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The Optilume® High Pressure Urological Balloon Dilation Catheter is indicated for dilation of the urinary tract.

The Optilume® High Pressure Urological Balloon Dilation Catheter is an 0.038" (0.97mm) guidewire and flexible cystoscope compatible over-the-wire (OTW) catheter with a dual lumen design with a tapered atraumatic tip. The Optilume® High Pressure Urological Balloon Dilation Catheter is used to exert radial force to dilate narrow urinary tract segments (strictures). The distal end of the catheter is a non-compliant inflatable balloon. The 75 cm long Optilume® High Pressure Urological Balloon Dilation Catheter is supplied in five balloon diameters ranging from 4-10mm and balloon lengths ranging from 20-80mm. The balloon catheter is supplied sterile for single use.

This document is an FDA clearance letter for a medical device called the "Optilume® High Pressure Urological Balloon Dilation Catheter." It details the regulatory review process, including the determination of substantial equivalence to a predicate device.

However, the provided text does not contain information about the acceptance criteria or a study that proves the device meets those acceptance criteria in the context of an AI/ML medical device.

The performance data mentioned in the document are solely related to engineering and material performance tests for a physical medical device (a balloon catheter), not an AI algorithm. These tests include:

• Biocompatibility Testing: Ensuring the materials are safe for use in the body.
• Performance Testing: Evaluating physical attributes like balloon diameter, length, inflation/deflation time, burst strength, and compatibility with other medical equipment.
• Sterilization: Validating the sterilization process.
• Packaging and Distribution: Ensuring the device remains sterile and functional during transport and storage.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving an AI/ML device's performance, as the provided input does not describe such a device or study.

The questions you've asked (about sample sizes for test sets, data provenance, expert ground truth, MRMC studies, standalone performance, training sets, etc.) are highly relevant for AI/ML medical device clearances but are not addressed in this particular FDA letter, as it's for a traditional hardware device.

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The Optilume Basic Urological Balloon Dilation Catheter is indicated for the dilation of urethral strictures.

The Optilume Basic Urological Balloon Dilation Catheter (Optilume Basic) is a 0.038" (0.97 mm) guidewire and flexible cystoscope compatible over-the-wire (OTW) catheter with a dual lumen design with a tapered atraumatic tip. The Optilume Basic is used to exert radial force to dilate narrow urethral segments (strictures). The distal end of the catheter is a semi-compliant inflatable balloon. The usable length is 75 cm and allows the device to be compatible with the working channel of a standard flexible cystoscope. The device has two radiopaque marker bands that indicate the working length of the balloon.

The device is sterilized using ethylene oxide in a Tyvek pouch. Post sterilization the pouched catheter is sealed in a foil pouch with desiccant and contained within a single unit carton.

The provided text describes the regulatory clearance of the Optilume Basic Urological Balloon Dilation Catheter (K191061) as substantially equivalent to a predicate device. It includes performance data for various engineering and biocompatibility tests, but it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of diagnostic accuracy, which would typically involve human readers and assessment of performance metrics like sensitivity, specificity, or AUC.

The document focuses on the physical and biological performance of the device itself, rather than evaluating an AI algorithm's diagnostic performance. Therefore, most of the requested information regarding acceptance criteria for diagnostic performance, sample sizes for test/training sets, expert involvement for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance cannot be extracted from this text.

Here's a breakdown of what can and cannot be extracted based on the provided document:

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

The document lists performance tests but does not provide explicit acceptance criteria values (e.g., "burst pressure > X atm") alongside the reported results. It only states that the device "underwent extensive testing" and "performed as intended."

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: Not applicable in the context of diagnostic "test set" as this is a medical device for dilation, not a diagnostic algorithm. For the GLP animal study, the sample size is not specified beyond "canines."
• Data Provenance: The GLP animal study was performed in "canines." No country of origin is mentioned for the animal study.

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. The performance data relates to the physical and biological characteristics of the device, not the interpretation of diagnostic images requiring expert ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) 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. This is not an AI-assisted diagnostic device.

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

Not applicable. This is not an algorithm.

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

For the engineering tests (e.g., balloon burst, tensile testing), the "ground truth" would be the established engineering specifications and physical properties of the materials. For biocompatibility, the ground truth is compliance with ISO 10993-1 standards. For the animal study, the "ground truth" refers to observation of device performance and absence of adverse events in living subjects.

