thread is pulled tight to form the distal loop configuration. Then the locking cam lever can be pushed down to snap into position, thereby locking the distal loop in position. The cope loop configuration is formed by pulling back the suture, and then the loop can be locked in place by sliding a latex sleeve over the suture.

Some catheter sets have a radiopaque marker to aid the user in placement. The proximal hub assembly of the devices provides a Luer lock hub to allow the user to connect to a fluid collection device (not subject of this submission). Accessories include introducing catheters, catheter securing devices, needles, cannulas, stylets, dilators, and wire guides.

The provided text is a 510(k) Summary for medical devices and does not contain information about acceptance criteria or a study proving that the device meets such criteria in the context of an AI-powered diagnostic system. Instead, it describes performance testing conducted to demonstrate substantial equivalence to predicate devices for traditional medical devices (catheter sets).

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study proving the device meets them, nor can I provide information regarding sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. This information is not present in the provided document.

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The Cook® Cystostomy Catheter Set is used for temporary suprapubic urinary diversion and drainage for less than or equal to four weeks.

The Cook® Cystostomy Catheter Set is composed of a single-lumen silicone catheter available in 8 to 12 French with a working length of 54 centimeters, a trocar stylet with access sheath having an outer diameter of 10 to 14 French with a length of either 11 or 11.2 centimeters, a drainage adapter with stopcock available in 12 to 16 gauge and a soft low-profile silicone catheter support with pull tie. The set is supplied sterile, intended for one-time use only, and packaged in a peelopen pouch with a three-year shelf life.

This document is a 510(k) premarket notification for a medical device called the Cook® Cystostomy Catheter Set. It does not describe an AI/ML powered device, nor does it contain information about diagnostic study performance acceptance criteria or a study proving that an AI/ML powered device meets those criteria.

Therefore, I cannot provide the requested information, which is specific to AI/ML device performance studies, based on the provided text. The document details the substantial equivalence of a physical medical device (catheter set) to predicate devices through physical and biological testing, not through AI/ML model performance evaluation.

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The One-Step Suprapubic Introducer is used for introducing a drainage catheter suprapubically into the bladder.

The One-Step Suprapubic Introducer is comprised of a stainless steel trocar stylet needle and a dilator with a peel-away sheath. The trocar stylet needle is 20 centimeters (cm) long with a trocar beveled tip at the distal end of the device. The dilator is 14-22 French (Fr) and 18-19 cm in length. The peel-away sheath is 14-22 Fr and 17 cm in length. The three components are designed to fit together to form a single assembly.

This document describes the Cook Incorporated One-Step Suprapubic Introducer (K182709) and its claim of substantial equivalence to a predicate device. The information provided focuses on the device's technical specifications and the performance tests conducted, rather than a clinical study involving human patients or AI systems. Therefore, many of the requested categories related to clinical studies, AI performance, and human reader effect sizes cannot be populated from the provided text.

Here's the breakdown of the information available:

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

The document broadly states, "All predetermined acceptance criteria were met" for all listed tests. Specific quantitative acceptance criteria are not provided.

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

The document does not specify the sample sizes used for any of the performance tests. The data provenance is Cook Incorporated, based in Bloomington, Indiana, U.S.A. The testing described appears to be prospective lab/bench testing, not clinical data.

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 question is not applicable as the document describes technical performance testing of a physical medical device, not a diagnostic device requiring expert interpretation or ground truth establishment in a clinical context.

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

This question is not applicable for the same reasons as #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

This question is not applicable. The device is a physical suprapubic introducer, not an AI system or a diagnostic tool that would be evaluated with an MRMC study comparing human readers with and without AI assistance.

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

This question is not applicable as the device is not an algorithm or an AI system.

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

This question is not applicable for the type of device and testing described. The "ground truth" for these engineering and biocompatibility tests would be the established test standards and specifications against which the device's performance is measured.

8. The sample size for the training set

This question is not applicable as the device is not an AI system that requires a training set.

