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FemVue MINI is intended to instill a consistent alternating pattern of saline and air as a continuous stream of contrast media into the uterus and fallopian tubes to be used in conjunction with an intrauterine catheter for performance of sono-hysterosalpingogram (Sono HSG).

Fem Vue® MINI is a dual-barrel contrast media syringe that can be connected to an intrauterine catheter for controlled delivery of saline-air contrast media during sono-hysterosalpingogram (Sono HSG) procedures. Sono HSG consists of an ultrasound evaluation of the fallopian tubes with or without assessment of the uterine cavity. The device operates by retraction of the plunger, which simultaneously fills the two syringes in the device with either air or saline. The device is then connected to a compatible uterine catheter, and when the plunger is depressed, a consistent stream of saline and air is delivered into the uterus and fallopian tubes. The device is provided sterilization and is intended for single-use.

Here's a breakdown of the acceptance criteria and the studies mentioned for the FemVue MINI Saline-Air Device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics. Instead, it states that "all predetermined acceptance criteria were met" for various tests. Therefore, the table below is constructed by inferring the acceptance criteria from the type of test conducted.

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

The document does not specify the sample sizes used for the individual bench performance tests. It only states that these tests were conducted. It also does not explicitly state the data provenance (e.g., country of origin) or if the studies were retrospective or prospective, though bench testing is inherently prospective.

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

This information is not provided in the document. The tests described are primarily physical, chemical, and functional bench tests, rather than clinical studies requiring expert ground truth for interpretation.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given the nature of the bench tests, it's unlikely a formal adjudication method (like 2+1, 3+1) would be applicable. The tests likely have objective pass/fail criteria.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document describes non-clinical performance data for a device, not a diagnostic algorithm that would typically require such a study to assess human reader improvement with AI assistance.

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

No, a standalone performance study (algorithm only) was not done. This device is a manual instrument, not an AI or software algorithm.

7. The Type of Ground Truth Used

For the non-clinical performance studies described, the "ground truth" refers to established engineering standards, material specifications, and functional requirements for a medical device. This is determined by the specific ASTM and ISO standards cited (e.g., ISO 11135 for sterility, ISO 10993 for biocompatibility, ASTM F1980-16 for accelerated aging). The concept of expert consensus, pathology, or outcomes data as ground truth is not applicable to these types of engineering and functional tests.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. This device is a hardware product, not a machine learning model that requires a training set.

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

This information is not applicable and therefore not provided, as there is no training set for this type of device.

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Use of the RELIEEV Uterine Manipulator Injector is indicated in Diagnostic Laparoscopy, Minilaparotomy, Fertility Exams, and Salpingoplasty procedures where manipulation of the uterus is required.

The "RELIEEV" Uterine Manipulator Injector is intended to be used during medical procedures where manipulation of the uterus or injection of fluids into the uterine lumen are needed. This device is a sterile, single use product consisting of a plastic (PVC) insertion tube that includes two lumens, one for inflation of a 10 mL intrauterine balloon (cuff) at the distal end of the insertion tube via the inflation valve using the provided 10 mL syringe and the other for injection of fluid through a distal end-port using a user-provided syringe via the Leur fitting. The device also includes a movable/removable rigid handle that allows alteration of the device insertion depth and includes a cervical stop, laser etched depth markings to aid in setting the insertion depth, and a pilot balloon to assess maintenance of cuff inflation. The device is curved to facilitate forward uterine manipulation. The device has an overall length of 36 cm and an outer diameter of the catheter component of 5.0 mm. When inflated with 10 mL of air, the balloon has a diameter of 23.0-24.9 mm.

This document is an FDA 510(k) summary for the "RELIEEV" Uterine Manipulator Injector. It describes the device and claims substantial equivalence to a predicate device, the Panpac Uterine Manipulator Injector, Model Umi 4.5 (K092980).

Based on the provided text, the device in question is a medical instrument, not an AI/software device. Therefore, the questions related to AI/software performance, ground truth, human readers, and training/test sets are not applicable to this document.

The acceptance criteria and study proving the device meets them are related to the physical and biological safety and performance of the Uterine Manipulator Injector, rather than an AI algorithm.

