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The CooperSurgical Milex pessaries are intended to provide support to pelvic organs when inserted in the vagina.

The following Indications for Use are associated with each of the following pessary styles:

Milex® Shaatz Folding Pessaries:
Shaatz pessary is indicated for temporary, nonsurgical management of pelvic organ prolapse in Stage I and Stage II prolapse, complicated by a mild cystocele.

Milex® Gellhorn Pessaries:
Gellhorn pessary is indicated for temporary, nonsurgical management of pelvic organ prolapse in Stage III prolapse or procidentia.

Milex® Ring Folding Pessaries:
Milex Ring Pessary is indicated for use as removable structures placed in the vagina to treat uterine prolapse, including cystocele and rectocele, as well as stress urinary incontinence in women.

Milex® Pessaries are intended for adult women as Obstetrical and Gynecological medical devices. Milex® Pessaries are distributed in a non-sterile condition made from silicone. The Milex Pessaries are available in a variety of styles, each having a range of sizes that is inserted into the vagina to function as a supportive structure of the uterus, bladder and rectum. All pessaries are produced in a like fashion, utilizing injection molding of liquid silicone rubber. The Milex Pessaries are manufactured in pink for single patient use.

This submission includes the following designs of Milex Pessaries: Shaatz Pessary, Gellhorn Pessary (Short and Long Stem), and Ring Folding Pessaries (Ring without support, Ring with support, Ring with knob without support, Ring with knob with support).

Based on the provided FDA 510(k) Clearance Letter and 510(k) Summary for CooperSurgical Milex® Pessaries, it's clear that this submission is for a medical device (vaginal pessaries) and NOT an AI/software device.

Therefore, many of the questions related to acceptance criteria, MRMC studies, standalone algorithm performance, ground truth establishment, and training/test sets for AI models do not apply to this specific clearance.

The "acceptance criteria" for this physical device are primarily based on demonstrating substantial equivalence to a predicate device through:

• Identical/Similar Indications for Use: Showing that the new device is intended for the same medical purposes as the predicate.
• Similar Technological Characteristics: Demonstrating that the materials, design, and fundamental principle of operation are comparable or that any differences do not raise new questions of safety or effectiveness.
• Performance Data (Bench Testing/Biocompatibility): Providing evidence that the device performs as intended and is safe for its intended use, typically through non-clinical testing.

Here's how to address the questions given the nature of the device:

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

For a physical device like a pessary, "acceptance criteria" are typically defined by demonstrating substantial equivalence to a predicate device and meeting established performance and safety standards through non-clinical testing. The "reported device performance" refers to the results of these tests and the comparison to the predicate.

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

• Sample Size: The document does not specify a "sample size" for a clinical test set in the way one would for an AI model or a clinical trial. The performance data is based on biocompatibility testing of the device material, which involves laboratory tests with specific biological samples (e.g., cell cultures, animal models for implantation/toxicity studies) rather than patient data.
• Data Provenance: Not applicable in the context of clinical patient data for this type of device. The data provenance would refer to the testing laboratories and their adherence to ISO standards for biocompatibility. The summary states "testing performed by CooperSurgical" and references international ISO standards.

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. This device is a physical medical device, not an AI or imaging diagnostic tool that relies on expert interpretation for ground truth.

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

• Not applicable. As above, this is for a physical device, not an AI model requiring human adjudication of results.

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 is for a physical device, not an AI-assisted diagnostic tool.

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

• Not applicable. This is not an algorithm or software.

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

• Ground truth for this device is established through adherence to international consensus standards for medical device biocompatibility (ISO 10993 series) and engineering performance standards for physical characteristics like dimensions, durability, and material properties. It's not based on clinical "outcomes data" or "expert consensus" in the diagnostic sense, but rather on meeting pre-defined safety and performance benchmarks.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device that requires a training set.

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

• Not applicable. This is not an AI/ML device.

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The ALLY II UPS™ (Uterine Positioning System) is intended to assist the surgical staff in mounting, positioning and holding uterine manipulators during gynecological laparoscopic surgical procedures. It is intended for use by trained operating room personnel in an operating room environment.

The ALLY II UPS™ (Uterine Positioning System) attaches to the operating room table and enables the bed-side assistant to readily mount, hold, and position the manipulator during laparoscopic surgical procedures. The ALLY II UPS enables access and provides the ability to maneuver and maintain the manipulator in a desired position. The ALLY II UPS consists of the ALLY II UPS and a manipulator adapter with built-in sterile drape, known as the adapter drape.

