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The Davol® Hysteroscopy Pouch Drape and Tubing Set is intended for the collection of distention and irrigation fluids during diagnostic or operative hysteroscopy.

The Davol Hysteroscopy Pouch Drape and Tubing Set consists of a Drape and Fluid Collection Tubing. The Drape is a blue polyethylene under-buttocks sheet with a clear, funnelshaped polyethylene fluid collection pouch. The sheet has a patient adhesive strip located at the edge closest to the pouch, as well as hand cuffs to facilitate placement under the patient. The cuffs are identified as left and right. The pouch is held open by a malleable wire support located at the top outside edge and it contains a spunbonded nylon fabric filtration screen to catch large tissue debris or surgical gauze, which prevents clogging the drainage port. The drainage port, located at the bottom of the pouch, has a hinged cap. The Fluid Collection Tubing includes a Drape Suction Set and an Outflow Tubing Set. The Drape Suction Set is supplied in a Y-configuration manufactured from three pieces of polyvinylchloride (PVC) tubing joined by a PVC Y-Connector. The Ouflow Tubing Set includes an anti-siphon feature which allows air to vent into the fluid path of the outflow tubing.

The provided text describes a 510(k) premarket notification for the Davol® Hysteroscopy Pouch Drape and Tubing Set. The submission focuses on establishing substantial equivalence to a predicate device, rather than providing a performance study with detailed acceptance criteria and results as typically found for novel device validations.

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

1. Table of Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" and "reported device performance" as typically seen in a performance study (e.g., accuracy, sensitivity, specificity, or objective metrics) is not applicable in this 510(k) submission. Instead, the submission relies on demonstrating substantial equivalence to a previously marketed predicate device. The "performance" is implicitly deemed equivalent if the technological characteristics and intended use are the same.

The comparison is presented in a "Comparison Chart" (Attachment 6-1) which lists features and whether both the new device (Davol Drape) and the predicate device (Microtek Drape) possess them. This serves as the basis for the "acceptance" of substantial equivalence.

Note: The "acceptance criteria" here are implicitly that the Davol Drape must possess the same features and intended use as the predicate Microtek Drape to establish substantial equivalence. The document explicitly states: "The Drape subject of this submission and the predicate product are identical as summarized in the Comparison Chart, Attachment 6-1."

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

Not Applicable. This submission is not a clinical performance study using a test set of patient data. It is a regulatory submission focused on comparing the design and intended use of a new device to a predicate device. Therefore, there is no "test set" in the context of clinical data.

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

Not Applicable. As there is no "test set" of clinical data being evaluated for performance, there are no experts establishing ground truth in that sense. The comparison of the device features was a direct comparison of physical and functional characteristics.

4. Adjudication Method for the Test Set

Not Applicable. No test set requiring expert adjudication 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 drape and tubing set, not an AI-powered diagnostic or assistive technology. No MRMC study was conducted.

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

Not Applicable. This device is a physical medical device (surgical drape and tubing) and does not involve an algorithm or AI.

7. The Type of Ground Truth Used

The "ground truth" in this context is the known characteristics and intended use of the legally marketed predicate device (Microtek Medical, Inc. Under Buttocks Drape and Fluid Collection Pouch). The new Davol Drape was compared directly against these known characteristics.

8. The Sample Size for the Training Set

Not Applicable. This submission does not involve a "training set" in the context of machine learning or algorithm development. The device is a physical product.

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

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

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The Proposed Device is indicated for the repair of inguinal hernia defects.

The Proposed Device, the Bard Sperma-Tex Preshaped Mesh, is manufactured from knitted polypropylene monofilament. The mesh is cut in a thumbnail design. A patch of e-PTFE is stitched onto one side of the mesh, at the rounded corner, with polypropylene monofilament.

The provided text is a 510(k) summary for a medical device (Bard® Sperma-Tex Preshaped Mesh), which focuses on demonstrating substantial equivalence to existing predicate devices rather than proving a device meets specific acceptance criteria through a full-fledged clinical study. Therefore, much of the requested information (like sample sizes for test sets, number of experts, adjudication methods, MRMC studies, training set details, and how ground truth was established in a clinical sense) is not present.