Here's the information extracted from the document, tailored to the type of device described:

Acceptance Criteria and Device Performance for "RELIEEV" Uterine Manipulator Injector

This device is a physical medical instrument, and its performance evaluation focuses on its physical characteristics, sterility, biocompatibility, and mechanical integrity, comparing it to a legally marketed predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The document details various tests performed to ensure the device meets safety and performance standards for a physical medical device. The "acceptance criteria" are implied by the successful completion of these tests per the referenced standards and the statement that "all predetermined acceptance criteria were met."

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

The document does not explicitly state the sample sizes for the various tests. It refers to established testing standards (e.g., ISO, ASTM, USP), which would specify appropriate sample sizes for each test type. The data provenance is from bench testing and laboratory evaluations conducted by the manufacturer (LI Medical Corporation LTD.) to support regulatory submission. This is a prospective assessment of newly manufactured devices under controlled conditions.

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

This concept is not applicable to the assessment of a physical medical device like a uterine manipulator. "Ground truth" in this context refers to the defined acceptable parameters for physical and biological performance, which are established by international standards and regulatory guidelines, not by individual experts evaluating images or clinical data.

4. Adjudication Method for the Test Set

Not applicable for a physical medical device. Performance is judged against specified engineering, material, and biological safety standards, not through adjudication of expert opinions.

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, as this is not an AI/software device.

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

Not applicable, as this is not an AI/software device.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on established industry standards and regulatory requirements for medical device safety and efficacy. This includes:

• Physical and mechanical properties (e.g., dimensions, tensile strength, inflation capabilities).
• Sterility assurance (e.g., EtO residuals).
• Biocompatibility (e.g., cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity).
• Packaging integrity.

These are quantitative metrics or pass/fail criteria derived from validated test methods.

8. The Sample Size for the Training Set

Not applicable, as this is not an AI/software device. There is no "training set" in the context of a physical medical device's performance validation; rather, there are samples tested according to predefined standards.

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

Not applicable, as this is not an AI/software device.

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FemChec® is intended to instill a consistent alternating pattern of saline and air as a continuous stream of contrast media into the uterus and fallopian tubes to be used in conjunction with an intrauterine catheter for performance of sono-hysterosalpingogram (Sono HSG).

FemChec® is a dual-barrel contrast media syringe that can be connected to an intrauterine catheter for controlled delivery of saline-air contrast media during sono-hysterosalpingogram (Sono HSG) procedures. Sono HSG consists of an ultrasound evaluation of the fallopian tubes with or without assessment of the uterine cavity. The device operates by retraction of the plunger, which simultaneously fills the two syringes in the device with either air or saline. The device is then connected to a compatible uterine catheter, and when the plunger is depressed, a consistent stream of saline and air is delivered into the uterus and fallopian tubes. The device is provided sterile via EO sterilization and is intended for single-use.

The provided text is a 510(k) summary for the FemChec Controlled Saline-Air Device (FCD-250), which is a medical device and not an AI or software device. Therefore, the questions related to AI/algorithm performance, training sets, test sets, ground truth establishment by experts, adjudication methods, and MRMC studies are not applicable to this document. The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data for a physical medical device.

However, I can extract the acceptance criteria and a summary of the studies performed from the provided text for the FemChec device.

1. Table of Acceptance Criteria and Reported Device Performance

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

This information is not applicable as the studies conducted are non-clinical bench performance and material compatibility studies for a physical device, not a performance study involving a test set of data points or images.

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

This information is not applicable. Ground truth establishment by experts is relevant for AI/software devices requiring interpretation of data (e.g., medical images), which is not the case for this physical medical device.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods are relevant for studies where multiple readers/experts assess cases, which is not applicable to the non-clinical studies for this physical device.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document describes non-clinical performance studies for a physical device.

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

This information is not applicable. The device is a physical medical instrument, not an algorithm.

7. The Type of Ground Truth Used

This information is not applicable in the context of AI/software performance. For the described bench tests, the "ground truth" would be established by the specifications and standards (e.g., flow rates, material properties, sterility levels) defined in the test protocols themselves, which are based on recognized international and ASTM standards.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical medical instrument, not an AI/software device that requires a training set.

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

This information is not applicable. The device is a physical medical instrument, not an AI/software device that requires a training set.

