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V-Loc™ 180 absorbable wound closure devices are indicated for soft tissue approximation where use of an absorbable suture is appropriate.

The V-Loc™ 180 absorbable wound closure device is prepared from a copolymer of glycolic acid and trimethylene carbonate. The absorbable wound closure device is available clear or green. The device is sterile, inert, noncollagenous and nonantigenic.

This document is a 510(k) summary for a medical device called the "V-Loc™ 180 Absorbable Wound Closure Device." It outlines the device's description, intended use, and its substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

The 510(k) summary explicitly states: "Performance testing is not applicable as there has been no change to the V-Loc™ 180 absorbable wound closure device." This means there was no new performance study conducted with a test set for this 510(k) submission. The device's approval is based on its substantial equivalence to a predicate device (K082662 - V-loc™ 180 Absorbable Wound). Therefore, information on sample size, test set data provenance, and ground truth for a new test set is not provided in this document.

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

Not applicable, as no new performance study with a test set was conducted for this 510(k). The device's performance relies on the previous evaluation of the identical predicate device.

4. Adjudication Method for the Test Set

Not applicable, as no new performance study with a test set was conducted for this 510(k).

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

No, an MRMC comparative effectiveness study was not done as part of this 510(k) submission. The FDA clearance is based on substantial equivalence, not a comparative effectiveness study showing improvement with AI.

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

Not applicable. This device is a physical wound closure device, not an AI algorithm, so the concept of standalone performance for an algorithm is irrelevant here.

7. Type of Ground Truth Used

Not explicitly stated for this 510(k). The device's performance is established by its identity to a predicate device, which would have undergone its own testing and established its efficacy through appropriate methods (e.g., in vitro, in vivo, or clinical studies) prior to its own approval. The biocompatibility for the materials was evaluated against ISO 10993-1:2003.

8. Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI algorithm requiring a training set.

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

Not applicable, as this is a physical medical device, not an AI algorithm.

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V-Loc™ 180 Absorbable Wound Closure Device is indicated for soft tissue approximation in where use of an absorbable suture is appropriate.

The V-Loc ™ 180 Absorbable Wound Closure Device is a suture prepared from a copolymer of glycolic acid and trimethylene carbonate. Each device has unidirectional barbs along the axis of the monofilament. The V-Loc ™ 180 Absorbable Wound Closure Device will be offered dyed with D&C Green No. 6 (21 CFR 74.3206) or clear (undyed) in sizes USP (EP) 2-0 (Metric 3), 0 (Metric 3.5) and 1 (Metric 4). They will be supplied in pre-cut lengths affixed to various needle types.

The input document is a 510(k) summary for the V-Loc™ 180 Absorbable Wound Closure Device. This document does not describe the acceptance criteria or results of a study in the format requested. It is a regulatory submission outlining the device description, indications, and substantial equivalence to predicate devices, but lacks detailed performance data with specific acceptance criteria and study results. Therefore, I cannot generate the requested table and answer the study-related questions based on the provided text.

Specifically, the "Performance Data" section merely states: "Performance testing was conducted to verify that the V-Loc™ 180 Absorbable Wound Closure Device is safe and effective and performs as intended." This general statement does not provide the specific metrics, criteria, or study outcomes needed to answer your request.

To fulfill your request, I would need a document that includes:

• A table or section explicitly listing acceptance criteria for various performance metrics (e.g., tensile strength, absorption rate, knot security, biocompatibility).
• Detailed results of the studies performed to demonstrate compliance with these criteria.
• Information on sample sizes, data provenance, ground truth establishment, expert qualifications, and study designs (e.g., standalone, MRMC) if applicable.

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The Autosuture™ ENDO GIA™ Staplers with ENDO GIA™ Single Use Loading Units with Staple Line Reinforcement have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and billary structures.

The Autosuture™ ENDO GIA™ Staplers with ENDO GIA™ Single Use Loading Units with Staple Line Reinforcement place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples is determined by the selection of the 3.5 mm or 4.8 mm Single Use Loading Unit (SULU). The ENDO GIA™ UNIVERSAL Single Use Loading Units (SULUs) with Staple Line Reinforcement are only available in the straight and articulating 45 mm and 60 mm length cartridges with the 3.5 mm or 4.8 mm staples. The staple line reinforcement material is a synthetic absorbable film prepared from synthetic polyester composed of glycolide, dioxanone, and trimethylene carbonate. The staple line reinforcement material is supplied on each SULU undyed (natural) and is secured to the anvil and cartridge with BIOSYN™ synthetic absorbable suture. Studies indicate that the staple line reinforcement material can be expected to retain measurable mechanical strength through 14 days and absorption should be complete between 90 and 110 days.

