The Aqueduct 200 Cervical Dilation Balloon Catheter is intended to be used whenever cervical softening and dilation is desired. Some examples are: treatment of cervical stenosis, IUD placement and removal, Radium placement, drainage of uterine cavity, endometrial biopsy, uterine curettage, suction cannula aspiration, operative hysteroscopy.

The Aqueduct 200 Cervical Dilation Balloon Catheter is a balloon cervical dilation catheter which enables the simultaneous dilation of both sides of the cervical canal. The subject device is an updated version of the Aqueduct 100 Cervical Dilation Balloon Catheter cleared under K160664 that merges two separate dilation balloons into one balloon, removes the anchor balloon, replaces the four-way hub with a three-way hub, and removes the stylet from the shaft. The catheter consists of a 2-lumen shaft. One lumen inflates a cylindrical dilation balloon. A second lumen is for infusion of saline solution and also contains a camera and camera cable. In use, the catheter is inserted through the vagina and cervical canal and into the uterus. Using visual feedback from the forward-looking camera and LED light source the physician advances the catheter through the cervical canal and identifies the end of the canal when entering the internal orifice of the uterus. When the physician identifies the orifice, the catheter is positioned inside the cervix. This aligns the cylindrical dilation balloon at the internal cervical os and external cervical os. The balloon is inflated with 12.5 ml of saline, providing gradual mechanical dilation of the cervix. The camera cable on the catheter connects to a camera module that provides power to the camera and allows connection to an HDMI port on a monitor to assess proper device placement during a clinical procedure. After 3 minutes of dilation of the internal and external orifices of the uterus, a controlled injection of 1-2.5 ml of saline may be made through the catheter infusion lumen which exits on the distal end of the catheter. Evidence that cervical dilation is complete can be determined once droplets of the saline injection are observed exiting through the external opening of the cervix. Optimal dilation of 8-9 mm within the cervical canal is typically achieved following 5 minutes of balloon dilation. The entire procedure from catheter insertion to removal is completed in 6-7 minutes. The deflation of the balloon is conducted by attaching a luer lock syringe to the swabable valve and removing saline from the balloon. The subject device is packaged in a mylar/Tyvek pouch and ethylene oxide (EO) sterilized to a SAL 10-6. The packaged device has a shelf-life of 15 months.

The provided text describes the Aqueduct 200 Cervical Dilation Balloon Catheter and its substantial equivalence to a predicate device. However, it does not contain information about a study proving the device meets specific acceptance criteria in the context of a clinical or performance study with human subjects, comparing its effectiveness or accuracy against a ground truth for a diagnostic or therapeutic outcome.

Instead, the document details various non-clinical performance data and testing conducted to demonstrate that the device itself is safe and performs as intended, largely in comparison to its predicate device or against engineering/manufacturing standards.

Below is an attempt to structure an answer based on the available information, with significant caveats that many requested sections are not applicable or not present in the document provided.

Acceptance Criteria and Device Performance Study for Aqueduct 200 Cervical Dilation Balloon Catheter

The provided 510(k) summary for the Aqueduct 200 Cervical Dilation Balloon Catheter (K202433) primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data and adherence to recognized standards. It does not appear to describe a study that involves clinical outcomes, diagnostic accuracy, or comparative effectiveness with human readers/AI, as would be typical for certain types of medical devices, especially those involving AI or diagnostic interpretation.

The "acceptance criteria" referred to in the document are primarily engineering and safety standards, and device functionality specifications, rather than clinical efficacy targets.

1. Table of Acceptance Criteria and Reported Device Performance

Since the document does not present acceptance criteria as quantitative targets for clinical performance (e.g., sensitivity, specificity for a diagnostic device), this table will list the types of tests performed and the general outcome reported.

2. Sample Size for Test Set and Data Provenance

This information is not applicable as the document describes non-clinical laboratory and bench testing, not a clinical study with a "test set" of patient data.

3. Number of Experts and Qualifications for Ground Truth

This information is not applicable. The "ground truth" for the tests performed was established by validated engineering standards, laboratory test results, and adherence to regulatory guidance, not expert consensus on clinical cases.

4. Adjudication Method

This information is not applicable. There was no clinical study involving interpretation or adjudication of cases.

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

A MRMC comparative effectiveness study was not performed or reported in this document. This type of study is typically conducted for diagnostic imaging devices or AI tools that assist human readers in interpreting clinical data. This device is a cervical dilation catheter, primarily a mechanical instrument.

