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The Altrus Thermal Tissue Fusion System is comprised of a dedicated energy source and disposable handpiece used to ligate (seal) and divide (cut) blood vessels and tissue bundles that fit into the jaws of the handpiece. The Altrus System utilizes a thermal energy platform to achieve the desired clinical effect.

The ConMed Altrus® Thermal Tissue Fusion System is indicated for open and laparoscopic techniques in general surgical and gynecological procedures for ligating (sealing) and dividing (cutting) of tissue when hemostasis is desired.

The modified Altrus Thermal Tissue Fusion System consists of the following devices:

• Altrus Thermal Tissue Fusion Energy Source
• Altrus Thermal Tissue Fusion Handpiece

The modified ConMed Altrus Thermal Tissue Fusion System employs focused thermal energy and pressure to simultaneously seal and divide tissue. By applying direct heat instead of electrical, radio frequency or ultrasonic energy, the system can reduce the potential of unintended thermal injury.

The energy source uses as LCD display, a power supply, amplifiers and associated electronic components coupled with several microprocessors and associated software to provide the energy to the accompanying handpiece. The energy source works in harmony with the handpiece in a closed loop communication process. This process allows the handpiece to provide information to the energy source regarding the tissue and adjust the predetermined electrical parameters in response to the effect on the tissue. As energy is delivered to the heaters in the distal portion of the handpiece, these heaters increase in temperature by means of resistive heating. This thermal effect coupled with mechanical pressure on the vessel provides the means for the fusion of the tissue between the jaws to form the ligation (seal). The cutting effect is accomplished in a similar manner, with a different set of parameters controlled by the software.

The modified ConMed Altrus Thermal Tissue Fusion handpiece is a single use device which is provided sterile. The device uses a parallel jaw closure mechanism with one flat jaw and one crowned jaw in which the vessels/tissues are grasped and through which pressure and heat are applied. The handpieces are available in 5mm and 10mm sizes with three shaft lengths for use in laparoscopic and open general surgical and gynecological procedures. Energy is delivered to the heaters by a cable which provides power to the handpiece as well as allows for communication between the handpiece and the energy source.

The purpose of this submission is to clear the following modifications to the device: (1) change in potting compound from Hysol to EPO-TEK 930-4: (2) change in dimensions and the addition of holes to the spacer component of the handpiece; (3) increase of the maximum number of activations to 450; (4) change in power supply and hardware components of the energy source; (5) modification to the algorithm, seal time and temperature to improve seal performance; (6) slight material changes to accommodate new suppliers; and (7) various changes to improve device manufacturability or cosmetic appearance

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the ConMed Altrus® Thermal Tissue Fusion System:

Due to the nature of the provided document (a 510(k) summary for a medical device), the information is presented in a regulatory context, focusing on demonstrating substantial equivalence to predicate devices rather than detailing a specific clinical study with detailed acceptance criteria and performance metrics in the way a diagnostic AI device might.

Therefore, for several of your requested points, the information is either not present in this type of document or is framed differently than for an AI diagnostic study. I will answer based only on the text provided.

Acceptance Criteria and Device Performance

Note on Acceptance Criteria: The document primarily uses the concept of "substantial equivalence" as the overarching acceptance criterion, meaning the modified device performs similarly to or better than previously cleared predicate devices without introducing new questions of safety or effectiveness. Specific numerical performance metrics (e.g., sensitivity, specificity, accuracy) typically associated with AI diagnostic studies are not applicable here as it's a surgical instrument.

Study Details

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

   • Sample Size: Not specified in the provided text. The document refers to "non-clinical bench and simulated use testing" and "performance testing" but does not give specific sample sizes for these tests (e.g., number of tissue samples, number of seals performed).
   • Data Provenance: Not specified. Given it's "non-clinical bench and simulated use testing," it implies laboratory or simulated environments, rather than human clinical data from a specific country. This is retrospective in the sense that it's testing a completed device design, but it's not "retrospective data" in the sense of analyzing past patient records.

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

   • Not applicable/Not specified. For a surgical device demonstrating performance related to tissue fusion and division, ground truth would likely be established through objective physical measurements (e.g., burst pressure, tensile strength of seals, histological analysis of tissue, visual inspection for effective cutting/sealing), rather than expert clinical consensus on images or diagnostic interpretations. The document does not mention human experts establishing ground truth for performance tests.

