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ProInsert™ is used during preparation of human sperm from a semen sample using density gradient separation during assisted reproductive procedures. ProInsert™ facilitates density gradient preparation and pellet retrieval following density gradient separation.

ProInsert™ is packaged in a sterile pouch, is single-use only, and includes the following components: Two 15 mL Conical Centrifuge tubes (one for the density gradient preparation and one for washing) 2 Pellet Retrieval Pipettes 1 ProInsert™

Here's a breakdown of the acceptance criteria and the study information for the ProInsert™ device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The document describes "Performance testing: functionality testing" and "Lot Release Tests" as the studies conducted.

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

• Sample Size for Test Set: The document does not specify a separate sample size for a "test set" in the context of clinical or comparative studies. The testing described appears to be a series of laboratory-based performance and safety evaluations.
• Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. Given the nature of the tests (e.g., endotoxin, sterility, HSSA), they are typically conducted in a laboratory setting.

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

This information is not applicable to the type of testing described for the ProInsert™. The "ground truth" for the performance criteria (e.g., endotoxin levels, sterility, sperm motility percentage) would be established by validated laboratory assays and measurement standards, not by expert consensus in this context.

4. Adjudication Method for the Test Set:

This information is not applicable. Adjudication methods are typically used in clinical studies where individual assessments or interpretations are involved (e.g., image reading). The tests described are objective laboratory measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size with AI Assistance:

No, an MRMC comparative effectiveness study was not done. The ProInsert™ is a physical labware device, not an AI-assisted diagnostic tool. Therefore, the concept of human readers improving with AI assistance is not relevant.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done:

No, a standalone study (in the context of an algorithm) was not done. The ProInsert™ is a physical medical device; there is no AI algorithm involved in its primary function.

7. The Type of Ground Truth Used:

The ground truth for the device's performance relies on objective laboratory measurements and validated assay results.

• Endotoxin: Measured against a quantitative limit (less than 1.0 EU/device).
• Sterility: Measured against a quantifiable sterility assurance level (SAL 10⁻⁶).
• Human Sperm Survival Assay (HSSA): Measured as a percentage of sperm motility.
• Functionality (gradient separation effectiveness): Compared to conventional separation procedures, implying successful implementation of the intended function.

8. The Sample Size for the Training Set:

This information is not applicable. There is no AI algorithm being trained for this device. The "training set" concept is typically used in machine learning or AI development.

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

This information is not applicable, as there is no training set for an AI algorithm.

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VitriBlast is intended for ultra-rapid freezing (vitrification) of human blastocysts. This kit is designed for use with Nidacon's ThermoBlast kit for optimal recovery of specimens. This product is used for assisted reproduction-technology procedures.

ThermoBlast is intended for the recovery of human blastocysts that have undergone ultra-rapid freezing (vitrification) using Nidacon's VitriBlast kit. It is designed for optimal thawing and recovery of the specimens. This product is used for assisted reproduction-technology procedures.

VitriBlast consists of 5 separate vials as described hereunder:

• VitriBlast 1: 10mL based on PureSperm Wash (K002630), with additional hSA.
• VitriBlast 2: 10mL same as solution 1, plus Ethylene glycol (7.5%) and DMSO (7.5%) both provided for separate addition.
• VitriBlast 3: 10mL same as solution 1, including Sucrose (0.67 M) and Ficoll (0.14 mM), plus Ethylene glycol (15%) and DMSO (15%), both provided for separate addition just prior to use.

ThermoBlast consists of 4 separate, 10 mL vials as follows:

• ThermoBlast 4: based on VitriBlast I with additional sucrose (0.33 M).
• ThermoBlast 5: based on VitriBlast I with additional sucrose (0.21 M).
• ThermoBlast 6: the same as VitriBlast | (2 vials).

