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Phasix™ ST Umbilical Hernia Patch is indicated for use in the reinforcement of soft tissue, where weakness exists, in procedures involving the repair of umbilical hernias.

Phasix™ ST Umbilical Hernia Patch is a sterile, single-use device for prescription use only. It is a self-expanding, fully resorbable mesh with a resorbable hydrogel coating and a positioning pocket and strap. Phasix™ ST Umbilical Hernia Patch is comprised of 2 layers of poly-4hydroxybutyrate (P4HB), with the posterior side being co-knitted with polyglycolic acid (PGA) fibers, identical to the mesh component of the secondary predicate device (Phasix™ ST Mesh with Open Positioning System). P4HB degrades through hydrolysis and a hydrolytic enzymatic digestive process and is essentially completely resorbed in 12-18 months. Phasix™ ST Umbilical Mesh is coated on the PGA surface with a resorbable, chemically modified sodium hyaluronate (HA), carboxymethylcellulose (CMC), and polyethylene glycol (PEG) based hydrogel. The hydrogel is identical to both the primary predicate device (Ventralex™ ST Hernia Patch (K101928) and the secondary predicate device (Phasix™ ST Mesh with Open Positioning System, K190185). The fascial side of the mesh allows for a prompt fibroblastic response through the interstices of the mesh, allowing for complete tissue ingrowth. The visceral side of the mesh is the resorbable hydrogel coating, which separates the mesh from underlying tissues and organ surfaces to help minimize tissue attachment to the mesh. Shortly after hydration in saline, the coating becomes a hydrated gel that is resorbed from the site in less than 30 days. Phasix™ ST Umbilical Hernia Patch contains SorbaFlex™ Memory Technology, which provides memory and stability to the mesh, facilitating ease of initial insertion, proper placement and fixation of the device. The SorbaFlex™ Memory Technology is comprised of an extruded polydioxanone (PDO) resorbable monofilament contained within a knitted P4HB containment sleeve. PDO is resorbed within 24-32 weeks. The PDO ring and hybrid positioning straps (comprised of P4HB and polypropylene materials that are connected by overlapping the materials and sewing them together with clear PP monofilament, with a delineation marker dyed blue with [phthalocyaninato(2-)] copper), are based on the design of the primary predicate Ventralex™ ST Hernia Patch (K101928). The subject device has the identical intended use as the primary and predicate devices; soft tissue repair/reinforcement.

The provided document does not describe acceptance criteria for a software device or a study proving that a software device meets those criteria.

Instead, the document is a 510(k) premarket notification summary for a physical medical device: Phasix™ ST Umbilical Hernia Patch.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies for a software device.

The document discusses the following types of testing for the physical medical device:

• Biocompatibility Testing: Conducted in accordance with ISO 10993-1. Many tests were not repeated as the materials were the same as previously cleared predicate devices. Tests included material chemical characterization (gravimetric analysis, GCMS, LCMS-UV-CAD, HS-GCMS, ICPMS, GPC), cytotoxicity, sensitization, irritation/intracutaneous reactivity, acute systemic toxicity, material mediated pyrogenicity, LAL, subacute/subchronic/chronic toxicity, genotoxicity (AMES, Mouse Lymphoma), and implantation tests.
• Product Testing (Performance Testing): This included "Substantial Equivalency Testing" covering physical characteristics (mesh weave, pore size, thickness, weight per unit area, stiffness, dimensions) and functional characteristics (ball burst strength, suture retention strength, tear strength, PGA pull-out strength, three-tack pluck force, gel disruption analysis). It also included functional testing of the subject device (25-degree recoil, containment sleeve puncture, strap attachment strength, pocket integrity), resorption profile of the ring and containment sleeve (in-vitro degradation of PDO), design validation usability testing, and human factors/simulated testing.
• Animal Studies: No new animal studies were conducted for the subject device. Instead, the safety and performance were evaluated based on animal and histological data from reference devices (Phasix™ Mesh, Phasix™ ST Mesh) and predicate devices (Phasix™ ST Mesh with Open Positioning System, Ventralex™ ST Hernia Patch). The PDO ring material was previously evaluated in a rat model.

If you have a document pertaining to a software device, please provide that, and I will do my best to extract the requested information.

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The Davol AquaSens Fluid Monitoring System 4000 is intended for use in gynecological surgical and diagnostic procedures. The system consolidates the supply and collection of irrigation fluids used during hysteroscopic procedures to distend the uterus and to clear the operative site of blood and debris. The system monitors irrigation fluid losses/gains and indicates when such losses/gains exceed a level pre-set by the surgeon.

The major components of the AquaSens FMS 4000 are a load cell assembly which includes an IV pole structure for supporting irrigation bags and fluid suction canisters and an Electronic Control Unit (ECU) that acquires information from the load cell assembly to calculate and display fluid loss/gain based on changes in total weight after the system is initialized.