The CooperSurgical ALLY II UPS is a non-patient contacting, electromechanical device that consists of a single, multi-segmented, articulated arm. The ALLY II UPS can be attached to the standard operating room bed rail, and a separate, sterile, disposable Adapter Drape that is used to attach a uterine manipulator to the ALLY II UPS. When unlocked, the flexible arm allows the attached manipulator to be positioned by the user. The arm can then be locked in the desired position by releasing a foot pedal, activating a linear actuator that applies tension to an internal cable, drawing the segments together and thus locking the arm. The segmented design of the arm allows lateral/medial movement from a single point to position the uterine manipulator.

The purpose of this submission is to gain clearance for minor modifications made to the ALL Y Uterine Positioning System to meet user needs and allow for user convenience. The overall functionality and interface of the ALLY II UPS for the user remains the same.

The provided document is a 510(k) Premarket Notification from the FDA for a medical device called the ALLY II UPS™ (Uterine Positioning System). This type of document is for medical devices, not AI/ML algorithms. Therefore, the questions related to AI/ML specific aspects like training data, ground truth establishment, MRMC studies, and standalone algorithm performance are not applicable to this submission.

The acceptance criteria and performance data described in this document relate to the physical and mechanical performance of the revamped medical device compared to its predicate.

Here's an analysis based on the provided text, focusing on the device's acceptance criteria and proven performance:

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

The document doesn't provide a direct table of acceptance criteria with corresponding performance values for the ALLY II UPS™. Instead, it broadly states that "The ALLY II UPS met the pre-determined acceptance criteria for each intended output." It lists the types of tests performed.

Implied Acceptance Criteria and Performance (based on Section VII. Performance Data):

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

• Sample Size: The document does not specify the sample size for any of the tests (Durability, Holding force, Range of motion, Link Soak, Foot Pedal Cable Retention).
• Data Provenance: The data provenance is internal testing performed by CooperSurgical, Inc. It is a prospective test in the sense that newly designed units of the ALLY II UPS™ were manufactured and then tested to demonstrate their performance. The country of origin for the testing is not explicitly stated but is implied to be within the company's operational context (likely US, given the FDA submission).

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 as this is a mechanical device, not an AI/ML system that requires expert interpretation for ground truth. The "ground truth" for this device would be defined by engineering specifications and objective measurements (e.g., force in Newtons, angles in degrees, material integrity).

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

Not applicable for this type of device. Adjudication methods are typically used in clinical studies or for establishing ground truth from human interpretations (e.g., radiology reads). The performance of this device is assessed through engineering and mechanical testing against predefined specifications.

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 mechanical uterine positioning system, not an AI-assisted diagnostic or therapeutic tool with human readers.

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

Not applicable. This is a purely mechanical device; there is no AI algorithm to test for "standalone" performance.

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

The "ground truth" in this context is defined by engineering specifications, mechanical measurements, and compliance with recognized standards. For example:

• Holding Force: Measured in units of force (e.g., Newtons or pounds) against a specified minimum.
• Range of Motion: Measured in degrees or specific positions achievable, defined by design.
• Durability: Performance over a specified number of cycles or operating hours.
• Material Integrity: Assessed through material science tests and visual inspection post-soak/cycle.
• Electrical Safety/EMC: Compliance verified against the specified IEC standards (60601-1 and 60601-1-2).

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model that requires a training set.

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

Not applicable. As stated above, this is not an AI/ML device.

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The CooperSurgical Advincula Delineator™ Uterine Manipulator is indicated to provide delineation of the vaginal fornices and maintain pneumoperitoneum as a uterine manipulator during Total Laparoscopic Hysterectomy, Laparoscopic Assisted Vaginal Hysterectomy and/or Laparoscopic Supra-Cervical Hysterectomy.

The Advincula Delineator Uterine Manipulator is intended for use during total laparoscopic hysterectomy (TLH), laparoscopic assisted vaginal hysterectomy (LAVH), and/or laparoscopic supracervical hysterectomy (LSH) procedures. It is single-use, disposable, and provided sterile. The device has a distal balloon built into the arched shaft, and a sliding colpotomy cup, called a Koh-Cup, that locks into place with a position lock. The handle at the proximal end allows the user to hold the device and to manipulate the uterus. When properly positioned, the outer rim of the Koh-Cup delineates the vaginal fornices and provides an anatomical landmark to facilitate uterine resection. An occluder balloon is used to maintain pneumoperitoneum during the procedure.

The Advincula Delineator Uterine Manipulator is available with Koh-Cups sized 2.5cm or 4.0cm in diameter. The Koh-Cup is made of Hytrel and the manipulator is made of stainless steel, silicone, various plastics, adhesives and inks. The subject device is intended to be used in hospitals.

