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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 Transvaginal Access Platform is intended to be inserted transvaginally to establish a path of entry for minimally invasive instruments while maintaining insufflation during laparoscopic-assisted and vaginal gynecological procedures. The device is also a conduit for the extraction of specimens.

The Transvaginal Access Platform consists of an access channel component that is placed transvaginally to create a pathway to gynecological organs in the pelvic cavity. A GelSeal cap attaches to the access channel at the opening of the vagina. The cap allows for insufflation and smoke evacuation. Sleeves inserted through the cap allow for passage of 5mm to 12mm laparoscopic instrumentation. Visualization is achieved via introduction of an endoscope through a sleeve. The device is provided sterile.

The Acceptance Criteria and supporting study information are derived from the "Discussion of Performance Data" and "Comparison with the Predicate Device" sections of the provided text.

Here's a breakdown of the requested information:

1. A 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)

• Sample Size:
  • Baekelandt et al. (2018) study: n=70
  • iNOTESs Society Registry data: n=906
• Data Provenance: The document does not specify the country of origin for either dataset.
  • Baekelandt et al. (2018): Randomized, single-center, single-blinded trial (Prospective).
  • iNOTESs Society Registry data: Registry data (Likely prospective, though details aren't fully specified).

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

This information is not provided in the document. The studies report "acceptable rates of peri- and post-operative complications," implying clinical assessment, but the number or qualifications of experts involved in determining these outcomes are not detailed.

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

This information is not provided in the document.

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 study was done that involved AI vs. human readers. The studies described (Baekelandt et al. and iNOTESs Registry) are clinical performance studies of a medical device (Transvaginal Access Platform), not an AI diagnostic tool. They compare different surgical approaches or document outcomes with the device.

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

• Not applicable. The device is a physical surgical access platform, not an algorithm. Therefore, no standalone algorithm performance study was performed.

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

• The ground truth for the clinical performance criteria ("acceptable rates of peri- and post-operative complications") appears to be clinical outcomes data, likely assessed by healthcare professionals involved in the care of the patients. This would include direct observation, patient follow-up, and review of medical records for complications.

8. The sample size for the training set

• Not applicable. This device is a physical medical device, not an AI or machine learning algorithm. Therefore, there is no "training set."

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

• Not applicable. As there is no training set for an AI algorithm, this question is not relevant.

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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 GelPOINT Transvaginal Access Platform is intended to be inserted transvaginally to establish a path of entry for minimally invasive instruments while maintaining pneumoperitoneum during laparoscopic hysterectomy. The instrument is indicated for use in laparoscopic assisted vaginal hysterectomies. The instrument is also a conduit for the extraction of specimens.

The GelPOINT Transvaginal Access Platform is a sterile, single use instrument that allows access to the vagina to perform laparoscopic assisted hysterectomy. The device consists of a cannula with suture ties, and a cap made of a flexible gel-like material. The gel cap has two stopcocks that can be used for insufflation or smoke evacuation. Four trocars are included and may be placed through the gel cap. The trocars allow insertion of standard laparoscopic instruments into the vagina. Construction materials include various polymers, silicone and stainless steel.

Packaging consists of a PTEG tray that is placed in a Tyvek/Mylar pouch and shipped in a carton. Sterilization is via Gamma irradiation; sterility assurance level is 10°.

This document describes the GelPOINT Transvaginal Access Platform, Models: C2A00, C2A01, C2A02, and its substantial equivalence to a predicate device. However, the provided text does not contain the specific acceptance criteria, detailed study results, or information about the study design typically requested for a detailed AI device evaluation.

The document focuses on the regulatory submission (510(k)) for a medical device that facilitates laparoscopic hysterectomies and specimen extraction. The performance data presented is for biocompatibility and mechanical testing of the physical device, not for an AI algorithm.

