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The ExCellerator Cervical Collection Device is a cervical spatula intended for collecting ectocervical specimens for the ThinPrep Pap test. The device is also intended to be used to aid in a more complete transfer of the specimen material from the endocervical brush (cytobrush) to the PreservCyt solution for ThinPrep testing. The ExCellerator device must be used with an IVD labeled endocervical brush.

The ExCellerator™ Cervical Collection Device is a non-sterile, single use, disposable cervical sampling device (spatula), comprised of inert food grade polypropylene plastic, intended for sampling the ectocervix during the cervical sample collection procedure. Additionally, it aids in more complete transfer of the cytological sample collected with an IVD labeled endocervical brush (cytobrush) into the PreservCyt vial for the preparation of ThinPrep Pap test slides.

Here's a summary of the acceptance criteria and the study proving the device meets them, based on the provided text:

Device: ExCellerator Cervical Collection Device
Purpose: Cervical spatula for collecting ectocervical specimens for ThinPrep Pap test and aiding transfer of endocervical brush specimens.

1. Table of Acceptance Criteria and Reported Device Performance

The document describes several types of testing with acceptance criteria.

Biocompatibility Assessments:

Structural Assessments:

Dimensional Assessments:

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The Kolplast Cervical Sample Collection Kit is intended for collection of cytological specimens from the ectocervix and the endocervix for conventional Pap Smear Test or Liquid-Based ThinPrep® Pap Test with PreservCyt® solution.

For prescription use only.

It is not intended for use in pregnant women and should be used by a clinical or other qualified health professional only.

The Kolplast Cervical Sample Collection Kit is composed of the Kolplast Cervical Brush Protected Tip and the Kolplast Cervical Plastic Spatula and is a single use, non-sterile, disposable manual gynecological device. The Cervical Brush Protected Tip is intended for the collection of cytological specimens from the endocervix and the Cervical Plastic Spatula is intended for the collection of cytological specimens from the ectocervix. The Cervical Brush Protected Tip has a head consisting of white nylon bristles, and secured by stainless steel to the plastic handle. During collection of endocervical cells, the Cervical Brush Protected Tip is inserted into the cervix, rotated once via the handle and removed from the cervix. The collected cytological specimen is then transferred to the glass slide by smearing, or to the preservative fluid in a container by rotating the tip 10 times while pushing against the container wall. The Kolplast Plastic Spatula is made of plastic and incorporates a long edge and a notched end. During collection of ectocervical cells, the notched end is put against and rotated 360° around the circumference of the ectocervix. The retained cytological specimen is then transferred to the same glass slide by smearing, or to the preservative fluid in the same container by swirling 10 times. The collected samples on glass slide, or in preservative fluid in a container will be sent to a cytology lab for Pap Test analysis.

This document describes a 510(k) premarket notification for the "Kolplast Cervical Sample Collection Kit," a Class II medical device. The submission aims to demonstrate substantial equivalence to a predicate device, the "Pap Smear Kit (K861389)."

Here's an analysis of the provided information concerning acceptance criteria and the study that proves the device meets them:

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

The document does not explicitly state numerical acceptance criteria for the clinical performance. Instead, it describes clinical tests conducted to ensure "effectiveness." The reported performance is that these tests were conducted and support the device's substantial equivalence to the predicate.

• Conventional Pap Smear Test
• Liquid-Based ThinPrep® Pap Test with PreservCyt® solution | Clinical tests were conducted to ensure effectiveness in collecting cervical specimens for both conventional Pap Smear Method and Liquid-Based Pap Test Method. The results supported substantial equivalence. |
  | Biocompatibility | No cytotoxicity, sensitization, or irritation | Met ISO 10993-5:2009 (Cytotoxicity), ISO 10993-10:2010 (Sensitization), and ISO 10993-10:2010 (Irritation) standards. |
  | Mechanical Performance | Adequate tensile strength (break/displacement), fixing resistance of bristles (decoupling rotation) | Mechanical tests conducted included tensile strength and decoupling rotation, ensuring performance. |
  | Shelf-Life | Maintains specifications for 5 years | Real-time aging studies demonstrated the device maintains specifications over a 5-year shelf life. |

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

The document mentions "clinical tests were conducted on this device to ensure effectiveness" but does not provide any details regarding the sample size, data provenance (e.g., country of origin), or whether the studies were retrospective or prospective.