However, I can extract the explicit acceptance criteria for the technological characteristics and the laboratory tests conducted to demonstrate similarity to the predicate devices.

Here's the information derived from the provided document:

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

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

• Sample Size: Not specified for any of the laboratory tests. The document broadly refers to "laboratory testing" and "material evaluations."
• Data Provenance: Not explicitly stated, but the tests appear to be conducted by the manufacturer ("Testing was performed to assess the effects of the new characteristics of the Proposed Device" and "laboratory testing"). It is retrospective in the sense that existing biocompatibility data from the Predicate Composix was leveraged. No indication of country of origin for new testing, but the submitting company is in the USA.

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

• Not applicable/Not specified. The "ground truth" here is based on established scientific methods and material property specifications, not expert consensus on diagnostic images or clinical outcomes.

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

• Not applicable/Not specified. Adjudication methods are typically relevant for human interpretation tasks, not material property testing.

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

• No, an MRMC comparative effectiveness study was not done. This device is a surgical mesh, not an AI-powered diagnostic device.

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

• Not applicable. This is not an algorithm, but a physical medical device.

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

• For biocompatibility: Ground truth was established by prior biocompatibility testing of the predicate device materials (polypropylene and e-PTFE) according to FDA General Memorandum #G95-1, indicating acceptability for tissue contact.
• For material properties (pore size, surface roughness, mesh integrity): Ground truth was based on established scientific benchmarks and references (e.g., "References indicate that a surface pore size of less than 1 micron on average minimized cellular penetration and tissue attachment." and "average roughness of less than 10 microns would minimize cellular and tissue attachment."). These benchmarks were used to compare the measured properties of the new device's components.

8. The sample size for the training set

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

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

• Not applicable.

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The Proposed HydroFlex Hysteroscopic Distention System is intended to provide distention and irrigation of the uterus with low viscosity fluids for diagnostic and/or operative hysteroscopy.

The modified HydroFlex HD system is designed to provide distention and irrigation of the uterus with low viscosity fluids during diagnostic or operative hysteroscopy. The system distends the uterus for better visualization during hysteroscopic procedures and flushes blood and tissue debris from the operative site. The modified HydroFlex HD hysteroscopic distention tubing set is intended for use with the HydroFlex Irrigation Pump Controller. Pressure in the pumping chamber is determined by the setting on the main controller which is calibrated to account for 16 inches of bag height above the outflow. Maximum static pressure (all outflow closed and no fluid flow) applied to the intrauterine space is limited to approximately 100mmHg or 2.0 psig, by the main controller. Rate of flow is dependent upon the pumping chamber pressure. Fluid will stop flowing when the back pressure in the system equals the pressure setting on the controller. Under static pressure conditions with no outflow this will equal the intrauterine pressure. The impeller continues to spin even with flow stopped and, in this way, the selected pressure is maintained. Flow will automatically resume when system back pressure falls below the selected pressure.

The provided text describes modifications to the Davol HydroFlex™ HD System, a hysteroscopic distention and irrigation system. The 510(k) submission aims to demonstrate substantial equivalence to previous versions and predicate devices.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size (number of devices or test runs) used for the performance testing. It refers to "testing was performed to evaluate the effect of the modifications on performance."

The data provenance is for a medical device manufactured by Davol Inc. in Cranston, RI, USA. The testing appears to be prospective testing conducted specifically for this 510(k) submission to demonstrate the performance of the modified device in comparison to its predicates.

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

This type of information is not applicable to this submission. The device is a fluid management system, and its performance is evaluated through engineering and functional testing against specified parameters (e.g., pressure, flow rate). There is no "ground truth" derived from expert interpretation of medical images or patient outcomes in the context of this device's performance claims.

4. Adjudication Method for the Test Set

This is not applicable as there is no human interpretation or subjective assessment involved that would require adjudication. Performance is measured objectively.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices that involve human interpretation of medical images or data. The HydroFlex HD System is an accessory device that provides mechanical functions (distention and irrigation).

