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The Aragon Surgical Caiman 5 Laparoscopic Instrument is a dedicated bipolar electrosurgical instrument intended for use in general surgical and gynecologic laparoscopic procedures where ligation and division of vessels is desired. The instrument creates a seal by the application of bipolar electrosurgical RF energy to vascular structures (vessels) interposed between the jaws of the device. A cutting blade is actuated for the division of tissue.

Indications for use include general laparoscopic procedures, including urologic, vascular, thoracic, and thoracsocopic, and gynecological laparoscopic procedures where ligation and division of vessels is performed. These procedures include: laparoscopically assisted vaginal hysterectomies, Nissen fundoplication, colectomy, adhesiolysis, oophorectomy etc.

The Aragon Surgical Caiman 5 Laparoscopic Instrument can be used on vessels up to and including 7mm, and tissue bundles as large as will fit in the jaws of the instrument.

The Aragon Surgical Lektrafuse RF System has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures.

The Aragon Surgical Caiman 5 Laparoscopic Instrument is provided as a sterile, single use device. The device is capable of vessel sealing, blunt dissection, grasping and dividing tissue enclosed within its iaws during open and laparoscopic procedures. The device is designed to be used with the Aragon Surgical RF Generator (K093075) and creates vessel ligation by the application of bipolar electrical RF energy and tissue division with a cutting blade.

The Aragon Surgical Lektrafuse RF Generator is designed to be used with Aragon Surqical RF instrumentation only. The Aragon Surgical Lektrafuse RF Generator is not compatible with any other handheld RF surgical instrumentation.

The provided text describes a 510(k) premarket notification for the Aragon Surgical Caiman 5 Laparoscopic Instrument, not a study performing a comparative effectiveness or standalone performance evaluation against acceptance criteria in the manner typically associated with clinical trials or AI/software validation. The document states that "Results of bench and pre-clinical evaluations were used to demonstrate that the Aragon Surgical Lektrafuse RF Generator and Caiman 5 Laparoscopic Instrument are substantially equivalent to the predicate devices and meets design, safety, and effectiveness criteria."

This is a regulatory submission focused on demonstrating substantial equivalence to predicate devices. It does not contain the detailed information about specific acceptance criteria and a study design with sample sizes, expert ground truth, or MRMC studies that you are asking for in the context of device performance validation against specified criteria.

Therefore, many of the requested fields cannot be filled directly from the provided text.

Here's an attempt to answer the questions based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list specific numerical acceptance criteria (e.g., minimum burst pressure, maximum thermal spread) or corresponding quantitative reported device performance data in a table format. The "acceptance criteria" are generally implied to be that the device performs equivalently to the predicate devices in terms of design, materials, principle of operation, and product specifications, and meets general safety and effectiveness criteria.

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

The document states "Results of bench and pre-clinical evaluations were used," but does not provide specific sample sizes for these tests, nor does it specify the data provenance (e.g., country of origin, retrospective/prospective nature).

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

This information is not provided in the document. The "bench and pre-clinical evaluations" likely involve engineering and possibly veterinary experts, but their number and specific qualifications are not detailed.

4. Adjudication method for the test set

This information is not provided in the document.

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

No such study (MRMC or involving AI assistance) is mentioned or implied in the document. This device is a surgical instrument, not an AI-powered diagnostic tool.

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

Not applicable, as this is a physical surgical instrument, not a standalone algorithm.

7. The type of ground truth used

The "ground truth" used for demonstrating substantial equivalence would primarily be the established performance characteristics and safety profiles of the predicate devices, along with the results from the bench and pre-clinical evaluations on the new device. These evaluations would typically involve measurements of parameters like seal strength, burst pressure, thermal spread, and tissue effects. The document does not specify whether pathology, outcomes data, or expert consensus was used specifically as "ground truth" for these evaluations.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that would have a training set. The "training" in this context would refer to the development and testing of the physical device.

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

Not applicable. See point 8.

Summary of Limitations:

The provided text is a 510(k) summary for a physical medical device (a laparoscopic electrosurgical instrument), not a report on a clinical study or a validation study for an AI algorithm. Therefore, many of the questions related to clinical study design, expert evaluation, AI performance, and specific statistical metrics are not addressed in this type of regulatory document. The primary goal of this submission is to demonstrate "substantial equivalence" to already marketed predicate devices, usually through technical comparisons and non-clinical testing, rather than a novel clinical effectiveness study against predefined quantitative performance criteria.

