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The VR Medical VCare 1000-300S Negative Pressure Wound Therapy System is an integrated wound management system, indicated for wound management via the application of negative pressure to the wound, in order for the removal of fluids, including wound exudates, irrigation fluids, body fluids and infectious materials. The system is intended for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.

The VR Medical VCare 1000-300S System is an AC-Powered portable suction device, with battery backup, that provides localized negative pressure when used with the VR Medical Perme-Foam Dressing to remove fluid, irrigation solutions and infectious materials from the wound. The systems consist of a powered suction pump device with a built-in placement holder for the disposable fluid collection canister, and a foam dressing kit. The kit consists of polyurethane foam, suction bell with connecting (drainage) tube and clamp, and polyurethane drape. The single-use foam dressing kit is packaged in a PE/PET peel pouch bag, which is gamma sterilized.

The Foam Dressing Kit (VR Medical Perme-Foam Dressing) can be sold alone or as a part of the VCare 1000-300S System in two sizes:

• Large foam dressing kit
• Medium foam dressing kit
• The Foam Dressing can be used for up to 72 hours of continuous use.

The provided text describes a 510(k) premarket notification for the VR Medical VCare 1000-300S System, a negative pressure wound therapy device. This document details the device's technical specifications and the testing conducted to demonstrate its substantial equivalence to predicate devices, rather than a study proving the device meets an acceptance criterion for diagnostic or screening performance.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" related to diagnostic performance (like sample size for test set, ground truth, experts, MRMC study, standalone performance) are not applicable or cannot be extracted from this document as it pertains to a medical device's physical and functional performance, safety, and equivalence, not its diagnostic or clinical efficacy in the traditional sense of an AI/imaging device.

However, I can extract information regarding the performance data (non-clinical tests) used to demonstrate substantial equivalence to predicate devices. While not "acceptance criteria" in the sense of a clinical trial's endpoint for AI performance, they serve as the "criteria" the device had to meet to be considered substantially equivalent.

Here's the information extracted and adapted to the best fit given the document's content:

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

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

• The document does not specify sample sizes for "test sets" in the context of diagnostic accuracy. The testing described is bench testing for device functionality, safety, and biocompatibility. For biocompatibility, it states "Perme-Foam Dressing samples were tested," but does not explicitly state the number of samples.
• Data provenance is not provided, other than the manufacturer being in China. The testing appears to be non-clinical (bench testing) rather than clinical data from patients or a specific country.

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 not a diagnostic device for which expert ground truth would be established. The "ground truth" for these tests are the standards themselves (e.g., IEC, ISO, functional specifications).

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

• Not applicable. Adjudication methods are typically for clinical case interpretation in diagnostic studies.

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 a negative pressure wound therapy device, not an AI-assisted diagnostic or imaging device.

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

• Not applicable. This is a physical medical device, not an algorithm, and the testing focuses on its physical and functional performance, not diagnostic accuracy.

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

• For the non-clinical tests, the "ground truth" refers to the established engineering and safety standards (e.g., IEC 60601-1, ISO 10993 series) and the device's functional specifications (e.g., delivering specific negative pressure, battery life). For biocompatibility, the ground truth is the successful passing of the specified ISO standard tests.

8. The sample size for the training set

• Not applicable. This device does not involve a "training set" in the context of an AI algorithm.

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

• Not applicable. This device does not involve a "training set" in the context of an AI algorithm.

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The ConMed VCARE® Retractor/Elevator is indicated for manipulation of the uterus, and iniection of fluids or gases 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 by sealing the vagina once colpotomy is performed.

