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The Femasys FemCerv is a sterile, disposable endocervical sampler indicated for single patient use in obtaining tissue samples from the endocervical canal for histological analysis. Clinical indications include: further evaluation of an abnormal Pap smear; cervical lesions extending into the endocervical canal; undiagnosed uterine bleeding.

The FemCerv Endocervical Sampler (FemCerv) is a sterile, disposable device that collects an endocervical tissue sample for histological evaluation.

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Device Performance for FemCerv™ Endocervical Sampler

1. Table of Acceptance Criteria and Reported Device Performance:

• Device functionality and integrity over cycle testing of opening and closing the sample collection chamber.
• Insertion capability in a model of the endocervical canal.
• Sheath opening functionality.
• Rotational functionality.
• Sheath closure.
• Sample release into a specimen container. | "A sample set of 29 devices was tested and passed all criteria." |
  | Shelf Life | Shelf life integrity up to 1 year accelerated aging:
• Same test methodology and acceptance criteria as bench testing. | "A sample set of 29 devices was tested and passed all criteria." |
  | Biocompatibility | ISO 10993 standards:
• Cytotoxicity.
• Irritation.
• Sensitization. | "Biocompatibility of components according to ISO 10993 standards: cytotoxicity, irritation, and sensitization was conducted and passed all criteria." |
  | Clinical Performance | Clinical Study:
• Insertion.
• Device opening and closing.
• Adequate sampling capability based upon a pathologist's evaluation. | "An 85.7% sample adequacy rate was based on sampling with 7 devices." (This is the reported performance for "adequate sampling capability") |

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

• Bench Testing: 29 devices
• Shelf Life Testing: 29 devices
• Clinical Study: 7 devices
• Data Provenance: The document does not explicitly state the country of origin. The clinical study involved subjects prior to scheduled hysterectomy, which implies a prospective collection of samples for the purpose of the study.

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

• The clinical study's sample adequacy was "based upon a pathologist's evaluation." The document does not specify the number of pathologists or their specific qualifications (e.g., years of experience).

4. Adjudication method for the test set:

• The document states that sample adequacy was based on "a pathologist's evaluation." It does not mention any specific adjudication method (e.g., 2+1, 3+1, none) among multiple experts, suggesting a single pathologist's assessment or an unstated internal process.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an endocervical sampler, not an AI-assisted diagnostic tool for image interpretation. Therefore, the concept of human readers improving with AI assistance is not applicable.

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

• No, this is a physical medical device for collecting tissue samples, not an algorithm. Therefore, the concept of standalone algorithm performance is not applicable.

7. The type of ground truth used:

• Clinical Study: The ground truth for sample adequacy was established by pathological evaluation of the collected tissue samples.

8. The sample size for the training set:

• The document does not describe a "training set" in the context of machine learning or AI. The tests mentioned are for verifying the physical properties and performance of the device itself.

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

• Not applicable, as there is no mention of a training set for an algorithm or AI model.

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FemSpec, LLC, FemECC™ Endocervical Curette is a sterile, disposable curette indicated for single patient use in obtaining tissue samples from the endocervical canal for histological analysis.

FemSpec, LLC, FemECC™ Endocervical Curette is a sterile, disposable curette.

This looks like a 510(k) clearance letter from the FDA for a medical device called the "FemECC™ Endocervical Curette." This type of document is a regulatory approval, not a clinical study report. Therefore, it does not contain the specific information requested about acceptance criteria, study design, or performance metrics.

The letter explicitly 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 (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976... "

This means the device was cleared based on its substantial equivalence to an already approved predicate device, not on a new clinical study demonstrating performance against specific acceptance criteria. The 510(k) process often relies on non-clinical testing (e.g., biocompatibility, sterilization validation, mechanical testing) and comparison to a predicate device's design and indications for use.

Therefore, I cannot provide the requested information based on this document.

To provide an answer to your prompt, a document detailing a clinical trial or performance study would be required.

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The Rocket Mucus Sampler is designed for optimum suction for the collection of cervical mucosal lining, post coital test (Huhner), external os or vaginal pool sampling. The Rocket Mucous Sampler enables the Ob/Gyn physician to collect the specimen and send it to the laboratory to be examined histologically or cytologically

The Rocket Mucus Sampler is designed for optimum suction for the collection of cervical mucosal lining, post coital test (Huhner), external os or vaginal pool sampling. It is comprised of 3 components: Plunger, O-ring and external tubing. Suction is created by pulling the plunger with a handle outward. It has a small OD of 2.6mm, which minimizes pain and discomfort to the patient. The Rocket Mucous Sampler enables the Ob/Gyn physician to collect the specimen and send it to the laboratory to be examined histologically or cytologically

The provided document is a 510(k) summary for a medical device called the "Rocket Mucus Sampler Syringe." It claims substantial equivalence to existing predicate devices, rather than presenting a study demonstrating the device meets specific acceptance criteria based on performance outcomes. Therefore, much of the requested information regarding acceptance criteria and a study to prove performance is not available in this document.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in terms of quantitative performance metrics (e.g., sensitivity, specificity, accuracy, or functional thresholds). Instead, the submission focuses on demonstrating substantial equivalence to existing predicate devices.

The table provided (paragraph 14) compares technological characteristics of the Rocket Mucus Sampler with three predicate devices:

Interpretation: The "Performance: Equivalent (E)" entry in the table is the closest to an "acceptance criterion," implying that the Rocket Mucus Sampler is expected to perform at a level comparable to the predicate devices for its intended use, which is optimal suction for the collection of cervical mucosal lining, post coital test (Huhner), external os or vaginal pool sampling. However, no specific metrics or thresholds are provided for this "performance."

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

Not applicable. The document does not describe a performance study with a test set. The 510(k) submission is based on demonstrating substantial equivalence to existing devices through a comparison of technological characteristics, not through new clinical or performance data.

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

Not applicable. No test set or ground truth derived from expert consensus is mentioned in the document.

4. Adjudication Method for the Test Set

Not applicable. No test set adjudication method is 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 physical medical instrument (a mucus sampler syringe), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study involving human readers and AI is not relevant to this submission.

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

Not applicable. This is not an algorithmic device.

7. The type of ground truth used

Not applicable. The submission relies on demonstrating substantial equivalence to predicate devices already on the market, rather than establishing a new ground truth based on pathology, outcomes data, or expert consensus from a new study. The "ground truth" here is the established safety and effectiveness of the existing predicate devices.

8. The sample size for the training set

Not applicable. This is not an algorithmic device that requires a training set.

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

Not applicable. No training set is described.

Summary of 510(k) Approach:

The K974032 submission for the Rocket Mucus Sampler Syringe is a 510(k) premarket notification which primarily relies on demonstrating substantial equivalence to legally marketed predicate devices. This means the manufacturer asserts that their new device is as safe and effective as, and has the same intended use and similar technological characteristics to, a legally marketed device that does not require premarket approval (PMA).

The "study" in this context is the comparison of technological characteristics against the predicate devices (Aspirette Endocervical Aspirator, SelectMucus, and Cervical Mucous Aspiration Catheter). The acceptance "criteria" are implicitly met if the FDA agrees that the Rocket Mucus Sampler Syringe is substantially equivalent to these predicates based on the provided comparison. No new clinical trials or performance studies with specific acceptance criteria are detailed in this summary. The FDA's letter (DEC 22 1997) confirms their finding of substantial equivalence, allowing the device to be marketed.

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