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The Bakri Postpartum Balloon is intended to provide temporary control or reduction of postpartum uterine bleeding when conservative management is warranted.

The Bakri Postpartum Balloon is designed to provide temporary control or reduction of postpartum uterine bleeding when conservative management is warranted. The Bakri Postpartum Balloon is an inflatable tamponade balloon designed and proven to be affective in reducing and controlling postpartum bleeding. The construction of the Bakri Postpartum Balloon is silicone rubber. Biocompatibility testing has shown the materials to meet the test requirements. Bench testing has proven the products durability during simulated use. The Bakri Postpartum Balloon is provided sterile in peel open pouches and is intended for one time use.

The provided text describes a 510(k) premarket notification for the Bakri Postpartum Balloon. The core of this submission is to demonstrate substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a clinical study.

Therefore, many of the requested sections (2-9 relating to study details) are not explicitly present in the provided documentation, as a different regulatory pathway was taken.

Here's a breakdown of the information that can be extracted and an explanation for the missing elements based on the nature of a 510(k) submission based on substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria/Performance Goal: The primary "acceptance criterion" for this 510(k) submission is substantial equivalence to a predicate device, specifically the SOS Bakri Tamponade Balloon Set (K013597).

Reported Device Performance:

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

This information is not provided as this submission relies on demonstrating substantial equivalence to a predicate device, not on a clinical trial with a "test set" for performance evaluation in the way requested. The "testing, gathered data, and the history of the predicate device" refer to the existing data for the already cleared predicate.

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 information is not provided for the same reasons as above. No specific "test set" with expert-established ground truth was part of this 510(k) for the new device.

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

This information is not provided as no specific clinical "test set" requiring adjudication for ground truth was used in this 510(k) submission.

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. This device is a manual obstetric-gynecologic instrument (balloon), not an AI-assisted diagnostic or therapeutic device. Therefore, MRMC studies and AI assistance metrics are irrelevant to this submission.

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

Not applicable. This is a physical medical device, not an algorithm or AI.

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

The "ground truth" for the current device's safety and effectiveness is primarily established through demonstration of substantial equivalence to an already legally marketed and cleared predicate device (SOS Bakri Tamponade Balloon Set K013597). This implies that the predicate device's safety and effectiveness (likely supported by historical data, clinical experience, and potentially older, pre-market clearance studies not detailed here) serves as the basis. The current submission highlights:

• "testing, gathered data, and the history of the predicate device... proves that the Bakri Postpartum Balloon is a safe and effective device."
• Biocompatibility testing results for the specific materials.
• Bench testing for durability.

8. The sample size for the training set

This information is not provided. As this is a 510(k) submission for a physical medical device based on substantial equivalence, there is no "training set" in the context of machine learning or AI.

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

This information is not provided. No "training set" in the context of machine learning or AI was used. The "ground truth" for the device's overall claims relies on its demonstrated equivalence to the predicate and the predicate's established track record.

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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.

Sydney IVF™ Blastocyst Freeze/Thaw Kits are aqueous solutions provided in glass vials with silicone rubber stoppers. The Sydney IVF™ Blastocyst Freezing Kit Buffers will be available in 20 mL fill volumes, the Sydney IVF™ Blastocyst Thaw Kit Buffers will be available in 20 mL fill volumes.

The provided text is a 510(k) Premarket Notification for the Sydney IVF™ Blastocyst Freeze/Thaw Kits. This document describes a medical device (freeze/thaw kits for blastocysts in assisted reproductive technologies), not an AI/ML powered device. Therefore, many of the requested categories in the prompt, which are specific to AI/ML device studies, are not applicable.

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

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

The document states: "The Sydney IVF™ Blastocyst Freeze/Thaw Kits were subjected to testing to assure satisfactory operating performance. The Sydney IVF™ Blastocyst Freeze/Thaw Kits passed the requirements of all tests." However, specific numerical acceptance criteria or detailed performance metrics are not provided in this 510(k) summary. It only states that the device "passed the requirements of all tests" and is "similar, with respect to intended use and technological characteristics, to the FDA published predicate device description." This implies the acceptance criteria were met, but the criteria themselves are not listed.

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

This information is not provided in the document. The type of testing performed is mentioned, but details on sample size, data provenance (country, retrospective/prospective) are absent.

