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The BiFlex Evo is intended to be a conduit for passage of endoscopes and other urological devices for the purpose of performing ureteroscopy procedures. The dual working lumen dilator with luer lock connections allows the user to insert guidewires and fluids.

The Bi-Flex Evo Ureteral Access Sheath is designed to create a conduit for urological procedural instruments. The device consists of two components: a flexible, coil reinforced sheath and a semirigid dual lumen dilator catheter with tapered distal tip. Both components are radiopaque and have hydrophilic coating. This device is sold in two sizes,10/12 and 12/14 FR, and two lengths, 35 and 45 cm.

This document is a 510(k) summary for a medical device called "Bi-Flex Evo," a ureteral access sheath. It describes the device, its intended use, and the testing performed to demonstrate its substantial equivalence to a predicate device.

Analysis of the provided text reveals that this document focuses on a physical medical device (a urological catheter/sheath) and its mechanical performance, biocompatibility, and sterilization, rather than an AI-powered diagnostic or imaging device.

Therefore, most of the requested information regarding acceptance criteria and studies for an AI/ML-based medical device (such as sample size for test/training sets, data provenance, expert ground truth adjudication, MRMC studies, standalone performance, etc.) is not applicable to this submission.

The document discusses "bench testing" to demonstrate mechanical strength and "biocompatibility" testing, which are standard for physical medical devices.

Here's the relevant information that can be extracted from the document, along with explanations for why other requested information is not present:

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

The document states: "All bench testing results confirmed that the products described in this submission met the necessary specification." However, it does not explicitly list the quantitative acceptance criteria for these tests (e.g., specific tensile strength values, burst pressures, etc.) nor the exact numerically reported performance results. It only provides a qualitative statement of meeting specifications.

Table of Acceptance Criteria and Reported Device Performance (as inferred):

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

• Not Applicable. This pertains to a physical device, not an AI model. "Test set" in this context would refer to the number of physical units tested. The document does not specify the number of devices used for bench testing, biocompatibility, or sterilization validation. Data provenance (country, retrospective/prospective) is not relevant for this type of device testing as it's not based on patient 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)

• Not Applicable. Ground truth in the context of AI/ML refers to labels for data. For a physical device, performance is evaluated against engineering specifications and international standards, not expert consensus on data interpretation.

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

• Not Applicable. This refers to methods for establishing ground truth for data labeling, which is not relevant for a physical medical device's performance testing.

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. MRMC studies are used to evaluate diagnostic imaging systems, often in conjunction with AI. This is a physical device (ureteral access sheath), not an imaging system or AI diagnostic tool.

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

• Not Applicable. This refers to AI algorithm performance. This device is a physical instrument.

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

• The "ground truth" for a physical device like this is its adherence to engineering specifications, material properties, and performance standards (e.g., mechanical strength, biocompatibility, sterility) as defined by established industry and regulatory guidelines (e.g., ISO, FDA guidance documents). There is no "expert consensus" on imaging or clinical outcomes data for its function.

8. The sample size for the training set

• Not Applicable. This refers to AI model training data.

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

• Not Applicable. This refers to AI model training data ground truth.

Summary of Device Performance/Compliance (as per 510(k) Summary):

The manufacturer conducted bench testing to demonstrate that the Bi-Flex Evo Ureteral Access Sheath:

• Provides adequate mechanical strength for its intended use.
• Meets necessary specifications for performance.
• Is biocompatible in accordance with ISO 10993.
• Has validated sterilization processes in accordance with recognized industry standards.
• The material change in the dilator (LDPE to Polyurethane) provides increased flexibility for safer introduction and does not affect the intended use or fundamental scientific technology.
• The addition of printed marks aids in visualization of penetration depth for safer insertion.

The conclusion is that the Bi-Flex Evo is substantially equivalent to its predicate device (Bi-Flex Ureteral Access Sheath K140441) and is safe and effective for its intended use.

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The Vesair Cystoscopic Sheath is intended to facilitate the introduction of catheters or instruments into the urethra. The Vesair Cystoscopic Sheath is indicated for use as a guide for urological catheters or instruments inserted into the urethra and as a lubricious barrier between the urethral tissue and the catheter or instrument.

The Vesair Cystoscopic Sheath is intended for use in visualizing the urethra and bladder as well as the establishment of a protective tract into the bladder to facilitate atraumatic insertion of catheters and instruments through the urethra.

