Search Results

The Fiber System is a single use device intended to be used for reinforcement of the rotator cuff, following or during repair by suture or suture anchors, where weakness exists in the soft tissue.

The Fiber Locker System is not intended to replace normal body structures or provide the full mechanical strength to support the rotator cuff. Sutures, used to repair the tear, and sutures or bone anchors, used to attach the tissue to the bone, provide mechanical strength for the repair.

The FiberLocker System is comprised of two components: (1) the FiberLocker Implant (SpeedPatch PET) and (2) an instrument (FiberLocker Instrument) for fixation of said implant. The implant, a needled textile felt is made out of polyester staple fibers and is non-degradable. The FiberLocker Instrument, a surgical micro-stapling or felting device, is a sterile, single use device designed for the fixation of medical felt patches in soft tissue.

The provided FDA 510(k) summary (K241219) for the FiberLocker System does not contain any information about acceptance criteria or a study design for evaluating software or AI performance.

This document describes a medical device called the "FiberLocker System," which is a surgical mesh primarily intended for rotator cuff reinforcement. The performance data presented focuses on the physical and biological characteristics of the implant and its fixation instrument, primarily through bench testing and animal studies.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies for AI/software performance. The provided text does not describe an AI or software component for which such criteria and studies would be relevant.

Here's a breakdown of why this information is not present in the document:

1. Nature of the Device: The FiberLocker System is a physical medical device (surgical mesh and instrument), not a software or AI-driven diagnostic or treatment tool.
2. Type of Performance Data: The "Performance Data" section details mechanical properties (tensile strength, suture pull-out, tear testing, corrosion), biocompatibility, and fixation performance in an ex-vivo animal model. These are standard tests for physical implants and surgical instruments.
3. Animal Studies: The animal study described assesses the biological response and biomechanical equivalence of the FiberLocker Implant compared to a predicate device, which is typical for implantable materials.
4. No Mention of Software/AI: The entire document focuses on the hardware aspects of the device. There is no mention of an algorithm, image analysis, diagnostic capabilities, or any form of artificial intelligence.

If this document were for an AI/software device, I would look for keywords like:

• Accuracy, sensitivity, specificity, AUC
• Ground truth, expert consensus, pathology
• Training set, test set, validation set
• Reader study, MRMC study
• FROC, ROC curves
• Algorithm performance, decision support

Since these terms and concepts are entirely absent, it confirms that the provided text does not relate to an AI-enabled medical device performance study.

Ask a specific question about this device

The Tri-Staple™ 2.0 Reloads have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. It may be used for transection of liver substance, hepatic vasculature and biliary structures, and for transection and resection of pancreas.

The Tri-Staple™ 2.0 curved tip reloads can be used to blunt dissect or separate target tissue from other tissue.

The Tri-Staple™ 2.0 Reloads and Tri-Staple™ 2.0 curved tip reloads 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 single use reload:

The Tri-Staple™ 2.0 reload is available in articulating 30 mm, 45 mm and 60 mm length, the Tri-Staple™ 2.0 curved tip reload is available in articulating 30 mm, 45 mm lengths and the Tri-Staple™ 2.0 black reload is available in articulating 45 mm and 60 mm lengths.

The Tri-Staple™ 2.0 reloads and Tri-Staple™ 2.0 curved tip reloads can be used with the GIA™ universal stapler, Endo GIA™ universal staplers, Endo GIA™ Ultra universal staplers, and Covidien™ powered stapler handles used with Endo GIA™ adapters.

This document is a 510(k) summary for a medical device called "Tri-Staple™ 2.0 Reloads." It's a regulatory submission to the FDA, demonstrating that the device is substantially equivalent to a previously cleared predicate device.

Based on the provided text, there is no information available about acceptance criteria and a study proving a device's performance in the context of an AI/ML medical device.

The document discusses a stapling reload device and focuses on:

• Device Name: Tri-Staple™ 2.0 Reloads
• Purpose of Submission: A line extension to expand the reorder code offering by adding a "1-Wire ID-chip assembly" to existing Endo GIA™ Reloads with Tri-Staple™ Technology. This chip enables communication between the reloads and a powered stapler handle (Signia™ Stapler).
• Substantial Equivalence: The primary argument is that adding the ID chip does not alter the intended use, indications, or user environment of the device, making it substantially equivalent to the cleared predicate device (K160176 - Signia™ Stapler).
• Studies Performed:
  • Non-clinical performance data or testing: "No new non-clinical performance data or testing has been performed." The rationale is that the technology and design of the 1-Wire ID-chip remain the same as previously cleared in K160176. Existing design verification is considered transferable.
  • Clinical performance data: "No clinical study has been performed."

