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The Carevix™ Suction Cervical Stabilizer is indicated to snare, grasp, hold and manipulate cervical tissue.

Carevix™ Suction Cervical Stabilizer is a sterile, single-use, two-piece device consisting of three main parts: a reloadable vacuum reserve embedded inside the main body, including a piston to generate the vacuum, an activation/deactivation push-button, and an anatomic-shaped suction head to put in contact with the cervix. The suction head includes a rod that connects the main body.

The provided text describes a 510(k) premarket notification for the Carevix™ Suction Cervical Stabilizer. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a full study report for a novel medical device, especially an AI/ML-driven one.

Therefore, many of the requested details, particularly those pertaining to AI/ML device performance (sample size for test set, data provenance, number of experts for ground truth, adjudication, MRMC studies, standalone performance, training set details), are not present in the provided text, as this is a traditional medical device submission.

Here's what can be extracted based on the provided text:

Acceptance Criteria and Device Performance:

The document states that the device was evaluated against its design and user specifications, and that "All the results were in accordance with the test acceptance criteria." However, it does not provide a table of specific quantitative acceptance criteria or the reported device performance metrics for different parameters (e.g., specific force applied, vacuum pressure achieved, or a pass/fail rate for a clinical outcome).

Instead, it lists the types of tests performed and their general outcomes:

Missing Information (as per the provided text):

• Sample size used for the test set and the data provenance: Not mentioned. The testing appears to be primarily bench testing (biocompatibility, sterilization, performance) rather than clinical studies with patient data.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not mentioned. Ground truth as typically understood for AI/ML devices (e.g., disease presence) is not relevant to this device's testing.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/not mentioned.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This is not an AI/ML device nor a diagnostic imaging device that would typically involve human readers.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, as this is not an AI/ML algorithm.
• The type of ground truth used: For biocompatibility, the ground truth is established by standardized lab tests (e.g., cell viability, skin irritation). For performance, the ground truth is the device's design specifications. No "expert consensus" or "pathology" ground truth is mentioned.
• The sample size for the training set: Not applicable, as this is not an AI/ML device.
• How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.

Summary of what the document focuses on instead:

The document outlines a 510(k) submission for a modified medical device. The primary goal is to demonstrate "substantial equivalence" to a previously cleared predicate device (ASPIVIX v1.1 Cervical Suction Tenaculum, K203820). This is achieved by:

• Comparing Indications for Use: Stating they are the same ("to snare, grasp, hold and manipulate cervical tissue").
• Comparing Technological Characteristics: Identifying both similarities and differences (e.g., changes in rod length, inner diameter, trigger mechanism, vacuum generation, and two-piece vs. one-piece design).
• Providing Safety and Performance Data for the Modifications: This includes:
  • Biocompatibility testing: Performed in accordance with ISO 10993-1, 10993-5, 10993-10, and ISO 14971:2019. Tests confirmed non-cytotoxic, non-sensitizing, and non-irritating results.
  • Sterilization validation: Performed via e-beam in accordance with ANSI/AAMI/ISO 11137-2:2013.
  • Performance and Safety testing: Conducted according to protocols used for the predicate device, with all results meeting acceptance criteria. The document states that newly identified risks (related to assembly) do not raise new questions of safety or effectiveness because they are identifiable before patient use.
• Conclusion: The testing results support the determination of substantial equivalence, meaning the modified device is considered as safe and effective as the predicate device.

In essence, this is a clearance for a physical medical instrument based on engineering and biological testing, not an AI/ML software device.

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The ASPIVIX v1.1 Cervical Suction Tenaculum is indicated to snare, grasp, hold and manipulate cervical tissue.

ASPIVIX v1.1 is a sterile, single-use, one-piece device that consists of four non-removable parts: a reloadable vacuum reserve embedded inside the main body, an activation / deactivation slider ring, a sliding tube to generate vacuum in the main body and an anatomic suction pad to put in contact with the cervix.

This document describes a 510(k) premarket notification for the ASPIVIX v1.1 Cervical Suction Tenaculum. It details the device's indications for use, comparison to a predicate device, and performance data provided to support substantial equivalence.

Based on the provided text, the device itself is a manual instrument, not an AI device. Therefore, many of the requested elements pertaining to AI device validation (e.g., sample size for test/training sets, data provenance, expert ground truth establishment, MRMC studies, standalone performance, etc.) are not applicable to this submission. The 510(k) summary focuses on demonstrating that the new manual device is as safe and effective as a legally marketed predicate device.

However, I can extract the information relevant to the performance data and acceptance criteria as described for this manual device.

