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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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The GripTract-GI Endoscopic Tissue Manipulator (GripTract) Lower GI Models are accessories intended to assist in positioning the distal end of an endoscope from the mucosal surface and assist with optical visualization, diagnosis, and endoscopic treatment.

GripTract Lower GI Models are indicated for use in the large intestine with any standard endoscope as follows:

The GripTract-GI™ Endoscopic Tissue Manipulator (GripTract) Lower GI Models are disposable, non-sterile accessories intended to assist in positioning the distal end of an endoscope from the mucosal surface and assist with optical visualization, diagnosis, and endoscopic treatment. There are four (4) different GripTract Lower GI Models (GT-CL170, GT-CL130, GT-CM170, and GT-CM130) which are indicated for use in the large intestine with standard endoscopes that have specific tip outer diameters and working lengths.

The GripTract Handpiece attaches to the endoscope control body just below the working channel. The soft End Cap with two integrated Fingers for tissue manipulation is placed on the distal end of the endoscope. Two Control Knobs in the Handpiece each operate a corresponding Finger, permitting the User to rotate and extend/retract the Fingers for tissue manipulation and visualization independent of the endoscope's movement or the presence of other tools in the endoscope's working channel.

Here's a breakdown of the acceptance criteria and study information based on the provided document, addressing each of your points:

Important Note: The provided document is a 510(k) summary for a medical device (GripTract-GI Endoscopic Tissue Manipulator Lower GI Models). This type of document focuses on demonstrating substantial equivalence to an existing predicate device rather than proving clinical efficacy or diagnostic accuracy for an AI/software device. Therefore, many of your questions, particularly those related to AI-specific studies (MRMC, standalone AI performance, ground truth establishment for training AI, etc.), are not applicable to this device and information. The device described is not an AI/software device.

The document primarily details non-clinical performance data to support the substantial equivalence claim.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't present a formal table of acceptance criteria with numerical performance targets against which the device was measured like typical AI/diagnostic studies. Instead, it lists various non-clinical tests performed and states whether the device "passed" or exhibited "equivalent force transmission" or "exceeded reported maximum pull forces."

Here's a summary derived from the "Summary of non-clinical performance testing" table and the subsequent paragraphs:

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

As this is a physical medical device (endoscopic tissue manipulator) and not an AI/software, the concept of a "test set" in the context of diagnostic data doesn't apply directly.

• Sample Size: The document does not specify particular "sample sizes" for the non-clinical tests in terms of number of devices tested. It refers to "worst-case simulated use," "repeated worst-case torsional load," and testing "at the dimensional extremes of the product line" for Torque Comparison. For Biocompatibility, it states "Final, finished devices tested."
• Data Provenance: Not applicable in the context of retrospective/prospective patient data or country of origin for such data. The data provenance is from bench performance testing conducted by the manufacturer, Actuated Medical, Inc.

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

Not applicable. "Ground truth" in the context of expert consensus on medical images or diagnostic outcomes is not relevant for this device's non-clinical performance testing. The "ground truth" for these tests would be the measured physical properties and performance characteristics against established engineering specifications and regulations.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are used for resolving discrepancies among expert readers in diagnostic AI studies. This is a non-clinical, bench testing document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improvement with AI vs. Without AI Assistance

Not applicable. This device is a physical medical instrument, not an AI or software that assists human readers in diagnostic interpretation. An MRMC study would not be performed for this type of device.

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. It is a physical device operated by a clinician.

7. The Type of Ground Truth Used

For the non-clinical performance tests, the "ground truth" is defined by:

• Engineering specifications and design requirements.
• Industry standards (e.g., ISO 10993-1 for biocompatibility).
• Quantitative measurements derived from bench testing (e.g., force measurements, dimensional checks, fatigue cycles).
• Simulated worst-case scenarios and interactions.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device, so there is no training set of data in that sense.

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

Not applicable. As there is no AI training set, there's no ground truth establishment process for it.

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The GripTract-Gl Endoscopic Tissue Manipulator (GripTract) is an accessory intended to assist in positioning the distal end of an endoscope from the mucosal surface and assist with optical visualization, diagnosis, and endoscopic treatment.

GripTract is indicated for use in the large intestine with any standard endoscope that has a distal tip outer diameter of 11.5 - 12.0 mm and working length of 168 - 170 cm.