This document describes the premarket notification (510(k)) for the Advincula Delineator™ Uterine Manipulator, which is a medical device and not an AI/ML powered device. As such, it does not involve the type of acceptance criteria and study designs typically associated with AI/ML device performance (e.g., sensitivity, specificity, MRMC studies, ground truth established by experts).

The acceptance criteria presented here are for the substantial equivalence of a modified medical device to a predicate device, focusing on material changes and packaging, rather than an AI algorithm's diagnostic or predictive performance.

Therefore, the requested information, specifically regarding AI/ML device performance, acceptance criteria, test set details, expert involvement, and ground truth methodologies, cannot be extracted from this document as it is not relevant to the described device and its review process.

Instead, the document focuses on:

• Acceptance Criteria (for device modification equivalence): The "acceptance criteria" here refer to demonstrating that changes made to the device (specifically, the Koh-Cup material and packaging) do not raise new questions of safety or effectiveness compared to the predicate device.

  • The criteria are met by passing a series of non-clinical performance tests.

• Study Proving Acceptance Criteria Met: The study undertaken was a series of non-clinical performance tests on the modified device.

Here's a breakdown of the relevant information provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the AI/ML specific questions (2-9), this document does not contain that information as the device is not an AI/ML product.

• 2. Sample size used for the test set and the data provenance: Not applicable. Testing was performed on physical device samples, not data sets.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML model is not relevant here. Device performance was assessed against engineering and biocompatibility standards.
• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
• 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 is not an AI-assisted device.
• 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. "Ground truth" here refers to the pre-established engineering and biocompatibility specifications and standards the physical device needed to meet.
• 8. The sample size for the training set: Not applicable. There is no training data set for this physical medical device.
• 9. How the ground truth for the training set was established: Not applicable.

In summary, the document details the testing performed to demonstrate that a physical medical device with material and packaging changes is substantially equivalent to a previously cleared predicate device, rather than the performance of an AI/ML algorithm.

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The Endosee System is used to permit viewing of the adult cervical canal and uterine cavity for the purpose of performing diagnostic and therapeutic procedures The types of procedures where the Endosee System could offer visualization include:

• Abnormal bleeding
• Infertility and pregnancy wastage
• · Evaluation of abnormal hysterosalpingogram
• · Intrauterine foreign body
• · Amenorrhea
• · Pelvic pain
• · Directed biopsy
• Removal of fibroids and polyps
• · Transection of intrauterine adhesions
• · Transection of intrauterine septa

The Endosee System can also be used to permit viewing of the adult urinary bladder through a minimally invasive approach by utilizing natural orifices for the purpose of performing diagnostic and therapeutic procedures.

The Endosee System is a handheld, battery-operated, portable endoscope that consists of a reusable Display Module with an LCD touchscreen monitor and a sterile, single-use cannula. It is intended for use in viewing the adult cervical canal, uterine cavity, or female urinary tract, including the bladder, during diagnostic or therapeutic hysteroscopy or cystoscopy procedures in an operating room, outpatient, or office setting. The Cannula has a light source and camera at the distal end, which are used for visualization and to capture image and video of the diagnostic area. The image and video signals are electronically transferred from the Cannula to the Display module via an electrical connector and cable, and the LCD monitor is used for viewing. The Endosee is provided with a Docking Station that recharges the battery in the Display Module and allows the user to download images/video from the internal device memory to an external computer.

The Endosee System is a handheld, battery-operated, portable endoscope used for viewing the adult cervical canal, uterine cavity, or female urinary tract during diagnostic or therapeutic procedures. The device under review (K200038) is a modification of a previously cleared device (K190639), with the primary changes being to indirect patient-contacting materials and additional shielding on the cannula board.

Here's the information regarding the acceptance criteria and the study that proves the device meets them:

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 numerical sample size for each specific non-clinical test conducted. However, it indicates tests were performed on "samples accelerated aged to 6-months per ASTM F1980-16." This implies that a sufficient number of devices were tested to draw statistically sound conclusions, in accordance with the specified standard.

The data provenance for the tests is entirely non-clinical bench testing. There is no mention of human patient data (retrospective or prospective) being used to evaluate the device's performance in this submission, as the submission focuses on demonstrating substantial equivalence through engineering and laboratory testing related to the physical changes.

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

Not applicable. This submission is for a medical device that does not involve algorithmic diagnostic or prognostic capabilities requiring expert interpretation for ground truth establishment. The ground truth for the non-clinical tests is based on established engineering and materials standards (e.g., ISO, ASTM, IEC).

4. Adjudication Method for the Test Set:

Not applicable. No expert adjudication method (e.g., 2+1, 3+1) was used as the evaluation was based on objective, quantifiable non-clinical test results against established engineering standards.

