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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 GLA™ stapler with Tri-Staple™ technology has applications in abdominal and thoracic surgical procedures for resection, transection and creation of anastomosis.

The GIA™ stapler with Tri-Staple™ technology places two triple staggered rows of titanium staples and simultaneously cuts and divides tissue between these two triple rows. The subject GIA™ stapler and cartridges with Tri-Staple™ technology are available in 60 mm staple line length and two staple sizes to accommodate tissue thicknesses: medium/thick and extra thick. Staplers for medium/thick tissue (purple cartridge) deploy three height-progressive rows of 3.0 mm. 3.5 mm and 4.0 mm titanium staples on either side of the tissue cut line. Staplers for extra thick tissue (black cartridge) deploy three height-progressive rows of 4.0 mm, 4.5 mm and 5.0 mm titanium staples on either side of the cut line. Each GIA™ stapler with Tri-Staple™ Technology may be reloaded with a GIA™ Cartridge with Tri-Staple™ Technology up to 7 times for a total of 8 firings per instrument.

The GIA™ Stapler with Tri-Staple™ Technology is manufactured with essentially the same patient contact materials that are utilized within the predicate device (K192720).

The GIA™ stapler with Tri-Staple™ technology has the same principle operation as the predicate device. The GIA™ Stapler with Tri-Staple™ Technology is a manual single-use device. It is provided sterile (ethylene oxide) with a 5-year shelf life, and intended for multiple use during a single procedure, which is the same as the predicate device (K192720).

The document describes a 510(k) premarket notification for the GIA™ Stapler with Tri-Staple™ Technology. A 510(k) submission aims to demonstrate that the new device is substantially equivalent to a legally marketed predicate device, rather than proving that it meets specific, novel acceptance criteria based on extensive clinical studies typical for novel devices.

Therefore, the "acceptance criteria" here refers to demonstrating that the subject device is substantially equivalent to the predicate device in terms of technological characteristics and performance, without raising new questions of safety or effectiveness. The study performed is a series of non-clinical performance tests.

Here's the breakdown of the information requested, based on the provided text:

1. A table of acceptance criteria and the reported device performance

Since this is a 510(k) submission focused on substantial equivalence, the "acceptance criteria" are implicitly that the subject device performs comparably to the predicate or reference device in specified non-clinical tests. The document doesn't provide explicit pass/fail criteria with numerical thresholds, but rather outlines the types of tests performed to demonstrate comparable performance.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the exact sample sizes for each of the non-clinical tests (bench, ex-vivo, in-vivo, biocompatibility). It only states that these tests "have been performed." The data provenance is not explicitly mentioned, but the submitter (Covidien) has corporate presence in both China (Leo Chen) and the USA (Katherine Y. Choi, U.S. Agent), suggesting the tests could have been conducted in various locations. Given the nature of these tests, they are inherently prospective experiments designed to evaluate device performance under controlled conditions.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This type of information is not applicable to this submission. "Ground truth" established by experts is typically relevant for diagnostic AI/imaging devices where human interpretation is the benchmark. For a surgical stapler, the "ground truth" is defined by objective physical and biological performance metrics (e.g., burst pressure, staple formation, hemostasis) measured in laboratory or animal settings, not by expert consensus on interpretations.

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

This is not applicable as there is no expert adjudication of results in the context of mechanical device performance testing. The results are based on objective measurements and established test procedures.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable. This type of study is used for evaluating diagnostic devices, particularly those involving human interpretation of medical images (e.g., AI in radiology). The GIA™ Stapler is a surgical instrument, not a diagnostic AI device. The submission explicitly states: "No clinical study is deemed necessary since the substantial equivalence has been sufficiently demonstrated by non-clinical studies."

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

This is not applicable. The device is a manual surgical stapler; it is not an algorithm or an AI product, and therefore does not have a "standalone" algorithmic performance. Its performance is intrinsically tied to its mechanical function and human use in a surgical setting.

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

As explained in point 3, the concept of "ground truth" in the diagnostic context is not directly applicable. For this device, the "ground truth" for performance evaluation is based on objective measurements from in-vitro (bench), ex-vivo, and in-vivo (animal) studies, such as:

• Physical measurements of staple formation.
• Measured firing force.
• Burst pressure of stapled tissues.
• Assessment of pneumostasis.
• Evaluation of hemostasis.
• Standardized biocompatibility test results.

8. The sample size for the training set

This is not applicable. The GIA™ Stapler is a mechanical surgical device, not an AI/machine learning model that requires a training set.

