Search Results

2 Way Latex Foley Catheters

Indicated where routine drainage of the bladder is required ether postoperatively or for patients with conditions requiring urine drainage.

3 Way Latex Foley Catheter

Indicated where routine drainage of the bladder is required either postoperatively or for patients with conditions requiring urine drainage and for patients requiring bladder irrigation.

The Rüsch Latex Gold Foley Catheter is available as 2 Way catheter, with a proximal funnel, non-return inflation valve and bladder fixation balloon, and 3 Way catheter which includes an additional irrigation channel with proximal funnel. The catheter is manufactured of natural latex, provided sterile, single use, and disposable. The inflation valve is designed for use with Luer lock syringe tips. Balloon inflation volumes in millimeters, as well as shaft size in French gauge (Fr.), Charrière (Ch.), or millimeters (mm), are indicated on the funnel of each individual catheters are siliconized, or surface finished with Polytetrafluoroethylene (PTFE). The Gold Foley Catheter maximum use/indwelling period is less than 30 days. The device has different models of catheters namely PURE GOLD, Gold Pediatric, Gold, and the Gold Haematuria.

The provided text is an FDA 510(k) Premarket Notification for a medical device: the Rüsch Latex Gold Foley Catheter. This document largely focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance. It does not describe acceptance criteria for an AI/software as a medical device (SaMD) or a study proving its performance against such criteria. The document explicitly lists nonclinical testing conducted for the physical Foley catheter, such as biocompatibility, sterilization validation, accelerated aging, and performance/functional testing per ASTM standards for a physical medical device.

Therefore, I cannot extract the requested information regarding acceptance criteria for an AI/software device, its performance, sample sizes for test/training sets, expert qualifications, or details about MRMC studies, as these types of studies were not conducted or described in this document for the Rüsch Latex Gold Foley Catheter.

The document pertains to a physical medical device. The "acceptance criteria" discussed implicitly are related to the successful completion of the listed nonclinical tests and demonstrating substantial equivalence to the predicate device, YiKang Latex Foley Catheter (K173340), for FDA clearance. The "study that proves the device meets the acceptance criteria" refers to the nonclinical testing detailed in section 7 of the document.

Here's how I can answer based on the provided text, interpreting "acceptance criteria" and "study" in the context of a physical medical device:

Acceptance Criteria for the Rüsch Latex Gold Foley Catheter (Based on Nonclinical Testing):

Study Information (for a Physical Medical Device):

1. Sample sizes used for the test set and the data provenance: Not explicitly stated as numerical sample sizes. The document refers to "testing" and "assessment" for each standard. The data provenance is internal testing conducted by the manufacturer (Teleflex Medical, Inc.) to comply with FDA recognized standards. The data is retrospective in the sense that the tests were performed on manufactured devices.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. These are laboratory-based, objective performance tests on the physical device, not subjective expert reviews of data like in AI/SaMD studies. The "ground truth" is defined by the standards (e.g., successful sterilization, acceptable biocompatibility levels, functional performance specifications).
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Testing is objective and based on meeting specified numerical or qualitative limits defined by the standards.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This is a physical device, not an AI/SaMD.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No. This is a physical device, not an AI/SaMD.
6. The type of ground truth used:
   • Biocompatibility: In vitro and in vivo biological responses as defined by ISO 10993 series of standards (e.g., cell viability, skin irritation, systemic toxicity, tissue reaction on implantation).
   • Sterilization: Sterility assurance level (SAL) achieved through validated processes per ISO 11137.
   • Accelerated Aging: Functional performance of the device and integrity of the sterile barrier system after simulated aging.
   • Performance/Functional Testing: Physical and mechanical properties (e.g., balloon inflation, flow rate, material integrity) as specified by ASTM 623-19.
7. The sample size for the training set: Not applicable. There is no "training set" as this is not an AI/ML model.
8. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) for a traditional medical device (Foley catheter) and does not contain the information requested for AI/SaMD performance studies.

