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The "RELIEEV" Suction Curette (Flexible 3.0/ Standard 3.6) is used to remove samples of materials from the uterus and from the mucosal lining of the uterus by scraping or vacuum suction. These devices obtain tissue samples for purposes of biopsy precancer screening or they can be used for menstrual extraction.

The "RELIEEV" Suction Curette is a sterile, disposable, single-use device used to obtain a sample from the uterine mucosal lining. It is available in two models – Flexible 3.0 and Standard 3.6 with outer diameters of 3.0 mm and 3.6 mm respectively. The device consists of a tube and piston made of polypropylene (PP) with a silicone O-ring. The subject device is packaged in medical paper grade pouch (60g).

This document describes the premarket notification (510(k)) for the "RELIEEV" Suction Curette. The information provided in the document does not contain details about acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML powered device, as the device is a physical medical instrument, not a software or AI-based product.

The document discusses performance data related to physical bench testing, biocompatibility, packaging and shipping validation, sterilization validation, and shelf life to demonstrate substantial equivalence to a predicate device.

To address your request, I will categorize the information presented in the document as it pertains to the performance and validation of this physical device.

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

Based on the provided document, specific numerical acceptance criteria values are generally not explicitly stated for each test, but rather the conclusion that the device "passed" or "performed according to product specifications" is given. The "Reported Device Performance" here reflects these summarized outcomes.

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

The document does not specify the exact sample sizes for the individual tests (e.g., number of devices tested for suction force, biocompatibility, etc.). It only states that "Physical bench testing was performed" and "The subject device test results were compared with the predicate device".

Data Provenance: The manufacturing company is LI Medical Corporation LTD. in New Taipei City, Taiwan. The studies were likely conducted either internally by the manufacturer or by contract testing laboratories performing the specified ISO and ASTM standards. The data is retrospective in the sense that the tests were performed on finished devices to support the 510(k) submission.

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

This question is not applicable to the "RELIEEV" Suction Curette as described in the document. This is a physical medical device, not a diagnostic device involving expert interpretation of data or images to establish a "ground truth" for a test set. The validation relies on objective physical, chemical, and biological testing standards.

4. Adjudication method for the test set

This question is not applicable. Adjudication methods (like 2+1, 3+1) are typically used for clinical studies involving human interpretation or subjective assessments, which are not detailed in this document for the provided device. The device validation relies on standardized tests with defined pass/fail criteria.

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 question is not applicable. An MRMC study is relevant for diagnostic devices that involve human readers interacting with images or data, often in the context of AI assistance. The "RELIEEV" Suction Curette is a physical instrument for tissue sampling.

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

This question is not applicable. This device is not an algorithm or software. It is a physical suction curette.

7. The type of ground truth used

This question is not directly applicable in the terms usually associated with AI/ML devices. For this physical device, "ground truth" is established through:

• Physical measurements and functional performance standards: Defined by product specifications and comparing against the predicate device.
• Standardized testing methods: Such as ISO and ASTM standards for biocompatibility, sterility, packaging, and shelf-life, which provide objective criteria for success or failure.
• Analytical chemistry and microbiology results: For biocompatibility and sterility.

8. The sample size for the training set

This question is not applicable. There is no AI/ML component described for this device, therefore no "training set" in that context. The device is validated through traditional engineering, biological, and sterility testing.

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

This question is not applicable, as there is no training set for an AI/ML algorithm for this physical device.

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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 Disposable Endometrial Suction Curette is indicated for obtaining endometrial tissue samples by vacuum suction for endometrial histopathology examination. The specimens obtained are then used for the following: Endometrial cancer detection, Determine response to estrogen replacement therapy, Detection of pathology resulting in: Infertility, menstrual disorders, abnormal or dysfunctional uterine bleeding, postmenopausal bleeding, endometrial dating.

The proposed device is single-use, sterile disposable endometrial suction curette, which is intended to obtain endometrial tissue samples by vacuum suction mainly for endometrial histopathology examination and cytological examination or clinical examination in Gynaecological examination. Disposable Endometrial Suction Curette, including Type A and Type B, consists of a rod, barrel ' and sealing ring. The rod is used to generate negative pressure to draw the sample (fluid or mucous) into the barrel. The barrel is used to contain the drawn samples. The sealing ring ensures that the handle can be assembled closed with the barrel for keeping certain negative pressure.