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

This concept is not applicable to this device. The HydroFlex HD System is a physical device, not an algorithm. Its performance is inherent to its design and functionality, which is what the testing evaluated.

7. The Type of Ground Truth Used

The "ground truth" for the performance testing in this submission is established through objective engineering measurements (e.g., pressure gauges, flow meters) against pre-defined specifications and regulatory guidance. For biocompatibility, the ground truth is adherence to established standards and guidelines (e.g., FDA General Program Memorandum #G9S-1).

8. The Sample Size for the Training Set

This is not applicable. The device is an electro-mechanical system, not an AI/ML algorithm that requires a training set.

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

This is not applicable, as there is no training set for this device.

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The HydroFlex HD Hysteroscopic Distention System is intended to provide distention and irrigation of the uterus with low viscosity fluids during diagnostic or operative hysteroscopy.

The HydroFlex HD system is designed to provide distention and irrigation of the uterus with low viscosity fluids during diagnostic or operative hysteroscopy. The system distends the uterus for for better visualization during hysteroscopic procedures and flushes blood and tissue debris from the operative site.

The HydroFlex HD hysteroscopic distention tubing set is intended for use with the HydroFlex Irrigation Pump Controller. Pressure in the pumping chamber is determined by the setting on the main controller which is calibrated to account for 16 inches of bag height above the outflow. Maximum static pressure (all outflow closed and no fluid flow) applied to the intrauterine space is limited to approximately 100mmHg or 2.0 psig, by the main controller. Rate of flow is dependent upon the pumping chamber pressure.

Fluid will stop flowing when the back pressure in the system equals the pressure setting on the controller. Under static pressure conditions with no outflow this will equal the intrauterine pressure. The impeller continues to spin even with flow stopped and, in this way, the selected pressure is maintained. Flow will automatically resume when system back pressure falls below the selected pressure.

The HydroFlex HD system is driven by an impeller pump which is powered by an electronic Controller. The input pressure is determined by the user selected setting on the electronic Controller. The Controller determines the speed of the impeller pump which drives the flow of irrigant and determines the resultant static pressure. Both the HydroFlex HD and the Zimmer CDIS system contain a pressure relief valve which limits the maximum intrauterine static pressure by releasing fluid through the valve and drain tube. The HydroFlex HD system pressure relief valve relieves static pressures if the pressure reaches 150mmHg.

The provided document is a 510(k) summary for the Davol Hydro-Flex HD System. It details the device's substantial equivalence to predicate devices based on laboratory bench testing. However, it does not contain the level of detail required for a comprehensive description of acceptance criteria and the study proving it meets those criteria, particularly concerning human reader performance, ground truth establishment for a training set, or specific sample sizes beyond the general mention of "laboratory bench testing."

Here's an attempt to extract the requested information, noting where the document is insufficient:

1. Table of Acceptance Criteria and Reported Device Performance

Note on Acceptance Criteria: The document primarily establishes "substantial equivalence" to predicate devices. The acceptance criteria are largely implicit in demonstrating that the HydroFlex HD system performs "adequately" and "similarly" to the predicate, or that differences do not raise new safety/effectiveness questions. Specific numerical acceptance criteria are not explicitly stated in most cases, beyond the pressure relief valve target.

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

• Sample Size: Not explicitly stated. The document refers to "Laboratory bench testing" on "three different hysteroscopes" at "low, mid-range and maximum input pressures." This suggests some experimental design, but specific N-values (e.g., number of test runs, replicates) are not provided.
• Data Provenance: The testing was "Laboratory bench testing" conducted by Davol Inc. (the manufacturer). This is a prospective test, as it was performed during the development and regulatory submission process for the new device. Country of origin for the data is implicitly the USA, where Davol Inc. is based.

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

• Not Applicable. This study is a bench test comparing device performance against predetermined physical parameters and predicate device performance. It does not involve human interpretation or diagnostic decision-making that would require expert-established ground truth.

4. Adjudication Method for the Test Set

• Not Applicable. As this was a laboratory bench test, there was no need for adjudication involving human readers or expert consensus. The measurements obtained would be objective (e.g., pressure readings, flow rates).