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):

The document does not provide any information about the number of experts used, their qualifications, or how ground truth was established for the clinical effectiveness studies. Clinical tests for Pap smears typically involve cytopathologists, but this is not specified here.

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

The document does not provide any information regarding the adjudication method used for the clinical effectiveness studies.

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

This device is a manual cervical sample collection kit, not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving AI assistance is not applicable and was not performed.

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

This device is a manual tool. Therefore, a standalone (algorithm only) performance assessment is not applicable and was not performed.

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

While not explicitly stated, for Pap Smear effectiveness studies, the ground truth would typically be established by cytopathology results from the collected specimens. However, the document does not confirm this.

8. The sample size for the training set:

As this is a manual medical device and not a machine learning algorithm, there is no concept of a "training set" in the context of this submission. The effectiveness is demonstrated through standard clinical performance tests.

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

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

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The Disposable Cervical Brush is intended for the collection of cervical cells for analysis by Pap smear methods. It is not intended for use in pregnant women and should be used by a clinician or other qualified health professional only.

The Disposable Cervical Brush is a non-sterile, disposable, colored cytological cervical spatula intended for collecting cytological materials from the surface of the cervix. This device consists of two components: a white colored head and a pink colored handle. The head contains a brush and a connection portion. The head and handle are physically connected through a male/female connection mechanism. The handle is made of Polypropylene (PP) and the head is made of low density polyethylene (LDPE). This device has a 3-years shelf-life.

The provided documentation is a 510(k) summary for a Disposable Cervical Brush, a medical device used for collecting cervical cells for Pap smear analysis. It outlines the device's technical specifications, intended use, and comparison to a predicate device to establish substantial equivalence.

Based on the provided text, here's a detailed breakdown of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative "acceptance criteria" for clinical performance. Instead, it focuses on demonstrating safety and performance through non-clinical testing and comparison to a predicate device. The underlying acceptance criterion for a 510(k) is substantial equivalence to a predicate device, meaning it is as safe and effective as the legally marketed predicate.

The reported performance is primarily derived from meeting established standards for biocompatibility and mechanical integrity, which implicitly demonstrate that the device performs as intended and is safe for its intended use.

Study Information

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 non-clinical (bench) testing for biocompatibility, mechanical performance, and chemistry. It does not mention a "test set" in the context of clinical data, as it's a 510(k) for a Class II manual instrument where clinical studies are often not required if substantial equivalence can be demonstrated through other means.
   • For the non-clinical tests, specific sample sizes are not provided, nor is the country of origin of the testing data or whether it was retrospective or prospective. It is implied these were prospective tests conducted to evaluate the device.

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

   • Not applicable. The document describes non-clinical testing, not a study involving expert-established ground truth on patient data.

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

   • Not applicable. This is not a clinical study involving adjudication of human-interpreted data.

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

   • Not applicable. This is not an AI/software device, and no MRMC study is mentioned. The device is a manual instrument for cell collection.

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

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

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

   • For the non-clinical tests, the "ground truth" or reference standards were established laboratory testing standards and methods for biocompatibility, mechanical properties, and chemical composition. For instance, cytotoxicity tests adhere to recognized protocols to determine the biological response.

7. The sample size for the training set

   • Not applicable. There is no mention of a "training set" as this is not a machine learning or AI device.

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

   • Not applicable. As there's no training set, there's no ground truth established for it.

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To obtain endocervical cells for Pap smear cytology test

The Puritan Histobrush consists of nylon bristles secured by stainless steel to a plastic handle. The device is used to obtain endocervical samples for Pap smear cytology. The device is for single use only and is non-sterile.

The provided text is a 510(k) summary for a medical device called "Histobrush Model 2188," a cervical cytology brush. This type of submission focuses on demonstrating substantial equivalence to a predicate device for safety and effectiveness, rather than proving performance against specific acceptance criteria through a standalone clinical study. Therefore, much of the requested information regarding acceptance criteria, study design, ground truth, and human expert involvement is not applicable or not provided in this document.

Here's an analysis of the provided information based on your request:

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

This document does not specify formal "acceptance criteria" in the way a performance claim for an AI/diagnostic device would. Instead, it focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and non-clinical testing. The "reported device performance" is essentially the equivalence shown through these tests and comparisons.