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 physical medical instrument, not an AI or imaging diagnostic tool that would typically involve human readers interpreting cases.

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

Not applicable. The Endosee System is a physical endoscope, not an algorithm. Therefore, "standalone" performance in the context of AI algorithms is not relevant to this submission.

7. The Type of Ground Truth Used:

The ground truth used for proving the device meets the acceptance criteria is established engineering and materials standards, along with internal company specifications for performance. These include:

• ISO 11135:2014 (Sterilization)
• ISO 11737-1:2018 (Bioburden)
• ISO 10993 (Biocompatibility series: -5, -10, -7)
• ASTM F1980-16 (Accelerated Aging)
• ISTA 3A:2008 (Ship Testing)
• ASTM 2096-11 (Bubble Leak)
• ANSI/AAMI ES 60601-1:2005/(R)2012 (Electrical Safety)
• IEC 60601-2-18:2009 (Electrical Safety for Endoscopes)
• IEC 60601-1-2:2014 (EMC)
• IEC 60601-1-15 (Drop Test)
• IEC 60529:2004 (IPX2 Ingress Test)
• IEC 62304:2006 (Software Verification)

8. The Sample Size for the Training Set:

Not applicable. This is a medical device, not an AI or machine learning model. There is no concept of a "training set" for the type of evaluation presented in this submission.

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

Not applicable. As there is no training set, there is no ground truth established for it in the context of this device.

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The Wallace Dual Lumen Oocyte Recovery System is a sterile, single-use device for ultrasonic-guided transvaginal collection of oocytes from the ovarian follicles.

The Wallace Dual Lumen Oocyte Recovery System consists of a 33 cm dual lumen stainless steel needle with a plastic needle hub, and aspiration, flushing, and vacuum tubing. The needle hub acts as a handle and is designed for the user to hold between the thumb and index finger. It 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 the secondary lumen that is attached to the flushing tubing. The needle aspiration tubing connects to a silicone bung that allows connection to a sample tube. The silicone bung is also connected to the vacuum tubing that allows connection to a vacuum source. The Wallace Dual Lumen Oocyte Recovery System is available in 16 or 17-gauge color-coded sizes (16G-Blue and 17G-Red). The needles are available in three aspiration tubing lengths: 500, 750, and 950 mm. The system includes flushing tubing of 700 mm length and vacuum tubing of 500 mm length. The device is provided sterile and is for single-use only.

The provided text is a 510(k) summary for a medical device (Wallace Dual Lumen Oocyte Recovery System) and does not contain information about studies related to AI or algorithm performance. The content focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing of physical attributes, such as needle size, biocompatibility, stability, shelf life, and mechanical performance.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies that prove a device meets criteria in the context of AI/algorithm performance, as these details are not present in the given document.

The document indicates that the device is a sterile, single-use system for ultrasonic-guided transvaginal collection of oocytes and does not mention any AI or software components.

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The Endosee System is used to permit viewing of the adult cervical canal and uterine cavity for the purpose of performing diagnostic and therapeutic procedures. The types of procedures where the Endosee System could offer visualization include:

• · Abnormal bleeding
• · Infertility and pregnancy wastage
• · Evaluation of abnormal hysterosalpingogram
• · Intrauterine foreign body
• · Amenorrhea
• · Pelvic pain
• · Directed biopsy
• · Removal of fibroids and polyps
• · Transection of intrauterine adhesions
• · Transection of intrauterine septa

The Endosee System can also be used to permit viewing of the adult urinary bladder through a minimally invasive approach by utilizing natural orifices for the purpose of performing diagnostic and therapeutic procedures.

The Endosee System is a handheld, battery-operated, portable endoscope that consists of a reusable Display Module with an LCD touchscreen monitor and a sterile, single-use cannula. It is intended for use in viewing the adult cervical canal, uterine cavity, or female urinary tract, including the bladder, to perform diagnostic and therapeutic hysteroscopy or cystoscopy procedures in an operating room, outpatient, or office setting. The Cannula has a light source and camera at the distal end, which are used for visualization and to capture image and video of the diagnostic area. The image and video signals are electronically transferred from the Cannula to the Display module via an electrical connector and cable, and the LCD monitor is used for viewing. The Endosee is provided with a Docking Station that recharges the battery in the Display Module and allows the user to download images/video from the internal device memory to an external computer.

The Endosee® System is a handheld, battery-operated endoscope used for viewing the adult cervical canal, uterine cavity, or female urinary tract for diagnostic and therapeutic procedures.