1. Table of Acceptance Criteria and Reported Device Performance

The document broadly states that "All test results were in accordance with the test acceptance criteria." However, it does not explicitly list the specific numerical acceptance criteria for each test. Instead, it lists the types of performance tests conducted and the general conclusion.

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

This information is not provided in the given text. The document refers to "testing" but does not specify the number of units or samples used for each test, nor the provenance (country of origin, retrospective/prospective) of any clinical data, as this is a physical medical device clearance, not an AI/software as a medical device (SaMD) submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable and not provided. As this is a manual medical device, there is no "ground truth" to be established by experts in the context of image interpretation or diagnostic accuracy. The testing involves physical and biological properties.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are typical for human reader studies with AI, which are not relevant for this manual device.

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

This information is not applicable and not provided. MRMC studies are used to evaluate diagnostic performance of AI or human readers, which is not the type of claim being made or evaluated for this manual device.

6. Standalone Performance (Algorithm Only)

This information is not applicable and not provided. This is a manual physical device, not an algorithm or software.

7. Type of Ground Truth Used

This information is not applicable in the AI/diagnostic sense. For this manual device, the "ground truth" or reference standards are the established performance metrics and biocompatibility standards (e.g., ISO standards for cytotoxicity, sensitization, irritation; mechanical testing standards for traction and bend strength).

8. Sample Size for the Training Set

This information is not applicable and not provided. This device does not involve machine learning or AI models with training sets.

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

This information is not applicable and not provided. As above, there is no training set as this is not an AI device.

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The Bioceptive Suction Cervical Retractor is indicated to snare, grasp, hold and manipulate cervical tissue.

Not Found

This is a 510(k) clearance letter for a medical device called the Bioceptive Suction Cervical Retractor. This type of document generally does not include detailed information about acceptance criteria and performance studies in the way you've requested for an AI/CAD device.

Here's why and what can be extracted:

• Device Type: The Bioceptive Suction Cervical Retractor is a manual surgical instrument. It's not an AI/CAD system or a diagnostic device that typically relies on specific metrics like sensitivity, specificity, or AUC as primary acceptance criteria.
• 510(k) Process: The 510(k) pathway demonstrates "substantial equivalence" to a legally marketed predicate device, not necessarily superior performance against a rigid set of quantitative criteria in the same way an AI device might. The focus is on ensuring the new device is as safe and effective as existing legally marketed devices.
• Content of the Letter: This letter confirms the FDA's decision regarding substantial equivalence based on a premarket notification. It doesn't contain the actual study data or detailed acceptance criteria for the device's functional performance beyond typical safety and efficacy considerations for a manual surgical tool.

Therefore, for this specific document and device, I cannot provide the complete information you requested. However, I can infer what would typically be relevant for such a device and what might have been part of the underlying submission if it were an AI device.

Information Extracted/Inferred (with significant limitations due to device type):

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

   • Acceptance Criteria: For a manual surgical instrument, acceptance criteria generally relate to:
     • Biocompatibility: The materials used must be safe for contact with human tissue.
     • Sterilization: The device must be able to be effectively sterilized.
     • Mechanical Strength/Durability: The device must withstand expected forces during use without breaking or failing.
     • Functional Performance (non-AI): The device must effectively "snare, grasp, hold and manipulate cervical tissue" as intended. This is typically demonstrated through bench testing, simulated use, and potentially animal or cadaver studies, but not with typical AI metrics.
     • Safety: No increased risk of harm compared to predicate devices.
   • Reported Device Performance: The letter indicates the device is "substantially equivalent." This implies that the performance in the areas listed above was deemed comparable to existing devices. Specific quantitative metrics like sensitivity or specificity are not applicable or provided here.

2. Sample size used for the test set and the data provenance: Not applicable/Provided. For a manual surgical device, "test set" would refer to the samples used for mechanical testing, biocompatibility testing, or in-vitro/ex-vivo studies. This information is not in the clearance letter.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Provided. Ground truth for a manual instrument's performance is typically established by engineering tests and clinical evaluation by surgeons, rather than expert consensus on diagnostic interpretations.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/Provided.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For a manual device, ground truth would relate to its physical and mechanical properties, sterility, and performance in achieving its stated function (e.g., successful grasping of tissue without damage). This is typically established through engineering standards, material testing, and surgical observation (if clinical studies were part of the submission).

8. The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.

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

In summary, the provided document is a regulatory clearance letter for a manual medical instrument. It does not contain the detailed performance data or study specifics that would be present for an AI-powered diagnostic device, which is what your questions seem to anticipate.

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JARIT® Hulka Uterine Tenaculum Forceps are indicated to stabilize the cervix and manipulate the uterine fundus under direct pelviscopic visualization in women whose uteri are anteverted or retroverted.

