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MONOCRYL™ Plus Antibacterial Sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.

MONOCRYL™ Plus Antibacterial Suture is a sterile, monofilament, synthetic, absorbable surgical suture composed of a copolymer of glycolide and (epsilon) s-caprolactone. The empirical formula of the polymer is (C2H2O2)m (C6H102)n.

MONOCRYL™ Plus Antibacterial Suture is available undyed and dyed with D&C Violet No. 2

MONOCRYL™ Plus Antibacterial Suture contains Irgacare®† MP (triclosan), a broad spectrum antibacterial agent, at no more than 2360 µg/m.

This document is a 510(k) premarket notification for a medical device called MONOCRYL™ Plus Antibacterial Suture. It seeks to demonstrate substantial equivalence to a previously cleared device. Therefore, the information provided focuses on the equivalence of the modified device to its predicate, rather than detailing a de novo study to establish acceptance criteria and prove performance against them as would be typical for a novel device or AI/software.

Based on the provided text, here's an analysis of the "acceptance criteria" and "study" as they relate to this specific 510(k) submission:

Understanding the Context:

This submission (K201996) is for a modified device (MONOCRYL™ Plus Antibacterial Suture) that is largely identical to a predicate device (MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 with 510(k) number K050845). The only reported changes are to the labeling, specifically updating in vitro effectiveness against an additional microorganism and including new descriptors/icons.

For a 510(k) involving minor changes, the "acceptance criteria" revolve around demonstrating that the modified device remains as safe and effective as the predicate, or that the changes do not raise new questions of safety or effectiveness. The "study" in this context refers to the data presented to support this claim, rather than a clinical trial for a new product.

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

Since this is a submission for a modified device essentially claiming no change in technological characteristics, the "acceptance criteria" are implicitly that the modified device retains the performance attributes of the predicate. The "reported device performance" is essentially a reaffirmation of the predicate's performance, along with specific in vitro data for the antibacterial claims.

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

The document mentions "in vitro efficacy studies" for the antibacterial claims. Details on the specific sample sizes (e.g., number of suture samples, number of bacterial cultures) are not provided in this summary. The data provenance is described as "in vitro," implying laboratory studies, rather than patient data. No information on country of origin or retrospective/prospective nature is given, as it's not a clinical study.

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

This type of information is generally relevant for AI/radiology devices where expert consensus is used to label images. For a physical medical device like a suture, "ground truth" for material properties and antibacterial efficacy is established through standardized laboratory testing and validated analytical methods (e.g., chemical analysis, microbiology assays). The document does not specify the number or qualifications of experts involved in running these in vitro tests, as this is typically handled by qualified laboratory personnel following established protocols.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for imaging interpretation, to resolve discrepancies between readers. This document describes laboratory in vitro studies for which such an adjudication method is not relevant.

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

Not applicable. This device is a physical surgical suture, not an AI or imaging diagnostic tool. Therefore, MRMC studies and human reader improvement with AI assistance are not relevant.

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

Not applicable. This document is about a physical medical device, not an algorithm or AI.

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

For the antibacterial claims, the "ground truth" would be established by the results of the microbiological in vitro assays which directly measure the inhibition of bacterial colonization on the suture material. For the material properties, the "ground truth" is established by chemical and physical testing against established standards (e.g., USP monographs). This is empirical data from laboratory studies, not consensus of human experts on subjective interpretations.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires training data.

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

Not applicable, as explained in point 8.

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The GYNECARE TVT Device is intended to be used as a pubo-urethral sling for treatment of Stress Urinary Incontinence (SUI), for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. The GYNECARE TVT Introducer and Rigid Catheter Guide are available separately and are intended to facilitate in the placement of the GYNECARE TVT Device.

The GYNECARE TVT Introducer is a reusable device intended to aid in the placement of the GYNECARE TVT Device retropubically.

The GYNECARE TVT Rigid Catheter Guide is a reusable device intended to facilitate the identification of the urethra and bladder neck during the placement of the GYNECARE TVT Device.

The GYNECARE TVT Device is intended to be used as a pubo-urethral sling for treatment of stress urinary incontinence (SUI), for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. The GYNECARE TVT Introducer and Rigid Catheter Guide are available separately and GYNECARE TVT Abdominal Guides and Couplers are included in each kit.

