Search Results

The ETHICON™ Total Energy System is intended to supply energy to surgical devices.
The ETHICON™ Total Energy System is an electrosurgical generator that provides power to monopolar, bipolar, and ultrasonic surgical instruments. It is indicated for surgical procedures requiring cutting or coagulation of soft tissue.

The subject device, The ETHICON™ Total Energy System, is an electrosurgical generator that integrates Advanced Energy (Advanced Bipolar and Ultrasonic) and Core Monopolar and Bipolar energy modalities into one system, the Ethicon Total Energy System. The subject device consists of two modules: the Communications Module (ETHCM and ETHUSC) and the Energy Module (ETHEM). Atop the Energy Module is the Communications Module and the User Screen. The Communications Module contains the power button and speakers, connects to the User Screen, distributes power to the system, and provides external interfaces for other connectivity to external devices including Ethernet and USB. One or two Energy Modules can be connected to the Communications Module. When two Energy Modules are connected, each Energy Module can independently power any of the energy modalities. This feature allows for simultaneous use of two surgical instruments in one system to support complex surgical procedures where two surgeons are operating on a patient at the same time. The User Screen features a touch-operable graphical user interface (GUI) for system settings adjustment, user profile management, and alarm troubleshooting. The ETHICON™ Total Energy System accessories include a cart for system transport, footswitches (single, double, round), and an output verification key. The cart provides a mobile platform with adjustable shelves and accessory storage. Additionally, the cart has custom features to create stability for the system including cut-outs on the top shelf for holding the rubber feet of a second module layers. Casters provide 360° mobility with locking tabs that lock to prevent unwanted cart movement. Footswitches may be used to control power delivery to connected instruments, enabling surgeons to activate the energy output hands-free. The different footswitches can be used for various energy modalities and instruments. Up to four footswitches can be connected to the Communications Module of the Ethicon Total Energy System at the same time. The footswitches are assigned to the desired instrument port via the User Screen GUI. Output Verification is a service mode of the system used to periodically confirm that the power outputs of each energy modality are within the required specifications. The Energy Output Verification Key is used by biomed/hospital facility servicing personnel to complete this process for annual maintenance on the Energy Module, with on-screen guidance to assist in this process. The ETHICON™ Total Energy System is compatible with Ethicon HARMONIC™, Ethicon ENSEAL™, and Ethicon MEGADYNE™ monopolar and bipolar instruments.

The provided FDA 510(k) summary for "The ETHICON™ Total Energy System" does not contain the specific details regarding acceptance criteria and the comprehensive study results typically found in a full scientific report.

However, based on the information provided, I can infer the general nature of the acceptance criteria and the studies performed, and explain what is missing from a complete answer regarding detailed acceptance criteria and proof of meeting them:

General Conclusion from the Document:
The FDA 510(k) summary states, "The subject device showed either equivalent or improved performance compared to the predicate devices and met all functional requirements of its features. It successfully met the acceptance criteria for bench testing, animal studies, usability, and electrical testing, demonstrating no new safety or effectiveness issues compared to the predicate."

This indicates that acceptance criteria were established and met for various aspects, but the specific, quantifiable criteria and the detailed results proving they were met are not explicitly listed in the provided text.

Here's an attempt to answer your request based on the available information, highlighting what is present and what is absent:

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

Missing Information: The document states that the device "met the acceptance criteria for bench testing, animal studies, usability, and electrical testing" and "demonstrated equivalent output, stability, and thermal spread control" compared to predicates. However, specific quantitative acceptance criteria and their corresponding reported device performance values are not provided in this 510(k) summary. For example, it doesn't state "Acceptance Criterion: Vessel burst pressure > X mmHg, Reported Performance: Y mmHg."

To illustrate what would be in such a table, based on the mentioned tests:

Ask a specific question about this device

The reprocessed Monarch Bronchoscope, used in conjunction with the Monarch Platform, is intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.

