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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 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 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 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 Supra-Cervical Hysterectomy (LSH).

The CooperSurgical Advincula Delineator™ Uterine Manipulator is a single use device, supplied sterile to the end user. It includes a cup shaped sliding colpo-pneumo occluder used to delineate the vaginal fornices, providing an anatomical marker to facilitate resection of the uterus, and a balloon to occlude the vaginal vault to maintain pneumoperitoneum during uterine resection.

The provided document is a 510(k) summary for the CooperSurgical Advincula Delineator™ Uterine Manipulator. It focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a study to prove a device meets those criteria from an AI/algorithm performance perspective.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, sample size for training set, how ground truth for training set was established) are not applicable to this type of medical device submission. This document describes a physical medical device, not an AI or algorithmic device.

However, I can extract the relevant performance data and conclusions presented in the document based on the provided text.

Here's a breakdown of the information that is available in the document, formatted as requested where possible:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative manner as one would for an AI algorithm (e.g., "sensitivity must be > 90%"). Instead, performance assessments were conducted to ensure the device performs comparably to its predicate and is safe and effective. The "acceptance" is implied by demonstrating substantial equivalence.

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

• Sample Size: Not specified in the 510(k) summary. These would typically be engineering bench tests involving a certain number of manufactured units, not patient data.
• Data Provenance: Not applicable as this relates to bench testing of a physical device, not patient data or geographical origin of data.
• Retrospective/Prospective: Not applicable.

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

• Not Applicable. This is a physical device, not an AI or image-based diagnostic tool requiring expert ground truth for performance evaluation of an algorithm. "Ground truth" for this device would be established by engineering specifications and physical measurements.

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

• Not Applicable. This relates to clinical interpretations, not bench testing of a physical device.

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 or diagnostic tool.

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

• Not Applicable. This is not an AI or algorithmic device.

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

• Not Applicable in the traditional sense. The "ground truth" for this device's performance would be derived from engineering specifications, material properties testing, and comparison to the predicate device's established performance through bench testing (e.g., measuring actual burst volume, tensile strength, confirming no leakage).

8. The sample size for the training set

• Not Applicable. This is not an AI or machine learning device that requires a training set.

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

• Not Applicable. This is not an AI or machine learning device.

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The Kronner Side-Kick is intended to assist the surgical staff in mounting, positioning and holding a uterine manipulator during gynecological laparoscopic surgical procedures. It is intended for use by trained operating room personnel in an operating room environment.

For holding uterine manipulators during laparoscopic or open surgery on female pelvic organs.

The Kronner Side-Kick uterine manipulator holder is used to mount, position and hold in position uterine or vaginal manipulators used in laparoscopic surgical procedures. It is made mostly from aluminum and stainless steel and is mounted to standard operating room tables and locked in position allowing surgical devices to be securely held in position for long periods of time. Use of the Sidek-Kick frees operating room staff for other activities and reduces fatigue associated with manually maintaining a device in position during surgical procedures.

The manipulator is inserted into the patient using standard technique, then the Side-Kick is joined to the manipulator.

With proper adapters the Side-Kick may be used with various manipulators, such as the RUMI, the V-Care and the Arch Koh,

A gas supply module, which can be attached to the operating table rail, transfers nitrogen or compressed air from the wall or a portable tank to the Side-Kick holder through two flexible lines. When the switch is turned on the Side-Kick joints are locked. When the switch is turned off the Side-Kick joints are unlocked.

Pressing a foot pedal releases all the Side-Kick joints for position changes. When the foot pedal is released the joints lock. The foot pedal is connected to the gas supply module through two lines covered by a protective hose.

A branched gas line connects the two luers of the Arm assembly to the gas supply module. A single gas line connects the gas supply module to the main pivot.