8. The sample size for the training set:

Not applicable. This is not a machine learning algorithm.

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

Not applicable. This is not a machine learning algorithm.

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The Ultraxx™ Nephrostomy Balloon Catheter is used to dilate the musculofascial tract, renal capsule, and parenchyma to establish and maintain a percutaneous tract.

The Inflation Device is recommended for use with balloon dilatation catheters to create and monitor the pressure in the balloon and to deflate the balloon.

The Ultraxx™ Nephrostomy Balloon Catheter is a double-lumen catheter indicated for a nephrostomy procedure by dilating the musculofascial tract, renal capsule, and parenchyma to establish and maintain a percutaneous tract. The device is intended for limited duration use, not to exceed 24 hours in the body.

The Ultraxx Nephrostomy Balloon Catheter Set is comprised of the Ultraxx balloon catheter, Amplatz sheath, and inflation device. The Ultraxx Nephrostomy Balloon Catheter is constructed from a radiopaque nylon tubing with a dilatation balloon on its distal end. The outer diameter of the catheter is available in 6 French (Fr) with a working length of 55 centimeters (cm). The balloon of the catheter is constructed from polyethylene terephthalate (PET) and is available in nominal inflated diameters of 6 to 10 millimeters (mm) with a length of 15 cm. A radiopaque marker band is positioned on the distal end of the balloon catheter which confirms accurate placement of the catheter. The maximum rated balloon pressure is 20 atm. The Amplatz sheath is available in either polytetrafluoroethylene (PTFE) or a clear polyvinyl chloride (PVC). Both sheaths are available in inner diameters of 18, 24, or 32 Fr with a working length of 17 cm. The Cook Sphere Inflation Device was cleared on March 3, 2004 under K032840. The inflation device is a one-piece, plastic, disposable inflation device with a lock lever design to control the piston, a manometer, and a connecting tube with a male rotating adapter.

The set will be supplied sterile and is intended for one-time use. The set is packaged in a peel-open pouch with a three-year shelf life.

This document, K181713, is a 510(k) premarket notification for a medical device (Ultraxx™ Nephrostomy Balloon Catheter Set). For this type of submission, the primary goal is to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than proving the device meets specific performance acceptance criteria through a traditional clinical study with a detailed test set, ground truth, and statistical analysis as one might find for a novel class III device or a new AI/ML-based diagnostic.

Therefore, the information typically included in a "Description of acceptance criteria and the study that proves the device meets the acceptance criteria" for a novel device, especially an AI one, is largely not applicable to this submission. This 510(k) explicitly states there were no changes to the subject device that would affect biocompatibility, sterility, or performance compared to the predicate devices.

However, I can extract the relevant information regarding the comparative claims made and the assessment of equivalence:

Device: Ultraxx™ Nephrostomy Balloon Catheter Set

Summary of Acceptance Criteria and Device Performance (as pertains to a 510(k) for substantial equivalence):

Further Details (as per the provided document):

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

   • Not applicable in the typical sense. This submission is based on demonstrating substantial equivalence to pre-existing, cleared devices. The "test set" here refers to the device itself and its components.
   • The document mentions "Packaging integrity testing following simulated distribution was performed." The sample size for this specific test is not detailed, but it would have been an engineering/bench test rather than a clinical or data-driven evaluation of performance against a "test set" of patient data.

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

   • Not applicable. The "ground truth" for a 510(k) for substantial equivalence relies on comparison to a predicate device's known characteristics and performance, not on expert labeling of a dataset.

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

   • Not applicable. No such adjudication process is described or implied for this type of submission.

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 device is a physical medical device (catheter set) used in a procedure, not an AI/ML-based diagnostic or imaging device. Therefore, MRMC studies and AI assistance are irrelevant.

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

   • Not applicable. As stated above, this is a physical medical device, not an algorithm.

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

   • Not applicable. The "ground truth" for this 510(k) is the established performance and characteristics of the predicate devices (K171601 and K032840), which presumably met their own regulatory requirements (likely via prior 510(k)s based on bench testing, limited animal/clinical data, and comparison to even older predicates).

7. The sample size for the training set:

   • Not applicable. No training set is used as this is not an AI/ML device.

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

   • Not applicable. No training set is used.