Here's an analysis of the provided information regarding its acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state formal "acceptance criteria" with specific thresholds or metrics for the device's performance in a table format. However, it does describe the areas of non-clinical performance testing conducted to demonstrate substantial equivalence to its predicate device (K183020). The conclusion states that the results of the testing demonstrate that the subject Endosee System is substantially equivalent to the predicate. This implies that the device met the performance expectations in these tested areas to be considered substantially equivalent.

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

The document does not specify the sample size for the test set in the non-clinical performance testing. It also doesn't mention data provenance such as country of origin or whether the data was retrospective or prospective, as the testing described is non-clinical performance (bench testing) rather than clinical studies on patients.

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

This information is not applicable. The non-clinical performance testing described involved validating the device's design, functional aspects, and safety standards, not comparisons against expert interpretation of medical images or patient outcomes. Therefore, no medical experts were involved in establishing ground truth for this type of testing.

4. Adjudication Method for the Test Set:

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of data by multiple readers, which is not the type of testing described here.

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

No MRMC comparative effectiveness study was done. The submission focuses on non-clinical performance testing to demonstrate substantial equivalence to a predicate device, not on comparing reader performance with and without AI assistance.

6. Standalone (Algorithm Only) Performance Study:

No standalone (algorithm only) performance study was done. This device is a physical endoscope system, not an AI-powered diagnostic algorithm.

7. Type of Ground Truth Used:

For the non-clinical performance testing, the "ground truth" would be the engineering specifications, functional requirements, and safety standards (e.g., IEC 60601-2-18) against which the device's performance was measured. It is not expert consensus, pathology, or outcomes data.

8. Sample Size for the Training Set:

This information is not applicable. There is no mention of a "training set" as this device is not an AI/ML algorithm that requires training data.

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

This information is not applicable, as there is no training set for this device.

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The Endosee System is used to permit viewing of the adult cervical canal and uterine cavity for the purpose of performing diagnostic procedures. Generally recognized indications for diagnostic hysteroscopy include:

• Abnormal bleeding
• Infertility and pregnancy wastage
• Evaluation of abnormal hysterosalpingogram
• Intrauterine foreign body
• Amenorrhea
• Pelvic pain

The Endosee System can also be used to permit viewing of the adult urinary bladder through a minimally invasive approach by utilizing natural orifices for the purpose of performing diagnostic procedures.

The Endosee System is a handheld, battery-operated, portable endoscope that consists of a reusable display module with an LCD touchscreen monitor and a sterile, single-use cannula. It is intended for use in viewing the adult cervical canal, uterine cavity, or female urinary tract, including the bladder, to perform diagnostic hysteroscopy or cystoscopy procedures in an operating room, outpatient, or office setting. The cannula has a light source and camera at the distal end, which are used for visualization and to capture image and video of the diagnostic area. The image and video signals are electronically transferred from the cannula to the display module via an electrical connector and cable, and the LCD monitor is used for viewing. The Endosee is provided with a docking station that recharges the battery in the display module and allows the user to download images/video from the internal device memory to an external computer.

The provided text describes the Endosee® System, a medical device used for diagnostic hysteroscopy and cystoscopy. The document, an FDA 510(k) summary, focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria for performance, a standalone study, or an MRMC study related to AI.

Therefore, many of the requested details about acceptance criteria, study design, and ground truth are not present in the provided text. The document primarily reports on non-clinical performance testing conducted to ensure safety and equivalence.

Here's a breakdown of the information that can be extracted and what cannot:

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

The document doesn't provide a table of acceptance criteria with corresponding performance metrics for diagnostic accuracy or clinical effectiveness. Instead, it lists various non-clinical engineering and safety tests performed. While these tests have internal acceptance criteria, they are not typically clinical performance metrics. The closest general "performance" reported are the specifications that match the predicate device, such as Field of View and Direction of View, which are design specifications rather than clinical performance outcomes.

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

The document does not describe a clinical test set or data provenance in terms of patient data. The "test set" refers to physical samples of the device components (cannulas, display modules) subjected to various engineering and safety tests. For example, for shelf-life testing, samples were "Aged to 6-months" but the number of samples is not specified. There is no information about country of origin for any clinical data as none was presented.

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 to the provided document. The "ground truth" in this context would typically refer to diagnostic accuracy established by expert clinicians (e.g., confirming the presence or absence of abnormalities in patient images). The provided document focuses on engineering and safety testing, not clinical diagnostic performance, and thus does not involve human experts establishing a clinical ground truth for a diagnostic test set.

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

This information is not applicable. Adjudication methods are used in clinical studies to resolve discrepancies among expert interpretations. The tests described are engineering and safety tests, which do not involve expert adjudication in this manner.