The modified VCARE® (Vaqinal-Cervical-Ahluwalia's-Retractor-Elevator) ("VCARE") is a disposable, single-use device for manipulation of the uterus and cervix in surgical and diagnostic procedures. The modified VCARE consists of an insulated manipulator tube having an inflatable balloon at its distal [to user] end and an anatomically configured cannula/handle for maintaining proper attitude of the uterus at the proximal end. The insulated manipulator tube is marked with reference graduations from the distal end (centimeters). The graduations are provided as a guide for comparison to a graduated uterine sound. VCARE incorporates a cervical cup to provide manipulation of the uterus, and retraction and elevation of the cervix. There are four (4) size variations of cervical cups - Small (S), Medium (M), Large (L), and Extra-Large (XL). The cervical cups are green and provide a colpotomy quide. Sites for suturing are located on the cervical cup. Differences between the predicate device and the modified VCARE improve device performance and functionality for uterine manipulation during the indicated procedures and are limited to: 1) New occluder design for sealing pneumoperitoneum once colpotomy is performed, 2) Improved handle design, and 3) Revised component retention mechanism and balloon length.

The provided documentation is a 510(k) Summary of Safety and Effectiveness for the ConMed VCARE® (Vaginal-Cervical-Ahluwalia's-Retractor-Elevator). This submission aims to demonstrate substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria in a detailed clinical study with a defined ground truth.

Therefore, many of the requested elements about acceptance criteria, study design, expert involvement, and ground truth establishment are not explicitly present in the provided text. The submission focuses on non-clinical performance testing and a comparison to a predicate device.

Here's an analysis of the provided information relative to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of acceptance criteria with specific quantitative targets and corresponding reported device performance. Instead, it broadly states that "Design verification demonstrates devices comply with design specifications and applicable sections" of various ISO and AAMI/ANSI standards. The "performance" is described in qualitative terms or by stating equivalence to the predicate.

The following table summarizes the types of performance aspects tested and the general conclusion, as specific numerical acceptance criteria are not provided.

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

• Test Set Sample Size: Not explicitly stated. The document refers to "non-clinical bench and simulated use testing" and "product bench testing," but does not provide specific sample sizes (e.g., number of devices tested).
• Data Provenance: The testing appears to be internal research and development ("design verification," "design validation testing") conducted by ConMed Corporation. The country of origin for the data is implied to be the United States, given that ConMed Corporation is based in Utica, NY. The testing is described as "simulated use environments," indicating prospective testing within a laboratory or controlled setting.

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

This information is not provided. The testing described is primarily engineering and materials performance, not diagnostic performance requiring expert interpretation for ground truth. The document mentions "user review and feedback" as a basis for design improvements, suggesting input from medical professionals indirectly informed the design, but not as part of a formal ground truth establishment for a test set.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of adjudication, as the tests described are objective, non-clinical performance assessments (e.g., material strength, sealing ability, compliance with standards).

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

No. This is not an AI/algorithm-based device, nor is it a diagnostic device where MRMC studies are typically performed. The device is a surgical instrument.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No. This question is not applicable as the device is a physical surgical instrument, not an AI algorithm.

7. The Type of Ground Truth Used

For the non-clinical performance and material testing, the "ground truth" would be the engineering specifications, relevant ISO/AAMI standards, and established physical/chemical properties. For "usability" and "ergonomics," implicit "ground truth" would derive from user feedback and design requirements aimed at surgical efficacy and safety, but not a formally defined ground truth in the context of diagnostic accuracy.

8. The Sample Size for the Training Set

Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI algorithms. The design process involves iterative development, testing, and refinement, but not a formally defined training set.

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

Not applicable. See point 8.

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The Vcare a is intended for wound management via application of continual or intermittent negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. It is indicated for management of chronic, acute, traumatic, sub-acute and dehisced wounds. partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. The Vcare a may promote healing by removal of excess exudates, irrigation fluids, and infectious material.

The Vcare a - is a Negative Pressure Wound Therapy system that comprises fixed components and disposables. The Vcare a maintains the functionality of existing devices while enhancing safety. The system has features that optimize the delivery of negative pressure to open wounds. The software requires the user to profile the patient and the system then limits the device's operational parameters to be compatible with the patient profile. The system incorporates safety features that control the system to prevent risk to the patient. The sensors and controls monitor and maintain target pressure and alarms, as needed, to help assure that target pressure is maintained and constant therapy is delivered. The safety features of the system include additional alarms, such as those that signal for possible bleeding, tubing blockage, a full or missing collection canister, inactive therapy, low battery and leaks in the seal of the dressing.

