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510(k) Data Aggregation
(279 days)
The Cryopette is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human blastocyst stage embryos.
The Cryopette consists of a cryostraw manufactured from polycarbonate-Lexan OQ-3820. This straw has a displacement bulb attached to one end of the cryostraw whose function is to aspirate and dispense the sample contained in the vitrification media in and out of the opposite (open) end of the cryostraw. The cryostraw is the only sample contacting portion of the Cryopette. The metering sheath provides structural rigidity for the Cryopette. The support ring provides a backstop and seal for the displacement bulb. The outer case encases the displacement bulb to provide a surface for labeling. The sealing mark, distal storage border and proximal storage border reference lines are found on the outside of the cryostraw.
The provided text describes the acceptance criteria and performance data for the Cryopette device. Here's a summary of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mouse Embryo Assay (MEA): >70% hatching at 96 hours | Hatching percentage well exceeded >70% at 96 hours (exact value not specified, but stated as "well exceeded") |
| Endotoxin (LAL) Levels: < 20 EU | Endotoxin levels < 20 EU |
| Mechanical Testing (Aspiration) | Aspirated samples appropriately; 100% (61/61) aspirated fluid as intended; 100% (61/61) delivered specimen to proper position |
| Mechanical Testing (Leakage) | No evidence of leakage following heat sealing; 100% (61/61) had intact seals and no leakage |
| Mechanical Testing (Intact after LN2) | 100% (61/61) remained intact after removing from liquid nitrogen |
| Blastocyst Survivability (Comparative) | Overall survival of mouse blastocysts for the Cryopette was 96% (compared to 84% for predicate) |
| Cooling Rates (Comparative) | -23,700 °C/min (equivalent to predicate device – exact value for predicate: -12,000 °C/min) |
| Warming Rates (Comparative) | 34,480 °C/min (equivalent to predicate device – exact value for predicate: 24,000 °C/min) |
| Sterilization Validation: SAL 10⁻⁶ | SAL of 10⁻⁶ |
| Shelf Life/Package Integrity | Maintained package integrity, sterility, and functionality for labeled shelf life (specific quantitative data not provided) |
2. Sample Size Used for the Test Set and Data Provenance:
- Mouse Embryo Assay (MEA), Endotoxin (LAL) Levels, Sterilization Validation, Shelf Life/Package Integrity: No specific sample sizes for these tests are explicitly stated in the provided text, but it mentions testing is performed "Each lot" for MEA and Endotoxin. The overall performance data pertains to the device's design verification rather than a specific "test set" in the context of an AI/human reader study.
- Mechanical Testing (Aspiration, Leakage, Intact after LN2): 61 Cryopettes were tested.
- Blastocyst Survivability (Comparative Testing): The sample size for the blastocyst survivability study is not explicitly stated in terms of number of blastocysts or replicates, but it compares the "overall survival of mouse blastocysts."
- Heating and Cooling Rates: Not specified.
- Data Provenance: The studies used mouse embryos/blastocysts, suggesting laboratory-based testing rather than clinical retrospective or prospective human data. The precise country of origin is not specified but the submission is for a US FDA 510(k).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. This device is a cryopreservation container, and the performance data relates to its physical and biological compatibility characteristics, not a diagnostic interpretation task that would involve human experts establishing ground truth for a test set. The performance is assessed via laboratory assays and mechanical tests.
4. Adjudication Method for the Test Set:
Not applicable, as the data collection does not involve human interpretation or adjudication in the context of diagnostic performance. The results are from objective laboratory tests and direct mechanical observations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of images or other data, which is not the case for a cryopreservation container.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical container, not an algorithm or AI system.
7. The Type of Ground Truth Used:
The "ground truth" for the performance claims is based on:
- Laboratory Assay Results: For Mouse Embryo Assay (embryo viability/hatching), Endotoxin levels.
- Direct Observation/Measurement: For mechanical testing (aspiration, leakage, intactness, dimensions), and sterilization assurance level.
- Comparative Experimental Results: For blastocyst survivability and heating/cooling rates, compared against a predicate device using laboratory experimental setups.
8. The Sample Size for the Training Set:
Not applicable. This device is not an AI/ML algorithm that requires a training set. The descriptions are of device verification and validation tests.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this device.
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(124 days)
The transfer of the removed blastomere from a holding vessel to a transport vessel. This device is NOT intended for blastomere biopsy from an embryo.
Stripper PGD® Micropipette and associated tip
This document is a 510(k) clearance letter from the FDA for a medical device called "Stripper PGD® Micropipette and associated tip." It states that the device is substantially equivalent to legally marketed predicate devices.
However, this document does not contain the information requested in the prompt regarding acceptance criteria, device performance, study details, or ground truth.
The letter is a regulatory approval document and focuses on the administrative aspects of device clearance rather than the detailed technical performance or the studies that would demonstrate compliance with acceptance criteria.
Therefore, I cannot extract the requested information from this provided text.
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(189 days)
The Mid-Atlantic Diagnostics Custom Products IVF Workstation is a laminar flow hood that is indicated for use as an accessory to assisted reproduction technologies/in vitro fertilization (ART/IVF) procedures.
The Mid-Atlantic Diagnostics Custom Products IVF Workstation is a laminar flow hood.
The provided document is a 510(k) clearance letter for a medical device: "Custom Products IVF Workstation Models: WKST-24x36, WKST-24x60, WKST-24x60, WKST-24x60, WKST-24x72, and WKST-24x72D."
This type of device, an IVF Workstation, is a laminar flow hood used as an accessory in assisted reproduction technologies. It is a piece of laboratory equipment designed to provide a sterile environment, not a diagnostic or AI-powered device.