The Vesair Cystoscopic Sheath Assembly includes a Visual Obturator, Sheath and the Vesair Single-Use Sterile Seal. The Sheath is provided non-sterile and requires cleaning and steam sterilization prior to use.

The provided text is a 510(k) premarket notification document for the "Vesair Cystoscopic Sheath." It primarily focuses on demonstrating substantial equivalence to a predicate device ("Guardian Urethral Sheath") rather than providing detailed acceptance criteria and study results for a new, AI-powered medical device.

Therefore, the document does not contain the information requested regarding:

1. A table of acceptance criteria and reported device performance: The document mentions "in vitro performance tests" but does not provide specific acceptance criteria (e.g., specific thresholds for success in a test) or the quantitative results of these tests.
2. Sample size used for the test set and data provenance: No information is given about sample sizes for any "test set" in the context of device performance, nor is there any mention of data provenance (e.g., country of origin, retrospective/prospective).
3. Number of experts and their qualifications for ground truth: This is irrelevant as the device isn't an AI/imaging device requiring expert ground truth for interpretation.
4. Adjudication method: Not applicable for this type of device and study.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as this is a medical device, not an AI-assisted diagnostic tool.
6. Standalone (algorithm only) performance: Not applicable, as there is no algorithm or AI component mentioned.
7. Type of ground truth used: Not applicable in the context of a new AI/imaging device. The "performance data" mentioned are for mechanical and material properties.
8. Sample size for the training set: Not applicable, as there's no machine learning or AI training involved.
9. How ground truth for the training set was established: Not applicable for the same reason.

The document lists "In Vitro Performance Testing" as part of the performance data, including:

• Design Verification Testing / Simulated Use Testing
• Ship Testing
• Repeat Steam Sterilization Testing
• Accelerated Aging

However, it does not provide the details of these tests, their acceptance criteria, or the results. It concludes by stating that "Based upon the in vitro performance tests, the Vesair Cystoscopic Sheath has been shown to be substantially equivalent to the currently marketed Guardian Urethral Sheath K141252."

To summarize, the provided text describes a regulatory submission for a medical device (a cystoscopic sheath) and its claim of substantial equivalence to a predicate device, focusing on material, design, and sterilization comparisons. It is not an AI/software device and therefore does not have the types of performance data, ground truth establishment, or study methodologies that would be relevant to the questions posed.

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The Bi-Flex Ureteral Access Sheath is intended to be a conduit for passage of endoscopes and other urological devices for the purpose of performing ureteroscopy procedures. The dual working lumen dilator with luer lock connections allows the user to insert guidewires and fluids.

The Bi-Flex Ureteral Access Sheath is designed to create a conduit for urological procedural instruments. The device consists of two components: a flexible, coil reinforced sheath and a semirigid dual lumen dilator catheter with tapered distal tip. Both components are radiopaque and have hydrophilic coating. This device is sold in two sizes, 10/12 and 12/14 FR, and two lengths, 35 and 45 cm.

The provided document is a 510(k) summary for the Bi-Flex Ureteral Access Sheath. It describes the device, its intended use, and its technological characteristics compared to a predicate device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical studies to establish novel performance criteria.

Therefore, the document does not contain the information requested in points 1-9 regarding specific acceptance criteria, detailed study designs, sample sizes, expert qualifications, or ground truth establishment typically found in performance studies for new, non-substantially equivalent devices or AI/software as a medical device (SaMD) clearances.

This 510(k) submission primarily relies on physical and functional testing to support the claim of substantial equivalence.

Here's what can be extracted based on the provided text, while also noting what is not present:

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

• Acceptance Criteria: Not explicitly stated as quantitative performance metrics with defined thresholds. The "acceptance criteria" for a 510(k) of this nature primarily revolve around demonstrating that the device is as safe and effective as the predicate device by meeting similar design and material specifications and passing standard physical and functional tests.
• Reported Device Performance:
  • "Results of physical and functional testing support a determination of substantial equivalents for the Bi-Flex Ureteral Access Sheath when compared to the predicate device." This is a high-level statement that general performance was found to be acceptable relative to the predicate. No specific numerical performance values are given.
  • The document lists various technological characteristics of the proposed device, which can be interpreted as design specifications that the device met to be considered substantially equivalent to the predicate. These are listed in "Table 1: Proposed Device" column. The implicit "acceptance criterion" for each of these is that it matches or is comparable to the predicate device's characteristic.