The provided text is a 510(k) summary for the Vcare a Negative Pressure Wound Therapy (NPWT) device. It describes the device, its intended use, and compares it to a predicate device (V.A.C. Therapy System). However, it does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria related to a diagnostic or AI-driven performance study.

The document is focused on demonstrating substantial equivalence to a predicate device for regulatory clearance, primarily by outlining features and safety aspects. It is not a clinical study report or a performance study for an AI/diagnostic device.

Therefore, I cannot fulfill your request for the specific points listed below based on the provided text:

1. A table of acceptance criteria and the reported device performance: The document compares features to a predicate device, but does not define acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or provide performance metrics (e.g., AUC, F1-score) from a study in the way an AI/diagnostic device would.
2. Sample size used for the test set and the data provenance: Not applicable, as no such performance study is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document is a regulatory submission for a physical medical device (NPWT system) and its features, focusing on safety and equivalence to an already marketed device, rather than a performance study of a diagnostic algorithm.

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VCARE Dx uterine manipulator/injector cannula is indicated for manipulation of the uterus, and injection of fluids during laparoscopic gynecologic procedures such as laparoscopic supracervical hysterectomy, minilap tubal ligation, laparoscopic tubal occlusion or diagnostic laparoscopy.

VCARE Dx™ uterine manipulator/injector cannula is a sterile, disposable, single-patient use device which consists of a hollow, rigid, insulated, anatomically curved manipulator tube (OD: 5mm; length: 48cm (19") including handle) with an inflatable PVC intrauterine balloon at the proximal end, graduations (cm) along the shaft measuring distance from the proximal end and a molded handle at the distal end for maintaining proper attitude of the uterus. The graduations on the shaft of the VCARE Dx™ can be used as a guide for comparison to a graduated uterine sound, if one is used. The intrauterine balloon is inflated by passing air via a standard syringe (not included) through the distally located pilot balloon/valve assembly. The internal tip of the manipulator tube is open to allow direct intrauterine introduction of dye/contrast media via the injector port on the rear of the handle, when prescribed. VCARE DxTM incorporates a component that seats against the cervix providing a positive stop from over-penetration of the uterine cavity and counter traction with the intrauterine balloon for effective manipulation. The rear portion of the device is secured at its proper depth with a locking mechanism situated at the rear of the main tube and external to the patient.

The provided K093556 document describes a 510(k) submission for the VCARE Dx uterine manipulator/injector cannula. The regulatory pathway for this device is based on demonstrating substantial equivalence to a predicate device. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are framed within the context of substantial equivalence rather than explicit performance targets.

Here's an analysis of the document's information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly define quantitative "acceptance criteria" for the VCARE Dx in terms of specific performance metrics or thresholds. Instead, the "acceptance criteria" were implied to be the performance specifications and functional design of the predicate device, VCARE (K955446). The study aimed to demonstrate that the VCARE Dx performed similarly to the predicate.

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

The document states: "A comparison test was performed between VCARE Dx (subject device) and VCARE (predicate device) to test similar performance specifications."

• Sample Size: The document does not specify the sample size used for this comparison test.
• Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It is a performance verification test likely conducted by the manufacturer.

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. Given that the study was a comparison of performance specifications between two devices, it's unlikely that external medical experts were used to "establish ground truth" in the way they would for, say, diagnostic accuracy. The assessment would have been against engineering specifications or functional outputs.

4. Adjudication Method for the Test Set:

This information is not provided in the document. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which doesn't appear to be the primary focus of this engineering comparison.

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

An MRMC comparative effectiveness study was not performed, nor is it applicable to this device. The VCARE Dx is a physical medical device (uterine manipulator/injector cannula), not an AI algorithm or diagnostic tool that assists human readers.