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2 Way SoftSimplastic Catheters:

Indicated where routine transurethral drainage of the bladder is required either postoperatively or for patients with conditions requiring transurethral urine drainage.

3 Way SoftSimplastic Catheters:

Indicated where routine transurethral drainage of the bladder is required either postoperatively, for patients with conditions requiring transurethral urine drainage and for patients requiring bladder irrigation.

The Rusch SoftSimplastic Foley Catheter is a balloon retention type catheter and is single use, disposable and sterile. The catheters are made of transparent PVC. They have a 2 lumen or 3 lumen shaft with proximal funnel, inflation valve and a distal retaining balloon made of latex. Balloon capacity is in ml and the shaft size in French gauge (Fr.) as indicated on the funnel of each individual catheter.

The provided text describes a 510(k) premarket notification for a medical device, the Rusch SoftSimplastic Foley Catheter, not an AI/ML medical device. Therefore, the information required to answer the prompt regarding acceptance criteria and studies for an AI/ML device (e.g., sample size for test/training sets, expert qualifications, ground truth establishment, MRMC studies) is not present in the document.

The document focuses on demonstrating substantial equivalence to a predicate device (Rusch Simplastic Foley Catheters) based on:

• Intended Use: Similar indications for use for bladder drainage and irrigation.
• Technological Characteristics: Similar balloon retention type, materials (PVC), sizes, lumens, sterilization method, single-use, and radiopacity. The key differences highlighted are a change in PVC plasticizer, extended shelf life, and slightly different size ranges.
• Non-Clinical Performance Testing: This includes:
  • Biocompatibility testing (e.g., cytotoxicity, sensitization, systemic toxicity, implantation) according to ISO 10993 standards.
  • Bench performance testing (e.g., visual inspections, strength, connector security, balloon safety, flow rate, kink stability, tensile force, radiopacity) according to ISO 20696, ASTM F623, and ASTM F640 standards.
  • Sterilization and Packaging validation according to ISO 11135-1, ISO 10993-7, ISO 11607, ASTM D4169, ASTM F1886, ASTM F88, EN 868-5, and ASTM F2096.

The document explicitly states: "Differences in technological characteristics between the subject and predicate devices do not raise different questions of safety and effectiveness." and "Performance test results demonstrate that the subject device is as safe and effective as the predicate device."

Therefore, I cannot provide the requested information regarding acceptance criteria and studies for an AI/ML device based on the provided text. The document pertains to a traditional medical device demonstrating substantial equivalence through non-clinical bench and biocompatibility testing, not an AI/ML algorithm requiring clinical performance studies against defined ground truth with human reader involvement.

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The subject device is a tubular device that is inserted through the urethra to pass urine from the bladder.

The Teleflex Rusch®FloCath Quick™ 18 French (Fr.) Coudé Hydrophilic Intermittent Catheter is single use, disposable and sterile. The catheter is made of clear polyvinylchloride (PVC) with vertically cut and softly rounded, polished eyes and has a hydrophilic coating. It is composed of a shaft with a proximal funnel and a tip. The funnel is made of PVC. The shaft size is an 18 French gauge and is identified on the packaging. The funnel is color coded red to facilitate size identification. The catheter is 40 cm in overall length. The FloCath Quick is an integrated package that contains the FloCath catheter with a blue protective catheter sleeve and a packet of sterile 0.9% saline. Before opening, the sterile saline pouch is broken to hydrate the catheter. The protective catheter sleeve allows for touchless insertion. The sleeve can also be pushed back and used as an extension to the catheter. The FloCath Quick packaging has a packaging hole to facilitate opening the catheter. Either the packaging hole or the adhesive patch on the catheter pack can be used to hang up the catheter in an appropriate, convenient location while the catheter is hydrated.

The provided text is a 510(k) summary for a medical device (Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria for performance metrics in a clinical context.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of algorithm performance or clinical outcomes are not applicable or cannot be extracted from this document, as it primarily details bench testing and a comparison to a predicate device for regulatory clearance.