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 information is not applicable as this is a medical device (reagents/media) approval, not an AI/ML diagnostic or prognostic tool requiring expert-established ground truth for a test set.

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

This information is not applicable for the same reason as point 3.

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 as this is not an AI/ML device involving human readers or comparative effectiveness studies with AI assistance.

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

This concept is not applicable as this is not an algorithm or AI system.

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

This information is not applicable in the context of an AI/ML device. For a medical device like this, "ground truth" would typically refer to established laboratory or clinical standards for performance such as viability, cryosensitivity, or absence of toxicity. These specific types of ground truth are not explicitly described beyond the general statement of "satisfactory operating performance."

8. The sample size for the training set

This information is not applicable as this is not an AI/ML device requiring a training set.

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

This information is not applicable as this is not an AI/ML device.

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Sydney IVF Embryo Biopsy Medium is intended for use in assisted reproduction technologies to facilitate the aspiration of blastomeres for pre-implantation genetic diagnosis.

Sydney IVF Embryo Biopsy Medium is an aqueous solution containing electrolytes and buffering agents, and is provided in glass vials with silicone rubber stoppers. Sydney IVF Embryo Biopsy Medium will be available in 20 mL fill volumes.

Here's a breakdown of the acceptance criteria and study information based on the provided text, recognizing that this document describes a traditional medical device (culture medium), not an AI/ML powered device. As such, many of the typical AI/ML study components (like expert consensus, ROC curves, multi-reader studies, etc.) are not applicable here.

Device Name: Sydney IVF Embryo Biopsy Medium

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly list numerical acceptance criteria or performance metrics because it's a traditional device submission focused on "substantial equivalence" to a predicate, rather than an AI/ML device with performance benchmarks.

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

This information is not provided in the document. For a traditional medical device like a culture medium, the "test set" would likely refer to batches of the product manufactured and subjected to quality control and performance testing (e.g., pH, osmolarity, sterility, and potentially cell culture performance). The document only states that the device was "subjected to testing." Data provenance (country of origin, retrospective/prospective) is not applicable or stated for this type of device.

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

This information is not applicable and not provided. For a culture medium, ground truth isn't established by human experts in the same way it would be for diagnostic imaging. Performance is typically assessed through laboratory tests and functional assays.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication typically refers to resolving disagreements among multiple human readers or experts, which is not relevant for testing a laboratory medium.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices, particularly those involving interpretation by human readers. It is not applicable to a culture medium.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This information is not applicable. The device is a physical culture medium, not an algorithm. Therefore, a standalone algorithm performance study was not done.

7. Type of Ground Truth Used

The concept of "ground truth" as it applies to AI/ML or diagnostic performance is not directly applicable here. For this type of device, the "ground truth" or standard of comparison relies on established scientific and manufacturing standards for culture media, and comparison to the predicate device's expected performance in supporting IVF procedures. This would likely involve:

• Physicochemical standards: pH, osmolarity, endotoxin levels, sterility, etc.
• Functional assays: Ability to support cell viability, growth, and development (e.g., embryo development in vitro).

8. Sample Size for the Training Set

This information is not applicable and not provided. "Training set" is a term used in machine learning. This device is a physical product, not an AI model, and therefore does not have a training set.

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

This information is not applicable and not provided. As there is no training set for a physical culture medium, the concept of establishing ground truth for it is irrelevant.

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The Tamponade Uterine Balloon Catheter Set is intended to provide temporary control or reduction of post-partum uterine bleeding when conservative management is warranted. The device is one time use and is supplied sterile. "Use of this device is intended to provide temporary control or reduction of post-partum uterine bleeding when conservative management is warranted."

The Tamponade Uterine Balloon Catheter Set is intended for use in reducing and controlling post-partum uterine bleeding. The materials of the Tamponade Uterine Balloon Catheter are all silicone. Biocompatability testing has shown the materials to meet the test requirements.

The provided text is a 510(k) Premarket Notification for the Tamponade Uterine Balloon Catheter Set. It primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than presenting a detailed study with acceptance criteria and device performance metrics in the way one would describe a diagnostic AI device or a novel therapeutic.