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

This is not applicable for the same reason as point 8.

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The device is intended for transection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general abdominal, gynecologic, thoracic, and pediatric surgical procedures.

The proposed device places two, triple-staggered rows of titanium staples and simultaneously divides the tissue from central line. The device is available in 70mm, 160mm three lengths. Reloads of Endoscopic Linear Cutting Staplers and Loading Units for Single Use are available in in five staple sizes to accommodate various tissue thickness: 2.5mm, 3.5mm, 4.1mm and 4.8mm. The device may be reloaded and fired up to 25 times for 1 firing in a single procedure.

This document is a 510(k) Premarket Notification from Ezisurg (Suzhou) Medical Co., Ltd. for their Endoscopic Linear Cutting Staplers and Loading Units for Single Use. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with detailed acceptance criteria and results. Therefore, much of the requested information regarding ground truth, expert opinions, and multi-reader studies is not applicable or available in this document.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists several performance tests conducted, but it does not explicitly state specific numerical acceptance criteria or quantitatively report the device's performance against them in a tabular format. Instead, it makes a general statement that "The test results demonstrated that the proposed device complies with the following standards" and were performed "to determine substantial equivalence."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document only mentions that "Non clinical tests were conducted," but does not specify the sample sizes for these tests or the origin of any data used.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable/not provided. The document describes a pre-market notification process for a surgical stapler, which relies on physical and mechanical performance testing, not on interpretation of medical images or expert consensus for diagnosis. Therefore, there is no "ground truth" established by experts in this context.

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

This information is not applicable/not provided. Adjudication methods are typically used in clinical studies or studies involving human judgment (e.g., image interpretation), which this submission does not describe. The tests mentioned are non-clinical, mechanical, and biological evaluations.

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

This information is not applicable/not provided. The device is an endoscopic linear cutting stapler, a physical surgical tool, not an AI-powered diagnostic or assistive technology that would involve human readers or AI assistance.

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

This information is not applicable/not provided. As explained above, the device is a mechanical surgical instrument, not an 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 objective measurements and adherence to international standards and internal design specifications. For example, the "Staple Formation Test" would have an objective standard for what constitutes a properly formed staple, likely visually assessed and measured against specifications. "Biocompatibility" is assessed against specific ISO standards. "Endotoxin Limit" is measured quantitatively against a defined limit. There is no expert consensus, pathology, or outcomes data used as ground truth for these types of engineering and biological performance tests.

8. The sample size for the training set

This information is not applicable/not provided. This document describes the testing of a physical medical device, not a machine learning model, so there is no "training set."

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

This information is not applicable/not provided as there is no training set for a physical medical device.

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The SigniaTM Loading Units with Tri-StapleTM 2.0 cartridges have applications in abdominal, gynecologic, pediatric and thoracie surgery for resection and creation of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and transection and resection of pancreas.

The SigniaTM Loading Units and Tri-StapleTM 2.0 Cartridges place staggered rows of titanium staples and simultaneously divides the tissue so that three 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 following single use Tri-StapleTM 2.0 cartridges:

Tri-Staple TM 2.0 cartridge, vascular/medium:

• Tan- three height progressive rows of 2.0 mm, 2.5 mm, 3.0 mm titanium staples on o either side of the cut line.
  Tri-StapleTM 2.0 cartridge, medium/thick:

• · Purple-three height progressive rows of 3.0 mm, 3.5 mm and 4.0 mm titanium staples on either side of the cut line.
  The Tri-StableTM 2.0 Cartridge is available in 45 mm and 60 mm lengths. The SigniaTM Loading Unit is available in articulating 45 mm and 60 mm lengths. Tri-StapleTM 2.0 Cartridges are able to be loaded into the SigniaTM Loading Unit by the User. SigniaTM Loading Units may be used up to twelve times in the same procedure. SigniaTM Loading Units with Tri-Staple TM 2.0 Cartridges, similar to the predicate devices, are compatible with Covidien's Endo GIA TM Ultra Universal manual stapler handles and iDriveTM Ultra powered stapler handle with associated Endo GIATM Adapter.

The provided text describes a medical device, the "Signia Loading Units with Tri-Staple™ 2.0 Cartridges," and its 510(k) submission to the FDA. However, the document does not contain information related to software, algorithms, AI, or diagnostic studies that would typically have the specific acceptance criteria and study design elements you've requested.

This document is a 510(k) summary for a surgical stapler system, which is a physical medical device. The "tests" performed are engineering and biological validations of the stapler's mechanical function and safety, not a study of an AI or algorithm's diagnostic performance.