Therefore, I cannot populate the requested table and sections with information about AI acceptance criteria, device performance, sample sizes, expert involvement, or ground truth for an AI algorithm, as this information is not present in the provided text.

Here's what can be extracted and what is missing, based on your request and the provided text:

Information based on the provided text (for a physical medical device, not an AI):

Study that Proves the Device Meets Acceptance Criteria (as described in the text):

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

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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 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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The Singh Colpotomizer System is indicated for use by a surgeon in laparoscopic procedures where uterine manipulation and visualization of the position of the vaginal fornices for colpotomy incisions is required. The surgeon makes the colpotomy incisions to access or remove intraperitoneal tissue.

The Singh Colpotomizer System is comprised of a reusable uterine manipulator with cervical screw attachment, a reusable sliding uterine tip (inner rod), reusable sliding and rotating funnels with a lip acting as a colpotomizer, an O ring and screw to hold the funnel in place, and a vaginal plug. The funnels are available in two sizes: 35 and 40mm.

In Laparoscopic Hysterectomy, the Uterine Cannula is inserted into the Uterus. The Vaginal Funnel slides onto the Uterine Cannula and is rotated manually during the operation to lift the Vaginal Wall for identification and incision during Laparoscopic Hysterectomy. This identifies the uterine arteries and ureters during this procedure.

Stainless steel and medical grade plastics are used in the manufacture of the subject device.

The provided text describes a submission for a medical device called the "Singh Colpotomizer System" for 510(k) clearance, asserting substantial equivalence to the previously cleared "Koh Colpotomizer System." The document focuses on non-clinical and clinical data to support this claim, rather than defining explicit acceptance criteria and then proving the device meets those criteria with a study.

Instead, the submission presents data from the device's clinical use and then concludes that these data, along with non-clinical testing, show the device does not raise new questions of safety and effectiveness compared to the predicate device. Therefore, the "acceptance criteria" can be inferred from the adverse events and successful outcomes reported.

Here's an attempt to structure the information based on your request, acknowledging that explicit "acceptance criteria" tables are not directly provided in the text in the way you've requested for AI device evaluations.

Inferred Acceptance Criteria and Reported Device Performance

Given the nature of this 510(k) submission, the "acceptance criteria" are not explicitly stated as numerical thresholds for device performance like sensitivity or specificity. Instead, they are implicitly tied to maintaining safety and effectiveness comparable to the predicate device, with a focus on acceptable rates of complications and successful procedure completion.

Note: The "acceptance criteria" above are inferred from the adverse events and successful outcomes reported to demonstrate that the device is safe and effective and does not raise new questions compared to its predicate. Specific numerical thresholds for "low incidence" are not defined in the provided text.

Study Information

Due to the nature of this being a 510(k) submission for a surgical instrument rather than an AI/software device, many of the requested categories (like sample size for test set, ground truth experts, MRMC studies, standalone performance, training set details) are not directly applicable or explicitly detailed in the provided text. However, I will answer what can be inferred or directly stated.

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

   • Sample Size: 2148 cases.
   • Data Provenance: Clinical performance data from the clinical use of the device in Western Australia since 2002. This is retrospective data from real-world use.

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 as the study is a retrospective review of clinical use. The "ground truth" for reported adverse events and successful completion would have been established by the operating surgeons and medical records, rather than a panel of independent experts reviewing cases for a specific "ground truth" determination in the context of an AI device.

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

   • This is not applicable and not mentioned. The data are from routine clinical use and records, not an adjudicated test set in the context of an AI algorithm.

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:

   • No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted as this device is a surgical instrument, not an AI or imaging diagnostic tool.

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

   • No, this is not applicable for a surgical instrument. The device is used by a surgeon who is always "in-the-loop."

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

   • The "ground truth" for the reported outcomes (adverse events, successful procedure completion, pneumoperitoneum maintenance) is based on outcomes data from routine clinical practice and medical records, as recorded by the operating surgeons and healthcare facilities.