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

• Not specified. The document mentions "physical and functional testing" but does not detail the specific tests, sample sizes, or where these tests were conducted.

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/Not specified. This is not an AI/SaMD device where expert-established ground truth is typically required for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) 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:

• No. This is not an AI/SaMD device for which an MRMC study would be conducted.

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

• No. This is a hardware medical device, not an algorithm.

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

• Not applicable in the usual sense for clinical performance. The "ground truth" for this device's performance would be engineering specifications and standards for material properties, mechanical integrity, and biocompatibility, as confirmed through physical and functional testing.

8. The sample size for the training set:

• Not applicable. This device does not involve a training set as it is not an AI/machine learning product.

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

• Not applicable. This device does not involve a training set.

Summary of Study:

The study involved physical and functional testing of the Bi-Flex Ureteral Access Sheath. The details of these tests, including specific methodologies and quantitative results, are not provided in this 510(k) summary. The purpose of this testing was to demonstrate that the new device is substantially equivalent to the predicate device (ROCAMED RocaUS Platinum, K120160) by comparing their intended use, technology, principles of operation, and materials. The FDA's clearance of K140441 indicates that based on the submitted data, the agency agreed with the claim of substantial equivalence.

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The Wijay EZ-Void™ External Catheter Valve is indicated for use, to aid in emptying the urinary bladder, for short-term (7 days or less) in adult patients with indwelling urethral or Suprapubic catheters and (1) who are capable of operating the device in accordance with its instructions for use, and (2) for whom normal bladder cycling is not contraindicated.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA to LeoMed, LLC regarding their "Wijay EZ-Void External Catheter Valve." This document confirms the device's substantial equivalence to a legally marketed predicate device.

However, the letter does not contain any information about acceptance criteria, device performance studies, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for either training or test sets.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document is solely an FDA clearance letter and does not include the technical study details you are asking for.

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The Guardian Urethral Sheath is intended to facilitate the introduction of catheters or instruments into the Guardian Urethral Sheath is indicated for use as a guide for urological catheters or instruments inserted into the uneticious barrier between the urethral tissue and the catheter or instrument.

Not Found

This document is a 510(k) premarket notification from the FDA for a device called the "Guardian Urethral Sheath." It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way you've described for an AI/software-based medical device.

The information provided is a letter from the FDA to the manufacturer, Solace Therapeutics, stating that their device, the Guardian Urethral Sheath, has been found substantially equivalent to a legally marketed predicate device. This is a common regulatory pathway for medical devices that are similar to existing ones.

Therefore, I cannot extract the requested information from this document because it is not present. The document focuses on regulatory approval based on substantial equivalence, not on performance criteria and studies demonstrating that a device (especially an AI-driven one) meets those criteria.

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The Guardian Urethral Sheath is intended to facilitate the introduction of catheters or instruments into the urethra. The Guardian Urethral Sheath is indicated for use as a guide for urological catheters or instruments inserted into the urethra and as a lubricious barrier between the urethral tissue and the catheter or instrument.

The Solace Guardian Urethral Sheath is an everting sleeve sheath with a backflow valve for the establishment of a protective tract to the bladder to facilitate atraumatic insertion of catheters and instruments through the urethra. The sheath consists of a thin-walled rigid plastic tube, an obturator, and an everting sleeve that deploys from the obturator during insertion to reduce friction. Improvements from the Generation I sheath include a silicone disc to improve patient comfort at the external contact point, a single handed fluid management system, and independent fill and waste lines.

The Urethral Sheath is supplied sterile and is single use. The working channel is sized to accommodate instruments up to 19 French. The sheath outside size is 24 French with a working length of 4.7 cm.

The Sheath helps the patient by protecting the urethra and reducing abrasion or tenderness resulting from instruments passing through the urethra.

This 510(k) summary describes a medical device, the Guardian Urethral Sheath, and its testing for substantial equivalence to a predicate device. However, it does not involve an AI/ML device, and therefore, many of the requested criteria related to AI/ML performance studies, such as sample sizes for test and training sets, ground truth establishment, expert adjudication, and MRMC studies, are not applicable.