In conclusion, this 510(k) submission (K181713) for the Ultraxx™ Nephrostomy Balloon Catheter Set explicitly states that there were no changes to the device (Ultraxx balloon catheter, Amplatz sheath, and the Cook Sphere Inflation Device) that would affect biocompatibility, sterility, or performance compared to its predicate devices. The only "modification" from the predicate devices was that the two predicate devices (Ultraxx™ Nephrostomy Balloon Catheter and Cook Sphere Inflation Device) are now provided together as a convenience kit.

Therefore, the "study" proving the device meets acceptance criteria is primarily the demonstration of identical characteristics to the already cleared predicate devices, supported by specific bench testing for the new "packaging configuration" (packaging integrity testing following simulated distribution). The success criterion for this submission was demonstrating "substantial equivalence" to the predicates, which was met as indicated by the FDA’s clearance letter.

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The Ureteral Dilator Sets are intended for the dilation of the ureter prior to ureteroscopy or stone manipulation.

The Ureteral Dilators are intended for the dilation of the ureteroscopy or stone manipulation.

The Ureteral Dilator Sets, and each individual Ureteral Dilator, are used for dilation of the ureter prior to ureteroscopy and/or stone manipulation. The Ureteral Dilator Sets are available in one of three sets: a set of 6 dilators, a set of 7 dilators and a wire guide, or a set of 9 dilators and a wire guide. The dilators are manufactured from either radiopaque ethylene vinyl acetate (EVA) or fluorinated ethylene propylene (FEP). Dilators manufactured with EVA are also available with hydrophilic coating. Dilators are also available individually. The wire guide is a stainless steel fixed core wire guide. The Ureteral Dilators and the Ureteral Dilator Sets are sterilized by ethylene oxide and intended for one-time use.

All Ureteral Dilators are manufactured with a length of 60 centimeters and range from 6.0 French to 18.0 French in diameter. The distal end of the dilators is tapered to a 0.040inch diameter endhole with the taper measuring 0.8-2.5 centimeters from the distal end, depending on the device French size. Additionally, the French size of each dilator is stamped at the proximal end.

The stainless steel fixed cored wire guide is manufactured with a diameter of 0.038 inches (0.97 millimeters) and a length of 145 centimeters.

The provided document is a 510(k) premarket notification for a medical device (Ureteral Dilator Sets and Ureteral Dilators). This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific performance criteria through a clinical or algorithmic study with defined acceptance criteria for a new, unproven technology.

Therefore, the document does not contain the kind of information requested in your prompt, which pertains to studies proving performance against acceptance criteria for an AI/ML or diagnostic device (e.g., sensitivity, specificity, physician improvement with AI assistance, ground truth establishment).

The "acceptance criteria" discussed in this document refer to bench testing for physical characteristics of the dilators, not clinical performance metrics or AI algorithm performance.

Here's why the document doesn't fit your prompt's requirements:

• Device Type: The device is a physical medical instrument (ureteral dilators), not an AI algorithm, diagnostic tool, or imaging system that would typically have performance metrics like sensitivity, specificity, F1-score, or require MRMC studies.
• Submission Type: A 510(k) for this type of device focuses on demonstrating substantial equivalence in terms of intended use, technological characteristics, and safety/effectiveness profiles compared to a predicate, often through bench testing and material characterization, rather than new clinical efficacy studies.
• Tests Performed: The tests listed (Tensile, Kink Resistance, Dilator Tip Rollback, Lubricity, Dimensional Verification, Radiopacity, Biocompatibility, Sterility, Packaging Integrity) are all bench tests and material/biological compatibility assessments, not performance studies involving human readers or AI output.

If I were to hypothetically interpret the "acceptance criteria" from the bench testing context within the provided document, here's how it would look, but please be aware this is not what your prompt is asking for in terms of AI/diagnostic device performance:

Hypothetical Table of "Acceptance Criteria" for Ureteral Dilators (Based on Bench Testing from Document)

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The Balloon In-deflation device is used for the inflation of a balloon dilatation catheter, to dilate the vessel or implant a stent.