The provided text describes a 510(k) summary for the Autosuture™ ENDO GIA™ Surgical Staplers with ENDO GIA™ Single Use Loading Units with Staple Line Reinforcement. However, it does not include information about specific acceptance criteria or an explicit study that proves the device meets those criteria in the context of a typical AI/software device evaluation.

The document mainly focuses on the device description, intended use, technological characteristics, and material safety. It states: "Performance evaluations were completed to verify that the Autosuture™ ENDO GIA™ Staplers with ENDO GIA™ Single Use Loading Units with Staple Line Reinforcement are safe and effective and perform as intended." This is a general statement and does not provide the detailed information requested regarding specific acceptance criteria, study design, sample sizes, ground truth establishment, or expert involvement, which are typical for studies assessing AI device performance.

Therefore, I cannot provide the requested information from the given text. The text does not contain:

1. A table of acceptance criteria and reported device performance: No specific performance metrics or acceptance thresholds are listed.
2. Sample size used for the test set and data provenance: No information on the number of cases or the origin of data used for performance evaluation.
3. Number of experts used to establish ground truth and their qualifications: No mention of expert involvement in establishing ground truth.
4. Adjudication method for the test set: Not applicable as no ground truth creation process is described.
5. MRMC comparative effectiveness study: The document does not describe a study involving human readers with or without AI assistance.
6. Standalone (algorithm only) performance: This device is a surgical stapler, not an AI algorithm, so standalone algorithm performance is not applicable in the usual sense. Its performance is inherent to its mechanical function and material properties.
7. Type of ground truth used: Not applicable as it's a physical device and not an AI interpreting data. The "ground truth" for a physical device would relate to its mechanical integrity and biological interaction, which is assessed through various engineering and biocompatibility tests.
8. Sample size for the training set: Not applicable as this is a physical device, not an AI system that requires a training set.
9. How the ground truth for the training set was established: Not applicable for the same reason.

The "performance evaluations" mentioned in the document likely refer to laboratory testing, mechanical robustness tests, biocompatibility assessments, and potentially animal studies, which are standard for surgical devices, rather than clinical studies involving human readers or AI algorithms that would generate the kind of data you're asking for.

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COPA AMD dressings are indicated for use in management of post-surgical incisions, pressure sores, venous stasis ulcers, diabetic ulcers, donor sites, abrasions, 1st and 200 degree burns, dermatologic disorders, other wounds inflicted by trauma and, as a secondary dressing or cover dressing for packed wounds.

COPA AMD is a hydrophilic polyurethane foam that is impregnated with Polyhexamethylene Biguanide Hydrochloride (PHMB), an antimicrobial agent that protects the dressing from bacterial penetration and colonization.

The provided text from the 510(k) Premarket Notification for the COPA AMD Antimicrobial Wound Dressing describes performance data related to its antimicrobial properties. The information pertains to the device's ability to prevent bacterial penetration and colonization.

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

1. Table of acceptance criteria and the reported device performance

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

• Sample size: Not explicitly stated in terms of the number of unique dressings or tests. The tests were performed in-vitro and an animal testing was also mentioned.
• Data provenance: The tests were described as "in-vitro and animal testing," indicating laboratory and possibly animal model experiments. The country of origin for these tests is not specified, but the submission is to the US FDA.

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

Not applicable. The performance data is based on laboratory (in-vitro) and animal testing, which typically relies on established microbiological and scientific protocols rather than expert consensus on subjective observations.

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

Not applicable. This type of adjudication is relevant for studies involving human interpretation (e.g., image reading), not for laboratory or animal testing results.

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 wound dressing, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.

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

Not applicable. This device is a physical wound dressing and does not involve an algorithm or AI.

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

The ground truth was established through microbiological assays (quantifying bacterial kill) for the in-vitro tests and likely biological endpoints related to infection or wound healing for the animal testing.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a training set. The "testing" referred to is for device performance, not algorithm training.