Here's an analysis of the provided text based on your prompt, highlighting the available information and noting where AI/ML-specific criteria are not met:

1. Table of Acceptance Criteria and Reported Device Performance

• Cytotoxicity
• Sensitization
• Irritation or Intracutaneous reactivity | Biocompatibility tests were conducted on the Guardian Urethral Sheath according to the requirements of ISO 10993:2009. The following were completed: Cytotoxicity, Sensitization, Irritation or Intracutaneous reactivity. (Implies satisfactory completion as it supports the conclusion of substantial equivalence). |
  | In Vitro Performance Testing:
• Simulated Use Testing
• Design Verification Testing
• Process Validation Testing | In vitro performance tests were performed on the Guardian Urethral Sheath. The following were performed: Simulated Use Testing, Design Verification Testing, Process Validation Testing. (Implies satisfactory completion as it supports the conclusion of substantial equivalence). |
  | Substantial Equivalence: Material, design, and function to the Generation 1 Guardian Urethral Sheath K052298. | "The Generation 2 Guardian Urethral Sheath is substantially equivalent in material, design and function to the Generation 1 Guardian Urethral Sheath K052298 (formerly CYSTOGLIDE INTRODUCER SHEATH)."
  "Based upon these biocompatibility and in vitro performance tests, the Guardian Urethral Sheath has been shown to be substantially equivalent to the currently marketed Guardian Urethral Sheath K052298." |

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

• Not Applicable (N/A) for AI/ML context. The testing described is for a conventional hardware medical device (a urethral sheath), not an AI/ML diagnostic or predictive algorithm. Therefore, there isn't a "test set" in the sense of a dataset for algorithm evaluation.
• The performance data provided are for physical and biological characteristics (biocompatibility, in vitro performance). The text does not specify sample sizes for these tests (e.g., number of devices tested for simulated use, number of animal subjects for biocompatibility, etc.).
• Data Provenance: Not specified for the general performance testing. Biocompatibility tests are standardized. "Simulated Use Testing" implies a lab setting.

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

• N/A for AI/ML context. Ground truth in the context of expert consensus for image or data interpretation is not relevant for this device. The "ground truth" for this device would be established by physical and chemical testing standards and clinical performance expectations. The text does not specify experts involved in establishing these test criteria or evaluating the results, beyond the implied expertise in conducting ISO standard tests.

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

• N/A for AI/ML context. Adjudication methods like 2+1 are used for resolving disagreements among human readers or labelers in AI/ML performance evaluation. This concept does not apply to the physical and biological testing of a conventional medical device.

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/ML device, so an MRMC study comparing human readers with and without AI assistance is not relevant and was not performed or described.

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

• N/A. This is not an AI/ML algorithm.

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

• For Biocompatibility: The ground truth is established by adherence to the ISO 10993:2009 standards for material safety (cytotoxicity, sensitization, irritation).
• For In Vitro Performance: The ground truth is established by Design Verification Testing, Simulated Use Testing, and Process Validation Testing, which would compare the device's performance against pre-defined engineering specifications and functional requirements. These are objective measures based on engineering and manufacturing standards.

8. The sample size for the training set

• N/A for AI/ML context. This is not an AI/ML device, so there is no "training set."

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

• N/A for AI/ML context. As there is no training set for an AI/ML model, this question is not applicable.

Summary of the Study Proving Acceptance Criteria:

The study proving the device meets the acceptance criteria is a series of biocompatibility tests and in vitro performance tests.

• Biocompatibility Testing: Conducted according to ISO 10993:2009 standards, which include tests for Cytotoxicity, Sensitization, and Irritation or Intracutaneous reactivity. The positive outcome of these tests implies that the device materials are safe for their intended use.
• In Vitro Performance Testing: This encompassed Simulated Use Testing, Design Verification Testing, and Process Validation Testing. These tests would evaluate the device's functional integrity, design specifications, and manufacturing consistency under controlled, laboratory conditions. For instance, simulated use testing would assess how the sheath performs during insertion and withdrawal of instruments, and how well the backflow valve functions, within a simulated anatomical environment. Design verification would confirm that the device meets its specified dimensions, material properties, and operational characteristics. Process validation would ensure that the manufacturing process consistently produces devices that meet these specifications.