The Balloon In-deflation Device is a 20ml or 30ml disposable device capable of producing a maximum pressure of 30atm/bars. It is fitted with a threaded plunger, a flexible high pressure extension tube, and a three-way high pressure stopcock. The luminescent pressure gauge with adjustable angle allows physician to read and monitor more easily in clinical environment. The product is designed under ergonomic principle that could be handled comfortably, easily and securely. The balloon in-deflation device mainly composes of four parts, injecting system (syringe), pressure gauge and extension tube, 3way stopcock, respectively. The syringe consists of a screw type plunger and a locking lever, by rotating palm grip to control the plunger; the pressure gauge is to measure pressure and the extension tube is to connect catheters. The angle of the pressure gauge can be re-adjusted during the procedure.

Based on the provided text, here's a description of the acceptance criteria and the study that proves the device meets them:

The document does not detail specific acceptance criteria for each performance characteristic of the Mastro Plus Balloon In-deflation Device. Instead, it asserts substantial equivalence to predicate devices through a comparison of design specifications and non-clinical performance testing. The overarching "acceptance criteria" appear to be that the proposed device must meet all design specifications and perform as safely and effectively as the predicate devices.

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

While explicit acceptance criteria are not presented as numerical targets to be met, the table below infers the performance characteristics evaluated and the proposed device's performance as compared to its predicates. The "Acceptance Criteria" column reflects the general expectation for substantial equivalence (i.e., being comparable to or within acceptable ranges of the predicate's performance).

2. Sample size 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 sample sizes for any of the non-clinical tests (biocompatibility or bench testing). It also does not provide details on the data provenance such as country of origin or whether the data was retrospective or prospective. The tests are described as general performance testing and biocompatibility testing.

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 section is not applicable. The device is a "Balloon In-deflation Device," which is a physical medical instrument used for inflation/deflation of balloons and stents. The "ground truth" here is established through engineering and biological testing against specifications and standards, not through expert clinical consensus on interpretations of medical data.

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

This section is not applicable. As above, the "test set" refers to physical device testing, not clinical data requiring adjudication by experts.

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 section is not applicable. The device is a physical medical instrument for catheter inflation/deflation, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance is irrelevant.

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

This section is not applicable. The device is a physical medical instrument, not an algorithm.

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

The "ground truth" for this device is established through:

• Design specifications: The device is designed to perform according to a set of pre-defined engineering and functional specifications (e.g., pressure range, volume dispensed per rotation, material composition).
• Recognized industry standards: Compliance with standards like ISO 11135-1:2006 for sterilization validation and ISO 11607-1:2006 for sterilization package performance.
• Biocompatibility testing results: Tests like pyrogen, endotoxin, acute systemic toxicity, irritation, cytotoxicity, skin sensitization, haemolysis, complement activity, and thrombosis tests provide "ground truth" regarding the device's biological safety.
• Bench testing results: Tests for appearance, positive/negative pressure sealing, male luer lock, capacity scale, and gauge accuracy provide "ground truth" for the device's physical and functional performance.

8. The sample size for the training set

This section is not applicable. This device is a physical medical instrument, not a machine learning model. Therefore, there is no "training set."

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

This section is not applicable. As stated above, there is no "training set" for this device.

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The Gyrus ACMI Uro - EZDilate Ureteral Balloon Dilation Catheter is recommended for dilation of the urinary tract.

The Gyrus ACMI Uro - EZDilate Ureteral Balloon Dilation Catheter is a reinforced catheter attached to a distal dilatation balloon. It has a radiopaque tip and two radiopaque markers positioned inside the balloon that define the working length. The balloon catheter can be used to dilate strictures of the urinary tract.

The provided text describes a traditional 510(k) Notification for a medical device, the Gyrus ACMI Uro - EZDilate Ureteral Balloon Dilation Catheter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical trial data or performance metrics against specific acceptance criteria for AI/algorithm-based devices.

Therefore, many of the requested details, particularly those related to AI/algorithm performance, ground truth establishment, expert adjudication, and comparative effectiveness studies, are not applicable to this document. The submission relies on engineering and sterility testing, as well as the similarity to an existing device, to establish safety and effectiveness.

Here's a breakdown of the available information:

Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for a 510(k) submission like this are primarily met through demonstrating substantial equivalence to a predicate device and compliance with relevant voluntary standards and performance testing. There are no specific quantifiable acceptance criteria presented in the document in the format of AI performance metrics (e.g., sensitivity, specificity, AUC).

The reported "device performance" is described through a summary of various engineering and material tests, rather than clinical outcomes or diagnostic accuracy.