However, I can extract the relevant bench testing performance data which serves as the "study" for this type of submission and interpret the "pass" results as meeting implicit acceptance criteria for substantial equivalence.

Here's the information that can be extracted, with explanations for what is not applicable:

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

For a 510(k) submission, the "acceptance criteria" for bench testing are generally that the device performs comparably to the predicate or meets established standards, and in all reported cases, the device "Passed". Specific numerical acceptance thresholds are not explicitly detailed in this summary for each test, but "Pass" indicates they were met.

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: The document does not specify the sample size for any of the bench tests conducted.
• Data Provenance: The document does not specify the country of origin of the data. The testing described is bench testing, not clinical data, so terms like "retrospective or prospective" do not directly apply.

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 (N/A). The "ground truth" concept is usually associated with clinical or image-based studies where expert consensus or diagnostic outcomes are used. This submission focuses on engineering bench tests and material biocompatibility, which do not typically involve experts establishing "ground truth" in this manner. The evaluations are based on compliance with international standards and internal protocols.

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

This section is Not Applicable (N/A). Adjudication methods are relevant for studies involving human interpretation or clinical endpoints, not for objective bench testing of device performance parameters.

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 (N/A). This device is a urological catheter, not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant.

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

This section is Not Applicable (N/A). As stated above, this is a physical medical device, not an algorithm.

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

This section is Not Applicable (N/A) in the traditional sense. For the bench tests, the "ground truth" or reference for assessment is established by the specified international and industry standards (e.g., EN 1616:1997, ASTM F623:2013, ISO 10993 series, ISO 11135-1:2014). Passing these standards serves as verification that the device meets defined engineering and safety specifications.

8. The sample size for the training set

This section is Not Applicable (N/A). This device is not an AI/ML algorithm that requires a training set.

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

This section is Not Applicable (N/A). As this is not an AI/ML device, there is no training set or ground truth in that context.

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The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate soft tissue to access certain areas of the abdomen. The system is used to grasp, manipulate, cut, cauterize and deliver Hem-o-lok® ligating clips to soft tissue during laparoscopic surgery.

Teleflex Medical's Percuvance™ Percutaneous Surgical System is a micro-laparoscopic platform that comprises fourteen (14) unique components, which are combined in various configurations to create a multifunctional set of instruments for laparoscopic procedures. In accordance with IEC 60601-1:2005 (A1:2012), the Percuvance™ system is classified as a BF active accessory with a rated accessory voltage of 1000VPeak. System components include two reusable Handles (Ratcheted and Non-Ratcheted), which are manipulated by the surgeon and connect to a Shaft, which is available in two lengths (29 cm and 36 cm), affords various Tool Tips (or End Effectors) to be attached in order to perform basic surgical manipulations. The Percuvance™ Handles, Shafts, and Tool Tips are not compatible or interchangeable with components from other percutaneous systems. Initial access to the surqical site is achieved with the Introducer Tool Tip attached to the Shaft. Once inside the patient, the Introducer Tool Tip is extracorporealized through a pre-inserted, central trocar and is then exchanged for one of the other Tool Tips, which include Scissors, Gripper Grasper, Johans Grasper, Maryland Dissector, Hook Cautery, Spatula Cautery and Clip Applier. No ligating clips are provided with the Percuyance™ Percutaneous Surgical System: however, the Clip Applier Tool Tip is compatible with Teleflex M/L Hem-o-lok® ligating clip (SKU 544230). Finally, the Seal Bridge, which is available in two sizes (5 mm and 12 mm), is used to protect the trocar seal and to aid in maintaining insufflation when it used in conjunction with a trocar to facilitate the extracorporeal exchange of Tool Tips.

This FDA 510(k) summary describes a medical device, the Percuvance™ Percutaneous Surgical System, and its substantial equivalence to a previously cleared predicate device. It does not contain information about the acceptance criteria or results from a study that typically involves human readers or AI.