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

• No. An MRMC study was not conducted as this is a physical device (hysteroscopic distention and irrigation system), not an AI or imaging diagnostic tool that relies on human interpretation. Therefore, there is no effect size of human readers improving with AI vs. without AI assistance.

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

• Yes (Implicit). The "Laboratory bench testing" described assessed the device's performance (flow rates, pressures, PRV function) independently of a human operator's skill or intervention beyond setting initial parameters. It's an "algorithm only" equivalent in the sense that the device's mechanical and electronic functions were tested in isolation to determine its inherent performance characteristics.

7. Type of Ground Truth Used

• The ground truth used for this study was based on:
  • Physical Measurements: Objective measurements of static pressure and flow rates.
  • Engineering Specifications: The design parameters for the HydroFlex HD (e.g., max static pressure of 100mmHg, PRV relief at 150mmHg).
  • Predicate Device Performance: The established performance characteristics of the Zimmer CDIS System and Linvatec Apex Universal Irrigation System served as benchmarks for demonstrating "substantial equivalence."
  • Regulatory Standards: Conformance to electrical safety (UL 2601-1, ANSI/AAMI ES1-1993) and EMC (IEC 601-1-2) standards.
  • Biocompatibility Standards: Conformance to FDA General Program Memorandum #G95-1.

8. Sample Size for the Training Set

• Not Applicable. This device is a mechanical and electronic system, not an AI or machine learning model that requires a training set of data.

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

• Not Applicable. No training set was used.

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Reconstruction of soft tissue deficiencies, such as for the repair of hernias and chest wall defects.

The proposed Composite Mesh is manufactured from knitted polypropylene monofilament with a diameter of 6 mil. The unique knitting process for the Composite Mesh produces a flat double layer of mesh. This double layer of mesh is knitted and interconnected simultaneously during the knitting process. One side of one layer of mesh is heat bonded to a single layer of expanded polytetrafluoroethylene (e-PTFF).

Here's an analysis of the provided text regarding the acceptance criteria and study for the Bard Composite Prosthesis:

Acceptance Criteria and Reported Device Performance

Study Information

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

   • Test Set Sample Size: Not explicitly stated for any of the individual tests. The document broadly mentions "Laboratory testing" and "in-vivo testing" without providing specific N values for the number of meshes tested, animals used, or human subjects.
   • Data Provenance: The studies were laboratory and in-vivo (animal) tests. The location of these labs or animal facilities is not specified, nor is whether the data is retrospective or prospective, though in-vivo testing inherently suggests prospective data collection in the context of device development.

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

   • This question is not applicable as the studies described are laboratory and in-vivo (animal) tests for device characteristics, not human clinical studies requiring expert ground truth for interpretation of patient data (e.g., imaging, pathology). The ground truth would be the objective measurements from the tests themselves (e.g., burst strength values, FTIR spectra, histological assessment by a veterinary pathologist for in-vivo tests). No "experts" in the clinical sense (like radiologists) were used to establish ground truth for this type of testing.

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

   • None. Adjudication methods are typically employed in clinical studies involving human subject data and expert interpretation (e.g., multiple radiologists reviewing scans and resolving discrepancies). This document describes laboratory and animal studies where direct measurements and observations, likely performed by trained technicians or scientists, serve as the data. Discrepancy resolution for such data would follow standard scientific practice (e.g., re-testing, calibration, statistical analysis), not an adjudication model.

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. An MRMC study is not applicable. This submission is for a surgical mesh, not an AI-powered diagnostic device or a system designed to assist human readers (e.g., radiologists). Therefore, there is no AI component, no human readers in an interpretive capacity, and no effect size regarding AI assistance.

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

   • No. This is not applicable. The device is a physical surgical implant, not an algorithm, so there is no standalone algorithm performance to evaluate.