• Balloon Burst Testing
• Balloon Kink Testing
• Durability Testing (cycle testing)
• Compliance Testing
• Balloon Shape Characteristics Testing
• Balloon Insertion Force Testing
• Balloon Cystoscope Compatibility Testing
• Balloon Deflation Testing |

Details Not Applicable or Not Provided in the Document:

1. Sample size used for the test set and the data provenance: This is not an AI/algorithm device that uses test sets of data for performance evaluation in the typical sense. The "testing" refers to bench testing and material compatibility.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI performance (e.g., diagnostic labels) is not part of this submission.
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 is not an AI-assisted diagnostic 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): Not applicable. The "ground truth" for this device's safety and effectiveness is primarily established through compliance with standards, material properties, and comparison to the predicate device's established safety record.
7. The sample size for the training set: Not applicable. This device does not involve machine learning or training sets.
8. How the ground truth for the training set was established: Not applicable.

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The Uromax Ultra Balloon Catheters are recommended for dilatation of the urinary tract.

The Balloon Dilatation Catheter, styled after the Gruntzig technique, is a multiple lumen catheter with a dilatation balloon mounted at the distal tip. Dilatation balloon catheters are used to exert radial force to dilate narrow ureteral segments.

The Uromax Ultra™ Balloon Dilatation Catheter did not involve a study of software/AI performance, thus many of the requested categories are not applicable. The device is a physical medical device, not a software or AI product.

Here’s a breakdown of the available information regarding its acceptance criteria and the study that proves it meets those criteria, given the context of a physical device submission:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly list acceptance criteria in a table format with corresponding performance results. Instead, it describes "performance testing (bench evaluation)" conducted to evaluate the effects of a design change. The conclusion is that the device demonstrates "equivalence of the Uromax Ultra Balloon Catheter to the predicate balloon dilatation catheter (K980795)."

Below is a table summarizing the tested characteristics:

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

The document states that "Boston Scientific has conducted performance testing with samples aged at T=0 and T=7 months accelerated aging." However, it does not specify the exact sample size used for these tests. The data provenance is internal to Boston Scientific, as these are bench evaluations of a physical device. No country of origin for the data is explicitly mentioned beyond the company's location (Marlborough, MA, USA), and it is a prospective bench study (evaluating new design changes).

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

This information is not applicable. The device is a physical catheter, and the "ground truth" for its performance is established through objective engineering measurements and tests against predefined specifications and comparisons to a predicate device, not through expert consensus on interpretations.

4. Adjudication Method for the Test Set

This information is not applicable as the "test set" consists of physical device samples undergoing engineering performance evaluations, not human interpretations requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that rely on human interpretation, often with AI assistance. The Uromax Ultra™ Balloon Dilatation Catheter is a therapeutic device, and its performance is evaluated through physical characteristics in bench testing.

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

No, this is not applicable. The device is a physical catheter, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for evaluating the Uromax Ultra™ Balloon Dilatation Catheter is based on objective engineering and performance specifications derived from the predicate device (K980795) and industry standards for balloon dilatation catheters. The goal was to demonstrate "substantial equivalence" regarding intended use, technological characteristics, and performance characteristics to the predicate device. Biocompatibility was supported by data from K121614 for a similar product.

8. The Sample Size for the Training Set

This information is not applicable as this is a physical device submission, not an AI/software submission that would involve a training set.

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

This information is not applicable for the reasons stated in point 8.

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The CYSTOGLIDE DILATING INTRODUCER SHEATH is intended to facilitate the dilation of urethral strictures and the introduction of catheters or instruments into the urethra. The CYSTOGLIDE DILATING INTRODUCER SHEATH is indicated for use as a urethral dilator and as a guide for urological catheters or instruments and as a lubricious barrier between the urethral tissue and the catheter or instrument.

The CYSTOGLIDE DILATING INTRODUCER SHEATH consists of a film, a sheath, a stabilizing hub and a dilator. The device can be front-loaded onto a urological guidewire.

The provided 510(k) summary for the CYSTOGLIDE DILATING INTRODUCER SHEATH does not contain specific acceptance criteria or a detailed study proving the device meets explicit performance metrics.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices based on "Performance data demonstrated no significant difference in the performance of the CYSTOGLIDE DILATING INTRODUCER SHEATH and the predicate device." This means the device's performance was compared to existing, legally marketed devices, rather than against predefined, quantitative acceptance criteria.

