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Denudation Pipettes are used for the removal of cumulus oocyte complexes (COC) from an oocyte prior to Intracytoplasmic Sperm Injection (ICSI) and In Vitro Fertilization (IVF) as well as for the handling of gametes, embryos and biopsied cells (polar bodies, blastomeres and trophectoderm) during assisted reproductive techniques (ART).

Denudation Pipettes are not intended for biopsy of cells from oocytes or embryos.

The Denudation Pipettes are extruded polycarbonate capillary tubes that are pulled at one end to form a tapered tip. They have an outer diameter (OD) of 0.9mm at the proximal end and fit into an actuating device. All tips are approximately 90mm in length and depending on the size of the pipette have a volumetric capacity of 18.6-21.9µl.

The Denudation Pipettes are supplied in a range of inner diameter (ID) sizes at the distal end as shown below:

• 80μm, 130μm, 140μm, 150μm, 160μm, 170μm, 180μm, 190μm, 210μm, 230μm, 250μm, 270μm, 290μm.

The Denudation Pipettes are radiation sterilized and provided in a sterile pouch, supplied in two packaging options. Each pouch contains 5 or 10 pipettes. All pipettes are intended for single use and disposable.

This 510(k) clearance letter is for Denudation Pipettes, a Class II medical device used in assisted reproductive technologies. This type of device is an instrument and does not fit the typical format for AI/ML-enabled devices so I have focused on the relevant mechanical and biological performance characteristics.

Acceptance Criteria and Device Performance

There is no single study described that proves the device meets all acceptance criteria. Instead, a series of non-clinical performance tests were conducted.

Here's a table summarizing the acceptance criteria and the reported device performance for the Denudation Pipettes:

Study Details for Acceptance Criteria

The document describes non-clinical performance testing rather than a single clinical study with patients. The testing focused on demonstrating the safety and effectiveness of the device's materials, manufacturing, and functionality.

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

• Mouse Embryo Assay (MEA): The sample size refers to the number of embryos used. The document does not specify the exact number of embryos tested, but it refers to the "2021 FDA guidance Mouse Embryo Assay for Assisted Reproduction Technology Devices," which would dictate the appropriate sample size and methodology.

• Endotoxin (LAL): The sample size would be the number of devices or extracts from devices tested. This is not explicitly stated.

• Sterilization Validation: This involves testing biological indicators and dose mapping; sample sizes for these are defined by ISO 11137 standards.

• Package Integrity and Shelf Life: Sample sizes would relate to the number of packages/devices tested at various time points and under different conditions. These are guided by the referenced ASTM standards.

• Device Dimension Validation: This involves measuring a sample of manufactured pipettes; the sample size is not specified.

• Data Provenance: This is not applicable in the usual sense (e.g., country of origin for clinical data) as these are non-clinical, laboratory-based tests conducted by the manufacturer or their designated testing facilities.

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

• This question is not applicable for this device and the presented non-clinical testing. Ground truth (e.g., disease presence) is not established by human experts in these types of performance tests. For MEA, the "ground truth" is whether an embryo develops into an expanded blastocyst, which is an observable biological outcome measured by trained laboratory personnel. For other tests, measurements are taken against defined specifications.

4. Adjudication method for the test set:

• This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies to resolve discrepancies between human readers' interpretations of data (e.g., medical images). Here, the tests involve objective measurements (e.g., percentages, concentrations, physical dimensions) or standard pass/fail criteria according to established protocols.

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 question is not applicable as this device is a physical tool (pipette) and not an AI-enabled device designed to assist human readers (e.g., radiologists). Therefore, no MRMC study or AI assistance evaluation was performed.

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

• This question is not applicable as this device is a physical tool and does not involve any algorithm or AI for standalone performance evaluation.

7. The type of ground truth used:

• Quantitative Measurements: For most tests (Endotoxin, Dimensions, Seal Strength), the ground truth is established by objective, measurable values that must fall within predefined specifications.
• Biological Outcome: For the Mouse Embryo Assay (MEA), the ground truth is the biological viability and development of mouse embryos to an expanded blastocyst stage. This is a recognized and standardized method for assessing the toxicity of materials coming into contact with gametes or embryos.
• Compliance with Standards: For sterility, package integrity, and shelf life, the ground truth is compliance with the requirements and methodologies outlined in the referenced ISO and ASTM standards.

