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The Signia™ small diameter curved tip gray and white reloads have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection and transection of vasulature using gray reloads and thin tissue and vasculature using white reloads.

The Signia™ small diameter regular (round) tip white reload has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection and transection of thin tissue and the creation of anastomosis.

Signia™ Small Diameter Reloads are 8 mm diameter reloads that shall be utilized for open and minimally invasive surgical procedures for the transection of tissue, specifically vascular and thin tissue structures. They shall be offered with both a curved tip (cleared in predicate submission K191070) and a new reqular (round) tip model. The Signia™ small diameter regular (round) tip white reloads shall be indicated for use in the creation of anastomosis.

The reload is the distal shaft and jaws of the stapler system comprised of a single-use knife. fixed anvil, and the fixed stapler cartridge with two (2) rows of titanium staples on either side of the cut line. The reload is single use only and the cartridges cannot be replaced.

Signia™ Small Diameter Reloads feature a narrow shaft, narrow end-effector, narrow anvil with either a curved tip or regular (round) tip, and multiple articulation angles up to 45 degrees. These features facilitate device access to smaller or tighter surgical spaces (e.g. intercostal) as well as difficult-to-reach vasculature. Signia™ Small Diameter Reloads shall be available in multiple configurations with the following features:

• Open Staple Height: 2.0 mm (grav cartridge) and 2.5 mm (white cartridge) ●
• Cartridge Length: 30 mm and 45 mm .
• Anvil Tip: Curved tip (gray and white) and Regular (Round) tip (white) ●
• Reload Shaft Length: Short (15 cm) and Long (24 cm) ●
• Reload Diameter (upper-shaft to distal end): 8 mm ●

The curved tip on the distal-end of the reload can be used to aid in positioning the reload around target tissue / vessels for subsequent firing. The working length of the Signia™ small diameter reload will fit down an 8mm trocar sleeve or larger, and is compatible with existing Covidien manual and powered stapling handles (see Section 11.10: Compatible Stapling Handles). The short shaft length (15 cm) is recommended for use in open, thoracoscopic or laparoscopic procedures and are compatible with appropriately-sized trocar sleeves, 8 mm or larger. The long shaft length (24 cm) is recommended for use in laparoscopic procedures with appropriately-sized trocar sleeves, 8 mm or larger. The Signia™ Small Diameter Reloads are recommended for use with Covidien compatible short stapler adapters and handles. The reloads contain an intelligence chip, which has the ability to communicate with the Covidien powered Signia™ Stapler handle that has a compatible communications interface.

Through this submission, a new reload model SIGSDL45VT with a regular (round) tip anyil shall be added to the stapling family of Signia™ Small Diameter Reloads as a line extension. Additionally, the indications of Signia™ Small Diameter regular (round) tip white reloads shall be expanded to include creation of anastomosis based on the supporting data provided in this submission.

This document describes the Signia™ Small Diameter Reloads for surgical staplers. The existing curved tip reloads were previously cleared, and this submission (K222641) adds a new regular (round) tip model and expands the indications for the regular (round) tip white reloads to include the creation of anastomosis.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with pass/fail thresholds. Instead, it details a comprehensive suite of performance tests performed to demonstrate substantial equivalence to a predicate device (K191070) and a reference device (K111825) for anastomosis. The fundamental acceptance criterion seems to be that the subject device performs comparably to or better than the predicate/reference devices in relevant performance tests.

Here's a summary of the performance tests conducted, implying "acceptance" if the subject device performs equivalently or acceptably:

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

The document provides the following details:

• Bench Tests: The specific sample sizes for each bench test are not provided.
• Animal Acute Tests: The specific sample sizes for these tests are not provided.
• Chronic Survival Testing in Animal:
  • Lobectomy (Thorax of Canine): Sample size not specified.
  • Nephrectomy, Splenectomy, Ovariohysterectomy (Abdomen of Porcine): Sample size not specified.
  • Jeju-Jejunostomy (Small Bowel of Canine): Sample size not specified.
• Provenance: All animal studies (acute and chronic) were conducted as pre-clinical studies by the manufacturer (Covidien). The country of origin for the animal studies is not explicitly stated but is typically conducted at contract research organizations. These are prospective studies given they are conducted to support a new device feature/indication.

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

This section is not applicable as the evaluation of the device performance is based on physical and biological measurements in bench and animal studies, not on interpretations by human experts establishing a "ground truth" for a test set in the context of diagnostic AI/imaging.

4. Adjudication method for the test set

This section is not applicable as the evaluation of the device performance is based on physical and biological measurements in bench and animal studies, not on adjudicating expert opinions.

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, an MRMC comparative effectiveness study was not done. This device is a surgical stapler, which is a physical medical device, not an AI-assisted diagnostic tool.

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

This section is not applicable. The device is a surgical stapler, not an algorithm.

7. The type of ground truth used

The "ground truth" in this context is established through:

• Physical measurements: For bench tests (e.g., staple formation, burst pressure, forces, dimensions).
• In-vivo observations and histological/pathological evaluation: For animal acute and chronic studies (e.g., tissue trauma, hemostasis, staple formation in tissue, long-term healing and integrity of staple lines, anastomosis success). This would involve veterinary pathologists and surgeons assessing outcomes.
• Usability testing: Direct observation and feedback from users (e.g., surgeons).

