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The Hope&Her Vaginal Dilators are tools intended for controlled dilation of the vagina. They can be used for dilation for an examination (by your doctor), in preparation for a surgical procedure or to help relieve the symptoms of vaginismus (condition that involves tightening of the vaginal muscles) and related painful sex.

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I'm sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific acceptance criteria. The document appears to be an FDA 510(k) clearance letter for a medical device called "Hope&Her Vaginal Dilator (Various)".

The letter confirms that the device has been reviewed and determined to be substantially equivalent to legally marketed predicate devices. It discusses regulatory matters such as general controls, additional controls for Class II/III devices, Quality System regulations, and reporting requirements. It also includes the official Indications for Use statement for the device.

However, it does not include:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes, data provenance, or the number/qualifications of experts.
• Information on adjudication methods, MRMC studies, or standalone algorithm performance.
• The type of ground truth used or details about training set size and ground truth establishment.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text.

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Hope&Her Vaginal Dilators are indicated for women who need vaginal dilation for an examination, in preparation for a surgical procedure, or for the relief of vaginismus.

Hope&Her Vaginal Dilators is a series of reusable, non-sterile, single user vaginal dilators that are used by patients to provide passive distention of the vaginal tissues using various sized dilators. The subject device has various sized rigid dilators that range from 15 mm to 38 mm in diameter (15, 22, 26, 30, 34, and 38 mm) and a handle to hold the dilator. The subject device is prescription-only. The subject device is composed polyester and polyamide. The subject device is distributed in heat-seal plastic bags.

This document is a 510(k) Summary for the Hope&Her Vaginal Dilators. It describes the device, its indications for use, and a comparison to a predicate device, along with non-clinical performance testing. The document states that performance testing was conducted to demonstrate substantial equivalence, but it does not contain information about acceptance criteria, clinical studies, or AI/software performance.

Therefore, I cannot extract the requested information regarding acceptance criteria and the study that proves the device meets them from the provided text. The document focuses on physical properties, biocompatibility, and reprocessing validation, which are non-clinical aspects.

Here's why I cannot fulfill your request based on the provided text:

• No Clinical Study Data: The document explicitly states "Summary of Non-Clinical Performance Testing" and lists tests like Biocompatibility (cytotoxicity, sensitization, irritation, systemic toxicity) and Physical Properties (appearance, diameter, tensile strength). There is no mention of clinical studies, human subject testing, or any performance metrics related to diagnostic accuracy or effectiveness in a clinical setting.
• No Acceptance Criteria for Clinical Performance: Since no clinical performance study is described, there are no acceptance criteria for such a study.
• No AI/Software Component: The device described is a physical medical device (vaginal dilators). There is no mention of any AI or software component, which would be necessary for "device performance" in the context of diagnostic accuracy, human reader improvement with AI assistance, or standalone algorithm performance.
• No Ground Truth Information: Ground truth establishment typically refers to clinical or diagnostic accuracy studies. As none are described, this information is not present.

The 510(k) process for a device like a vaginal dilator often relies on substantial equivalence based on technological characteristics and non-clinical performance (like biocompatibility and physical properties) rather than extensive clinical efficacy trials, especially if a well-established predicate device exists and the indications for use are similar.

In summary, the provided text does not contain the information requested about acceptance criteria and a study proving the device meets them in the context of clinical performance, diagnostic accuracy, or AI-assisted performance.

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The balloon dilatation catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.

This balloon dilatation catheter is not intended for the expansion or delivery of a stent.

Hoper Rapid Exchange (LPRX) Balloon Dilatation Catheter is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System. The proximal shaft is a polymer coated stainless steel tube. The steel construction is designed to optimize proximal pushability with a smooth transition to a distal shaft specifically designed to be highly trackable. The semi-compliant balloon material allows dilatation with precise control of balloon diameter and length. Two radiopaque platinum marker bands are located within the balloon segment. The catheter is compatible with 5F or larger guiding catheters. The internal lumen of the catheter accepts a standard 0.014 inch PTCA guide wire. The proximal part of the guide wire enters the catheter's tip and advances coaxially out the catheter's proximal port, thereby allowing both coaxial guidance and rapid exchange of catheters with a single standard length guide wire.

Two marked sections are located on the hypo tube shaft to indicate catheter position relative to the tip of either a brachial or femoral guiding catheter.

