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The CSC Series Intraluminal Stapler for Single Use have applications throughout the alimentary tract for the creation of end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries.

The PPHplus Series PPH Stapler and Purse Sets for Single Use have application for general surgical treatment of hemorrhoids.

The TST Series Tissue-Selecting Therapy Stapler have application for general surgical treatment of anorectal wall defects by means of transanal stapling and resection of mucosal and musculomucosal tissue.

The proposed device, CSC Series Intraluminal Stapler for Single Use is a sterilized and disposable surgical instrument intended to be used throughout the alimentary tract for the creation of end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries. It 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 resected by the circular knife, and then a circular anastomosis is created.

The proposed device, PPHplus Series PPH Stapler and Purse Sets for Single Use is a sterilized and disposable surgical instrument, which has application for general surgical treatment of hemorrhoids. It 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 sets are commonly used in the procedures for prolapsed and hemorrhoids. They are also used for other applications when circular or semicircular stapling of anorectic tissue is required.

The proposed device, TST Series Tissue-Selecting Therapy Stapler is a sterilized and disposable surgical instrument, to be used in the surgical treatment of prolapse and hemorrhoids. This device also uses the Stapled Transanal Rectal Resection (STARR) surgical treatment of anorectal wall defects and obstructed defecation syndrome, with a single-fire staple. It is a set of instruments that facilitate delivery of a circumferential, staggered, double-row of staples while simultaneously resecting a segment of compressed soft tissue. The set is also Used for other applications where circular or semicircular or 1/3 circular stapling of anorectal tissue is desired.

This document describes the 510(k) summary for three intraluminal stapler devices. The submission focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing. It does not contain information about clinical studies with human participants, expert review of data, or AI performance metrics.

Here's an analysis of the provided information concerning acceptance criteria and device performance:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides a comparison table for each proposed device against its predicate device, outlining various specifications which act as acceptance criteria. The "Proposed Device" column lists the performance or specifications of the new device, which are implicitly understood to meet the stated criteria by being "Same" or "Similar" to the predicate, with differences not affecting safety or effectiveness.

For all three devices (CSC Series, PPHplus Series, TST Series):

Device-Specific Performance (Examples from tables):

• CSC Series Intraluminal Stapler (Table 3-1):

  • Outsider Diameter: 21, 25, 29, 33 mm (Proposed); Similar (Predicate)
  • Cutting Diameter: 12.7, 16.4, 20.0, 24.4 mm (Proposed); Similar (Predicate)
  • Number of Staples: 16, 20, 24, 28 (Proposed); Similar (Predicate)
  • Closed Staple Height: 2.0 mm (Proposed); Similar (Predicate)
  • Closed Staple Form: Image (Proposed); Same (Predicate)

• PPHplus Series PPH Stapler (Table 3-2):

  • Outsider Diameter: 33.5 mm (Proposed); Similar (Predicate)
  • Cutting Diameter: 24.4 mm (Proposed); Similar (Predicate)
  • Number of Staples: 32 (Proposed); Same (Predicate)
  • Closed Staple Height: 1.3, 1.6 mm (Proposed); Similar (Predicate)

• TST Series Tissue-Selecting Therapy Stapler (Table 3-3):

  • Outsider Diameter: 31.5, 33.5, 36.5 mm (Proposed); Similar (Predicate)
  • Cutting Diameter: 22.4, 24.4, 26.4 mm (Proposed); Similar (Predicate)
  • Number of Staples: 30, 32, 34 (Proposed); Similar (Predicate)
  • Closed Staple Height: 1.3, 1.6, 2.0 mm (Proposed); Similar (Predicate)

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

The document states that "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device." These non-clinical tests include Performance Testing (Physical Specification, Closed Staple Height, Pressure Resistance, Tensile Strength, Force to Fire), Endotoxin Limit, Package Integrity, and Shelf Life.

• Sample Size for Test Set: Not explicitly stated. The tests are described generally, without specific numbers of devices or samples tested.
• Data Provenance: The tests are non-clinical (laboratory/bench testing) and do not involve human or animal subjects in the sense of clinical trials. The country of origin for the data is implicitly the country where Touchstone International Medical Science Co., Ltd. conducts its testing, which is P.R. CHINA. The data is prospective in the sense that these tests were conducted on the newly manufactured devices to support the 510(k) submission.