Therefore, providing a table of acceptance criteria and reported device performance as requested, along with details about sample sizes, ground truth establishment, expert qualifications, and MRMC studies, is not possible based on the information given. The document does not provide these types of details because the approval pathway is substantial equivalence, not a demonstration of meeting specific performance endpoints.

However, I can extract and summarize the available information related to performance and study references:

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

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

• Sample Size: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document only refers to "Performance data."

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

• Not applicable/Not specified. The document does not describe a study involving human expert evaluation for establishing ground truth or performance.

4. Adjudication method for the test set

• Not applicable/Not specified.

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 physical medical device (dilating introducer sheath), not an AI/software device that would involve human readers or comparative effectiveness studies with AI assistance.

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

• Not applicable. This is a physical medical device.

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

• Not applicable/Not explicitly stated. The "performance data" likely refers to bench testing or animal model studies assessing physical properties and functionality mimicking the intended use, rather than clinical ground truth as understood in diagnostic AI/imaging studies. The comparison is to a predicate device's performance.

8. The sample size for the training set

• Not applicable. This is for a physical device, not an algorithm requiring a training set.

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

• Not applicable.

Summary based on available information:

The 510(k) submission for the CYSTOGLIDE DILATING INTRODUCER SHEATH demonstrates substantial equivalence based on a comparison to predicate devices, specifically stating "Performance data demonstrated no significant difference in the performance of the CYSTOGLIDE DILATING INTRODUCER SHEATH and the predicate device." The document does not provide details on quantitative acceptance criteria, specific study designs (e.g., sample sizes, provenance), expert involvement, or AI-related metrics as it pertains to a physical medical device rather than a diagnostic algorithm or AI system.

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The Inflation Device is recommended for use with balloon dilatation catheters to create and monitor the pressure in the balloon and to deflate the balloon.

The Athor Modiour & Locking palm grip that control that control the plunger, a manometer to measure pressure and a connecting tube.

The provided text describes a 510(k) premarket notification for the "Atrion Medical QL® Inflation Device". It is a submission for a medical device, and as such, the concept of "acceptance criteria" and "study proving the device meets acceptance criteria" as typically understood in the context of clinical trials for diagnostic algorithms or AI models does not directly apply here.

Instead, the document focuses on demonstrating substantial equivalence to legally marketed predicate devices, which is the primary regulatory pathway for devices like this. Substantial equivalence means that the new device is as safe and effective as a legally marketed device that is not subject to PMA (Premarket Approval).

Here's an analysis based on the provided text, addressing the points you requested where applicable, and highlighting why some points are not relevant to this type of device and submission:

Analysis of Acceptance Criteria and Device Performance for Atrion Medical QL® Inflation Device (K032840)

1. Table of Acceptance Criteria and Reported Device Performance:

For a device like the Atrion Medical QL® Inflation Device, the "acceptance criteria" are primarily based on demonstrating that it performs equivalently to predicate devices in its fundamental functions and does not raise new questions of safety or effectiveness. The document states:

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

This information is not applicable to this type of 510(k) submission. The "test set" and "data provenance" as described in the context of AI/diagnostic algorithm validation (e.g., country of origin, retrospective/prospective) are not relevant here. This submission relies on engineering testing and comparison to predicate device specifications, rather than clinical data sets in that sense.

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

This information is not applicable. The "ground truth" for a device like an inflation device is based on objective engineering specifications (pressure, material safety, leak integrity, etc.) and its functional equivalence to predicate devices, not expert consensus on medical images or diagnoses.

4. Adjudication Method for the Test Set:

This information is not applicable. Adjudication methods (e.g., 2+1, 3+1) are for resolving discrepancies in expert interpretations, typically in diagnostic studies. This is not how the performance of an inflation device is evaluated.

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

This information is not applicable. MRMC studies are used to assess the impact of a diagnostic tool on human reader performance. The Atrion Medical QL® Inflation Device is a surgical accessory, not a diagnostic tool requiring such a study.

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

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

7. The type of ground truth used:

The "ground truth" for this device's safety and effectiveness determination is primarily based on:

• Engineering Specifications and Performance Testing: Demonstrating the device meets its functional requirements (e.g., pressure range, leak-free operation, material integrity).
• Predicate Device Equivalence: Showing that its design, materials, and intended use are substantially equivalent to previously cleared devices.
• Biocompatibility Testing: Ensuring materials in contact with body fluids are safe.