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

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

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The Cool-tip™ Switching Controller is to be used with the Cool-tip™ RF System and is intended for use in percutaneous, laparoscopic, intraoperative coagulation and ablation of tissue, such as the partial or complete ablation of non-resectable liver tumors, and osteoid osteoma tumors within bone.

The Cool-tip™ Switching Controller (CTSW Control) is an adjunct device for the Cooltip™ RF Ablation Generator. Power from the generator is routed to the controller and allows the physician to ablate lesions with one single Cool-tip electrode or one cluster electrode, or simultaneously with two or three single pre-placed electrodes. The controller sequentially switches power between the electrodes. Power is applied to the first electrode until the tissue impedance rises to the target value (30 percent above the baseline value), or until 30 seconds have elapsed. Then power is switched to the next electrode. Power is switched repeatedly until the selected procedure time is reached. The controller does not alter the basic functions available on the generator. The controller has the same timing, temperature measurement, and impedance measurement functions available on the generator. The controller does not change the power available at the electrodes compared to the generator without the controller. The indications for use and the control mechanisms for the Switching Controller remain the same as for the generator. The Switching Controller is an accessory that allows for the simultaneous activation of multiple electrodes. Activation of multiple electrodes during a single treatment session is a convenience for the physician and allows for the ablation of multiple lesions simultaneously, or for the ablation of one large tumor when the electrodes are placed 2 cm apart. Placing three single electrodes in close proximity produces a cluster electrode where the physician is controlling the cluster spacing. The controller automates the manual function of cauterization of the electrode track by controlling the temperature during electrode removal. The front panel of the Switching Controller contains an on/off power switch, activation switches for ablation and cauterization, ablation timer displays and buttons, three (3) electrode ports for the connection of selected electrodes, three (3) buttons for activating selected electrode channels, three (3) temperature probe displays with adjacent green bars to indicate the activated electrode channel, and three (3) current/watts displays for each electrode channel. The Cool-tip™ Switching Controller is comprised of the following components: Switching controller, Cable, which delivers power from the generator to the controller. The Switching Controller is connected to the Cool-tip RF generator by a dedicated cable that delivers power from the generator to the switching controller. The Switching Controller cannot direct power to the electrodes without the generator.

The Cool-tip™ Switching Controller is an adjunct device for the Cool-tip™ RF Ablation Generator, designed to facilitate the simultaneous activation of multiple electrodes. It routes power from the generator, allowing the physician to ablate lesions with one single electrode, one cluster electrode, or simultaneously with two or three pre-placed electrodes. The controller sequentially switches power between electrodes until the selected procedure time is reached. It also automates the manual function of cauterization during electrode removal.

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

The provided text does not explicitly state numerical acceptance criteria for a specific performance metric (like accuracy, sensitivity, or specificity). Instead, the acceptance is based on the device demonstrating safety and efficacy comparable to a predicate device. The key performance aspect is the ability of the switching controller to produce similar therapeutic effects (lesions) as the predicate device when using various electrode configurations.

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

The study involved preclinical testing on bovine liver, both ex vivo (outside the body) and in vivo (in a living organism). The document does not specify a precise numerical sample size (e.g., number of livers, number of ablation procedures, or number of electrodes tested).

However, the data provenance is clearly stated as bovine liver, indicating an animal model. The study is described as "preclinical testing," implying it's a prospective study designed to compare the new device to the predicate.

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

The document does not provide information on the number or qualifications of experts used to establish ground truth for the test set.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method for the test set. The comparison of lesion characteristics likely involved direct measurement and observation rather than expert consensus on a diagnostic outcome.

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

No, an MRMC comparative effectiveness study was not conducted. This device is an accessory to an existing RF ablation system and its performance demonstration focuses on the equivalence of the generated lesions, not on diagnostic accuracy involving human readers.

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

This question is not applicable in the context of this device. The Cool-tip™ Switching Controller is a hardware accessory that automates power delivery for RF ablation electrodes. It does not involve algorithms for interpretation or generate diagnostic outputs that would have a "standalone performance" in the typical sense of AI/software. Its performance is intrinsically tied to its interaction with the RF generator and electrodes.

