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Fetal Pillow is intended to elevate the fetal head and facilitate delivery of the fetus in women requiring a Caesarean Section at full dilation or those requiring a Caesarean Section after a failed instrumental vaginal delivery. Fetal Pillow is indicated for use at a gestational age ≥37 weeks.

The Fetal Pillow is an inflatable balloon device which consists of the following components:

• Silicone Balloon: Dome shaped balloon attached to base plate, inflated to elevate fetal head.
• Base plate: Oval shaped silicone base plate (9.3cm x 5.0cm) with internal connecting channel to allow attachment to silicone tube.
• Silicone Tube: 4mm tube attaches to connecting channel of base plate for inflation
• Two-way tap: Two-way stopcock at distal end of silicone tube, allows for inflation/deflation of balloon.
• Syringe: 60cc polypropylene syringe attached to distal end of silicon tube, used to inflate balloon with saline solution.

The Fetal Pillow is a single use, disposable, sterile device.

The subject device is a dome shaped, balloon, cephalic evaluation device that enables the elevation of the fetal head to facilitate delivery of the fetus. The inflation and application of the device only occurs under direct control of the user.

This FDA 510(k) clearance letter for the "Fetal Pillow" does not describe performance acceptance criteria or a study that proves the device meets those criteria. Instead, it states that the purpose of this 510(k) submission is to update clinical references in the Instructions for Use based on current literature, implying no new performance testing was conducted for this specific submission.

The letter explicitly mentions:

• "There were no design changes between the subject and predicate device, therefore, no additional performance data was presented as part of this 510(k) submission."
• "The information provided demonstrates that the Fetal Pillow is as safe and effective as the predicate device and supports a determination of substantial equivalence."

Therefore, based solely on the provided text, it's impossible to answer your questions about acceptance criteria and a study proving its performance, as no such study was conducted for this particular 510(k) submission. The clearance is based on the substantial equivalence to a predicate device (DEN150053), which would have had performance testing for its initial De Novo classification.

However, I can extract information related to the predicate device (DEN150053) as hinted by the included references, and explain why a detailed answer to your request isn't possible from this document.

Analysis based on the provided document (and limitations for your detailed request):

The document is a 510(k) clearance for a device called "Fetal Pillow." The key takeaway is that this specific submission (K243799) is not about proving new performance through new studies because the device's design is identical to its predicate (DEN150053). The purpose of this 510(k) was to update clinical references in the Instructions for Use. Therefore, the detailed questions about performance studies (sample size, ground truth, expert adjudication, MRMC studies, standalone performance) cannot be answered from this document because such studies were not performed for K243799.

The reference to "United States Food and Drug Administration. De Novo Classification Request For Fetal Pillow. De Novo Summary (DEN150053). 2015;1-14" strongly suggests that the original performance data would be found in the De Novo Summary for the predicate device, DEN150053.

Attempted Answer (highlighting what can't be answered from the provided text):

Since new performance data was not presented for K243799 due to substantial equivalence, the following sections cannot be populated with information from this document. Any information would be speculative or would require accessing the original DEN150053 De Novo summary.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size and Data Provenance:

• Test Set Sample Size: Not applicable/Not provided in this 510(k). No new test set data was generated for K243799.
• Data Provenance: Not applicable/Not provided. The clinical references cited (Lassey et al., Hanley et al.) are external literature reviews/studies, not a primary study conducted for this 510(k). The original De Novo submission (DEN150053) for the predicate device would contain this information.

3. Number of Experts and Qualifications for Ground Truth:

• Not applicable/Not provided in this 510(k). No new ground truth establishment was described as no new performance study was conducted.

4. Adjudication Method:

• Not applicable/Not provided in this 510(k). No new performance study required adjudication.

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

• Not applicable/Not provided in this 510(k). No MRMC study was conducted or referenced as part of this submission for K243799. The device is a physical, interventional device, not an AI or imaging device, so conventional MRMC studies (as typically seen for diagnostic AI) would be less relevant.

6. Standalone Performance (Algorithm Only):

• Not applicable. The "Fetal Pillow" is a physical medical device, not a software algorithm. Its performance is tied to its physical characteristics and user interaction, not an algorithm's output.

7. Type of Ground Truth Used:

• Not applicable/Not provided in this 510(k). Any ground truth used would have been for the predicate device's original clearance, likely clinical outcomes from trials.

8. Training Set Sample Size:

• Not applicable. This is a physical device, not an AI/ML algorithm requiring a training set in the conventional sense.

9. How Ground Truth for Training Set was Established:

• Not applicable. Same as above.

Summary regarding the provided document:

The provided 510(k) clearance letter for the "Fetal Pillow" (K243799) is a substantial equivalence determination. This means the FDA found the device to be as safe and effective as a legally marketed predicate device (DEN150053) without requiring new clinical performance data for this specific submission. The stated purpose of K243799 was to update clinical references in the Instructions for Use, not to present new performance studies. Therefore, the detailed questions about sample sizes, expert adjudication, ground truth, and AI/MRMC studies are not addressed within this document, as these types of studies were not conducted for K243799. The information you seek would typically be found in the original De Novo classification summary (DEN150053) for the predicate device.