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The Rejoni Intrauterine Catheter is for the delivery of contrast media or saline into the uterine cavity during Hysterosalpingography (HSG) or Sonohysterography (SHG) for examination of the uterus and fallopian tubes.

When used for HSG. the Rejoni Intrauterine Catheter can be used for evaluation of tubal patency.

The Rejoni Intrauterine Catheter is used to access the uterine cavity for the delivery of saline for Sonohysterography (SHG).

The Rejoni Intrauterine Catheter is a sterile, single lumen uterine catheter that facilitates access to the uterus to deliver fluids during Hysterosalpingography (HSG) or Sonohysterography (SHG). The Rejoni Intrauterine Catheter consists of an inner shaft and an additional support sheath over the proximal portion of the catheter shaft to provide additional stiffness. A repositionable stopper ("acom") is connected to the support sheath, which is placed on the catheter shaft, and can be repositioned from 0 cm up to 10 cm from the distal tip of the catheter. The stopper maintains placement of the catheter against the external cervical os during the procedure, and a luer lock-style adapter on the proximal end is available for compatibility with syringes. The distal end contains a straight through hole for delivery of fluids during the procedure.

The Rejoni Intrauterine Catheter is a sterile, single-lumen uterine catheter intended for delivering contrast media or saline into the uterine cavity during Hysterosalpingography (HSG) or Sonohysterography (SHG) for examination of the uterus and fallopian tubes. It can also be used for evaluation of tubal patency during HSG.

Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria:

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 sample sizes used for each specific test (e.g., how many devices were used for tensile testing, biocompatibility, etc.). However, it indicates these were pre-clinical tests (lab-based) rather than clinical studies with patient data. Therefore, data provenance such as country of origin of data or retrospective/prospective characteristics is not applicable in this context.

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

Not applicable. The described studies are pre-clinical performance and safety tests (mechanical, biocompatibility, sterility, shelf life) rather than studies that require expert-established ground truth on diagnostic accuracy, for example. The "ground truth" for these tests is defined by established industry standards (ISO, ASTM) and the device's own design specifications.

4. Adjudication Method:

Not applicable. As noted above, these are pre-clinical tests following defined protocols and standards, not studies requiring expert adjudication of results.

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

No, an MRMC comparative effectiveness study was not done. The device is a physical catheter, not an AI-assisted diagnostic tool requiring evaluation of human reader improvement.

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

No, a standalone (algorithm only) study was not done. This device is a manual instrument and does not involve an algorithm.

7. Type of Ground Truth Used:

The ground truth for these tests is implicitly or explicitly defined by:

• Design Specifications: For mechanical and functional performance, the device's own engineering and design requirements serve as the ground truth.
• International Standards (ISO, ASTM): For biocompatibility, sterility, and packaging/shelf life, the ground truth is established by the specified ISO and ASTM standards and their acceptance criteria (e.g., non-cytotoxic, SAL of 10$^{-6}$).

8. Sample Size for the Training Set:

Not applicable. This is a physical medical device, not an AI/machine learning algorithm that requires a training set.

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

Not applicable, as there is no training set for this 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 Uterine ElevatOR PRO with OccludOR Balloon™ is indicated for manipulation of the uterus, and injection of fluids or gases during laparoscopic procedures including total laparoscopic hysterectomy, laparoscopic assisted vaginal hysterectomy, laparoscopic tubal occlusion, and diagnostic laparoscopy. The Uterine ElevatOR PRO with OccludOR Balloon™ maintains pneumoperitoneum during laparoscopic procedures by sealing the vagina once colpotomy is performed.

The Uterine ElevatOR PRO with OccludOR Balloon™ is a sterile, single-use medical device used to manipulate the uterus and cervix in surgical and diagnostic procedures. The device includes an insulated and anatomically designed stainless steel shaft with an intrauterine balloon and reference graduations (centimetres) at the proximal [to patient] end and an external handle at the distal end. The intrauterine balloon is inflated with air using a standard syringe (not included). The device has a vaginal cup that is pushed along the shaft to support a green cervical cup. The cervical cup provides a guide for colpotomy. There are four sizes of cervical cups available, 32mm, 37mm, and 40mm, which correspond to the different model numbers. A locking assembly secures the position of the vaginal cup and therefore the cervical cup. Sites for suturing are located on the cervical cup. An Occluder Balloon further reduces leakage of pneumoperitoneum during laparoscopic surgery. A port at the distal end of handle provides a channel for injection of fluids or gases.

