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The Towako Transmyometrial Embryo Transfer Set is indicated for transfering IVF embryo(s) into the endometrial cavity through the myometrium for patients undergoing Assisted Reproductive Procedures.

The Towako Transmyometrial Embryo Transfer Set is comprised of an echo tipped stainless steel 19 Gauge needle, matching stainless steel stylet and a 2 Fr polyethylene transfer catheter. The stylet fits into the needle with both bevels flush, and is inserted with the stylet in-situ to prevent blockage of the needle lumen and provide stiffness to the needle during insertion. When the needle is positioned correctly, the stylet is removed and the transfer catheter with the embryos loaded is inserted to allow embryo transfer. The device is used when difficulty is experienced in transferring embryos into the uterine cavity using a standard trans-cervical route. The Towako Transmyometrial Embryo Transfer Set is a sterile and single-use device.

The provided text is a 510(k) Premarket Notification from the FDA for a medical device called the "Towako Transmyometrial Embryo Transfer Set." It describes the device, its intended use, comparison to a predicate device, and performance data.

However, the document does not contain information about a study involving an AI/Machine Learning device and its performance against acceptance criteria. The listed performance data pertains to traditional medical device testing such as biocompatibility, mouse embryo assay, endotoxin testing, mechanical performance testing, and stability testing. There is no mention of a test set, ground truth, expert readers, or any other elements related to the evaluation of an AI algorithm as requested in your prompt.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria for an AI/ML device based on the provided text. The text describes the regulatory clearance process for a physical medical device, not a software or AI medical device.

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The Double Lumen Ovum Aspiration Need for laparoscopic or ultrasound guided transvaginal aspiration and flushing of oocytes from ovarian follicles for patients undergoing Assisted Reproductive procedures.

Double Lumen Ovum Pick-up Needles consist of a double lumen stainless steel needle with a manipulating handle. The manipulating handle has two ports: the central port through which oocytes are aspirated via the central lumen, and a secondary side port to allow flushing of follicles via a secondary lumen. The needle is intended to be used to aspirate oocytes from follicles of human ovaries via a laparoscopic or ultrasound guided transvaginal path.

The Double Lumen Ovum Aspiration Needles are sterile and single-use devices.

The Double Lumen Ovum Aspiration Needles are available in 16 or 17 gauge sizes and three lengths: 30, 33 and 35 cm. The needles are provided with an aspiration tube of 75 cm length and a vacuum tube with a length of 70 or 100 cm.

Here's a breakdown of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document describes design verification and validation activities for a medical device (Double Lumen Ovum Aspiration Needles), not a study involving human data, algorithms, or test sets in the context of medical imaging or AI.

Therefore, the concepts of "sample size used for the test set," "data provenance," "country of origin of the data," and "retrospective or prospective" are not applicable to this type of device submission. The tests were performed on the device itself or its materials.

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

This information is not applicable as the document describes physical/material testing of a medical device, not a diagnostic or AI-driven system requiring expert ground truth establishment.

4. Adjudication Method for the Test Set

This information is not applicable for the reasons stated above.

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 submission is for a physical medical device, not an AI-based diagnostic tool.

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

This information is not applicable. This submission is for a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on established industry standards (e.g., ISO, USP) and internal functional requirements for biocompatibility, mechanical performance, and sterility. For the Mouse Embryo Assay (MEA), the "ground truth" would be the development of a control group of embryos.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" as this is not an algorithm or AI model.

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

This information is not applicable. There is no "training set" or associated ground truth establishment for an AI model.

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The COOK Vacuum Pump is intended for the aspiration of eggs (ova), during assisted reproduction procedures using low flow, intermittent vacuum.

The COOK Vacuum Pump (K-MAR-5200) is an electrically-powered, vacuum pump that is used for the collection of ova (eggs) from ovarian follicles for use in in vitro fertilization (IVF) procedures. The COOK Vacuum Pump provides vacuum levels ranging from -10 mmHg to -500 mmHg. . It is supplied non-sterile.

The disposable Vacuum Line with Hydrophobic Filter (K-DVLF-240) is an accessory to the COOK Vacuum Pump and is used to connect the vacuum pump to an ovum aspiration needle. This component has been designed and tested to withstand the maximum vacuum pressures associated with the COOK Vacuum Pump. The Vacuum Line with Hydrophobic Filter (K-DVLF-240) is provided sterile (ethylene oxide sterilization) for single use only, and has a shelf-life of three years.

