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Indications for use would be when the patient cannot feed him/herself and cannot be fed by another person. This catheter would be placed Nasogastrically and nutrients supplied through catheter to the patient.

Nasogastric Feeding Tube (4Fr, 6Fr, 10Fr and 12Fr; sterile and non-sterile)

The provided document is a 510(k) premarket notification approval letter for a Nasogastric Feeding Tube. It does not contain any information about acceptance criteria, device performance studies, or AI/software validation.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance
2. Sample sizes or data provenance for a test set
3. Number and qualifications of experts for ground truth
4. Adjudication method
5. MRMC comparative effectiveness study or effect size
6. Standalone performance study
7. Type of ground truth used
8. Sample size for the training set
9. How ground truth for the training set was established

The document is a regulatory approval notice, confirming that the FDA found the device (a physical medical device, not a software or AI product) substantially equivalent to a predicate device. It focuses on regulatory compliance rather than detailed performance study results.

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INTENDED USE STATEMENT: The Perineometer (Biofeedback monitor) and vaginal probe are intended to be used to assist the patient in exercising her pelvic muscles (referred to Kegal exercises) which may lead to increased bladder control.

The PERINEOMETER & VAGINAL PROBE , is a passive device which will allow the patient to visually monitor their Kegal exercise progress.

The Vaginal probe is a Single patient use only device comprised of a medical grade Silicone shaft with a silicone balloon (Inflatable to enlarge to accomodate various vaginal sizes.) and a oolvurethane connector tube. The silicone balloon is mounted in such a way that when pressure is applied to it, air will be displaced through it's connector tubing. This air displacement is being monitored by the biofeedback monitor will cause the LED lights to turn on in proportion to the pressure exerted. This probe is similar to the legally marketed probe via 510(k) numbers (K902843) and (K913736) except that in this case we are inflating the balloon to provide gentle pressure to the vaginal wall. This will allow the probe to be customized for the patients individual vaqinal size.

The Perineometer (Biofeedback Monitor) is powered by rechargeable batteries. To prevent a potential shock hazard this unit will not function while it is being recharged. The Perineometer is identical to the biofeedback monitor which had been 510(k) approved for use in fecal incontinence (K902843). Thus, in the case of this 510(k) submission, we only seek to expand its use for general Kegal exercises.

SYSTEM DESCRIPTION: The patient inserts the vaginal probe which is connected to the Perineometer. Once the probe is inflated until it provides gentle pressure to the vaginal wall. As the pelvic muscles expand and contract (Kegal exercises) the pressure in the probe changes and these pressure changes are converted into a visual signal on the Perineometer (biofeedback monitor). The visual signal on the Perineometer is a series of LEDs (lights) which provide the patient with a real time representation of pelvic muscle activity.

This submission describes the Biosearch Medical Products, Inc. "PERINEOMETER & VAGINAL PROBE" for assisting patients with pelvic muscle exercises to improve bladder control. The device consists of a Perineometer (biofeedback monitor) and a vaginal probe.

Here's an analysis of the acceptance criteria and supporting studies based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly define quantitative acceptance criteria for the "PERINEOMETER & VAGINAL PROBE" in terms of performance metrics like sensitivity, specificity, or accuracy. Instead, the focus is on demonstrating substantial equivalence to legally marketed predicate devices through material biocompatibility and functional similarity.

Therefore, the "acceptance criteria" can be inferred as meeting the safety and material requirements of similar devices and demonstrating comparable functionality.

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

The document does not describe a specific clinical "test set" in the way typically expected for performance claims (e.g., a cohort of patients randomized to use the device). The device's performance is primarily established through:

• Substantial Equivalence: Comparison to existing, legally marketed predicate devices.
• Material Biocompatibility Testing: Conducted on components (e.g., Anorectal Probe Assembly, Silicone, Polyurethane Tubing). The "sample size" for these tests would refer to the number of material samples tested, but this detail is not provided.
• Data Provenance: The biocompatibility tests are listed with "Test Date" (e.g., 11/11/91 for Anorectal Probe Assembly) or "Vendor Provided." This indicates the data is from laboratory testing of materials and components, likely retrospective given the dates. There is no information about the country of origin for the data or whether it was prospective or retrospective in a clinical sense.

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

There is no mention of experts establishing a "ground truth" in a clinical context for a test set. The submission relies on:

• Regulatory Standards: USP Class VI for plastics, ANSI/HIMA MD 70.1, British BS 5081,176 for check valve.
• Previous Approvals: The Perineometer's equivalence to existing 510(k)-approved devices (K902843, K913736).
• Expertise in Biocompatibility: The "Nontoxic" and "Meets requirements" results imply assessment by experts in material science and biocompatibility testing, but their specific qualifications or number are not detailed.

4. Adjudication Method for the Test Set

As there is no described clinical "test set" or human assessment of device performance for the purpose of establishing clinical efficacy or accuracy in this submission, there is no adjudication method mentioned. The primary "adjudication" is the FDA's review of the substantial equivalence claim based on the provided material and functional comparisons.

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

No MRMC comparative effectiveness study was done or reported in this submission. The effectiveness of the device is inferred from its similarity to predicate devices already on the market and the general understanding that pelvic muscle exercises improve bladder control. There is no mention of human readers or AI assistance, let alone an effect size.

