Search Results

The Flexi Shelf Pessary is indicated for use as a removable structure placed in the support of a second to third degree prolapse or procidentia.

Not Found

I am sorry, but the provided text does not contain information about the acceptance criteria or a study that proves a device meets those criteria. The document is an FDA 510(k) clearance letter for the Panpac Flexi Shelf Pessary, which concerns the regulatory approval of a medical device based on its substantial equivalence to a predicate device, not on specific performance acceptance criteria and associated studies.

Therefore, I cannot fulfill your request for the detailed information on acceptance criteria and study findings based on the provided text.

Ask a specific question about this device

For transcervical aspiration of the uterine cavity.

Not Found

I am sorry, but the provided text does not contain information about the acceptance criteria and the study details for a device. The document is an FDA 510(k) premarket notification letter for "Panpac Disposable Vacuum Curettes," indicating its substantial equivalence to a predicate device. It defines the device's indications for use but does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample size or data provenance for a test set.
3. Number or qualifications of experts used for ground truth.
4. Adjudication method for a test set.
5. Information on a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or effect size.
6. Results from a standalone algorithm-only performance study.
7. The type of ground truth used (e.g., pathology, outcomes data).
8. Sample size for a training set.
9. How ground truth for a training set was established.

Therefore, I cannot fulfill your request based on the provided input.

Ask a specific question about this device

Panpac Vaginal Pessaries are indicated for the use as removable structures placed in the vagina to treat uterine prolapse, including cystocele, rectocele as well as stress urinary incontinence in women.

Not Found

This document is an FDA 510(k) clearance letter for the "Panpac Disposable Pessary Fitting Set." It primarily confirms substantial equivalence to a predicate device and outlines regulatory responsibilities, but it does not contain information about acceptance criteria or a study proving the device meets those criteria.

The core of the request asks for specific details about acceptance criteria and a study. Since this type of information is generally found in the 510(k) submission itself (which includes detailed test reports and performance data), and not in the clearance letter, I cannot fulfill the request directly from the provided text.

The closest relevant information from the document is the "Indications for Use" statement, which describes the intended medical application of the device:

• Device Name: Panpac Disposable Pessary Fitting Set
• Indications for Use: Panpac Vaginal Pessaries are indicated for the use as removable structures placed in the vagina to treat uterine prolapse, including cystocele, rectocele as well as stress urinary incontinence in women.

To answer your specific questions, I would need access to the actual 510(k) summary or the full submission documentation.

Ask a specific question about this device

Ask a specific question about this device

The Panpac Word/ Bartholin Catheter is used for the treatment of abscesses and cysts of the Bartholin gland.

Not Found

I am sorry, but based on the provided document, there is no information about acceptance criteria, device performance, or any studies related to the Panpac Word/Bartholin Catheter.

The document is a 510(k) premarket notification letter from the FDA to Panpac Medical Corporation, informing them of the substantial equivalence determination for their device. It focuses on regulatory compliance, outlining general controls provisions and other applicable regulations. It also includes the "Indications for Use" statement for the device.

Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.

Ask a specific question about this device

Panpac Vaginal Dilators are indicated for women who need vaginal dilation for an examination, a surgical procedure, or for the relief of vaginismus.

Panpac Vaginal Dilators has four different size (small, medium, large and extra large) in three family types; Family A, Family B and Family C with variant sizes.

This document is a 510(k) Premarket Notification from the FDA for a medical device called "Panpac Vaginal Dilators." This type of document is usually a regulatory approval and does not contain or describe a study on the device's technical performance or acceptance criteria in the way you've outlined.

Therefore, I cannot extract the requested information regarding acceptance criteria and study details. The document primarily focuses on:

• Device Identification: Panpac Vaginal Dilators
• Regulation Number/Name: 21 CFR § 884.3900, Vaginal stent
• Regulatory Class: II
• Product Code: HDX
• Applicant: Panpac Medical Corporation
• FDA Determination: Substantially equivalent to legally marketed predicate devices.
• Indications for Use: Vaginal dilation for examination, surgical procedure, or relief of vaginismus.
• General Controls: Mentions requirements for registration, listing, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

There is no mention of performance studies, acceptance criteria, sample sizes, ground truth establishment, or expert reviews in this regulatory clearance letter.

Ask a specific question about this device

The Bellota Sonohysterography Catheter with Cervical Cone (Model: UIC 5FA) is used to access the uterine cavity for saline infusion sonohysterography procedure.

The Bellota Sonohysterography Catheter without Cervical Cone (Model: UIC 5F) is used to access the uterine cavity for saline infusion sonohysterography procedure.

Not Found

The provided OCR text is a 510(k) clearance letter for the Bellota Sonohysterography Catheter. This type of document from the FDA states that a medical device has been found substantially equivalent to a predicate device already on the market.

It is important to understand that 510(k) clearance typically does not involve a clinical study to prove the device meets specific acceptance criteria in terms of performance measures like sensitivity, specificity, or improvement in human reader performance for an AI/software device. Instead, K102898 focuses on demonstrating substantial equivalence in terms of design, materials, indications for use, and safety with a legally marketed predicate device.

Therefore, the information requested in your prompt (acceptance criteria, study details, sample sizes, ground truth, expert qualifications, etc.) is not typically found or required for a medical device cleared via a 510(k) pathway, especially for a physical device like a catheter. These types of detailed performance studies are more common for novel devices, PMA (Pre-Market Approval) devices, or increasingly for AI/Machine Learning-based medical devices that make diagnostic or prognostic claims.

Based on the provided document, I cannot fulfill the request for information on acceptance criteria and a study proving device performance because the document does not contain this information.

The document primarily focuses on:

• Identifying the device (Bellota Sonohysterography Catheter).
• Stating its intended use (accessing the uterine cavity for saline infusion sonohysterography).
• Declaring that it is substantially equivalent to legally marketed predicate devices.
• Outlining regulatory compliance requirements.

Ask a specific question about this device

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.

Ask a specific question about this device

Panpac Vaginal Pessaries are indicated for the use as removable structures placed in the vagina to treat uterine prolapse, including cystocele as well as stress urinary incontinence in women.

Not Found

I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA regarding a medical device called "Panpac Vaginal Pessaries". It indicates the device is substantially equivalent to legally marketed predicate devices and outlines regulatory requirements.

However, this document does NOT contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

Therefore, I cannot fulfill your request for this specific information based on the provided text.

Ask a specific question about this device

Ask a specific question about this device