The conclusion drawn from these tests is that the Guardian Urethral Sheath (Generation 2) has been shown to be substantially equivalent to its predicate device (Guardian Urethral Sheath K052298) in terms of material, design, and function. The FDA's 510(k) clearance further confirms this determination of substantial equivalence, based on the provided data.

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The Gyrus ACMI Variable Length Access Sheath is intended to be used to permit direct passage of catheters or other devices for the purpose of performing diagnostic and surgical procedures (e.g.,nephrostomy, cystoscopy, ureteroscopy, etc.) in the urinary tract.

Gyrus ACMI Vari-Pass™ Adjustable Length Access Sheath is a single use, sterile disposable product. The device consists of a sheath (manufactured from PTFE with BiOs) and dilator (manufactured from HDPE with BaS02) to facilitate the passage of catheters and other urological devices in the urinary tract. The sheath length is adjustable to the size necessary for the procedure. The dilator is attached to the sheath via a locking leur. The leur connector also allows for injection or irrigation or contrast fluid. For ease of visualization, the dilator and sheath are radiopaque.

The provided text describes a Special 510(k) Notification for the Gyrus ACMI Vari-Pass™ Adjustable Length Access Sheath and primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study with specific acceptance criteria and performance data in the traditional sense of a clinical or analytical performance study.

Therefore, many of the requested elements for a study showing device performance against acceptance criteria are not directly available in the provided text.

Here's an attempt to extract and infer information based on the given text:

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

The submission primarily relies on demonstrating substantial equivalence through non-clinical testing comparing the modified device to predicate devices. The "acceptance criteria" are implicitly that the modified device performs no worse than the predicate devices across relevant performance characteristics.

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 mentions "nonclinical testing" but does not specify sample sizes for these tests. It's also not a clinical study, so terms like "test set" in the context of clinical data are not directly applicable. The testing is likely laboratory-based. No country of origin or retrospective/prospective nature is mentioned, consistent with non-clinical, in-vitro 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 is not applicable as the submission describes non-clinical testing for substantial equivalence, not a study requiring expert-established ground truth on clinical cases.

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

Not applicable, as it's a non-clinical submission for substantial equivalence.

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 an access sheath for urological procedures, not an AI-assisted diagnostic tool.

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

Not applicable. This device is an access sheath, not an algorithm.

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

For the non-clinical testing, the "ground truth" would likely be the established performance characteristics and safety profile of the predicate devices, against which the new device's performance was compared. This comparison would be based on engineering specifications and material science, not clinical outcomes or expert consensus on patient data.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable.

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The ROCAMED RocaUS Platinum is intended to be a conduit for passage of endoscopes and other urological devices for the purpose of performing ureteroscopy procedures. The dual working lumen dilator with luer lock connections allows the user to insert guidewires and fluids.

The ROCAMED RocaUS Platinum is designed to create a conduit for urological procedural instruments. The device consists of two components: a flexible, coil reinforced sheath and a semirigid dual lumen dilator catheter with tapered distal tip. Both components are radiopague and have hydrophilic coating. This device is sold in two sizes, 10/12 and 12/14 FR.

The provided documentation is a 510(k) summary for the ROCAMED RocaUS Platinum, a ureteral access sheath. This type of submission focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific clinical performance acceptance criteria in the same way a new AI/ML-driven diagnostic device might.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set information) are not applicable or not present in this document because it is not a clinical study report for a diagnostic or treatment outcome device. The "performance data" referred to in this document relates to physical and functional testing, not clinical performance measures like accuracy or sensitivity.

Here's an attempt to fill in the table and address the questions based on the provided text, indicating where information is not applicable (N/A) or not provided (NP):

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) for a medical device (ureteral access sheath) demonstrating substantial equivalence, the "acceptance criteria" are primarily met through comparison to predicate devices across technological characteristics and intended use, supported by physical and functional testing. There are no explicit performance metrics like sensitivity, specificity, or accuracy derived from a clinical study with a test set that would have numerical acceptance criteria.