The provided text describes a 510(k) summary for a Disposable Endometrial Suction Curette (K102847). This submission is for a medical device that obtains tissue samples, and the regulatory review focuses on substantial equivalence to a predicate device rather than novel performance claims. As such, the information you're requesting regarding acceptance criteria from clinical studies as typically understood for AI/diagnostic algorithms is largely not applicable in this context.

Here's an explanation based on the provided text:

1. Table of acceptance criteria and the reported device performance:

Important Note: The provided text does not include any acceptance criteria related to diagnostic accuracy, sensitivity, or specificity by comparing device output to a ground truth, which would typically be present for an AI-powered diagnostic device. This is because the device itself is a sampling tool, not a diagnostic algorithm. Its "performance" is about its ability to obtain a sample, not to interpret it.

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

• Sample Size for Test Set: Not applicable. The "tests" mentioned are primarily engineering and functional tests of the physical device, not clinical studies involving a patient test set in the way an AI diagnostic would have. No patient data or clinical samples are described as being used for the purpose of determining performance for this 510(k) submission.
• Data Provenance: Not applicable.

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):

• Number of Experts/Qualifications: Not applicable. There was no clinical ground truth established for a test set in the context of this device's performance evaluation for the 510(k) submission. The "ground truth" for the device's function would be its ability to physically collect a sample, which is assessed through engineering tests.

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

• Adjudication Method: Not applicable. No clinical test set or subjective interpretations requiring adjudication were involved.

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:

• MRMC Study: No. This device is a physical sampling tool, not an AI or diagnostic algorithm that would assist human readers in interpretation. Therefore, an MRMC study is not relevant.

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

• Standalone Performance: No. This is a physical medical device, not an algorithm.

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

• Type of Ground Truth: Not applicable in the context of diagnostic performance. The "ground truth" for this device's function would be the successful collection of endometrial tissue, which is assessed through its mechanical and functional tests. The subsequent diagnostic examination of the collected specimen (e.g., for cancer) would use pathology as ground truth, but that is a downstream process performed by a lab, not part of this device's performance evaluation.

8. The sample size for the training set:

• Sample Size for Training Set: Not applicable. This is not an AI/machine learning device.

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

• Ground Truth for Training Set: Not applicable.

Summary of the Study (as described for this device):

The "study" described for the Disposable Endometrial Suction Curette (K102847) is a non-clinical performance evaluation focused on engineering and functional testing, rather than a clinical trial measuring diagnostic accuracy.

• Purpose: To demonstrate that the proposed device is substantially equivalent to a legally marketed predicate device (SelectCells™Mini, K974819).
• Methodology:
  • "Tests have been developed which are considered sufficient to ensure the efficacy and safety of the device for its intended use."
  • These tests included:
    • Visual inspection: To confirm the device's physical appearance and integrity.
    • Dimensional checks: To ensure the device conforms to design specifications.
    • Functional tests: To verify that the device can perform its intended mechanical action (e.g., generating negative pressure to aspirate samples).
• Key Finding: Based on these tests, the device was determined to be "substantially equivalent" to the predicate device. This means the FDA found that the new device is as safe and effective as the predicate device already on the market, despite not explicitly detailing all test results. The 510(k) process primarily relies on demonstrating equivalence rather than proving novel efficacy.

In essence, this submission is for a physical instrument, and its "performance" means it works as intended mechanically to collect a sample, not that it interprets diagnostic information. Therefore, the types of detailed acceptance criteria, ground truth, and studies typically associated with AI/diagnostic algorithms are not documented in this 510(k) summary.

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An endometrial suction curette, such as The Curette and Preferred Curette (available in 2.5 and 3.0 mm outer diameters), are devices used to remove samples of materials from the uteris and from the mucosal lining of the uterus by scraping or vacuum suction. These devices obtain itssue samples for purposes of biopsy precancer screening or they can be used for menstrual extraction.

An endometrial suction curette, such as The Curette and Preferred Curette (available in 2.5 and 3.0 mm outer diameters), are devices used to remove samples of materials from the uteris and from the mucosal lining of the uterus by scraping or vacuum suction.

This is a 510(k) premarket notification for a medical device (endometrial suction curettes) and not a study describing the acceptance criteria or performance of an AI/ML powered device. Therefore, I cannot provide the requested information.