Since this document pertains to a surgical stapler reload and its electrical communication feature (an ID chip), and not an AI/ML-based device, the requested information regarding acceptance criteria, study design for AI/ML performance, ground truth, sample sizes, expert qualifications, adjudication methods, and MRMC studies is simply not present in this text.

Therefore, I cannot populate the table or answer the specific questions related to AI/ML device performance validation.

Ask a specific question about this device

The Signia™ Stapler, when used with Endo GIA™ single-use reloads, Endo GIAM single-use reloads with Tri-Staple™ Technology. Tri-Staple™ 2.0 single-use reloads and Sigma™ loading with Tri-Staple™ 2.0 single-use cartidges. has applications in abdominal, gynecological, pediatic, and thoracic surgery for resection, and creation of anastomosis. It may be used for transection of liver substance, hepatic vasculature, and biliary stuctures and for transection and resection of the pancreas.

The Signia™ Stapler, when used with Endo GIA™ curved tip single use reloads or Tri-Staple™ 2.0 curved tip single-use reloads, can be used to blunt dissect or separate target tissue from other certain tissue.

The Signia TM Stabler, when used with single use Radial Reloads 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 the pancreas.

The Signia™ Stapler, when used with Endo GIA™ single use reinforced reloads with Tri-Staple™ Technology preloaded with polyglycolic acid staple line reinforcement or Tri Staple™ 2.0 single use reinforced reloads preloaded with polyglycolic acid staple line reinforcement, has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection of tissue and creation of anastomosis. It may be used for transection of liver substance, hepatic vasculature and biliary structures, and for transection and resection of the pancreas.

The Signia™ Stapler is a battery powered microprocessor controlled surgical stapler that provides pushbutton powered maneuverability and firing of compatible Covidien stapling reloads. The Signia™ Stapler when used with a compatible reload is a surgical device for stapling and cutting tissues. The Signia™ Stapler is intended to be used by medical professionals qualified in the transportation, preparation, cleaning, sterilization, and use of surgical devices. All of which stay unchanged when compared to the predicate device.

The Signia™ Stapler is composed of the Signia™ Power Handle, Signia™ Power Shell, and Signia™ Linear Adapter. System accessories include the Signia™ Reusable Insertion Guide, Signia™ Manual Retraction Tool, Signia™ Single Bay Charger, Signia™ Sterilization Tray (optional), and Signia™ Four-Bay Smart Charger (optional).

The design modification is to introduce the new software version for the Signia™ Power Handle. The new software will extend the real time force gauge display on the Signia™ Power Handle for the non-intelligent reloads that are already in the market without an ID chip. Currently, the force gauge is displayed only when an intelligent reload with an ID chip is attached to the Signia™ Stapler. By installing the new software, the force gauge will be displayed consistently for all compatible Covidien reloads. This is a user interface/display change but does not impact how the handle operates.

The FDA 510(k) summary for the Signia™ Stapler with new software (K201672) does not include specific acceptance criteria or an explicit study proving the device meets those criteria in the way typically found for diagnostic algorithms. This submission is for a modification to an existing surgical stapler, primarily focusing on a software update that affects the user interface and display of a force gauge. Therefore, the details requested in your prompt (e.g., sample size for test sets, ground truth establishment, MRMC studies) are not directly applicable or present in this document.

However, I can extract the relevant information regarding the software change and the types of studies performed to demonstrate substantial equivalence.

Here's a breakdown of the available information in the context of your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for the software change in terms of metrics like sensitivity, specificity, or accuracy, which are common for diagnostic AI. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence through verification and performance testing that the software change does not negatively impact safety or effectiveness.

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

The document states: "Non-clinical performance data such as software verification and performance testing have demonstrated substantial equivalence to the predicate device."

• Test set sample size: Not specified. The testing would likely involve internal software verification and validation (V&V) tests, which might use various simulated scenarios or bench test results rather than a "test set" in the sense of clinical data.
• Data provenance: Not explicitly stated as country of origin. Given it's "non-clinical performance data" and "software verification and performance testing," it would be internal engineering and quality testing rather than retrospective or prospective clinical data.

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

• Number of experts: Not applicable/not specified. For software verification and performance testing of a device's functional display, the "ground truth" is typically defined by the device's design specifications and expected behavior, verified by engineers.
• Qualifications of experts: Not applicable/not specified.

4. Adjudication Method for the Test Set

• Adjudication method: Not applicable/not specified. This type of software change would not typically involve expert adjudication in the way clinical diagnostic studies do.

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

• MRMC study: No. The document explicitly states: "Clinical performance data – No clinical study has been performed." This is not a diagnostic AI device requiring comparison with human readers.

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

• This concept is not directly applicable in the terms of a standalone diagnostic algorithm. The software update is for a component of a surgical stapler, which is always used by a human surgeon. The "performance" being evaluated is whether the software correctly displays the force gauge for non-intelligent reloads without affecting the device's core functionality or safety. This is a functional and safety assessment within the device, not a standalone diagnostic output.