8. The sample size for the training set:

• This question is not applicable. There is no "training set" in the context of this device's non-clinical performance testing. Training sets are relevant for machine learning algorithms.

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

• This question is not applicable for the same reason as above.

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V-DENUPET is used for the removal of cumulus oocyte complexes (COC) from an oocyte prior to Intracytoplasmic Sperm Injection (ICSI) and In Vitro Fertilization (IVF) as well as for the handling of oocytes and embryos during assisted reproductive techniques (ART). V-DENUPET is not intended for biopsy of cells from oocytes or embryos.

The V-DENUPET is a polycarbonate micropipette. All tips are 90 mm in length, and depending on the size of the tip have a volumetric capacity of 20-25 µl. All pipettes have an outer diameter of 900 µm at the proximal end that is connected to an aspiration device.

The V-DENUPET is supplied in a range of inner diameter sizes at the distal end as shown below:

• Sizes 125 µm, 135 µm, 140 µm, 150 µm, and 175 µm are suitable for oocyte . denudation.
• Sizes 175 µm, 200 µm, 275 µm, 300 µm, and 600 µm are suitable for oocyte . and embryo handling.
  V-DENUPET micropipettes are radiation sterilized and provided in a sterile pouch containing a polypropylene vial containing 10 micropipettes. Each pipette is for single-use only.

The provided text describes the V-DENUPET, a micropipette used in Assisted Reproductive Technologies (ART). However, it does not include acceptance criteria or a study proving the device meets acceptance criteria in the context of AI/algorithm performance. The document is an FDA 510(k) summary for a medical device (a micropipette), focusing on non-clinical performance testing for physical characteristics, sterility, and biocompatibility, not for an AI device.

Therefore, I cannot provide the requested information about acceptance criteria for an AI device, study details, sample sizes, expert qualifications, or MRMC studies, as this information is not present in the provided text.

The closest relevant information from the document is related to the device's performance criteria, not an AI algorithm:

Acceptance Criteria and Reported Device Performance (Non-AI device)

I cannot answer the following questions based on the provided text, as it pertains to an AI/algorithm study, and the document describes a physical medical device:

1. Sample size used for the test set and the data provenance.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
3. Adjudication method for the test set.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of how much human readers improve with AI vs without AI assistance.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
7. The sample size for the training set.
8. How the ground truth for the training set was established.

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EZ-Tip pipettes are for denudation, i.e. removing the cumulus from an occyte prior to Intracytoplasmic Sperm Injection (ICSI) and In Vitro Fertilization (IVF) and for handling gametes, embryos and biopsied cells (polar bodies, blastomeres and trophectoderm) during assisted reproductive techniques (ART). EZ-Tips are not intended for biopsy of cells from oocytes or embryos.

The EZ-Grip provides aspiration and expulsion capabilities to plastic pipettes when fitted during assisted reproduction procedures.

The EZ-Tip pipette is an extruded medical grade polycarbonate capillary that is pulled at one end to form a tapered tip. It has an outer diameter (OD) of 0.9 mm at the proximal end and fits to an actuating device such as the EZ-Grip. All tips are approximately 90 mm in length and depending on the size of the tip they have a volumetric capacity of 15.9 - 25.4 µl.

Pipette Tips are supplied in a range of inner diameter (ID) sizes at the distal end as shown below:

• Size 75 µm, 200 µm, 250 µm, 290 µm, 600 µm are suitable for specimen handling
• Sizes 125 µm, 135 µm, 145 µm, 155 µm, 170 µm are suitable for denudation

The EZ-Tip is supplied sterile in one of two packaging options; individually blister packed or pouch packed in a vial containing 20 tips. All pipettes are intended single use and disposable.

The EZ-Grip is a hand held, reusable actuator or pipeter for plastic pipettes. It consists of a machined aluminium barrel containing stainless steel and PTFE internal working mechanisms, a titanium plunger wire and medical grade silicone and nylon seals. The plunger mechanism is designed to be compatible with 0.9 mm OD plastic pipettes and it has an aspiration volume range of 0.2 µl to 3 µl with a blow-out volume of 1.4 µl above the adjusted aspiration volume setting.