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The Aragon Surgical Teleo Instrument is a dedicated bipolar electrosurgical instrument intended for use in general surgical and gynecologic procedures where ligation and division of vessels is desired. The instrument creates a seal by the application of bipolar electrosurgical RF energy (coagulation) to vascular structure (vessels) interposed between the jaws of the device. A cutting blade is actuated for the division of tissue.

The indications for use include general surgical procedures (including urologic, vascular, thoracic, and thoracoscopic), and gynecologic surgery procedures where ligation and division of vessels is performed. These procedures include: vaginal hysterectomies, Nissen fundoplication, colectorny, adhesiolysis, bowel resections and oophorectomy etc., or any procedure where vessel ligation (cutting and sealing), tissue grasping, and dissection is performed.

The device can be used on vessels up to and including 7mm and bundles as large as will fit in the jaws of the instrument.

The Aragon Surgical Teleo Instrument has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the system for these procedures.

The Aragon Surgical RF Systems consists of two components: the Aragon Surgical Generator and the Aragon Surgical Teleo Instrument. The Aragon Teleo Instrument is provided as sterile and is intended for single use. The device is capable of vessel sealing, blunt dissection, grasping and dividing tissue enclosed within its jaws.

The provided text is a 510(k) summary for the Aragon Surgical Teleo Instrument. This document primarily focuses on demonstrating substantial equivalence to a predicate device based on design, materials, function, and intended use. Therefore, it does not contain the kind of detailed information typically found in a clinical study report that would establish acceptance criteria and prove a device meets them through empirical data.

Here's a breakdown of what can and cannot be extracted from the provided text based on your questions:

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

• Cannot be provided: The document does not define specific acceptance criteria (e.g., performance metrics, thresholds) for the Teleo Instrument, nor does it report detailed performance data from a specific study against such criteria. The basis of clearance is substantial equivalence to a predicate device (K090306), not a demonstration of novel performance against predefined metrics.

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

• Cannot be provided: The document does not describe any specific "test set" in the context of an AI/algorithm evaluation. The "pre-clinical evaluation" mentioned is not detailed enough to extract sample size or data provenance.

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)

• Cannot be provided: This information is not relevant to the type of 510(k) submission presented, which is not for an AI/CADe device requiring expert ground truth for image interpretation.

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

• Cannot be provided: Same as above, not relevant or present.

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

• Cannot be provided: The device is an electrosurgical instrument, not an AI/CADe system. Therefore, MRMC studies are not applicable or mentioned.

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

• Cannot be provided: The device is not an algorithm.

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

• Cannot be provided: No ground truth definition is relevant or provided in this context. The "pre-clinical evaluation" would likely involve engineering tests, animal studies, or cadaver studies, but specifics are not given.

8. The sample size for the training set

• Cannot be provided: Not an AI device, so no training set.

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

• Cannot be provided: Not an AI device.

Summary of available information from the document:

• Device Name: Aragon Surgical RF System Teleo Instrument
• Predicate Device: Aragon Surgical RF System/L2 Instrument (K090306)
• Basis for Clearance: Substantial equivalence to the predicate device.
• Key Statement regarding equivalence: "The technological characteristics of the Aragon Surgical Teleo Instrument are identical to those of the cited predicate electrosurgical device. K090306. This device is equivalent in terms of design, materials, and principal of operation. The modification between the Aragon Surgical Teleo Instrument and the predicate device does not raise new issues regarding safety or effectiveness."
• Conclusion: "Based on the design, materials, function, intended use, and pre-clinical evaluation, the Aragon Surgical Teleo Instrument is substantially equivalent to devices currently marketed under the Federal Food, Drug and Cosmetic Act. In addition, the Aragon Surgical Teleo Instrument raises no new safety or effectiveness issues. Therefore, safety and effectiveness are reasonably assured, justifying 510(k) clearance."

This 510(k) focuses on the "identity" of the device's technology and intended use with a previously cleared device, asserting that no new safety or effectiveness issues are raised by any modifications. It does not present de novo performance data against specific acceptance criteria.