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

There is no mention of an MRMC comparative effectiveness study, nor is there any indication that the Endosee System incorporates AI or is intended for AI-assisted interpretation. The device is a direct visualization tool.

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

Not applicable. The Endosee System is a hardware device for direct visualization; it does not feature an algorithm that would operate in a "standalone" mode for diagnostic interpretation.

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

Not applicable. As noted above, since no clinical performance study focused on diagnostic accuracy is described, there's no mention of how clinical ground truth would be established. The "ground truth" for the engineering tests would be adherence to the specified technical standards and design requirements.

8. The sample size for the training set

Not applicable. The document does not describe any machine learning or algorithm development that would involve a "training set."

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

Not applicable, as there is no training set described.

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The CooperSurgical Advincula Delineator Uterine Manipulator is indicated to provide delineation of the vaginal fornices and maintain pneumoperitoneum as a uterine manipulator during Total Laparoscopic Hysterectomy (TLH), Laparoscopic Assisted Vaginal Hysterectomy (LAVH) and/or Laparoscopic Supracervical Hysterectomy (LSH).

The Advincula Delineator is a uterine manipulator that is intended for use during total laparoscopic hysterectomy (TLH), laparoscopic assisted vaginal hysterectomy (LAVH), and/or laparoscopic supracervical hysterectomy (LSH) procedures. It is single-use, disposable, and provided sterile. The device has a distal balloon built into the arched shaft, and a sliding colpotomy cup, called a Koh-Cup, that locks into place with a position lock. The handle at the proximal end allows the user to hold the device and to manipulate the uterus. When properly positioned, the outer rim of the Koh-Cup delineates the vaginal fornices and provides an anatomical landmark to facilitate uterine resection. An occluder balloon is used to maintain pneumoperitoneum during the procedure.

The Advincula Delineator is available with Koh-Cups sized 2.5cm, 3.5cm or 4.0cm in diameter. There are flexible plastic and Ultem plastic Koh-Cups available for use in electrocautery procedures, and a version with a stainless-steel outer rim for use in harmonic scalpel or laser procedures.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text.

Device: Advincula Delineator™ Uterine Manipulator (K180429)

Type of Device: Uterine Manipulator, Class II

This device is not an AI/ML powered device, so all the acceptance criteria and study information is related to mechanical and material performance, not algorithmic performance. Therefore, sections pertaining to expert review, MRMC studies, standalone performance, and training/test set details for AI/ML will be marked as "Not Applicable (N/A)".

1. Table of Acceptance Criteria and Reported Device Performance

This device is a physical medical device, not a software or AI/ML product. The acceptance criteria focus on mechanical performance and biocompatibility.

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

The document does not explicitly state the numerical sample size for each test (e.g., number of devices tested in the pull-off or compression tests). However, it implies testing was performed on a sufficient number of devices to demonstrate the device meets acceptance criteria.

• Data Provenance: The tests are explicitly non-clinical performance and design validation tests on the physical device itself. The "cadaveric model" implies testing was performed using human cadavers.
  • Country of Origin of the Data: Not specified, but likely performed by or for CooperSurgical, Inc. in the US.
  • Retrospective or Prospective: These are prospective tests performed specifically for regulatory submission.

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

N/A. This is a physical device, not an AI/ML system requiring expert interpretation or ground truth establishment in a diagnostic context. The "ground truth" here is the physical performance of the device against engineering specifications.

4. Adjudication Method for the Test Set

N/A. Adjudication methods like 2+1 or 3+1 are relevant for subjective interpretations (e.g., in medical image reading). For objective engineering tests (pull-off, compression, biocompatibility), the results are typically quantitative and directly measured against a specification.

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

No. An MRMC study is not applicable to a uterine manipulator. These studies are typically performed to assess the impact of AI on human reader performance for diagnostic tasks.

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

No. This a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on engineering specifications, material science principles, and established biocompatibility standards (e.g., ISO 10993). For the design validation, the "ground truth" was the device "performs as intended and meets user needs" in a cadaveric model, which would be an outcome-based assessment in a simulated use environment.

8. The Sample Size for the Training Set

N/A. This term is applicable to AI/ML models. For a physical device, the concept of a "training set" is not relevant in the same way. The design and manufacturing processes are iterative, but there's no defined "training set" as in machine learning.

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

N/A. As above, this concept doesn't apply to this kind of device.

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SAGE Vitrification Kit is intended for use in the vitrification of oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.

SAGE Vitrification Warming Kit is intended for use in the thawing of virtified oocytes (MI), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.