The 4x reprocessed Monarch Bronchoscope. MBR-000211-B. (hereafter referred to as "Proposed Device") is similar to the 2x reprocessed Monarch Bronchoscope, MBR-000211-B, (hereafter referred to as "Predicate Device").

The Original Monarch Bronchoscope. MBR-000211-A. (hereafter referred to as "Co-Predicate Device") cleared under K193534 is identical to the 2x reprocessed Monarch Bronchoscope ("Predicate Device"), cleared under K203614.

Both device designs are controlled by Auris Health, Inc., throughout their total product lifecycle.

The Monarch Bronchoscope is a component of, and must be used with, the Monarch Platform, cleared under K193534. The Monarch Bronchoscope is connected to the robotic arms of the Monarch Platform to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures. The Proposed Device is a reprocessed single-use device that is either discarded or returned to Auris for reprocessing after clinical use. The original singleuse Monarch Bronchoscope was cleared for one clinical use under K193534. The reprocessed single-use (rSUD) Monarch Bronchoscope was cleared for two (2) clinical uses under K203614. This premarket notification intends to gain market clearance for a reprocessed single-use (rSUD) Monarch Bronchoscope that can be reprocessed up to three (3) times, for a total of four (4) clinical uses.

Identical to the Predicate Device, the Reprocessed Monarch Bronchoscope, consisting of the Inner Scope ("scope") and the Outer Sheath ("sheath"), has 4-way articulation controlled by continuous, direct, visual control of the physician using the Monarch Platform. The Proposed Device contains a working channel through which biopsy devices, or other working channel instruments, may be introduced. The distal tip of the Proposed Device has a camera control unit (CCU) that collects live images that are then transmitted to the physician's display interface of the Monarch Platform. The camera transmits vision data to the Monarch Tower through the camera cable. The single-use, manually controlled, working channel instruments compatible with the Proposed Device are identical to the working channel instruments compatible with the Predicate Device.

The provided text describes the regulatory clearance of a reprocessed medical device, the Monarch Bronchoscope, and its performance testing to demonstrate substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria for a diagnostic algorithm, nor does it detail a study that proves a device meets such criteria in terms of diagnostic performance (e.g., sensitivity, specificity).

The document is a 510(k) premarket notification letter from the FDA, confirming clearance for the "4x reprocessed Monarch Bronchoscope" (meaning it can be reprocessed up to three times for a total of four clinical uses). The performance testing described focuses on the physical and functional integrity of the reprocessed device, not on diagnostic accuracy of an algorithm or an AI component.

Therefore, many of the requested items (e.g., acceptance criteria for diagnostic performance, sample sizes for test/training sets, expert qualifications, MRMC studies, standalone algorithm performance, type of ground truth) are not applicable or cannot be extracted from this document.

Here's an attempt to answer the questions based only on the provided text, highlighting where information is absent or not relevant to diagnostic algorithm validation:

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

The document provides a list of performance tests conducted for the reprocessed bronchoscope, with "Pass" as the result, indicating that the device met internal design specifications and applicable standards for safe and effective reprocessing. These are functional and safety-related criteria for the physical device, not diagnostic performance metrics.

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 performance tests refer to "worst case device conditioning" but do not specify the number of devices or clinical cases used in these tests. The data provenance is not mentioned.

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 the type of device and testing described. The document pertains to the reprocessing of a physical bronchoscope, not a diagnostic algorithm requiring expert ground truth for image interpretation or diagnosis.

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

This information is not applicable to the type of device and testing described. Adjudication methods are typically relevant for human-in-the-loop or diagnostic studies, which are not detailed here.

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 to the type of device and testing described. The document does not mention an AI component or any MRMC studies.

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

This information is not applicable to the type of device and testing described. The Monarch Bronchoscope is a physical device; there is no mention of a standalone algorithm.

