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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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The iDrive™ Ultra sterilization tray (IDRVTRAY) is intended to provide storage for the iDrive™ Utra powered stapling system during sterilization, storage and transportation within the hospital environment. The iDrive™ Ultra Sterilization Tray is only intended to maintain sterility of the enclosed devices if it is used in conjunction with an FDA cleared sterilization wrap and has only been evaluated for a non-stacked configuration. The tray can contain at a maximum: one (1) iDrive™ Ultra powered handle, two (2) Endo GIA™ adapters, two (2) iDrive™ battery insertion guides and one (1) iDrive™ Ultra manual adapter tool. The tray is intended to be sterilized by the following cycles:

Prevacuum Steam Cycles 132°C for 4 minutes 134°C for 3 minutes

Vacuum Dry: 20 minutes

The iDrive™ Ultra sterilization tray is an optional, over-the counter, accessory to aid in storage and sterilization of the iDrive™ Ultra powered handle, Endo GIA™ adapter, iDrive™ battery insertion guide and iDrive™ Ultra manual adapter tool. It can simultaneously accommodate the following components:

One (1) iDrive™ Ultra powered handle

Two (2) Endo GIA™ adapters

Two (2) iDrive™ battery insertion guides

One (1) iDrive™ Ultra manual adapter tool

The iDrive™ Ultra sterilization tray is an aluminum tray which is perforated to allow penetration of steam during steam sterilization. The tray can be processed through a minimum autoclave cycle of either 134°C for 3 minutes or 132°C for 4 minutes while being wrapped with a CSR wrap or within a sterilization container system.

Here's an analysis of the provided text regarding the iDrive™ Ultra sterilization tray, focusing on acceptance criteria and supporting studies.

Important Note: The provided document is a 510(k) Summary of Safety and Effectiveness, which is a premarket notification for a medical device. This type of document primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing a detailed report of a new clinical study. As such, information regarding AI performance metrics (like sensitivity, specificity, F1 score), sample sizes for AI training/testing, expert qualifications, and MRMC studies will not be present as this device is a physical sterilization tray, not an AI diagnostic or assistive tool.

1. Table of Acceptance Criteria and Reported Device Performance

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

Due to the nature of the device (a physical sterilization tray) and the document (510(k) Summary), this information is not applicable in the context of an AI/algorithm test set. The "test set" here refers to the actual physical trays and associated sterilization equipment used for physical, performance-based testing.

• Sample Size: Not explicitly stated as a number of "samples" in the way an AI study would define it. The testing involved multiple sterilization cycles and evaluations on the physical device. Typically, for such devices, a statistically significant number of cycles or tests are performed (e.g., n=3 for replicates, or stress testing until failure for durability), but the exact numbers are not detailed in this summary.
• Data Provenance: Not explicitly stated. The testing would have been conducted by Covidien, LLC, likely in their own laboratories or through contract labs. It's prospective testing for the purpose of this submission.
• Country of Origin: Not specified for the testing itself, but the submitter is Covidien LLC from North Haven, CT, USA.

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

This is not applicable as the device is a physical sterilization tray, not an AI system requiring expert-derived ground truth. The "ground truth" for sterilization effectiveness would be determined by objective measures (e.g., biological indicators, chemical integrators, sterility assays, temperature/pressure monitoring) according to validated protocols, not expert consensus on images or interpretations.

4. Adjudication Method for the Test Set

Not applicable for a physical device. Adjudication methods like 2+1 or 3+1 refer to how discrepancies in expert ratings are resolved for diagnostic classifications, which is irrelevant for a sterilization tray.

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 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

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance of a sterilization tray involves objective, verifiable outcomes related to sterilization efficacy and device integrity:

• Sterilization Efficacy: Achieved by passing established sterilization cycle parameters (temperature, pressure, time, vacuum dry time) and demonstrated sterility through biological indicators (killing of spore-forming bacteria), chemical indicators (color change), and physical monitoring of the autoclave cycle.
• Material Compatibility: Demonstrated by conformity to ISO 10993-1.
• Durability/Reusability: Demonstrated by the tray's physical integrity and functional performance after repeated sterilization cycles.
• Containment/Organization: Demonstrated by the physical fit of the specified components within the tray.

8. The Sample Size for the Training Set

Not applicable, as this is not an AI/machine learning device.

