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510(k) Data Aggregation
(130 days)
The Echelon Contour™ Curved Cutter with Reload is intended for transection in colorectal surgical procedures.
The Echelon Contour™ Curved Cutter Stapler with reload is a multifire, single patient use device with a curved head that cuts and staples. The device will provide ligation of colorectal structures when permanent ligation is required.
The device delivers four staggered rows of titanium staples, with a knife between the second and third row of staples, and staples and creates a 40 mm curved transection. The device is designed with a feature which prevents closing if a used reload is in the instrument.
Another feature is provided to prevent firing unless the closure trigger is latched in the closed position. A retaining pin holds tissue in place and can be positioned either manually or by squeezing the closure trigger.
The instrument is preloaded with a either a blue or green reload. The instrument may be further loaded for a maximum of six firings per instrument during a single procedure.
Each reload includes a knife blade with two staggered rows of staples on each side, an anvil, a yellow cutting washer, a retaining pin, and a staple retainer.
The provided text describes a 510(k) premarket notification for the "Echelon Contour™ Curved Cutter Stapler with Reload." This device is a surgical stapler, and the supporting documentation focuses on demonstrating its substantial equivalence to a legally marketed predicate device.
The study presented is not for an AI/ML medical device, but rather a traditional medical device (a surgical stapler). Therefore, many of the requested criteria related to AI/ML device studies (such as sample size for test/training sets, data provenance, expert ground truth, MRMC studies, standalone performance of an algorithm, etc.) are not applicable to this submission.
The document primarily details bench testing, biocompatibility testing, accelerated aging stability, sterilization, and animal studies to demonstrate substantial equivalence to a predicate device. It explicitly states: "Clinical Studies: This submission does not include data from Clinical Studies."
Here's an attempt to fill out the table and answer the questions based only on the provided text, noting where information is not applicable or not provided.
Acceptance Criteria and Device Performance for Echelon Contour™ Curved Cutter Stapler with Reload
1. Table of Acceptance Criteria and Reported Device Performance (as derived from the text):
| Acceptance Criteria Category | Specific Test/Study | Reported Device Performance |
|---|---|---|
| Bench Testing | Leak Onset Pressure Equivalency | "The new device was shown to have equivalent performance to the predicate device" |
| Formed Staple Height (FSH) Equivalency | "The new device was shown to have equivalent performance to the predicate device" | |
| Staple Line Integrity and Staple Form Quality Equivalency | "The new device was shown to have equivalent performance to the predicate device" | |
| Force to Close | "The new device was shown to have equivalent performance to the predicate device" | |
| Force to Fire | "The new device was shown to have equivalent performance to the predicate device" | |
| Handle Performance Characterization | "The new device was shown to have equivalent performance to the predicate device" | |
| Biocompatibility | ISO Cytotoxicity | "No findings of toxicological concern" |
| ISO Sensitization | "No findings of toxicological concern" | |
| ISO Irritation (Intracutaneous Reactivity) | "No findings of toxicological concern" | |
| ISO Acute Systemic Toxicity | "No findings of toxicological concern" | |
| USP Material Mediated Pyrogenicity | "No findings of toxicological concern" | |
| Stability | Accelerated Aging Stability | "Device performance was maintained for the proposed shelf life." |
| Sterilization | Pyrogen testing | "Minimal to no risk for the staples with respect to the presence of endotoxins." |
| Animal Study | Hemostasis study | "The new device was shown to have equivalent performance to the predicate device" |
| Survival study | "The new device was shown to have equivalent performance to the predicate device" | |
| MR Safety | Non-clinical testing | "Staples in the device are MR conditional." |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated for each bench test or animal study. The overall approach is to show "equivalence" to a predicate device, rather than derive absolute performance metrics from a large sample.