Therefore, much of the requested information cannot be directly extracted from this document. This submission is for a physical medical device, not an AI software.

Here's the information that can be extracted or inferred, and explanations for what cannot:

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

This information is not present in the provided 510(k) document. A 510(k) for a device like this primarily demonstrates substantial equivalence to predicate devices, focusing on materials, design, indications for use, and manufacturing processes, rather than presenting specific quantitative performance criteria and results like sensitivity, specificity, or precision. The "acceptance criteria" for a 510(k) are typically regulatory in nature (e.g., meeting biocompatibility standards, sterilization validation, etc.), not performance metrics of the device against a defined clinical outcome.

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

This information is not present. The document does not describe a clinical test set in the traditional sense. Substantial equivalence for this type of device is usually established through comparison to legally marketed predicate devices and validation of manufacturing and material properties, not a clinical trial with a defined test set of patients.

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 information is not applicable/not present. As there is no described clinical test set with ground truth establishment, this detail is not relevant to this 510(k) submission.

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

This information is not applicable/not present.

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/not present. This is a physical uterine balloon catheter, not an AI-assisted diagnostic or therapeutic device.

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

This information is not applicable/not present.

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

This information is not applicable/not present.

8. The sample size for the training set

This information is not applicable/not present. This is a physical device, not an AI algorithm requiring a training set.

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

This information is not applicable/not present.

Summary of Extracted Information:

The 510(k) document primarily describes the device, its intended use, and its substantial equivalence to predicate devices. It states:

• Device Name: Tamponade Uterine Balloon Catheter Set
• Intended Use: To provide temporary control or reduction of post-partum uterine bleeding when conservative management is warranted.
• Predicate Devices: Mentor U-Stasis balloons and the Balloon Uterine Stent manufactured by Cook OB/GYN®.
• Basis for Substantial Equivalence: Indications for use, design, materials of construction, manufacturing process controls, Quality Assurance Program, packaging, and sterilization procedures similar to currently marketed devices. The materials are all silicone, and biocompatibility testing showed they meet requirements.

The document does not contain the specific performance "acceptance criteria" and detailed study results typical for an AI software or a novel clinical intervention requiring extensive performance validation. Its purpose is to demonstrate that the new device is as safe and effective as a legally marketed predicate device.

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The Transmyometrial Embryo Transfer Sets are used for transferring IVF embryo (s) into the endometrial cavity through the myometrium. These devices are sterile and intended for one time use. The Transmyometerial Embryo Transfer Set should not be used on a patient with an active vaginal or intrauterine infection, a sexually transmitted disease, a recent uterine perforation. cervical stenosis or other cervical abnormalities which would preclude embryo transfer, a recent cesarcan section, a recent pregnancy (or is currently pregnant), or if a patient currently has an intrauterine device.

The Transmyometrial Embryo Transfer Set is used for transferring IVF embryo(s) into the endometrial cavity through the myometrial Embryo Transfer Set should not be used on a patient with an active vaginal or intrauterine infection, a sexually transmitted discase, a recent uterine perforation, cervical stenosis or other cervical abnormalities which would preclude embryo transfer, a recent cesarean section, a recent pregnanty (or is currently program), or if the patient currently has an intrauterine device. The materials used in this device are TFE and 300 Series Stainless Steel. Both materials are widely used in the medical field and biocompatibility is assured.

The provided text is a 510(k) Premarket Notification for a medical device (Transmyometrial Embryo Transfer Set). This type of submission is a regulatory process to demonstrate substantial equivalence to a legally marketed predicate device, rather than a study designed to demonstrate performance against specific acceptance criteria.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria. The submission focuses on demonstrating substantial equivalence based on indications for use, design, construction, and materials, primarily by comparing it to predicate devices from Cook Australia.

Specifically, the following information is not present in the provided text:

1. A table of acceptance criteria and the reported device performance: This document does not define specific performance metrics or acceptance criteria for the device, nor does it report any performance data against such criteria.
2. Sample size used for the test set and the data provenance: No test sets or data provenance are mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Ground truth establishment is not relevant to a substantial equivalence demonstration for a device of this nature.
4. Adjudication method for the test set: No test sets or adjudication methods are mentioned.
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 entirely an AI/algorithm-related study type and is not applicable to an embryo transfer set.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as there are no performance studies described.
8. The sample size for the training set: Not applicable, as there is no algorithm or 'training set' for this physical medical device.
9. How the ground truth for the training set was established: Not applicable for the same reason as above.