The EZ-Grip is supplied non-sterile with validated protocols for cleaning and sterilization included in the Instructions for Use.

The provided document describes the non-clinical testing and assessment of the EZ-Tip and EZ-Grip devices to demonstrate their substantial equivalence to predicate devices (The Stripper micropipet and micropipeter tips and The Stripper device, respectively). The study does not involve human subjects or AI, but rather focuses on physical, chemical, and biological performance characteristics relevant to assisted reproductive techniques (ART).

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• EZ-Tip MEA & Endotoxin Testing: Three lots of EZ-Tip were tested.
• EZ-Grip MEA Testing (Plunger Wires): Three lots of EZ-Grip plunger wires were tested.
• EZ-Grip Device Life Bench Testing: Not explicitly stated as a number of devices, but it involved simulating one year of use (16,000 actuations) on at least one device.
• Provenance: All tests described are non-clinical, laboratory-based assessments of the physical device components and their interaction with biological samples (mouse embryos). The data provenance is from laboratory testing and not from human clinical data, nor is country of origin of the data specified beyond the company being in the UK.

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

This information is not applicable as the described studies are non-clinical and do not involve human diagnostic assessment or expert-determined ground truth in the typical clinical sense. The "ground truth" here is objective laboratory measurements (e.g., percentage of hatched blastocysts, endotoxin levels, physical performance metrics).

4. Adjudication Method for the Test Set

This information is not applicable as the described studies are non-clinical and do not involve human diagnostic assessment requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. A MRMC comparative effectiveness study was not done. This study is focused on the non-clinical performance of medical devices for ART, not comparative effectiveness of human readers or AI.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

No. This is not an AI/algorithm-based device. It is a physical medical device (pipettes and a pipettor).

7. The Type of Ground Truth Used

• For Mouse Embryo Assays (MEA): The "ground truth" is the observed biological outcome of mouse embryo development (percentage of hatched blastocysts), which is a direct biological measure.
• For Endotoxin Testing: The "ground truth" is the measured endotoxin level, a chemical quantification.
• For Sterilization, Packaging, and Bench Testing: The "ground truth" is compliance with established international standards and internal product specifications for physical and functional performance.

8. The Sample Size for the Training Set

Not Applicable. There is no "training set" as this is not an AI/machine learning study.

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

Not Applicable. There is no "training set" as this is not an AI/machine learning study.

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InteGlobal MicroTips TPLG-130 are used for Denuding, handling blastomeres, oocytes and oocyte stripping. LifeGlobal MicroTips TPLG-180, TPLG-225 and TPLG-275 are used for handling embryos and blastocysts.

Not Found

This document does not contain information about acceptance criteria or a study proving that a device meets such criteria.

The provided text is an FDA 510(k) clearance letter for the "LifeGlobal Micro Tips" device. This letter confirms that the device has been found substantially equivalent to a legally marketed predicate device, allowing it to be marketed. It discusses regulatory compliance, labeling requirements, and contact information for further inquiries.

However, it does not include any details on:

• Specific performance acceptance criteria (e.g., accuracy, precision, sensitivity, specificity).
• Any studies (clinical or non-clinical) that were conducted to evaluate the device's performance against such criteria.
• The methodologies for any such studies (sample size, data provenance, ground truth establishment, expert qualifications, adjudication, MRMC studies, standalone performance).
• Any reported device performance metrics.

Therefore, I cannot provide the requested table or answer any of the questions regarding acceptance criteria and studies.

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The Embryo Biopsy Pipette is intended to aspirate a blastomere or trophectoderm to diagnose genetic disorders prior to embryo selection.

The Polar Body Biopsy Pipette is intended to aspirate polar bodies to diagnose genetic disorders prior to embryo selection.

The Testicular Sperm Extraction Pipette is intended to extract sperm cells from biopsied tessue.