8. The sample size for the training set:

This information is not applicable. This is not an AI/ML device, so there is no "training set" in the computational sense. The design and testing are based on engineering principles and regulatory standards.

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

This information is not applicable for the same reasons as point 8.

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GIMMI ALPHA® Gastro-Urology and Laparoscopic Endoscopes, Endoscopic Accessories and GIMMI devices for minimally invasive gastrointestinal (GI), genitourinary (GU), and laparoscopic diagnostic and/or therapeutic indications are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/urologic and minimally invasive procedures.

GIMMI ALPHA Endoscopes are comprised of rigid, panoramic telescopes using rod lens technology. The body contact portions are composed of surgical grade stainless steel, which is commonly used in medical devices for a wide range of applications and has a long history of biocompatibility for human use.

Laparoscopic and urological-gastroenterologic and related accessories are composed of reusable handle and shaft assemblies and removable, reusable tip assemblies. Needle holders and other Class I devices included in the endoscopic catalogs may be onepiece. The instruments are designed and manufactured specifically for the purpose of manipulating soft tissue structures (grasping, cutting, dissecting, coagulating and suturing).

Minimally Invasive Gl and GU Devices are design specific for short term use in diagnostic and/or therapeutic procedures

This document is a 510(k) premarket notification for the GIMMI ALPHA® Endoscopic Instruments & Accessories. It establishes substantial equivalence to various predicate devices and describes the general characteristics of the device. However, it does not contain a detailed study with specific acceptance criteria and performance results directly comparable to those criteria in a quantitative manner.

Instead, the document states general compliance and conformance without providing numerical performance metrics or detailed study designs.

Therefore, many of the requested sections regarding specific acceptance criteria, performance data, sample sizes, ground truth establishment, and expert involvement cannot be extracted from this document based on the provided text.

Here's what can be inferred and what cannot:

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

• Acceptance Criteria: Not explicitly stated with quantifiable thresholds in the provided text. The document broadly states "safety, effectiveness, and reliability."
• Reported Device Performance: Not reported numerically. The document states, "All results were in conformance with the cited harmonized device standards" and "The results of design validation raise no new issues of safety and effectiveness."

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

• Sample Size: Not specified.
• Data Provenance: Not specified, but likely from GIMMI GmbH's internal testing.

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

• This information is not provided as the document does not detail specific clinical or performance studies involving "ground truth" established by experts. The "ground truth" in this context would typically refer to definitive diagnoses or outcomes for a clinical study comparing the device's output to reality, which is not described.

4. Adjudication method for the test set

• Not applicable/not provided, as no expert-adjudicated test set is described.

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

• This is not applicable. The device is described as "Endoscopic Instruments & Accessories" and devices "for minimally invasive GI, GU, and laparoscopic diagnostic and/or therapeutic indications." It is a physical medical device, not an AI-powered diagnostic tool, and therefore, an MRMC study with AI assistance is not relevant to this submission.

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

• This is not applicable as the device is a physical instrument, not a standalone algorithm.

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

• Not applicable/not specified for a clinical performance study involving "ground truth." The "performance and physical tests" would likely rely on engineering standards and measurements rather than medical ground truth.

8. The sample size for the training set

• Not applicable, as this is a physical medical device, not a machine learning algorithm requiring a "training set."

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

• Not applicable for the same reason as above.

Summary based on the provided text:

The document serves as a regulatory submission confirming that the GIMMI ALPHA® Endoscopic Instruments & Accessories are "substantially equivalent" to predicate devices. It states that:

• The devices have the same intended use.
• They are made of the same materials.
• They are produced to the same international and FDA-recognized standards.
• "All materials used... were subjected to performance and physical tests to evaluate safety, effectiveness, and reliability of the devices."
• "All results were in conformance with the cited harmonized device standards."
• "The results of design validation raise no new issues of safety and effectiveness."

However, it refrains from providing detailed study protocols, quantitative performance data, or specific acceptance criteria with reported numerical results. The substantiation relies on adherence to general standards and comparison to existing, cleared predicate devices rather than a new, detailed clinical performance study with defined acceptance criteria.

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