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The Aragon Surgical Laparoscopic (L2) Instrument is a dedicated bipolar electrosurgical instrument intended for use in general surgical and gynecologic laparoscopic procedures where ligation and division of vessels is desired. The instruments create a seal by the application of bipolar electrosurgical RF energy (coagulation) to vascular structure (vessels) interposed between the jaws of the device. A cutting blade is actuated for the division of tissue.

The indications for use include general laparoscopic procedures, (including urologic, vascular, thoracic, and thoracoscopic), and gynecological laparoscopic procedures where ligation and division of vessels is performed. These procedures include: vaginal hysterectomies, Nissen fundoplication, colectorny, adhesiolysis, bowel resections, and oophorectomy etc., or any procedure where vessel ligation (cutting and sealing), tissue grasping, and dissection is performed.

The device can be used on vessels up to and including 7mm and bundles as large as will fit in the jaws of the instrument.

The Aragon Surgical Laparoscopic Instrument has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the system for these procedures.

The Aragon Surgical Laparoscopic Instrument(L2) is provided as a sterile, single use device. The device is capable of vessel sealing, blunt dissection, grasping and dividing tissue enclosed within its jaws during open and laparoscopic procedures. The device is designed to be used with the Aragon Surgical RF Generator (K081312) and creates vessel ligation by the application of bipolar electrical RF energy and tissue division with a cutting blade.

Here's an analysis of the provided text regarding the Aragon Surgical Laparoscopic Instrument (L2) and its performance data, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document, a 510(k) summary, does not explicitly state specific acceptance criteria in measurable terms (e.g., "burst pressure of X mm Hg," "seal time of Y seconds"). Instead, it broadly states that:

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

The document mentions "bench and pre-clinical evaluations" but does not specify the sample size for any test sets used. The data provenance is not explicitly stated as retrospective or prospective, nor does it detail country of origin, but it can be inferred that these were controlled evaluations conducted by the manufacturer, Aragon Surgical, Inc., presumably in a laboratory or animal setting ("pre-clinical").

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

The document does not provide any information about 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 specify any adjudication method (e.g., 2+1, 3+1, none) for the test set.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported in this 510(k) summary. This type of study typically involves human readers (e.g., radiologists) evaluating cases with and without AI assistance to measure the effect size of AI on their performance. The device described here is a surgical instrument, not an AI diagnostic tool.

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

This is not applicable as the device is a surgical instrument, not an algorithm or AI system. Its performance is inherently linked to its physical interaction with tissue and the surgeon's use.

7. Type of Ground Truth Used

The document implies that the ground truth for the "bench and pre-clinical evaluations" would be based on direct measurements of physical properties of vessel seals (e.g., burst pressure, seal integrity) and visual or histological assessment of tissue effects in the pre-clinical (likely animal) models, compared to established predicate devices. However, the exact nature of the ground truth is not explicitly detailed.

8. Sample Size for the Training Set

The document describes "bench and pre-clinical evaluations" for performance data. As this is a physical medical device, not a machine learning algorithm, there is no concept of a "training set" in the traditional sense. The development and testing of such a device involve iterative design, prototyping, and testing, but not the training of an algorithm on a distinct dataset.

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

As explained above, there is no "training set" in the context of this device. Therefore, the establishment of ground truth for a training set is not applicable.

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The Aragon Surgical RF System is indicated for tissue sealing and division during the performance of abdominal hysterectomy. The instrument can seal vessels up to 7mm. This device is not effective for use in tubal sterilization/tubal coagulation for sterilization purposes.

The Aragon Surgical RF System consists of the Aragon Surgical Radiofrequency Energy (RF) Generator and a handheld Instrument, foot pedal, and power coad. The Aragon Surgical Instrument connects to the RF Generator. The Aragon Surgical Instrument is supplied sterile and is intended for single use. The Instrument uses a bipolar design, which means that a return pad is not required for operation. Software is utilized in the operation of the Aragon Surgical RF Generator.

The provided text describes the Aragon Surgical RF System and its 510(k) premarket notification (K081312) but does not contain information regarding specific acceptance criteria for performance metrics or a detailed study proving the device meets particular criteria, such as sensitivity, specificity, accuracy, or any comparative effectiveness data with human readers.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices through bench and pre-clinical evaluations.

