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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 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:

Detailed Study Information:

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

   • In-vitro circulating blood loop test: Not explicitly stated, but the test involved comparing a coated catheter to an uncoated control.
   • Coating durability test: Involved one catheter subjected to simulated dialysis conditions for 720 hours, with measurements taken periodically.
   • In-vivo ovine model: 6 sheep were used. Each sheep had both a coated and non-coated catheter implanted.
   • Data Provenance: The studies were conducted as bench (in-vitro) and animal (in-vivo) testing. The animals used were sheep (ovine model). The origin of the in-vitro blood (bovine blood) is mentioned.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" here is objective measurement data from experiments (e.g., platelet count, thrombus weight, heparin activity), not expert interpretation of images or observations requiring multiple human readers.

3. Adjudication method for the test set: Not applicable, as there was no subjective assessment requiring adjudication. Outcomes were determined by quantitative measurements. In the in-vitro test, retrieved catheters were visually inspected and then placed in a gamma counter for quantification. In the in-vivo test, gravimetric analysis was performed.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a medical device for direct patient contact/treatment, not an AI diagnostic or interpretive tool.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical catheter, not a standalone algorithm.

6. The type of ground truth used: Experimental measurement data:

   • Quantification of radiolabeled platelet adhesion via gamma counter.
   • Gravimetric analysis of thrombus weight.
   • Measurement of heparin activity levels.

7. The sample size for the training set: Not applicable. This is not a machine learning model, so there is no training set. The term "training set" is usually reserved for AI/ML contexts.

8. How the ground truth for the training set was established: Not applicable. See point 7.

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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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