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

Not applicable. This document describes non-clinical engineering and performance testing of a medical stapler. There is no "ground truth" established by experts in the context of diagnoses or interpretations of medical images/data, as there would be for an AI device. The "ground truth" here refers to the actual measured physical properties and performance characteristics of the device during bench testing, compared against predetermined engineering specifications or predicate device performance.

4. Adjudication Method for the Test Set

Not applicable. As described above, this is non-clinical bench testing. There is no adjudication method in the context of expert review or consensus for patient-related outcomes. The judgment is based on objective measurements and adherence to specifications.

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 document is for a surgical stapler, not an AI or imaging device. Therefore, no MRMC study or AI assistance evaluation was performed.

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

Not applicable. This document is for a surgical stapler, not an AI or algorithm-based device.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests can be considered the objectively measured performance characteristics of the device itself (e.g., measured closed staple height, actual pressure resistance, force to fire, endotoxin levels). These measurements are then compared against established engineering specifications, regulatory standards (like ASTM F 67-06 for Titanium), and the performance of the legally marketed predicate devices.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device; therefore, there is no "training set."

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

Not applicable, for the same reason as above.

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The LS Series Linear Stapler and Reloads have application or transection of tissue for abdominal, gynecological, pediatric and thoracic surgical procedures.
The CLC Series Curved Linear Cutter and Reloads is intended for transection, resection, and/or creation of anastomoses. The instrument has application in multiple open or minimally invasive general (gastrointestinal and skeletal muscle), gynecologic, and thoracic surgical procedures.
The LC Series Linear Cutter and Reloads have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection, and the creation of anastomoses.
The ELC Series Endoscopic Linear Cutter and Single Use Loading Unit have applications in general, abdominal, gynecologic, pediatric and thoracic surgery for resection, and creation of anastomoses. They may be used for transection of liver substance, hepatic vasculature and biliary structures.

The proposed device, LS Series Linear Stapler and Reloads is a sterilized and disposable surgical instrument intended to be used in the resection of tissue for abdominal, gynecological, pediatric and thoracic surgical procedures. It places a double staggered row of titanium staples. It is available in 30 mm, 45 mm, 60 mm and 90 mm staple line length for use in various applications. Three staple sizes (2.5 mm, 3.5 mm, and 4.8 mm) are available to accommodate various tissue thicknesses. Each stapler could be reloaded no more than 11 times for total 12 firings. It has two configurations: (1) LS serials are staplers, and (2) LSC serials are Reloads. Each of them has various specifications.
The proposed device, CLC Series Curved Linear Cutter and Reloads are sterilized and disposable surgical instrument, which has application in multiple open or minimally invasive general (gastrointestinal and skeletal muscle), gynecologic, urologic, and thoracic surgical procedures. It is mainly suitable for low rectal resection and anastomosis of tissues where manual anastomosis is difficult. It places four staggered curved row of titanium staples on the tissue upon activation, and cut the tissue between staple lines. It is available in 37mm and 43mm lengths. Two staple sizes (3.8 mm and 4.8 mm) are available to accommodate various tissue thicknesses. Each stapler could be reloaded no more than 7 times for total 8 firings. It has two configurations: (1) CLC serials are staplers, and (2) CLCC serials are reloads. Each of them has various specifications.
The proposed device, LC Series Linear Cutter Stapler and Reloads are sterilized and disposable surgical instrument, which has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection, and the creation of anastomoses. It places two double staggered rows of titanium staples and simultaneously cut and divides tissue between the two double rows. It is available in 60 mm, 80 mm and 100 mm lengths. Three staple sizes (3.8 mm, 4.2mm and 4.5 mm) are available to accommodate various tissue thicknesses. Each stapler could be reloaded no more than 11 times for total 12 firings. It has two configurations: (1) LC serials are staplers, and (2) LCC serials are reloads. Each of them has various specifications.
The proposed device, ELC Series Endoscopic Linear Cutter and Single Use Loading Unit are sterilized and disposable-surgical instrument, which has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures. It places two, triple-staggered rows of titanium staples and simultaneously divides the tissue from central line. Five staple sizes (2.0mm, 2.5mm, 4.0mm, and 4.8mm) are available to accommodate various tissue thicknesses. Each cartridge could be reloaded no more than 7 times for total 8 firings. It can be adapted for all of the reload sizes available. It has two configurations: (1) ELC-G and ELC-T serials are staplers, and (2) MG and RG serials are cartridges. Each of them has various specifications.