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

   • Objective Measurements and Observations from Laboratory and In-Vivo Testing:
     • Laboratory Tests: Direct physical measurements (e.g., pore size, surface roughness, suture retention force, burst pressure), and chemical analyses (e.g., FTIR and DSC spectroscopy data).
     • In-Vivo Tests (Animal Model): Quantitative measurements (e.g., organ adhesion scores/measurements) and qualitative assessments (e.g., histological evaluation by a veterinary pathologist for tissue ingrowth characteristics and inflammatory response).
   • The "ground truth" here is the scientific data generated by standardized testing protocols and observed biological responses in the animal models, compared to predicate devices.

7. The sample size for the training set:

   • Not Applicable. The Bard Composite Prosthesis is a physical medical device, not a machine learning model. Therefore, there is no "training set" in the context of AI development.

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

   • Not Applicable. As there is no training set (as defined in machine learning), there is no ground truth to establish for it. The development of the device likely involved engineering specifications, materials science, and iterative testing, but not in the framework of a "training set" for an algorithm.

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Both the Pneumatic API system and the Battery API system are designed to provide controlled pulsatile irrigation to a joint during arthroscopic surgical procedures. The pulsatile action of the pump irrigation and mechanical debridement of tip brush help to remove blood, tissue debris, loose bodies, and foreign matter from the joint cavity. When connected to a suction source the device's can be used to aspirate fluids and debris from the joint cavity. The device's will be provided as sterile single patient use devices.

The Pneumatic API System, Battery API System, Simpulse Plus Suction Irrigator System and the Simpulse SOLO Suction Irrigator System are jet lavage devices intended to provide controlled powered pulsatile irrigation for the cleansing and debridement of surgical sites (the Simpulse Plus and Simpulse SOLO also have the extended indication of providing irrigation to wound/burns). When connected to a suction source, the devices can be used to aspirate fluids and debris from the surgical site.

The API Irrigation/Brush tip and the Davol Femoral Canal Irrigation Brush Tip are both intended to provide pulsatile irrigation for the cleansing and debridement of orthopaedic surgical sites. In addition ,both of these tips and the Acufex Microsurgical Rasp are intended to provide mechanical debridement of surfaces during orthopaedic surgical procedures.

The API Suction Tip and the Davol Arthroscopic Outflow Cannula are intended to allow for the outflow of fluid and debris from the joint space during arthroscopic surgical procedures.

Both the Pneumatic API system and the Battery API system are designed to provide controlled pulsatile irrigation to a joint during arthroscopic surgical procedures. The pulsatile action of the pump irrigation and mechanical debridement of tip brush help to remove blood, tissue debris, loose bodies, and foreign matter from the joint cavity. When connected to a suction source the device's can be used to aspirate fluids and debris from the joint cavity. The device's will be provided as sterile single patient use devices. The major components of the systems are as follows:

Pneumatic Arthroscopy Pulsed Irrigator System: The Pneumatic Arthroscopy Pulsed Irrigator (API) system consists of the Davol Simpulse Plus Handle with the API Irrigation/Brush Tip and the API Suction Tip. The Pneumatic API System functions by means of a pneumatically activated pump membrane (diaphragm) contained within the pump assembly to generated the pulsating fluid output. The pump membrane is activated by pressure from an air/nitrogen source.

Battery Arthroscopy Pulsed Irrigator System: The Battery Arthroscopy Pulsed Irrigator System consists of the Davol Simpulse SOLO Handle with the API Irrigation/Brush Tip and the API Suction Tip. The Battery API system uses a mechanical pumping system to generate the pulsating fluid output. It is powered with four (4) standard AA alkaline batteries with an output amperage of approximately 1.8 amperes, with a voltage of 6 volts, dc (direct current). The batteries power a motor which activates movement of a bellows pump. The pumping system and power source are housed in the device's handle which will be manufactured from cyrolite (acrylic polymer). The batteries are contained in a battery enclosure within the device's handle.

The provided text describes a 510(k) summary for the Davol Arthroscopy Pulsed Irrigator Systems, which is a medical device. This type of document is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device.