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

Not applicable, as this is not an AI/machine learning device.

Summary of the Study Proving Device Meets Acceptance Criteria (from the 510(k) Summary):

The document states: "PERFORMANCE DATA: Testing has been performed and includes testing to the following standards: - ANSI/AAMI ST77:2006 - AAMI TIR30:2003 ."

These standards are critical for sterilization practices and medical device material compatibility, respectively:

• ANSI/AAMI ST77:2006 (or its current version): This standard typically covers "Containment devices for reusable medical device sterilization." It would detail requirements and test methods for instrument trays, wrappers, and containers regarding their ability to facilitate sterilization, prevent recontamination, and withstand reprocessing.
• AAMI TIR30:2003 (or its current version): This Technical Information Report (TIR) from AAMI focuses on "A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices." While the tray itself isn't a "reusable medical device" in the same sense as an instrument, this TIR often provides guidance on material compatibility and resistance to reprocessing methods, including sterilization.

Implicit Study Design:

The "study" would involve:

1. Preparation: Loading the iDrive™ Ultra sterilization tray with the specified maximum configuration of instruments/components.
2. Sterilization Cycles: Running the loaded tray through the specified prevacuum steam cycles (132°C for 4 minutes and 134°C for 3 minutes, both with a 20-minute vacuum dry time) in a validated autoclave, likely using an FDA-cleared sterilization wrap.
3. Sterility Assurance: Monitoring the sterilization cycle parameters, and using biological and chemical indicators to confirm that sterility was achieved within the tray.
4. Material Compatibility/Integrity: Visual and functional inspection of the tray and its components after multiple sterilization cycles to ensure no degradation, melting, warping, or other adverse effects that would compromise its function or the sterility of the contents.
5. Biocompatibility: Evidence of compliance with ISO 10993-1, likely through material certificates and prior evaluations of the silicone and aluminum materials.
6. Load Capacity Testing: Demonstrating that the tray can safely support 15 pounds without structural failure.

The "acceptance criteria" are implied by the successful completion of these tests in accordance with the cited standards and the stated operational parameters for the device. The conclusion of the 510(k) is that, based on this testing and comparison to predicate devices, the iDrive™ Ultra sterilization tray is substantially equivalent and safe and effective for its intended use.

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The Endo GIA™ Reload has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.

The subject device and the predicate device both are a linear or articulating reload that is attached to a stapler handle. The reload contains staples, a cutting blade, and an anvil which to form the staples. Once the reload is attached to the stapler handle, the trigger on the handle is manually squeezed once to close the anvil in order to clamp the tissue. Once the anvil is fully closed, it securely retains the tissue until it is opened. To fire either the subject or predicate device, a safety must be physically and intentionally disengaged after full clamp-up. Once the safety has been disengaged, the trigger can be squeezed additional times to fire the staples and advance the cutting blade. The number of firing squeezes will increase the cartridge length. The subject and predicate Endo GIA™ reloads are sterilized via ethylene oxide, have 45mm or 60mm staple cartridge lengths, 3.5mm or 4.8mms titanium staples, single use and disposable devices. The subject device contains two modifications compared to predicate, the addition suture slots and blunt blades within the anvil and cartridge of the reload. These two minor modifications are the only differences between the subject device and the predicate device. The addition of the suture slots and blunt blades are the result of refurbishment of components from a previously cleared device (K080898). The suture slots within the previously cleared device (K080898) secured suture on the anvil and cartridge to hold reinforcement material. The blunt blades would cut the suture in order to deploy the reinforcement material when the reload is fired. The subject device is refurbished by removing the sutures and tissue reinforcement material.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Endo GIA™ Reload device, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states, "The result of these tests demonstrates that the proposed device Endo GIA™ Reload is substantially equivalent to the predicate device." While it doesn't provide specific quantitative results for each criterion, the overall statement indicates successful performance against the set criteria.

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

The document does not explicitly state the sample sizes for the "in vitro" or "in vivo" performance tests. It also does not specify the country of origin of the data or whether the studies were retrospective or prospective.

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

This information is not provided in the document. The studies listed are engineering/performance tests (e.g., staple formation, force, cytotoxicity), not clinical studies requiring expert ground truth for interpretation.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. The performance tests are quantitative or qualitative assessments of device mechanics and biocompatibility, not requiring an adjudication method.