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

This information is not applicable in the context of diagnostic performance. For the safety and functional tests performed, the "ground truth" would be the established engineering and biological standards and specifications the device aims to meet (e.g., sterility, electrical safety, cleaning effectiveness).

8. The sample size for the training set

This information is not provided and is not applicable as there is no mention of an algorithm or machine learning model being developed or trained.

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

This information is not applicable as there is no mention of algorithmic training or ground truth for such a purpose.

Ask a specific question about this device

The Reprocessed PENTARAY® NAV eco High-Density Mapping Catheter is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart. The Reprocessed PENTARAY® NAV eco High-Density Mapping Catheter provides location information when used with compatible CARTO™ 3 EP Navigation Systems. This catheter is not compatible with CARTO™ 3 EP Navigation Systems prior to Version 3.x.

The Reprocessed PENTARAY® NAV eco High-Density Mapping Catheter is designed to facilitate electrophysiological mapping of the heart with the CARTO® 3 EP Navigation System. It is designed for deployment in a heart chamber through an 8 Fr guiding sheath. This deflectable catheter consists of multiple 3 Fr spines on the distal tip, each spine having multiple platinum electrodes that are used for stimulation and recording. A magnetic location sensor embedded in the deflectable tip transmits location information to the CARTO® 3 EP Navigation System. The catheter has two electrodes on the deflectable tip to provide for visualization of the tip when used with the CARTO® 3 EP Navigation System. Pushing forward on the catheter thumb knob deflects the tip; pulling back on the thumb knob straightens the tip. This catheter includes an irrigation lumen for connection to a source of continuous drip anticoagulant fluid.

The provided text describes the 510(k) summary for the Reprocessed PENTARAY® NAV eco High-Density Mapping Catheter. This document outlines the device's characteristics and the non-clinical tests performed to demonstrate its substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this medical device are implicitly derived from demonstrating substantial equivalence to the predicate device, the original PENTARAY® NAV eco High-Density Mapping Catheter (Biosense Webster K123837). The tests performed cover various functional, safety, and manufacturing aspects to ensure the reprocessed device performs as intended and is safe for use.

Ask a specific question about this device

The reprocessed Monarch Bronchoscope, used in conjunction with the Monarch Platform, is intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.

The reprocessed Monarch Bronchoscope, MBR-000211-B, (hereafter referred to as "Proposed Device") is identical to the Original Monarch Bronchoscope, MBR-000211-A, (hereafter referred to as "Predicate Device"), which is a component of, and must be used with, the Monarch Platform, cleared under K193534. The Monarch Bronchoscope is connected to the robotic arms of the Monarch Platform to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures. The Proposed Device is a reprocessed single-use device that can be reprocessed up to one (1) time.

The Monarch Bronchoscope, consisting of the Inner Scope ("scope") and the Outer Sheath ("sheath"), has 4-way articulation controlled by continuous, direct, visual control of the physician using the Monarch Platform. The Proposed Device contains a working channel through which biopsy devices, or other working channel instruments, may be introduced. The distal tip of the Proposed Device has a camera control unit (CCU) that collects live images that are then transmitted to the physician's display interface of the Monarch Platform. The camera transmits vision data to the Monarch Tower through the camera cable. The single-use, manually controlled, working channel instruments compatible with the Proposed Device are identical to the working channel instruments compatible with the predicate Monarch Platform bronchoscope.

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The document implies the acceptance criteria through the description of the tests and the "Pass" results. Specific numerical or qualitative thresholds for "Pass" are not detailed in the provided text.

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

The document does not explicitly state the numerical sample size used for the test set for each performance test. It mentions "worst case device conditioning" for several tests, implying that specific devices were subjected to these conditions.

Regarding data provenance:

• Country of Origin: Not specified in the provided text.
• Retrospective or Prospective: Not explicitly stated. Given the nature of performance testing for reprocessing validation, it would typically involve prospective testing of reprocessed devices.