Here's a breakdown of the information provided and what is missing in relation to your request:

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

• Not provided. The document states "Comprehensive bench testing was completed on the modifications identified below to ensure the system performed equivalently (or better) to the predicate system." However, specific quantitative acceptance criteria or detailed performance results in a table format are not present. The "Comparative Characteristics" table (pages 7-8) compares the proposed device to the predicate in terms of features and intended use, but not measured performance against pre-defined criteria.

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

• Not provided. The document mentions "bench testing" and "stability testing" but does not specify sample sizes for these tests or details about data provenance.

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 information is relevant for studies involving human interpretation or image analysis where ground truth is established by experts. This document describes a surgical instrument and its functional testing, not a diagnostic or interpretive device.

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

• No. This is not an AI-based diagnostic or interpretive device. Therefore, no MRMC study or AI-related effectiveness is discussed.

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

• No. This is not an AI-based device.

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

• Not explicitly described in terms of "ground truth" for clinical outcomes. The document refers to "bench testing" and "stability testing" to ensure the device performs "equivalently (or better) to the predicate system." The "ground truth" for these types of tests would be established engineering standards, material properties, and functional performance measurements against design specifications and predicate device performance. For biocompatibility, the ground truth is adherence to ISO standards.

8. The sample size for the training set

• Not applicable. This is not a machine learning or AI-driven device.

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

• Not applicable. This is not a machine learning or AI-driven device.

Summary of the Study and Device Performance (based on the provided text):

The document describes the Percuvance™ Percutaneous Surgical System, a micro-laparoscopic platform for grasping, manipulating, cutting, cauterizing, and delivering ligating clips during laparoscopic surgery.

The study to support its 510(k) clearance (K181852) was a substantial equivalence review against a predicate device (K153063 for the system, and K133202 for the clip applier technology and ligating clips).

Device Performance Information (extracted from the text):

The document states:

• "Comprehensive bench testing was completed on the modifications identified below to ensure the system performed equivalently (or better) to the predicate system."
• "Existing design, usability validations and packaging (ship) testing, performed on the predicate device still adequately covers the proposed device."
• "Stability testing was repeated on the sterile components and their packaging to support the legacy extended 3 year shelf life according to aging methods and test methods previously submitted in the predicate 510(k) in support of the initial 1 year shelf life."
• "Though the majority of the electrosurgical safety testing submitted for the system is still valid, certain electrosurgical safety tests were repeated at a third party test house to support the Shaft metal lock tube change."
• "Biocompatibility data submitted for the Percuvance system still adequately represents the proposed system, as no new patient contacting materials were introduced. However, as a result of Shaft's green ink band modification, which is pad printed on the Shaft's proximal knob, a full biocompatibility panel was completed. Additionally, cytotoxicity testing was performed on the Shaft metal lock tube change."

Conclusion from the document:
"Based upon the testing presented throughout the submission and in this 510(k) Summary, Teleflex Medical's Percuvance™ Percutaneous Surgical System is substantially equivalent in to the predicate device cleared to market via 510(k) K153063. The modifications to the proposed Percuvance™ Percutaneous Surgical System do not introduce any new issues of safety and effectiveness."

This submission relies on demonstrating that the modified device performs as well as the predicate device through various engineering and material tests, rather than a clinical study with specific acceptance criteria on diagnostic accuracy or reader performance typically seen with AI/imaging devices.

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MiniLap instruments are a family of minimally invasive devices with the means to penetrate soft tissue to access certain areas of the human anatomy. The devices are used to grasp. hold, and manipulate other soft internal tissues, as well as items such as hernia mesh, during pediatric and adult surgery.

The MiniPolar Instruments are used to cut and cauterize soft tissue during pediatric and adult surgery.

The MiniLap System with MiniGrip Handles grasping instruments have applications in a variety of general, thoracic, gynecologic, urologic, laparoscopic procedures for manipulation of tissue, as well as items such as hernia mesh, during pediatric and adult surgery.