Here's a breakdown of the acceptance criteria and the study details for the Nidacon VitriBlast™ and ThermoBlast™ devices, based on the provided text:

Acceptance Criteria and Reported Device Performance

The submission does not explicitly state pre-defined acceptance criteria in terms of numerical thresholds for performance metrics. Instead, the "acceptance" appears to be based on demonstrating safety, effectiveness, and substantial equivalence to predicate devices, primarily through the clinical outcomes observed. The key metrics reported from the clinical study are:

Study Information

1. Sample Size and Data Provenance:

   • Test Set Sample Size:
     • Number of thawed blastocysts: 424
     • Number of transferred blastocysts: 391
     • Number of transfers: 385
   • Data Provenance: Clinical data from The Fertility Centre at Carlanderska Hospital in Gothenburg, Sweden. The data is retrospective, as the products were used routinely at the clinic for two years before Nidacon became the manufacturer, and the data reflects all results from 2007 onwards.

2. Number of Experts and Qualifications for Ground Truth:

   • The document does not explicitly state the "number of experts" used to establish ground truth in the context of adjudication. Instead, the ground truth is derived from the routine clinical practice and outcomes data from The Fertility Centre, which has been described as one of the world's leading clinics in ART. The clinic's founder, Dr. Matts Wikland, started it in 1987, and it was the first European laboratory to be accredited according to ISO/IEC 17025 in 1998. This implies that the clinical staff (embryologists, doctors) involved in the procedures and data collection are highly qualified ART professionals.

3. Adjudication Method for the Test Set:

   • No explicit adjudication method (e.g., 2+1, 3+1) is mentioned. The clinical outcomes (survival, implantation, pregnancy, birth) are direct results of the procedures and are presumably recorded as per standard clinical practice at a leading fertility clinic.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study is a clinical outcome study of the media itself, not an AI or imaging device with human readers.

5. Standalone (Algorithm Only) Performance Study:

   • No, a standalone (algorithm only) performance study was not done. This is a medical device (vitrification and thawing media), not an algorithm or AI.

6. Type of Ground Truth Used:

   • The ground truth is based on clinical outcomes data from actual human patient treatments (e.g., blastocyst survival, implantation confirmation, clinical pregnancy diagnosis, live births, observed malformations).

7. Training Set Sample Size:

   • No explicit "training set" sample size is mentioned in the context of an algorithm. The clinical data presented is the primary evidence for effectiveness. However, it's mentioned that the products were "developed during scientific collaboration between Nidacon International AB and The Fertility Centre," implying an iterative development process that would have involved extensive testing and refinement of the media formulations. The clinical use at the center prior to Nidacon becoming the manufacturer could be seen as an extensive "real-world" testing phase.

8. How Ground Truth for Training Set was Established:

   • As this is not an AI/algorithm-based device, there isn't a "training set" in the traditional sense for an algorithm. The development of the media (VitriBlast™ and ThermoBlast™) relied on:
     • Bench testing: pH, Osmolality, One cell MEA, MEA according to intended use, Endotoxin level measurements.
     • Animal Non-Clinical Trials: Two types of Mouse Embryo Assay (MEA) testing (FDA recommended 2-cell MEA %blast 96h and performance evaluation according to intended use).
     • Clinical experience and collaboration: The products were developed in scientific collaboration with The Fertility Centre, which had been using vitrification methodology since 2005 and whose "same recipe" Nidacon later became the manufacturer for. This indicates that the formulation was refined and validated through significant clinical experience and observation of outcomes over time by ART specialists at a leading clinic.

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The product is intended to be used cryopreservative for protecting human sperm during cryopreservation, an adjunct to one of the techniques for ART (assisted reproductive technology).

Sperm CryoProtec™ is a buffered salt solution containing human serum albumin and glycerol (10%), has a stable shelf-life of at least 12 months in the unopened bottle at ambient temperature. The product has extremely low endotoxin levels, protects sperm during cryopreservation, and is produced according to cGMP (pharmaceutical device registration). No material of animal origin is included in the product and no antibiotics are present, since antibiotics can have a detrimental effect on sperm. Glycerol, which is also toxic to sperm, is present at the lowest concentration found to be compatible with a cryoprotectant effect.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Sperm CryoProtec™ device:

The provided documents are a 510(k) summary and the FDA's clearance letter. These documents describe the device and its intended use, and state that the device is substantially equivalent to a predicate device based on clinical trials and comparative testing. However, they do not provide detailed acceptance criteria or the specific methodologies of the clinical trials or comparative testing. The information is high-level and focuses on regulatory equivalence rather than detailed performance metrics.