- Data Provenance: Not specified in terms of country of origin. The studies are described as "non-clinical data" and "animal study" conducted in accordance with FDA's Good Laboratory Practice Standard (21 CFR 58). It's a regulatory submission for a physical device, not an AI model, so "retrospective or prospective" doesn't directly apply in the usual sense of human clinical data collection.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a medical device (stapler) submission, not an AI/ML device that requires human expert annotation for ground truth. Performance is assessed through physical measurements, chemical tests, and animal models.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods like 2+1 or 3+1 refer to human experts reviewing and agreeing on ground truth in studies involving subjective interpretation (e.g., image analysis for AI). This device relies on objective measurements in bench and animal studies to demonstrate equivalence.
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/ML device, nor is it a study involving human readers or comparative effectiveness in diagnosing or interpreting medical images.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This category applies to AI algorithms. This submission is for a physical surgical stapler.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the bench tests: "Ground truth" is established by standard engineering and mechanical test methodologies (e.g., force measurements, physical dimensions of staples, pressure leakage tests).
- For biocompatibility: Adherence to ISO standards and toxicology findings.
- For animal studies: Physiological outcomes (hemostasis, survival) in animal models compared to the predicate device.
- No "expert consensus," "pathology," or "outcomes data" in the typical clinical study sense described for ground truth.
8. The sample size for the training set:
- Not Applicable. This is not an AI/ML device that requires a "training set."
9. How the ground truth for the training set was established:
- Not Applicable. As above, no training set for an AI/ML model.
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(289 days)
The Single Use Circular Stapler has application throughout the alimentary tract for end to side and side to side anastomoses.
The Single Patient Use Endo Cutter and Reload is intended for transection, and/or creation of anastomoses. The instrument has application in multiple open or minimally invasive general, gynecologic, thoracic, and pediatric surgical procedures. It can be used with tissue buttressing materials.
The Single Patient Use Linear Cutter and Reload have application in gastrointestinal, gynecologic, thoracic, and pediatric surgery for transection, resection, and/or creation of anastomoses and can be used with staple line or tissue buttressing materials, such as bovine pericardium.
The Single Patient Use Linear Stapler and Reload has applications in abdominal, gynecological, pediatric and thoracic surgical procedures for resection of tissue and creation of anastomosis, including occlusion of the left atrial appendage in open procedures. They may be used for transection and resection of pancreas.
The Single Use Hemorrhodial Circular Stapler has application throughout the anal to perform surgical treatment of hemorrhoidal disease.
The Single Patient Use Transverse Cutter and Reload is intended for transection and/or creation of anastomoses. The instrument has application in multiple open or minimally invasive general (gastrointestinal and skeletal muscle stapling), gynecologic, urologic, and thoracic surgical procedures.
The Single Patient Use Transverse Cutter and Reload places four staggered curved row of titanium staples on the tissue upon activation, and cut the tissue between staple lines. The device is available in 40mm length with reload in 3.8mm and 4.5mm staple size. The device may be reloaded and fired up to 5 times in a single procedure.
Single Use Circular stapler places a double staggered, circular row of titanium staples upon activation, which was achieved by squeezing the handles firmly as far as they could go. Immediately after formation of the staples, the excess tissue will be resect by the circular knife, and then a circular anastomosis is created. The stapler are available in 21mm, 26mm, 29mm, 32mm and 34mm six specifications. The staple sizes are 4.8mm and 5.5mm.
Single Patient Use Endo Cutter and Reload places two, triple-staggered rows of titanium staples and simultaneously divides the tissue from central line. The devices are available in 30mm, 45mm and 60mm three lengths. Reloads are available in five staple sizes to accommodate various tissue thicknesses: 2.0mm, 2.5mm. 3.5mm. 3.8mm and 4.2mm. The device may be reloaded and fired up to 5 times in a single procedure.
Single Patient Use Linear Stapler and Reload places a double staggered row of titanium staples and is available in 30mm, 45mm, 60mm staple line length for use in various applications. Three staple sizes (2.5mm, 3.8mm and 4.5mm) are available to accommodate various tissue thicknesses. It may be reloaded and fired up to 4 times for a total 5 firing in a single procedure.