8. The sample size for the training set

This section is not applicable as this is a physical medical device, not a machine learning model that requires a training set.

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

This section is not applicable.

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The Signia™ small diameter gray and white reloads have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection and transection of vasculature using gray reloads and thin tissue and vasculature using white reloads.

The Signia™ Small Diameter Reload is an 8mm diameter reload that will be utilized for open and minimally invasive surgical procedures for transection and resection of tissue and specifically, vascular and thin tissue structures.

The reload is the distal shaft and jaws of the stapler system; comprised of a single-use knife, fixed curve tip anvil and stapler cartridge with two (2) rows of staples on either side of the knife blade.

The Signia™ Small Diameter Reload features a narrow shaft diameter, narrow end-effector, curved-tip anvil, multi-articulation angles, and delivers two staggered rows of titanium staples on either side of the cut line. These features facilitate device access during surgery in smaller/fighter intercostal spaces, smaller surgical spaces and difficult to reach vessels/vasculature.

The Signia™ Small Diameter Reload places staggered rows of titanium staples and simultaneously divides the tissue so that two staggered rows of staples are placed on either side of the cut line. The size of the staples is determined by the selection of the single use reload.

The Signia™ small diameter reload is available in multiple configurations with the following features:

• . Open Staple Height: 2.0 mm (gray cartridge) and 2.5 mm (white cartridge)
• . Cartridge Length: 30 mm and 45 mm
• Anvil Tip: Curved .
• Reload Shaft Length: Short (15 cm) and Long (24 cm) .
• Reload Diameter (mid-shaft to distal end): 8 mm ●

The curved tip on the distal-end of the reload can be used to aid in positioning the reload around target tissue/vessels for subsequent firing and placement of staples. The working length of the Signia™ small diameter reload will fit through an 8mm trocar sleeve or larger and is compatible with existing Endo GIA™ handles and Signia™ adapters. The short shaft lengths (15cm) are recommended for use in open or thoracic procedures and are compatible with thoracic trocar sleeves. The long shaft lengths (24 cm) are recommended for use in laparoscopic procedures with 8 mm diameter trocar sleeves. Signia™ small diameter reloads are recommended for use with Covidien compatible short Stapler handles and adapters. Signia™ small diameter reloads contain an intelligence chip. The intelligence chip has the ability to communicate with Covidien powered stapler handles that have a compatible communications interface.

The provided text describes the regulatory clearance of the Signia™ Small Diameter Reloads, a surgical stapler with implantable staples. It outlines the device's indications for use, technological and performance characteristics, and a comparison to predicate devices. The document also lists the various tests performed to demonstrate substantial equivalence, but it does not provide detailed acceptance criteria or the study results for those criteria. Instead, it states that "The design differences were found to not affect the substantial equivalence through applicable design verification activities and risk analysis that showed continued conformance to applicable technical design specifications and performance requirements, applicable medical device performance standards, and other nonclinical testing."

Therefore, based solely on the provided text, I cannot complete a table of acceptance criteria and reported device performance, nor can I provide information about sample sizes for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth used, or training set sample size and ground truth establishment. This information is typically found in detailed study reports or design verification documents, which are not part of this 510(k) summary.

The document explicitly states: "This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence." This indicates that a clinical study with human patients to assess performance against specific acceptance criteria (as you've described) was not performed or was not the primary basis for demonstrating substantial equivalence for this particular 510(k) submission.

The tests listed (Functional performance, Chronic survival testing in animal, Usability, Biocompatibility, Electrical Safety, EMC/EMI, Sterilization, Stability/Shelf-life) are primarily non-clinical assessments used for design verification and comparison to predicate devices to demonstrate that the new device performs similarly and is as safe and effective.

To answer your request, if this were a hypothetical scenario where such data was available and analogous to an AI/ML device, the table would look like this:

1. Table of Acceptance Criteria and Reported Device Performance

Given the information provided:

2. Sample size used for the test set and the data provenance: Not specified. The document mentions "Bench and Animal (Acute)" tests and "Chronic survival testing in animal" but does not give specific sample sizes for these tests or the provenance of the animal data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this submission did not rely on clinical performance data and thus did not describe a scenario where expert ground truth would be established in the context of human data interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no clinical performance study with human readers/interpreters is described.
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 MRMC study was done, as this is a surgical stapler, not an AI-assisted diagnostic device, and the submission explicitly states no reliance on clinical performance data.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device (surgical stapler), not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the non-clinical tests described, the "ground truth" would be established by physical measurements, engineering standards, animal physiological responses, and laboratory assays, rather than expert consensus, pathology, or outcomes data in humans. The document does not detail specific metrics or 'ground truths' for each test beyond listing the test types.
8. The sample size for the training set: Not applicable, as this is a physical medical device and not an AI/ML algorithm that would undergo a "training set" process.
9. 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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