6. Standalone Performance Study (Algorithm Only)

A standalone algorithm performance study was not performed or reported. The device includes a camera, but its primary function is visual feedback for proper placement of the mechanical dilation component. It does not appear to involve an AI algorithm for diagnosis or interpretation.

7. Type of Ground Truth Used

The "ground truth" for the reported performance data was based on:

• Validated laboratory methods and equipment: For biocompatibility (cytotoxicity, sensitization, irritation), sterility, EO residuals, packaging integrity.
• Engineering specifications and standards: For electrical safety, EMC, optical performance (e.g., resolution, field of view), and bench performance (e.g., burst pressure, dimensions, bond strength), referenced against ISO and IEC standards.
• Simulated aging conditions: For shelf-life performance testing.

8. Sample Size for the Training Set

This information is not applicable as there is no mention of a training set for an algorithm in the provided document.

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

This information is not applicable as there is no mention of a training set.

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The Aqueduct 100 Plus Cervical Dilation Balloon Catheter is intended to be used whenever cervical softening and dilation is desired. Some examples are: treatment of cervical stenosis, IUD placement and removal, Radium placement, drainage of uterine cavity, endometrial biopsy, uterine curettage, suction cannula aspiration, operative hysteroscopy.

The Aqueduct 100 Plus Cervical Dilation Balloon Catheter is a balloon cervical dilation catheter which enables the simultaneous dilation of both sides of the cervical canal. The subject device is an updated version of the Aqueduct 100 Cervical Dilation Balloon Catheter cleared under K160664 that merges two separate dilation balloons into one balloon, removes the anchor balloon, replaces the four-way hub with a three-way hub, and removes the stylet from the shaft. The catheter consists of a 2-lumen shaft. One lumen inflates a cylindrical dilation balloon. A second lumen is for infusion of saline solution. In use, the catheter is inserted through the vagina and cervical canal and into the uterus. The catheter is positioned inside the cervix. The user aligns the cylindrical balloon at the internal cervical os and external cervical os. The balloon is inflated with 12.5 ml of saline, providing gradual mechanical dilation of the cervix. After 3 minutes of dilation of the internal and external orifices of the uterus, a controlled injection of 1-2.5 ml of saline may be made through the catheter infusion lumen which exits on the distal end of the catheter. Evidence that cervical dilation is complete can be determined once droplets of the saline injection are observed exiting through the external opening of the cervix. Optimal dilation of 8-9 mm within the cervical canal is typically achieved following 5 minutes of balloon dilation. The entire procedure from catheter insertion to removal is completed in 6-7 minutes. The deflation of the balloon is conducted by attaching a luer lock syringe to the swabable valve and removing saline from the balloon. The subject device is packaged in a mylar/Tyvek pouch and ethylene oxide (EO) sterilized to a SAL 10-6. The packaged device has a shelf-life of 15 months.

The provided document is a 510(k) premarket notification for a medical device called the "Aqueduct 100 Plus Cervical Dilation Balloon Catheter." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving novel effectiveness through clinical studies.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, a study proving the device meets those criteria, or details about ground truth, expert adjudication, or MRMC studies.

Here's why and what information is available:

• No Acceptance Criteria for Clinical Performance: As this is a 510(k) for substantial equivalence, clinical performance acceptance criteria in the sense of accuracy, sensitivity, specificity, or reader agreement are not typically established or reported here. The "acceptance criteria" discussed implicitly are related to demonstrating that the new device is as safe and effective as the predicate device through non-clinical performance and biocompatibility.
• No Study Proving Device Meets Acceptance Criteria for Clinical Performance: There isn't a clinical study designed to "prove" the device meets specific performance metrics in human use. Instead, the "study" is a collection of engineering, biocompatibility, and sterilization tests.
• No Information on Sample Sizes for Test/Training Sets, Data Provenance, Expert Ground Truth: These details are relevant for AI/ML device studies or clinical trials evaluating diagnostic/prognostic effectiveness, which is not the nature of this submission.
• No MRMC Comparative Effectiveness Study: There is no mention of a human-reader comparative effectiveness study because this device is a physical medical device, not an AI diagnostic tool.
• No Standalone (algorithm only) Performance: This is a physical catheter, not an algorithm.
• No Ground Truth Type: The concept of "ground truth" (e.g., pathology, outcomes data) doesn't apply in the context of this 510(k) submission, as it relates to evaluating the accuracy of a diagnostic or prognostic claim, which is not being made here for the new device itself.