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

For the non-clinical tests (biocompatibility, tensile strength, fiber removal force, wire removal force), the sample sizes are not specified in this document.
The data provenance is not specified regarding country of origin or whether it's retrospective/prospective, as no clinical study on human subjects is described. The tests are non-clinical (laboratory-based).

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

Not Applicable. This document describes non-clinical engineering and materials testing, not a study requiring human experts to establish ground truth for a diagnostic outcome.

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

Not Applicable. As there's no diagnostic test set or human expert review, there's no adjudication method 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 Applicable. This device is a manual medical instrument (cervical cytology brush), not an AI or imaging diagnostic device. Therefore, no MRMC study or AI assistance evaluation was performed or is relevant here.

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

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

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

The "ground truth" for the non-clinical tests would be the established engineering and material standards for the specific tests conducted (e.g., specific force thresholds for tensile strength, biocompatibility standards). These are implied standards relevant to the predicate devices, as the comparison is one of substantial equivalence. No pathology or outcomes data is referenced.

8. The sample size for the training set

Not Applicable. This is not an AI/machine learning device that requires a training set.

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

Not Applicable. As above, no training set for an algorithm is relevant here.

In summary:

This 510(k) submission for the Histobrush Model 2188 demonstrates substantial equivalence by comparing its technological characteristics and non-clinical test results (biocompatibility, mechanical strength) to previously cleared predicate devices. It does not involve clinical studies with human participants, AI algorithms, or the establishment of diagnostic ground truth by experts from patient data. The "study" referenced is a series of non-clinical, laboratory-based tests to ensure the new device performs similarly and safely to existing products.

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PapCone® is a medical device intended for the collection of exfoliated cervical cells for analysis by Pap smear methods. The PapCone is not intended for use in pregnant women.

The PapCone® consists of an axially symmetric polystyrene grip with a round platform carrying a foam cone (PUR Foam B 2240), which is intended to collect exfoliated epithelial cervical cells for andysis by Pap smear methods. Due to its shape, dimension and the porosity of the foam used for PapCone® it is possible to obtain cells from the endocervix and the ectocervix. The design of the foam prevents distortion of the cells during sampling and transfer. During a gynecological examination the foam cone portion of the PapCone® is inserted for $1/3 into the cervical canal and is rotated two times for collection of cervical cells are transferred to a glass slide by applying gentle pressure and rotating the PapCone® evenly against the direction of streak on the slide, this allows for a uniform distribution of cells on the slide. To ensure the adequate coverage of the periphery of the transition zone, it is generally recommended to swap the periphery additionally with a second instrument (e.g. PapCone® or a spatula). Transfer these cells to the same glass slide. The device is offered non sterile.

The PapCone® is a medical device intended for the collection of exfoliated cervical cells for analysis by Pap smear methods. The key performance criteria for such a device relate to its ability to effectively collect and release cells.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical targets in the provided text. However, the study aims to demonstrate substantial equivalence to predicate devices by showing comparable performance in collecting and releasing particles and comparable clinical outcomes.

The study aims to demonstrate that the PapCone® is substantially equivalent to the predicate devices (Cervex-Brush® and Puritan Foam Tip Swab Model 2197) in terms of intended use, principles of operation, materials, and performance.

Study Details Proving Device Meets Acceptance Criteria

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

• Bench Test: The exact sample size for the bench test is not explicitly stated in terms of number of individual tests or repetitions for each device. The results are presented as "Mean value," "Standard dev.," "Max.," "Min.," and "Spread," implying multiple measurements were taken for each device.
  • Data Provenance: Not specified, but likely laboratory-based bench testing.
• Clinical Performance Evaluation:
  • Sample Size: 31,000 smears were taken and compared.
  • Data Provenance: The study was conducted in Europe after the legal marketing of PapCone® (SANDER H. et. al: Sampling devices for cytological examinations, 2007). This indicates prospective data collection for the clinical comparison.

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

• Bench Test: Not applicable as the "ground truth" for particle collection/release would be based on quantitative measurements. No human experts are mentioned for this part.
• Clinical Performance Evaluation: The text states "The statistical detection rate of positive cytological findings was equal for the compared instruments." This implies a cytological evaluation by trained professionals (e.g., cytotechnologists, pathologists). However, the specific number and qualifications of these experts are not provided.