This is a 510(k) premarket notification for a medical device called the "Uterine ElevatOR PRO with OccludOR Balloon™", not an AI/ML device. Therefore, the request for acceptance criteria and study details related to AI/ML device performance (such as sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types) is not applicable.

The document describes performance data for a physical medical device, which includes:

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

The document broadly states that "In all testing, the subject device met the pre-specified acceptance criteria." However, it does not provide a specific table detailing each acceptance criterion and the corresponding reported device performance. It lists the types of tests conducted:

• Irritation per ISO 10993-10:2010
• Sensitization per ISO 10993-5:2010
• Acute Systemic toxicity per ISO 10993-11:2017
• Pyrogenicity per ISO 10993-11 and USP | "The subject device is considered externally communicating device & surface contact device that may come in contact with tissue and breached or compromised surface respectively for a duration of less than 24 hours."
  "met the pre-specified acceptance criteria." |
  | Performance & Mechanical | - Intrauterine balloon integrity & concentric inspection
• Intrauterine balloon inflation stability test for a defined time period.
• Intrauterine balloon burst test
• Intrauterine balloon fatigue test
• Intrauterine balloon adhesion strength test
• OccludOR balloon outer diameter inspection & leakage free test
• OccludOR balloon deflation time test
• OccludOR balloon capacity test- reliability/safety
• OccludOR balloon fatigue durability test
• OccludOR balloon burst test
• Vaginal cup air leakage test
• Cervical cup temperature test
• Air inflation valve test
• Dye-injection port compliance & leakage test
• Thumb screw strength test
• Locking force test of vaginal cup
• Ease of movement of vaginal cup along the shaft
• Cervical cup detachment force test
• Cervical cup stopper adhesion strength test
• Device tensile strength
• Handle joint strength
• Tip deflection
• Ultrasonic welding strength | "In all testing, the subject device met the pre-specified acceptance criteria." |

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

The document does not specify sample sizes for any of the tests, nor does it provide information on data provenance (country of origin, retrospective/prospective). This type of detail is typically found in full study reports, not a 510(k) summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable, as this is a physical medical device and not an AI/ML device relying on "ground truth" derived from expert consensus. The "truth" for this device's performance is determined by meeting physical and biological specifications through various standard engineering and biocompatibility tests.

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

Not applicable for a physical medical device as described.

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, as this is a physical medical device and not an AI/ML device involving human readers or AI assistance.

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

Not applicable, as this is a physical medical device without an algorithm component.

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

Not applicable for a physical medical device. The "ground truth" here is adherence to engineering specifications and biocompatibility standards.

8. The sample size for the training set:

Not applicable, as this is a physical medical device and not an AI/ML device that requires a training set.

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

Not applicable, as there is no training set or AI/ML model for this physical medical device.

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The use of the DUMI ManipulatOR is indicated in diagnostic laparoscopy, mini laparotomy, fertility exams, and salpingoplastic procedures where manipulation of the uterus is required.

The DUMI ManipulatOR is a sterile, single use, disposable medical device designed for the intra-operative manipulation of both the anteverted and retroverted uterus as well as facilitating simple and effective dye studies. The device includes an anatomically designed balloon at the distal end that is injected with air by syringe through the luer connector of inflation valve. The three-way hub can accommodate fluid and can be used for dye studies.

1. Table of Acceptance Criteria and Reported Device Performance:

The document outlines various tests conducted to demonstrate the safety and effectiveness of the DUMI ManipulatOR, primarily by establishing substantial equivalence to a predicate device. The acceptance criteria are generally "successfully met predetermined acceptance criteria" or demonstrating performance "at least the same as the predicate device." Specific numerical criteria are not always explicitly stated in this summary, but the types of tests and their successful outcome are.

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

The document does not explicitly state specific sample sizes for each individual test. However, it references several standards that typically dictate sample size requirements for testing and quality control:

• ISO 2859-1:1999: "Sampling procedures for inspection by attribute - Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection." This standard would have guided the sample sizes for attribute inspection tests.
• ASTM F3172-15: "Design verification device size and sample selection for Endovascular devices." While the DUMI ManipulatOR is not an endovascular device, this standard indicates that sample size selection for design verification was a considered aspect of the testing strategy.