JARIT Hulka Uterine Tenaculum Forceps are an 11-inch long stainless steel, ring-handled instrument with ratchet closure having a single-tooth hook at the distal end of one arm and a 3.6 mm diameter uterine sound probe at the distal end of the other arm. The device is reusable, sterilizable and packaged non-sterile.

The provided document is a 510(k) summary for a medical device called JARIT® Hulka Uterine Tenaculum Forceps. This type of filing is for demonstrating substantial equivalence to a predicate device, not for proving the device meets specific acceptance criteria through a clinical study. Therefore, the information requested in your prompt regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies is not applicable to this document, as these types of studies are typically required for premarket approval (PMA) applications or de novo classifications, not 510(k) clearances for devices like this.

The document states: "The JARIT Hulka Uterine Tenaculum Forceps are substantially equivalent to the legally marketed predicate devices. The devices have the same intended use, design, materials and processing." This statement, along with the device description, serves as the basis for clearance.

To directly answer your questions based on the provided text:

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

   • N/A. The document does not describe acceptance criteria in the context of a performance study. Its equivalence is based on "same intended use, design, materials and processing" as predicate devices.

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

   • N/A. No test set or data provenance is mentioned as part of a performance study.

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)

   • N/A. No experts or ground truth establishment are part of this 510(k) submission.

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

   • N/A. 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

   • N/A. The device is a manual surgical instrument, not an AI-assisted diagnostic tool. No MRMC study or AI component is relevant.

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

   • N/A. Not applicable, as this is a physical, manual instrument.

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

   • N/A. No ground truth is mentioned.

8. The sample size for the training set

   • N/A. No training set is mentioned.

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

   • N/A. No training set or ground truth establishment is mentioned.

In summary, the provided document is a 510(k) clearance based on substantial equivalence, and therefore does not contain the information you requested about acceptance criteria, study data, or ground truth pertaining to device performance studies.

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To snare, grasp, hold and manipulate cervical and intravaginal tissue.

GYN Disposables Tenaculum 356T is made of glass reinforced polycarbonate. The GYN Disposable Tenaculum is supplied in a Tyvek pouch and has been sterilized by gamma radiation.

The GYN Disposables Tenaculum 356T is a medical device used to snare, grasp, hold, and manipulate cervical and intravaginal tissue. The device is made of glass-reinforced polycarbonate and is supplied sterile by gamma radiation.

Here's an analysis of the acceptance criteria and the studies that demonstrate the device meets them:

Acceptance Criteria and Reported Device Performance

The document describes several tests conducted to ensure the device's safety and performance. The acceptance criteria are generally qualitative (e.g., "met the minimum acceptance criteria," "did not induce cytotoxicity," "passed").

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The FemSuite, LLC, FemTen™ Cervical Tenaculum is a sterile, disposable, manual instrument indicated for single patient use to hold and manipulate the cervix. This device is typically used in conjunction with endometrial biopsy.

Not Found

The provided text is a 510(k) clearance letter from the FDA for a medical device called the "FemTen™ Cervical Tenaculum". It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The document discusses the regulatory classification of the device, its intended use, and the FDA's determination of substantial equivalence to previously marketed devices. However, there is no mention of performance metrics, study designs, sample sizes, expert qualifications, ground truth establishment, or comparative effectiveness studies.

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

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The Burbank Tenaculum is an accessory used in conjunction with the Vascular Control Systems flostat™ Clamp. The device is intended to seize and hold the cervix and to hold and secure the flostat Clamp in place, during audible Doppler procedures.

This Tenaculum is only indicated for use with the flostat Clamp and Transvaginal Doppler Probe for bilateral uterine artery detection and temporary control of bleeding during conservative gynecologic surgery such as laparoscopic myomectomy.

The Burbank Tenaculum is a ring-handled instrument with a tooth at the distal end of one arm and a guiderod attached to the distal end of the other arm. The proximal end of the guiderod is threaded to guide insertion of the Vascular Control Systems flostat Clamp into the vagina and secure the Clamp in place.

A uterine sound, at the distal end of the guiderod, is intended for insertion through the cervical opening into the uterine cavity.

The provided text describes a medical device, the Burbank Tenaculum, and its regulatory clearance process through a 510(k) submission. However, it does not contain information about acceptance criteria, device performance studies, sample sizes, expert involvement, or any of the other specific study-related details requested in your prompt.

The document is a "Summary of Safety and Effectiveness" and an FDA clearance letter, which focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed performance study results that would typically include acceptance criteria and specific statistical outcomes.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input. The document explicitly states:

• "The Burbank Tenaculum has been designed and tested per design control procedures and was found to meet its product specifications." This is a general statement and does not provide specific acceptance criteria or study details.
• "The Burbank Tenaculum does not raise new issues of safety, effectiveness, or performance of the product." This reinforces the substantial equivalence claim but doesn't offer performance metrics.