• 2 lumens
• Dilator Material: LDPE+BaSO4
• Sheath Material: Pebax-SST-PTFE
• Fr Size: 10/12, 12/14
• Length: 35 cm
• Guidewire compatibility: 0.032", 0.035" |
  | Safety | Implied by substantial equivalence to legally marketed predicate devices and successful physical/functional testing. Changes in dilator material (LDPE instead of PTFE) stated to "ease insertion into the patient and reduce trauma." |
  | Performance (Functional) | Results of physical and functional testing support substantial equivalence. (Specific reported performance values for these tests are not detailed in this summary). |
  | Materials | Materials chosen are considered substantially equivalent or improved (e.g., LDPE for dilator) compared to predicate devices, based on physical and functional testing. |

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

• Sample Size for Test Set: Not applicable. This document refers to physical and functional testing, not a clinical test set of patient data. The specifics of samples used for these engineering tests (e.g., number of devices tested for tensile strength or burst pressure) are not provided in this summary.
• Data Provenance: Not applicable for clinical test data. The physical and functional testing would have been conducted by Promepla SAM.

3. 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 understood for diagnostic device performance (e.g., pathology, expert consensus on images) is not relevant for this type of medical device submission, which relies on physical and mechanical properties and comparison to predicates.

4. Adjudication method for the test set

Not applicable.

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

Not applicable. This device is not an AI-assisted diagnostic tool and therefore did not undergo an MRMC study related to AI assistance.

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

Not applicable. This device is not an algorithm.

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

Not applicable in the context of clinical "ground truth." The "ground truth" for this device's performance would be against engineering specifications and predicate device characteristics, verified through physical and functional testing.

8. The sample size for the training set

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

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

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

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The Avail Sterile Water Filled Syringe is intended to be used to provide a sterile liquid for catheter inflation after insertion.

A sterile, water filled, single patient use syringe designed for catheter inflation only. Not for injection. The syringes are bulk packaged for sale to customers for inclusion in urological kits. The syringes are not marketed or sold as separate devices from urological kits. The intended use of the device is to provide a sterile liquid for Foley catheter inflation after insertion. The syringe cap is removed, the syringe luer tip connects directly to the catheter valve. The sterile water is expressed to inflate the catheter. The syringe is disconnected and discarded after use.

The provided submission, K112209, is for a Sterile, Water Filled Syringe (Pre-filled Catheter Inflation Syringe) by Avail Medical Products Inc. This device is not a software/AI device, but rather a medical device intended for catheter inflation. Therefore, most of the requested information regarding acceptance criteria, study details, ground truth, expert involvement, and AI-related metrics (like MRMC or standalone performance improvement) are not applicable to this type of submission.

Here's a breakdown of the relevant information from the document, acknowledging the limitations for a non-AI product:

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

Since this is a non-AI medical device, the "acceptance criteria" are related to its physical and functional characteristics, and substantial equivalence to a predicate device, rather than diagnostic performance metrics.

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

This information is not applicable as there was no "test set" in the context of an AI study. The "testing" referred to in the document is non-clinical performance and materials testing, not data-driven evaluation with a clinical test set.

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 there was no "test set" and no ground truth established by experts in the context of an AI algorithm's performance.

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

This information is not applicable as there was no "test set" requiring adjudication.

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, an MRMC comparative effectiveness study was not done. This is a non-AI medical device; such a study is not relevant.

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

No, a standalone performance study in the context of an AI algorithm was not done. This is a non-AI medical device.

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

This information is not applicable as there was no "ground truth" in the context of evaluating an AI algorithm's performance. The "ground truth" for this device's functionality would be that it effectively and safely inflates catheters as intended, confirmed through engineering and biocompatibility testing.

8. The sample size for the training set:

This information is not applicable as there was no "training set" for an AI algorithm.

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

This information is not applicable as there was no "training set" for an AI algorithm.

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The Avail Sterile, Latex Free, Water Filled Syringe is intended to be used to provide sterile water for catheter inflation after insertion.

The Avail Sterile, Latex Free, Water Filled Syringe is a sterile, single patient use, disposable device that is substantially equivalent to the predicate device and other pre-filled syringes. The device is designed for catheter inflation only and is intended for single patient use as was the predicate device.

The provided text does not contain information about acceptance criteria, device performance, or a study proving that a device meets acceptance criteria. The documents are a 510(k) summary and an FDA clearance letter for a pre-filled catheter inflation syringe. They focus on establishing substantial equivalence to a predicate device and outlining regulatory information.

Therefore, I cannot populate the requested tables and information based on the provided text.

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