The provided text is a 510(k) Premarket Notification from the FDA regarding the "COOK Vacuum Pump". This document primarily focuses on the device's substantial equivalence to a predicate device and does not contain information about clinical studies or performance data related to AI/algorithm-driven medical devices. Therefore, I cannot provide the requested information regarding acceptance criteria and study results for an AI device.

The document discusses the following:

• Device Name: COOK Vacuum Pump
• Indications for Use: Aspiration of eggs (ova) during assisted reproduction procedures using low flow, intermittent vacuum.
• Predicate Device: COOK Ultra Quiet Vacuum Pump & Regulator (K992070)
• Technological Characteristics: Comparison of vacuum range, boost function, controller type, and presence of software.
• Non-Clinical Performance Testing: Electrical Safety, Electromagnetic Compatibility, Software Verification and Validation, Sterilization Validation, Shelf-Life Testing.

Specifically, regarding your request, this document does not include:

• A table of acceptance criteria and reported AI device performance.
• Sample sizes, data provenance, or details of a test set for an AI algorithm.
• Information on experts used to establish ground truth for an AI test set.
• Adjudication methods for an AI test set.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness studies for human readers with/without AI assistance.
• Standalone AI algorithm performance.
• Type of ground truth for an AI algorithm.
• Sample size for an AI training set.
• How ground truth for an AI training set was established.

The "Software Verification and Validation Testing" mentioned refers to the general software development lifecycle and testing process of the embedded software controlling the vacuum pump, not to artificial intelligence or machine learning model validation.

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Sydney IVF Culture Oil is intended for use as an oil overlay for culture of gametes, zygotes, or embryos in assisted reproduction technology (ART) and micro-manipulation procedures.

Sydney IVF Culture Oil is designed to protect gametes and embryos during ART processing by providing a barrier between the embryo culture media and the air, thereby minimizing evaporation, and reducing fluctuations in osmolality. Sydney IVF Culture Oil consists of pharmaceutical grade mineral oil.

Sydney IVF Culture Oil is provided in glass vials (50 ml). This product is a single use, aseptically-filtered device.

The Sydney IVF Culture Oil is intended for use as an oil overlay for the culture of gametes, zygotes, or embryos in assisted reproduction technology (ART) and micromanipulation procedures. The study was conducted to expand the shelf-life of the device from 90 days to 20 weeks when stored at 2-8℃.

Here's a breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: The document does not specify the exact number of units of Sydney IVF Culture Oil tested for the shelf-life study. It refers to a "real-time shelf-life study."
• Data Provenance: The study was conducted by William A. Cook Australia Pty Ltd in Australia. It is a prospective, real-time shelf-life study.

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

Not applicable. This device is not an AI/imaging diagnostic device requiring expert interpretation for ground truth. The acceptance criteria are based on standardized laboratory assays (MEA, LAL, Sterility).

4. Adjudication Method for the Test Set

Not applicable. As noted above, the ground truth is established by objective laboratory assays, not expert consensus requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This device is a culture oil, not an AI diagnostic tool, and therefore human reader performance is not relevant.

6. Standalone Performance

Yes, a standalone performance study was done in the form of a real-time shelf-life study. This study evaluated the performance of the device (Sydney IVF Culture Oil) itself against pre-defined specifications without human intervention or interpretation as part of the primary outcome.

7. Type of Ground Truth Used

The ground truth used for the acceptance criteria are:

• Mouse Embryo Assay (MEA): A biological assay, an established standard for assessing the suitability of materials for embryo culture, providing an objective measure of embryo development.
• Endotoxin (LAL): A chemical assay (Limulus Amebocyte Lysate assay), a standard method for detecting bacterial endotoxins.
• Sterility: A microbiological test, an established standard for confirming the absence of viable microorganisms.

8. Sample Size for the Training Set

Not applicable. This device is not an AI/machine learning device that requires a training set. The study pertains to the physical and biological stability of a manufactured product over time.

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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Sydney IVF Gamete Buffer is used to physically wash and store gametes in preparation for the IVF process.

Sydney IVF Gamete Buffer is a HEPES buffered physiologic solution used to physically wash gametes in preparation for the fertilization step in the IVF process. Sydney IVF Gamete Buffer can be used for both sperm and oocytes. This solution can be used to wash oocytes of excess blood following aspiration and also as a short term storage solution until transfer to a fertilisation medium. Sydney IVF Gamete Buffer is based upon the formulation of a 20 mM HEPES buffered media containing salts, non-essential amino acids, glucose, 10 mg/mL Human Serum Albumin (HSA) and 0.01 mg/mL Gentamicin. Sydney IVF Gamete Buffer is packaged in 20, 50 or 100 mL borosilicate Type I glass vials with Fluorotec coated rubber stoppers held in place with a tamper evident seal. These products are single use, sterile (aseptic filtration) devices. It has a shelf life of 20 weeks when stored at 2 - 8 °C.