To answer your request, I would need a document that specifically details the design verification and validation studies, including the test protocols, acceptance criteria, results, and statistical analyses performed for the device.

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The SafeTChoice™ Transvaginal Ultrasound Probe Holder System is an accessory intended for use in conjunction with a transvaginal ultrasound transducer. The SafeTChoice™ Transvaginal Ultrasound Probe Holder System is intended to seize and hold the cervix and to hold and secure an ultrasound transducer in place, while performing sonographic procedures.

The Safe TChoice™ Transvaginal Ultrasound Probe Holder System is an accessory used in conjunction with a transvaginal ultrasound transducer. The device is intended to hold and secure the ultrasound transducer in place on a uterine tenaculum, while performing the sonographic procedure. The configuration of the device allows the physician to manipulate the ultrasound transducer with one hand, thus freeing the other hand to perform the required procedure. The SafeTChoice™ Transvaginal Ultrasound Probe Holder System consists of a reusable uterine tenaculum with an adaptor bar, a sterile, disposable adaptor and a disposable probe connector.

The provided text does not contain information about acceptance criteria or a study proving the device meets them. The document is a 510(k) summary for the SafeTChoice™ Transvaginal Ultrasound Probe Holder System, outlining its description, indications for use, and a claim of substantial equivalence to a predicate device. It includes the FDA's clearance letter.

Therefore, I cannot fulfill the request to provide:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method.
5. Information on a multi-reader multi-case (MRMC) comparative effectiveness study.
6. Information on a standalone performance study.
7. The type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This type of information is typically found in performance studies, validation reports, or clinical trial summaries, which are not present in this 510(k) summary. The 510(k) process for this specific device relies on substantial equivalence to a legally marketed predicate device rather than new performance data against acceptance criteria.

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The Burbank Tenaculum is an accessory used in conjunction with the Vascular Control Systems Transvaginal Doppler Probe. The device is intended to seize and hold the cervix and to hold and secure the Transvaginal Doppler Probe in place, while performing audible Doppler procedures.

The Burbank Tenaculum is a stainless steel, ring-handled instrument with a hook at the distal end of one arm and a guide rod attached to the distal end of the other arm. The proximal end of the guide rod is threaded to guide insertion of the Vascular Control Systems Transvaginal Doppler Probe (TDP) into the vagina and secure the TDP in place. A uterine sound is brazed at the distal end of the guide rod intended to be inserted through the cervical opening into the uterine cavity.

The provided text describes a medical device, the Burbank Tenaculum, seeking 510(k) clearance. This means it is claiming substantial equivalence to legally marketed predicate devices, rather than establishing entirely new performance criteria through extensive clinical trials. Therefore, the information typically associated with acceptance criteria and a study to prove they are met (like a multi-reader multi-case study, detailed ground truth establishment, or specific performance metrics with statistical analysis) is not present in this document.

Instead, the document focuses on demonstrating that the Burbank Tenaculum is as safe and effective as its predicate devices based on design similarities and intended use.

Here's an analysis based on the information provided, specifically addressing your points where possible:

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

The document does not provide a table of explicit, quantifiable acceptance criteria or reported device performance in the manner one might expect for a new, higher-risk device. The clearance is based on substantial equivalence to predicate devices. The "reported device performance" is essentially the qualitative claim that it meets its product specifications and does not raise new safety or effectiveness issues, similar to already marketed devices.

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

No test set sample size or data provenance is mentioned. The clearance is based on design and material comparisons to predicate devices, and internal design control procedures.

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

Not applicable. No ground truth was established by experts for a test set in the context of this 510(k) submission.

4. Adjudication method for the test set

Not applicable. No test set 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 is a medical instrument (tenaculum), not an AI device or imaging analysis tool. 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 manual surgical instrument, not an algorithm.

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

The concept of "ground truth" as it applies to diagnostic or AI devices is not relevant here. The ground for substantial equivalence is the design, materials, intended use, and functioning characteristics comparison to existing, legally marketed predicate devices, and the claim that it meets its own product specifications.

8. The sample size for the training set

Not applicable. As a physical instrument, there is no "training set" in the machine learning sense. The "training" essentially comes from engineering design, material selection, and manufacturing processes, guided by existing device standards and performance of predicates.

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

Not applicable. There is no training set mentioned. The "ground truth" for its design and manufacturing would be established through engineering specifications, material properties, and adherence to quality systems and design controls (as mentioned: "The Burbank Tenaculum has been designed and tested per design control procedures and was found to meet its product specifications and does not raise new issues of safety, effectiveness, or performance of the product.").

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