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

A standalone performance study in the context of an "algorithm only" or "AI" is not applicable to this device. It is a physical medical device. The "performance verification" was a comparison of the device itself to its predicate.

7. The Type of Ground Truth Used:

For the performance verification, the "ground truth" was effectively the established performance specifications and functional design of the legally marketed predicate device (VCARE). The study aimed to show that VCARE Dx met these same functional and specification standards. It was not a diagnostic device where pathology or outcome data would be the ground truth.

8. The Sample Size for the Training Set:

This is not applicable as the VCARE Dx is a physical medical device and does not involve a "training set" in the context of machine learning or AI algorithms.

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

This is not applicable for the reasons stated above.

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The ConMed VCARE® Retractor/Elevator is indicated for manipulation of the uterus and injection of fluids or gases 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 by sealing the vagina once colpotomy is performed.

The CONMED VCARE® (Vaginal-Cervical Ahluwalia's Retractor-Elevator) Retractor/Elevator is a disposable, single-use device for manipulation of the uterus and cervix during surgical and diagnostic procedures. The device consists of a rigid, anatomically curved manipulator tube having at its proximal end an inflatable (intrauterine) balloon for insertion into the uterus to manipulate and maintain the proper attitude of the uterus during procedures snch as hysteroscopy, Laparoscopic Assisted Vaginal Hysterectory (LAVH), and Total Laparoscopic Hysterectomy (TLH). The intrauterine balloon is inflated by passing air from a syringe through a pilot balloon located at the distal end of the device and via a lumen internal to the manipulator (main) tube. Inflation is maintained by a one-way valve positioned in the pilot balloon. The pilot balloon also serves as an indicator of intrauterine balloon inflation. VCARE® incorporates a system of cone-like components of which the forward or cervical cone surrounds and supports the cervix and the rear cone/fiexible tube or vaginal cone is slid along the main tube to adjust the depth of balloon 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 cone/flexible tube component is secured at its proper depth with a locking mechanism situated at the rear of the flexible tube and external to the patient. At the rear of the device is a molded handle which allows the surgeon to manipulate the uterus to the position most desirable for the procedure being performed. At the extreme rear of the device is a standard male luer lock connection suitable for attachment of a standard syringe for injection of fluids or gases into the uterus through the main tube when diagnostic procedures are prescribed.

The provided text {0} describes the ConMed VCARE® (Vaginal-Cervical Ahluwalia's Retractor-Elevator) Retractor/Elevator.

Here's an analysis of your questions based on the provided text:

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)

The document states, "Performance of the ConMed VCARE® (Vaginal-Cervical Ahluwalia's Retractor-Elevator) Retractor/Elevator was tested and passed all functional and biocompatibility criteria." However, it does not specify:

• The sample size used for the test set.
• The data provenance (country of origin, retrospective or prospective nature of the data).

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 document refers to functional and biocompatibility testing, not an expert-driven evaluation for establishing ground truth or performance against a clinical gold standard.

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

This information is not provided in the document. The testing described appears to be engineering/functional and biocompatibility testing, not a clinical trial requiring adjudication of results based on expert consensus.

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

An MRMC study was not performed as this device is a physical surgical tool, not an AI or imaging diagnostic device. Therefore, there is no AI assistance or human reader improvement effect size to report.

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

This question is not applicable as the device is a physical surgical retractor/elevator, not an algorithm or software.

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

The document indicates "functional and biocompatibility criteria" were used as the basis for evaluation. For functional criteria, this would likely involve engineering specifications and tests (e.g., inflation pressure maintained, locking mechanism integrity, material strength). For biocompatibility, it would involve standard biological safety tests (e.g., cytotoxicity, sensitization) in accordance with relevant standards. These are not typically described as "ground truth" in the same way clinical outcomes or expert consensus would be for diagnostic AI.

8. The sample size for the training set

This question is not applicable as the device is a physical surgical retractor/elevator, not a computational model requiring a training set.

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

This question is not applicable for the same reason as above.

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