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

   • Not applicable/Not specified. As noted above, the "ground truth" for this type of device performance testing would typically be objective physical measurements, not human adjudication of diagnostic interpretations.

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:

   • No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI diagnostic algorithms where human readers interpret medical images. The Altrus system is a surgical instrument.

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

   • Yes, in essence, standalone testing was done. The "non-clinical bench and simulated use testing" and "performance testing" referenced in section H assess the device's inherent performance characteristics (e.g., seal strength, cutting ability, thermal management) independently of a specific human operator's skill or interpretation. The device's "algorithm, seal time and temperature" were modified and presumably tested for their direct impact on seal performance. However, there's always a human using the surgical device, so it's not "algorithm-only" in the diagnostic sense, but the engineering performance tests are standalone.

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

   • The document does not explicitly state the "type of ground truth." However, based on the nature of the device (thermal tissue fusion system), ground truth would likely be established through:
     • Physical measurements: e.g., burst pressure testing of sealed vessels, tensile strength of fused tissue, measurement of thermal spread, assessment of cutting completeness.
     • Histological analysis: Microscopic examination of treated tissue to confirm cell fusion and integrity.
     • Compliance with engineering specifications: Verification that the device operates within defined parameters (e.g., temperature, power output).

7. The sample size for the training set:

   • Not applicable/Not specified. This is not an AI diagnostic algorithm that requires a "training set" of data in the machine learning sense. The device's "algorithm" controls its operational parameters (seal time, temperature) and would have been developed through engineering design, prototyping, and iterative testing, not by training on a large dataset.

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

   • Not applicable/Not specified for the reasons stated above. The device's internal parameters (like seal time and temperature for its algorithm) would have been established through engineering principles, material science, and empirical testing to achieve the desired tissue effect.

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The LigaSure™ Open Dissector Divider is a bipolar electrosurgical instrument intended for use with the LigaSure™ Generator in open, general, surgical procedures where dissection, ligation and division of vessels is desired. This device creates ligation by application of bipolar electrosurgical RF anerizy and pressure to vessels/tissue interposed between the jaws of the device. The ligation can then be transected using the built in cutting mechanism. The device can be used for vessels up to and including 7 mm in diameter and tissue bundles as large as will fit into the jaws of the instrument.

Indications for use include general, open procedures including urologic, vascular, thoracic, and plastic and reconstructive, procedures where dissection, ligation and division of vessels are performed such as: spleenectomies, thryoidectomies, nephrectomies, prostatectomies, bowel resection are clobe vomy.

The LigaSure Vessel Sealing 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 LigaSure Open Dissector Divider is a multi-functional, electrosurgical instrument intended for use with the LigaSure Vessel Sealing Generator (K981916) when performing open surgery. The instrument is capable of sealing and dividing vessels and tissue clamped between its jaws, grasping tissue, and dissection. Sealing of vessels and tissue containing vessels can be activated using the activation button on the device or via a footswitch. The instru incorporates a mechanical cutting mechanism that divides tissue.

The instrument attaches to the LigaSure™ generator with a ten (10) foot cable and a "smart" connector that identifies the instrument type to the generator. The instrument is supplied sterile for single-use.

The provided text describes the Valleylab LigaSure™ Open Dissector Divider (K041587) and its clearance by the FDA without extensively detailing specific acceptance criteria or a comprehensive study report in the format requested. The document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance metrics against pre-defined acceptance criteria.

However, based on the information provided, I can infer and extract some relevant details regarding the device's performance and the nature of the evaluation.

Inferred Acceptance Criteria and Reported Device Performance (based on the summary's scope):

The document states that performance (bench) testing and a preclinical study were conducted to ensure the device "functions as intended" and "meets design specifications," and that "sufficient data were obtained to show that the device is substantially equivalent to the predicate devices, and meets safety and effectiveness criteria." While specific numerical targets for acceptance criteria are not explicitly given, the general criteria can be inferred from the device's intended use and comparison to predicates.

Study Details:

The provided text only briefly mentions the types of studies conducted without providing extensive details on their methodology or results.