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

This question is not applicable for the same reasons as #8.

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The O'Brien Suprapubic Peel-Away Access Set is used for introducing a drainage catheter suprapubically into the bladder.

The Cook® SP Tube Introducer Set is used for introducing a drainage catheter suprapubically into the bladder.

The O'Brien Suprapubic Peel-Away Access Set includes a peel-away sheath, dilator, trocar needle and wire guide. The peel-away sheath is available in even-numbered French sizes ranging from 16.0 to 20.0 and measures 22 centimeters in length. Dual knobs allow the sheath, manufactured from thick wall radiopaque polytetrafluoroethylene material, to be peeled back and removed.

The Cook SP Tube Introducer Set is comprised of a 20 Fr sheath which is 15 cm in length, an introducer that fits within this sheath, two dilators, a wire guide and needle.

This document is a 510(k) Premarket Notification for the O'Brien Suprapubic Peel-Away Access Set and the Cook® SP Tube Introducer Set. It does not describe an AI/ML device or its performance characteristics.

Therefore, I cannot provide details on the acceptance criteria and study proving device meets acceptance criteria as typically requested for AI/ML medical devices. The document concerns traditional medical devices (catheter introducer sets) and focuses on demonstrating substantial equivalence to a predicate device through engineering and biocompatibility testing, not clinical performance metrics of an AI algorithm.

The document states:

• Performance Data: "The subject devices... were subjected to applicable testing to assure reliable design and performance under the testing parameters. The following tests have been conducted... Radiopacity Testing, Peel-Away Shaft Tensile Test, Dilator Shaft Tensile Test, Peel Force, Rollback Testing, Dilator Hub-to-Shaft Tensile Test, Compatibility Testing, Biocompatibility Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, and Acute Systemic Toxicity, Sterilization, Package integrity and stability, Shelf-life. All predetermined acceptance criteria were met."

However, it does not provide the specific acceptance criteria or the detailed results of these tests. It only states that they were met, which is common in a 510(k) summary where full test reports are not typically included.

The information you requested (sample sizes for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types, etc.) are all relevant for AI/ML device evaluations and are not applicable or present in this submission for conventional medical devices.

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The Universa® Loop Drainage Catheter Set is intended to provide percutaneous urine drainage from the genitourinary system.

The Universa® Malecot Drainage Catheter Set is intended to provide percutaneous urine drainage from the genitourinary system.

The Universa® Percutaneous Drainage Catheter Sets include introductory and exchange sets available with either a loop (6-14 Fr) or a Malecot catheter (8-24 Fr). Suprapubic sets are available with a Malecot catheter (8-16 Fr). Each set includes a drainage catheter and connecting tube, and may also include straightening stylets, trocar needle with obturator, hollow needle, wire guide, dilators, silicone retention disc with pull tie, or one-way stopcock. The devices will be supplied sterile and intended for one-time use.

The provided text describes a 510(k) premarket notification for two medical devices: the Universa® Loop Drainage Catheter Set and the Universa® Malecot Drainage Catheter Set. It does not describe an AI/ML device or a study involving such a device. Therefore, many of the requested categories (such as sample sizes for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable to this document.

However, I can extract the information related to acceptance criteria and the studies performed for these physical medical devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample size: Not specified in the provided document.
• Data provenance: Not applicable. These are physical device tests, not data-driven studies.

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

• Number of experts: Not applicable. Ground truth for these physical device tests is established through engineering and biological standards, not expert consensus on data interpretation.
• Qualifications of experts: Not applicable.

4. Adjudication method for the test set

• Adjudication method: Not applicable. Performance is measured against physical test standards.

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

• MRMC study: No. This is not an AI/ML device.

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

• Standalone study: No. This is not an AI/ML device.

7. The type of ground truth used

• The "ground truth" for these physical device tests is based on:
  • Engineering specifications and material properties (for tensile strength, flow rates).
  • Functional design requirements (for retention).
  • International standards (ISO 10993-1 for biocompatibility).
  • Instructions for use for simulated clinical performance.