Bipolar Grasper instruments with bipolar cautery have applications in a variety of general, thoracic, gynecologic (except for use in female sterilization), urologic, laparoscopic, and endoscopic procedures for manipulation and coagulation of tissue and for manipulation of items such as hernia mesh during pediatric and adult surgery.

The Teleflex MiniLap® Percutaneous Surgical System is a family of minimally invasive surgical devices that provide a surgeon with the means to penetrate soft tissue to access certain areas of the human anatomy, then grasp, hold and manipulate other soft internal tissue within the body that are related to the surgical procedure.

The MiniLap Percutaneous Surgical System has two families presented in this 510(k). The first is the MiniLap ThumbGrip Instruments, which have a thumb grip handle to control the instrument tips. These instruments are available in electrosurgical and non-electrosurgical configurations. The second product family discussed in this 510(k) is the MiniLap MiniGrip Graspers, which have a pistol grip handle that allows single handed device operation to control the jaws.

ThumbGrip Instruments and MiniGrip Graspers are disposable manual instruments designed for direct introduction to the surgical site without the need for a traditional insertion conduit. These instruments are used for grasping, holding and manipulating soft internal tissues. These percutaneous instruments provide the benefit of reduced trauma due to no surgical incision closure and the elimination of one or more trocars.

This document is a 510(k) Premarket Notification from the FDA regarding the Teleflex MiniLap System. It does not describe an AI/ML medical device, but rather a set of minimally invasive surgical instruments. Therefore, the requested information about acceptance criteria, study details for AI/ML performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training sets, and ground truth establishment methods for an AI device cannot be extracted from this document.

The document primarily focuses on demonstrating substantial equivalence of the Teleflex MiniLap System to previously cleared predicate devices based on technological characteristics, materials, and performance data from engineering tests, rather than clinical study results involving AI performance metrics.

Here's a breakdown of why this document doesn't contain the requested information for an AI/ML device:

• Device Type: The Teleflex MiniLap System consists of mechanical and electrosurgical instruments (graspers, probes) for surgical procedures. It is not an AI/ML diagnostic or prognostic tool.
• Performance Data Section: The "K. Performance Data" section refers to "Ship testing" (packaging integrity), "design verification and validation" (engineering tests), and testing to IEC standards for electrosurgical devices. It does not mention any clinical studies involving image analysis, AI algorithms, or human reader performance.
• Substantial Equivalence: The entire submission hinges on demonstrating that the new devices are "substantially equivalent" to existing, legally marketed predicate devices. This regulatory pathway (510(k)) often relies on non-clinical data and comparison to predicates, rather than extensive clinical efficacy trials typically required for novel AI technologies.

In summary, as this document pertains to traditional surgical instruments and not an AI/ML medical device, the specific details requested about AI/ML performance acceptance criteria and study methodologies are not present.

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The Rusch Brilliant Balloon Catheter is indicated for routine transurethral drainage of the bladder.

The Rusch Silicone Foley Catheter is a balloon retention type catheter and is single use, disposable and sterile. The retention balloon is attached to the silicone two-lumen shaft. One lumen is used for drainage and the other lumen for inflation of the balloon. Sterile water is used to inflate and deflate the balloon. The distal end has two opposite eye holes which are used for drainage. On the opposing end of the shaft are a connective funnel and a Luer activated valve.

The provided document is a 510(k) Summary for the Rusch Silicone Foley Catheter, which is a medical device. This type of document focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific efficacy or diagnostic performance acceptance criteria through clinical studies. Therefore, much of the information requested about acceptance criteria and detailed study design for diagnostic performance is not present in this document.

However, I can extract information related to the non-clinical performance testing which served to demonstrate substantial equivalence.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide specific numerical acceptance criteria (e.g., a specific peel strength in Newtons) or reported numerical performance data for the subject device. It states what was tested and the conclusion that the subject device is substantially equivalent.

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

• Sample Size: Not specified for any of the individual non-clinical performance tests.
• Data Provenance: The tests are "bench testing" which are conducted in a laboratory setting. No country of origin is specified for these tests, but the applicant is Teleflex Medical, Inc. in the USA. The data is retrospective in the sense that the tests were performed and analyzed to support this 510(k) submission.

