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Biopsy micropipets are used to aspirate polar bodies or blastomeres containing genetic material for the purpose or pre-implantation genetic diagnosis. These devices are intended for single use and will be supplied sterile. The labeling will contain the following statement, in prominent and boxed format:

"This tool is indicated for embryo or blastomere biopsy, which may be done in order to perform preimplantation genetic diagnosis (PGD) on the genetic material in the biopsied cell(s). Tests for PGD are currently developed and their performance characteristics are determined by individual laboratories for their own use. The enafactoriance of these tests may vary depending on the particular assay and disease performance of ammy these tests have not been cleared or approved by the Food and Drug Administration."

Biopsy Micropipets are used to remove polar bodies from the zygote (polar body) or blastomeres from the embryo (blastomere biopsy) for the purpose of preimplantation genetic diagnosis. These devices are manufactured from borosilicate glass on which 2 cell mouse embryo and endotoxin testing are performed. They are manufactured following procedures of the Humagen Quality System. The pipets are manufactured to specific sizes or the size may be modified to meet customer specifications.

The provided text is a 510(k) summary for Humagen Fertility Diagnostics, Inc.'s Polar Body and Blastomere Biopsy Micropipets. It does not contain information about acceptance criteria or a study proving the device meets said criteria as typically found for complex medical devices with performance claims (e.g., diagnostic accuracy, sensitivity, specificity).

The document is primarily a declaration of substantial equivalence to a predicate device (K990847), focusing on the device's physical characteristics, intended use, and manufacturing processes rather than its performance in biopsy procedures. The key aspects that would usually be covered in a performance study for AI/diagnostic devices are explicitly stated as being determined by individual laboratories, not by the manufacturer for this submission.

Therefore, many of the requested sections cannot be filled from the provided text.

Here's a breakdown of what can and cannot be answered based on the input:

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

• Acceptance Criteria: Not explicitly stated in the document. The submission focuses on substantial equivalence based on manufacturing, material, and general dimensions to a previously cleared predicate device, rather than performance metrics related to the biopsy procedure itself.
• Reported Device Performance: Not reported. The document states: "Individual laboratories currently develop and determine performance characteristics for their own use. It is understood that the FDA has not currently cleared or approved these procedures." This indicates that the manufacturer is not providing performance data for the biopsy function of the pipets in this 510(k).

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

• Not applicable/Not provided. No performance study data is presented for the biopsy function in this document. The document mentions "2 cell mouse embryo and endotoxin testing" performed on the materials, but details of such testing (sample size, criteria, results) are not provided in this summary.

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)

• Not applicable/Not provided. No ground truth establishment related to the biopsy procedure's efficacy or outcomes is discussed in this submission.

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

• Not applicable/Not provided.

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

• Not applicable/Not provided. This device is a physical microtool, not an AI or diagnostic algorithm requiring reader studies.

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

• Not applicable/Not provided. This is a physical device, not an algorithm.

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

• Not applicable/Not provided, for the reasons mentioned above. The only "testing" mentioned is for the materials ("2 cell mouse embryo and endotoxin testing"), but details are not elaborated to define a ground truth methodology.

8. The sample size for the training set

• Not applicable/Not provided. No training set is mentioned as this is not an AI/algorithm device.

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

• Not applicable/Not provided.

Summary of Device-Specific Information from the Text:

• Device Name: Blastomere Biopsy Micropipet, Polar Body Biopsy Micropipet
• Intended Use: For polar body or blastomere biopsy, which may be done to perform pre-implantation genetic diagnosis (PGD) on the genetic material in the biopsied cell(s).
• Manufacturing: Made from borosilicate glass, manufactured following Humagen Quality System procedures.
• Testing Mentioned (without details): 2 cell mouse embryo and endotoxin testing performed on the materials.
• Substantial Equivalence Claim: Similar to other micropipets manufactured by Humagen and approved under K990847, varying only by size and shape of the tip. Testing and controls are stated to be the same as the predicate.
• Key Disclaimer: "Individual laboratories currently develop and determine performance characteristics for their own use. It is understood that the FDA has not currently cleared or approved these procedures." This is reiterated in the Indications for Use statement in a prominent, boxed format.

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The micropipet family's intended use is to manipulate zygotes during the ICSI procedure.

The micropipets are used in the tissue culture techniques performed by embryologists when injecting a single sperm into an egg, or assisting an embryo in hatching prior to reimplantation.

The micropipets are tools used in procedures that have been developed to aid infertile couples achieve pregnancy. Specifically, the ICSI procedure is beneficial in cases where the male fertility is impaired.