3. Adjudication Method for the Test Set:

• Bench Test: Not applicable. Measurements are quantitative.
• Clinical Performance Evaluation: The document does not specify an adjudication method for the cytological findings. It refers to a "statistical detection rate," suggesting standard cytological diagnostic procedures were followed, but without details on how discrepancies (if any) were resolved or how ground truth was established by expert consensus.

4. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No, an MRMC comparative effectiveness study was not done.
• The clinical study compared the PapCone® to a spatula and brush combination and cotton tip. It focused on device performance in terms of sampling effectiveness, patient/physician acceptance, and detection rate, not on assessing human reader performance with or without AI assistance. The PapCone® is a physical sampling device, not an AI-powered diagnostic tool.

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

• No, this is not applicable. The PapCone® is a physical medical device for cell collection, not an algorithm, so a standalone algorithm performance study was not conducted.

6. The Type of Ground Truth Used:

• Bench Test: Quantitative measurements of particle release.
• Clinical Performance Evaluation: "Positive cytological findings." This implies the ground truth for diagnostic accuracy was established through standard cytopathological diagnosis (microscopic examination of Pap smears). The "increased representative sampling due to increased number of cells" refers to a biological ground truth related to cellularity.

7. The Sample Size for the Training Set:

• Not applicable. The PapCone® is a physical medical device, not an AI or machine learning model, so there is no training set in the conventional sense.

8. How the Ground Truth for the Training Set Was Established:

• Not applicable. As stated above, there is no training set for this device.

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The (Endo)cervical Sampler is intended for the collection of endocervical cells for PAP smear analysis. This device is not intended for use in pregnant women.

Not Found

The provided text is a 510(k) premarket notification approval letter for an '(Endo)cervical Sampler'. It does not contain any information regarding acceptance criteria or a study that proves the device meets those criteria.

The letter confirms that the FDA has reviewed the submission and determined the device to be substantially equivalent to legally marketed predicate devices. It focuses on regulatory compliance, marketing authorization, and general controls, rather than performance data or study details.

Therefore, I cannot provide the requested information based on the input text.

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For the collection of cervical cytology specimens for Pap test analysis. The SoftPAP™ Cervical Sample Collector should not be used after the first 10 weeks of gestation in pregnant patients.

The CytoCore, Inc. SoftPAP™ Collector is a multicomponent assembly for the collection of exfoliated cervical epithelial cells. Its major components are a disposable Balloon assembly (Balloon and rod), and a reusable Handle. The Balloon provides the conformal surface upon which the cells are collected. The Handle provides a means of manipulating and expanding the Balloon during the sampling process. The Balloon inflates against the cervix and conformally contacts the entire areas to be sampled, namely the ectocervical, the transformation zone, and the endocervical surfaces.

The provided text is a 510(k) premarket notification for a medical device called the "CytoCore SoftPAP™ Collector." This document focuses on demonstrating substantial equivalence to a predicate device, the CytoCore e2™ Collector (K013285), following modifications to the e2 Collector for physician ease-of-use and manufacturability while not affecting the intended use, indications for use, or patient contact components.

Therefore, this document does not contain information about acceptance criteria or a study designed to prove the device meets specific performance criteria against scientific metrics.

Instead, the core of this submission is to show that the new device is as safe and effective as the previously cleared predicate device. This is primarily done by:

1. Stating the modifications: The document details changes between the e2 Collector and the SoftPAP Collector, such as the transition from a single integrated unit to a separate reusable handle and single-use collection device, and changes in the balloon collapse and inflation mechanisms.
2. Affirming no impact on critical aspects: The document explicitly states that "The modifications did not affect the Intended Use, Indications for Use, balloon material, balloon inflation profile, or any components that come in contact with the patient or patient cells."

Based on the provided text, I cannot provide the requested information regarding acceptance criteria and a study proving their attainment because such information is not present in this 510(k) submission document.

Here's why the requested information is absent:

• 510(k) Substantial Equivalence: A 510(k) is primarily intended to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This often involves showing that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety and effectiveness. It doesn't typically require new clinical studies or new acceptance criteria if the changes are minor and do not alter the fundamental performance or safety aspects.
• Predicate Device Relies on Prior Approval: The predicate device, CytoCore e2™ Collector (K013285), would have been cleared based on its own set of performance data and acceptance criteria. Since the SoftPAP™ Collector is deemed substantially equivalent and the modifications did not affect critical performance aspects, the FDA does not require new performance studies to re-prove the device's efficacy or safety against new acceptance criteria in this specific context.