The GYNECARE TVT Abdominal Guides and Couplers are single use devices used to facilitate placement of the GYNECARE TVT Device when placed in a top-down retropubic fashion (also known as an abdominal approach).

The GYNECARE TVT EXACT Continence System is intended to be used as a pubo-urethral sling for treatment of female Stress Urinary Incontinence, resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

The GYNECARE TVT EXACT Continence System Trocar is a single use device intended to aid in the placement of the GYNECARE TVT EXACT Continence System retropubically.

The GYNECARE TVT Rigid Catheter Guide is a reusable device intended to facilitate the identification of the urethra and bladder neck during the placement of the GYNECARE TVT EXACT Continence System.

The GYNECARE TVT Obturator Device is intended to be used in women as a sub-urethral sling for the treatment of stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

The GYNECARE TVT Obturator Helical Passers and Atraumatic Winged Guide are intended to aid in the placement of the GYNECARE TVT Obturator Device.

The GYNECARE TVT ABBREVO Continence System is intended for use in women as a suburethral sling for the treatment of SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

The GYNECARE TVT ABBREVO Helical Passers and Atraumatic Winged Guide are intended to aid in the placement of the GYNECARE TVT ABBREVO Device.

GYNECARE TVT™ Tension-free Vaginal Tape System: Consists of PROLENE™ Polypropylene Mesh (tape) with clear plastic Sheaths and stainless steel needles. The mesh is knitted filaments of extruded polypropylene strands. GYNECARE TVT™ Reusable Introducer (available separately) is a reusable stainless steel instrument. GYNECARE TVT™ Rigid Catheter Guide (available separately) is a non-sterile reusable stainless-steel instrument.

GYNECARE TVT™ with Abdominal Guides Tension-free Support for Incontinence System: Includes GYNECARE TVT™ Abdominal Guide, a sterile disposable instrument, and GYNECARE TVT™ Coupler, a sterile disposable polypropylene connector.

GYNECARE TVT EXACT™ Continence System: A sterile, single patient use procedure kit consisting of the GYNECARE TVT EXACT Continence System Trocar Sheath / Implant Assembly (blue PROLENE™ Polypropylene Mesh with clear plastic Sheaths and white Trocar Sheaths) and the GYNECARE TVT EXACT Continence System Trocar (stainless-steel Trocar Shaft and plastic Trocar Handle).

GYNECARE TVT™ Obturator System: A sterile, single patient use procedure kit consisting of the GYNECARE TV Obturator Device (undyed or blue PROLENE™ polypropylene mesh with clear plastic sheath and plastic tube receptacles) and the GYNECARE TVT™ Obturator Helical Passers and Atraumatic Winged Guide (two stainless steel, curved wire helical passers with plastic handles and a stainless steel accessory instrument).

GYNECARE TVT ABBREVO™ Continence System: A sterile, single-patient use procedure kit consisting of the GYNECARE TVT ABBREVO Implant Assembly (blue PROLENE™ Polypropylene Mesh with clear plastic Sheaths and Helical Passer Sheaths, and Positioning Lines) and the GYNECARE TVT ABBREVO Placement Loop (PROLENE Polypropylene Monofilament loop with an attached polypropylene button). Also includes GYNECARE TVT ABBREVO™ Helical Passers and Atraumatic Winged Guide (two stainless steel, curved wire helical passers with plastic handles and a stainless steel accessory instrument).

The provided document is a 510(k) summary for the GYNECARE TVT™ System and related devices. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving safety and efficacy through new clinical studies against specific acceptance criteria.

Therefore, the document does not contain information about:

• Clearly defined acceptance criteria for device performance.
• A standalone study proving the device meets specific acceptance criteria.
• Sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth for test and training sets.

Instead, the document states:

• Substantial Equivalence: The primary assertion is that "the subject devices are substantially equivalent to their respective predicate devices."
• Technological Characteristics: "The subject devices and their respective predicate devices are identical and therefore have the same technological characteristics."
• Differences from Predicates: The only stated differences are in "labeling (Instructions for Use)" which have been "revised to meet the new European Union (EU) Medical Device Regulation (MDR) requirements" and include additional information such as warnings, adverse events, safety information, and information for patients. Minor clarifications to "Indications and Contraindications statements" were also made.
• Performance Data: "No performance data are needed to evaluate these labeling changes." This explicitly states that no new performance studies were conducted or required for this particular submission.