Micropipets are fabricated from 1 mm. diameter borosilicate glass capillary tubes. One end of the glass tube is pulled to a much smaller diameter using a glass puller with a heated coil. Diameters range from 2 - 3 um to 200 um depending upon the type of micropipet. Most micropipets are ground on a microgrinder to produce a beveled or flat opening. Generally, a sharp spike is pulled on beveled micropipets by touching the bevel to a heated glass bead and withdrawing quickly. Angles may be added along the shaft of the micropipet per request of the end user to best fit their micromanipulation equipment. Specifications for each variation of micropipet is as follows:

Intracytoplasmic Sperm Injection Micropipets (ICSI) - pulled to a 6 to 7 um outer diameter, 4 to 5 um inner diameter with a 35 or 50 degree bevel and a short, sharp point or may be made with no point. May be straight or with an angle (15 - 45 degrees as specified), 0.5mm from the beveled end. Any of these parameters may be modified to meet customer specifications.

Spermatid ICSI Micropipets - pulled to a 9 um outer diameter, 7 to 8 um inner diameter with a 35 or 50 degree bevel and a short, sharp point at the tip. May be straight or with an angle (15 to 45 degrees as specified), 0.5 mm from the beveled end. Again, parameters may vary somewhat depending on customer specifications.

Holding Micropipets - one end is pulled to the specified outer diameter, which can range from 65 um to 180 um, scored and cut to yield a blunt opening of the appropriate size, and polished over a hot glass bead to a 20 to 25 um inner diameter opening, unless otherwise specified. Small holding micropipets are pulled to an outer diameter of 65 to 95 um, medium holdings are pulled to an outer diameter of 100 to 120 um, large holdings are pulled to an outer diameter of 125 to 150 um, and extra large holding micropipets are pulled to an outer diameter of 155 to 180 um. Holding micropipets may be angled or straight.

Assisted Hatching Micropipets - one end is pulled to a standard outer diameter of 8 to 10 um unless otherwise specified, with a blunt opening. Other outer diameter sizes are available upon request. Assisted hatching micropipets may be straight or angled (15 to 45 degrees as specified), 0.5 mm from the tapered end.

Subzonal Insertion Micropipets (SUZI) - one end is pulled to a 10 to 12 um outer diameter with a 40 degree bevel, and a short, sharp point at the tip. SUZI micropipets may be straight or angled (15 to 45 degrees as specified), 0.5 mm from the tapered end.

Partial Zona Dissection Micropipets (PZD) - one end is pulled to a long, thin taper with a closed, sharp point. PZD micropipets may be straight or angled (15 to 45 degrees as specified), 0.5 mm from the tapered end.

Denuding Micropipets - one end is pulled and then cut with a diamond knife to an opening of 150 or 190 um inner diameter with a blunt opening.

The provided text describes the acceptance criteria and study for the Humagen Fertility Diagnostics, Inc. micropipets.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set:

  • Mouse Embryo Bioassay: For the toxicity test, 25 µl tissue culture medium was used, and embryos were cultured starting at the two-cell stage. The number of embryos used in each group (treated and control) is not explicitly stated, but it would involve enough embryos to assess the "combined percent of embryos developing to expanded and/or hatching blastocysts."
  • Sterilization: The "Methods" for determining the minimum established radiation dose (AAMI Method 1, SIP) would involve a sample size to achieve statistical confidence in the 10⁻⁶ SAL, but the specific number is not provided. Quarterly dose audits are conducted.
  • Endotoxin: No specific sample size is provided, but each lot of micropipets is tested.

• Data Provenance: The data is generated from in vitro laboratory testing of the device itself (mouse embryo bioassay, sterilization validation, endotoxin testing). There is no mention of human clinical data, retrospective, or prospective studies in this context. The testing is described as internal quality control and validation for the specific device.

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

• Mouse Embryo Bioassay: The interpretation of mouse embryo development (expanded and/or hatching blastocysts) would typically be performed by trained embryologists or laboratory personnel experienced in bioassays. The document does not specify the number or qualifications of experts involved in assessing the mouse embryo results.
• Sterilization and Endotoxin Testing: These tests are objective laboratory assays. The "ground truth" is established by the specified chemical and biological measurement methods (e.g., AAMI Method 1 for sterility, Limulus Amebocyte Lysate assay for endotoxin). While experts design and oversee these tests, the ground truth is derived directly from the assay results against predefined criteria, not from expert consensus on subjective observations. The document mentions an "outside testing laboratory" for quarterly dose audits, implying involvement of qualified personnel from that lab.

4. Adjudication method for the test set

• Mouse Embryo Bioassay: The criteria for non-toxicity are objective: "within 10% of the control group, and no contamination." If multiple individuals assess the embryos, their readings would need to align with these objective criteria. No specific adjudication method (e.g., 2+1, 3+1) is mentioned, suggesting direct application of the criteria.
• Sterilization and Endotoxin Testing: These are objective laboratory tests with predefined cut-offs. Adjudication is not typically needed in the sense of reconciling different expert opinions; rather, the results are compared directly to the numerical acceptance criteria.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This document describes a medical device (micropipets) that is a tool, not an AI or diagnostic imaging system. Therefore, the concept of "human readers" and "AI assistance" as typically applied in MRMC studies is not relevant here.