The Embryo Biopsy, Polar Body Biopsy, and Testicular Sperm Extraction Pipettes are 970 microns (um) outer diameter borosilicate glass tubing that is bent and tapered. The Embryo Biopsy Pipette is tapered to a flat, smooth tip inner diameter of 30 um and 35 um. It is intended to be used for blastomere or trophectoderm aspiration. The Polar Body Biopsy Pipette is tapered to an inner diameter of 20 um and beveled to a spike to assist in piercing through the zona pellucida to biopsy the polar body. The Testicular Sperm Extraction Pipette is tapered to a flat angle with an inner diameter of 6.5 um. These pipettes are intended to extract sperm cells from biopsied testicular tissue. The device is supplied gamma sterilized and is intended for one-time use.

The document describes three medical devices: Embryo Biopsy Pipette, Polar Body Biopsy Pipette, and Testicular Sperm Extraction Pipette. The acceptance criteria and the studies performed to demonstrate equivalence are detailed as follows:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample sizes for each specific test (MEA, LAL, Functionality). It mentions "lot release" for MEA and LAL testing, implying that samples are taken from each manufacturing lot. The data provenance is not specified in terms of country of origin or whether it was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the document. The tests performed are laboratory-based and do not involve human expert adjudication for establishing ground truth in a clinical sense.

4. Adjudication Method

Not applicable, as the tests performed are laboratory-based and do not require expert adjudication in the context of clinical interpretation or diagnostic performance.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document describes performance testing for the physical and biological characteristics of the pipettes, not diagnostic efficacy involving human readers.

6. Standalone (Algorithm Only) Performance Study

No, a standalone (algorithm only) performance study was not done. The devices are physical microtools used in assisted reproduction procedures, not AI algorithms.

7. Type of Ground Truth Used

The ground truth used for these tests is based on objective, quantifiable biological and physical criteria:

• MEA: Successful development of mouse embryos to the blastocyst stage.
• LAL: Presence of endotoxins measured in Endotoxin Units.
• Functionality Study: Observable physical performance of the pipettes (aspirating fluid without breaking or leaking).
• Shelf Life: Maintenance of sterility and functional characteristics over time.
• Sterilization Validation: Adherence to FDA recognized standards.

8. Sample Size for the Training Set

Not applicable. These are physical medical devices, not AI/ML algorithms that require training sets.

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

Not applicable, as there is no training set for these physical devices.

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The Flexipet® Denuding Pipettes are intended to be used for blastomere or polar body manipulation, occyte and embryo manipulation, or denuding.

The Flexipet® Manipulation Pipettes are intended to be used for blastomere or polar body manipulation, oocyte and embryo manipulation, blastocyst handling, and manipulation of the oocyte-cumulus complex.

The Flexipet® Denuding Pipettes are polycarbonate tubes with inner diameters measuring 600 um (microns) at the proximal end which taper in diameter in a range from 120 µm to 170 µm on the distal end. The micropipettes are all 3.5 inches in length and constructed from polycarbonate. The devices are supplied gamma sterilized and are intended for one-time use.

The Flexipet® Manipulation Pipettes are polycarbonate tubes with inner diameters measuring 600 um (microns) at the proximal end which taper in diameter in a range from 80 um to 600 um on the distal end. The micropipettes are all 3.5 inches in length and constructed from polycarbonate. The devices are supplied gamma sterilized and are intended for one-time use.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• MEA Testing: The document refers to "lot-release Mouse Embryo Assay testing," implying that samples from manufacturing lots were tested. The specific sample size (number of embryos or pipettes tested per lot) is not provided.
• LAL Testing: Similar to MEA, "lot-release tested" implies samples from manufacturing lots. The specific sample size is not provided.
• Cytotoxicity Testing: The number of devices or test extracts used is not specified.
• Accelerated Aging: The number of devices subjected to accelerated aging is not specified.
• Pull-Out Force Testing: The number of pipettes tested is not specified.
• Aspiration Test: The number of pipettes tested is not specified.

The data provenance is not explicitly stated. Given that these are release tests for a manufactured device, it is presumed to be prospective testing carried out by the manufacturer (Cook Incorporated) at their facilities.

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

This document describes performance testing for a medical device (pipettes), not an AI algorithm that requires expert-established ground truth. Therefore, this information is not applicable. The "ground truth" for these tests are objective, measurable criteria (e.g., embryo development percentage, endotoxin levels, reaction grades, force measurements, successful fluid aspiration).

