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The CrossGlide™ ETS Plus is indicated for use for sonohysterography and to remove material from the uterus and from the mucosal lining of the uterus by scraping and vacuum suction in order to obtain tissue for histological biopsy.

The CrossGlide™ ETS Plus is a sterile, disposable, single-use device which enables saline infusion sonohysteroraphy and the removal of mucosal tissue from the uterus for histological biopsy. The CrossGlide™ ETS Plus contains a Delivery Catheter with an everting Membrane, an Inner Aspiration Catheter that contains a lumen for saline infusion and aspiration. The everting Membrane places the Inner Aspiration Catheter into the uterine cavity. A proximal luer connector allows a 10cc luer lock syringe to infuse saline into the uterine cavity for sonohysterography. The 10cc syringe can be used to remove the saline from the uterine cavity and create negative pressure. Movement of the CrossGlide™ ETS Plus device, after creating negative pressure with the 10cc syringe, removes material and tissue from the uterine cavity.

This document is a 510(k) summary for the CrossGlide™ ETS Plus, an endometrial suction curette and accessories. It focuses on demonstrating substantial equivalence to a predicate device, the CrossBay™ Endometrial Tissue Sampler (K192534), and references another device, the CrossBay SonoSure™ Sonohysterography and Endometrial Sampling Device (K133144).

The provided text does not include a study describing the acceptance criteria and performance of an AI-powered device. Instead, it discusses a medical device and its performance through various physical and functional tests, biocompatibility testing, sterilization validation, and packaging/shipping validation.

Therefore, I cannot fulfill your request to provide information about the acceptance criteria and study proving an AI device meets those criteria, or details regarding sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, as these items are not present in the provided document.

The document describes the following for the CrossGlide™ ETS Plus:

1. A table of acceptance criteria and the reported device performance:
There is no specific table of acceptance criteria for a new AI device's performance. Instead, the document discusses performance data for the CrossGlide™ ETS Plus physical device.

The remaining requested information (2-9 pertaining to AI studies) is not available in the provided text.

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The CrossGlideTM ETS, Endometrial Tissue Sampler, is indicated for use to remove material from the uterus and from the mucosal lining of the uterus by scraping and vacuum suction in order to obtain tissue for histological biopsy.

The CrossGlide™ ETS, Endometrial Tissue Sampler, is a sterile, disposable, single-use device which enables the removal of mucosal tissue from the uterus for histological biopsy. The CrossGlide™ ETS contains a Delivery Catheter with an everting Membrane and an Inner Aspiration Catheter. The everting Membrane places the Inner Aspiration Catheter into the uterine cavity. Movement of the ETS device, after creating negative pressure with the 3cc syringe, removes material and tissue from the uterine cavity.

The provided text describes the CrossGlide™ ETS, an Endometrial Tissue Sampler, and its submission for FDA 510(k) clearance. The document focuses on establishing substantial equivalence to a predicate device rather than presenting a standalone study with detailed acceptance criteria and performance data for the device itself.

Based on the information provided, here's a breakdown of the requested elements:

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

The document does not explicitly state quantitative acceptance criteria or a specific study that proves the device meets these criteria in the context of clinical performance (e.g., diagnostic accuracy or tissue yield). Instead, it lists various tests conducted to demonstrate substantial equivalence to a predicate device and safety/functionality.

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

The document does not mention a clinical test set in the traditional sense of patient data for evaluating diagnostic or clinical performance. The "test sets" mentioned relate to engineering and safety validation:

• Biocompatibility tests: Sample sizes are typically small and determined by the specific ISO standard. Data provenance is implied to be from laboratory testing performed by the manufacturer or contracted labs.
• Sterilization validation: Sample sizes are determined by AAMI/ISO standards. Data provenance is from laboratory testing.
• Packaging, Shipping, Shelf-Life & Device Functionality: Sample sizes are determined by specific ASTM guidance. Data provenance is from laboratory testing.
• Functional testing (uterine model): The specific number of devices tested on the uterine model is not provided. Data provenance is from laboratory testing using a physical model, not human data.

There is no mention of country of origin for any human data or whether studies were retrospective or prospective, as no human studies are described in detail.

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

Not applicable. There is no described "test set" of patient cases requiring expert interpretation to establish ground truth for clinical performance. The ground truth for the engineering and safety tests would be defined by the specifications of the standards (e.g., whether a material is cytotoxic, whether a sterile barrier is maintained, whether a specific force is withstood).