This document describes the Sydney IVF Gamete Buffer and its substantial equivalence to a predicate device. However, it does not contain the information you requested regarding the acceptance criteria and a study proving a new device's performance against those criteria in the context of an AI/human-in-the-loop system.

This document is a 510(k) summary for a medical device (a buffer solution for IVF), not for a device that involves AI, image analysis, or human reader performance. The "performance data" section refers to bench testing for the buffer solution itself (pH, osmolality, endotoxin, etc.), and functional tests like the 2-cell Mouse Embryo Assay (MEA) and Human Sperm Survival Assay (HSSA) to confirm its suitability for its intended use. It's a comparison to ensure the new buffer is as safe and effective as an existing one, not a study of algorithm performance.

Therefore, I cannot extract the requested information from the provided text.

Here's why each point you asked for cannot be answered from this document:

1. A table of acceptance criteria and the reported device performance: While the document lists performance specifications (pH, osmolality, endotoxin, MEA, HSSA) for the Sydney IVF Gamete Buffer and implies they are similar to the predicate, it doesn't present them in a formal acceptance criteria and reported performance table for a new device's diagnostic or AI performance.
2. Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to samples of the buffer solution or biological assays, not a set of clinical data for an AI system.
3. Number of experts used to establish the ground truth... and their qualifications: Not applicable. Ground truth for an AI system is established by human experts, not through chemical and biological assays of a buffer solution.
4. Adjudication method: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This type of study is for evaluating human performance with and without AI assistance, which is not relevant to a gamete buffer solution.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable in the context of AI. The "ground truth" for the buffer solution's performance is derived from standardized laboratory tests (e.g., pH meter readings, osmolality measurements, biological assay results).
8. The sample size for the training set: Not applicable. There is no AI model being trained.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document describes a medical device of a completely different nature than what your questions target.

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Sydney IVF Blastocyst Cryopreservation Kit is intended for use in assisted reproduction technologies for cryopreservation of blastocysts.
Sydney IVF Blastocyst Thawing Kit is intended for use in assisted reproduction technologies for thawing of cryopreserved blastocysts.

The Sydney IVF Blastocyst Cryopreservation and Thawing Kits are intended for cryopreservation and thawing of human blastocysts. The Sydney IVF Blastocyst Cryopreservation and Thawing Kits provide users with the ability to cryopreserve supernumerary embryos created during the in vitro fertilization procedure and then to thaw them for use at a future point in time.

The Sydney IVF Blastocyst Cryopreservation Kit consists of three solutions containing increasing concentrations of cryoprotectant (both glycerol and sucrose are used). These buffers were designed to be used sequentially in order to remove water from embryos prior to cryopreservation. The removal of water prevents ice crystal formation inside the embryo thereby limiting damage and improving viability. It contains 12 mg/mL Human Serum Albumin (HSA) and 0.01mg/mL Gentamicin. Sydney IVF Blastocyst Cryopreservation Kit is designed for use with Sydney IVF Blastocyst Thawing Kit.

The Sydney IVF Blastocyst Thawing Kit consists of four solutions with decreasing concentrations of cryoprotectants (sucrose) which are used sequentially throughout the thawing process. It contains 12 mg/mL Human Serum Albumin (HSA) and 0.01mg/mL Gentamicin. It is designed for use with Sydney IVF Blastocyst Cryopreservation Kit.

Sydney IVF Blastocyst Cryopreservation and Thawing Kits are provided in glass vials with Fluorotec® coated rubber stoppers held in place with a tamper evident seal. Sydney IVF Blastocyst Cryopreservation Kit is packaged in a carton box containing 3 x 20mL solutions per kit. The Sydney IVF Blastocyst Thawing Kit is packaged in a carton box containing 4 x 20mL solutions per kit.

The provided text describes a Special 510(k) submission for the Sydney IVF Blastocyst Cryopreservation Kit and Sydney IVF Blastocyst Thawing Kit (K152717). This submission is for reproductive media, not an AI/ML medical device. Therefore, many of the requested categories pertaining to AI/ML device studies (e.g., sample size for test set, data provenance, ground truth experts, adjudication methods, MRMC studies, standalone performance) are not applicable to this document.