Here's an analysis based only on the provided text, outlining why certain sections of your request cannot be fulfilled:

1. Table of acceptance criteria and the reported device performance:

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

• Sample Size (Test Set): Not specified. The document mentions "bench and pre-clinical evaluations" but does not provide details on the number of samples, cases, or procedures involved.
• Data Provenance: Not specified. It only states "bench and pre-clinical evaluations." There is no mention of country of origin, or whether the studies were retrospective or prospective.

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 document does not describe a study involving human experts establishing ground truth for a test set, as might be found in imaging or diagnostic device submissions. The evaluations mentioned are "bench and pre-clinical," implying laboratory and possibly animal studies.

4. Adjudication method for the test set:

• Not applicable/Not specified. As there's no mention of studies involving human readers or interpretation, no adjudication method would be detailed.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:

• No. The document does not describe an MRMC comparative effectiveness study. This type of study is common for diagnostic imaging devices where human interpretation is a key component. The Aragon Surgical RF System is an electrosurgical device for tissue sealing and division.

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

• The device itself is a tool used by a surgeon. "Standalone performance" in this context would refer to the device's physical and functional capabilities (e.g., sealing strength, heat generation, division effectiveness). The document generally states that "bench and pre-clinical evaluations" were conducted to demonstrate it "meets design, safety, and effectiveness criteria." However, specific standalone performance metrics and results beyond "can seal vessels up to 7mm" are not provided.

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

• Not explicitly stated. For "bench and pre-clinical evaluations," ground truth would likely be established through objective measurements (e.g., burst pressure testing for vessel seals, histological examination for tissue damage/seal integrity, temperature measurements) rather than expert consensus or pathology in the context of clinical expert interpretation.

8. The sample size for the training set:

• Not applicable/Not specified. The term "training set" typically refers to data used to train machine learning algorithms. While "Software is utilized in the operation of the Aragon Surgical RF Generator," the document does not describe the development of an AI algorithm based on a training set. The evaluations focus on the physical performance of the device itself.

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

• Not applicable/Not specified, as there is no mention of a training set or AI algorithm development in the provided text.

Summary of Device and Performance Information Available from the Text:

• Device Name: Aragon Surgical RF System
• Indication for Use: Tissue sealing and division during abdominal hysterectomy, specifically sealing vessels up to 7mm.
• Demonstrated Equivalence: Substantially equivalent to predicate devices (LigaSure™ Vessel Sealing System K981916 and LigaSure™ Open Dissector Divider K041587) in terms of design, materials, principle of operation, and product specifications.
• Performance Data: "Results of bench and pre-clinical evaluations were used to demonstrate that the Aragon Surgical System is substantially equivalent to the predicate devices and meets design, safety, and effectiveness criteria." The capability to "seal vessels up to 7mm" is explicitly mentioned.
• Conclusion: The FDA determined the device is substantially equivalent to legally marketed predicate devices, justifying 510(k) clearance.

The document provided is a 510(k) summary focused on regulatory clearance via substantial equivalence, which often does not include the detailed performance study results that would be found in a peer-reviewed publication or a more comprehensive technical report.

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The Aragon Surgical LapCap is intended for use in the peri-umbilical region of the abdominal wall with a Veress needle for the establishment of a pneumoperitoneum during gynecologic (pelvic) and general surgical (intraabdominal) laparoscopic procedures.

The Aragon Surgical LapCap is a single-use device used during laparoscopic surgical procedures. The device consists of a bell-shaped polycarbonate dome housing containing a pass-through port for introduction of a standard Veress needle and a vacuum port for attachment to a standard hospital vacuum line.

The provided text does not contain any information about acceptance criteria or a study proving device performance.

The document is a 510(k) summary and the FDA's clearance letter for the Aragon Surgical LapCap. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed performance studies or pre-defined acceptance criteria for the new device's efficacy or accuracy.

Therefore, I cannot populate the requested table and information points as the source material does not contain the necessary details.

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The Aragon Surgical LapCap is intended for use in the peri-umbilical region of the abdominal wall with a Veress needle for the establishment of a pneumoperitoneum during gynecologic (pelvic) and general surgical (intraabdominal) laparoscopic procedures.