In summary, there is no study described in this document that proves acceptance criteria because the submission's purpose is to demonstrate substantial equivalence based on identical technological characteristics and updated labeling, not new performance data.

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The Gynecare TVT ABBREVO™ Helical Passers and Atraumatic Winged Guide are intended to aid in the placement of the GYNECARE TVT ABBREVO™ device.

The Gynecare TVT™ Obturator Helical Passers and Atraumatic Winged Guide are intended to aid in the placement of the GYNECARE TVT™ Obturator device.

The Helical Passers are two stainless steel, curved wire passers with plastic handles that are designed to deliver the GYNECARE TVT ABBREVO™ & GYNECARE TVT™ Obturator Implant. The Helical Passers are provided as left and right units, pre-assembled to the GYNECARE TVT ABBREVO™ & GYNECARE TVT™ Obturator Implant Assembly.

The Winged Guide is a stainless steel accessory instrument that facilitates consistent passage of the GYNECARE TVT ABBREVO™ & GYNECARE TVT™ Obturator Implant Assembly through the dissection tract.

The provided document is a 510(k) summary for surgical instrumentation and describes performance testing for those instruments, not for an AI/ML device. Therefore, it does not contain information about acceptance criteria or studies related to AI/ML device performance.

The document discusses the following types of performance testing for the GYNECARE TVT ABBREVO™ and GYNECARE TVT™ Obturator Helical Passers and Atraumatic Winged Guide:

• Sterilization validation: To demonstrate the devices are sterile to an SAL of 10^-6.
• Package integrity: To ensure the sterility of the packaged devices.
• Dimensional and mechanical performance: To confirm the instruments meet design specifications and can withstand intended use.
• Biocompatibility: Including cytotoxicity, sensitization, and irritation tests to ensure the materials are safe for patient contact.
• Shelf life: To validate the stability and performance of the devices over their intended storage period.

The document concludes that the subject devices are substantially equivalent to their predicate devices and meet the special controls outlined in 21 CFR 884.4910.

Since this document does not pertain to an AI/ML device, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to AI/ML performance.

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The GYNECARE TVT™ Reusable Introducer is a reusable device intended to aid in the placement of the GYNECARE TVT Device retropubically.

The GYNECARE TVT™ Reusable Rigid Catheter Guide is a reusable device intended to facilitation of the urethra and bladder neck during the placement of the GYNECARE TVT Device and GYNECARE TVT EXACT Continence System.

The GYNECARE TVT EXACT™ Continence System Trocar is a single use device intended to aid in the placement of the GYNECARE TVT EXACT Continence System retropubically.

The subject devices include the following components:

GYNECARE TVT™ Reusable Introducer
GYNECARE TVTTM Reusable Rigid Catheter Guide
GYNECARE TVT EXACT™ Continence System Trocar

The subject devices are intended to be used with the GYNECARE TVT™ Device and GYNECARE TVT EXACT™ Continence System intended to treat stress urinary incontinence.

GYNECARE TVT™ Reusable Introducer
The GYNECARE TVT™ Introducer is provided non-sterile and is reusable. The Introducer is made of stainless steel. It consists of two parts, a handle and an inserted threaded metal shaft. The Introducer is intended to facilitate the passage of the GYNECARE TVT™ Device from the vagina to the abdominal skin. It is connected and fixed to the threaded end of the shaft, prior to inserting the needle with the tape.

GYNECARE TVT™ Reusable Rigid Catheter Guide
The GYNECARE TVT™ Rigid Catheter Guide is a non-sterile reusable instrument intended to facilitate the identification of the urethra and the bladder neck during the surgical procedure. It is inserted into a Folev catheter (recommended size 18 French) positioned in the urethra. To facilitate insertion, it can be lubricated with gel.