8. The sample size for the training set

• Sample size: Not applicable. This is not an AI/ML device, so there is no training set in that context.

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

• Ground truth establishment: Not applicable. No training set for an AI/ML context.

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The Suprapubic Catheter and Introducer Set is indicated for drainage of the bladder through a needle puncture or stab wound over the bladder. For use no greater than 29 days.

Suprapubic catheters are Foley catheters that are placed with an introducer through a needle puncture or stab wound over the bladder to allow bladder irrigation and / or drainage of the bladder. They are available in two (2) tip styles, closed and open tip, The introducer kit includes a number of components including: Scalpel, Syringe, 18 gauge needle, Dilator and Peelable sheath, and Guidewire

This is a 510(k) summary for a medical device and does not contain information about a clinical study with detailed acceptance criteria and performance metrics in the way you've requested for an AI/ML device.

Here's an explanation of why the requested information cannot be fully provided based on the provided text, and what can be extracted:

• Device: Suprapubic Catheter and Introducer Set
• Submission Type: 510(k) Premarket Notification. This type of submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel efficacy or performance through extensive clinical trials as might be required for a PMA or for an AI/ML device.

Analysis of the Provided Text (and why it doesn't fit the AI/ML study request)

The document describes a conventional medical device (catheter and introducer set) and its comparison to predicate devices, focusing on demonstrating substantial equivalence based on:

• Indications for Use: Identical or similar to predicates.
• Technology and Construction: Identical or substantially equivalent materials, design, manufacturing, shape, and sizes, with the catheter often being an OEM product from a predicate manufacturer.
• Environments of Use: Identical to predicates.
• Patient Population: Identical to predicates.
• Indwelling Time: Identical to predicates.
• Convenience Kit: Comparison of kit components.
• Non-Clinical Testing Summary: This is the only area where "testing" is mentioned, but it's for physical performance of the device components (balloon burst, volume maintenance, deflation, guidewire fracture, flexion, tensile strength, corrosion) against established standards (ASTM F623, ISO 11070). This is not a study assessing diagnostic accuracy or clinical outcomes in humans, nor does it involve AI/ML.
• Materials: Biocompatibility testing per ISO 10993-1 and G95-1.

Therefore, many of your specific requests are not applicable to this 510(k) submission:

1. A table of acceptance criteria and the reported device performance: The "performance" reported here is adherence to physical/material standards, not diagnostic accuracy. The acceptance criteria are "met the performance requirements of the standards" (ASTM F623, ISO 11070).
2. Sample size used for the test set and the data provenance: Not applicable. There's no "test set" of patient data for an algorithm. The testing is material/device-specific.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" establishment in a clinical sense.
4. Adjudication method: Not applicable.
5. MRMC comparative effectiveness study: Not applicable. This is not an AI-assisted device.
6. Standalone (algorithm only) performance: Not applicable. There's no algorithm.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable. No training set for an algorithm.
9. How the ground truth for the training set was established: Not applicable.

What can be extracted (re-interpreting "acceptance criteria" for a 510(k) of a conventional device):

For a 510(k) submission like this, "acceptance criteria" are generally framed as demonstrating substantial equivalence to predicate devices and meeting relevant recognized standards for the device's physical and material properties.

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical/Material Focus)

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The Swan Valley Medical Transurethral Suprapubic endo-Cystostomy (T-SPeC®) Surgical System is intended for suprapubic bladder catheterization (cystostomy) and drainage. The catheter should not be allowed to remain indwelling for more than 29 days.

The T-SPeCTM Surgical System is, in effect, a sterile suprapubic catheter and accessory kit consisting of a) a suprapubic catheter; b) a catheter punch instrument used to create a cystostomy and place the suprapubic catheter; and c) a piston syringe to fill the catheter balloon after placement.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Swan Valley Medical Transurethral Suprapubic endo-Cystostomy (T-SPeC™) Surgical System:

1. Table of Acceptance Criteria and Reported Device Performance

A critical point to note is the absence of specific, quantitative acceptance criteria and their corresponding reported performance values within this 510(k) summary. The summary states that "various bench performance studies have been performed" but does not detail the specific criteria or the results of those studies. The primary "acceptance criterion" articulated is the demonstration of "substantial equivalence" to predicate devices based on non-clinical data.