What the document does provide in lieu of your requested information:

The document outlines a series of non-clinical performance tests conducted to demonstrate that the changes in the Aqueduct 100 Plus Cervical Dilation Balloon Catheter (compared to its predicate, the Aqueduct 100) do not raise new questions of safety or effectiveness.

Here's a summary of the non-clinical "acceptance criteria" (or verification activities) and "reported performance" (results) as derived from the document:

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

• Sensitization (ISO 10993-10:2010): Device demonstrated to be non-sensitizing.
• Irritation (ISO 10993-10:2010): Device demonstrated to be non-irritating. |
  | Sterilization Validation | Device must achieve a Sterility Assurance Level (SAL) of 10-6 via Ethylene Oxide (EO) sterilization, with acceptable EO residuals. | - EO sterilization cycle validated using the overkill method per ANSI/AAMI/ISO 11135:2014.
• Ethylene Oxide residuals evaluated according to ISO 10993-7:2008.
• The subject device utilizes the same sterilization process, chamber, and cycle as the predicate device. |
  | Bench Performance Testing | Device must meet performance requirements for intravascular catheters (ISO 10555-1, -4) and microbiological methods (ISO 11737-1). Also, performance must be maintained after accelerated aging (15-month shelf life). | - Performance tests performed according to ISO 10555-1:2013 and ISO 10555-4:2013.
• Microbiological methods tested according to ISO 11737-1:2018.
• Performance maintained after accelerated aging to simulate a 15-month shelf life for the following:
  • Dimensional Verification
  • Balloon Burst Pressure (> 8 atm reported in comparison table, and successfully passed after aging)
  • Balloon Fatigue
  • Balloon Inflation/Deflation Time
  • Catheter Bond Strength
  • Catheter Pushability
• Conclusion: The submitted performance testing demonstrates that the subject device is as safe and effective as the predicate device. |

2. Sample Sizes, Data Provenance, Experts, Adjudication, MRMC, Standalone Performance, Ground Truth Type (Not applicable for this document)

As explained above, these categories are not relevant to a 510(k) submission for a physical device demonstrating substantial equivalence. The document does not provide such information.

3. Sample Size for Training Set & Ground Truth for Training Set (Not applicable)

Again, these concepts are related to machine learning models or clinical trials, neither of which are described in this 510(k) submission. There is no "training set" for a physical medical device. The "ground truth" for non-clinical tests is established by adhering to recognized international standards and standard laboratory practices.

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The CrossBay™ Cervical Dilator Catheter System is intended to be used whenever cervical softening and dilation is desired. Some examples are:

• Treatment of cervical stenosis
• IUD placement and removal
• Placement of instruments for intrauterine radiotherapy
• Endometrial biopsy
• Global endometrial ablation
• Uterine tissue removal
• Uterine curettage
• Diagnostic hysteroscopy
• Operative hysteroscopy

This device is not intended for use in the induction of labor.

The CrossBay Cervical Dilator Catheter System is a sterile, single use device composed of an inflation device, dilator catheter, everting membrane, and dilator balloon which enable softening and dilation of the cervical canal. The CrossBay Cervical Dilator Catheter System contains an Inflation Device and a Dilator Catheter that accesses the cervix using a hydraulic pressure-filled everting Membrane. The Inflation Device provides the hydraulic energy with saline supplied by the user. Once placed at the exocervix, the Dilator Catheter advances through the cervix by everting the Membrane through the endocervix. A Dilator Balloon is attached to the inner tube of the device that is positioned across the cervix when the everting Membrane is fully everted. The Inflation Device is then used to further pressurize the system to split open the everting Membrane to expose the Dilating Balloon. The Inflation Device is used to pressurize the Dilator Balloon to the prescribed level. Once dilated, the Dilator Catheter is removed from the cervix and the subsequent uterine cavity procedure can commence.

The CrossBay Cervical Dilator Catheter with Dilator Balloon is provided in three sizes of 5mm, 7mm, and 9mm. The three sizes are identical except for the diameter of the Dilator Balloon when pressurized.