The acceptance criteria are not explicitly stated in a quantifiable manner (e.g., "flow rate must be > X L/min"), but rather the study aims to show equivalence to predicate devices in terms of performance characteristics. The conclusion states that the devices compare favorably based on the testing performed.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document refers to "laboratory bench testing" and "all materials" for biocompatibility. Specific sample sizes (N per test) for each type of bench testing are not provided.
• Data Provenance: The testing was conducted as "Laboratory bench testing". The country of origin is not specified, but it's implied to be within the manufacturer's (Davol Inc.) R&D or contracted labs. The data is prospective as it was generated specifically for this 510(k) submission.

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

• Not Applicable. This study is for a medical device (irrigator systems) and involves bench testing of physical performance characteristics and biocompatibility. It does not involve human interpretation of medical images or patient data that would require experts to establish a "ground truth" in the diagnostic sense. The comparison is against established performance of predicate devices.

4. Adjudication Method for the Test Set

• Not Applicable. As mentioned above, this is laboratory bench testing of physical performance, not diagnostic evaluation requiring adjudication. The assessment is based on direct measurement and comparison of physical parameters.

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

• No. This is a bench study of a physical medical device. MRMC studies are typically used for diagnostic imaging devices or algorithms where human readers interpret medical cases.

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

• Not Applicable. This is not an algorithm or AI device. The "standalone" performance refers to the device's inherent mechanical and material performance. The conducted tests (flow rate, pressure, biocompatibility) can be considered the "standalone" performance of the device components.

7. The Type of Ground Truth Used

• Predicate Device Performance and Industry Standards: The "ground truth" for this study is essentially the established and accepted performance characteristics of the legally marketed predicate devices (Davol Simpulse Plus Suction Irrigator, Davol Simpulse SOLO Suction Irrigator, Davol Femoral Canal Irrigation Brush Tip, Davol Arthroscopy Outflow Cannula, Acufex Microsurgical Rasp) and adherence to biocompatibility standards (General Program memorandum #G95-1). The new device is deemed acceptable if its performance "compares favorably" to these established benchmarks.

8. The Sample Size for the Training Set

• Not Applicable. This is a medical device bench study, not a machine learning model, so there is no training set in that context.

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

• Not Applicable. As there is no training set for a machine learning model, this question is not relevant to the provided text.

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To be connected to suction / vacuum assemblies to filter smoke particulates / aerosols, and retain aqueous fluids generated during laparoscopic electrosurgery or laser surgery.

Hydrophobic multilayered filter with vacuum tubing for attachment to wall vacuum or suction source.

This document is a 510(k) summary for the Davol Plume Filter and focuses on demonstrating substantial equivalence to a predicate device, the Contain™ Hydrophobic Safety Filter, rather than establishing specific acceptance criteria for a new device's performance through a dedicated study.

Therefore, the provided text does not contain the information needed to answer many of your questions, as it describes a different type of regulatory submission. There is no independent study described here that measures device performance against acceptance criteria in the way you've outlined.

However, I can extract the relevant information where available:

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

The document primarily focuses on establishing "substantial equivalence" to a predicate device, not on setting new performance acceptance criteria for a novel device. The key performance claim made is:

2. Sample sized 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 submission relies on the established performance of the predicate device.

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. This type of expert assessment is not relevant for a 510(k) submission focused on substantial equivalence based on design and materials.

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

This information is not applicable and not provided. This document describes a physical filter, not an AI-powered diagnostic device, so MRMC studies are not relevant.

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

This information is not applicable and not provided. This document describes a physical filter, not an algorithm.

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

The document does not describe a "ground truth" establishment in the context of a new performance study. It relies on the established performance of the predicate device (Contain™ Hydrophobic Safety Filter), which presumably had its performance validated through testing by a similar claim.

8. The sample size for the training set

This information is not applicable and not provided. There is no "training set" as this is not an AI/machine learning device.

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

This information is not applicable and not provided.

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The HydroFlex LI System is designed to provide controlled irriqation during laparoscopic procedures. The system helps flush blood and tissue debris from the operative site during laparoscopy to aid in visualization. It may also be used for dissection of filmy adhesions (i.e. hydrodissection), hydrodissolution of blood clot formations, and peritoneal lavage.