Single Patient Use Linear Cutter and Reload place two double staggered rows of titanium staples and simultaneously cut and divides tissue between the two double rows. The devices are available in 55mm, 60mm, 75mm, 80mm and 100mm lengths. Reloads are available in four staple sizes to accommodate various tissue thicknesses: 2.5mm, 3.8mm, 4.2mm. It may be reloaded and fired up to 4 times for a total 5 firings in a single procedure.
Single Use Hemorrhoidal Circular Stapler is a set of instruments that place a double staggered, circular row of titanium staples. Immediately after the formation of staples, the circular knife blade resects the excess of compressed mucosa. The stapler are available in 30mm, 34mm and 36mm four specifications. The staple size is 4.5mm. It cannot be reloaded.
The provided text is a 510(k) summary for several surgical staplers and does not contain the specific information required to answer the prompt questions regarding acceptance criteria and a study proving device performance against those criteria in the context of an AI-powered diagnostic device.
This document describes surgical staplers, which are physical medical devices, not AI-powered diagnostic devices. The performance tests mentioned (pressure resistance, closed staple height, staple formation, force to fire) are mechanical tests of the staplers themselves, comparing them to predicate devices. There is no mention of "acceptance criteria," "reported device performance" in terms of diagnostic metrics, "sample size for test set," "data provenance," "experts creating ground truth," "adjudication method," "MRMC study," "standalone performance," "type of ground truth" (for diagnosis), "training set size," or "ground truth for training set."
The document concludes that the proposed devices are "Substantially Equivalent (SE) to the predicate devices" based on non-clinical tests (biocompatibility and mechanical performance tests). This is a regulatory finding for a traditional medical device, not a performance evaluation for an AI diagnostic algorithm.
Therefore, I cannot extract the requested information from the provided text.
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(134 days)
The Single Use Circular Stapler has application throughout the alimentary tract for end to side and side to side anastomoses.
The Single Patient Use Endo Cutter and Reload is intended for transection, and/or creation of anastomoses. The instrument has application in multiple open or minimally invasive general, gynecologic, thoracic, and pediativ surgical procedures. It can be used with tissue buttressing materials.
The Single Patient Use Linear Cutter and Reload are intended for use in multiple open or minimally invasive surgical procedures for the transection of tissues. Linear cutters are also intended for creation of anastomoses in these procedures.
The Single Patient Use Linear Stapler and Reload has applications in abdominal, gynecological, pediatric and thoracic surgical procedures for resection of tissue and creation of anastomosis, including occlusion of the left atrial appendage in open procedures. They may be used for transection and resection of pancreas.
The Single Use Hemorrhoidal Circular Stapler has application throughout the anal to perform surgical treatment of hemorrhoidal disease.
The Single Patient Use Transverse Cutter and Reload is intended for transection and or creation of anastomoses. The instrument has application in multiple open or minimally invasive general (gastrointestinal and skeletal muscle stapling), gynecologic, urologic, and thoracic surgical procedures.
The Single Patient Use Transverse Cutter and Reload places four staggered curved row of titanium staples on the tissue upon activation, and cut the tissue between staple lines. The device is available in 40mm length with reload in 3.8mm and 4.5mm staple size. The device may be reloaded and fired up to 5 times in a single procedure.
Single Use Circular stapler places a double staggered, circular row of titanium staples upon activation, which was achieved by squeezing the handles firmly as far as they could go. Immediately after formation of the staples, the excess tissue will be resect by the circular knife, and then a circular anastomosis is created. The stapler are available in 21mm, 29mm, 32mm and 34mm six specifications. The staple sizes are 4.8mm and 5.5mm.