The Kronner Side-Kick remains external to the patient's body at all times.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Set

The provided document states "Kronner Sidekick and Sidekick uterine manipulator adapters are factory tested." This implies that all manufactured units undergo this testing. Therefore, the sample size for the test set would be 100% of the production units. The data provenance is prospective, from factory testing conducted by Kronner Prototypes, Inc. The country of origin is not explicitly stated but is implied to be the USA, given the company's address (Roseburg, OR) and submission to the FDA.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

The document does not mention the use of external experts to establish ground truth for the factory acceptance testing. The testing appears to be internal to Kronner Prototypes, Inc., and overseen by their design analysis and quality control processes.

4. Adjudication Method (Test Set)

No formal adjudication method (like 2+1 or 3+1) is described for the factory testing. The criteria are likely assessed against predefined specifications by internal personnel.

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

No multi-reader multi-case (MRMC) comparative effectiveness study was mentioned in the provided document. The device is a physical holder, not an imaging or diagnostic AI tool that would typically involve such a study to compare human reader performance with and without AI assistance.

6. Standalone Performance Study

Yes, a standalone performance study was conducted in the form of "factory testing." The results of this testing are what is described under the "Reported Device Performance" in the table above. The document emphasizes that "Design analysis and testing has been conducted to confirm that basic functional characteristics of the subject device is substantially equivalent to the predicate device cited, and that design output meets the design input requirements." This pertains to the standalone performance of the device itself.

7. Type of Ground Truth Used

The ground truth used for the factory testing is based on predefined design input requirements and functional specifications for the device. These specifications would dictate what constitutes "satisfactory attachment," "required range of motion," "required strength," and proper performance and assembly.

8. Sample Size for Training Set

The concept of a "training set" is not applicable to this device. The Kronner Side-Kick Uterine Manipulator Holder is a physical medical device, not an AI or machine learning algorithm that requires a dataset for training.

9. How Ground Truth for Training Set Was Established

As there is no training set for a physical device, this question is not applicable.

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The LSI Solutions® ForniSee™ is intended for use as a uterine manipulator in laparoscopic hysterectomy surgical procedures to identify the vaginal fornices and manipulate the uterus.

LSI SOLUTIONS® ForniSee™ System will provide aid in the tissue manipulation typically encountered in patients requiring a hysterectomy. The ForniSee™ System provides single-patient use FS Devices and its companion reusable FS Sounds; these components are made from common surgical metals and polymers. Sterile disposable, mostly plastic, FS Device surgical hand tools will be offered in three different sizes designated as either FS-30, FS-35 or FS-40, with the number indicating the increasing diameter of the inside of the device's distal cervical cups. The FS Device is designed with an optional integrated vaginal illumination component. FS Sounds are reusable implements, which are essentially customized angled shafts or sounds constructed of cleanable and resterilizable surgical quality metal; the distal ends of these FS Sounds will be offered in four different sizes ranging in length from 6 to 8 to 10 to 12cm. FS Devices fit over FS Sounds to provide an effective means of uterine manipulation during laparoscopic surgery. FS Devices and FS Sounds will be manufactured at our facility in Victor, New York.

The LSI SOLUTIONS® ForniSee™ System Uterine Manipulator and Accessories, a medical device intended for use as a uterine manipulator in laparoscopic hysterectomy surgical procedures, demonstrated its effectiveness and safety through various performance tests and clinical studies.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the LSI SOLUTIONS® ForniSee™ System are implicitly derived from the successful outcomes observed during its clinical performance testing and the comparison to the predicate device. The primary criteria revolve around safe and effective uterine manipulation and delineation of vaginal fornices during laparoscopic hysterectomy procedures, without causing device-related adverse events, maintaining pneumoperitoneum, and facilitating successful surgical outcomes.

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

• Sample Size: 50 elective hysterectomy patients.
• Data Provenance: Prospective. The clinical performance testing was achieved through Institutional Review Board (IRB) approved studies. The studies were conducted at two separate medical centers within the USA, each with its own gynecological surgeon Principal Investigator (PI).