However, I can extract information related to the device's performance, stability, and comparison to its predicate.

Here's the information that can be extracted:

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

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Sydney IVF Sperm Cryopreservation Buffer is intended for use as a buffer to prevent damage to sperm samples during cryopreservation and thawing.

Sydney IVF Sperm Cryopreservation Buffer consists of an aqueous solution intended for use as a buffer to prevent damage to sperm samples during cryopreservation and thawing. The IVF technician will use the buffer to cryopreserve washed spermatozoa, including MESA (microsurgical epididymal sperm aspiration) and TESA (testicular sperm extraction) samples. Sydney IVF Sperm Cryopreservation Buffer contains glycerol as a cryoprotectant, and HEPES (4-(2-hydroxyethyl)-1-piperazineethanesulfonic acid) as a buffer. This product is used to cryopreserve washed sperm and store them for future use.

Sydney IVF Sperm Cryopreservation Buffer contains Human Serum Albumin (HSA) (4 mg/mL) and Gentamicin (0.01 mg/mL). The device is available as a 20 mL fill only.

The Sydney IVF Sperm Cryopreservation Buffer is provided in glass vials with Fluorotec coated rubber stoppers held in place with a tamper evident seal. These products are single use, sterile (aseptic filtration) devices.

I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves a device meets the acceptance criteria in the context of an AI-powered medical device or diagnostic.

The document is a 510(k) clearance letter from the FDA for a product called "Sydney IVF Sperm Cryopreservation Buffer." This product is a chemical solution, not an AI-powered device or a device that uses algorithms and data analysis in the way implied by the questions (e.g., test sets, training sets, ground truth from experts, MRMC studies).

Therefore, I cannot populate the table or answer the specific questions about the study design because the document describes a chemical product's regulatory clearance based on "substantial equivalence" to a predicate device, focusing on its formulation, shelf-life, and biological performance (e.g., sperm survival, embryo assay), rather than the performance of an AI algorithm.

To answer your prompt, I would need a document describing the validation of an AI-powered medical device or a related diagnostic algorithm.

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Sydney IVF Follicle Flush Buffer is intended for use during in vitro fertilization procedures for follicle flushing and oocyte collection.

Sydney IVF Fertilization Medium is intended for use during in vitro procedures for insemination of oocytes.

Sydney IVF Cleavage Medium is intended for use during in vitro fertilization procedures for culture and transfer of cleavage stage embryos.

Sydney IVF Blastocyst Medium is intended for use during in vitro fertilization procedures for extended culture and transfer of embryos.

The Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage Medium and Sydney IVF Blastocyst Medium are used for processing eggs and embryos during in vitro fertilization procedures.

Sydney IVF Follicle Flush Buffer is used to flush the follicles during oocyte recovery. It contains Gentamicin (0.01mg/mL) and is available in 100 mL vials.

Sydney IVF Fertilization Medium maintains oocytes in a 6% CO2 environment until insemination and fertilization is complete. Sydney IVF Fertilization Medium contains Humans Serum Albumin (HSA) (5 mg/mL) and Gentamicin (0.01 mg/mL). It is available in 20, 50 or 100 mL vials.

Sydney IVF Cleavage Medium facilitates the first two days of embryonic growth post fertilization. Sydney IVF Cleavage Medium contains HSA (5 mg/mL) and Gentamicin (0.01 mg/mL). It is available in 20, 50 or 100 mL vials.

Once an embryo has reached the Day 3 (eight-cell) stage, it is then transferred into Sydney IVF Blastocyst Medium. This medium has been metabolically balanced to maximize blastocyst development rates and is suitable for blastocyst transfer. Sydney IVF Blastocyst Medium contains HSA (5 mg/mL) and Gentamicin (0.01 mg/mL). It is available in 20 or 50 mL vials.

The Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage Medium and Sydney IVF Blastocyst Medium are provided in glass vials with Fluorotec® coated rubber stoppers held in place with a tamper evident seal. These products are single use, sterile (aseptic filtration) devices.

This document describes the FDA 510(k) clearance for Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage Medium, and Sydney IVF Blastocyst Medium. It is not a study proving a device meets acceptance criteria through clinical trials or performance metrics of an AI/software device. Instead, it demonstrates substantial equivalence to a predicate device based on similar technological characteristics and performance specifications for the storage and use of IVF media.