Therefore, the document does not contain any information regarding acceptance criteria, device performance metrics (like sensitivity, specificity, or AUC), sample sizes for test or training sets, expert qualifications, ground truth establishment, or any comparative effectiveness studies (MRMC or standalone AI performance) as it pertains to AI or diagnostic algorithms.
The 510(k) clearance for this device is based on substantial equivalence to legally marketed predicate devices, meaning it does not require clinical trials or performance studies that would involve the metrics you've requested. The review focuses on its design, materials, and intended use as a manufacturing/processing aid rather than an AI-driven diagnostic tool.
In summary, all the requested information regarding acceptance criteria and a study proving device performance is NOT applicable to this K030525 clearance letter.
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(196 days)
"THE STRIPPER®" MICROPIPET FAMILY'S INDICATION FOR USE IS T0 MANIPULATE AND TRANSFER ZYGOTES AND EMBRYOS DURING IVF AND ICSI PROCEDURES.
"THE STRIPPER®" MICROPIPETS ARE USED IN THE TISSUE CULTURE TECHNIQUES PERFORMED BY EMBRYOLOGISTS WHEN PREPARING OOCYTES FOR IVF, ICSI AND ASSISTED HATCHING TECHNIQUES PRIOR TO RE-IMPLANTATION.
"THE STRIPPER®" MICROPIPETS ARE TOOLS USED IN PROCEDURES THAT HAVE BEEN DEVELOPED TO AID INFERTILE COUPLES ACHIEVE PREGNANCY.
REMOVES CUMULUS AND CORONA CELLS FROM OOCYTE FOR CONFIRMATION OF FERTILITY DURING IVF.
REMOVES CUMULUS AND CORONA CELLS FROM OOCYTE PRIOR TO ICSI PROCEDURES.
USED TO TRANSFER EMBRYOS AND OOCYTES THROUGH VARIOUS MEDIA AND SOLUTIONS DURING THE IVF PROCEDURE.
"THE STRIPPER®" micropipetter is a hand held device used to create the vacuum necessary for "THE STRIPPER®" micropipetter tips to aspirate and dispense fluid and cellular material. Its' components include an aluminum barrel that houses a stainless steel plunger and spring, an aluminum plunger shaft with finger pad, o-rings, washer and collet for securing "THE STRIPPER®" tips.
"THE STRIPPER®" micropipette tips are fabricated from polycarbonate tubing wherein one end of the tube is pulled to a much smaller dimension to produce tips of varying internal dimensions.
The provided document describes the "THE STRIPPER®" Micropipetter and Micropipetter Tips, a device used in In Vitro Fertilization (IVF) and Intracytoplasmic Sperm Injection (ICSI) procedures. The document includes information on the device's testing procedures and, by extension, its acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mouse Embryo Bioassay (Toxicity Testing) | |
| % Development to Blastocyst at 96 hours (Test Article) | > 70% |
| % Development to Blastocyst at 96 hours (Control Medium) | > 70% (Indicates a valid assay) |
| Sterility Testing | |
| Sterility Assurance Level (SAL) | 10⁻⁶ |
| Minimum Radiation Dose (for sterilization) | 15 kGy (Established by AAMI Method I, SIP) |
| Maximum Radiation Dose (for sterilization) | 25 kGy |
| Endotoxin Testing (Limulus Amebocyte Lysate Assay) | |
| Endotoxin Level per device | < 0.03 EU/ml |
2. Sample Sizes Used for the Test Set and Data Provenance:
- Mouse Embryo Bioassay: The text states "microdrops" are used, and embryos are added to "both the test and control medium." It does not specify the exact number of embryos per microdrop or the total number of embryos tested per lot. The data provenance is implied to be prospective as each "lot of micropipettes" is tested. The country of origin of the data is not specified but is implicitly from Mid-Atlantic Diagnostics, Inc. in the USA.
- Sterility Testing: The sterilization validation program follows the United States Pharmacopeia 23 (71) procedure. The document mentions "every lot being validated for sterility." The exact sample size (number of devices per lot tested) is not specified. Data provenance is prospective per lot.
- Endotoxin Testing: "Each lot of micropipettes is also tested." The specific number of devices tested per lot is not stated. Data provenance is prospective per lot.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
The document does not mention the use of experts to establish the ground truth for the device's performance tests. The tests (mouse embryo bioassay, sterility, endotoxin) are laboratory assays with objective, measurable outcomes, not requiring expert human interpretation for ground truth establishment in the described context.
4. Adjudication Method for the Test Set:
Not applicable. The described tests are laboratory assays with predefined quantitative thresholds for acceptance, not requiring an adjudication method involving human interpretation.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not conducted. The provided document focuses on the safety and performance characteristics of "THE STRIPPER®" itself through laboratory testing, not on comparing the effectiveness of human readers with and without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Yes, a standalone study was done. The performance evaluation presented is entirely based on the device's intrinsic characteristics through laboratory assays (mouse embryo bioassay, sterility testing, endotoxin testing). There is no "human-in-the-loop" component to these performance measurements.
7. Type of Ground Truth Used:
The ground truth for the performance evaluations is based on:
- Biological/Empirical Outcomes: For the mouse embryo bioassay, the ground truth is the observable development of mouse embryos to the blastocyst stage after exposure to the device extract, compared to a control.
- Quantitative/Analytical Measurements: For sterility, the ground truth is the absence of microbial growth as determined by validated microbiological methods to a specified Sterility Assurance Level. For endotoxin, the ground truth is the measured concentration of endotoxins in EU/ml as determined by the Limulus Amebocyte Lysate assay.
8. Sample Size for the Training Set:
Not applicable. This device is a manual micropipetter and tips, not an AI/ML algorithm. Therefore, there is no "training set" in the context of an algorithmic model.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of device.
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