GripTract is a single-use, non-sterile, endoscope accessory intended to ensure complete positioning of an endoscope and assist with optical visualization, diagnosis, and endoscopic treatment. It is indicated for use in the large intestine with any standard endoscope that has a distal tip outer diameter of 11.5 - 12.0 mm and a working length of 168 - 170 cm.

The GripTract Handpiece attaches to the endoscope control body just below the working channel. The soft End Cap with two integrated Fingers for tissue manipulation is placed on the distal end of the endoscope. Two Control Knobs in the Handpiece each operate a corresponding Finger, permitting the User to rotate and extend/retract the Fingers for tissue manipulation and visualization independent of the endoscope's movement or the presence of other tools in the endoscope's working channel.

The provided text describes the regulatory clearance for the GripTract-GI Endoscopic Tissue Manipulator (K231254). It outlines the device's intended use and provides non-clinical performance data to demonstrate its safety and effectiveness.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Key Takeaway: The provided document is a 510(k) summary for a medical device (GripTract-GI Endoscopic Tissue Manipulator). It focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific numerical performance acceptance criteria typical of AI/ML device studies. Therefore, many of the requested criteria (e.g., specific quantitative metrics, sample sizes for training/test sets for AI, expert numbers for ground truth, MRMC studies) are not directly applicable or explicitly stated in this type of regulatory submission for a mechanical device.

However, I can extract the information related to the device's performance and the studies conducted to show its safety and effectiveness.

Acceptance Criteria and Device Performance (based on provided text)

The acceptance criteria for this device are primarily related to its functional performance, safety, and compatibility, demonstrated through various non-clinical tests. The "performance" is reported as "Pass" for each test, indicating that the device met the pre-defined criteria for that specific test.

Study Details (based on provided text)

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

   • Usability Testing: "A total of 15 Users" for both "Set-Up" and "Use" usability tests.
   • Porcine Testing: Number of animals or procedures is not specified, but it's an "in vivo porcine testing" in "worst-case procedure."
   • Other Bench Tests: Sample sizes are not explicitly stated for product specification verifications, distribution, shelf-life, reliability, or bench safety (other than the endoscope viewing area comparison).
   • Data Provenance: The studies are non-clinical, primarily bench and animal (porcine) testing. No explicit mention of country of origin for the data or whether it's retrospective/prospective (these terms are more relevant for human clinical studies).

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

   • This information is not provided. For non-AI mechanical devices, the "ground truth" is typically established by engineering specifications, validated test methods, and potentially expert interpretation for things like tissue damage in animal studies. The "users" in usability testing are relevant, but their "qualification" is broadly "intended user population" (medical specialists).

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

   • Not applicable/mentioned for this type of non-clinical device testing.

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 device is a mechanical accessory, not an AI-powered diagnostic tool requiring human reader comparison studies.

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

   • Not applicable. This is a mechanical device, not an algorithm. Bench tests evaluate the device's standalone performance.

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

   • Bench Performance: Engineering specifications and ASTM/ISO standards.
   • Usability: Defined user tasks and absence of serious use errors, likely determined by observation and user feedback against pre-defined criteria.
   • Biocompatibility: ISO 10993 standards and their associated pass/fail criteria (e.g., lack of cytotoxicity, sensitization).
   • Porcine Testing: Visual and histological mucosal damage assessment compared to a control (endoscope-only procedures), suggesting pathology as a component of ground truth for tissue effects.

7. The sample size for the training set:

   • Not applicable. This is not an AI/ML device, so there is no "training set."

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

   • Not applicable.

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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 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 HK-WQ-II are indicated for manipulation of the uterus, and injection of fluids during laparoscopic gynecologic procedures such as lapacervical hysterectomy, minilap tubal ligation, laparoscopic tubal occlusion or diagnostic laparoscopy.

The HK-ZQ-I and HK-ZQ-II are intended for use in laparoscopic procedures where it is desirable to delineate the vaginal fornices and the surgeon intends to remove or access intraperitonial tissue through the vagina by use of a colpotomy or culdotomy incision; such as laparoscopically assisted vaginal hysterectomies, total laparoscopic hysterectomies, while maintaining pneumoperitoneum by sealing the vagina while a colpotomy is performed.

There are four versions of the subject device. HK-WQ-I and HK-WO-II have a curved central guide rod, while the HK-ZQ-I and HK-ZQ-II have a central guide rod which can be rotated (or "flexed") up or down using a dial on the handle.