I am sorry, but based on the provided text, there is no information about a study proving the device meets acceptance criteria for an AI/ML powered medical device. The document pertains to a 510(k) premarket notification for a mechanical medical device (CrossBay Cervical Dilator Catheter System), not an AI/ML product.

Therefore, I cannot provide the requested information regarding:

• A table of acceptance criteria and reported device performance for an AI/ML device.
• Sample size used for the test set or data provenance for an AI/ML device.
• Number of experts or their qualifications for establishing ground truth for an AI/ML device.
• Adjudication method for an AI/ML device test set.
• MRMC comparative effectiveness study or effect size for AI assistance.
• Standalone (algorithm only) performance for an AI/ML device.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI/ML device.
• Sample size for the training set or how ground truth was established for the training set for an AI/ML device.

The document discusses non-clinical performance data for the mechanical dilator, including bench testing, biocompatibility, sterilization, package integrity, and shelf life. These are standard tests for a physical medical device to demonstrate substantial equivalence to a predicate device, not for an AI/ML model's performance.

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The Aqueduct 100 Cervical Dilation Balloon Catheter is intended to be used whenever cervical softening and dilation is desired. Some examples are: treatment of cervical stenosis, IUD placement and removal, Radium placement, drainage of uterine cavity, endometrial biopsy, uterine curettage, suction cannula aspiration, operative hysteroscopy.

The Aqueduct 100 Cervical Dilator is a triple-balloon cervical dilation catheter which enables the simultaneous dilation of both sides of the cervical canal. The catheter consists of a 3-lumen shaft. One lumen inflates an anchoring balloon. A second lumen inflates the 2 cylindrical dilation balloons. The third lumen is for infusion of saline solution and also contains a fixed stiffening stylet to add rigidity to the catheter. The stylet is permanently sealed within the infusion lumen. In use, the catheter is inserted through the vagina and cervical canal and into the uterus where the distal spherical balloon is inflated. The catheter is then withdrawn until the spherical balloon comes into contact with the internal orifice of the uterus, which positions and anchors the catheter within the cervix. This aligns the two cylindrical balloons at the internal cervical os and external cervical os. The balloons are inflated with saline providing gradual mechanical dilation of the cervix.

After 3 minutes of dilation of the internal and external orifices of the uterus, a gentle, controlled injection of 1ml, and up to 2.5ml, of saline can be made through the catheter infusion lumen which exits between the two balloons (and inside the cervical canal). Evidence that cervical dilation is complete can be determined once droplets of the saline injection are observed entering through the external opening of the cervix. Optimal dilation of 8-9mm within the cervical canal is typically achieved following 5 minutes of balloon dilation. The entire procedure from catheter insertion to removal is completed in 6-7 minutes.

The Aqueduct 100 Cervical Dilator is packaged in a mylar/Tyvek pouch and EO sterilized to SAL 10-6.

The provided document describes the Aqueduct 100 Cervical Dilation Balloon Catheter and its substantial equivalence determination, but it does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria in the context of an AI/human reader study.

The document indicates "Performance Data" were provided in support of the substantial equivalence determination, but these refer to biocompatibility and in vitro performance tests relevant to the device's physical properties and safety, not a clinical study involving human readers or AI performance.

Therefore, I cannot fulfill the request as the necessary information (acceptance criteria for AI/human performance, study design details, expert qualifications, etc.) is not present in the provided text.

The closest information provided is:

1. A table of acceptance criteria and the reported device performance: This information is not provided for an AI or human reader study. The document lists the following in vitro performance tests:

2. Sample size used for the test set and the data provenance: Not applicable, as no such study is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method (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.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document focuses on the physical and material equivalence of the Aqueduct 100 Cervical Dilation Balloon Catheter to its predicates based on biocompatibility and in vitro performance testing, not on clinical performance or diagnostic accuracy improved by AI or human readers.

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The UTAH CVX-RIPE™ is intended to mechanically improve the favorability of the cervix of pregnant patients at term gestation, in which induction of labor is medically indicated.

The UTAH CVX-RIPE™ is a double balloon catheter. The tip is placed through the vagina and into the cervical canal. The distal balloon is positioned against the internal cervical os and inflated with saline. The proximal balloon is positioned against the external cervical os and inflated with saline, providing gradual mechanical cervical dilation by simultaneously applying pressure on the internal and external cervical os. The materials used to manufacture the device, and which have patient contact, are all medical grade silicone.