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

This is not applicable as the tests described are objective, quantitative or semi-quantitative laboratory tests without a need for expert adjudication.

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 document describes performance testing for physical pipettes, not an AI algorithm.

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

This is not applicable. The document describes performance testing for physical pipettes, not an AI algorithm.

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

The "ground truth" for the tests described are objective, pre-defined measurable outcomes based on biological (e.g., embryo development, cytotoxicity), chemical (e.g., LAL endotoxin), and physical (e.g., force, flexibility, aspiration) properties and performance specifications of the device.

8. The sample size for the training set:

This is not applicable. This document describes performance testing for physical pipettes, not an AI algorithm that requires a training set.

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

This is not applicable. This document describes performance testing for physical pipettes, not an AI algorithm that requires a training set.

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Biopsy pipettes are used in assisted reproduction techniques (ART) for the removal of blastomere(s) from embryos or polar bodies from oocytes, which may be done in order to perform preimplantation genetic diagnosis (PGD) on the genetic materials in the biopsied cell(s).

The Biopsy pipette is part of the RI Pipettes range. Other pipettes available in this range include ICSI Injection, ICSI Holding, and Assisted Hatching pipettes.

Biopsy pipettes are offered in a range

• ID sizes - 14μm, 20μm, 25μm, 30μm, 40μm .
• bend angles 0°, 15°, 20°, 25°, 30°, 35°, 40°, 45° .
• . tip profiles - flat , non-spiked (bevelled), spiked

All pipettes in this range are manufactured from very fine borosilicate glass, packed individually into a Twista-Pak (primary packaging) and sealed in a medical pouch. They are then batch sterilised by gamma irradiation.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:

Device: RI Pipettes - Biopsy

1. Table of Acceptance Criteria and Reported Device Performance

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

• Non-pyrogenic (LAL) and Non-embryotoxic (MEA): The document states "Each finished batch of pipettes is tested". This implies a continuous testing process rather than a single, fixed test set size. The specific number of pipettes tested per batch for these assays is not provided.
• Data Provenance: The document does not explicitly state the country of origin for the data for these performance tests. Given that Research Instruments Ltd. is based in the UK, it's reasonable to infer the testing was conducted in the UK or by laboratories recognized by UK/EU standards, but this is not explicitly stated. The studies are prospective in the sense that they are routine batch release tests.
• Sterilization, Packaging, and Shelf Life Validation: These are validation studies performed on representative samples, not on a batch-by-batch basis. The specific sample sizes for these validation studies are not provided in the document.

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

This information is not applicable to the provided document. The performance tests described (LAL, MEA, sterilization, packaging, and shelf life) are objective laboratory and engineering tests, not subjective assessments requiring expert consensus.

4. Adjudication method for the test set:

This information is not applicable. The tests are objective and do not involve human adjudication in the way medical image analysis or clinical trials might. The acceptance criteria themselves serve as the 'adjudication' standard.

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 information is not applicable. This device is a microtool for assisted reproduction, not a diagnostic AI system or an imaging device that would typically involve human readers or AI assistance in interpretation.

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

This information is not applicable. This device is a physical tool, not an algorithm.

7. The type of ground truth used:

• Non-pyrogenic (LAL): The ground truth is established by a quantitative measure of endotoxin levels, with an objective threshold of "< 20 EU/device." This is a laboratory assay.
• Non-embryotoxic (MEA): The ground truth is established by the survival and development rate of mouse embryos to blastocyst stage within a specified timeframe, with an objective threshold of "≥ 80% blastocyst after 120h." This is a biological assay.
• Sterilization validation: The ground truth is compliance with international standards (ISO 11137-1:2006 and ISO 11137-2:2007) which dictate methods for achieving and verifying sterility assurance levels.
• Packaging validation: The ground truth is compliance with international and ASTM standards (ISO 11607-2:2006, ASTM F1980-07, ASTM F1886-09, ASTM F2054-13, and ASTM F1929-12) which define performance requirements for sterile barrier systems.
• Shelf life: The ground truth is the device maintaining its "specifications" (which would include the LAL, MEA, and physical characteristics) over time, as measured by real-time aging studies.