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

No MRMC comparative effectiveness study was done or reported in this 510(k) submission. This device is a surgical stapler reload and its performance is evaluated through engineering and in vivo animal studies, not through human reader interpretation of images.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study

Not applicable. The Endo GIA™ Reload is a physical medical device, not an algorithm or AI system.

7. Type of Ground Truth Used

The "ground truth" for the performance tests would be defined by the pre-established engineering specifications, material standards, and biological responses expected from a safe and effective stapling device. For example:

• Staple formation: Visual and microscopic inspection against defined staple geometries.
• Insertion/Removal force: Measurement against specified force limits.
• Tissue trauma, knife cut, staple formation (in vivo): Histopathological evaluation of tissue samples, gross observation of staple lines and cutting performance in animal models.
• Biocompatibility tests (Cytotoxicity, ETO Residual, Passivation): Adherence to ISO and ASTM standards and guidelines.

8. Sample Size for the Training Set

Not applicable. This device does not involve a "training set" in the context of machine learning or algorithms. Its development and testing rely on engineering design, material science, and pre-clinical validation.

9. How 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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The Versaport™ Bladeless Optical Trocar is intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry. The trocar may be used with or without visualization for primary and secondary insertions.

The Versaport™ V2 Bladeless Optical Trocar 11mm and 12mm with a transparent cannula is available in standard (100mm), short (70mm) and long (150mm) cannula lengths. The Versaport™ V2 Bladeless Optical Trocar with transparent cannula and obturator allows optical entry for visualization of tissue layers during insertion. The obturator housing contains a scope retention mechanism. The trocar housing contains internal seals to prevent loss of pneumoperitoneum when instruments are inserted into a port or withdrawn completely from a port. The 11mm and 12mm Versaport™ seal system accommodate instruments indicated as 5mm up to 11mm and 12mm respectively. These features are the same as the Versaport™ V2 Bladeless Optical Trocar (5mm) [K112349].

The proposed device (Versaport™ V2 Bladeless Optical Trocar, 11mm and 12mm) has similar design, lengths, and optical features as the predicate devices. The Versaport™ V2 Bladeless Optical Trocar, 11mm and 12mm, includes a transparent cannula, a bladeless obturator with a transparent optical window at the distal end, an obturator housing scope retention mechanism and external interlocking snaps. The scope retention mechanism is located within the obturator housing allowing for secured insertion and retention of an appropriately sized 0° laparoscope for visualization of tissue layers during insertion into the body cavity. There is a 3 way stopcock for insufflation and rapid desufflation. The external interlocking snaps secure the obturator to the cannula. The Versaport™ Bladeless V2 Optical trocar is equivalent to the predicate devices in terms of its intended use and fundamental technology.

The provided submission is a 510(k) Summary of Safety and Effectiveness for a medical device (Versaport™ V2 Bladeless Optical Trocar System). It describes the device, its intended use, and states that in-vitro and in-vivo tests were performed to verify performance and substantial equivalence to predicate devices. However, it does not provide specific acceptance criteria or detailed results of those studies.

Here's a breakdown based on the information available:

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

Note: The document only states that these performance aspects were "verified" and that the device performs "as intended" and is "substantially equivalent" to predicate devices. It does not provide the specific quantitative or qualitative acceptance criteria used for each test, nor the actual measured performance values that demonstrated compliance.

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

• Sample sizes: Not specified in the provided document.
• Data provenance: Not specified (e.g., country of origin, retrospective or prospective).

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 to this type of device submission. This device is a surgical instrument (trocar), not an imaging or diagnostic device that requires expert interpretation for ground truth.

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

This information is not applicable as it pertains to methods for resolving discrepancies in expert interpretations, which is not relevant to testing a surgical instrument.

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. This device is not an AI-powered diagnostic tool, and therefore, MRMC studies involving human readers or AI assistance are not relevant.

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

This information is not applicable. This device is a physical surgical instrument and does not involve algorithms or AI.

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

For the performance tests mentioned (e.g., leak resistance, forces, visualization), the "ground truth" would be established by objective measurements and functional requirements defined by engineering specifications and surgical practice standards, rather than expert consensus on diagnostic images or pathology. For example, "leak resistance" would be measured against a defined threshold of acceptable leakage. "Visualization of tissue layers" would be assessed through direct observation during in vivo testing.