GYNECARE TVT EXACT™ Continence System Trocar
The GYNECARE TVT EXACT™ Continence System Trocar consists of the stainless steel Trocar Shaft and the plastic Trocar Handle. The Trocar Shaft is designed to fit inside the white Trocar Sheaths on the GYNECARE TVT EXACT™ Continence System Implant / Trocar Sheath Assembly, and is used to position the GYNECARE TVT EXACT™ Continence System Implant in the patient from a vaginal incision up through the abdominal wall.

This document describes a 510(k) premarket notification for reusable surgical instruments (GYNECARE TVT™ Reusable Introducer, GYNECARE TVT™ Reusable Rigid Catheter Guide) and a single-use instrument (GYNECARE TVT EXACT™ Continence System Trocar), which are accessories for urogynecologic surgical mesh systems. The submission asserts substantial equivalence to predicate devices (K974098 and K132054).

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

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a numerical or pass/fail threshold manner for performance. Instead, it lists the types of performance tests conducted and concludes that the devices meet the requirements, implying that the results of these tests were considered acceptable.

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

The document does not specify the sample sizes used for any of the performance tests (e.g., how many devices were tested for mechanical performance, sterilization, or reprocessing).

The data provenance (e.g., country of origin, retrospective/prospective) is not mentioned. These were likely conducted in a controlled laboratory environment by the manufacturer.

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

This type of information is not applicable to the performance characteristics studied for these medical instruments. The "ground truth" for mechanical performance, sterility, or biocompatibility is established through objective laboratory testing and industry standards, not through expert consensus on interpretation, as might be the case for an AI diagnostic device.

4. Adjudication Method for the Test Set:

This is not applicable as the tests relate to objective engineering and biological performance characteristics, not subjective clinical interpretations.

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

No, an MRMC comparative effectiveness study was not done. These devices are surgical instruments, not diagnostic tools that would directly assist human readers in interpreting images or data. Therefore, the concept of "effect size of how much human readers improve with AI vs. without AI assistance" is not relevant here.

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

No, a standalone performance study in the context of an algorithm is not applicable. These are physical medical devices, not software algorithms.

7. The type of ground truth used:

The "ground truth" for these tests would be established by:

• Sterilization Validation: Demonstrated sterility to a specified Sterility Assurance Level (SAL) through objective microbiological testing.
• Mechanical Performance: Adherence to engineering specifications and relevant industry standards for strength, durability, and dimensional accuracy, measured objectively.
• Biocompatibility: Compliance with ISO 10993 standards, assessed through laboratory tests (e.g., cell culture for cytotoxicity, animal models for sensitization/irritation).
• Reprocessing Validation: Demonstrated effectiveness of cleaning, disinfection/sterilization, and functional integrity after multiple reprocessing cycles, verified through objective testing.
• Package Integrity: Objective tests to ensure sterile barrier integrity.
• Shelf Life: Stability and functional integrity over time, verified through accelerated aging or real-time shelf-life studies.

8. The Sample Size for the Training Set:

This concept is not applicable. These are physical medical instruments and do not involve machine learning algorithms that require training data.

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

This concept is not applicable for the same reason as above (no machine learning involved).

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ULTRAPRO™ Mesh is indicated for the repair of abdominal wall hernias and abdominal wall deficiencies that require the addition of a reinforcing material to obtain the desired surgical result.

ULTRAPRO ADVANCED™M Mesh is indicated for the repair of abdominal wall hernias and abdominal wall deficiencies that require the addition of a reinforcing material to obtain the desired surgical result.

ULTRAPRO™ Mesh is manufactured from approximately equal parts* of absorbable poliglecaprone-25 monofilament fiber and nonabsorbable polypropylene monofilament fiber. The polymer of the undyed and dyed polypropylene fiber (phthalocyanine blue, Color Index No .: 74160) is identical to the material used for dyed/undyed PROLENE™ suture material. Poliglecaprone-25 fiber consists of a copolymer containing glycolide and &-caprolactone; this copolymer is identical to the material used for MONOCRYL™ suture. After absorption of the poliglecaprone-25 component, only the polypropylene mesh remains. The structure and size of this remaining mesh are optimally designed for the physiological stresses of the abdominal wall.