In summary, the provided document does not contain the information you requested because it's a 510(k) submission focused on demonstrating substantial equivalence, not on establishing and meeting new performance acceptance criteria through a novel study.

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The Diamics CerCol Cervical Sample Collector is indicated for the collection of cervical cytology material and its transfer for Pap analysis. The Diamics CerCol Cervical Sample Collector is not intended for use in pregnant women.

This device consists of a reusable handle and a multi-component assembly. The reusable handle provides a means of expanding and manipulating the CerCol™ Cervical Sample Collector so that the surface areas of the endo-cervix, ecto-cervix and transition zones of the cervix are completely contacted by the CerCol™ Cervical Sample Collector tip for the collection, transport, analysis and testing of exfoliated cervical epithelial cells. The CerCol™ Cervical Sample Collector will be available as a single use, non-sterile disposable device and the reusable handle will be available separately, but both components must be used together as part of the CerCol™ Cervical Sample Collector System.

The document K062433 describes the Diamics CerCol™ Cervical Sample Collection System, a device intended for the collection of cervical cytology material for Pap analysis. The submission focuses on demonstrating substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission primarily evaluates substantial equivalence based on the ability of the device to collect satisfactory cervical samples, indicated by the rate of satisfactory results and the presence of endocervical/transformation zone components, which are crucial for effective Pap testing.

Note: The acceptance criteria are largely implied by demonstrating clinical performance comparable to the predicate device and by meeting pre-defined parameters in bench testing. Numerical targets are primarily derived from the predicate's performance or internal benchmarks for mechanical aspects.

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

• Clinical Study 1:
  • Test Set Size: 265 standard (predicate device) collections and 265 CerCol™ Cervical Sample Collections.
  • Data Provenance: Pooled across two centers. No country of origin is explicitly mentioned, but typically for FDA submissions, studies are conducted in the US or in countries with comparable medical standards. The study appears to be prospective or concurrent as it compares two collection methods simultaneously.
• Clinical Study 2:
  • Test Set Size: 102 CerCol™ Cervical Sample Collector collections.
  • Data Provenance: Conducted at one center. No country of origin is explicitly mentioned. This study also appears to be prospective.

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

The document does not explicitly state the number or qualifications of experts used to establish the ground truth for interpreting the Pap analysis results. It refers to "satisfactory results" and "endocervical/transformation zone component," which would typically be determined by trained cytotechnologists and/or pathologists. However, the specific details about these experts are not provided in this summary.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method (e.g., 2+1, 3+1). It only mentions that the studies resulted in "satisfactory results," implying that the assessment of sample quality was done according to established laboratory protocols.

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

No, an MRMC comparative effectiveness study was not done. The studies described are clinical studies comparing the sample collection efficacy of the device to a predicate device, focusing on the quality of the collected sample rather than the diagnostic accuracy improvement of human readers with AI assistance.

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

This is a medical device for sample collection, not an AI or algorithm-based diagnostic tool. Therefore, a standalone algorithm-only performance study is not applicable to this device. The "Performance Data" section primarily addresses mechanical bench testing of the device components.

7. The Type of Ground Truth Used

The ground truth used in the clinical studies is based on the assessment of sample adequacy for Pap analysis. This includes:

• Satisfactory Result: Indicating that the collected sample is sufficient for cytological examination.
• Presence of Endocervical/Transformation Zone (EC/TZ) Component: Cytological evidence showing that cells from this critical area of the cervix (where most cervical cancers originate) have been collected. This assessment is typically made by trained laboratory personnel (cytotechnologists/pathologists) based on microscopic examination of the prepared slides.

8. The Sample Size for the Training Set

This document only describes performance and clinical studies for a medical device that collects samples. It does not describe an AI or machine learning model, so there is no "training set" in the context of AI. The "manufacturing process" section mentions Quality Control (QC) tests performed on 100% of manufactured devices, which could be considered an internal quality assurance process but not a "training set" for an algorithm.

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

As there is no AI/ML model described, there is no "training set" and thus no ground truth established for it in this document.

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The Cervex-Brush Combi is intended for the collection of cervical cells for analysis by Pap smear methods and / or by methods for detecting sexually transmitted disease (STD). The Cervex-Brush Combi is not intended for use in pregnant women.