7. Type of Ground Truth Used

• Type of ground truth: The "ground truth" for this software modification would be the design specifications and expected functional behavior of the device's display and operation. The verification and performance testing would confirm that the software change aligns with these predefined specifications and does not introduce new safety or effectiveness concerns.

8. Sample Size for the Training Set

• Training set sample size: Not applicable/not specified. As this is a software update for a medical device's user interface, it is likely developed through traditional software engineering processes, not machine learning that requires a "training set" in the AI sense.

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

• Ground truth for training set: Not applicable. (See point 8).

In summary: The FDA 510(k) for the Signia™ Stapler with new software focuses on demonstrating that a software update to extend display functionality does not alter the device's intended use, indications, or fundamental safety and effectiveness profile. The "study" referenced is non-clinical performance and software verification testing, which confirms adherence to design specifications rather than clinical outcomes or diagnostic accuracy comparisons.

Ask a specific question about this device

The Signia™ stapler, when used with the Signia™ circular adapters and Tri-Staple™ 2.0 circular single use reloads, has applications throughout the alimentary tract for the creation of end-to-end, end-to-side, and side-to-side anastomoses in both open and laparoscopic surgeries.

The Signia™ stapler, when used with the Signia™ circular adapters and Tri-Staple™ 2.0 circular single use reloads, is a battery powered microprocessor controlled stapler that provides push-button powered maneuverability and firing of compatible reloads. The Signia™ Stapler is intended to be used by medical professionals qualified in the transportation, cleaning, sterilization, and use of surgical devices. The Signia™ stapler is intended for use in a sterile operating room environment in surgical procedures where surgical stapling is indicated.

The Signia™ circular adapters are reusable instruments that connect with the assembled Signia™ Power Handle and the Signia™ Power Shell to make up the Signia™ stapler. The circular adapters are composed of motor-mating connectors, sensor gauge, and device communications interfaces to provide functionality and communications between compatible reloads and the Signia™ Power Handle. The user can manually rotate the handle in 0, 90, 180 degrees to position the device if required, and the user can fire within these locked and rotated positions. The circular adapters are available in two shaft lengths, standard and extra-long, and both sizes are compatible with the new Tri-Staple™ 2.0 circular reloads.

The Tri-Staple™ 2.0 circular reloads place a circular triple staggered row of titanium staples. After staple formation, the knife blade resects the excess tissue, creating a circular anastomosis such as end-to-end, end-to-side, or side-to-side anastomosis as the user sees fit. The new circular reloads will be offered for a medium/thick tissue thickness range, which is identified by the purple staple guide. The circular reloads deploy three height-progressive rows of 3.0 mm. 3.5 mm and 4.0 mm titanium staples. The Tri-Stable™ 2.0 technology incorporated in the reloads is essentially the same as the legally-marketed predicate K172361 in terms of reload design. The circular reloads are provided sterile for single use, and available in five lumen sizes: 21, 25, 28, 31, and 33 mm. The Tilt-Top™ anvil is available with all circular reloads.

To create a circular anastomosis, the Signia™ Stapler consists of the Signia™ Power Handle, Signia™ Power Shell, Signia™ Circular Adapter, and Tri-Staple™ 2.0 circular reload. The existing system accessories such as Signia™ Reusable Insertion Guide, Signia™ Manual Retraction Tool, Signia™ Single Bay Charger, Signia™ Sterilization Tray (optional), and Signia™ Four-Bay Smart Charger (optional) can be also used.

The provided document is a 510(k) Summary for a medical device (Signia Circular Adapters and Tri-Staple 2.0 Circular Reloads for use with the Signia Stapler). It describes the device, its intended use, and substantial equivalence to a predicate device, supported by non-clinical studies. However, it does not contain a machine learning/AI component or corresponding studies.

Therefore, I cannot extract the information required in the prompt regarding acceptance criteria and studies that prove a device meets those criteria through AI/ML performance. The document focuses on showing substantial equivalence based on engineering and performance tests relevant to a traditional medical device, not an AI-powered one.

If there were a section describing an AI/ML component, I would look for information such as:

• Acceptance Criteria Table: A table outlining specific performance metrics (e.g., sensitivity, specificity, accuracy, F1-score) and their target values.
• Reported Device Performance: The actual measured performance of the AI device against those metrics.
• Sample Size and Data Provenance: Details about the dataset used for testing, including its size, origin (e.g., country, institution), and whether it was prospective or retrospective.
• Ground Truth Experts: The number and qualifications of experts involved in establishing the ground truth labels for the test data.
• Adjudication Method: How disagreements among experts were resolved to establish the final ground truth.
• MRMC Study: Information on multi-reader multi-case studies, including the effect size (improvement in human performance with AI assistance).
• Standalone Performance: Details of any study evaluating the algorithm's performance without human intervention.
• Type of Ground Truth: The method used to determine the true labels (e.g., pathology, long-term follow-up, expert consensus).
• Training Set Sample Size: The amount of data used to train the AI model.
• Training Set Ground Truth: How the ground truth for the training data was established.