The document discusses the regulatory approval for "The Curette and Preferred Curette" and confirms that the FDA has determined the device is substantially equivalent to legally marketed predicate devices. It outlines general controls, regulations, and reporting requirements for medical devices.

The "Indications for Use" section simply describes what the device is used for, which is to "remove samples of materials from the uterus and from the mucosal lining of the uterus by scraping or vacuum suction" for "biopsy precancer screening or ... menstrual extraction." This is a description of the device's intended clinical application, not a performance study with acceptance criteria for an algorithm.

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FemSpec, LLC, FemTest™ Endometrial Suction Curette is a sterile, disposable curette indicated for single patient use in obtaining tissue samples from the endocervical canal and for histological analysis of the uterine mucosal lining. It is indicated for:

• Cancer screening
• Endometrial dating
• Determining response to estrogen replacement therapy
• Bacterial culturing
• Detection of pathology resulting in infertility
• Monitoring patients receiving Tamoxifen therapy
• Evaluating secondary amenorrhea

FemSpec, LLC, FemTest™ Endometrial Suction Curette is a sterile, disposable curette.

The provided text describes the 510(k) clearance for the FemTest™ Endometrial Suction Curette. This document is a regulatory approval, not a scientific study describing performance criteria and results of a device.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving device performance because the provided text does not contain such details. It is a regulatory letter confirming substantial equivalence to a legally marketed predicate device, not a performance study.

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The Endometrial Sampling Syringe can be used for a variety of clinical conditions which could include the following:

• For histological biopsy of the endometrium & endo-cervix in post menopausal screening. .
• Hormone therapy monitoring. .
• Endometrial dating .
• Detection of endometrial carcinoma .
• Bacterial culturing .

This device is being designed to allow the safe and effective the histologic biopsy of the endomethum "and" endometrial carcinoma, endometrial dating and bacterial culturing. This is achieved by a design where the slim form of the sampling syringe makes in most This is actieved by a dealer which as a polypropylene sheath permitting easy entry into the uterine cavity. The sheath / cannula mechanism gives good suction and when combined with the shape and form of the curette opening gives good sample extraction.

The provided document set describes the Rocket Medical plc Endometrial Sampling Syringe, which was submitted for 510(k) clearance. This means the device demonstrated substantial equivalence to a predicate device already on the market, rather than proving its safety and effectiveness through extensive clinical trials for de novo approval. Therefore, the information requested regarding acceptance criteria, specific study designs, sample sizes, ground truth establishment, expert adjudication, and comparative effectiveness studies is largely inapplicable or not detailed in this specific submission.

Here's an attempt to answer the questions based on the provided text, highlighting where information is not available due to the nature of a 510(k) submission focused on substantial equivalence:

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

For a 510(k) submission, the "acceptance criteria" are typically related to demonstrating equivalence in design, materials, and intended use to a predicate device. "Reported device performance" in this context refers to the comparison against the predicate, primarily on physical characteristics.

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

• Sample Size: Not applicable. The submission states, "The device has yet to be clinically evaluated but has been subjected to a real laboratory performance testing against competitor product." This indicates in vitro or bench testing, not human subject testing with a "test set" in the sense of clinical data. There is no information on the number of samples used in this laboratory testing.
• Data Provenance: The device is manufactured by Rocket Medical plc in Tyne & Wear, England. The laboratory performance testing would have been conducted internally or by a contracted lab. The data is likely non-clinical/bench test data, not patient data.

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

Not applicable. As described, no clinical "test set" with human subjects requiring expert ground truth establishment was used for this 510(k) submission. The evaluation was laboratory-based comparison to a predicate device.

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

Not applicable. No clinical "test set" with human subjects requiring adjudication was used.

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 sampling syringe, not an AI-assisted diagnostic tool or a device that impacts human reader performance. No MRMC study was performed.

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

Not applicable. This is a medical device (syringe), not an algorithm or AI system.

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

Not applicable. For the in vitro or bench testing, the "ground truth" would be the measurable physical and functional specifications of the predicate device, against which the new device was compared. For example, comparing the actual sampling hole size of the Rocket syringe to the stated size of the Unimar Pipelle. There's no pathological, outcomes, or expert consensus ground truth mentioned for this type of submission.