Single Patient Use Endo Cutter and Reload places two, triple-staggered rows of titanium staples and simultaneously divides the tissue from central line. The devices are available in 30mm, 45mm and 60mm three lengths. Reloads are available in six staple sizes to accommodate various tissue thicknesses: 2.0mm, 2.5mm, 3.5mm, 3.8mm, 4.1mm, 4.2mm. The device may be reloaded and fired up to 5 times in a single procedure.
Single Patient Use Linear Stapler and Reload places a double staggered row of titanium staples and is available in 30mm, 45mm, 60mm, 75mm and 90mm staple for use in various applications. Three staple sizes (2.5mm, 3.8mm and 4.5mm) are available to accommodate various tissue thicknesses. It may be reloaded and fired up to 4 times for a total 5 firing in a single procedure.
Single Patient Use Linear Cutter and Reload place two double staggered rows of titanium staples and simultaneously cut and divides tissue between the two double rows. The devices are available in 55mm, 60mm, 75mm, 80mm and 100mm lengths. Reloads are available in four staple sizes to accommodate various tissue thicknesses: 2.5mm, 4.2mm and 4.5mm. It may be reloaded and fired up to 4 times for a total 5 firings in a single procedure.
Single Use Hemorrhoidal Circular Stapler is a set of instruments that place a double staggered, circular row of titanium staples. Immediately after the formation of staples, the circular knife blade resects the excess of compressed mucosa. The stapler are available in 30mm, 34mm and 36mm four specifications. The staple size is 4.5mm. It cannot be reloaded.
The provided document is a 510(k) Summary for TGS Medical Co., Ltd.'s range of stapling devices (Circular Stapler, Hemorrhoidal Circular Stapler, Linear Stapler, Linear Cutter, Endo Cutter, and Transverse Cutter). The acceptance criteria and supporting studies are presented in the form of non-clinical tests to establish substantial equivalence to predicate devices, rather than a standalone clinical study on the effectiveness of the proposed devices.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document presents "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device." The acceptance criteria are essentially compliance with specific international and national standards related to medical devices. The reported device performance is that the proposed device complies with these standards, demonstrating substantial equivalence to the predicate devices.
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ISO 10993-1:2009 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process) | Complies |
| ISO 10993-5:2009 (Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity) | Complies |
| ISO 10993-10:2010 (Biological evaluation of medical devices - Part 10: Test for irritation and delayed-type hypersensitivity) | Complies |
| USP 38-NF 33 (Bacterial Endotoxins Tests) | Complies |
| ASTM F 88/F88M-09 (Standard test method for seal strength of flexible barrier materials) | Complies |
| ISO 11137-2: 2013 (Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose) | Complies |
Additionally, the comparison tables (Table 1 through Table 6) implicitly define acceptance criteria by comparing the proposed device's characteristics against those of the predicate devices. The "reported device performance" in these tables is that the proposed device's characteristics (e.g., intended use, cutting mechanism, operation principle, safety mechanism, closed staple height, closed staple form, patient-contact material, sterilization, endotoxin limit, labeling) are "Same" as or comparable to the predicate devices, or compliant with relevant regulations (e.g., 20 EU for Endotoxin Limit, Conforms with 21 CFR 801 for Labeling).
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Non clinical tests were conducted to verify that the proposed device met all design specifications..." However, it does not provide details on the specific sample sizes used for each of the non-clinical tests (e.g., number of devices tested for seal strength, number of samples for cytotoxicity). The data provenance is also not explicitly stated beyond being "non clinical tests." There is no indication of country of origin for the testing itself, nor whether the data is retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The document refers to non-clinical tests against established standards and predicate devices, which implies adherence to standardized methodologies rather than expert consensus on a test set.
4. Adjudication Method for the Test Set
This information is not applicable/provided. The evaluation is based on non-clinical tests against defined standards and comparison to predicate devices, not on human adjudication of a test set.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance
This information is not applicable. The device is a surgical stapler, not an AI-assisted diagnostic or therapeutic device that involves human readers or an MRMC study.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done
This information is not applicable. The device is a physical surgical stapler, not an algorithm.