Therefore, many of the requested items cannot be definitively answered from the provided text.

Acceptance Criteria and Device Performance

The provided text states: "The results of clinical trials and comparative testing against predicate product indicates that the new device is as safe and effective as the predicate device." This is the core acceptance criterion presented – substantial equivalence in safety and effectiveness to the predicate device.

Table of Acceptance Criteria and Reported Device Performance:

Study Details (Based on available information in the document)

Given the limited information, assumptions are made where necessary or the item is marked as "Not specified."

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

   • Sample Size: Not specified. The document only mentions "clinical trials and comparative testing."
   • Data Provenance: Not specified. It does not mention country of origin or whether it was retrospective or prospective.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified. The document does not detail how individual data points were evaluated or by whom.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not specified.

4. 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:

   • MRMC Study: Not applicable. This device is a cryopreservative, not an AI or imaging diagnostic device that would involve "human readers."
   • Effect Size: Not applicable.

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

   • Standalone Performance: Not applicable as this is a medical chemical/biological product, not an algorithm. The "performance" refers to the product's ability to protect sperm.

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

   • The "ground truth" for the effectiveness of a cryopreservative would typically involve objective laboratory parameters following cryopreservation and thawing, such as sperm motility, viability, and perhaps success rates in assisted reproductive technologies (ART) if clinical outcomes were part of the trials. The document broadly states "clinical trials and comparative testing," implying that relevant metrics were measured and compared to the predicate device.

7. The sample size for the training set: Not applicable. This is not an AI/machine learning device that requires a training set in the conventional sense. The "training" here would be product development and formulation.

8. How the ground truth for the training set was established: Not applicable. (See #7).

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The product is intended to be used for decreasing the motility and movements of sperm before ICSI.
SpermCatch™ is a medium designed to modulate sperm motility in a physiological manner, to facilitate injecting a single sperm into an oocyte (ICSI). ICSI is an available procedure in Assisted Reproduction Technology (ART).

SpermCatch is optimised for slowing sperm motility prior to ICSI and is ready-to-use in direct replacement for PVP products. SpermCatch is supplied as a sterile (filtered), isotonic salt solution. Volume 5x100 uL. Product No. SC-100

The provided text is a 510(k) summary for the SpermCatch device, which is an assisted reproduction medium. It states that the device is "as safe and effective as the predicate device" based on "clinical trials and comparative testing." However, the document does not include specific acceptance criteria, detailed study designs, or reported device performance metrics in the format requested.

Therefore, I cannot fully complete the table and answer all questions directly from the provided text. The information below reflects what can be extracted and highlights what is missing.

Acceptance Criteria and Device Performance

Missing Information: The document does not provide quantifiable acceptance criteria (e.g., minimum percentage reduction in sperm motility, range of viability maintained, etc.) or specific numerical results from the device's performance that directly address such criteria.

Study Details

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

   • Sample Size: Not specified. The document mentions "clinical trials and comparative testing" but does not provide details on sample size for any test sets.
   • Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

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

   • Not specified. The document does not describe how ground truth was established for any "clinical trials" or "comparative testing" that might have been conducted.

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

   • Not specified.

4. 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 an assisted reproduction medium, not an AI-powered diagnostic or interpretive tool that would involve human "readers" or AI assistance in that context.

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

   • Not applicable. This is a medical device (a liquid medium), not an algorithm.

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

   • Not specified. Given the device's function (slowing sperm motility), ground truth would likely involve measurements of sperm motility, viability, and potentially fertilization rates, but the exact method for establishing this is not detailed.

7. The sample size for the training set:

   • Not applicable/Not specified. As a medical device (a liquid medium) rather than a machine learning algorithm, the concept of a "training set" in the AI sense does not apply directly. If "training set" refers to data used to formulate the product, this is not disclosed.

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

   • Not applicable/Not specified. See above.

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The product is intended for use as an oil overlay during gamete and embryo culture for ART, (Assisted Reproduction Technology) and during manipulations outside the incubator.