8. The sample size for the training set

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

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

Not applicable. As above, this is not an AI/ML device.

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THE DEVICE IS INDICATED FR USE To Rt MATERIAL THE UTERUS 1010 UTERUS By SCRAPING / / N THE AND SUCTION IN ORDER TO OBTAIN નિર રે. 151-624 LOGICAL MENSTRALAL of for EXTRACTIO

The ETO sterilized MAS w/ Syringe is used to obtain a sample of differential endometrial tissue. The MAS w/ syringe is a 3mm (O.D.) endometrial suction device that has a Randall-like cutting edge at its distal end and is packaged with a twist-and-lock syringe. The syringe will provide a vacuum or suction during the procedure. The MAS w/ syringe is sterile unless the package is opened or damaged and designed for single patient use only.

The ETO sterilized MAS without syringe is used to obtain a sample of differential endometrial tissue. The MAS is a m 3.5mm (O.D.) endometrial suction curette that has a fenestration on the wall at its distal end and a tight fitting piston that will provide a vacuum or suction during the procedure as it is pulled proximally. The MAS is sterile unless the package is opened or damaged and designed for single patient use only.

The provided text describes a 510(k) summary for the "Marina Ampler Sampler (MAS) with and without syringe," which is an endometrial suction curette. The document aims to demonstrate substantial equivalence to a predicate device, the "Curelle from Bioteque Corporation" (510k #K915491).

However, the submission does not contain acceptance criteria for a device's performance that would require a study to prove it meets those criteria. Instead, it focuses on demonstrating substantial equivalence in technological characteristics to a legally marketed predicate device.

Therefore, the requested information cannot be fully provided as it pertains to a different type of validation and performance evaluation than what is presented in this 510(k) summary.

Here's an breakdown of why the requested information isn't available in this document:

1. Acceptance criteria and reported device performance (Table): Not applicable. This document is a 510(k) summary for a Class II device, where the primary goal is to show the new device is as safe and effective as a predicate device, not necessarily to meet specific, quantifiable performance thresholds with a new, standalone study. The table provided (paragraph 14) compares technological characteristics to the predicate device, not performance against pre-defined acceptance criteria. The performance is stated as "Identical" to the predicate.

2. Sample size, data provenance for test set: Not applicable. No clinical outcome or diagnostic performance test set is described. The comparison is based on design, materials, and intended use as compared to the predicate device.

3. Number of experts and qualifications for ground truth: Not applicable. Ground truth, as typically used in the context of diagnostic accuracy studies (e.g., for AI/imaging devices), is not established or discussed here.

4. Adjudication method: Not applicable. No test set requiring expert adjudication for ground truth is present.

5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This is a medical device (endometrial suction curette), not an AI/imaging diagnostic device that would typically undergo such a study to evaluate human reader improvement with AI assistance.

6. Standalone (algorithm only) performance: Not applicable. This device is a manual medical instrument not an algorithm.

7. Type of ground truth used: Not applicable. As explained above, ground truth in the context of performance evaluation of diagnostic algorithms is not part of this submission. The "ground truth" for this 510(k) is the established safety and effectiveness of the predicate device.

8. Sample size for training set: Not applicable. This is not an AI/machine learning device. No training set is involved.

9. How ground truth for training set was established: Not applicable.

Summary of Device Equivalence (from Paragraph 14):

The submission demonstrates substantial equivalence by comparing the Marina Ampler Sampler (MAS) with and without syringe to the predicate device, Curelle from Bioteque Corporation (510k #K915491), based on technological characteristics.

The study described here is a comparison of technological characteristics to demonstrate substantial equivalence to a legally marketed predicate device, rather than a performance study against predefined acceptance criteria for a novel device or an AI algorithm.

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An endometrial suction curette, such as Bioteque's Curelle, Preferved Corelle, or Coteq 2.5, are devices used to remove samples of materials from the uterus and from the mucosal lining of thee uterus by scraping or vacuum suction These devices obtain tissue samples for purpos of biopsy & precancer screening or they can be used for menstrual extraction.

An endometrial suction curette, such as Bioteque's Curelle, Preferved Corelle, or Coteq 2.5

I am sorry, but the provided text only contains regulatory information about FDA clearance for endometrial suction curettes. It does not include any details about acceptance criteria, study designs, performance data, or ground truth establishment for a medical device. Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them based on the given input.

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