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

This device, the "PERINEOMETER & VAGINAL PROBE," is a biofeedback system that provides a visual signal (LED lights) in proportion to pressure exerted by pelvic muscles. It is an interactive device used by the patient (human-in-the-loop) to guide their exercises. Therefore, the concept of a "standalone (algorithm only)" performance assessment does not apply to this type of medical device. Its function is to facilitate human action, not to perform an automated diagnostic or therapeutic task independently.

7. The Type of Ground Truth Used

The "ground truth" in this submission is primarily based on:

• Established Biocompatibility Standards: USP Class VI, ISO standards, and previous FDA approvals for material safety.
• Functional Similarity to Legally Marketed Predicate Devices: The reference to previous 510(k) clearances (K902843, K913736, K945611, K862410, K891774) indicates that the performance of these devices in assisting pelvic muscle exercises and improving bladder control is the benchmark.
• Scientific Consensus: The statement "Presently many Orologists of the country are recommending pelvic muscle exercises to their female patients since the exercises improve urinary continence" implies a general medical consensus on the efficacy of the underlying therapy (Kegal exercises).

8. The Sample Size for the Training Set

There is no "training set" in the context of machine learning or AI models described in this document. The device is a mechanical/electronic biofeedback tool, not an AI or algorithm-based system that requires training data.

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

As there is no training set, this question is not applicable.

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The Syringe Flushing/Cleaning Pump is intended to clean the Biosearch Endoscopic Instruments. The Syringe Flushing/Cleaning Pump is a device that helps remove debris that may get trapped inside the Biosearch Endoscopic Instrument.

The Disposable Syringe Flushing/Cleaning Pump for Biosearch Endoscopic Instruments, is a similar design to an existing legally marketed device. It is composed of a variety of medical grade plastics. The threaded connector is especially designed to fit the flushing port of the Biosearch Endoscopic device which impedes water leakage during the cleaning process. The dual check valve is an important feature because it provides an efficient transfer of the water, and/or cleaning fluid. This will provide a sanitary environment for the medical health professional to perform the extensive cleaning of the Biosearch Endoscopic Instruments.

The provided document is a 510(k) premarket notification for a medical device (Biosearch Syringe Flushing/Cleaning Pump for Biosearch Endoscopic Instruments). This type of document is for demonstrating substantial equivalence to a legally marketed predicate device, not typically for reporting on a study that establishes acceptance criteria for a new device's performance against clinical endpoints.

Instead, the document focuses on safety and effectiveness primarily through demonstrating:

1. Substantial Equivalence: By comparing the device's features and intended use to an existing legally marketed device (MILL-ROSE "Cleaning Adapter" {K922204}).
2. Biocompatibility: By detailing tests performed on the materials used in the device.

Therefore, the requested information about acceptance criteria, device performance from a study, sample sizes, expert adjudication, MRMC studies, standalone performance, and ground truth establishment for clinical efficacy or diagnostic accuracy is not applicable to this document. The device is a cleaning pump, not a diagnostic or therapeutic clinical device that would require such studies for its clearance.

However, I can extract information related to the material safety (biocompatibility) tests which serve as acceptance criteria for the various materials used in the device.

Acceptance Criteria and Study for Material Safety (Biocompatibility)

The "studies" described here are biocompatibility tests for the materials used in the device. The acceptance criterion is generally compliance with USP Class VI requirements or specific extractable/cytotoxicity test results.

1. Table of Acceptance Criteria and Reported Device Performance (Material Biocompatibility)

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: Not explicitly stated in terms of number of test subjects or samples per test for each material. Biocompatibility tests usually involve a statistical number of in vitro or in vivo samples (e.g., cell cultures, animal models) as defined by the specific USP or ISO standards for each test. This document only reports the results against the standard.
• Data Provenance: "Vendor Supplied" for many materials, indicating the data was provided by the raw material manufacturers. Some tests have specific dates (e.g., 6/26/91-6/28/91), suggesting they were conducted at specific times, likely by the material vendors or contract labs. The country of origin for the data is not specified, but the applicant company is US-based. These are typically retrospective reports on material properties.

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

• Not Applicable. For biocompatibility tests, the "ground truth" is defined by the established scientific protocols and criteria within the USP (United States Pharmacopeia) guidelines or similar international standards (e.g., ISO 10993). The interpretation is typically performed by specialists in toxicology or microbiology, rather than expert consensus as in a clinical diagnostic study. No specific number or qualifications of "experts" are provided in this document as would be for clinical endpoint studies.

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

• Not Applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements in human interpretations of clinical data. This is not relevant for standardized laboratory biocompatibility tests, where results are objectively measured against 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

• Not Applicable. This device is a manual cleaning pump, not an AI-assisted diagnostic or therapeutic tool. No MRMC study was performed or is relevant.

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

• Not Applicable. This is a mechanical device, not an algorithm.

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

• The "ground truth" equivalent for these material tests is compliance with established biological safety standards and test parameters (e.g., USP Class VI requirements, specific elution limits, absence of cytotoxicity). These standards are developed through extensive scientific research and consensus in the field of biocompatibility.

8. The sample size for the training set

• Not Applicable. This is not a machine learning or AI-driven device, so there is no "training set."

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

• Not Applicable. (No training set).

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