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

This type of information is not applicable to the non-clinical performance (bench testing) described. Bench tests do not involve expert interpretation or ground truth establishment in the way a clinical diagnostic study would.

4. Adjudication Method for the Test Set

This is not applicable as there were no expert interpretations requiring adjudication for these bench tests.

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

No MRMC study was done. This document describes a medical device (catheter) for drainage, not an AI or diagnostic imaging device that would typically involve an MRMC study.

6. Standalone (Algorithm Only) Performance Study

No standalone performance study of an algorithm was done. This is a physical medical device.

7. Type of Ground Truth Used

For the bench tests, the "ground truth" would be the engineering specifications and established test methods (e.g., ISO standards, internal company standards) for measuring properties like peel strength, security, and reliability. This is not "expert consensus," "pathology," or "outcomes data" in the clinical sense. For biocompatibility, the ground truth is established by the successful completion of tests adhering to ISO 10993.

8. Sample Size for the Training Set

No training set is mentioned or applicable. This is not a machine learning or AI device.

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

Not applicable as there is no training set.

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These catheters are indicated for routine transurethral drainage of the bladder or for routine post-operative transurethral drainage and irrigation of the bladder.

The Rusch Simplastic Folev Catheter is a balloon retention type catheter and is single use, disposable and sterile. The catheters are made of transparent PVC. They have a 2 lumen or 3 lumen shaft with proximal funnel, inflation valve and a distal retaining balloon made of latex. Balloon capacity is in ml and the shaft size in French gauge (Fr.) as indicated on the funnel of each individual catheter.

This document is a 510(k) summary for the Rusch Simplastic Foley Catheters (K162989). It focuses on establishing substantial equivalence to predicate devices through a comparison of features and non-clinical performance testing. It does not describe a study in the typical sense of evaluating AI performance or human reader improvement.

Therefore, the requested information, which is largely geared towards evaluating an AI/CADe device's performance, cannot be extracted from this document. This document concerns a medical device (foley catheters), not an AI system. The "acceptance criteria" here refers to the device meeting specific engineering and performance standards, not diagnostic accuracy metrics.

However, I can extract the relevant non-clinical performance testing information as an analogy to acceptance criteria and the study that proves it, interpreting "device performance" in the context of a physical medical device.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:
This information is not provided in the document. The document states "bench testing" was performed, but does not detail the sample sizes for each test. Data provenance (country of origin, retrospective/prospective) is also not applicable for physical device bench testing in the same way it would be for clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as this is not a study requiring expert interpretation of results for ground truth establishment (e.g., image interpretation). These are physical device performance tests.

4. Adjudication method for the test set:
This information is not applicable as this is not a study requiring adjudication of expert interpretations.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This information is not applicable as this document does not describe a study involving human readers or AI.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable as this document does not describe an algorithm or AI system.

7. The type of ground truth used:
For the non-clinical performance tests, the "ground truth" would be established engineering specifications and regulatory standards. For example, a "Balloon Peel Strength" test would have an a priori defined minimum force requirement for the balloon to remain attached. For biocompatibility, the ground truth is compliance with ISO 10993 standards.

8. The sample size for the training set:
This information is not applicable as this document does not describe a machine learning model or training set.

9. How the ground truth for the training set was established:
This information is not applicable as this document does not describe a machine learning model or training set.

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The Arrow Epidural Catheter kit permits access to the epidural space for the administration of epidural anesthetic. The epidural catheter kit is intended for use up to 72 hours.

The Arrow Epidural Catheter Kit consists of the epidural catheter packaged with various combinations of accessory components including 0.2 Micron In-Line Flat Anesthesia Conduction Filter necessary for the catheter insertion procedure.

This document is a 510(k) summary for the Arrow Epidural Catheter Kit, which is a medical device. It does not describe an AI/ML device, therefore, the requested information points (1-9) about acceptance criteria and study proving device meets acceptance criteria are not applicable in the context of an AI/ML device.