Here's a breakdown of the acceptance criteria and study findings for the AquaSens Fluid Monitoring System 4000, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria. Instead, it relies on a comparison to a predicate device. The implied acceptance criterion is that the new device performs "within the given specifications" and demonstrates "substantially equivalent" performance to the predicate device.

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

• Test Set Sample Size: Not explicitly stated. The document refers to "laboratory testing" conducted to compare the devices.
• Data Provenance: The testing was conducted internally by Davol, Inc. ("Laboratory testing was conducted to compare the proposed device to the predicate device."). There is no mention of country of origin for the data or whether it was retrospective or prospective. It appears to be prospective lab testing.

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

Not applicable. This device is a fluid monitoring system, not an AI or diagnostic imaging device that relies on expert interpretation of data to establish ground truth. The "ground truth" for its performance would be highly accurate weight measurements and electrical/mechanical performance metrics.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this isn't a study involving human interpretation. The testing involved direct measurement and comparison to specifications of a mechanical/electronic device.

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 or imaging devices where human interpretation plays a role.

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

Yes, the performance study effectively constitutes a standalone evaluation. The "laboratory testing" assesses the device's intrinsic ability to measure weight loss and manage modes, independent of a human operator's influence on its core measurement function. While a human interacts with the device (e.g., initiating PAUSE/RUN), the performance data focuses on the device's mechanical and electronic accuracy in response to these inputs and fluid changes.

7. The Type of Ground Truth Used

The ground truth used for this type of device would be:

• Accurate Weight Measurements: Using calibrated scales or industrial standards to verify the device's ability to accurately measure fluid weight changes.
• Electrical and Mechanical Specifications: Compliance with engineering specifications for power modes (AC, DC, low battery) and button functionality.

8. The Sample Size for the Training Set

Not applicable. This device is a fluid monitoring system, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. Its functionality is based on established physical principles (weight measurement) and electronic design, not learned patterns from data.

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

Not applicable, as there is no training set for this type of device.

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The Davol® ArthroVent™ Outflow Tubing is designed to control the amount of suction during arthroscopic procedures by controlling the amount of ambient air entering the outflow tubing set. It is for use with Davol's HydroFlex-AD Arthroscopic Distention System (reference 0025800, 0025200, 0025210), Arthro-Flo High Flow Irrigator (reference 0015000), and Gravity In-Flow Tubing Sets (reference 0088220, 0088240, and 0037870).

The proposed Davol® ArthroVent™ Outflow Tubing allows the user to regulate suction during arthroscopic procedures. It consists of two flexible suction connectors, flexible polyvinyl chloride (PVC) inlet and outlet tubes, and a suction regulator assembly. The variable control suction regulator assembly contains a one-way flapper valve, kidneyshaped main vent hole and secondary air channels. The secondary channels provide an alternate airflow path if the main vent were inadvertently obstructed. When the main vent is open, the suction regulator assembly allows ambient air into the system to reduce suction delivered to the operative site. As a user convenience, the outlet tube has a pinch clamp to close off suction.

This document describes the Davol® ArthroVent™ Outflow Tubing, an arthroscopic accessory designed to regulate suction during arthroscopic procedures. The provided text contains limited information regarding definitive acceptance criteria, and specific details about a formal study proving acceptance. However, based on the Performance Data section, we can infer the acceptance approach.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document mentions "Bench testing" using "a simulated knee model" and "currently marketed inflow products." However, it does not specify:

• The exact sample size (number of devices tested, number of runs, etc.) for the bench tests.
• The data provenance (e.g., country of origin, retrospective or prospective). This was a bench test, so geographical origin for "data" is less relevant than for clinical data, but the specifics of the test setup are missing.

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

• The document does not provide any information about experts being used to establish a "ground truth" for the test set. The study described is a bench test comparing performance to a predicate, not a clinical trial requiring expert interpretation of results for ground truth.

4. Adjudication Method for the Test Set

• Given that the study was a bench test comparing performance metrics, an adjudication method in the context of clinical interpretation (like 2+1 or 3+1 for expert consensus) is not applicable and therefore not mentioned.

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

• No, an MRMC comparative effectiveness study was not conducted. The document describes a bench test, not a study involving human readers or clinical cases.

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 mechanical arthroscopic tubing product, not an AI algorithm or software. The "performance" being evaluated is the physical function of the tubing in regulating suction.

7. The Type of Ground Truth Used

• For the bench testing described, the "ground truth" would be objective physical measurements of characteristics like suction level, flow rate, or pressure generated/regulated, as compared to the predicate device. It's not expert consensus, pathology, or outcomes data in the usual medical device sense. The document states "Results for both products were similar," implying quantitative comparisons were made against predefined performance characteristics or established functional ranges.

8. The Sample Size for the Training Set

• This question is not applicable. The device is a physical medical device, not an AI model requiring a "training set."

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

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

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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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