The Davol HydroFlex LI system and the Davol Endo-Flo are intended to provide controlled irrigation during laparoscopic procedures. The devices flush blood and tissue debris from the operative site during laparoscopy to aid in visualizatior and may also be used for dissection of filmy adhesions (i.e. hydrodissection), hydrodissolution of blood clot formations, and peritoneal lavage.

The HydroFlex LI System is designed to provide controlled irriqation during laparoscopic procedures. The system helps flush blood and tissue debris from the operative site during laparoscopy to aid in visualization. It may also be used for dissection of filmy adhesions (i.e. hydrodissection), hydrodissolution of blood clot formations, and peritoneal lavage.

The HydroFlex LI disposable Fumping Chamber/Tubing Set is intended for use with the HydroFlex irrigation pump Controller. Pressure in the pumping chamber is determined by the setting on the main Controller which is calibrated to account for two feet of baq height above the outflow. Maximum static pressure (all outflow closed and no fluid flow) applied to the pre-attached probe tip is limited to approximately 500 mmHg, or 10.C psig, by the main controller. The controller defaults to gravity at an input pressure less Rate of flow is dependent upon pressure than 70mmHq. selection on the controller and probe tip selection.

Fluid will not flow when the back pressure in the system equals the pressure setting on the controller, e.g., when the in the off position. Under static pressure probe is conditions with no outflow, this will equal the controller setting. The impeller continues to spin even with flow stopped, and, in this way, the selected pressure i s maintained. Flow will automatically resume when system back pressure falls below the selected pressure, e.q., when the probe is open to flow.

The HydroFlex LI system is driven by an impeller pump which is powered by an electronic Controller (electromechanical control is similar to U.S. Endoscopy Group's Laparoscopic Irrigation System and Suction Irrigation Tubing Set and the Linvatec Apex™ Universal Irrigation The input pressure is determined by the user System). selected setting on the electronic Controller. The Controller determines the speed of the impeller pump which drives the flow of irrigant.

In addition, the design of the HydroFlex system reusable main Controller is such that it can be used as a multipurpose fluid irrigation system (dependent on the disposable Pump Tubing set used with the Controller).

Both systems contain fluid contact components made from cyrolite and polyvinylchloride. Other materials of the HydroFlex LI system differ from the Endo-Flo system.

This 510(k) premarket notification describes the Davol HydroFlex LI System, a laparoscopic irrigation system. The document focuses on establishing substantial equivalence to predicate devices, particularly the Davol Endo-Flo system.

Here's an analysis of the provided text in the context of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal acceptance criteria with specific numerical targets. Instead, it relies on demonstrating that the new device performs adequately relative to predicate devices, particularly in terms of "adequate irrigant flow rate."

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

The document does not mention a "test set" in the context of clinical data or patient samples. The "tests" described are primarily engineering performance tests (flow rates, pressure, electrical safety, biocompatibility) of the device itself. Therefore, sample sizes for a clinical test set are not applicable and not provided. The data provenance is also not applicable for a clinical test set in this context.

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

Given the nature of the submission (510(k) for a medical device that performs irrigation), there is no mention of "experts" establishing ground truth in the way one might for an AI/diagnostic study. The "ground truth" for this device would be established by objective measurements and standardized tests rather than expert interpretation of clinical data.

4. Adjudication Method for the Test Set

Not applicable. There is no clinical test set requiring adjudication in this submission.

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

Not applicable. This submission is for a physical medical device (laparoscopic irrigation system), not an AI/diagnostic software. Therefore, an MRMC study and AI assistance are not relevant.

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

Not applicable. This submission is for a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for demonstrating substantial equivalence is based on objective engineering and laboratory test measurements (e.g., pressure readings, flow rate measurements, electrical safety test results, material biocompatibility test results). It is not based on expert consensus, pathology, or outcomes data in a clinical trial sense. The "ground truth" is that the device can reliably provide controlled irrigation within safe and effective parameters, comparable to predicate devices, as validated by standardized testing methods.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of AI or machine learning for this physical medical device.

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

Not applicable. There is no "training set" for this device.

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