7. The sample size for the training set:

   • This concept is not applicable. The device is a physical surgical instrument; there is no "training set" in the context of machine learning. The clinical performance data (2148 cases) represents real-world usage data.

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

   • Not applicable, as there is no "training set" in the machine learning sense for this device.

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The McCartney Access Tube is intended to be inserted transvaginally to establish a path of entry for minimally invasive instruments and as a template for dissection, while maintaining pneumoperitoneum during laparoscopic hysterectomy. The instrument is indicated for use in laparoscopically assisted vaginal hysterectomies. The instrument is also a conduit for the extraction of specimens.

The McCartney Access Tube is a sterile, single use instrument consisting of a silicone rubber tube, a polypropylene body and a silicone rubber cap. The McCartney Access Tube is available in 35mm and 45mm diameters. The instrument is packaged with a stopcock that can be inserted on the cap in order to insufflate and desufflate the peritoneum along with minizing gas leakage. The cap has two valves for 5mm and 10mm minimally invasive instrument access. The distal end of the silicone rubber tube is beveled and has a textured surface for internal identification.

The provided document is a 510(k) Summary of Safety and Effectiveness Information for the McCartney Access Tube dated August 29, 2005. This type of regulatory submission is for medical devices and focuses on establishing substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical studies or setting performance acceptance criteria with detailed statistical analysis as is common for AI/ML-driven devices.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, and ground truth establishment is not present in this document, as it falls outside the scope of a traditional 510(k) for a non-AI/ML device.

Specifically:

1. A table of acceptance criteria and the reported device performance: Not applicable. The document focuses on demonstrating substantial equivalence to a predicate device based on intended use, design, and materials, not on specific performance metrics or acceptance criteria for statistical-based outcomes.
2. Sample size used for the test set and the data provenance: Not applicable. No clinical test set data or study details are provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set requiring expert ground truth is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set requiring adjudication is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-driven device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI-driven device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No study requiring ground truth is described.
8. The sample size for the training set: Not applicable. This is not an AI-driven device, so there is no training set.
9. How the ground truth for the training set was established: Not applicable. This is not an AI-driven device, so there is no training set or associated ground truth.

Summary of Device Acceptance (from the provided document):

The acceptance of the McCartney Access Tube is based on the FDA's determination of substantial equivalence to a legally marketed predicate device (KOH Colpotomizer System, K954311). This means the FDA found that the new device is as safe and effective as the predicate device.

The FDA's letter states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."

The "study" or evidence proving this equivalence relies on:

• Comparison of Intended Use: The McCartney Access Tube has a "similar intended use" to the predicate device.
• Comparison of Technological Characteristics: While the McCartney Access Tube has a "different design and constructed of different materials" from the predicate, the 510(k) process concludes that these differences do not raise new questions of safety or effectiveness. The document itself does not detail specific performance characteristics or comparison points other than stating similarity in intended use. It's implicit that the manufacturer provided sufficient information (e.g., bench testing, material safety data) to convince the FDA that the new design/materials do not alter its fundamental safety and effectiveness in its intended application.

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The Manipuseal device is indicated for use in all laparoscopic surgical procedures where use of a uterine manipulator is appropriate and the surgeon intends to remove intraperitoneal tissue through the vagina by use of a colpotomy on culdotomy incision.