ULTRAPRO ADVANCED™ Macroporous Partially Absorbable Mesh is a sterile, partially absorbable mesh*, designed for the repair of abdominal wall hernias and other abdominal wall deficiencies. The device is manufactured out of dyed (phtalocyanine blue) and undyed nonabsorbable polypropylene monofilaments (3.5 mil PROLENE™) as well as a twist, composed of dyed (phtalocyanine blue) and undyed non-absorbable polypropylene monofilaments (3.5 mil PROLENE™) and undyed absorbable poliglecaprone 25 monofilaments (5 mil MONOCRYL™). Blue stripes provide orientation.

I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) premarket notification letter from the FDA to Ethicon Inc. regarding ULTRAPRO™ Mesh and ULTRAPRO ADVANCED™ for surgical mesh.

It primarily focuses on:

• FDA's determination of substantial equivalence to previously marketed predicate devices (ULTRAPRO™ Mesh K033337 and ULTRAPRO ADVANCED K150906).
• Device description: detailing the materials and composition of the mesh.
• Indications for Use: for the repair of abdominal wall hernias and deficiencies.
• Summary of Technological Characteristics: stating that the subject devices are identical to the predicate devices in terms of technology, materials, construction, manufacturing, and sterilization, with only labeling changes for clarity and regulatory expectations.
• Conclusion: affirming substantial equivalence based on identical intended use and technological characteristics to the predicate devices.

There is no mention of:

• Specific acceptance criteria (e.g., performance metrics, thresholds).
• Details of any study conducted to demonstrate the device meets acceptance criteria.
• Information regarding sample sizes, data provenance, expert qualifications, ground truth establishment, or comparative effectiveness studies (MRMC, standalone algorithm performance).

Therefore, I cannot fulfill your request to describe acceptance criteria and a corresponding study based on the provided text.

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The EVICEL™ Application Device is intended for the simultaneous topical application of the two biological components of EVICEL® Fibrin Sealant via dripping (no air pressure) or via spraying (CO2 pressure only, utilizing the pressure regulator unit) onto the surface.

The EVICEL Application device is a sterile single used to apply the two biological components of the EVICEL® Fibrin Sealant (Human). Accessory tips are also provided separately to help provide the user different options for various clinical uses. The pressure regulator (Class I, Exempt) may also be provided as an accessory to help reduce the pressure of the gas obtained from a CO2 source to within the recommended range for use.

This document does not contain any information regarding acceptance criteria or a study that proves a device meets specific acceptance criteria.

The provided text is a 510(k) premarket notification summary for the "EVICEL™ Application Device." Its primary purpose is to demonstrate substantial equivalence to a predicate device, not to present data from a performance study against acceptance criteria.

Here's a breakdown of why the requested information cannot be extracted from this document:

• No Acceptance Criteria or Performance Data: The document explicitly states, "Since there are no changes to the device design, principles of operation and fundamental scientific technology, we conclude that the proposed device is substantially equivalent to the predicate device under the Federal Food, Drug, and Cosmetic Act." This indicates that a new performance study to establish acceptance criteria for the new device was not performed because it is identical to an existing, cleared device.
• Focus on Substantial Equivalence: The entire document revolves around demonstrating that the new device is "exactly the same as the current EVICEL Application device," with only changes to the Indications for Use and a contraindication. This regulatory pathway (510(k)) often relies on demonstrating similarity to a legally marketed predicate device rather than conducting a full de novo efficacy or performance study.

Therefore, I cannot populate any of the requested sections (1-9) as the necessary information is not present within the provided text.

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ETHICON Mesh is indicated for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.

The proposed ETHICON Mesh is a sterile partially absorbable mesh implant, designed for repair of fascial structure of the pelvic floor in vaginal wall prolapse. The mesh implant is constructed of knitted filaments of equal parts of absorbable poliglecaprone-25 monofilament fiber and nonabsorbable polypropylene monofilament fiber.

The provided text, K082216, is a 510(k) premarket notification for a medical device (ETHICON Mesh) and does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way typically seen for AI/ML-driven devices or diagnostics.

Instead, this submission focuses on establishing substantial equivalence to previously marketed predicate devices for a surgical mesh. The "Performance Data" section is brief and refers to material biocompatibility and functional requirements, not clinical or diagnostic performance criteria as one would find for an AI algorithm.