Given the nature of the device (uterine manipulator) and the tests performed (physical, mechanical, biocompatibility, sterilization, packaging), the data would be prospective as the tests were conducted specifically for this submission.

The provenance of the data is not explicitly stated per test but is implied to be from testing labs associated with The O.R. Company Pty Ltd, an Australian company with offices in Australia, North America, and Hong Kong. The testing was conducted to meet international and US FDA standards.

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

This information is not provided in the document. The tests described are primarily objective, quantitative engineering, microbiological, and chemical tests. Clinical expert "ground truth" (e.g., radiologists, pathologists) is typically relevant for diagnostic devices or AI algorithms that interpret medical data. For a manual surgical instrument, the "ground truth" for performance is established through defined acceptance criteria in engineering standards, material science, and regulatory guidelines.

4. Adjudication Method for the Test Set:

This information is not applicable/provided. Adjudication methods (like 2+1, 3+1) are usually relevant in clinical trials or studies where human interpretation or consensus is required to establish a gold standard for disease presence or other clinical outcomes. The tests performed for the DUMI ManipulatOR are laboratory-based and objective, with outcomes determined by measurement against predetermined standards.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not conducted and is not applicable to this device. The DUMI ManipulatOR is a manual surgical instrument, not an AI-powered diagnostic or assistive tool for image interpretation. Therefore, there is no concept of "human readers" or "AI assistance" in its evaluation.

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

No, a standalone algorithm-only performance assessment was not done. The DUMI ManipulatOR is a physical medical instrument, not an algorithm or AI system.

7. The Type of Ground Truth Used:

The "ground truth" for this device's performance is based on:

• Engineering and Material Standards: Defined specifications and performance limits derived from international and national standards (e.g., ISO, ASTM).
• Predicate Device Equivalence: The performance of the predicate device (Panpac Uterine Manipulator Injector, Model UMI 4.5) serves as a benchmark for comparison in several performance tests. The new device must perform "at least the same as" the predicate.
• Regulatory Requirements: Compliance with quality management systems (ISO 13485, 21 CFR 820), risk management (ISO 14971), and biocompatibility guidelines (ISO 10993 series).

8. The Sample Size for the Training Set:

This information is not applicable. The DUMI ManipulatOR is not an AI/machine learning device, so there is no concept of a "training set" for an algorithm. The device itself is manufactured, and its performance is verified through testing.

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

This information is not applicable as there is no "training set" for this type of device.

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The Intrauterine Access Balloon Catheter is used for delivery of contrast medium into the uterine cavity during hysterosalpingography (HSG) for examination of the uterus and fallopian tubes, and evaluation of tubal patency. The catheter lumen accepts catheters up to 6 French in diameter to access the uterine cavity for assessment of tubal patency.

The Selective Salpingography Catheter is intended to be used through a uterine access device and positioned at the tubal ostium for injection of contrast medium for fluoroscopic evaluation of tubal patency.

The IAB and SSG Catheters facilitate access to the uterus and tubal ostium to deliver contrast media during diagnostic procedures.

The IAB Catheter is 9 French (Fr) in diameter and has a 23 cm working length. It is designed with a polyurethane shaft and a silicone distal balloon with a 2-cc inflation volume. The catheter includes two lumens, one for balloon inflation and the other can be used to inject contrast medium into the uterus for hysterosalpingography (HSG) and as an access channel that accepts devices up to 6 Fr in diameter for use in assessing tubal patency. The Intrauterine Access Balloon Catheter is packaged with a shipping stylet and a 3 mL syringe that is used to inflate the balloon with sterile media.

The SSG Catheter is manufactured from braided polyethylene and is designed with an angled distal tip with a radiopaque tungsten band. The catheter is 5.5 Fr in diameter and has a 40 cm working length. The SSG Catheter is intended to be used through a dimensionally compatible access catheter (IAB Catheter) to gain access to the uterine cavity for a more selective visualization of the fallopian tubes when positioned at the tubal ostium.

Both devices are supplied sterile (ethylene oxide) and are intended for single-use only.