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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 G210 InviCell Plus with SignipHy™ pH Monitoring System is a bench-top incubator that is intended to provide a controlled environment at or near body temperature and gas levels (CO2, O2, and N2) for the development of gametes and/or embryos during In Vitro Fertilization (IVF) / Assisted Reproductive Technology (ART) treatments.

The G210 InviCell Plus with SignipHy™ pH Monitoring System includes an accessory for pH monitoring of surrogate samples of bicarbonate-based culture media used for ART procedures.

The G210 InviCell Plus with SignipHy™ pH Monitoring System is an assisted reproduction incubator that includes an accessory pH monitoring feature. The incubator component of this device (G210 Invicell) is regulated under 21 CFR 884.6120, product code PBH (exempt). The incubator includes 10 incubation chambers and one larger preparation chamber that is used for the equilibration of plates/oil before use. The tri-gas incubator provides a controlled environment (temperature, CO2/O2/N2) for gametes and embryos in the incubation chambers.

The pH monitoring feature of the G210 InviCell Plus with SignipHy™ pH Monitoring System is controlled separately and does not impact the operation or incubator functions of the device. The SignipHy™ pH Monitoring System consists of the following components:

• . SignipHy™ TrakPod – An LED-based, optical pH measurement instrument. The SignipHy TrakPod is physically supported within the chassis of the incubator and allows monitoring of one incubator chamber. It is a USB connected fluorescent measurement device with a fiber optic cable and fixture that connects to the SignipHy sv2 Sensor inside an incubator chamber. The SignipHy TrakPod and SignipHy sv² Sensor together detect the pH of a liquid sample.
• . SignipHy™ sv2 Sensor – The SignipHy sv2 Sensor is a single-use, polystyrene, ethylene oxide sterilized vessel that is loaded with a sample of bicarbonate-buffered assisted reproduction technology (ART) media with a pH between 6.8 and 7.2 for pH tracking. The bottom of the sensor includes a membrane that is impregnated with a dye that is affected by the pH of the media sample. The sensor fits into the SignipHy TrakPod fiber optic fixture located in an incubation chamber. SignipHy sv2 Sensors can be used for measuring pH at one-minute intervals for three days or 30-minute intervals for seven days.
• . SignipHy™TrakStation – A tablet computer running proprietary software that initiates pH readings, displays results, and stores pH measurement data over time. Up to eight SignipHy TrakPods can be connected to a single SignipHy TrakStation.
• SignipHy™ qc² Alignment Tool - A fluorescent reference device for use in system alignment and quality control.

To make a pH measurement, the SignipHy TrakPod sends green light flashes (peak 518 nm) through the fiber optic fixture. The dye in the membrane reacts by sending back flashes of light at a different wavelength (peak 600 nm). The SignipHy TrakPod reads this result and calculates the pH of the media sample that is then displayed on and stored in the SignipHy™TrakStation.

Here's a breakdown of the acceptance criteria and the studies performed for the G210 InviCell Plus with SignipHy™ pH Monitoring System, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Note: Specific quantitative values for "all specifications" for pH monitoring, or the exact numerical results for linearity, stability, precision, accuracy, and interfering substances, are not detailed in the provided text. The document states they "met all specifications."

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

The document does not explicitly state the sample sizes used for the test sets in the "Non-Clinical Performance Testing" section. It describes the types of tests conducted:

• Shelf-Life of SignipHy™ sv2 Sensors: Tested "real-time aged samples after shipping/distribution." The number of samples is not specified.
• Mouse Embryo Assay (MEA): Tested under "worst-case conditions (samples taken every minute for 96h)." The number of embryo samples is not specified.
• pH Monitoring Validation Testing: Tested various parameters, but the number of samples for each is not provided.

The data provenance is not explicitly mentioned (e.g., country of origin). Based on the context of an FDA submission for a US company (CooperSurgical Inc., Trumbull, CT), it is highly likely the studies were conducted in the US or in compliance with US regulatory standards. The studies appear to be prospective in nature, as they involve testing the device's performance under specified conditions.

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

The document does not specify the number of experts or their qualifications for establishing ground truth in the specific performance tests mentioned.

• In the Shelf-Life of SignipHy™ sv2 Sensors performance testing, the ground truth for pH measurement was established by comparison to a "gold standard (blood gas analyzer)." This implies the use of a validated, established method as the reference truth, rather than expert consensus on subjective interpretation.
• For the Mouse Embryo Assay (MEA), the acceptance specification uses a clear biological endpoint ("≥90% blastocysts at 96h"), which would be objectively assessed rather than requiring expert consensus to establish ground truth for each case.

4. Adjudication Method for the Test Set

The document does not describe any adjudication methods (e.g., 2+1, 3+1) for the test sets. The tests performed are objective performance measurements against established standards or gold standards (like a blood gas analyzer), which typically do not involve subjective expert adjudication.