SAGE Vitrification Kit (ART-8025 and ART-8026): This kit includes two solutions (Equilibration Solution and Vitrification Solutions in the kit consist of a MOPS-buffered media containing non-essential and essential amino acids. gentamicin sulfate, and human serum albumin. These solutions also contain the cryoprotectants ethylene glycol, dimethyl sulfoxide (DMSO) and sucrose as described below:

Equilibration Solution (ES): 7.5% (v/v) each of DMSO and ethylene glycol. Vitrification Solution (VS): 15% (v/v) each of DMSO and ethylene glycol, and 0.6 M sucrose

SAGE Vitrification Warming Kit (ART-8030 and ART 8031): This kit includes three solutions (1.0M Sucrose Warming Solution [1.0 M WS], 0.5M Sucrose Warming Solution [0.5 M WS], and MOPS Solution [MS]). All solutions in the kit consist of a MOPS-buffered media containing non-essential and essential amino acids, gentamicin sulfate, and human serum albumin. These solutions contain the cryoprotectant sucrose at the level described in their names (i.e., 1.0M, 0.5M, or no sucrose).

Solutions in the SAGE Vitrification Kit and SAGE Vitrification Warming Kit are aseptically-filtered and are provided to users in either 5 ml Type 1 borosilicate glass vials with a rubber closure and an aluminum seal (ART-8025 and ART-8030) or 2 ml polypropylene vials with cap (ART-8026 and ART-8031). The solutions in ART-8025 and ART-8030 are single-use only devices, whereas solution in ART-8026 and ART-8031 are to be used within 7 days after opening.

The provided text is a 510(k) summary for the SAGE Vitrification Kit and SAGE Vitrification Warming Kit. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study design with acceptance criteria for a new, AI/ML-driven medical device. Therefore, a direct response to your request, which implies an AI/ML device study, is not fully supported by the provided document.

However, I can extract the closest analogous information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" from this document as understood within the context of reproductive media and supplements, not AI/ML devices.

Here's a breakdown based on the provided document, interpreting "acceptance criteria" as product specifications and "study" as performance testing and literature review to support substantial equivalence:

1. Table of Acceptance Criteria (Product Specifications) and Reported Device Performance

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

The document does not describe a traditional "test set" in the sense of a dedicated, pre-defined dataset for a single study, as would be done for an AI/ML device. Instead, it relies on a summary of non-clinical performance testing (in-house lab tests) and clinical performance data from published journal articles.

• Non-Clinical Test Samples: Not explicitly quantified in terms of sample size (e.g., number of batches, number of media samples tested for pH, osmolality, endotoxin). The Mouse Embryo Assay (MEA) states "1-cell MEA" but doesn't specify the number of mouse embryos or replicate tests.
• Clinical Performance Data: This is derived from 9 cited journal articles. The sample sizes vary per study and are reported within the summaries:
  • Literature 1: 11 subjects, surplus MII oocytes (quantity not specified).
  • Literature 2: 6 subjects, surplus MII oocytes (quantity not specified).
  • Literature 3: General results/meta-analysis context, not a specific sample size.
  • Literature 4: 2353 MII oocytes.
  • Literature 5: 54 study subjects, 413 MII oocytes.
  • Literature 6: 37 subjects, 74 embryos.
  • Literature 7: 849 pronuclear-stage (PN) zygotes vitrified, 339 PN zygotes thawed over 103 cycles.
  • Literature 8: 24 warming cycles (after OHSS risk).
  • Literature 9: Control group of 102 warming cycles.
• Data Provenance: Not explicitly stated for all studies, but generally refers to clinical studies likely conducted in fertility clinics. The original journal articles (listed in Section XI) would contain this information. Given the context of the device and product development, it is likely these studies were retrospective or prospective clinical trials focusing on IVF outcomes. There is no mention of country of origin for the clinical data within this extract.

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

This concept is not directly applicable to this type of device (reproductive media). The "ground truth" for non-clinical tests is established by laboratory measurements against predefined product specifications. For the clinical performance, the "ground truth" relates to actual biological outcomes (survival, fertilization, pregnancy, live birth), which are typically reported by clinicians and embryologists involved in the treatment, not "experts establishing ground truth for a test set" in the AI/ML sense. No specific number of experts or their qualifications for establishing ground truth are mentioned.

4. Adjudication Method for the Test Set

Not applicable. There is no "adjudication method" described as one would expect for an AI/ML device's test set. Clinical outcomes are reported as observed, not adjudicated by an independent panel.

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

Not applicable. This device is a media kit, not an interpretation tool for image data. Therefore, no MRMC study was performed or described.

6. If a Standalone (Algorithm Only Without Human-in-the Loop Performance) was Done

Not applicable. This is not an AI/ML algorithm. The performance is of the media used by humans in a clinical setting.