NidOil™ is a light, highly purified, paraffin oil product to be used as an overlay for gamete and embryo culture in the incubator, and for manipulations outside the incubator. Shelf life of two years from production date in unopened bottle Spec. density of 0.82 - 0.87 glcm; Dynamic viscosity (20 ℃) 25.0 - 80.0 mPas Cinematic viscosity (40 ℃)

This document describes a 510(k) submission for a medical device called NidOil™. It's a reproductive media product. Crucially, this document is a 510(k) summary, not a detailed study report. Therefore, much of the information you've requested regarding specific study details, sample sizes, expert qualifications, and detailed performance metrics is not present in the provided text.

The primary method for demonstrating safety and effectiveness in a 510(k) submission is to show substantial equivalence to a predicate device, not necessarily to perform extensive de novo clinical trials with detailed performance acceptance criteria as might be expected for novel AI/diagnostic devices.

Here's an analysis based on the provided text, highlighting what is and isn't available:

Acceptance Criteria and Device Performance

The concept of "acceptance criteria" in a typical quantitative sense (e.g., sensitivity, specificity thresholds) is not explicitly detailed in the provided K012123 document. The acceptance criteria for a 510(k) submission like this, seeking substantial equivalence, generally revolve around demonstrating that the new device is as safe and effective as a legally marketed predicate device.

Table of Acceptance Criteria and Reported Device Performance

• Shelf life: two years from production date in unopened bottle
• Spec. density: 0.82 - 0.87 g/cm³
• Dynamic viscosity (20 ℃): 25.0 - 80.0 mPas
• Cinematic viscosity (40 ℃):

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The product is intended to be used for diluting PureSperm® (K980814 and K984172) sperm separation medium to prepare the different layers of a density gradient. PureSperm® Buffer has been formulated to optimize the function of the original PureSperm®.

PureSperm® Buffer is supplied as a sterile (autoclaved SAL 10-3) isotonic salt solution. It is optimised for the dilution of PureSperm® or PureSperm® 100 in the preparation of density centrifugation gradients for separating and purifying human sperm. Two layers are commonly used for the gradient: 40% and 80%. This system effectively isolates the best sperm from lymphocytes, epithelial cells, abnormal or immature sperm, cell debris and bacteria. PureSperm® Buffer is CE marked in countries of the European Union. It is supplied in 100 and 250 ml bottles.

This document is a 510(k) summary for the PureSperm® Buffer, a medical device used in assisted reproduction. The information provided heavily emphasizes the substantial equivalence of the device to a predicate device rather than detailing specific performance criteria or a comprehensive study report in the way a contemporary AI/ML device submission would.

Therefore, many of the requested points regarding acceptance criteria, performance metrics, and study design are not applicable or not provided in this 2001 510(k) submission. This is typical for device submissions from this era, especially for reproductive media which are generally considered lower risk than software-as-a-medical-device.

Here is the information extracted and formatted to the best of what's available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The submission relies on "substantial equivalence" to a predicate device (K000621, SpermRinse™) rather than setting and meeting de novo acceptance criteria. Specific quantitative performance metrics are not specified in this summary.

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

• Sample Size: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document mentions "clinical trials and comparative testing," but no details are provided.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified. Given the nature of the device (reproductive media) and the era of the submission, formal adjudication methods like 2+1 or 3+1 are highly unlikely to have been part of the assessment for this type of product.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its Effect Size

• MRMC Study: No, an MRMC study was not done. This type of study is primarily relevant for imaging-based diagnostic devices where human readers are interpreting data, which is not the case for this reproductive media.
• Effect Size: Not applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was done

• Standalone Study: Not applicable. This device is a biochemical solution, not an algorithm or AI.

7. The Type of Ground Truth Used

• Type of Ground Truth: Not explicitly stated. The submission primarily relies on "comparative testing" against a predicate device and "clinical trials." For reproductive media, ground truth would likely be established through in-vitro biological assays (e.g., sperm viability, motility, morphology post-processing) and potentially in-vivo outcomes data (e.g., fertilization rates, pregnancy rates in clinical use), but these details are not present in this 510(k) summary.

8. The Sample Size for the Training Set

• Sample Size: Not applicable. This device is a biochemical solution, not an AI/ML algorithm that requires a training set.

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

• Ground Truth Establishment: Not applicable. This device is a biochemical solution, not an AI/ML algorithm.

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