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

   • Sample Size: Not specified. The document only states "Performance (bench) testing and a preclinical study were done."
   • Data Provenance: Not specified, but generally, bench testing and preclinical studies for FDA submissions are conducted domestically (USA) or in accredited labs globally. The document does not indicate if it was retrospective or prospective, though preclinical studies are inherently prospective.

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

   • Not specified. The document does not mention the involvement of experts in establishing ground truth for the performance studies, other than the general oversight and review by the manufacturer's regulatory and R&D teams.

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

   • Not specified. The document does not describe any expert adjudication process for the performance testing.

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:

   • No. This device is an electrosurgical instrument, not an AI/imaging device. Therefore, an MRMC study with human readers/AI assistance is not applicable to its evaluation. The "improvement with AI vs. without AI" is not relevant here.

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

   • Yes, implicitly. The "Performance (bench) testing" and "preclinical study" described are likely standalone evaluations of the device's physical and functional capabilities, independent of human interaction for interpretation (as would be the case for an imaging algorithm). The device's performance (e.g., sealing strength, cutting efficacy) is assessed directly.

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

   • For bench testing, ground truth would be based on engineering specifications and measurements (e.g., burst pressure for sealed vessels, tensile strength, cut precision).
   • For the preclinical study, ground truth would involve direct observation, potentially physiological measurements, and possibly pathology if tissue samples were analyzed for sealing integrity or thermal damage. The document does not specify.

7. The sample size for the training set:

   • Not applicable. This device is a physical electrosurgical instrument, not a machine learning model, so there is no "training set."

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

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

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The LigaSure™ 5mm Vessel Sealer-Divider is a bipolar electrosurgical instrument intended for use with the LigaSure Generator in general and gynecologic laparoscopic surgical procedures where ligation and division of vessels is desired. The instrument creates a seal by application of RF electrosurgical energy to vascular structures (vessels) interposed between the jaws of the instrument. A blade within the instrument is surgeonactuated to divide tissue.

Indications for use include general laparoscopic procedures including urologic, vascular, thoracic and thoracoscopic, and gynecologic laparoscopic procedures where ligation and division of vessels is performed. These procedures include: laparoscopically assisted vaginal hysterectorny, Nissen fundoplication, colectomy, adhesiolysis, oophorectomy, etc. The LigaSure Vessel Sealing System has not been shown to be effective for tubal sterilization or tubal coaqulation for sterilization procedures, and should not be used for these procedures.

The LigaSure 5mm Vessel Sealer-Divider can be used on vessels up to and including 7mm diameter, and tissue bundles as large as will fit in the jaws of the instrument.

The LigaSure 5mm Laparoscopic Sealer-Divider is a multi-functional electrosurgical instrument for use with the LigaSure Vessel Sealing Generator (K981916) when performing laparoscopic surgery. The instrument is capable of sealing vessels, dividing vessels and tissue clamped between its jaws, grasping tissue, and blunt dissection. The outer diameter of the instrument shaft is 5mm, with a working length of 37 cm. Controls are located on the instrument handle. All controls can be operated with either the right or left hand.

The instrument attaches to the generator with a "smart" connector that identifies the instrument type to the LigaSure generator, and a ten (10) foot cable. The instrument is supplied sterile for single-use.

The provided text is a 510(k) premarket notification for a medical device, the Valleylab LigaSure™ 5mm Laparoscopic Sealer-Divider. It asserts substantial equivalence to predicate devices and describes the device's intended use and technological characteristics. However, it does not contain detailed information about specific acceptance criteria, study designs, sample sizes, expert qualifications, or adjudication methods for performance data demonstrating the device meets acceptance criteria.

The document states: "Performance testing and pre-clinical studies were performed to ensure that the LigaSure™ 5mm Laparoscopic Sealer-Divider functions as intended, and meets design specifications. Sufficient data were obtained to show that the device is substantially equivalent to the predicate devices, and meets safety and effectiveness criteria."

This statement confirms that studies were done, but the specifics of how "design specifications" and "safety and effectiveness criteria" were defined, measured, and met are not included in the provided text.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported performance, sample sizes used, data provenance, number and qualifications of experts, adjudication methods, details of MRMC or standalone studies, or how ground truth was established, as this information is not present in the provided K031011 document.

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