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

• No, a standalone algorithm performance study was not conducted. This device is a physical tool used by embryologists. It does not involve a software algorithm or AI operating in a standalone mode.

7. The type of ground truth used

• Mouse Embryo Bioassay (Toxicity): The ground truth for toxicity is based on biological outcomes data (embryo development to expanded and/or hatching blastocysts in treated vs. control groups).
• Sterilization and Endotoxin Levels: The ground truth for sterility and endotoxin levels is based on objective biological/chemical assay results (e.g., bacterial growth, Limulus Amebocyte Lysate reaction) compared against predefined scientific/regulatory standards.

8. The sample size for the training set

• There is no mention of a "training set" in the context of this device. The described testing procedures are for quality control and validation of manufacturing lots, not for training a machine learning model.

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

• Not applicable, as there is no training set for a machine learning model described for this device.

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The NewLife Dish's intended use is to hold zygotes/embryos during micromanipulation or other tissue culture procedures in the IVF laboratory.

NewLife Dishes are used in the tissue culture techniques performed by embryologists when injecting a single sperm into an egg, or assisting an embryo in hatching prior to reimplantation.

The dishes are disposable tissue culture labware used in procedures that have been developed to aid infertile couples achieve pregnancy. Specifically, the ICSI procedure is beneficial in cases where the male infertility is impaired.

NewLife Dishes are fabricated from polysterene and are 60 mm. diameter. Dishes are made with or without clear lids, etched or unetched. Etched dishes have a center circle with 8 smaller circles inside the larger circle, and a 9th circle inside the 8 circles. There are numbers 1 through 8 outside the large circle, with the number 1 at the top of the dish. Unetched dishes have center circles, but no other circles are etched on the dishes. Dishes are disposable, intended for one time use only.

Here's a breakdown of the acceptance criteria and study information for the NewLife Dish, 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

• Sample Size for Mouse Embryo Bioassay: The text states, "25 ul tissue culture medium...For NewLife Dishes, the MEA is performed in the test dish, providing continuous exposure." and "Control droplets of medium were not exposed to product before receiving embryos." It further mentions "embryos were cultured in the media beginning at the two-cell stage." However, it does not specify the number of dishes or the precise number of embryos used per assay for either the test or control groups within each lot. It just describes the procedure.
• Data Provenance: The study appears to be prospective testing conducted by the manufacturer, Humagen Fertility Diagnostics, Inc., on each lot of their NewLife dishes. There is no information about the country of origin of the data beyond the manufacturer being in Charlottesville, VA, USA.

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

• This information is not provided in the document. The ground truth (embryo development, endotoxin levels, sterility) is established by laboratory testing methods (mouse embryo bioassay, Limulus Amebocyte Lysate assay, gamma radiation verification) rather than human expert consensus for the test set.

4. Adjudication Method for the Test Set

• This information is not applicable as the "ground truth" for the performance criteria is determined by laboratory assay results and compliance with specified numerical thresholds, not by human expert review requiring adjudication.

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

• No, an MRMC comparative effectiveness study was not done. This device is a piece of labware, and its performance is evaluated through direct biological and chemical testing, not by comparing human reader performance with and without AI assistance.

6. If a Standalone Study Was Done

• Yes, a standalone study was done. The performance evaluation for the NewLife Dish (toxicity, endotoxin, sterility, packaging integrity) directly assesses the device itself against established criteria, without involving human users for performance assessment.

7. The Type of Ground Truth Used

• The ground truth used for evaluating the device's performance is a combination of:
  • Biological Assay Outcomes: The development of mouse embryos to expanded and/or hatching blastocysts, compared against control, as an indicator of non-toxicity.
  • Chemical Assay Results: Endotoxin levels measured by the Limulus Amebocyte Lysate assay.
  • Physical/Biological Validation: Sterility assurance levels achieved through gamma radiation and validation of packaging to maintain sterility over a defined shelf life.
• In essence, the ground truth is based on established laboratory and manufacturing control standards relevant to medical devices used in assisted reproduction.

8. The Sample Size for the Training Set

• This device does not involve a "training set" in the context of an AI/machine learning model. The product is a manufactured item, and its performance is assessed through testing of each production lot against predetermined specifications. Therefore, this question is not applicable.

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

• As there is no training set for an AI/machine learning model, this question is not applicable. The "ground truth" for the device's performance (i.e., the acceptance criteria) was established through industry standards and scientific understanding of what constitutes a safe and effective tissue culture dish for IVF procedures.

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