The document states: "The Transmyometrial Embryo Transfer Set is substantially equivalent to other Transmyometrial Embryo Transfer Sets in terms of indications for use, design, construction and materials equivalence. Specifically, this device is similar to the Intra-Endometrial Embryo Transfer Set manufactured by Cook Australia." This highlights a comparison of physical and functional attributes to existing devices, not a performance study against acceptance criteria.

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The Intracytoplasmic Sperm Injection (ICSI) Micro-Injection Pipettes are used for the intracytoplasmic single sperm injection of oocytes. The Holding Pipettes are used to hold the oocyte in position with the application of vacuum. The Denuding Pipettes are used to remove the cumulus cell layers. The Assisted Hatching/Zona Drilling Pipettes are used to make a hole in the zona pellucida to enable blastomere removal or embryo assisted hatching.

The Intractoplasmic Sperm Injection (ICSI) Micro-Injection Pipettes are used for the intracytoplasmic single sperm injection of oocytes, the Holding Pipettes are used to hold the oocyte in position with the application of vacuum during single sperm injection with the micro-injection pipette, the Denuding Pipettes are used to remove cumulus cell layers, and the Assisted Hatching/Zona Drilling Pipettes are used to make a hole in the zona pellucida to enable blastomere removal or embryo assisted hatching. These devices are manufactured entirely from borosilicate glass. Mouse Embryo Toxicity testing has been performed on the borosilicate glass. Results show the material meets the requirements of these tests.

The provided text describes a 510(k) Premarket Notification for various micro-injection pipettes used in assisted reproduction. However, it does not contain information about specific acceptance criteria or a study proving the device meets particular performance metrics.

Instead, the submission relies on demonstrating substantial equivalence to existing predicate devices based on indications for use, design, construction, and materials. The "study" mentioned is Mouse Embryo Toxicity testing, but this is a material compatibility test and not a performance study in the context of clinical effectiveness or accuracy.

Here's a breakdown of the requested information based on the provided text, highlighting what is not available:

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: Not applicable/Not provided. There is no mention of a "test set" in the context of a performance study for the pipettes' intended use.
• Data Provenance: Not applicable/Not provided. The Mouse Embryo Toxicity testing is implicitly laboratory-based, but no details on the origin or type of data are given for any performance evaluation.

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

• Number of Experts: Not applicable/Not provided. No performance study requiring expert ground truth is described.
• Qualifications of Experts: Not applicable/Not provided.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable/Not provided. No performance study requiring adjudication is described.

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

• MRMC Study Done: No. There is no mention of an MRMC study or any study comparing human readers (or users of the device) with or without AI assistance. The devices are tools, not AI algorithms.
• Effect Size of Human Readers with vs. without AI: Not applicable/Not provided.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

• Standalone Study Done: No. The devices are physical tools (pipettes), not algorithms. Performance is related to their physical properties and material safety, not an algorithm's standalone capability.

7. Type of Ground Truth Used

• Type of Ground Truth: For the material safety (Mouse Embryo Toxicity test), the "ground truth" would be established by the defined pass/fail criteria of the toxicity test itself, likely based on viability or developmental benchmarks of mouse embryos exposed to the material. No clinical or diagnostic "ground truth" is established for the pipettes' functional performance.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable/Not provided. The submission describes medical devices (pipettes), not an AI algorithm requiring a training set.

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

• How Ground Truth Was Established: Not applicable/Not provided. As above, these are physical devices, not an AI algorithm with a training set.

Summary of the K983596 Submission's Approach:

The K983596 submission primarily establishes substantial equivalence by demonstrating that the Intracytoplasmic Sperm Injection (ICSI) Micro-Injection Pipettes, Holding Pipettes, Denuding Pipettes, and Assisted Hatching/Zona Drilling Pipettes are similar in indications for use, design, construction, and materials to previously marketed predicate devices (Humagen Fertility Diagnostics Inc., SWEMED LAB International AB, and Cook Australia products available in Europe).