However, I can provide the available information related to the device and its testing as presented in the document:

Device Type: Medical Device (non-AI/ML). Specifically, an Anesthesia Conduction Kit.

G. Indications for Use:
The Arrow Epidural Catheter kit permits access to the epidural space for the administration of epidural anesthetic. The epidural catheter kit is intended for use up to 72 hours.
Patient Population: Adult

H. Technological Characteristics Comparison to the predicate:
The proposed Arrow Epidural Catheter Kit with 0.2 Micron In-Line Flat Anesthesia Conduction Filter is substantially equivalent to the predicate device (Arrow Epidural Catheter Kit - K143581) with respect to indications for use, technology, and construction. The differences mentioned are minor and related to the filter component:

• Filtration Area: Predicate: 3.8 cm², Proposed: 5.25 cm²
• Housing Material: Predicate: Modified acrylic, Proposed: Modified Acrylic (This appears to be a re-statement, not a difference in material, possibly a clarification from the manufacturer)
• Filter Material: Predicate: Polyethersulfone, Proposed: Supor Polyethersulfone
• Kit Components: Same, except for the 0.2 Micron Anesthesia Conduction Filter.

I. Performance Data:
A summary of tests relied upon to demonstrate substantial equivalence to the predicate is provided. These tests are physical and biological performance tests for the medical device components.

J. Conclusion:
"The Arrow Epidural Catheter kit has the same indications for use and technology of construction as the predicate devices. Performance test results demonstrate that the proposed device meets its intended use. It is for these reasons that the proposed device can be found substantially equivalent."

Since this document pertains to a traditional physical medical device and not an AI/ML powered device, the requested information points (1-9) regarding acceptance criteria and studies for AI/ML performance (e.g., sample sizes for test/training sets, expert qualifications, ground truth methods, MRMC studies, standalone performance) are not applicable to the content provided. The "performance data" provided refers to the physical and biological tests conducted on the device's components to ensure its safety and effectiveness.

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'cottony'TM II Polyester Suture Tape is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, orthopedic and neurological procedures.

Deknatel Pledgets are indicated as sterile, single use, implantable devices for general suture reinforcement and suture buttressing.

Deknatel Polyester Suture Tapes are nonabsorbable, sterile surgical sutures composed of Poly(ethylene terephthalate). They are prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component. Deknatel Polyester suture tapes are provided braided, undyed (white) and dyed

Deknatel Pledgets are precut pieces from a sheet of polytetrafluoroethylene (PTFE) fabric used to spread the load the suture against host tissue.

The document provided is a 510(k) summary for the 'cottony' II Polyester Suture Tape and Pledgets. It states that the device is substantially equivalent to a predicate device (K021019) and preamendment devices. However, it does not contain a study that proves the device meets specific acceptance criteria in terms of performance metrics like sensitivity, specificity, accuracy, or effect size.

Instead, the document primarily focuses on establishing substantial equivalence through:

1. Indications for Use: The 'cottony' II Tape is for general soft tissue approximation and/or ligation (including cardiovascular, ophthalmic, orthopedic, and neurological procedures), and the Pledgets are for suture reinforcement and buttressing. These indications are aligned with the predicate device.
2. Technological Characteristics: A comparison was performed which demonstrated equivalence in performance characteristics.
3. Materials: All patient-contacting materials comply with ISO10993-1.
4. Performance Data (Non-clinical testing): Testing was performed in accordance with ISO11607-1:2006 (packaging) and USP 36-NF 31 <871> (sutures-needle attachment), and <881> (tensile strength) to demonstrate substantial equivalence to the predicate devices.

Therefore, I cannot provide the specific details requested in the acceptance criteria table and the subsequent points (2-9) because this type of information (e.g., sample size, data provenance, number of experts for ground truth, MRMC study results, standalone performance, training set details) is typically found in clinical studies or detailed performance verification reports, which are not part of this 510(k) summary. The 510(k) process relies on demonstrating equivalence to a legally marketed predicate, rather than establishing de novo performance metrics with acceptance criteria like those described for AI/ML devices.