The UTAH CVX-RIPE™ consists of an 18 Fr., 42 cm silicone catheter with a silicone tip and two silicone balloons. Each balloon is independently inflated via a separate inflation lumen through color coded check valves located at the proximal end of the device. The check valves are marked accordingly, "U" for the distal uterine balloon and "V" for the proximal vaginal balloon. A malleable stainless steel stylet is included for ease of placement. The stylet is placed through a third separate lumen that is closed at the distal tip. The stylet is preloaded in the catheter.

This document is a 510(k) premarket notification for the UTAH CVX-RIPE™ cervical ripening balloon catheter. It asserts substantial equivalence to a predicate device, the Cook® Cervical Ripening Balloon (K131206).

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" with numerical or performance targets in a tabular format that is typically expected for, say, diagnostic accuracy or predictive power. Instead, it lists mechanical performance tests and states that the device successfully met the requirements of these tests.

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

The document does not specify a separate "test set" in the context of clinical data for performance evaluation. The performance tests mentioned are mechanical/bench tests. For these mechanical tests, the sample sizes are not explicitly stated. The document does not refer to any human-patient data collection (retrospective or prospective) for this 510(k) submission, as it relies on substantial equivalence to a predicate device based on similar intended use and technological characteristics, supported by bench testing. Therefore, there is no information on data provenance (e.g., country of origin).

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

This information is not applicable and not provided. The "test set" here refers to mechanical performance tests, not clinical data requiring expert human assessment for ground truth.

4. Adjudication Method for the Test Set:

This is not applicable as the "test set" refers to mechanical performance tests, not a clinical study involving human readers or adjudicators.

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

This type of study was not done. The submission is for a mechanical medical device (a balloon catheter), not an AI-powered diagnostic or assistive tool.

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

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

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

For the mechanical performance tests, the "ground truth" would be the engineering specifications and expected physical behavior validated through laboratory testing. For example, for "Balloon Deflation Reliability," the ground truth is simply whether the balloons did, in fact, deflate properly according to specified parameters. There is no biological or patient-related "ground truth" in this context.

8. The sample size for the training set:

This is not applicable. There is no machine learning or AI component to this device that would require a "training set." The training referenced in the document would be for healthcare professionals on how to use the device, not a dataset for an algorithm.

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

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

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Dilapan-S is to be used whenever cervical softening and dilation is desired. Some examples are:

• 1. Cervical stenosis
  • a. related to dysmenorrhea
  • b. considered a possible cause of infertility
  • c. resulting from cauterization or conization
• 2. Placement and removal of intrauterine devices
• 3. Induction of labor
• 4. Radium placement
• 5. Drainage of uterine cavity
• 6. Endometrial biopsy
• 7. Uterine curettage
• 8. Suction cannula aspiration
• 9. Operative hysteroscopy

DILAPAN-S is a hygroscopic cervical dilator that is manufactured from AQUACRYL, a proprietary hydrogel. The dilators are firm hygroscopic rods, similar in shape to natural laminaria tents. DILAPAN-S is capable of increasing in diameter on average from three (3) millimeters to 8.3-10 mm, or four (4) millimeters to 10-12.5 millimeters within 4-6 hours as they absorb moisture from the genital tract.

In clinical trials, DILAPAN-S has been shown to dilate the cervix gradually. It may not be necessary to use general or local anesthetics during the insertion process, thereby eliminating their associated risks to the patient. A Marker String is tied securely to the handle of the DILAPAN - S, and is provided to indicate location.

DILAPAN-S is capable of increasing its volume as it absorbs moisture from the genital tract through hygroscopic action. The volume of DILAPAN-S subsequently exerts radial pressure on the surrounding structures (uterine neck) to dilate progressively. Endocervical pressure on the uterine neck results in mechanical dilation and promotes cervical ripening through reversible cell dehydration and local endogenous prostaglandins release promoting collagen reorganization.

DILAPAN-S is available in boxes of 10 or 25 dilators and in the following dimensions: 4mm x 65mm, 4mm x 55mm, 3mm x 55mm. Each DILAPAN - S is individually wrapped in a single foil pouch and is sterilized by gamma radiation.