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

This information is not provided in the given text. The tests described are primarily engineering and safety validation tests (cleaning, functional, electrical, biocompatibility, sterilization) rather than clinical studies requiring expert interpretation of results to establish ground truth in a diagnostic context.

4. Adjudication Method for the Test Set:

This information is not provided in the given text. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., image reading) where disagreement needs resolution. The described tests are objective performance tests which would not typically involve such adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or described in the provided document. The submission focuses on demonstrating the safety and effectiveness of a reprocessed bronchoscope compared to its original form, primarily through laboratory and performance testing, not direct comparative clinical effectiveness with human readers.

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

This question is not applicable to the device described. The Monarch Bronchoscope is a physical medical device, specifically a reprocessed bronchoscope, not an algorithm or AI system. Therefore, the concept of "standalone performance" in the context of an algorithm does not apply. The performance tests described (cleaning, functional, electrical, biocompatibility, sterilization) are evaluations of the hardware itself.

7. The Type of Ground Truth Used:

The "ground truth" for the performance tests is established by:

• Engineering Specifications/Design Requirements: Functional and system compatibility tests verify performance against the original design.
• International Standards: Compliance with standards like AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-18 for electrical safety and EMC, ISO 10993-1:2018 for biocompatibility, and ISO 11135:2018 for sterilization.
• Validated Processes: For cleaning and sterilization, the ground truth is established by the successful validation of the reprocessing protocol itself, ensuring devices meet specified cleanliness and sterility levels (e.g., SAL of 10-6).

8. The Sample Size for the Training Set:

This information is not applicable as the device is a reprocessed physical instrument, not an AI/ML algorithm that requires a "training set."

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

This information is not applicable as the device is a reprocessed physical instrument, not an AI/ML algorithm.

Ask a specific question about this device

Ask a specific question about this device

These Systems are intended for the following:

Hooks, Plate/Rods, Plates, Rods and Screws

When intended to provide stabilization as an adjunct to fusion of the cervical junction (occipitocervical junction (occiput-T3), the plate/rod, plates, rod, hook and screw (3.2 mm cortex) components of the Synthes CerviFix, Axon, OC Fusion and Synapse Systems are indicated for skeletally mature patients using allograft for the following: · Degenerative Disc Disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)

• · Spondylolisthesis
• · Spinal stenosis
• Fracture/dislocation
• Atlantoaxial fracture with instability
• Occipitocervical dislocation
• · Revision of previous cervical spine surgery
• Tumor

When used to treat these cervical and occipitocervical conditions, screws are limited to occipital fixation only.

Hooks and Rods

The rod and hook components are also intended to provide stabilization to promote fusion following reduction of fracture/ dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

Rods, Clamps, Screws, Nuts, Variable Axis Screws, Locking Screws and Transverse Bars

The rods, clamps, screws, nuts, variable axis screws and transverse bars are intended to promote fusion following reduction of fracture/dislocation or trauma in the upper thoracic spine (T1-T3).

The use of these screws (3.5 mm, 4.0 mm cancellous and 3.5 mm and 4.2 mm cortex) is limited to placement in T1-T3 in treating thoracic conditions only. They are not intended to be placed in or treat conditions involving the cervical spine.

The Synthes CerviFix, Axon, and Synapse Systems can also be linked to the Synthes Universal Spinal System using the 3.5 mm/6.0 mm and 4.0 mm/6.0 mm parallel connectors from that system and via the CerviFix tapered rods using lamina hooks, transverse process hooks, pedicle hooks, 4.2 mm screws, and the 5.0 mm/6.0 mm parallel connector.

The Synthes System can be linked to the DePuy EXPEDIUM 5.5 Titanium Spine System using the 3.5 mm/5.5 mm and 4.0 mm/5.5 mm titanium tapered rods.

Warning: This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic (T4-T12) or lumbar spine.

The tapered rods are intended to create a single construct by linking system components that receive different rod diameters. These rods are manufactured from titaniumaluminum-niobium (Ti-6Al-7Nb (TAN)). These rods taper from a diameter of 3.5 mm or 4.0 mm to a diameter of 5.5 mm and are both 500 mm in length.