7. The Type of Ground Truth Used

• Non-Clinical Performance:
  • Physical/Chemical Properties: Measured values (pH, Osmolality, Endotoxin) compared to defined ranges.
  • Biological Functionality: Mouse Embryo Assay (MEA) results (percentage blastocysts at 96h).
  • Sterility: Absence of microbial growth.
• Clinical Performance:
  • Clinical Outcomes Data: Survival rates, fertilization rates, clinical pregnancy rates, live birth rates following the use of the media in human oocyte/embryo vitrification and warming procedures. This is observational outcomes data from fertility treatments.

8. The Sample Size for the Training Set

Not applicable directly. This is not an AI/ML device that requires a "training set." The development of the media would involve research and formulation, but not in the sense of an AI model's training data.

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

Not applicable, as there is no "training set" for an AI/ML model for this device. The development of the media relies on cryobiology principles and empirical testing to achieve the desired cryoprotective properties and support oocyte/embryo viability.

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The Endosee Hysteroscope and Disposable Diagnostic (Dx) Cannula are used to permit viewing of the adult cervical canal and uterine cavity for the purpose of performing diagnostic procedures.

Generally recognized indications for diagnostic hysteroscopy include:

• Abnormal bleeding
• Infertility and pregnancy wastage
• Evaluation of abnormal hysterosalpingogram
• Intrauterine foreign body
• Amenorrhea
• Pelvic Pain

The Endosee Hysteroscope and Disposable (Dx) Cannula can also be used to permit viewing of the adult urinary bladder through a minimally invasive approach by utilizing natural orifices for the purpose of performing diagnostic procedures.

The Endosee system is a handheld, battery-operated endoscope that consists of two components: a reusable Handheld Monitor and a sterile, single use cannula. The Endosee is intended for use in viewing the cervical canal and uterine cavity for the purpose of performing diagnostic hysteroscopy procedures in an outpatient or in an office setting. The Endosee can also be used to permit viewing of the urinary bladder, via the urethra, for the purpose of performing diagnostic cystoscopy procedures in an outpatient or office setting.

The Disposable Diagnostic (Dx) Cannula is inserted through the cervix to view the cervical canal and uterine cavity. The Dx Cannula can also be inserted through the urethra to view the bladder. This enables the evaluation and diagnosis of the uterine cavity or the urinary bladder for pathology. The cannula includes a camera and LED light source at the distal end to illuminate the desired location for better user visualization, as well as to capture image and video of the diagnostic site. The video signal is electronically transferred to the Handheld Monitor of the Endosee Hysteroscope by an electrical connector, and an LCD touchscreen monitor on the reusable Handheld Monitor is used for viewing.

The provided text describes non-clinical performance testing for the Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula to support expanding its indications for use to include cystoscopy applications.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set Sample Size: Not explicitly stated, but the study utilized "cadaveric specimens."
• Data Provenance: Retrospective (cadaveric specimens) from an unspecified country (likely the US, given the FDA submission).

3. Number of Experts and Qualifications

• Number of Experts: Not explicitly stated. The text mentions "all participants" in the simulated operating room environment, but their specific qualifications are not detailed beyond being able to "affirm that the cannula enabled visualization." It can be inferred they are likely medical professionals, potentially urologists, given the context of cystoscopy applications and a simulated operating room.

4. Adjudication Method

• Adjudication Method: Not explicitly stated. The acceptance criteria indicate that "all participants must affirm" the visualization. This suggests a form of consensus or agreement among the participants, but the specific method (e.g., voting, discussion) is not described.

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

• MRMC Study: No, a multi-reader multi-case comparative effectiveness study was not explicitly conducted as described in the provided text. The study focused on the standalone performance of the device's visualization capabilities.

6. Standalone Performance Study

• Standalone Study: Yes, a standalone performance study was conducted. The purpose was to "determine that the subject device enables acceptable visualization of the bladder in a standard urological procedure as it is currently designed." This refers to the algorithm/device itself (the cannula with its camera and light source) and its ability to provide clear visuals, not its performance in conjunction with human interpretation in a comparative effectiveness study.

7. Type of Ground Truth Used

• Ground Truth: Expert consensus based on direct visualization. The ground truth was established by the "participants" in the simulated operating room environment affirming that they could see all intended targets in the bladder using the device.

8. Sample Size for the Training Set

• Training Set Sample Size: Not applicable/not mentioned. This was a direct performance validation study of a physical device's visualization capabilities, not an AI/algorithm development study.

9. How Ground Truth for the Training Set was Established

• Ground Truth for Training Set: Not applicable. As this was not an AI/algorithm development study, there was no separate training set for which ground truth would need to be established by experts for machine learning purposes.

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