Each device is a sterile, disposable, single-patient use device which consists of a manipulator shaft with an inflatable intrauterine balloon at the proximal end. The intrauterine balloon is inflated by liquid via a standard syringe injected through the check valve. The internal injection tip of the manipulator shaft is open to allow direct intrauterine introduction of medicine liquid via the injector port. The device also incorporates a vaginal sealing balloon which is inflated by liquid via a standard syringe injected through the check valve to seal the vagina and maintain pneumoperitoneum. The location of the uterus can be adjusted by the handle.

Each device version can be used with a cervical cup. During use, the open-end of the cup rests on the cervix. There are two versions of the cup- a ceramic version and a polyphenylene sulfite version. For both materials, the cup is available in four different sizes - 30mm, 35mm, 40mm and 46mm.

This document is a 510(k) premarket notification for uterine manipulators (HK-WQ-I, HK-WQ-II, HK-ZQ-I, and HK-ZQ-II). As such, it primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a clinical study with detailed performance metrics.

Therefore, much of the requested information (like acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth provenance) is not present in this type of regulatory submission, as these devices are not AI/ML-based.

However, I can extract the information that is available regarding non-clinical performance tests:

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

The document does not provide a table of acceptance criteria with specific numerical targets. Instead, it lists the types of non-clinical performance tests conducted to demonstrate that the subject devices perform similarly to their predicate devices and meet safety requirements. The "reported device performance" is implied to be successful, as the conclusion states that the devices are substantially equivalent.

Non-Clinical Performance Tests Conducted:

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

This information is not provided in the document. The tests are non-clinical (laboratory/benchtop) and do not involve human or patient data in the sense of a clinical study.

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 is not applicable as the studies are non-clinical performance and safety tests, not studies requiring expert interpretation or ground truth establishment in a diagnostic context.

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

Not applicable for non-clinical 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

Not applicable. This device is a manual surgical instrument, not an AI/ML-based diagnostic or assistive technology.

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

Not applicable. This device is a manual surgical instrument, not an algorithm.

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

Not applicable. For non-clinical tests, "ground truth" would be the measured physical properties against a standard or specification.

8. The sample size for the training set

Not applicable. There is no training set as this is not an AI/ML device.

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

Not applicable. There is no training set.

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

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

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

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

Device: Advincula Delineator™ Uterine Manipulator (K180429)

Type of Device: Uterine Manipulator, Class II

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

1. Table of Acceptance Criteria and Reported Device Performance

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

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

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

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

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

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

4. Adjudication Method for the Test Set

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

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

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

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

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

7. The Type of Ground Truth Used

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

8. The Sample Size for the Training Set

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

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

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

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The Unicare System is indicated for manipulation of the uterus and injection of fluids during laparoscopic procedures such as Laparoscopic Assisted Vaginal Hysterectomy (LAVH), Total Laparoscopic Hysterectomy (TLH), minilap, laparoscopic tubal occlusion, or diagnostic laparoscopy and also maintains pneumoperitoneum during a colpotomy.

The Unicare Manipulator is indicated for manipulation of the uterus and injection of fluids during laparoscopic procedures, such as minilap, laparoscopic tubal occlusion, or diagnostic laparoscopy.

The new Unicare System™ is a sterile, disposable, single-use device for manipulation of the uterus and cervix during surgical and diagnostic procedures. The Unicare System™ consists of the Unicare Manipulator™, a rear Stabilizer™, and a set of interchangeable, forward Collars™.

The Unicare Manipulator™ is a rigid, anatomically curved cannula having at its proximal end a tip for insertion into the uterus to manipulate and maintain the proper attitude of the uterus. The Unicare Manipulator incorporates a sliding tube component with a proximal ball that provides a positive stop from over-penetration of the uterine cavity and counter traction with the tip for manipulation. At the distal end of the device is a handle which allows the surgeon to manipulate the uterus to the position most desirable for the procedure being performed. At the extreme distal end of the device is a standard luer port suitable for attachment of a standard syringe for injection of fluids or gases into the uterus through the cannula.

The Unicare System also incorporates a set of interchangeable, forward Collars™ and a rear Stabilizer™. The appropriately sized Collar surrounds the cervix, delineates the fornix, and supports and defines the vaginal wall. The rear Stabilizer and a sliding tube are slid along the cannula to adjust the depth of tip insertion and seal the vaginal cavity from within to maintain pneumoperitoneum and prevent abdominal deflation once the vagina is entered during laparoscopic procedures such as during a colpotomy. The rear Stabilizer and sliding tube components are secured at their proper depth with a locking mechanism situated distal to the sliding tube and external to the patient.