4. Adjudication method for the test set

Not applicable. As no clinical test set requiring expert interpretation is described, no adjudication method is mentioned.

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 endometrial tissue sampler, a physical medical device for tissue collection, not an AI-powered diagnostic tool. Therefore, an MRMC study related to AI performance is irrelevant to this submission.

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

Not applicable. This is not an algorithm or AI device.

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

For the engineering and safety studies described:

• Biocompatibility: Ground truth is against established limits and responses per ISO standards.
• Sterilization: Ground truth is against sterility assurance levels (SALs) defined by AAMI/ISO standards, and residual limits.
• Mechanical/Functional: Ground truth is against design specifications and functional requirements (e.g., maintaining negative pressure, correct deployment).
• Uterine Model: Ground truth for comparison would be the ability to successfully deploy and collect "specimens" from the model as intended by the device design, presumably measured by quantitative factors or visual assessment of model interaction.

8. The sample size for the training set

Not applicable. This is not an AI/algorithm device that requires a training set.

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

Not applicable.

Summary Conclusion from the Document:

The provided document (a 510(k) summary) focuses on demonstrating substantial equivalence of the CrossGlide™ ETS to a legally marketed predicate device (Marina Ampler (MAS), K021876). The "study" described is a collection of engineering and validation tests (biocompatibility, sterilization, packaging, shelf-life, and functional testing using a uterine model) to ensure the new device is safe and performs as intended, and that its differences from the predicate device do not raise new questions of safety or effectiveness. It does not present a clinical study with detailed acceptance criteria for diagnostic performance or tissue yield, as would be common for diagnostic AI tools.

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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 CrossBay IVF Embryo Transfer Catheter Set is intended for ultrasound-guided introduction of embryos into the uterine cavity following in vitro fertilization.

The CrossBay IVF Embryo Transfer Catheter Set is a sterile, single use device composed of disposable components supporting the transfer of an in vitro fertilized embryo to the uterus. The CrossBay IVF Embryo Transfer Catheter Set is comprised of a Delivery Catheter with a 6 Fr Inner Catheter and everting membrane that accesses the cervix and uterine cavity; a 3cc syringe for supplying aseptically filtered media or saline to the Delivery Catheter; and a 3 Fr Embryo Transfer Catheter that is supplied in a separately sealed pouch. The Delivery Catheter contains an acorn tip for seating the distal end of the Delivery Catheter at the exocervix. The Embryo Transfer Catheter contains a stainless steel band at the distal end to provide additional echogenicity to the catheter for ultrasound guided procedures. The Embryo Transfer Catheter has markings on its proximal end at 1 cm intervals to aid in determining the depth of insertion. The Embryo Transfer Catheter can extend a maximum distance of 4 cm beyond the distal end of the fully everted membrane when completely inserted into the Delivery Catheter. The maximum insertion depth of the Embryo Transfer Catheter and fully everted membrane is 9 cm.

The provided text describes the CrossBay IVF Embryo Transfer Catheter Set and its comparison to a predicate device, the Wallace Sure View™ Embryo Replacement Catheters & Trial Transfer Catheters (K033084), to demonstrate substantial equivalence for regulatory approval.

Here's a breakdown of the acceptance criteria and the study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a consolidated table of acceptance criteria for all aspects of the device in a typical format. Instead, acceptance criteria are embedded within the "Performance Data" section for specific tests.

However, based on the provided text, we can construct the following table for the criteria that are clearly stated:

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

• Sample Size (for specific tests where mentioned):
  • Mouse Embryo Assay (MEA): Three lots of product.
  • Endotoxin Testing: Three lots of product.
  • Testing for Shelf-Life/Accelerated Aging: "samples exposed to accelerated aging conditions". Specific number not defined beyond "samples".
• Data Provenance: The document does not specify the country of origin of the data. The studies appear to be retrospective bench and lab-based tests conducted on manufactured device samples. There is no mention of prospective clinical studies or human-based data.

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

This section is not applicable as the studies described are bench tests, biocompatibility tests, and sterilization validations, which do not involve expert interpretation or ground truth establishment in the traditional sense of clinical imaging or diagnostic studies. The "ground truth" for these tests is based on established scientific and engineering principles, and the measured physical/biological properties of the device.