This device consists of handle with a multi-bristled, soft plastic brush mounted on it. The bristles are intended to collect cervical cells for testing and evaluation. For the middle part of the Cervex-Brush Combi the cell-collecting ability of the device is comprised of substantially eccentrically placed parallel plastic bristles, forming a brush head that is connected to the handle. The eccentrically placed bristles are positioned on opposite sides of a square base. The top of the brush is rounded. Digital rotation with gentle pressure by way of the handle causes to scrape and remove cytological material simultaneously from the ectocervix and the endocervix. Because the bristles are plastic, wet or humid cells are not absorbed so that the cytological material can easily be transferred to a glass slide or a preservative fluid and sent to the laboratory for evaluation. The device is offered sterile and nonsterile. The Cervex-Brush Combi head is composed of polyethylene, the same material that is used for the Cervex- Brush.

The provided document is a 510(k) summary for the Cervex-Brush Combi, a medical device for collecting cervical cells. This type of submission focuses on demonstrating substantial equivalence to pre-existing devices, rather than presenting a performance study with acceptance criteria in the manner requested for AI/algorithm-based devices.

Therefore, the requested information outlining acceptance criteria and a study proving the device meets those criteria cannot be fully provided from this document. The document specifically states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976." This indicates that the approval is based on equivalence, not on a new performance study against specific acceptance criteria for a novel device.

However, I can extract information related to the device's characteristics and its equivalence claim, which serves as its "proof" of meeting regulatory requirements in this context.

Here's a breakdown of what can be inferred and what cannot:

What can be extracted/inferred from the document:

• Device Performance: The document claims the device is "substantially equivalent in terms of intended use, design, manufacturing processes, physical properties, and principles of operation" to its predicate devices (Cervex-Brush® and EndoCervex-Brush). This equivalence is the basis for its market entry, implying it performs comparably to already approved devices.
• Intended Use/Acceptance: The device is "intended for the collection of cervical cells for analysis by Pap smear methods and / or by methods for detecting sexually transmitted disease (STD)." The device meets this intended use by being substantially equivalent to devices already accepted for this purpose.

What cannot be extracted from this document (as it's not a study report for a novel AI device):

• A table of explicit acceptance criteria (e.g., sensitivity, specificity thresholds) and reported device performance against those criteria.
• Sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, type of ground truth used for such studies, or training set details. These are typically part of a de novo approval or a PMA for a novel device, especially AI/ML.

Based on the provided document, here's a best-effort response, highlighting what is available and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The "study" proving the device meets its "acceptance criteria" (which are defined implicitly by the characteristics of the predicate devices) is the 510(k) Substantial Equivalence Determination. The FDA concluded that the Cervex-Brush Combi is "substantially equivalent" to the predicate devices (Cervex-Brush® and EndoCervex-Brush) manufactured by Rovers Medical Devices BV, based on its intended use, design, manufacturing processes, physical properties, and principles of operation.

Key Information from the Document:

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

• Not Applicable. This document is a 510(k) summary for a physical medical device (a cervical cell scraper), not an AI/software device. The approval is based on demonstrating substantial equivalence to predicate devices, not on a performance study with a test set of data in the context of an AI algorithm. Therefore, details about a "test set" in that sense are not provided.

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

• Not Applicable. See point 2.

4. Adjudication method for the test set:

• Not Applicable. See point 2.

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. See point 2. This device is a cell collection instrument, not an AI-assisted diagnostic tool.

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

• Not Applicable. See point 2 and 5.

7. The type of ground truth used:

• Implied Ground Truth/Standard: The "ground truth" for this type of submission is the established performance and safety profile of the predicate devices (Cervex-Brush® and EndoCervex-Brush). The Cervex-Brush Combi is assessed against these already legally marketed and accepted devices.

8. The sample size for the training set:

• Not Applicable. See point 2. This is not an AI/ML device requiring a training set.

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

• Not Applicable. See point 2 and 8.

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For use as a diagnostic accessory. A blunt instrument used to scrape and remove cytological material from the surface of the cervix or vagina.

Cervical Scraper

This document is an FDA 510(k) clearance letter for a Cervical Scraper (K042527). It confirms substantial equivalence to a predicate device but does not contain information about acceptance criteria or a study proving device performance.

Therefore, I cannot fulfill the request to describe acceptance criteria and associated studies from the provided text. The document primarily focuses on regulatory approval and indications for use.

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