The Unicare Manipulator™ will be offered and sold separately from the Unicare System™. The Unicare Manipulator"™ does not include a rear Stabilizer" or a set of interchangeable, forward Collars", and is therefore indicated only for a subset of procedures of the Unicare System™

This document (K163214) describes a 510(k) submission for the Unicare System & Unicare Manipulator, a uterine manipulator. The submission focuses on demonstrating substantial equivalence to a predicate device (VCARE manufactured by Conmed Corporation, K071907) rather than providing extensive details on a standalone study with human readers or clinical performance.

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

1. Table of acceptance criteria and the reported device performance

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

The document explicitly states: "No clinical testing has been performed in support of this Unicare System™ and Unicare Manipulator™ 510(k) submission." Therefore, there is no test set in the context of clinical data for AI device performance. The testing performed was non-clinical (biocompatibility, mechanical, packaging, sterility, accelerated aging) and involved the physical devices. The sample sizes for these specific non-clinical tests are not detailed beyond "the device was evaluated." Data provenance is not applicable as it was non-clinical lab testing.

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

Not applicable. As no clinical testing was performed, no ground truth was established by experts from patient data.

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

Not applicable. No clinical testing or expert review of clinical data was conducted.

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 MRMC comparative effectiveness study was done. The submission is for a physical medical device, not an AI-assisted diagnostic tool for human readers.

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

No standalone algorithm performance study was done. This is a physical device, not an algorithm.

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

For the non-clinical performance testing (biocompatibility, mechanical, packaging, sterility, accelerated aging), the "ground truth" would be established by the industry standards and methodologies (e.g., ISO and ASTM standards) that define acceptable performance. For instance, for sterility, the ground truth is "sterile" as determined by ISO 11137 standards. For biocompatibility, it's non-cytotoxic, non-irritating, etc., as per ISO 10993 standards.

8. The sample size for the training set

Not applicable. There is no AI algorithm being trained, so no training set is relevant.

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

Not applicable. There is no AI algorithm being trained, so no training set or ground truth for it was established.

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The ColpoWave Colpotomizer and CerviGrip Uterine Manipulator is indicated for use by a surgeon in laparoscopic procedures where uterine manipulation of the position of the vaginal fornices for colpotomy incisions is required, and for maintaining pneumoperitoneum during vaginal vault closure.

The Surgitools Pty Ltd. ColpoWave Colpotomizer and CerviGrip Uterine Manipulator consists of the ColpoWave™ Colpotomizer, CerviGrip™ Uterine Manipulator, and the ColpoWave™ Balloon accessory. All parts are made without natural latex rubber and supplied sterile to be disposed of after use.

The single-use CerviGrip™ Uterine Manipulator is designed with an integrated cervical screw, a sliding uterine tip, tail screw that can lock the uterine tip in place, and a screw to hold the colpotomizer in place. The CerviGrip™ Uterine Manipulator is manufactured with ABS polymer and 304 Stainless Steel.

The ColpoWave™ Colpotomizer is non-fenestrated and has incorporated two different sizes due to the double-ended colpotomizer design (30mm or 40mm diameter). Cup shape with one partial circumferential raised lip at each end and a second partial raised circumferential lip 20mm from each end providing the surgeon with a known distance to help gauge pelvic distances during dissection. The ColpoWave™ Colpotomizer is manufactured with green ABS polymer to provide better visualization (greater contrast than white against tissue).

The ColpoWave™ Balloon is an optional accessory, which is inflated to fit various vaginas.

The provided FDA 510(k) summary for the ColpoWave™ Colpotomizer and CerviGrip™ Uterine Manipulator does not contain information about acceptance criteria and a study that proves the device meets those criteria in the context of clinical performance or diagnostic accuracy. This document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data (bench testing, biocompatibility, sterilization validation, and shelf-life testing).

Therefore, I cannot provide the requested information regarding acceptance criteria and clinical study details (sample size, data provenance, expert ground truth establishment, adjudication, MRMC studies, standalone performance, or training set details) from the provided text.

However, I can extract the non-clinical performance data that was used to demonstrate the device's safety and effectiveness.

Non-Clinical Performance Data

The device's safety and effectiveness and substantial equivalence were demonstrated through the following non-clinical tests:

1. Table of Acceptance Criteria (Implied) and Reported Device Performance:

Since explicit acceptance criteria values are not provided, I will list the type of performance testing and the outcome, implying that the device met the internal requirements, and national/international standards for these tests.

