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ARMADA Ureteral Dilator Set: Used for step by step dilatation of the intramural and ureter and / or for stone manipulation.
ARMADA Nottingham One Step Dilator: Used for one step dilatation of the intramural portion and ureter.
ARMADA Amplatz Renal Dilator Set: Used for progressive dilatation for tract prior to percutaneous kidney stone removal.
ARMADA Renal Dilator: Used for dilatation of Renal Tract.
Glider Amplatz Sheath: Used to maintain previously established nephrostomy tract.
Fascial Dilator: Fascial Dilators are used for dilatation of percutaneous track over the guidewire.
Introducer Sheath: Used for introducing safety wire during nephrostomy.
Introducer Catheter: Used for guiding renal dilators for establishing nephrostomy tract.

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I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for "Allwin Dilator & Sets", which specifies the device's indications for use and regulatory information. However, it does not describe any acceptance criteria or a study that proves the device meets specific performance criteria through a rigorous testing process involving AI or human reader performance.

Therefore, I cannot provide:

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

This document is a regulatory approval letter for a medical device (dilators and sets), not a technical report or study detailing the validation or performance of an AI/ML diagnostic tool.

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The Allwin Ureteral Catheters are used for drainage of urine from the ureter and they allow the delivery of contrast media.

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This document is an FDA 510(k) clearance letter for a medical device (Allwin Ureteral Catheters), not a study report or clinical trial summary. Therefore, it does not contain the information requested regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or multi-reader multi-case studies.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory requirements. It doesn't detail the performance validation methods or results for the device itself.

To answer your request, you would need access to the actual 510(k) premarket notification submission (K220730) which would contain the data from performance testing, if such data was required and submitted for this type of device. However, for a Class II device like a ureteral catheter (product code KOD), performance testing might focus on physical properties, biocompatibility, and sterilization rather than image analysis performance metrics.

In summary, the provided text does not contain the information needed to answer your questions about acceptance criteria and study data for device performance.

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The SureStrip Virification Straw is cryopreservation storage device. It is intended for use in vitrification procedures to contain and maintain human oocytes (MII), 4-8 cell stage embryos, or blastocyst stage embryos.

The SureLock Vitrification Straw is a cryopreservation storage device. It is intended for use in vitrification procedures to contain and maintain human oocytes (MII) or 1-cell stage embryos.

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The provided text includes a 510(k) clearance letter for the SureStrip Vitrification Straw and SureLock Vitrification Straw. However, this document does not contain information regarding acceptance criteria or a study proving the device meets said criteria.

The document states that the devices are substantially equivalent to legally marketed predicate devices, which means they do not require new performance studies to demonstrate safety and effectiveness for a 510(k) clearance.

Therefore, I cannot provide the requested information from the given text.

The information I would have looked for, but is absent, includes:

1. A table of acceptance criteria and reported device performance.
2. Sample size and data provenance for a test set.
3. Details on experts used for ground truth.
4. Adjudication method.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done.
6. If standalone performance was evaluated.
7. Type of ground truth used.
8. Sample size and ground truth establishment for a training set.

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Allwin Embryo Transfer Catheters are used to introduce in vitro fertilized (IVF) embryos into the uterine cavity. Allwin Embryo Transfer Catheters (Pro Embryo Trans, Pro Echo Trans, Twinkle Pro Embryo Trans, and Bulb Trans Star ETC) include stylets or soft obturators intended to assist in uterine access of the guide catheter during an embryo transfer procedure.

Allwin Stylets and Soft Obturators are intended to be used with Allwin Embryo Transfer Catheters to assist in uterine access of the guide catheter during an embryo transfer procedure.

Allwin ETC include the following models: Embryo Trans, Twinkle Embryo Trans, Bulb Trans Ultra, Bulb Trans Star, Pro Embryo Trans, and Twinkle Pro Embryo Trans Embryo Transfer Catheter.

Allwin ETC Stylets and Soft Obturators include the following models: Stylet For Embryo Trans / Twinkle Embryo Trans, Stylet For Pro Embryo Trans / Pro Echo Trans / Twinkle Pro Embryo Trans, Stylet for Bulb Trans Ultra / Bulb Trans Star, Soft Obturator For Pro Embryo Trans / Twinkle Pro Embryo Trans Embryo Transfer Catheter.

This FDA 510(k) clearance letter pertains to Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets, and Soft Obturators. It is a clearance for a medical device, not an AI/ML algorithm. Therefore, the provided text does not contain the information required to answer the questions about acceptance criteria for an AI/ML device, a study proving its performance, sample sizes, expert involvement, or ground truth establishment.

The document discusses the regulatory process for medical devices and confirms that the Allwin devices are substantially equivalent to legally marketed predicate devices. It outlines the "Indications for Use" for these physical medical devices, but there is no mention of any AI or software component requiring performance evaluation as described in the prompt.

Therefore, I cannot provide a table of acceptance criteria, device performance, sample sizes, or details about experts and ground truth as these are not relevant to the content of this specific FDA letter.

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ALL WIN Ureteral stents are intended to temporarily facilitate drainage of urine from kidney to bladder by trained physician. The recommended target population is adults and pediatrics. The indwelling time should not exceed thirty (30) days.

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The provided text is an FDA 510(k) clearance letter for various ureteral stents. It primarily details the regulatory process, product classification, and general controls applicable to these medical devices. It does not contain information on acceptance criteria or studies proving the device meets those criteria.

Therefore, I cannot provide the requested information about acceptance criteria and device performance based on the provided text. The document is a regulatory communication, not a performance study report.

To answer your request, I would need a different type of document, such as a summary of safety and effectiveness, a clinical study report, or a premarket submission detail that includes the performance data.

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Allwin Ovum Pickup Needles are used for laparoscopic or ultrasound guided transvaginal retrieval of oocytes from ovarian follicles.

Allwin Ovum Pickup Needles (ACE Single Lumen Ovum Pickup Needle, OVUMPICK Double Lumen Ovum Pickup Needle, ACE-FL Single Lumen Ovum Pickup Needle with Flushing Line, ACE-M Manual Single Lumen Ovum Pickup Needle).

This FDA letter is a notification of substantial equivalence for a medical device (Allwin Ovum Pickup Needles). It does not contain information about acceptance criteria or specific studies that prove the device meets these criteria. The document 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..."

This means the FDA has determined the new device is as safe and effective as a legally marketed device already on the market, based on the information provided by the manufacturer in their 510(k) submission. However, the details of the studies and acceptance criteria used by the manufacturer to demonstrate this substantial equivalence are not included in this letter. The letter is the FDA's final decision, not the manufacturer's submission itself.

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Allwin Intra Uterine Insemination Catheters are intended for the introduction of washed spermatozoa into the uterine cavity.

Not Found

The provided text is a 510(k) clearance letter from the FDA for Allwin Intra Uterine Insemination Catheters. It establishes that the device is substantially equivalent to legally marketed predicate devices.

However, the document does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance criteria. The letter focuses on regulatory clearance based on substantial equivalence and general controls, rather than outlining performance metrics or the results of a specific performance study.

Therefore, I cannot provide the requested information.

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