8. The sample size for the training set:

This information is not applicable. This device is a physical instrument, not a machine learning model that requires a training set. The descriptions relate to manufacturing and quality control processes.

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

This information is not applicable. As stated above, this device does not involve a training set.

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The manufactured microtools are to be used for Assisted Reproductive Technology (ART) and Reproductive Medicine (RM), and the specific pipette indication is as follows:

Injection Pipette: tool used in IVF/Assisted Reproduction Technology (ART) laboratories for intracytoplasmic sperm injection (ICSI)

Holding Pipette: tool used in IVF/Assisted Reproduction Technology (ART) laboratories for holding oocyte or embryo during ICSI or biopsy

Biopsy Pipette: tool used in IVF/Assisted Reproduction Technology (ART) laboratories for removal of blastomere(s) from embryos, which may be done in order to perform preimplantation genetic diagnosis on the genetic material in the biopsied cell(s)

Polar Body Biopsy Pipette: tool used in IVF/Assisted Reproduction Technology (ART) laboratories for removal of polar bodies from occytes, which may be done in order to perform pre implantation genetic diagnosis on the genetic material in the biopsied cell(s)

Assisted Hatching Pipette: tool used in IVF/Assisted Reproduction Technology (ART) laboratories to create a defect in the zona pellucida chemically using Tyrode's acid solution in order to perform assisted hatching of embryos

Denuding Pipette: tool used in IVF/Assisted Reproduction Technology (ART) laboratories to denuding cumulus cells from oocytes by delivering enzymes to aid separation

Partial Zona Pipette: tool used in IVF/Assisted Reproduction Technology (ART) laboratories to cut zona pellucida to create a defect in the zona pellucida mechanically in order to perform assisted hatching of embryos mechanically

The following Jieying Microtools are made of glass capillary tubing. They range in sizes and have various degrees of beveled angles as necessary for each individual application. They are gamma radiated and tested for endotoxin and mouse embryo. These devices are assisted reproduction microtools/pipettes that are used in the laboratory to denude, micromanipulate, or hold human gametes or embryos for assisted hatching, intracytoplasmic sperm injection (ICSI), or other assisted reproduction methods.

• a. Injection pipette;
• b. Holding pipette;
• c. Biopsy pipette;
• d. Polar body biopsy pipette;
• e. Denuding pipette;
• f. Partial zona dissection (PZD) pipette;
• g. Assisted hatching (AH) pipette.

The provided document describes Jieying Laboratory Inc.'s micro-manipulation pipettes and their equivalence to predicate devices, focusing on the safety and performance characteristics for regulatory approval.

Acceptance Criteria and Device Performance:

Study Details:

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

   • The document does not explicitly state the specific sample sizes for the LAL, MEA, and sterility tests. It refers to "each batch" for LAL and "samples" for MEA and sterility testing.
   • The data provenance is not specified regarding country of origin or whether it was retrospective or prospective. It is implied to be internal testing conducted by Jieying Laboratory Inc.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts: Not applicable. The ground truth for these tests (endotoxin levels, embryo development, sterility) is established by quantitative laboratory assays with predefined thresholds, not by expert consensus.

3. Adjudication Method for the Test Set: Not applicable. The tests are laboratory assays with clear pass/fail criteria, not subjective assessments requiring adjudication.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This type of study is not relevant for the described safety and performance tests of micro-manipulation pipettes. These are not imaging devices or diagnostic tools requiring human interpretation.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No. This is not an AI/algorithm-based device. The "device" refers to physical micro-manipulation pipettes.

6. The type of ground truth used:

   • LAL Testing: Quantitative measurement of endotoxin units (EU/device).
   • MEA Testing: Percentage of 1-cell zygotes developing to the blastocyst stage.
   • Sterility Testing: Confirmation of absence of microbial growth.

7. The sample size for the training set: Not applicable. This is not a machine learning or AI device that requires a training set. The "training" in this context would refer to the development and validation of the manufacturing processes and quality control methods.

8. How the ground truth for the training set was established: Not applicable, as there is no training set in the context of an AI/ML device. For the manufacturing and quality control processes, the "ground truth" is established through standard laboratory methods and regulatory guidelines (e.g., ISO, FDA guidance) for medical device manufacturing and testing.