Since this information is not present in the provided document, I cannot fulfill the request as it relates to AI/ML device performance.

Ask a specific question about this device

The Signia™ Stapler, when used with Endo GIA™ single-use reloads, Endo GIA™ single-use reloads with Tri-Staple™ Technology, Tri-Staple™ 2.0 single use reloads and Signia™ loading units with Tri-Staple™ 2.0 single-use cartridges, has applications in abdominal, gynecological, pediatric, and thoracic surgery for resection, and creation of anastomosis. It may be used for transection of liver substance, hepatic vasculature, and biliary structures and for transection and resection of the pancreas.

The Signia™ Stapler, when used with Endo GIA™ curved tip single use reloads or Tri-Staple™ 2.0 curved tip single-use reloads, can be used to blunt dissect or separate target tissue from other certain tissue.

The Signia™ Stapler, when used with Endo GIA™ single use Radial Reloads 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 the pancreas.

The Signia™ Stapler, when used with Endo GIA™ single use reinforced reloads with Tri-Staple™ Technology preloaded with polyglycolic acid staple line reinforcement or Tri Staple™ 2.0 single use reinforced reloaded with polyglycolic acid staple line reinforcement, has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection of tissue and creation of anastomosis. It may be used for transection of liver substance, hepatic vasculature and biliary structures, and for transection and resection of the pancreas.

The Signia™ Stapler is a battery powered microprocessor controlled surgical stapler that provides push-button powered maneuverability and firing of compatible Covidien stapling reloads. The Signia™ Stapler is compatible with Endo GJA™ single-use reloads, Endo GIA™ single-use reloads with Tri-Staple™ Technology, Tri-Staple™ 2.0 single use reloads, and Signia™ loading units with Tri-Staple™ Otape - roomnology, The Signia™ Stapler when used with the abovementioned family of Endo GIA™ reloads is a surgical device for stapling and cutting tissues. The Signia™ Stapler is intended to be used by medical professionals qualified in the transportation, preparation, cleaning, sterilization, and use of surgical devices. All of which stay unchanged when compared to the predicate device.

The Signia™ Stapler is composed of the Signia™ Power Handle, Signia™ Power Shell, and Signia™ The Signia - System accessories include the Signia™ Reusable Insertion Guide, Signia™ Manual Retraction Tool, Signia™ Single Bay Charger, Signia™ Sterilization Tray, and this submission introduces a new accessory, Signia™ Four-Bay Smart Charger. The Smart Charger's primary purpose introduces a new as the Signia Single-Bay Charger in K160176, but the difference is that Smart Charger offers enhanced features such as four charging stations, a touch-screen LCD display, and data management interface in order to improve user convenience.

This document describes a 510(k) premarket notification for a medical device: the Signia™ Four-Bay Smart Charger, an accessory to the Signia™ Stapler. The submission aims to demonstrate substantial equivalence to a legally marketed predicate device.

Crucially, this document explicitly states that no clinical study has been performed to demonstrate performance of the device itself. The substantial equivalence is based on non-clinical studies. Therefore, it is not possible to provide information on acceptance criteria and a study proving device performance as requested, because such a study was explicitly stated as not performed.

The document focuses on the safety and technological characteristics of the charger accessory and its equivalence to a prior charger, not on clinical performance of the stapler system which it charges.

Here's why the requested information cannot be extracted from the provided text:

• No Clinical Performance Data: The statement "Clinical performance data -- No clinical study has been performed. The substantial equivalence has been demonstrated by non-clinical studies" directly contradicts the premise of the questions regarding device performance, acceptance criteria, and study details.
• Focus on Charger, Not Stapler: The device under review (Signia™ Four-Bay Smart Charger) is an accessory to the Signia™ Stapler. The 510(k) submission focuses on the charger's safety and features (e.g., four charging stations, touchscreen, data management) as substantially equivalent to an existing charger, not on the clinical performance of the stapler itself in surgical procedures.
• "Acceptance Criteria" for a Charger: While there are non-clinical acceptance criteria mentioned for the charger (Software V&V, Electrical Safety, EMC Testing, Usability Evaluation), these are engineering and regulatory compliance criteria, not clinical performance metrics tied to patient outcomes or diagnostic accuracy. They do not involve "device performance" in the sense of a medical outcome.

Therefore, I cannot fulfill your request for specific details on "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of clinical performance, as the document clearly states no such clinical study was done for this submission.

The information provided is specific to the regulatory approval process for an accessory and its non-clinical testing.

Ask a specific question about this device