Therefore, I cannot populate the table or answer most of your detailed questions about acceptance criteria, AI performance, ground truth, or expert involvement as they are not applicable to the information provided in this document.

Here's what can be extracted, focusing on the device performance and the nature of the non-AI testing described:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a mechanical surgical device, the "acceptance criteria" are related to mechanical and biological function rather than diagnostic accuracy. The document states that "design differences were found to not affect safety or performance through applicable design verification activities that showed continued conformance to applicable technical design specifications and performance requirements, applicable medical device performance standards, and other nonclinical testing." Specific numerical acceptance targets are not provided in this summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified for individual tests. The document mentions "bench tests using simulated tissue medium" and "in vivo and ex vivo tests using porcine and canine animal models."
• Data Provenance: Not specified, but animal models (porcine and canine) were used for some tests. The studies were likely conducted internally or by contract research organizations. The nature suggests they are prospective experiments/tests as part of device development and validation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable. This is a hardware device validation, not a diagnostic study requiring expert ground truth for interpretation of medical images or data. The "ground truth" here would be the successful mechanical function of the stapler and the physical/physiological outcomes (e.g., successful hemostasis).

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

• Not Applicable. Adjudication methods are typically used in diagnostic studies for resolving discrepancies in expert interpretations. This device undergoes engineering and biological performance testing.

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 a hardware device, not an AI or diagnostic software. Therefore, no MRMC study or AI assistance improvement metrics are relevant or provided.

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

• Not Applicable. No algorithms or AI are described.

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

• For the bench tests: The "ground truth" would be objective engineering measurements and pre-defined acceptance ranges for mechanical parameters (e.g., staple formation geometry, force measurements).
• For the in vivo/ex vivo tests: The "ground truth" would be direct observation of physiological outcomes (e.g., absence of acute air leak, successful hemostasis, measurement of burst pressure, visual assessment of tissue trauma). This is direct observation of device effect on biological tissue.
• For biocompatibility: Conformance to ISO Standard 10993-1.

8. The sample size for the training set

• Not Applicable. This is not an AI/machine learning device. There is no "training set" in the context of the information provided. The development and testing of this device would involve engineering design iterations and subsequent verification/validation tests.

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

• Not Applicable. No training set for an algorithm is described.

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The Endo GIA™ Radial Reload with Tri-Staple™ Technology has application in open or minimally invasive general abdominal, gynecologic, pediatric and thoracic surgery for resection and transection of tissue and creation of anastomosis, as well as application deep in the pelvis, i.e. low anterior resection. It may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.

The single use Endo GIA™ radial reload with Tri-Staple™ technology places three radial (curved) staple rows 60mm in length on each side of a cut line and simultaneously divides the tissue between the third and fourth lines, creating a 60mm curved transection. The medium/thick radial reload places height progressive titanium staple rows. The reloads may be inserted through an access device such as a hand access device or comparable access port. The Endo GIA™ radial reloads with Tri-Staple™ Technology may be used with the Endo GIA™ Ultra Universal, Endo GIA™ Universal, GIA™ Universal and iDrive™ Ultra stapler handles.

The provided text describes a 510(k) summary for the "Endo GIA™ Radial Reload with Tri-Staple™ Technology," a surgical stapler. However, it does not contain specific acceptance criteria, detailed results from a study, or the information needed to fill out all the requested categories.

The document states that "Design verification and pre-clinical validation studies were conducted to demonstrate that the subject device Endo GIA™ Radial Reload are safe and effective and perform as intended." It lists categories of tests conducted: "In Vitro" (Firina Force, Retraction Force, Staple Formation) and "In Vivo" (Free Bleed Evaluation, Air Leak Test, Burst Evaluation, Tissue Grasping and Trauma, Biocompatibility). It concludes that "The result of these tests demonstrates that the subject device Endo GIA™ Radial Reload with Tri-Staple Technology is substantially equivalent to the predicate device."

Based on the provided text, I cannot complete the requested tables and information as many specific details are missing. For instance, it doesn't give precise numerical acceptance criteria, the reported device performance against those criteria, sample sizes, data provenance details, expert qualifications, adjudication methods, or information regarding AI assistance, standalone algorithm performance, or ground truth establishment for training sets.

Therefore, I can only provide a general description of what the document implies about the studies, noting the missing information.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified in the provided text.
• Data Provenance: The studies were "Design verification and pre-clinical validation studies" including "In vitro and in vivo testing." No country of origin is mentioned, nor is it specified if the data was retrospective or prospective.