8. The sample size for the training set

This information is not applicable. This device is not an AI/ML model that requires a training set.

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

This information is not applicable. As above, this device does not use a training set.

Summary of what the document does provide regarding the study:

The document (specifically "PERFORMANCE DATA" on Page 2) states that a study was performed, encompassing:

• Study Type: A combination of in-vitro (laboratory) and in-vivo (live subject) tests.
• Purpose: To verify that the performance of the Versaport™ V2 Bladeless Optical 11mm and 12mm trocars is substantially equivalent to the predicate devices and performs as intended.
• Tests Performed:
  • In Vitro Leak Resistance
  • In Vitro Instrument Insertion and Removal Forces
  • In Vitro Snap Feature Retention Force
  • In Vitro Scope Insertion and Retention Forces
  • In Vitro and In Vivo Penetration Force
  • In Vitro and In Vivo Fixation Force
  • In Vivo Visualization of Tissue Layers

Missing Information:

Crucially, this 510(k) summary provides a high-level overview of the tests conducted but lacks detailed quantitative results, specific acceptance criteria, and specific methodologies (e.g., sample sizes, experimental setup details) that would typically be found in a full study report. This level of detail is usually present in the full 510(k) submission, but not always in the publicly available summary.

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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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The iDrive™ Ultra powered handle and Endo GIA™ adapter, when used with Endo GIA™ single use reloads have applications in abdominal, gynecological, pediatric, and thoracic surgery for resection, transection, and creation of anastomosis. It may be used for transection and resection of liver substance, hepatic vasculature, and biliary structures and for transection and reseation of pancreas.

The iDrive™ Ultra powered handle and Endo GIA™ adapter, when used with Endo GIA™ curved tip single use reloads, can be used to blunt dissect or separate target tissue from other certain tissue.

The iDrive™ Ultra powered handle and Endo GIA™ adapter, when used with the Endo GIA™ Radial Reload with Tri-Staple™ Technology, has applications 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 of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.

This 510(k) introduces an accessory to the iDrive™ Ultra powered handle and Endo GIA™ adapter system (K121510), the iDrive™ Ultra reusable manual adapter tool. The iDrive™ Ultra reusable manual adapter tool is a reusable, handheld device that can be used to operate an Endo GIA™ adapter manually. It can be used to complete a firing, retract the knife and open the jaws, and to articulate an Endo GIA™ reload. The "manual tool" is not intended to initiate a reload firing. It is intended to provide the user with a manual method of operating the reload.

In addition. this premarket notification reports non-significant changes made to the iDrive™ Ultra powered handle and Endo GIA™ adapter (K121510) since their clearance in July 2012. At the time of their implementation, these changes did not necessitate a 510(k) notification. These changes are described in this 510(k) according to the FDA Draft Guidance "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications 510(k)".

The provided text describes a 510(k) premarket notification for a surgical stapler system accessory, the iDrive™ Ultra reusable manual adapter tool, and non-significant changes to the iDrive™ Ultra powered handle and Endo GIA™ adapter. However, the document does not contain specific acceptance criteria or details of a study that proves the device meets such criteria in terms of quantitative performance metrics.

The document states: "Verification and validation activities were performed and these activities are described in Section 11: Declarations of Conformity and Summary Reports. These evaluations demonstrate that the iDrive™ Ultra reusable manual adapter tool, and the iDrive™ Ultra system as a whole, functions as intended." Unfortunately, "Section 11: Declarations of Conformity and Summary Reports" is not included in the provided text.

Based on the information given, I cannot provide a table of acceptance criteria and reported device performance or answer most of the specific questions about the study design, sample sizes, expert involvement, or ground truth.

Here's what can be extracted:

• Device Name: iDrive™ Ultra reusable manual adapter tool (accessory) and iDrive™ Ultra powered handle and Endo GIA™ adapter (system).
• Intended Use: The manual adapter tool is for operating an Endo GIA™ adapter manually, completing a firing, retracting the knife, opening jaws, and articulating a reload. It is not intended to initiate a reload firing or for patient contact.
• Safety: The manual adapter tool is comprised of materials that are in accordance with ISO 10993-1.

Regarding your specific points, based only on the provided text:

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

   • Cannot be provided. The document states "Verification and validation activities were performed" and "These evaluations demonstrate that... [the device] functions as intended," but it does not list specific measurable acceptance criteria or their corresponding performance results.