7. The Type of Ground Truth Used

The ground truth for this study was based on the characteristics of the lesions produced by the RF ablation. The statement "lesions produced... are comparable" implies a physical assessment of ablation zones (e.g., size, shape, completeness) as the reference for comparison. This would likely involve macroscopic and/or microscopic examination of the ablated tissue.

8. The Sample Size for the Training Set

The document does not mention a training set. This is not a machine learning device, so the concept of a training set as used in AI development is not applicable here.

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

As there is no training set for this hardware device, this question is not applicable.

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The ForceTriad™ is a full-featured electrosurgical generator intended for open and laparoscopic surgical procedures where the surgeon requires electrosurgical cutting, coagulation, or vessel sealing (tissue fusion). The generator is intended for use in general, laparoscopic and gynecologic surgical procedures where ligation of vessels, pulmonary vasculature, or lymph vessels, is desired. The system creates a vessel ligation (seal) by the application of bipolar electrosurgical RF energy (coagulation) to vessels interposed between the jaws of the device. The generator can also be used with standard bipolar devices where bipolar cutting or coagulation is desired.

The indications for use include general (including urologic, thoracic, plastic and reconstructive), laparoscopic, and gynecological procedures where electrosurgical cutting and coagulation of tissue, and sealing (fusion) of vessels, including pulmonary vessels, and tissue bundles is performed. including such procedures as bowel resections, hysterectomies (both vaginal and abdominal), laparoscopic cholesystectomies, laparoscopically assisted vaginal hysterectomies, gall bladder procedures, Nissen fundoplication, adhesiolysis, oophorectomy, etc. The devices can be used on vessels (arteries, veins, pulmonary arteries, pulmonary veins, lymph) up to 7mm and bundles as large as will fit in the jaws of the instruments.

The LigaSure tissue fusion function has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use this function for these procedures.

The ForceTriad™ generator is a full-featured electrosurgical generator with monopolar, bipolar, and Valleylab LigaSure™ vessel sealing outputs. This 510(k) only applies to the LigaSure™ Vessel sealing portion of the generator. The generator is electrically isolated, microcontroller-based device, incorporating closed-loop control for all output modes implemented in the microcontroller firmware. The generator incorporates Instant Response™ technology to constantly measure the electrical impedance of the tissue and instantaneously adjust the generator output to maintain the desired power.

The generator is used with a selection of instruments designed for use with the ForceTriad and the LigaSure Vessel Sealing generator. All of the instruments are capable of sealing vessels up to, and including, 7mm, and tissue bundles as large as can fit in the jaws of each instrument. When a LigaSure™ instrument is applied to a vessel or tissue bundle and RF energy is applied, the collagen and elastin in the tissues are reformed by heat and pressure to fuse vessel walls, thereby forming a permanent seal. The microprocessor in the generator monitors the tissue properties, stops the application of energy, and allows a brief period of cooling before indicating that cycle is complete.

No changes are being made to the design or operation of any of the devices within the current system. The change as proposed in this 510(k) notification is to the intended use as described above and the resulting labeling changes.

This document describes the ForceTriad™ Electrosurgical Generator, specifically its LigaSure™ Vessel Sealing System component. The submission is a 510(k) for a change in intended use and labeling, as the technological characteristics of the device have not been modified.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

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

   The document does not explicitly state quantitative acceptance criteria in a table format. However, it implicitly defines successful performance for the LigaSure™ vessel sealing function:

   Acceptance Criteria (Implied)	Reported Device Performance
   Effective sealing of pulmonary vasculature	Pre-clinical studies (acute and chronic) and bench testing have shown that the ForceTriad Electrosurgical Generator effectively seals pulmonary vasculature.
   Seals with burst pressures substantially greater than physiologic pressures in the vessels	Pre-clinical studies (acute and chronic) and bench testing have shown that the ForceTriad Electrosurgical Generator produces seals with burst pressures substantially greater than the physiologic pressures in the vessels.
   Capability to seal vessels up to and including 7mm	All of the instruments are capable of sealing vessels up to, and including, 7mm. The devices can be used on vessels (arteries, veins, pulmonary arteries, pulmonary veins, lymph) up to 7mm.
   Capability to seal tissue bundles as large as can fit in the jaws of each instrument	All of the instruments are capable of sealing tissue bundles as large as can fit in the jaws of each instrument. The devices can be used on... bundles as large as will fit in the jaws of the instruments.
   Formation of a permanent seal to fuse vessel walls	When a LigaSure™ instrument is applied to a vessel or tissue bundle and RF energy is applied, the collagen and elastin in the tissues are reformed by heat and pressure to fuse vessel walls, thereby forming a permanent seal. The microprocessor in the generator monitors the tissue properties, stops the application of energy, and allows a brief period of cooling before indicating that cycle is complete.