Summary of available information related to performance criteria (though not in the requested format):

The following information cannot be extracted from the provided document as it does not describe a study involving algorithms, AI, or specific clinical performance metrics with detailed acceptance criteria of the type implied by the questions:

2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and their qualifications.
4. Adjudication method for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improvement with AI vs without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc).
8. The sample size for the training set.
9. How the ground truth for the training set was established.

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The Hudson RCI® AquaPak® Sterile Prefilled Nebulizer adds sterile water or saline solution in aerosol form to a patient's breathing gases. It may be used with pediatric (ages 2 years and above) and adult patients.

Hudson RCI® AquaPak® Sterile Prefilled Nebulizers provide sterile water or sterile saline for inhalation therapy. Nebulizers generate aerosol, a fine mist of liquid water (or sodium chloride solution) that is suspended in the gas to be inhaled by the patient during aerosol therapy.

The Hudson RCI® AquaPak® Sterile Prefilled Nebulizers consist of two components, a sterile adaptor and a prefilled sterile reservoir. The adaptor may be type 028 or type 033. The standard model with a yellow collar (type 028) and the quiet model with a blue collar (type 033) feature an adjustable air entrainment window, which provides a specific oxygen concentration by entraining room air into the oxygen stream. Prefilled sterile reservoirs for the Hudson RCI® AquaPak® Sterile Prefilled Nebulizers come in three sizes; 440ml, 760ml and 1070ml, and may be sterile water or sterile sodium chloride solution. The sterile reservoirs are cleared under K141214, and are presented here for reference only. Each reservoir, when combined with an adaptor component, provides nebulizer functionality when connected to a gas source.

The primary purpose of this Traditional 510(k) submission is to change the nebulizer adaptor cleared in K141214 from non-sterile, and update the packaging materials and shelf life to maintain sterility.

The document describes a 510(k) summary for the Hudson RCI® AquaPak® Sterile Prefilled Nebulizers. This is a medical device submission, and the content provided outlines the device, its intended use, and the testing performed to demonstrate its substantial equivalence to a predicate device.

Here's an analysis of the provided text in the context of your request for acceptance criteria and study details:

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

The document provides a table outlining the tests performed and a general statement about performance. Specific quantitative acceptance criteria are not explicitly listed in a separate column, but the "Principle of Test" column often hints at what was being measured. The reported device performance for these tests is generally stated as "The device passed all of the acceptance criteria for the tests" or "The packaging passed all of the acceptance criteria for the tests."

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 states "Bench testing has been performed". However, it does not specify the sample size used for any of the tests (e.g., how many devices were tested for lift pressure, nebulization rate, etc.). It also does not mention the country of origin of the data or whether the data was retrospective or prospective. Given it's bench testing, it's typically prospective in nature, but this is not explicitly stated.

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 to the provided document. The document describes a technical device (nebulizer) performance assessment, not an AI or diagnostic device that requires expert-established ground truth for image or data interpretation. The ground truth for these tests would be objective measurements against established engineering and industry standards.

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

This section is not applicable for the same reasons as point 3. Adjudication methods are relevant for subjective interpretations, typically in diagnostic studies with multiple human readers.

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 document describes the performance of a medical device (a nebulizer), not an AI algorithm designed to assist human readers or interpreters.

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

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

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

The ground truth for the type of testing described (packaging integrity, sterility, lift pressure, oxygen entrainment, nebulization rate, particle size distribution) would be objective measurements against predefined engineering specifications and regulatory standards. For example, sterility would be verified by microbiological testing against a defined sterility assurance level (SAL), and particle size distribution would be measured using validated instruments against a specified range. It's not expert consensus, pathology, or outcomes data in this context.

8. The sample size for the training set

This section is not applicable. The document describes the testing of a physical medical device. There is no mention of a "training set" as this term is typically used in the context of machine learning or AI development.

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

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

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