The Aragon Surgical LapCap is a single-use device used during laparoscopic surgical procedures. The device consists of a bell-shaped polycarbonate dome housing containing a pass-through port for introduction of a standard Veress needle and a vacuum port for attachment to a standard hospital vacuum line.

This 510(k) summary does not contain the detailed information necessary to answer all parts of your request. It's a premarket notification for a medical device (Aragon Surgical LapCap) seeking substantial equivalence to existing devices. Therefore, it focuses on comparing the new device's intended use and technological characteristics to predicates, rather than presenting a detailed study with acceptance criteria and specific performance metrics in the way you've outlined.

Specifically, the document does not contain:

• A table of acceptance criteria and reported device performance.
• Sample sizes for a test set, data provenance, or details on how ground truth was established for such a set.
• Information on the number or qualifications of experts, or adjudication methods for a test set.
• Results from a multi-reader multi-case (MRMC) comparative effectiveness study, or effect size of AI improvement.
• Results from a standalone algorithm (AI) performance study.
• Details on the sample size for a training set or how ground truth was established for it.

The document is a regulatory submission for a physical medical device (a laparoscopic insufflator accessory), not an AI/software device whose performance would typically be evaluated against such criteria. The "study" mentioned here is a demonstration of substantial equivalence to predicate devices based on intended use and technological characteristics, rather than a clinical performance study with specific quantitative acceptance criteria of the kind usually seen for algorithmic diagnostics.

Therefore, I cannot populate the requested table and information based on the provided text. The document's purpose is to demonstrate that the device is "substantially equivalent" to already approved devices, meaning it doesn't raise new questions of safety and effectiveness, not to prove performance against specific numerical targets.

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This device is used in surgery for the application of wires to the jaws of adults and children. The device can be used to directly wire bony segments together, or for the application of arch bars to the teeth for stabilization of bony fragments or wiring the teeth together (maxillomandibular fixation).

22, 24 and 26 gauge annealed 316LVM stainless steel wire in 5 ft. coils packaged in a thermoplastic cartridge that mounts on forceps

This request cannot be fulfilled. The provided text is a 510(k) summary for a medical device (Aragon Wiring System Wire Cartridge) which outlines its substantial equivalence to existing predicate devices. However, this type of document, particularly for devices like wires for mandibular fixation, typically does not contain acceptance criteria for device performance or the results of a study designed to prove the device meets such criteria.

Medical devices cleared through the 510(k) pathway demonstrate substantial equivalence, meaning they are as safe and effective as a legally marketed predicate device. This often relies on comparing technical characteristics, materials, and intended use to existing devices, rather than conducting new performance studies with specific acceptance criteria and detailed statistical analysis on human subjects that would be typical for a drug or a novel, high-risk medical device.

Therefore, I cannot extract the requested information because it is not present in the provided text. The document explicitly states: "The technical differences between this product and the predicate devices do not adversely affect safety or efficacy," which is the core conclusion for a 510(k) clearance, not a report of meeting specific performance metrics through a study.

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1. Curing of all light cured bonding materials.
2. Curing of pit and fissure sealants (unfilled resins).
3. Curing for all classes of composite restorations (filled resins).
4. Curing for endodontic composite cores.
5. Curing composite cements for porcelain facings and inlays.
6. Curing of light activated periodontal splint material.
7. Curing of light activated prosthetic reline and repair material.
8. Curing used in the fabrication of laboratory indirect light activated restorations and provisional restorations.
9. Illumination purposes for the adjunctive use in caries detection.
10. Illumination purposes for the adjunctive use for endodontic orifice location.
11. Light activation for bleaching materials for teeth whitening.

Not Found

This is a 510(k) clearance letter for the Arago II device, a light curing unit. This document does not contain information about acceptance criteria or a study proving the device meets those criteria.

The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..."

This means the device was cleared based on a demonstration of substantial equivalence to a previously legally marketed predicate device, not on meeting specific performance acceptance criteria via a new study. The 510(k) process typically involves showing that a new device is as safe and effective as a predicate through various comparisons, which may include performance data, but it does not necessarily require a separate, new clinical study with pre-defined acceptance criteria if substantial equivalence can be demonstrated through other means (e.g., comparison of technical characteristics, non-clinical tests).

Therefore, I cannot provide the requested information from the provided text.

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