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

No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned in the provided text. The device is an incubator with a pH monitoring system, not an imaging or diagnostic device that requires human interpretation of outputs. Therefore, a study comparing human readers with and without AI assistance is not applicable to this device.

6. Standalone (Algorithm Only) Performance Study

Yes, standalone performance studies were done for the pH monitoring system. The "pH Monitoring Validation Testing" directly assesses the device's ability to measure pH against specifications for linearity, stability, precision, accuracy, and interfering substances, without human intervention in the pH measurement process itself. Similarly, the "Shelf-Life" testing on the SignipHy™ sv2 Sensor performance compared subject device pH measurements to a "gold standard (blood gas analyzer)." The MEA also assessed the device's impact directly.

7. Type of Ground Truth Used

The ground truth methods used in the performance studies include:

• Comparison to a Gold Standard: For pH measurement accuracy and performance at end of shelf-life, the device's pH measurements were compared to a "gold standard (blood gas analyzer)."
• Objective Biological Endpoint: For the Mouse Embryo Assay (MEA), the ground truth was the objective biological outcome of embryo development ("≥90% blastocysts at 96h").
• Established Industry Standards and Specifications: Many tests adhere to ISO, AAMI, ASTM, and IEC standards, where the ground truth is compliance with the defined parameters and limits of those standards (e.g., seal strength, electrical safety, EMC).

8. Sample Size for the Training Set

The document does not provide details on the sample size for any training set. The device appears to be a hardware-based system with proprietary software for measurement and display, rather than a machine learning/AI diagnostic system that typically requires large training datasets. The software documentation mentioned (minor level of concern) also suggests it's not primarily a learning algorithm.

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

Since no training set details are provided or implied for a learning algorithm, there is no information on how its ground truth might have been established. The documented testing focuses on validating the device's physical and functional performance against established benchmarks and specifications.

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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 Wallace Dual Lumen Oocyte Recovery System in 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 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 consists of a 17 gauge needle that is 33 cm long, and 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.

Based on the provided text, the device in question is the Wallace Dual Lumen Oocyte Recovery System, an ovulation retrieval needle. The document does not describe a study involving an AI/algorithmic device or human readers. Instead, it details the non-clinical performance testing conducted to demonstrate substantial equivalence to a predicate device.

Therefore, many of the requested sections (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, MRMC study, standalone performance, training set ground truth establishment) are not applicable as they pertain to the evaluation of an AI or algorithm, which is not the subject of this 510(k) summary.

Here's an analysis of the available information:

Acceptance Criteria and Device Performance for the Wallace Dual Lumen Oocyte Recovery System

The device under review is an assisted reproduction needle, not an AI or algorithm. The acceptance criteria and performance data provided relate to the physical and biological characteristics of the device to demonstrate its safety and effectiveness, primarily through comparison to a legally marketed predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The document describes various non-clinical performance tests and their acceptance criteria (implicitly met as the conclusion states the device passed all testing).

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

• Sample Size: Not explicitly stated for each test (e.g., number of needles tested for mechanical performance, number of packages for integrity). However, the methods refer to standard test procedures (e.g., ISO, ASTM), which typically define sample sizes.
• Data Provenance: The document describes non-clinical laboratory testing of the device itself, not human clinical data or imaging data. Therefore, concepts like country of origin or retrospective/prospective are not applicable.

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

• Not Applicable. This device is a physical medical instrument, not an AI/algorithmic software. "Ground truth" in this context refers to the defined scientific and engineering standards and methods for assessing the device's physical, chemical, and biological properties, which are established by standard organizations (e.g., ISO, ASTM, USP) and verified by qualified laboratory personnel.

4. Adjudication Method for the Test Set

• Not Applicable. As this is non-clinical performance testing of a physical device, there is no "adjudication" of expert opinions in the sense of image interpretation. Test results are objective measurements against defined standards.

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

• No. This is not an AI/algorithmic device or diagnostic tool. An MRMC study would be irrelevant.

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

• Not Applicable. This is a physical medical device. "Standalone performance" in this context refers to the device's ability to meet its specifications independently, which is what the non-clinical performance testing aimed to demonstrate.

7. The Type of Ground Truth Used

• Defined Standards and Measurable Performance Metrics: The "ground truth" for this device's performance is based on established international and national standards (e.g., ISO, ASTM, ANSI/AAMI, USP) for sterility, biocompatibility, mechanical properties, and packaging integrity. Tests evaluate quantitative and qualitative measures directly against these benchmarks (e.g., specific thresholds for endotoxin, percentage of embryo development, strength limits, leak absence).

8. The Sample Size for the Training Set

• Not Applicable. This refers to an AI/algorithmic device, not a physical medical instrument. There is no concept of a "training set" for the type of evaluation described.

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

• Not Applicable. Again, this is for AI/algorithmic development. The "ground truth" for evaluating this physical device is established through adherence to recognized industrial and medical device testing standards and protocols.

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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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