Here's a breakdown of the acceptance criteria and study information for the Dilapan-S device, based on the provided FDA 510(k) summary:

Please note: This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel device's performance against pre-defined acceptance criteria for a new application. As such, the information provided primarily relates to comparative testing and literature review rather than a single, comprehensive study with explicit acceptance criteria for this specific submission.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state pre-defined acceptance criteria in the typical sense (e.g., "The device must achieve X sensitivity and Y specificity"). Instead, the approach is to demonstrate that Dilapan-S performs "as well as or better than" the predicate device through comparative testing and established clinical use.

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

• Sample Size for Test Set: Not explicitly stated as a single "test set" in the context of this 510(k) summary. The document refers to:
  • "Comparison testing... with Laminaria" for swell, expansion force, diameter variations, and speed of swelling. The number of samples for these bench tests is not provided.
  • "Numerous clinical studies" and "clinical performance data" for safety and effectiveness. The sample sizes for these referenced studies are not detailed in this summary.
• Data Provenance: The document does not specify the country of origin for the referenced clinical studies. It also doesn't explicitly state whether the data was retrospective or prospective. Given the submission date, some referenced clinical studies could be retrospective reviews of existing data or prospectively conducted trials published prior to the submission.

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

This information is not provided in the 510(k) summary. Given that the submission relies on comparative bench testing and existing clinical literature, there isn't a directly described "ground truth" establishment process for a specific test set within this document, nor is there mention of experts establishing a ground truth for this submission's testing. The "truth" for effectiveness is implied by the scientific literature and comparison to the predicate.

4. Adjudication Method for the Test Set

This information is not provided. As there isn't a defined "test set" in the sense of a clinical trial with specific endpoints requiring adjudication by experts, an adjudication method is not 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

No. This device is a physical medical device (cervical dilator), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to AI assistance for human readers is not applicable.

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

No. As noted above, this is a physical medical device, not an algorithm. Therefore, "standalone algorithm" performance is not applicable.

7. The Type of Ground Truth Used

The "ground truth" for this device's substantial equivalence is established through:

• Bench Testing Data: Direct measurements of physical properties like swelling diameter, swelling rate, and expansion force, comparing Dilapan-S to the predicate device (Laminaria).
• Clinical Literature: Referenced "numerous clinical studies" which demonstrate the safe and effective use of Dilapan-S. These likely use outcomes data (e.g., achieved dilation, complications, patient experience) as their ground truth.
• Biocompatibility Standards: Adherence to established ISO 10993 standards provides ground truth for material safety.

8. The Sample Size for the Training Set

Not Applicable. This device is not an AI/machine learning algorithm, so there is no "training set" in the traditional sense.

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

Not Applicable. As there is no training set, there is no explanation of how its ground truth would be established.

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The Cook® Cervical Ripening Balloon is indicated for mechanical dilation of the cervical canal prior to labor induction at term when the cervix is unfavorable for induction.

The Cook® Cervical Ripening Balloon is a double-balloon catheter designed to mechanically ripen the cervix prior to labor induction at term when the cervix is unfavorable for induction. The tip of the Cook® Cervical Ripening Balloon is placed through the vagina and the cervical canal into the uterus. The distal balloon is positioned against the internal cervical os and inflated with up to 80 mL of saline; the proximal balloon is positioned against the external cervical os and also inflated with up to 80 mL of saline. The Cook Cervical Ripening Balloon provides gradual mechanical cervical dilation by simultaneously providing pressure on the internal and external cervical os.

In addition to the standard version, the Cook® Cervical Ripening Balloon is also available with a removable stylet to add rigidity to the catheter and aid in placement of the balloon through the cervix. The stylet runs the length of the catheter shaft of the Cook® Cervical Ripening Balloon in a separate lumen that is closed at the distal tip. The user removes the stylet from the device once the distal uterine balloon is above the level of the internal cervical os.

The Cook® Cervical Ripening Balloon is indicated for mechanical dilation of the cervical canal prior to labor induction at term when the cervix is unfavorable for induction. This device is regulated under 21 CFR § 884.4260 as a Class II device (Hygroscopic Laminaria cervical dilator).

Acceptance Criteria and Device Performance:

The provided document describes a series of verification tests to demonstrate the reliable design and performance of the Cook® Cervical Ripening Balloon. The acceptance criteria are implicitly defined by the successful completion of these tests.

Study Details:

The provided text describes a premarket notification for a medical device (510(k)) and outlines the verification testing performed. It does not describe a clinical study in the traditional sense with patient data, statistical analyses, or comparative effectiveness. Instead, it focuses on engineering and biocompatibility testing. Therefore, many of the requested details are not applicable to the information provided.