The provided document focuses on the K181770 510(k) submission for the Intrauterine Access Balloon Catheter and the Selective Salpingography Catheter, demonstrating substantial equivalence to predicate devices. It does not contain information about a study proving device meets acceptance criteria in the manner described in the request, such as a clinical study with a test set, expert ground truth, multi-reader, multi-case study, or standalone algorithm performance.

However, the document does list performance data from bench studies that were conducted to ensure reliable design and performance, with predetermined acceptance criteria being met. This implies that the device does meet specific acceptance criteria based on these bench tests.

Here is the information extracted from the document regarding the acceptance criteria and the "studies" (bench performance tests) that prove the device meets them:

Acceptance Criteria and Reported Device Performance

Note: The document describes "predetermined acceptance criteria" rather than specifying precise quantitative values for each. The reported performance indicates that these criteria were met.

The remaining requested information pertains to clinical performance studies, which are not detailed in this 510(k) submission as no such studies were needed for substantial equivalence based on the provided document. The document lists bench performance studies as the primary evidence.

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

• Not applicable / Not provided for the device. The document describes bench performance studies (e.g., tensile testing, lumen patency, balloon integrity). These are laboratory tests on device units, not tests on clinical patient data. Therefore, concepts like "test set" in the clinical sense, "data provenance," "country of origin," or "retrospective/prospective" do not apply.

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

• Not applicable / Not provided. The device performance was assessed against engineering specifications and industry standards in bench testing, not against expert clinical ground truth.

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

• Not applicable / Not provided. Adjudication methods are typically relevant for clinical studies involving human interpretation or subjective assessments, which were not part of the described bench performance tests.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No, an MRMC study was not done. This type of study is for AI/human-in-the-loop performance, which is not relevant to this medical device submission.

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

• No, a standalone algorithm performance study was not done. This submission is for a physical medical device, not an AI algorithm.

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

• Engineering specifications, industry standards, and internal procedures served as the "ground truth" or reference for the bench performance tests. For instance, material properties (tensile strength), dimensional tolerances, and functional requirements (balloon integrity, lumen patency) were assessed against predefined, objective criteria.

8. The sample size for the training set

• Not applicable / Not provided. No "training set" in the context of machine learning or clinical data was mentioned or used for this device. The bench tests involved samples of manufactured devices.

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

• Not applicable / Not provided. As there was no training set in the clinical or AI context, no ground truth needed to be established for it. The "ground truth" for the device's acceptable performance was established by engineering design specifications, relevant ISO standards, ASTM standards, and Cook's internal procedures.

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The Margolin HSG Cannula is for the delivery of contrast media or saline into the uterine cavity during Hysterosalpingography (HSG) or Sonohysterography (SHG) for examination of the uterus and fallopian tubes. When used for HSG, the Margolin HSG Cannula can be used for evaluation of tubal patency.

The Goldstein Sonohysterography Catheter is used to access the uterine cavity for the delivery of saline for Sonohysterography (SHG).

The Margolin HSG Cannula and Goldstein Sonohysterography Catheter are single lumen uterine catheters that facilitate access to the uterus to deliver fluid (contrast media or saline) during diagnostic procedures. Both feature a silicone "acom" wedge that seals the cervical canal and maintains the position of the catheter during the procedure.

This is a 510(k) summary for medical devices (Margolin HSG Cannula and Goldstein Sonohysterography Catheter) and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical study for novel performance metrics with acceptance criteria, expert ground truth, or statistical power.

Therefore, many of the requested data points (e.g., effect size of human readers with/without AI, sample size for training set, specific study design for clinical performance against pre-defined acceptance criteria, detailed ground truth establishment for a test set) are not presented in this document because they are not typically required for a 510(k) submission for these types of devices. The "performance data" section rather lists engineering and biocompatibility tests.

However, based on the provided text, I can extract the following information:

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

The document states: "All predetermined acceptance specifications were met in the following tests." However, the specific numerical acceptance criteria for each test are not explicitly detailed in this summary. The performance is reported as meeting these unspecified specifications.

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

The document does not specify the sample sizes for the "performance data" tests. The data provenance is not mentioned, as these are primarily engineering and bench tests, not clinical studies in a specific geographical location. The studies are prospective in the sense that they are conducted on manufactured devices to test design specifications.