The only specific testing mentioned is Mouse Embryo Toxicity testing performed on the borosilicate glass material from which the pipettes are made. The submission states, "Results show the material meets the requirements of these tests," which serves as evidence of biocompatibility and material safety, rather than functional performance or clinical efficacy against specific acceptance criteria.

The FDA's successful clearance (K983596) indicates acceptance of this substantial equivalence argument, rather than a direct demonstration of meeting explicit performance criteria through a dedicated clinical or comparative study as might be expected for novel or higher-risk devices or AI algorithms.

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The COOK Mini-Incubator is intended to be used to store and preserve gametes and/or embryos at or near body temperature.

The COOK Mini-Incubator is a small microprocessor-controlled, carbon dioxide (CO2) incubator that provides two separate humidified incubation chambers, each accepting up to four NUNC® or FALCON® 4-well culture trays. Designed for bench top use, the COOK Mini-Incubator provides controlled temperature and CO2 gas flow.

The provided text describes the COOK Mini-Incubator, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the detailed information required to fill out a table of acceptance criteria and a comprehensive study description as requested.

The document states: "The COOK Mini-Incubator was subjected to testing to assure satisfactory operating performance. The COOK Mini-Incubator passed the requirements of all tests." This is a high-level statement without specific outcomes or methodology.

Therefore, I cannot provide the requested information from the given text.

Here's why and what's missing:

• Acceptance Criteria Table: The document doesn't list any specific performance metrics or their acceptable ranges (e.g., temperature stability, CO2 concentration accuracy, humidity levels).
• Reported Device Performance: No actual performance data (e.g., "temperature maintained at 37°C +/- 0.5°C") is provided.
• Sample Size (Test Set): The document does not mention the number of devices or experimental replicates used in the testing.
• Data Provenance: No information about the origin of the data (e.g., country, retrospective/prospective).
• Number of Experts/Qualifications (Ground Truth): This type of device (an incubator) typically doesn't involve expert readers for ground truth in the way medical imaging AI devices do. The "ground truth" would be objective measurements from calibrated instruments. The document doesn't describe who conducted the tests or their qualifications (e.g., "engineers with X years of experience in thermal dynamics").
• Adjudication Method: Not applicable for this type of device testing as described.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: This is relevant for AI-assisted image analysis where human readers interpret medical images. It is not applicable to a device like an incubator.
• Standalone Performance: While the "algorithm only" concept doesn't apply, the device's standalone performance was assessed (it underwent testing to assure satisfactory operating performance). However, the details of that performance are absent.
• Type of Ground Truth: For an incubator, ground truth would be established by calibrated sensors and instruments measuring temperature, CO2, and humidity. This is not explicitly stated, nor are the specific methods.
• Sample Size (Training Set): Not applicable for this type of device where performance is validated through physical testing, not a machine learning model.
• How Ground Truth for Training Set was Established: Not applicable.

In summary, the provided FDA 510(k) summary is a high-level regulatory document confirming substantial equivalence, but it does not contain the detailed technical study results or acceptance criteria that would typically be found in a design verification and validation report for the device.

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The Ovum Pick-Up Aspiration Needles are used for aspiration and flushing of oocytes from ovarian follicles.

The Ovum Pick-Up Aspiration Needle is used for transvaginal ultrasound or laparoscopic aspiration/flushing of oocytes from ovarian follicles.

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, or a study that evaluates the device's performance. The document is a 510(k) summary and an FDA clearance letter for an "Ovum Pick-Up Aspiration Needle." It primarily focuses on demonstrating substantial equivalence to a predicate device and outlining the device's intended use.

The text does not contain the following information:

1. A table of acceptance criteria and the reported device performance: This type of data is typically found in performance studies, which are not present in this document.
2. Sample size used for the test set and the data provenance: No performance testing data is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no performance study is described.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not applicable.
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.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document states: "Cook OB/GYN understands due to the recent reclassification there are no predicate devices. We have used Cook Australia products as our predicate to illustrate safety and effectiveness." and "The Ovum Pick-Up Aspiration Needle is substantially equivalent to predicate Ovum Pick-Up Aspiration Needles in terms of indications for use, design, construction and materials equivalence." This indicates that the clearance was based on substantial equivalence (comparing to existing similar devices) rather than new performance studies with specific acceptance criteria.

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