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

   • The document describes verification testing rather than testing on a clinical "test set" of patient data. The "samples" would refer to the number of devices tested for each engineering and biocompatibility test (e.g., how many balloons were burst tested, how many catheters were tensile tested). This information (specific sample sizes per test) is not provided in the summary.
   • Data provenance for these engineering tests would typically be the manufacturing facility or a contract testing lab. This information is not explicitly stated, nor is it typically included in a high-level 510(k) summary for engineering tests. The tests are "simulated use conditions," implying laboratory or bench testing rather than human subject data.

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

   • Not applicable. Ground truth, in the context of clinical studies, refers to a definitive diagnosis or outcome. For engineering and biocompatibility tests, "ground truth" is typically defined by scientific principles, standards (like ISO 10993-1), and pre-defined pass/fail criteria. These tests are conducted by engineers and scientists, not typically by medical experts establishing a "ground truth" for patient cases.

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

   • Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials or studies involving human assessment (e.g., image interpretation) where there might be disagreement among reviewers. For physical product verification tests, the results are typically objective measurements against pre-defined specifications.

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 device is a physical medical device (balloon catheter), not an AI-powered diagnostic or assistive tool. MRMC studies are used for evaluating diagnostic performance, especially of AI/CAD systems.

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

   • Not applicable, for the same reason as above. This is a physical device, not an algorithm.

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

   • For the engineering tests, the "ground truth" is defined by the technical specifications, standards (e.g., ISO 10993-1 for biocompatibility), and physical laws that govern the device's performance. The successful demonstration against these criteria means the device performs as intended and meets safety requirements.

7. The sample size for the training set:

   • Not applicable. There is no "training set" in the context of physical medical device verification testing as described. This term applies to machine learning or AI models.

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

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

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The Atad Pre-Induction Cervical Dilator is indicated for mechanical dilation of the cervical canal prior to labor induction a term when the cervix is unfavorable for induction.

The Atad Dilator is an 18Fr, 400mm, natural latex, three-lumen, double latex balloon catheter with a corresponding valve for each balloon and a disabled third lumen that is not intended to be used.

Acceptance Criteria and Device Performance Study for the Atad Pre-Induction Cervical Dilator

Based on the provided 510(k) summary (K040625), the Atad Pre-Induction Cervical Dilator is a medical device for cervical dilation. The provided documentation does not explicitly state "acceptance criteria" in the typical sense of numerical thresholds for performance metrics. Instead, the summary focuses on demonstrating substantial equivalence to a predicate device (Quality Medical Solutions, LLC Laminaria Cervical Dilator, K021012), primarily through a comparison of technological characteristics and clinical performance.

The "acceptance criteria" can be inferred from the comparative table and the stated conclusion of "substantial equivalence" to the predicate device. The study aims to show that the Atad Dilator is as safe and effective as the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Since explicit acceptance criteria are not provided, the table below infers "acceptance criteria" as the comparable performance to the predicate device and lists the reported performance of the Atad Dilator.

Note: The reported performance of the Atad Dilator meets or in some cases exceeds (e.g., shorter required dilation time, lower Cesarean delivery range, no packing needed) the characteristics of the predicate device, supporting substantial equivalence.

2. Sample Size and Data Provenance for the Test Set

The document states: "The safety and effectiveness of the Atad Dilator for cervical dilation prior to labor induction in women at term has been demonstrated in several clinical trials."

• Sample Size Used for the Test Set: The specific sample sizes for the "several clinical trials" are not provided in this 510(k) summary.
• Data Provenance: The country of origin of the data is not explicitly stated. Given the submitter's address (Haifa, Israel), it is plausible that some or all of the clinical trials were conducted in Israel, but this is not confirmed in the document. The data is prospective, as it comes from clinical trials demonstrating safety and effectiveness.

3. Number of Experts and Qualifications for Ground Truth Establishment

The document does not specify the number of experts used or their qualifications for establishing ground truth in the clinical trials mentioned. Clinical trials typically involve medical professionals (doctors, nurses) for patient management and data collection, but the role of specific "experts" for ground truth adjudication (as might be seen in imaging studies) is not detailed.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the data collected in the clinical trials. Clinical trial data collection involves standard medical procedures and possibly independent monitoring, but a formal adjudication process for "ground truth" in the context of diagnostic device assessment is not described.