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. These are engineering performance tests, not clinical performance studies requiring expert ground truth for interpretation (e.g., image analysis, diagnosis).

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

Not applicable. This concept applies to clinical studies where multiple reviewers' opinions need to be reconciled to establish a ground truth, which is not the case for these bench tests.

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. These are medical devices (cannulas and catheters) used for fluid delivery, not AI-powered diagnostic or assistive tools. Therefore, an MRMC study related to human readers improving with AI assistance is entirely irrelevant to this document.

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

Not applicable. As stated above, these are physical medical devices, not algorithms.

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

For the performance tests listed, the "ground truth" is defined by the technical specifications and standards (e.g., ISO 11135-1:2007 for sterilization, ASTM D4169-16 for transportation, ASTM F2096-11 for bubble leak, ISO 10993 series for biocompatibility, and "Cook's predetermined acceptance specifications" for dimensional, patency, tensile, and force tests). There's no clinical ground truth established by experts or pathology for these types of tests.

8. The sample size for the training set

Not applicable. There is no AI or machine learning model being "trained" for these medical devices.

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

Not applicable for the same reason as point 8.

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The Cook® Silicone Balloon HSG Catheter is used for delivery of contrast medium or saline into the uterine cavity and fallopian tubes for the evaluation of tubal patency using hysterosalpingography, or to access the uterine cavity for saline infusion sonohysterography.

The Cook® Silicone Balloon HSG Catheter is a dual lumen polyurethane catheter that is manufactured in 5.0 or 7.0 French (Fr) sizes and is 30 cm in length. The Cook® Silicone Balloon HSG Catheter is available with an open-end tip, or a closed-end tip with a single side port. The silicone balloon is designed with a balloon volume of 1.0 mL (5.0 Fr) or 1.5 mL (7.0 Fr). Depending upon the device a 1 or 3 mL syringe is provided with the balloon catheter.

The Cook® Silicone Balloon HSG Catheter will be supplied sterile (ethylene oxide) and is intended for one-time use. The set is packaged in a peel-open pouch. The 5.0 Fr size catheter has a three-year shelf-life, and the 7.0 Fr size catheter has a two-year shelf-life.

This document describes the safety and effectiveness testing for the Cook® Silicone Balloon HSG Catheter, but it is not an AI/ML medical device submission. Therefore, it does not contain the specific information requested about acceptance criteria, study details (sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, training set details), which are typically required for AI/ML device submissions.

The provided document is a 510(k) Premarket Notification for a physical medical device. It demonstrates substantial equivalence to a predicate device through bench performance studies and other non-clinical tests.

However, I can extract and present the available information in a format that addresses some aspects of your request, even if it doesn't align with an AI/ML context:

Acceptance Criteria and Device Performance (Based on available information for a physical device)

Summary of Study Details (for a physical medical device, not AI/ML):

1. Sample Size used for the test set and data provenance:

   • The document implies that an adequate number of units were tested to demonstrate statistical significance and meet pre-defined acceptance criteria for bench performance and other non-clinical tests.
   • Specific numerical sample sizes for each test are not provided in this summary.
   • Data Provenance: The tests are described as "Performance Data" and "Bench Performance studies," indicating the data was generated from laboratory testing of the physical catheter devices. Country of origin for data or retrospective/prospective nature is not applicable as this is not a clinical study on patient data.

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

   • Not applicable. This is not an AI/ML device that generates diagnostic outputs requiring expert interpretation for ground truth. The "ground truth" for this physical device is defined by the physical properties and performance specifications of the device itself (e.g., balloon inflates, no leaks, proper tensile strength).

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

   • Not applicable. This is not an AI/ML device or a clinical study requiring adjudication of diagnostic interpretations.

4. 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 a physical medical device, not an AI/ML software.

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

   • Not applicable. This is a physical medical device, not an AI/ML software.

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

   • The "ground truth" for this device's performance is based on engineering specifications and testing standards (e.g., ISO, ASTM standards, pre-defined internal acceptance specifications).

7. The sample size for the training set:

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

8. How the ground truth for the training set was established:

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

Conclusion from the document:

"The results of the performance testing described above demonstrates that the Cook® Silicone Balloon HSG Catheter is as safe and effective as the predicate device and supports a determination of substantial equivalence." (Page 6)

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