The Synthes Synapse System is a hook, rod and pedicle screw spinal system intended to provide posterior stabilization of the upper spine (C1-T3) as an adjunct to fusion in skeletally mature patients. This system consists of multiple components manufactured from either titanium aluminum niobium (Ti-6Al-7Nb (TAN)) or commercially pure grade 4 Titanium and include rods (straight, tapered and curved), plate/rods, hooks, clamps, screws, nuts, variable axis screws, locking screws, transconnector clamps, transverse bars, parallel connectors and variable axis/top loading transconnectors. These system components are implanted using Class I general surgical instruments. A complete occipital-cervical-thoracic construct can be created by using components from the previously cleared Synthes CerviFix System, Synthes Axon System, and Synthes OC Fusion System. When combined with the Synthes Universal Spinal System (including Matrix) using parallel connectors or tapered rods, constructs can extend from the occiput to the lower spine.

This document is a 510(k) premarket notification for the DePuy Synthes Spine's Synapse System. It primarily focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance, rather than conducting a de novo study with acceptance criteria and a specific performance study as one might see for novel AI/ML devices or completely new technologies.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes, and expert adjudication as they would apply to an AI/ML algorithm or a new diagnostic device are not present in this document.

Here's an analysis of what can be extracted and what information is missing based on the provided text:

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

• Acceptance Criteria: Not explicitly defined in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy). The document focuses on demonstrating substantial equivalence to predicate devices. This means the "acceptance criteria" are generally that the device performs as well as the predicate device and has similar technological characteristics and intended use.
• Reported Device Performance: No specific quantitative performance metrics (e.g., success rates, failure rates, accuracy) are reported for the Synapse System in this document. The "performance" assessment is based on the lack of change from the predicate device and engineering rationale.

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

• Test Set Sample Size: Not applicable/not provided. This document does not describe a clinical study with a "test set" in the context of evaluating a diagnostic or AI/ML algorithm.
• Data Provenance: Not applicable/not provided.

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/not provided. Ground truth establishment by experts for a test set is not described as this is not a study evaluating human reader or algorithm performance on a test set.

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

• Not applicable/not provided. No test set adjudication method is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This document pertains to a spinal fixation system, not an AI-assisted diagnostic tool.
• Effect Size of AI: Not applicable, as no AI component or human reader study is described.

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

• Standalone Performance: No, a standalone performance study as described (algorithm only without human-in-the-loop performance) was not done. This document is not about an algorithm or AI device.

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

• The concept of "ground truth" as it would apply to a diagnostic or AI algorithm study is not applicable here. The document relies on previous testing and validation of the predicate devices and engineering rationale.

8. The sample size for the training set

• Not applicable/not provided. There is no mention of a "training set" as this is not an AI/ML device.

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

• Not applicable/not provided.

Summary of Device and Regulatory Basis:

This 510(k) submission for the Synapse System (incorporating tapered rods) is a request for clearance based on substantial equivalence to predicate devices (Synthes Synapse System, DePuy EXPEDIUM Spine System, and Synthes Matrix Spine System). The core argument for equivalence is:

• Technological Characteristics: The design, material (titanium alloy), and established performance of the tapered rods and other Synapse System components remain unchanged from their previously cleared predicate versions.
• Intended Use: The intended use of the devices also remains unchanged from their predicate versions (as an adjunct to fusion for various spinal conditions in skeletally mature patients, primarily C1-T3).
• Performance Data: Instead of new performance testing, an engineering rationale is provided because the designs and technological characteristics are unchanged and have been "extensively tested in their predicate submissions." The specific modification being addressed is the ability of the Synapse System to link with the DePuy EXPEDIUM 5.5 Titanium Spine System using titanium tapered rods.