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

   • Cannot be provided. This information is not present in the document.

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

   • Not applicable / Cannot be provided. There is no mention of a test set with human-established ground truth in this type of mechanical device submission. The verification/validation would likely involve engineering tests, functional tests, and material biocompatibility tests.

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

   • Not applicable / Cannot be provided. This concept is generally relevant for AI/diagnostic devices where human interpretation is critical for ground truth, not for the functional testing of a mechanical surgical stapler.

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 describes a mechanical surgical device and an accessory, not an AI or diagnostic imaging device. Therefore, MRMC studies and "human readers" improving with "AI assistance" are not relevant to this submission.

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

   • Not applicable. This is a mechanical device, not an algorithm.

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

   • Cannot be explicitly determined from the provided text. For mechanical devices, "ground truth" would typically refer to established engineering specifications, mechanical tolerances, material properties, and functional requirements. For example, a stapler's ground truth might be "all staples fire successfully," "staple formation meets specifications," or "clamping force is within tolerance." The text only vaguely refers to "functions as intended."

8. The sample size for the training set:

   • Not applicable / Cannot be provided. This device is not an AI/machine learning model, so there is no "training set" in that context.

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

   • Not applicable / Cannot be provided. As above, no training set for an AI model is involved.

In summary: The provided 510(k) summary focuses on device description, intended use, and substantial equivalence to a predicate device. It confirms that verification and validation activities were performed and demonstrated the device functions as intended, but it explicitly omits the details of those activities and their specific results, referring to an external "Section 11: Declarations of Conformity and Summary Reports" which is not included. This type of submission for a mechanical device typically does not involve the kinds of studies (e.g., MRMC, AI performance) that your detailed questions are tailored for.

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The iDrive ™ Ultra powered handle and En do GIA ™ adapter, when used with En do GIA ™ single use reloads have applications in abdominal, gynecological, pediatric, and thoracic surgery for resection, transection, and creation of anastomosis. It may be used for transection and resection rof liver substance, hepatic vasculature, and biliary structures and for transection and resection of pancreas.

The iDrive ™ Ultra powered handle and Endo GIA TM adapter, when used with Endo GIA TM curved tip single use reloads, can be used to blunt dissect or separate target tissue from other certain tissue.

The iDrive ™ Ultra powered handle and En do GIA TM adapter, when used with the Endo GIA TM Radial Reload with Tri-Staple ™ Technology, has applications in open or minimally invasive raneral 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 of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.

Surgical stapler with a powered handle, delivering implantable titanium staples.

The provided submission describes a surgical stapler, the iDrive™ Ultra powered handle and Endo GIA™ adapter, and does not relate to an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details, expert involvement, and ground truth for an AI/ML device is not applicable and cannot be extracted from this document.

The document focuses on the safety and effectiveness of a physical medical device, not a software algorithm. The "Performance Data" section lists various in-vitro and in-vivo tests for the stapler's mechanical and biological properties, as well as adherence to electrical safety standards. This is typical for a traditional 510(k) submission for a non-AI device.

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The Wound Protector is indicated for use to access the abdominal cavity during surgery through an atraumatically retracted incision, deliver maximum exposure of the abdominal cavity with minimum incision size, and protect against wound contamination during laparoscopic and open surgery. Additionally, the small size Wound Protector is indicated for use to access the thoracic cavity during cardiac and general surgical procedures through an atraumatically-retracted incision.

Wound retraction device providing access and protection from wound contamination. The Wound Protector Cylindrical Film is designed to retract an incision and provide protection from wound contamination. The Interior and Exterior rings are flexible to aid insertion, film retraction, and removal.

The provided text describes a 510(k) summary for the Covidien Wound Protector, a sterile surgical drape. This document focuses on the device's technical characteristics and performance data related to its physical properties and usability, rather than clinical performance against specific metrics like accuracy or diagnostic efficacy that would require a study with human subjects, ground truth, and statistical analysis.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable to this type of device and the information provided. The "performance data" section in the document refers to a series of in-vitro and in-vivo tests designed to confirm the device's mechanical integrity and functionality, not a clinical study to prove efficacy or diagnostic capability.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document lists the tests performed, and the 510(k) clearance implies that the device met the acceptance criteria for all these tests. Specific numerical values for the performance are not provided in this summary.