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

   The document states: "Pre-clinical studies (acute and chronic) and bench testing have shown that the ForceTriad Electrosurgical Generator effectively seals pulmonary vasculature..."

   • Sample size: Not specified.
   • Data provenance: Not specified, but "pre-clinical studies" generally implies laboratory or animal studies, and "bench testing" is laboratory-based. No information on country of origin is provided. Both would be considered prospective studies in their design.

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

   Not applicable. The performance is assessed through objective biophysical measurements (e.g., burst pressure) and physical observation of sealing, not through expert human interpretation of images or clinical outcomes that require expert consensus for ground truth.

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

   Not applicable. Adjudication methods like 2+1 are typically used for establishing ground truth from multiple human readers, often in image-based diagnostic studies. This study relies on objective physical measurements and observations.

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

   Not applicable. This is a medical device performance study, not a diagnostic AI study involving human readers.

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

   Yes, the performance data presented is for the device operating in a standalone manner. The device itself (the ForceTriad™ Electrosurgical Generator with its LigaSure™ functionality) is assessed based on its ability to achieve effective vessel sealing and high burst pressures, without human intervention in the sealing process once initiated. The human's role is in operating the device, not in interpreting its output for the technical performance measurements.

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

   The ground truth is established through objective biophysical measurements (e.g., burst pressure testing) and direct observation of physical outcomes (e.g., effective sealing/fusion of vessels). This type of ground truth is based on engineering and physiological principles rather than expert interpretation of medical data.

8. The sample size for the training set

   Not applicable. This device is not an AI/machine learning model in the sense that it requires a "training set" of data to develop its algorithm. The device's operation is based on established electrosurgical principles and a microcontroller-based closed-loop control system. Its parameters are likely determined through engineering design and validation, not a data-driven training process.

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

   Not applicable, as there is no "training set" in the context of this electrosurgical generator's design and validation described here.

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The device is indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.

Polysorb* Synthetic Absorbable Suture with Modified Packaging shall remain identical to the predicate device, an absorbable poly(glycolide/L-lactide) surgical suture. with the addition to the packaging of an injection port to the inner foil pouch.

The provided document is a 510(k) summary for a medical device, specifically an absorbable surgical suture. It describes the device, its intended use, and its equivalence to a predicate device. It does not present a study that establishes acceptance criteria for new functionality or a new AI/software-driven device. Instead, it refers to "in-vitro studies" to demonstrate substantial equivalence to a predicate device for an existing product with a modified packaging.

Therefore, many of the requested categories are not applicable to the information provided in this 510(k) summary. I will fill in the applicable information and note when a section is not applicable.

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

The document does not specify quantitative acceptance criteria. It states that "In-vitro studies were performed...to demonstrate that the functional performance of the suture is substantially equivalent to the predicate device when pre-wetted with sterile saline (0.9% NaCl) using the injection port for up to 12 hours at room temperature prior to use." This implies that the performance after pre-wetting should be comparable to the predicate device.

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

• Sample size: Not specified in the provided 510(k) summary.
• Data provenance: Not specified, but the studies were "in-vitro."

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

Not applicable. This device is a surgical suture, and the studies were "in-vitro" to assess physical properties and performance, not diagnostic interpretations requiring expert ground truth establishment.

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

Not applicable. See point 3.

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

Not applicable. This is not an AI/software-driven device.

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

Not applicable. This is not an AI/software-driven device.

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

Not applicable. The equivalence was based on "functional performance" in "in-vitro studies," likely involving mechanical testing or other objective physical measurements, rather than clinical ground truth as understood in diagnostic AI.

8. The sample size for the training set

Not applicable. This is not an AI/software-driven device, so there is no "training set."

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

Not applicable. See point 8.