The design of this dilatation catheter does not incorporate a lumen for distal dye injections or distal pressure measurements.

The product can be used to expand stenotic coronary vessel, and improve myocardial bleeding. This kind of balloon catheter possesses such merits as moderate compliance, high pressure resistance, minor diameter, etc.

The provided text describes a medical device, the Hoper™ PTCA Balloon Dilatation Catheter, and its 510(k) summary for FDA clearance. However, it does not include information about acceptance criteria or a study proving the device meets those criteria in the context of clinical performance or a comparative effectiveness study with human readers.

The "Performance Testing" section lists various in vitro performance tests and biocompatibility tests. It states that "The test results met all acceptance criterions, were similar to predicate devices, and ensured that the Hoper™ PTCA Balloon Dilatation Catheter design and construction are suitable for its intended use as recommended by the Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters (FDA, September 8, 2010)."

This indicates that acceptance criteria were met for these technical and biological safety aspects, but the specific numerical acceptance criteria and detailed study results for each test are not provided in the summary.

Based on the provided text, I cannot answer the specific questions about clinical acceptance criteria and related studies, as the document focuses on regulatory clearance based on substantial equivalence to predicate devices through technical performance and biocompatibility testing, rather than a clinical trial or AI performance evaluation.

Therefore, for the requested information, the answer is:

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

   • The document states that "The test results met all acceptance criterions" for the listed in vitro performance tests and biocompatibility tests.
   • However, specific numerical acceptance criteria or detailed quantitative performance data for each test (e.g., maximum allowable balloon inflation/deflation time, minimum bond strength, specific cytotoxicity results) are not provided in this summary. The summary only confirms compliance without detailing the criteria or results.

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

   • This information is not provided for the in vitro performance tests or biocompatibility tests. No clinical test set is described.

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):

   • This is not applicable, as no clinical test set or ground truth established by experts is mentioned in the provided text.

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

   • This is not applicable, as no clinical test set requiring adjudication 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:

   • This is not applicable. The device is a PTCA Balloon Dilatation Catheter, not an AI imaging analysis tool, and no MRMC study or AI assistance is mentioned.

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

   • This is not applicable, as the device is not an algorithm or AI system.

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

   • For the in vitro tests, the "ground truth" would be the engineering specifications and recognized standards (e.g., ISO, ASTM, FDA guidance documents) against which the device performance was measured. For biocompatibility, it's about meeting established safety limits for chemical and biological interactions. No clinical ground truth (like pathology or outcomes data) is mentioned as being used for these tests.

8. The sample size for the training set:

   • This is not applicable, as the device is not an AI system that requires a training set.

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

   • This is not applicable, as the device is not an AI system.

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The Res-Q Continuous Nebulizer is a device to used under the medical supervision in hospital, nursing homes, extended care facilities and outpatient clinics. The Res-Q Continuous Nebulizer is a high output nebulizer to be used to deliver aerosolized medications and diagnostic formulations. It provides additional hydration to help loosen secretions for patients whom extended therapy is required. Patient population: Asthma, pneumonia, COPD, or any other condition in which sympathomimetic ammines, parasympathetic ammines, or other appropriate medications would be nebulized. The Res-Q Continuous Nebulizer requires 50 psig source gas. HE air or oxygen may be added via Multi-gas inlet.

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The provided text describes a 510(k) premarket notification for a medical device called the "Res-Q Continuous Nebulizer." This document is a letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices.

However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. These details are typically found in the scientific documentation submitted as part of the 510(k) application, which is not included in this letter.

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

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This device is to be used under medical supervision in hospitals, nursing homes, extended care facilities and outpatient clinics. The HOPE nebulizer is a high output nebulizer to be used by patients who require aerosolized medications. It provides additional hydration to help loosen secretions for patients whose condition is such that superior sympathomines, parasympathetic amines, or other appropriate medications would be nebulized. It is intended for use with bronchodilators, corticosteroids, antibiotics, mucolytics, and diagnostic formulations.

HOPE Nebulizer

The provided document is a 510(k) premarket notification letter from the FDA for the "Hope Nebulizer II". It indicates that the device has been found substantially equivalent to a predicate device marketed before May 28, 1976. However, this document does not contain any information regarding acceptance criteria, device performance studies, or details about such studies. It is a regulatory approval letter, not a study report or technical specification document.

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

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