The Manipuseal device is comprised of an occluding balloon, Manipuseal uterine manipulator and tip, and a CO2 Port. Manipulator consists of a toroidal or doughnut shaped balloon that is manufactured from silicone. The occluding balloon is designed to be inflated using a maximum of 180 ml of room air. The occluding balloon is an integral part of the Manipuseal device and is neither replaceable nor removable. The occluding balloon is filled using a commercially available 50 ml The occluding balloon occludes the vagina, while the Manipuseal syringe. manipulator is positioned in the patient and is used for manipulation. The Manipuseal is a standard uterine manipulator, which consists of a handle, body and tip made from Acrylonitrate-Butadiene-Styrene (ABS). Once the manipulator tip is positioned in the cervix, the surgeon then commences the laparoscopic portion of the procedure. By moving the Manipuseal handle outside of the patient, the tip of the device moves, therefore positioning the cervix/uterus to provide a clearer view of the surgical field. The Manipuseal provides full anteversion, retroversion, and lateral motion for greater visibility and uterine movement. The CO2 port is made up of a standard luer connection and is color coded green for easy identification. The insufflator is connected to the luer lock connector using a standard insufflator tube with an inline filter. The insufflator's maximum deliverable pressure is 14-16 mm Hg. It is also possible to produce pneumoperitoneum by connecting the insufflator to the trocar ports (a standard laparoscopic procedure).

The provided document is a 510(k) summary for the "In Situ Systems Manipuseal," a uterine manipulator/occluder. It details the device, its intended use, predicate devices, and performance testing, among other things. However, it does not explicitly define acceptance criteria in terms of specific quantitative metrics (e.g., accuracy, sensitivity, specificity thresholds) for a device meant to be proven against such criteria.

The "studies" mentioned are limited to:

• Biocompatibility testing: This indicated the device "is biocompatible." No specific acceptance criteria or detailed results are provided.
• Occluder Balloon burst testing: This showed the balloon "can withstand burst testing up to 2.5 times the recommended inflation." No specific acceptance criteria (e.g., minimum burst pressure) or detailed results are provided.
• Clinical study: This study "demonstrated that the Manipuseal was associated with less short term morbidity and a faster recovery rate during either abdominal or vaginal hysterectomy procedures in 358 patients." No explicit acceptance criteria or detailed results beyond this qualitative statement are provided.

Given the nature of the device (a physical surgical instrument) and the context of a 510(k) submission seeking substantial equivalence to predicate devices, the "acceptance criteria" are generally implied to be that the device performs safely and effectively for its intended use, similar to the predicate devices. The studies conducted aim to demonstrate this, rather than meet specific numerical performance thresholds typically associated with AI/software devices.

Therefore, many of the requested elements for AI/software device evaluation (like sample size for test sets, data provenance, ground truth establishment by experts, MRMC studies, standalone performance, training set details) are not applicable or not provided in this type of submission for a physical medical device.

However, based on the provided text, I can extract the relevant information and indicate where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria are "implied" as specific quantitative thresholds (e.g., "burst pressure must be > X mmHg") are not explicitly stated in the document.

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

• Sample Size for the Clinical Study: 358 patients.
• Data Provenance: New Zealand (retrospective or prospective status is not specified, but typically clinical studies are prospective, though the document does not confirm this.)

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

• Not Applicable / Not Provided. For a physical device like a uterine manipulator, "ground truth" as conceptualized for AI/diagnostic devices (e.g., expert consensus on image findings) is not relevant. The "ground truth" here is the clinical outcomes and safety observed in patients. Clinical judgments in the study would have been made by the surgeons and medical staff involved, who are implicitly qualified by their roles.

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

• Not Applicable / Not Provided. This concept is specific to studies where multiple readers interpret data and reconcile disagreements. For a clinical study observing patient outcomes with a physical device, this type of adjudication is not typically performed or relevant.

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. This is a physical medical device, not an AI or diagnostic imaging device. An MRMC study is not relevant.

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

• No. This question is not applicable to a physical medical device.

7. The type of ground truth used

• Clinical Outcomes/Safety Data: The "ground truth" effectively derived from patient outcomes (morbidity, recovery rate) as observed in the clinical study.

8. The sample size for the training set

• Not Applicable / Not Provided. This question is for AI/machine learning models. For a physical device, there is no "training set." The device is designed, manufactured, and then tested.

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

• Not Applicable / Not Provided. As there is no training set for a physical device, this question is not relevant.

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