4. Adjudication Method for the Test Set

This section is not applicable for the reasons stated in point 3. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which are not present here.

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

No. The document does not describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. This type of study is used to assess human reader performance, often in diagnostic imaging, which is not relevant to this device's testing.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

This section is not applicable. The device is an embryo transfer catheter set, a physical medical device. It does not involve algorithms or AI. The performance tests described evaluate the physical, chemical, and biological properties of the device itself.

7. Type of Ground Truth Used

The "ground truth" for the various performance tests is based on:

• Established engineering specifications and product design.
• Validated laboratory methods and consensus standards (e.g., ISO, ASTM, USP).
• Direct measurement and observation of physical properties.
• Biological responses (e.g., mouse embryo development for MEA, cellular reactions for biocompatibility).

For example, for MEA, the ground truth is the observable blastocyst formation rate in the mouse embryo cultures, and for endotoxin, it's the measured endotoxin level.

8. Sample Size for the Training Set

This section is not applicable. The device is a physical medical device, not a machine learning or AI model, so there is no "training set."

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

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

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The CrossBay SonoFlow Sonohysterography and Sonohysterosalpingography Device is indicated for use to access the uterine cavity for sonohysterography and sonohysterosalpingography procedures. The SonoFlow Device can instill salineonly or a mixture of saline and air for performance of saline infusion sonohysterography and sono-hysterosalpingography (Sono-HSG), respectively, for the evaluation of the fallopian tubes and/or the uterus. The following are generally recognized clinical indications for saline infusion sonohysterography and sonohysterosalpingography procedures: suspected polyps, fibroids, adhesions, endometrial thickening, and/or the selective evaluation of fallopian tube patency.

The CrossBay Medical SonoFlow™ Device is a catheter that enables saline and air infusion of contrast media to perform sonohysterosalpingography and sonohysterography procedures. The catheter is comprised of standard polymer materials and contains a silicone acorn tip to enable a cervical seal. The distal end of the device contains an aeration component that provides an alternating pattern of saline and air as a stream of contrast media into the uterus and fallopian tubes. The proximal end of the device contains a handle with an air supply opening that allows the physician to reduce or eliminate the amount of air infusion selectively by occluding the opening of the air supply. The proximal end of the device contains an empty PVC bag that can be filled with saline. The device is provided sterile and is intended for single use only.

This document is a 510(k) Summary for the CrossBay SonoFlow Sonohysterography and Sonohysterosalpingography Device. It outlines the device's characteristics and demonstrates its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a specific study proving the device meets those criteria, nor does it detail AI performance or ground truth establishment.

Therefore, I cannot provide the requested information based on the provided text. The document focuses on demonstrating substantial equivalence through bench testing, biocompatibility, sterilization validation, and packaging/shipping validation, rather than clinical performance testing with specific acceptance criteria that would typically involve AI evaluation.

Here's what the document does provide regarding testing:

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

• Not present in the document. The document states "Bench testing confirmed that the CrossBay Medical SonoFlow Device performs according to the product specifications" and "Passing results were obtained" for various tests, but it does not specify what those product specifications or acceptance criteria were for device performance. It also doesn't provide specific performance metrics beyond "passing."

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

• Not present in the document. The document mentions that tests were conducted on "ethylene oxide sterilized units at baseline and on devices subjected to accelerated aging conditions equivalent to six (6) months." However, it does not specify the sample size for these units or the provenance of any data beyond mechanical testing. There's no mention of a "test set" in the context of diagnostic performance or clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not present in the document. This type of information would be relevant for a study evaluating diagnostic performance, particularly with AI. This document does not describe such a study.

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

• Not present in the document. This would pertain to a diagnostic performance study, which 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

• Not present in the document. There is no mention of AI in this submission, nor of a MRMC study.

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

• Not present in the document. There is no mention of an algorithm or AI in this submission.

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

• Not present in the document. This would be relevant for a diagnostic performance study, which is not described.

8. The sample size for the training set

• Not present in the document. No training set is mentioned as there's no AI component.

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

• Not present in the document. No training set is mentioned as there's no AI component.

Summary of available information related to performance testing:

The document primarily focuses on demonstrating the device's substantial equivalence to existing predicate devices (Femasys, Inc. - FemVue Saline-Air Device K110288 and FemVue Catheter System K083690, and CrossBay Medical Inc. - SonoSure Sonohysterography and Endometrial Sampling Device K133144).