Therefore, many of the requested elements are not applicable in this context. Here's a breakdown of what can be extracted and what cannot:

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

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Sydney IVF Hyaluronidase is intended for use to facilitate removal of the cumulus cells surrounding oocytes in assisted reproduction technology (ART) procedures.

Sydney IVF Hyaluronidase is an enzymatic preparation containing 80 IU/mL Hyaluronidase (of ovine origin) in a Bicarbonate buffered media supplemented with 5 mg/mL Human Serum Albumin (HSA) and 10 ug/mL Gentamicin.

Sydney IVF Hyaluronidase is provided sterile (aseptically filtered) and is packaged in glass vials with Fluorotec coated rubber stoppers held in place with a tamper evident seal. It is available in a 5 pack carton box with each vial containing 1 mL of Sydney IVF Hvaluronidase.

The provided text describes the Sydney IVF Hyaluronidase device and its substantial equivalence to a predicate device, focusing on its formulation, shelf-life, and performance. However, it does not contain the kind of detailed information typically found in a study demonstrating the device meets specific acceptance criteria with reported device performance against those criteria in a tabular format, nor does it provide information about the methodology of such a study (sample sizes, expert involvement, adjudication, etc.).

The document is a 510(k) summary for regulatory clearance, which primarily focuses on demonstrating substantial equivalence to a previously cleared device. It mentions "performance data" and "stability & shelf life" but doesn't present a formal study report with acceptance criteria and results in the requested format.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and the reported device performance.
• Sample sizes used for the test set and data provenance.
• Number of experts and their qualifications for ground truth.
• Adjudication method for the test set.
• MRMC comparative effectiveness study effect size.
• Standalone performance.
• Type of ground truth used (beyond "MEA data").
• Sample size for the training set.
• How ground truth for the training set was established.

However, I can extract the relevant information known about the device's performance based on the document:

The document states that the Sydney IVF Hyaluronidase (the proposed device) and the predicate device (K023353 - Sydney IVF Hyaluronidase) share similar performance specifications and that the proposed device has been validated in stability studies.

Here's what can be pieced together from your request and the provided text:

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

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Sydney IVF Sperm Medium is intended for use during in vitro fertilization procedures to process sperm.
Sydney IVF Sperm Gradient Kit is intended for use during in vitro fertilization procedures to separate motile sperm from seminal plasma.
Sydney IVF Spermient is intended for use during in vitro fertilization procedures to separate motile sperm from seminal plasma.

The Sydney IVF Sperm Medium, Sydney IVF Sperm Gradient Kit and Sydney IVF Spermient are used for processing sperm during in vitro fertilization procedures.
Sperm Medium is used to provide a "liquid" and nutritious environment for the sperm to maintain its motility for the "swim up" procedures and the following fertilization process. The medium contains 10 mg/mL Human Serum Albumin (HSA) and 0.01 mg/mL Gentamicin. It is available in 20, 50 or 100 mL vials.
Sydney IVF Sperm Gradient Kit is used to separate sperm based on density, using density gradient solutions. Sperm Gradient Kit contains both 40% density solutions and is comprised of silane coated silica particles which are diluted in a HEPES buffer. The sperm gradient has the dual purpose of enriching motile sperm populations and removing sperm inhibitory compounds normally present in the eiaculate. It contains 10 mg/mL HSA and 0.01 mg/mL Gentamicin. Sydney IVF Sperm Gradient Kit is available in 20 or 50 mL vials, packaged in a carton box, consisting of one vial filled with the 40% sperm gradient solution, and a second vial filled with the 80% sperm gradient solution.
Sydney IVF Spermient is intended to separate sperm based on density, using density gradient solutions. This is achieved by diluting the Spermient into various concentrations with a HEPES buffered solution. It contains colloidal silica coated with an inert polymer (silane) and has been formulated to be isotonic. Spermient contains 10 mg/mL HSA and 0.01 mg/mL Gentamicin. It is available in 20 or 100 mL vials.
The Sydney IVF Sperm Medium, Sydney IVF Sperm Gradient Kit and Sydney IVF Spermient are provided in glass vials with Fluorotec® coated rubber stoppers held in place with a tamper evident seal.. These products are single use, sterile (aseptic filtration) devices.

The provided document is a 510(k) summary for the Sydney IVF Sperm Medium, Sydney IVF Sperm Gradient Kit, and Sydney IVF Spermient. This document indicates that the device's main modification from its predicate was an extended shelf-life. The acceptance criteria and the study that proves the device meets them are described in the "PERFORMANCE DATA" section.

Here's the breakdown:

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

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