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The Palindrome Emerald 14.5 fr Cuffed catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. The performance of the heparin coating on this catheter in reducing platelet adhesion on the catheter surface for up to 720 hours of dialysis treatment is supported by bench and animal testing. It may be inserted either percutaneously or by cutdown.

The Palindrome™ Emerald™ 14.5 Fr Chronic Hemodialysis Catheter with Heparin Coating has a radiopaque polyurethane shaft with two large inner lumens designed in a "double D" configuration. The distal end of the catheter extends to a symmetrical tip. The proximal end of the catheter shaft contains a polyurethane hub assembly and silicone extension sets. The catheter contains a heparin coating on its surface, from the tip of the catheter to the cuff on the external surface, and throughout the entire length on the internal surface (tip to luer adapters), for the purpose of reduction of platelet adhesion. Results of in-vitro studies using bovine blood against an uncoated catheter demonstrate a 60% reduction in platelet adhesion along the catheter surface of the proposed device.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:

Device: Palindrome™ Emerald™ 14.5 Fr Chronic Hemodialysis Catheter with Heparin Coating

Acceptance Criteria and Reported Device Performance:

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The Kendall Genius 2 Infrared Tympanic Electronic Thermometer is intended for use in patients in Acute and Alternate care settings to provide temperature measurements from the tympanic membrane and equivalent measurements of core, oral, rectal, and axillary temperature based on the tympanic reading.

The Genius 2 is a new infrared tympanic electronic thermometer comprised of a battery operated handheld thermometer unit tethered to a base station. This Class II device is an electronic clinical thermometer that measures temperature by sensing infrared emmisions from the tympanic membrane in the ear canal. Through offest adjustments, equivalent site temperatures can be displayed for oral, rectal, core, and axillary temperatures based on the tympanic reading. This clinical electronic thermometer offers a streamlined graphical user interface that walks the user through temperature measurement.

The provided text is a 510(k) summary for the Kendall Genius 2 Infrared Tympanic Electronic Thermometer. While it states that "Performance data for the Kendall Genius 2 Infrared Tympanic Electronic Thermometer is compared to that of the predicate device... Results of verification / validation demonstrate that the modified device is substantially equivalent to the legally marketed device," it does not actually include the detailed performance data or a specific study proving the device meets acceptance criteria.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer questions 2 through 9 based on the provided text. The document focuses on establishing substantial equivalence to a predicate device (Kendall FirstTemp Genius Tympanic Thermometer, K920713) based on intended use, materials, physical characteristics, and performance characteristics, but it does not present the specific data from such performance comparisons.

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The CUSA Excel Ultrasonic Surgical Aspirator System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft and hard (e.g.: bone) tissue is desirable, including Neurosurgery, Plastic and Reconstructive Surgery, General Surgery, Orthopedic Surgery, Gynecological Surgery, Thoracic Surgery, Laparoscopic Surgery and Thoracoscopic Surgery.

The CUSA Excel Ultrasonic Surgical Aspirator System (CUSA) is an ultrasonically vibrating surgical device which, in combination with irrigation and aspiration, fragments, emulsifies and removes unwanted tissue. It allows the selective dissection of target tissue while preserving vessels, ducts and other delicate structures. The CUSA Excel System consists of a console which provides control and power functions, a surgical handpiece which provides ultrasonic mechanical energy, a titanium handpiece tip and flexible irrigation flue, and a suction/irrigation system (manifold tubing and cooling water canister). A tip has been added to the CUSA Excel system to enable it to abrade bone. Testing was completed to demonstrate that the tip will abrade bone. The tip is manufactured from the same materials as in the other CUSA Excel tips.

The provided text is a 510(k) summary for the Radionics CUSA Excel Ultrasonic Surgical Aspirator System with Bone Tip. This document describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain any information about acceptance criteria, device performance metrics (such as accuracy, sensitivity, specificity), sample sizes for test sets or training sets, expert qualifications, adjudication methods, or results from comparative effectiveness studies.

The text simply states: "Testing was completed to demonstrate that the tip will abrade bone." This is a general statement and does not provide quantified performance data or details of a study that would establish specific acceptance criteria.

Therefore, I cannot fulfill the request to provide the detailed information required for the table and all the numbered points because the provided document does not contain this type of performance study data.

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