(137 days)
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
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Compliance with design specifications | Device complies with design specifications. |
| Compliance with applicable standards (AAMI/ANSI ES60601-1:2005, ISO 11607-1:2006, ISO 11135-1:2007, AAMI/ANSI ST67:2011, ISO 10993-7:2008) | Design verification testing demonstrates compliance with these standards. |
| Biocompatibility of patient-contacting materials (ISO 10993-1:2009) | Material analysis demonstrates compliance with ISO 10993-1:2009. |
| Substantial equivalence to predicate devices in performance | Performance testing demonstrates the device performance is substantially equivalent to the predicate devices. |
| Maintenance of safety and efficacy with modifications | Differences between predicate and modified design do not raise new risks of safety or efficacy. |
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
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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.
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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.
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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.
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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.
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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.
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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).
- 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:
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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.
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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.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.