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

• Not applicable as this is a medical device (surgical stapler), not an AI/imaging device requiring expert interpretation for ground truth. The "ground truth" would be related to mechanical performance and biological outcomes, verified through instrumental measurements and observable biological effects in the tests mentioned (e.g., successful staple formation, absence of air leaks, no excessive bleeding, tissue integrity).

4. Adjudication method for the test set:

• Not applicable for this type of device testing. Performance is evaluated against engineering and biological criteria, not expert consensus on interpretations.

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 device is a surgical stapler, not an AI or imaging diagnostic tool.

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

• Not applicable. This device is a surgical stapler, not an AI algorithm.

7. The type of ground truth used:

• The "ground truth" would be objective measurements and observations from the in vitro (e.g., force measurements, visual inspection for staple formation) and in vivo (e.g., observation of bleeding, pressure tests for leaks, histological examination for tissue trauma) tests. It is based on established engineering and biological performance standards for surgical staplers.

8. The sample size for the training set:

• Not applicable. This device is a surgical stapler and does not involve AI training sets.

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

• Not applicable. This device is a surgical stapler and does not involve AI training sets or associated ground truth establishment.

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For Stapler: The reusable staplers have applications in abdominal, gynecological, pediatric and thoracic surgical procedures for resection, transection and creation of anastomosis. They may be used for transection and resection of the pancreas.

For Reload: The ReliaMax™ single use gastrointestinal anastomosis reload when used with ReliaMax™ reusable gastrointestinal anastomosis stapler have applications in abdominal, gynecological, pediatric and thoracic surgical procedures for resection, transection and creation of anastomosis. They may be used for transection and resection of the pancreas.

Reusable surgical stapler with a single use reload

The provided text describes a 510(k) summary for the ReliaMax™ Gastrointestinal Anastomosis Stapler and Reload. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a standalone study with specific performance metrics against those criteria for the ReliaMax device itself.

Based on the provided information, I can extract the following:

1. Table of Acceptance Criteria and Reported Device Performance

There is no explicit table of acceptance criteria with numerical targets for clinical performance (e.g., sensitivity, specificity) against which the ReliaMax™ device's performance is reported. Instead, the document states: "The results of this testing demonstrates that the ReliaMax™ Gastrointestinal Anastomosis Staplers and Reloads are substantially equivalent to the predicate device."

The performance evaluations conducted are listed as:

Note: The document does not provide the specific numerical results of these tests for either the ReliaMax™ device or the predicate device, nor does it define explicit "acceptance criteria" they were compared against, beyond the general goal of demonstrating substantial equivalence.

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

The document mentions "in vitro and in vivo performance evaluations" were conducted. However, no specific sample sizes for these test sets are provided, nor is the data provenance (e.g., country of origin, retrospective/prospective nature) detailed.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable as the provided text describes a medical device study (stapler for surgical procedures) which typically relies on objective physical or biological measurements rather than expert consensus on image interpretation or similar diagnostic tasks. Ground truth for a surgical stapler would involve measuring physical properties and biological outcomes in tested tissues/animals.

4. Adjudication Method

This information is not applicable for the type of device study described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC study is not applicable as this is a surgical stapling device, not an imaging or diagnostic device requiring human reader interpretation. No human-in-the-loop performance is described.

6. Standalone Performance Study

Yes, a standalone performance study was done for the ReliaMax™ device. The "Performance Data" section explicitly states: "In vitro and in vivo performance evaluations were conducted to demonstrate that ReliaMax™ Gastrointestinal Anastomosis Staplers and Reloads are safe and effective and that they perform as intended." This indicates algorithmic (device-only) performance testing. However, the exact methodology and detailed results for these evaluations are not provided beyond the general summary.

7. Type of Ground Truth Used

The ground truth for the "in vitro and in vivo performance evaluations" would have likely been based on objective measurements of physical and biological properties. For example:

• Staple Formation Verification: Visual inspection or microscopic analysis of staple formation.
• Hemostasis: Measurement of blood leakage.
• Burst Strength: Measurement of pressure at which the stapled anastomosis fails.
• Lung Air Leak: Measurement of air leakage from stapled lung tissue.
• Forces and Reliability: Physical measurements using load cells and endurance testing.

8. Sample Size for the Training Set

There is no mention of a "training set" in the context of this device study. Surgical staplers are typically evaluated through engineering tests and non-clinical (e.g., animal, cadaver) studies, not through AI/machine learning models that require training data.

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

This question is not applicable as no training set for an AI/ML model is mentioned.

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