7. The Type of Ground Truth Used
For the non-clinical tests, the "ground truth" is implied by the established international and national standards (e.g., ISO 10993 series, USP, ASTM, ISO 11137-2) and the characteristics of the legally marketed predicate devices. The tests evaluate compliance with these standards and equivalence to the predicate devices.
8. The Sample Size for the Training Set
This information is not applicable. This document describes a 510(k) submission for mechanical surgical devices, not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the same reason as above.
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(27 days)
ECHELON, ECHELON ENDOPATH™ and ECHELON FLEX families of endoscopic linear cutters and reloads are intended for transection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. They can be used with staple line or tissue buttressing materials. The instruments may also be used for transection and resection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen.
The ECHELON, ECHELON ENDOPATH and ECHELON FLEX families of endoscopic linear cutters and reloads are sterile, single patient use instruments that simultaneously cut and staple tissue. There are six staggered rows of staples, three on either side of the cut line. The ECHELON FLEX™ 45 mm Powered Plus instruments have a staple line that is approximately 45 mm long and a cut line that is approximately 42 mm long. The shaft can rotate freely in both directions and an articulation mechanism enables the distal portion of the shaft to pivot to facilitate lateral access to the operative site. The instruments are packaged with a primary lithium battery pack that must be installed prior to use. There are specific requirements for disposing of the battery pack. Refer to the Battery Pack Disposal section. The instruments are packaged without a reload and must be loaded prior to use. A staple retaining cap on the reload protects the staple leg points during shipping and transportation. The instruments' lock-out feature is designed to prevent a used or improperly installed reload from being refired or an instrument from being fired without a reload. The ECHELON ENDOPATH™ Echelon Endoscopic Linear Cutter Reloads are sterile, single patient use devices. They come in five colors corresponding to different closed staple heights, with the intention of being used in different tissue thicknesses. They are loaded into a Linear Cutter and deliver staples into the tissue when the instrument is fired. There are 70 staples in the 45mm length reload.
This document is a 510(k) Premarket Notification from the FDA regarding the "Echelon Flex 45mm Powered Plus Articulating Endoscopic Linear Cutters, Echelon Endopath Endoscopic Linear Cutter Reloads, 45mm". It is a medical device approval document and does not contain information about an AI/ML device study. Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement, as these elements pertain to the evaluation of AI/ML device performance, which is not covered in this document.
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(48 days)
The ENDOPATH ECHELON™ and ECHELON FLEX™ families of endoscopic linear cutters and reloads are intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. They can be used with staple line or tissue buttressing materials. The instruments may also be used for transection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen.
The Echelon Flex Powered Plus Articulating Endoscopic Linear Cutters are sterile, single patient use instruments that simultaneously cut and staple tissue through a battery powered firing system. The instruments deliver six staggered rows of staples, three on either side of the cut line. The instruments are available in two shaft lengths: regular and long. The shaft can rotate freely in both directions and incorporates an articulation mechanism, which enables the distal portion of the shaft to pivot to facilitate lateral access to the operative site. The instruments are packaged with a battery pack that must be installed prior to use. The Echelon Endoscopic Linear Cutter Reloads (+ Gripping Surface Technology) are designed for use with the Echelon Endoscopic Linear Cutter devices (Echelon, Echelon Flex, Echelon Flex Powered and Echelon Flex Powered Plus) in a 60mm configuration.
This document describes a 510(k) submission for surgical staplers and reloads, focusing on substantial equivalence to predicate devices. It does not contain information about the acceptance criteria for an AI/ML powered device or a study proving that an AI/ML device meets such criteria.
The submitted text focuses on the device's mechanical and electrical performance, biocompatibility, and electromagnetic compatibility. It is a traditional medical device submission, not specifically related to software as a medical device (SaMD) or AI/ML.
Therefore, I cannot provide the requested information, such as acceptance criteria table, sample sizes for test/training sets, expert qualifications, or details about MRMC studies.
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