The "Performance Data" section details the following:

• Bench Testing: Confirmed performance according to product specifications (details not provided), including functionality, bond/joint tests, and fluid/air delivery. Tests were done on new and aged units.
• Biocompatibility testing: Asserted applicability of data from the reference device (CrossBay SonoSure device K133144) due to similar materials and manufacturing. This included Cytotoxicity, Vaginal Irritation, and Sensitization.
• Sterilization Validation: Asserted applicability of data from the reference device (CrossBay SonoSure device K133144) due to equivalent components, materials, dimensions, weight, and sterilization methodology. Complied with ISO 11135-1:2007 and ISO 10993-7:2008.
• Packaging and Shipping Validation: Successfully conducted per ASTM guidelines (ASTM F1929, D642, 5276).

In conclusion, this document primarily addresses the mechanical, material, and sterility aspects of the medical device for a 510(k) submission, not the diagnostic or AI performance with associated acceptance criteria and ground truth studies that your questions suggest.

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The CrossBay SonsoSure Sonohysterography and Endometrial Sampling Device is indicated for use to access the uterine cavity for saline infusion sonohysterography and to obtain endometrial biopsy, if indicated, utilizing the same device.

The CrossBay Medical SonoSure Device is a catheter that enables saline infusion sonohysterography procedures and endometrial biopsy collection within a single device. The catheter is comprised of standard polymer materials and contains a silicone acorn tip to enable a cervical seal. The distal end of the device contains a retractable nylon brush for endometrial biopsy sampling. The distal end of the device contains an empty PVC bag that can be filled with saline. The device is provided sterile and is intended for single use only.

Here's an analysis of the provided text regarding the CrossBay Medical SonoSure Sonohysterography and Endometrial Sampling Device:

Acceptance Criteria and Device Performance Study

Based on the provided 510(k) summary, the device's acceptance criteria and performance are primarily evaluated through non-clinical performance data (bench testing and biocompatibility). The document emphasizes substantial equivalence to predicate devices rather than establishing novel clinical performance metrics with specific acceptance criteria in a dedicated clinical study.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify a numerical sample size for the "test set" in terms of clinical subjects. The performance data discussed is non-clinical (bench testing, biocompatibility, sterilization, packaging). For these types of tests, samples would be units of the device itself (e.g., a certain number of devices for mechanical testing, material samples for biocompatibility). Specific numbers are not provided.
• Data Provenance: The data is generated through "physical bench testing," "biocompatibility testing," and "sterilization" and "packaging and shipping validation studies." This indicates the data is from laboratory or controlled testing environments, not from clinical subjects or patient data. Therefore, "country of origin" or "retrospective/prospective" is not applicable in the typical sense for clinical studies. It's internal product development and testing data.

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

• This question is not applicable as the provided documentation describes non-clinical performance and does not involve establishing ground truth from experts on a test set (e.g., imaging diagnosis, pathology review). The "ground truth" for these tests are typically established by objective, measurable engineering and scientific standards (e.g., pass/fail criteria for mechanical strength, established limits for cytotoxicity).

4. Adjudication Method for the Test Set

• This question is not applicable as the assessment is based on non-clinical performance data against established standards and specifications, not on subjective expert interpretation 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.
• The device is a physical medical instrument (catheter, brush), not an AI-powered diagnostic or assistive tool. Therefore, the concept of "human readers improving with AI assistance" is not relevant to this device.

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

• No, a standalone performance study was not done.
• The device is a physical medical instrument, not an algorithm, and does not operate "standalone" without human interaction/use.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• For the non-clinical tests described, the "ground truth" is derived from established scientific and engineering standards and specifications. For instance:
  • Mechanical strength: Pass/fail criteria dictated by product specifications and engineering principles.
  • Biocompatibility: Conformance to ISO 10993 standards and FDA guidance.
  • Sterilization: Compliance with ISO 11135-1 and ISO 10993-7.
  • Packaging: Adherence to ASTM guidelines.
• There is no mention of expert consensus, pathology, or outcomes data being used to establish a "ground truth" for the performance evaluation presented.

8. The Sample Size for the Training Set

• This question is not applicable. The device is a physical medical instrument and does not involve machine learning or AI, thus there is no "training set."

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

• This question is not applicable as there is no training set for this device.

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