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

• Sample Size: Not explicitly stated for each test. The performance data refers to in-vitro and in-vivo testing. For in-vivo tests, the sample size would typically refer to the number of animals or human subjects, but this is not provided. For in-vitro tests, the sample size would be the number of units tested.
• Data Provenance: The document does not specify the country of origin of the data. It mentions both in-vitro (laboratory) and in-vivo testing, but does not indicate if it was retrospective or prospective. Given the nature of a 510(k) submission for a physical device, these tests are typically prospective tests conducted specifically for the submission.

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

• Not Applicable. This device is a physical surgical drape, not an AI or diagnostic device that relies on interpretation of data to establish ground truth with experts. The "tests" are about physical properties and usability, not diagnostic accuracy.

4. Adjudication method for the test set

• Not Applicable. As there's no diagnostic component requiring expert judgment or consensus, no adjudication method like 2+1 or 3+1 is relevant.

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. This is not an AI-assisted diagnostic or imaging device. Therefore, an MRMC comparative effectiveness study is not relevant to its evaluation.

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

• Not Applicable. This is a physical surgical device, not an algorithm.

7. The type of ground truth used

• For physical/mechanical tests (in-vitro): Ground truth is established by objective measurements against industry standards (e.g., ASTM D3787, ASTM D412) or established engineering specifications for strength, tear resistance, etc.
• For usability/in-vivo tests: Ground truth for "Ease of Use," "Incision Retraction," "Tissue Trauma," etc., would be established through observation, subjective assessment by trained personnel (possibly surgeons or medical professionals simulating use), and potentially histological examination for tissue trauma. However, the specific methodology for establishing this "ground truth" (or assessment criteria) is not detailed.
• For biocompatibility: Ground truth is established by adherence to the ISO 10993-1:2009 standard, which involves specific biological evaluation tests to ensure the materials are safe for patient contact.

8. The sample size for the training set

• Not Applicable. This is a physical medical device, not an AI algorithm that requires a training set.

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

• Not Applicable. As there is no training set for an AI algorithm, this question is not relevant.

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The Endo GIA™ Universal Staplers with Duet TRS™ reloads have applications in abdominal, gynecologic and pediatric surgery for resection, transection and creation of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas. The Duet TRS™ Reloads with Tri-Staple™ Technology have applications in abdominal, gynecologic and pediatric surgery for resection and creation of anastomoses. They may be used for resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.

The Duet TRS™ Reloads when used with Endo GIA™ Staplers place two, triple-staggered rows of titanium staples along with two layers of absorbable tissue reinforcement material (one layer on cartridge side and one laver on anvil side) and simultaneously divides the tissue and reinforcement material between the two, triple-staggered staple rows. The Duet TRS™ Reloads with Tri-Staple™ Technology when used with Endo GIA™ Staplers places two, triple-staggered rows of titanium staples along with two layers of absorbable tissue reinforcement material (one layer on cartridge side and one layer on anvil side) and simultaneously divides the tissue and reinforcement material between the two, triple-staggered staple rows. The staple line reinforcement material is a synthetic absorbable film prepared from synthetic polyester composed of glycolide, dioxanone, and trimethylene carbonate. The staple line reinforcement material supplied on each Reload is undyed (natural) and secured to the anvil and cartridge with BIOSYN™ synthetic absorbable suture. The Endo GIA™ Universal and Ultra Universal Staplers (K111825) with associated staple cartridge reloads are articulating, disposable surgical staplers that simultaneously transect and staple various types of internal tissues. Each can be used in both endoscopic and open surgical procedures, is available in multiple sizes, is for endoscopic procedures and can be introduced and used through appropriately sized trocar endoscopic access cannulae.

I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details for a medical device study.

The document is a 510(k) summary for Duet TRS™ Reloads, which are surgical staplers. It primarily focuses on:

• Identification of the device and submitter.
• Description of the device and its intended use.
• Comparison to predicate devices.
• Confirmation of materials used.
• A statement that performance evaluations were NOT required to support a labeling modification, indicating that no new performance data was generated for this specific submission.

Therefore, I cannot fulfill your request to describe the acceptance criteria and study proving device meets them, as the necessary information is absent from the provided text.

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Endo GIA™ Staplers: The Endo GIA™ Staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.

Endo GIA™ Radial Reload with Tri-Staple™ Technology: 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.