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

The provided 510(k) summary does not mention a "test set" in the context of clinical or performance data for an AI/algorithm-based device.

• Sample Size for Test Set: Not applicable as no clinical or AI-specific performance testing is detailed.
• Data Provenance: Not applicable. The submission explicitly states, "No clinical performance testing was performed." The equivalence is based on non-clinical bench studies.

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

• Number of Experts: Not applicable. As no clinical performance testing or "test set" requiring expert ground truth was conducted, no experts were used for this purpose.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Since no clinical performance testing requiring a "test set" with expert review was conducted, no adjudication method was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size of Human Readers Improve with AI vs. Without AI Assistance

• MRMC Study: No. The provided text does not mention any MRMC comparative effectiveness study. This is not an AI/software as a medical device (SaMD) submission where such studies would be typical.
• Effect Size: Not applicable.

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

• Standalone Performance: No. The device is a "Surgical System" consisting of physical medical instruments (catheter, punch instrument, syringe), not a standalone algorithm or software. Therefore, the concept of "algorithm only" performance is not relevant to this submission.

7. The Type of Ground Truth Used

• Type of Ground Truth: Not applicable in the context of clinical or AI performance. The "ground truth" for this device's safety and effectiveness relies on established engineering principles, material science, and performance testing benchmarks for similar physical medical devices (e.g., integrity of materials, sterility, functionality of mechanical components). The "ground truth" is essentially conformance to design specifications and recognized standards for physical medical devices, as demonstrated by bench testing.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This is a submission for a physical medical device, not an AI/machine learning model. There is no concept of a "training set" in this context.

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

• How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for a physical device.

Summary of the Study:

The study proving the device meets its "acceptance criteria" (which in this case is primarily substantial equivalence to predicate devices for safety and effectiveness) consists of non-clinical bench performance studies.

The 510(k) summary explicitly states: "No clinical performance testing was performed. Substantial equivalence for the subject device is based on the aforementioned non-clinical bench studies."

These bench studies covered:

• Suprapubic Catheter design and performance.
• Catheter accessory design and performance.
• Biocompatibility.
• Sterilization Validation & Shelf Life.

The detailed results and specific acceptance parameters of these bench studies are not provided in the 510(k) summary (which is common for these summaries). The FDA's decision to clear the device implies that the non-clinical data was sufficient to demonstrate substantial equivalence to legally marketed predicate devices for the stated intended use.

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The endoscopic instruments presented in this submission are for use in laparoscopy (abdominal and gynecological surgery) for puncture of the abdominal cavity and establishment of a port of entry for endoscopic instruments.

Aesculap's Hybrid Trocar System can be used in laparoscopic general surgery. gynecology, and urology. The trocars are made from biocompatible materials. They are available as reusable in 3.5, 5, 10 or 12mm diameter with lengths of 60, 110, and 150mm. The trocars are offered with or without a stopcock, and threaded or smooth. The devices are color coded for easy identification.

This 510(k) submission (K101937) for the Aesculap Hybrid Trocar System does not include any data from a clinical study or performance data to prove the device meets acceptance criteria.

The document explicitly states:

"No applicable performance standards have been promulgated under Section 514 of the Food, Drug, and Cosmetic Act for these devices."

This indicates that clinical acceptance criteria and subsequent studies demonstrating their fulfillment were not a requirement for this particular submission. The substantial equivalence was established by comparing the device's technological characteristics to existing predicate devices (K942053, K982623, and K071976).

Therefore, I cannot provide the requested information regarding acceptance criteria, study data, sample sizes, expert qualifications, etc., as it is not present in the provided document.

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