Therefore, I cannot fulfill your request for a table of acceptance criteria, device performance, sample sizes, ground truth information, expert details, or MRMC study results because this document does not contain that type of information.

The relevant information from the document related to "performance" is:

• Performance Data Mentioned: "Biological reactivity of the materials has been assessed using methods specified in ISO 10993-1, and the material was found to be acceptable for its intended use. Results of functional performance testing indicate that the proposed device meets or exceeds all functional requirements."
• Conclusion Basis: Substantial equivalence to predicate devices (GYNECARE GYNEMESH® PS PROLENE® Soft Mesh and GYNECARE PROLIFT+M™ Pelvic Floor Repair Systems) based on similar technological characteristics.

This type of 510(k) submission generally relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, often through material characterization, mechanical testing, and comparison of technological characteristics, rather than extensive clinical performance studies with specific statistical endpoints that would be required for a novel device or a device making diagnostic claims.

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PROCEED Surgical Mesh may be used for the repair of hernias and other fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

PROCEED Surgical Mesh is a sterile, thin, flexible laminate mesh deigned for the repair of hernias and other fascial deficiencies. The mesh product is comprised of an oxidized regenerated cellulose (ORC) fabric, and PROLENE* Soft Mesh, a nonabsorbable polypropylene mesh, which is encapsulated by a polydioxanone polymer. The polypropylene mesh side of the product allows for tissue ingrowth while the ORC side provides a bioresorbable layer that physically separates the polypropylene mesh from underlying tissue and organ surfaces during the wound-healing period to minimize tissue attachment to the mesh. The polydioxanone provides a bond to the ORC layer.

This document is a 510(k) summary for the PROCEED Surgical Mesh, comparing it to a predicate device. It confirms substantial equivalence based on technological characteristics and intended use, but it does not contain any information about acceptance criteria or a study proving the device meets those criteria.

The document discusses:

• Submitter and contact information
• Trade Name, Common Name, Classification Name, and Product Code
• Predicate Device: PROCEED Trilaminate Surgical Mesh
• Device Description: A sterile, thin, flexible laminate mesh for hernia repair, comprised of oxidized regenerated cellulose (ORC) fabric and PROLENE* Soft Mesh, encapsulated by polydioxanone polymer. The polypropylene mesh side allows for tissue ingrowth, while the ORC side provides a bioresorbable layer to minimize tissue attachment.
• Intended Use: For the repair of hernias and other fascial deficiencies requiring reinforcing or bridging material.
• Technological Characteristics: Stated as "identical to the predicate device, PROCEED SURGICAL Mesh."
• Conclusions: "The descriptive information provided about PROCEED Surgical Mesh demonstrates substantial equivalence to the predicate device."
• FDA Clearance Letter: Confirming substantial equivalence.
• Indications for Use Statement: Reiterating the intended use.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, study details, sample sizes, ground truth, or MRMC studies, as none of this information is present in the provided text.

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The Endoscopic Applicator is intended for use in delivering hemostatic agents to bleeding surgical sites through a 5mm trocar or larger.

The Endoscopic Applicator device is a sterile single use, disposable device intended for use in delivering hemostatic agents to bleeding surgical sites through a 5mm trocar or larger. The Endoscopic Applicator consists of two components; (1) a minimally reflective stainless steel cannula and (2) a plastic stylet (obturator). The Endoscopic Applicator is designed with a luer connector, for connection to a syringe containing the hemostatic agent. The packaging used for the Endoscopic Applicator is a pouch that consists of a see-through laminated film and TYVEK. Alternatively, a second pouch may be used. Either package configuration is placed within a paperboard carton.

The provided text does not contain information about acceptance criteria or a study proving that an Endoscopic Applicator device meets acceptance criteria.

Instead, the document is a 510(k) summary for a medical device (Endoscopic Applicator) seeking substantial equivalence to a predicate device. It explicitly states that "performance testing was considered unnecessary" and "clinical data was deemed unnecessary to demonstrate equivalence of the new device to the predicate device for its intended purpose."

Therefore, I cannot provide the requested information based on the given text.

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