DST Series™ GIA™ Staplers: The DST Series™ GIA™ Staplers and the DST Series™ SGIA™ Knifeless Stapler have applications in abdominal, gynecological, pediatric and thoracic surgical procedures for resection, transection and creation of anastomosis. The SGIA™ Knifeless stapler may be used for occlusion of the left atrial appendage in open procedures. They may be used for transection and resection of pancreas.

DST Series™ TA™ Staplers: The Auto Suture™ TA™ Reloadable staplers have applications in abdominal, gynecological, pediatric and thoracic surgical procedures for resection or transection 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 Endo GIA™ Stapler places two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples is determined by the selection of the appropriate single use reload that is available in 30, 45 and 60 mm lengths as well as being available with optional Duet TRS™ staple line reinforcement material and optional curved-tip anvil for reloads with Tri-Staple™ Technology.

The Endo GIA™ Single Use Radial Reload with Tri-Staple™ Technology places two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples is determined by the selection of the appropriate single use reload that is available in a 60 mm length only.

The DST Series™ GIA™ Stapler place two double staggered rows of titanium staples and simultaneously divides the tissue between the two double rows. The size of the staples is determined by the selection of the appropriate single use reload that is available in 60, 80 and 100 mm lengths.

The DST Series™ SGIA™ Knifeless Stapler places two double staggered rows of titanium staples. The size of the staples is determined by the selection of a 2.5 mm staple size single use reload available in a 60 mm length only.

The DST Series™ TA™ Stapler places a double staggered row of titanium staples. The size of the staples is determined by the selection of the appropriate single use reload that is available in 30, 45, 60 and 90 mm lengths.

This document is a 510(k) Summary of Safety and Effectiveness for the Endo GIA™ Staplers, DST Series™ GIA™ Staplers, and DST Series™ TA™ Staplers. The primary change highlighted is the inclusion of a specific indication for use in the transection and resection of the pancreas.

Here's an analysis of the provided text in relation to your request:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for functional performance (e.g., staple line integrity, leak rates, burst pressure). Instead, the "acceptance criteria" are implied by the claim of substantial equivalence to predicate devices and the successful clinical literature review.

Study Details

1. Sample size used for the test set and the data provenance:
   The document mentions a "clinical literature review." This implies that the 'test set' was not a de novo, prospectively collected dataset for this specific submission, but rather existing published clinical data. The exact sample size (number of patients or cases) of the literature review is not specified. The data provenance (country of origin, retrospective/prospective) is also not specified, as it would depend on the individual studies included in the review.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   The document does not describe a process for establishing ground truth with a specific number of experts for a 'test set' in the traditional sense of an AI/diagnostic device study. The "clinical literature review" relies on the reported outcomes and findings of published studies, where the "ground truth" would have been established by the inherent diagnostic and surgical practices of the medical professionals involved in those studies (e.g., surgeons performing the procedures, pathologists examining resected tissue, follow-up clinicians assessing outcomes). The qualifications of these implicit "experts" from the literature are not detailed but would generally be medical professionals specializing in surgery (abdominal, gynecologic, pediatric, thoracic) and pathology.

3. Adjudication method for the test set:
   Not applicable in this context. The clinical literature review does not describe an adjudication process for a specific test set. The review synthesizes findings from multiple studies, and any form of "adjudication" would be at the discretion of the original study authors or implicitly through the peer-review process of the medical literature itself.

4. 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 surgical device, not a diagnostic AI device. The submission does not describe an MRMC study or any AI assistance. The clinical literature review supports the device's intended use, not the performance of human readers with or without AI.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Not applicable. This is a physical surgical stapling device, not a software algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   For the clinical literature review, the "ground truth" would have been derived from the outcomes data (e.g., successful transection, anastomosis integrity, post-operative complications, patient survival) and potentially pathology results from the surgical procedures described in the reviewed literature. It would be based on the established clinical practices and follow-up prevalent in those studies.

7. The sample size for the training set:
   Not applicable. This is a medical device, and the "clinical literature review" is not a "training set" in the context of machine learning. The device design and manufacturing process would involve extensive engineering testing and simulations, but the literature review serves to expand the intended use based on existing clinical evidence, not to train an algorithm.

8. How the ground truth for the training set was established:
   Not applicable, as there is no training set in the AI sense for this device submission.

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