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

No, an MRMC comparative effectiveness study was not done. The Atad Pre-Induction Cervical Dilator is a medical device (a catheter for mechanical dilation), not an imaging or diagnostic AI device. Therefore, a multi-reader multi-case study comparing human readers with and without AI assistance is not applicable to this type of product.

6. Standalone (Algorithm Only) Performance Study

No, a standalone (algorithm only) study was not done. This device is a physical medical instrument (a catheter) that functions through mechanical dilation, not an algorithm. Therefore, an "algorithm only" performance study is not applicable. Its performance is evaluated through its physical interaction with the human body in a clinical setting.

7. Type of Ground Truth Used

The ground truth for the clinical trials would have been established through direct clinical observation and measurement of outcomes. This includes:

• Clinical Measurements: Cervical dilation (e.g., in centimeters or Bishop score changes).
• Patient Outcomes: Time to delivery, mode of delivery (vaginal vs. Cesarean), incidence of preterm labor, late abortions, complications (cervical tears, infection), and ease of device insertion/removal.
• Clinical Assessment: Physicians' assessments of safety and effectiveness.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical instrument, not an AI/machine learning algorithm that requires a "training set" in the computational sense. The "training" for such devices typically refers to engineering design, material selection, and manufacturing process optimization, which are not based on data sets in the same way an AI model is.

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

Not applicable. As stated above, this device does not have a "training set" in the context of AI/ML. The "ground truth" in its development would refer to engineering specifications, material properties, and preclinical testing results (e.g., burst pressure, flow rate testing as mentioned in the summary) compared against established standards for medical devices.

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Laminaria is intended for use whenever it is desirable to dilate the cervical canal, such as Uterine curettage, Labor induction, IUD placement and removal, and Radium placement

This single use device is a hygroscopic laminaria cervical dilator designed to dilate (stretch open) the cervical os by cervical insertion of a cylindrical and expansible material into the cervical canal, made from the root of a seaweed (laminaria digitata). Laminaria expands when it absorbs moisture.

The ability to increase in size slowly (usually 6 to 24 hours) is of advantage in physiologically dilating a closed body orifice such as the cervical canal. When used improperly, it may cause the patient major discomfort or uterine complications

Laminaria is available in 2, 3, 4, 5, 6, 7, 8 and 9 mm diameter sizes with a length varving between 50 and 65 mm. Each laminaria is drilled and attached to a 75-95 mm string to facilitate removal from the cervical canal (the last digit of the product code reflects its size)

Laminaria is intended for use whenever it is desirable to dilate the cervical canal, such as uterine or suction curettage, labor induction, IUD placement and removal, and Radium placement

This 510(k) submission describes the Laminaria cervical dilator and claims substantial equivalence to a predicate device, the Staol Laminaria Tents from Norscan Trading Group. The submission focuses on demonstrating that the new device has identical characteristics to the predicate, rather than presenting a study to prove its performance against acceptance criteria in the typical sense of a novel device.

Here's an analysis based on the provided text, addressing your specific questions:

1. Table of Acceptance Criteria and Reported Device Performance

Instead of predefined acceptance criteria and a performance study against them, the submission uses a comparative approach against a predicate device. The "performance" is considered "identical" to the predicate.

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

The document does not describe a specific "test set" or clinical study with patient data. The argument for the device's safety and effectiveness relies on its technological characteristics being identical or similar to the predicate device, which is already legally marketed. Therefore, there's no data provenance in the context of a new clinical study. This is typical for a 510(k) submission where substantial equivalence is claimed based on similarities to a predicate rather than novel performance data.

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

Not applicable. As no new clinical "test set" was generated, there was no need for experts to establish ground truth for such a set.

4. Adjudication method for the test set

Not applicable. No new clinical "test set" was generated.

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 a medical device (cervical dilator), not an AI-powered diagnostic tool. Therefore, an MRMC study or AI assistance is not relevant to this submission.

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

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

7. The type of ground truth used

The "ground truth" in this context is the safety and effectiveness profile established for the predicate device. The underlying assumption is that because the Laminaria device is technologically equivalent to the predicate, it shares the same safety and effectiveness profile.

8. The sample size for the training set

Not applicable. There is no machine learning or AI component that would require a "training set."

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

Not applicable. There is no machine learning or AI component.

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