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

Not applicable. The document explicitly states: "There was no human clinical testing required to support the substantial equivalence of the subject device." The tests performed were laboratory-based (bench testing, biocompatibility, sterilization, shelf-life).

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

Not applicable. No clinical test set with corresponding expert ground truth was utilized.

4. Adjudication Method for the Test Set:

Not applicable. No clinical test set or adjudication method was used.

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 surgical instrument, 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 device is a surgical instrument.

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

Not applicable. As no human clinical testing was performed, no clinical ground truth (expert consensus, pathology, outcomes data) was established for the device. The "ground truth" for the non-clinical tests would have been the established performance specifications and regulatory standards for mechanical properties, biocompatibility, sterilization, and shelf life.

8. The sample size for the training set:

Not applicable. This device is a surgical instrument, not a machine learning or AI model that requires a training set.

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

Not applicable. As no training set was used, no ground truth for a training set was established.

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The ManipulatOR is indicated for manipulation of the uterus during laparoscopic procedures including laparoscopic assisted vaginal hysterectomy (LAVH), laparoscopic tubal occlusion, and diagnostic laparoscopy. The ManipulatOR, when used together with the McCartney Tube, is indicated for manipulation of the uterus during laparoscopic procedures requiring maintenance of pneumoperitoneum, such as total laparoscopic hysterectomy (TLH).

The ManipulatOR PRO is indicated for manipulation of the uterus during laparoscopic procedures such as laparoscopic assisted vaginal hysterectomy (LAVH), total laparoscopic hysterectomy (TLH), laparoscopic tubal occlusion and diagnostic laparoscopy. The ManipulatOR PRO maintains pneumoperitoneum by sealing the vagina once colpotomy is performed.

The ManipulatOR and ManipulatOR PRO are sterile, single-use uterine manipulators indicated for uterine manipulation and preventing loss of pneumoperitoneum during laparoscopic gynecology procedures. The ManipulatOR and ManipulatOR PRO are silicone insulated and anatomically designed stainless steel manipulators with a silicone intrauterine balloon at one end and an external handle at the other end. The balloon is inflated with air using a 20cc syringe that is supplied with the device.

The ManipulatOR and ManipulatOR PRO are designed to improve physician visibility of the uterus and cervix during various medical examinations and procedures. Like many uterine elevators currently in the market place, the ManipulatOR and ManipulatOR PRO are designed for use in surgical procedures requiring cervical uterine motions with elevation and retraction of the vaginal fornices. The ManipulatOR and ManipulatOR PRO can help to create the tension on the tissue to assist in ligament dissection. In the most commonly used procedure, the total laparoscopic hysterectomy, the uterine elevator must expose the fornix and seal the vagina following removal of the uterus.

The provided document is a 510(k) summary for the Gynetech ManipulatOR and ManipulatOR PRO devices. It describes the devices, their intended use, and claims substantial equivalence to previously cleared predicate devices.

However, the document does not contain information about acceptance criteria, detailed study designs, specific device performance metrics, sample sizes for test or training sets, ground truth establishment, or expert involvement for a performance study.

Instead, the document primarily focuses on:

• Indications for Use: What the device is cleared to do.
• Technological Characteristics: How the device is similar to and different from its predicate, largely related to material changes (addition of colorants).
• Performance (mention only): A general statement that the devices were subjected to safety and performance testing for the initial 510(k) review and passed biocompatibility testing. It states this testing "demonstrated the functionality and safety of the device for its intended use."

Therefore, based solely on the provided text, I cannot complete the requested tables and information about acceptance criteria and a study proving device performance in detail.

The document states: "The ManipulatOR and ManipulatOR PRO were subjected to safety and performance testing by the manufacturer for the initial 510(k) review." and "The performance testing undertaken for the initial 510(k) review demonstrated the functionality and safety of the device for its intended use." This is a summary statement, not a detailed report of a performance study. No specific metrics like sensitivity, specificity, accuracy, or other quantitative performance measures are given.

In the context of 510(k) submissions, "performance testing" often refers to engineering and bench testing to ensure the device meets its design specifications and safety requirements, rather than a clinical study evaluating diagnostic accuracy or reader improvement. The described changes (colorants) are material changes, and the associated performance testing would likely be focused on biocompatibility and mechanical property verification, not a clinical study of efficacy.

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