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Blastomere Biopsy Pipettes: The intended use of the Blastomere Biopsy Pipettes is for removal of blastomere(s) from embryos, which may be done in order to perform preimplantation genetic diagnosis on the genetic material in the biopsied cell(s).

Polar Body Biopsy Pipettes: The intended use of the Polar Body Biopsy Pipettes is for removal of polar bodies from oocytes, which may be done in order to perform preimplantation genetic diagnosis on the genetic material in the biopsied cell(s).

The Blastomere Biopsy Pipettes are very fine glass pipettes used in IVF/Assisted Reproduction Technology (ART) laboratories for the aspiration of blastomere(s) from embryos for the purpose of preimplantation genetic diagnosis. These pipettes have an inner diameters varying from 18-42 um based customer's preferences and the stage of the embryos being biopsied. The tip may be flat or beveled at 45 degrees, then fire polished, and bended to 10 - 45 degrees or straight.

The Polar Body Biopsy Pipettes are very fine glass pipettes tools used in IVF/Assisted Reproduction Technology (ART) laboratories for the aspiration of polar bodies from oocytes and embryos for the purpose of preimplantation genetic diagnosis. These pipettes have an inner diameters varying from 13-15 um. The tip may be flat or beveled at 45 degrees, then fire polished, and bended to 10-45 degrees or straight. Some of the tip may be pulled to form a sharp spike after polishing based customer's preferences.

These devices are intended for one-time use and will be marked sterile.

These devices are manufactured entirely from borosilicate glass. They are manufactured to specific sizes or the size may be modified to meet customer specifications, following procedures of the Sunlight Quality System. The final products are batch tested as part of a quality assurance program using Mouse Embryo Toxicity testing and endotoxin testing. The acceptance specifications of these tests are ≥80% of 2-cell mouse embryos to blastocysts and endotoxin ≤ 0.5 EU/device.

The Sunlight Medical, Inc. Biopsy Pipettes (Blastomere Biopsy Pipettes and Polar Body Biopsy Pipettes) underwent a 510(k) submission (K092554) to demonstrate substantial equivalence to predicate devices rather than a direct clinical performance study with acceptance criteria in the traditional sense. The equivalence was established based on similarities in indications for use, materials, physical construction, manufacturing processes, and quality controls.

Here's an analysis based on the provided document:

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

The submission does not specify "acceptance criteria" for clinical performance as would be seen in a diagnostic accuracy study. Instead, the "acceptance specifications" refer to quality control tests performed on the manufactured devices. The primary "performance" reported is related to the equivalence to the predicate device and the results of these quality control tests.

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

There is no test set of clinical images or cases described for evaluating device performance in a clinical setting. The "test set" for the quality control criteria would be a sample of manufactured pipettes, but the number of devices tested is not specified. The provenance of the data for these quality control tests (Mouse Embryo Toxicity and Endotoxin) is from the manufacturer's internal "Quality Assurance Program".

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 there was no test set requiring expert ground truth for clinical performance evaluation.

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

This is not applicable as there was no test set requiring adjudication for clinical performance evaluation.

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 surgical tool (pipette) and not an AI-assisted diagnostic device. Therefore, no MRMC study or AI assistance evaluation was performed.

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

This is not applicable. The device is a physical tool, not an algorithm.

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

The "ground truth" for the quality control tests is based on established biological and chemical assays:

• Mouse Embryo Toxicity: The ability of 2-cell mouse embryos to develop to the blastocyst stage in the presence of the device's leachables. This is an accepted biological indicator for cytotoxicity in reproductive medical devices.
• Endotoxin Test: Quantification of bacterial endotoxins, which is a standard safety measure for medical devices that may come into contact with biological systems.

8. The sample size for the training set

This is not applicable. There is no "training set" in the context of device performance in a clinical scenario or AI training, as this is a physical medical device. The "training" for the device would pertain to the manufacturing process and quality system setup, for which sample sizes are not specified in the document.

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

This is not applicable as there is no training set of clinical data. The "ground truth" for manufacturing consistency and quality is established through standard operating procedures, material specifications, and quality control methodologies (like the mouse embryo and endotoxin tests).

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