The provided text describes a 510(k) premarket notification for several series of surgical staplers and reloads (LS Series Linear Stapler, CLC Series Curved Linear Cutter, LC Series Linear Cutter, and ELC Series Endoscopic Linear Cutter). The submission aims to demonstrate substantial equivalence to previously cleared predicate devices.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context are tied to non-clinical testing performed to show substantial equivalence. The document summarizes performance testing and other evaluations rather than a clinical study with human patients or an AI algorithm's performance.

Here's an analysis based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative sense for each parameter, but rather compares the proposed device's characteristics and performance to that of a predicate device. The implicit acceptance criterion is that the proposed device must perform "the same" or "similarly" to the predicate device in aspects deemed critical for safety and effectiveness, and any differences must not affect safety and effectiveness.

The non-clinical tests conducted include:

• Performance Testing: Physical Specification, Closed Staple Height Dimensions, Pressure Resistance Evaluation, Maximum Tensile Strength of Staple Line Repair, and Force Required to Fire Stapler.
• Endotoxin Limit
• Package Integrity: Dye penetration tests and seal strength test.
• Shelf Life

Here's a table combining the general performance parameters across the different proposed devices, with the understanding that "Same" implies meeting the implicit acceptance criteria of being equivalent to the predicate device. Where specific values are given for the Proposed Device and "Same" or "Similar" for the Predicate, it means the proposed device meets that value and is considered acceptable in comparison to the predicate.

Table of Acceptance Criteria (Implicit) and Reported Device Performance

The study that proves the device meets (or is substantially equivalent to) these criteria is the "Non-Clinical Test Conclusion" section, which states: "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device."

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

The document specifies "Non clinical tests were conducted," including "Performance Testing, including Physical Specification, Closed Staple Height Dimensions, Pressure Resistance Evaluation, Maximum Tensile Strength of Staple Line Repair and Force Required to Fire Stapler." It also mentions "Endotoxin Limit," "Package Integrity," and "Shelf Life" tests.

The exact sample sizes for these non-clinical tests are not explicitly stated in the provided text. The data provenance is also not explicitly detailed, but it would have been generated internally by the manufacturer, Touchstone International Medical Science Co., Ltd., likely from their manufacturing and testing facilities. These are generally prospective tests conducted on manufactured devices/lots.

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

This is a non-clinical device submission for surgical staples and cutters. The "ground truth" in this context is established by engineering specifications, material standards (e.g., ASTM F 67-06 for titanium), and performance measurements against those specifications and the predicate device's known performance. There were no human experts establishing a "ground truth" in a diagnostic or clinical sense. The evaluation of test results would be performed by engineers and quality control personnel.

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

Not applicable. As this is a non-clinical device test for engineering specifications, there is no "adjudication method" involving multiple human readers as would be seen in clinical or image-based AI studies. The data would be analyzed against predetermined engineering specifications and comparison data from the predicate device.

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 submission is for surgical stapling devices, not an AI-assisted diagnostic tool. Therefore, no MRMC study or evaluation of human reader improvement with AI assistance was performed.

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

Not applicable. This is not an AI algorithm.

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

The "ground truth" for this device evaluation is based on:

• Engineering specifications and design requirements: For parameters like dimensions, materials, and mechanical properties.
• International/Industry Standards: Such as ASTM F 67-06 for titanium.
• Comparison to predicate device performance: The "Same" or "Similar" designations in the comparison tables imply that the predicate device's established performance serves as a benchmark for the proposed device.

8. The sample size for the training set

Not applicable. This is not an AI algorithm, so there is no training set.

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

Not applicable. This is not an AI algorithm, so there is no training set or ground truth establishment for one.

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