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

• Number of Experts: At least two gynecological surgeon Principal Investigators (PIs) (one at each medical center) were involved in conducting the studies and evaluating the device's performance.
• Qualifications: The experts were described as "gynecological surgeon Principal Investigator (PI)s." While specific experience levels (e.g., "10 years of experience") are not provided, their role as PIs in IRB-approved surgical studies implies significant clinical expertise in gynecological surgery and hysterectomy procedures.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method for the test set in the traditional sense of resolving discrepancies between multiple independent expert assessments of an outcome.

Instead, the clinical performance results were directly reported by the "gynecological surgeon Principal Investigator (PI)s" at each of the two medical centers. Observations and outcomes, including adverse events, estimated blood loss, pneumoperitoneum maintenance, and overall effectiveness, were reported by these PIs. For example, "Several minor intra-operative observations were noted but deemed by the PIs as expected in their patients or of no significant consequence." This suggests that the PIs' individual clinical judgment served as the primary basis for evaluating events and outcomes.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly described or performed. The study focused on the standalone performance of the ForniSee™ system in a clinical setting, without directly comparing its AI-assisted performance (as no AI component is mentioned) against human readers or human readers without AI assistance. The comparison was primarily against a predicate device's technological characteristics and overall intended use, not its clinical outcomes in a head-to-head MRMC trial.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Yes, from the perspective of the device itself (not an algorithm in the AI sense), a standalone performance assessment was conducted through the clinical study. The ForniSee™ System was used by surgeons in a real-world surgical setting, and its direct performance (e.g., ability to manipulate the uterus, identify fornices, maintain pneumoperitoneum) was evaluated by the operating surgeons (PIs). The study assessed the device's efficacy and safety when used as intended, independent of a comparison to a human performing the task without the device.

7. Type of Ground Truth Used

The ground truth for the clinical performance testing was established by expert clinical assessment and surgical outcomes data. The PIs (gynecological surgeons) directly observed and assessed the device's performance during surgery, recorded clinical outcomes (e.g., successful hysterectomy, blood loss, pneumoperitoneum maintenance, adverse events), and conducted post-operative follow-ups. This involved:

• Clinical observation: Direct assessment by operating surgeons of the device's functionality and impact during the procedure.
• Surgical outcomes: Documentation of successful completion of the hysterectomy, conversion rates, and intra-operative issues.
• Patient follow-up: Post-operative examinations and patient reports to assess recovery and any long-term complications.

8. Sample Size for the Training Set

The document does not mention a "training set" in the context of an algorithm or AI development. The device is a mechanical uterine manipulator, not an algorithm that requires a training set. The "development" of the product line involved "Cadaver research" and extensive "non-clinical tests" (biocompatibility, sterilization, aging, shipping, bench testing), which serve as pre-clinical development and validation phases, rather than a "training set" for an algorithm.

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

Since the device is a mechanical instrument and not an AI algorithm, there is no "training set" in the conventional sense of machine learning, nor a "ground truth" to be established for such a training set. The development process, including "Cadaver research" and extensive "non-clinical tests," provided data and insights that informed the device's design and confirmed its physical and material properties, but this is distinct from establishing ground truth for algorithmic training.

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This Utenine Manipulator Injector (Model UMI-4,5) is indicated for use in Diagnostic Laparotomy, Minilaparotomy, Fertility, Examinations, and Salpingoplastic procedures where manification of the uterus is required. This product also facilitates, the sealing of cervical os while providing a fluid injection port.

Panpac Uterine Manipulator Injector, Model UMI-4.5

I apologize, but the provided text focuses on an FDA clearance letter for a medical device called the "Panpac Uterine Manipulator Injector (Model UMI - 4.5)". This type of document is a regulatory approval, not a scientific study report.

Therefore, the information required to populate a table of acceptance criteria, device performance, and details about a study with sample sizes, expert qualifications, adjudication methods, or ground truth types is not present in the provided text.

The document confirms that the device is "substantially equivalent" to legally marketed predicate devices, which is a regulatory standard, not a performance metric from a specific study as you've requested. It primarily deals with the administrative aspects of FDA clearance.

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Ask a specific question about this device