In essence, this document is a regulatory filing asserting that because the device is fundamentally the same as previously cleared devices, new comprehensive performance studies (as would be required for a novel device or AI/ML product) are not necessary.

Ask a specific question about this device

Shoulder: Bankart Repair, SLAP Lesion Repair, Capsular Shift or Capsulolabral Reconstruction
Hip: Capsular Repair, Acetabular Labral Repair

The proposed device is a suture-anchor to be used for soft tissue fixation to bone. The Gryphon Anchor is a cannulated, ribbed anchor, made of either non-absorbable PEEK (Polyetheretherketone) or absorbable Biocryl® RapideTM (composite of β-TCP and PLGA copolymer). Size #1 blue Permacord™ suture (UHMWPE braided suture) is preloaded on the anchor. The suture incorporates a pre-tied sliding knot (ProKnot knot). The Permacord suture is a non-absorbable suture that conforms to USP except for oversized diameter. The device is provided as sterile; the device is for single patient use only.

The provided document describes a 510(k) submission for a medical device, the GRYPHON™ ANCHOR w/PROKNOT™ Technology. This submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets new acceptance criteria through a clinical or performance study with a test set, ground truth experts, and MRMC studies as typically seen in AI/Software as a Medical Device (SaMD) submissions.

The "study" in this context is the non-clinical testing performed to show the new device performs similarly to the predicate device.

Here's how to interpret the information based on the provided text, addressing your points where possible, and noting when the information is not applicable to this type of device submission:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (an orthopedic anchor), the "acceptance criteria" are typically related to mechanical performance characteristics that demonstrate equivalence to the predicate.

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

• Sample Size for Test Set: Not explicitly stated. For mechanical testing of medical devices like this, the "sample size" refers to the number of physical anchors and sutures tested. This is typically determined by engineering standards and statistical power calculations to demonstrate a certain level of confidence in the performance. The document only states "Fixation strength testing, suture knot strength testing and suture fray testing were conducted."
• Data Provenance: The testing was "conducted" by DePuy Mitek. The provenance of the "data" itself (e.g., patient data, country of origin, retrospective/prospective) is not applicable here as this is mechanical testing of the device itself, not clinical data from patients.

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

• This is not applicable for this type of device submission. Ground truth, in the context of expert review, is relevant for diagnostic devices or AI/SaMD where human interpretation or clinical outcomes are the gold standard. For an orthopedic anchor, the "truth" is established by physical measurements and engineering specifications, not expert consensus.

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

• Not applicable. Adjudication methods are used in studies involving human interpretation or clinical outcomes to resolve discrepancies in ground truth labeling. For mechanical testing, the "adjudication" is based on objective measurements and established thresholds.

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. MRMC studies are specific to diagnostic imaging devices, particularly those involving AI. This device is a surgical implant (an anchor), not an imaging or diagnostic tool.

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

• Not applicable. This device does not have an algorithm component.

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

• The "ground truth" for this device's performance relies on engineering specifications, standardized test methods (e.g., ASTM standards, USP for sutures), and direct physical measurements (e.g., force required for fixation failure, suture break strength, degree of fraying). The "truth" is objective, measurable, and compared against established performance criteria from the predicate devices.

8. The sample size for the training set

• Not applicable. This device does not involve a "training set" in the context of machine learning. The design and manufacturing processes are established through engineering principles, not data-driven training.

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

• Not applicable. As there is no training set, there is no ground truth to establish for it.

Ask a specific question about this device

The RIGIDLOOP Adjustable Cortical Fixation System is indicated for fixation of soft tissue to bone in Femoral Cruciate Ligament Reconstruction.

The proposed device is a cortical fixation system composed of titanium button, adjustable suture (Ultra-high molecular polyethylene (UHMWPE)), leading suture (UHMWPE and green Polyester (PET) co-braid) and training suture (green PET). Length of the suture loops is adjustable to the desired length. The proposed device provides a fixation in cruciate ligament reconstructive surgery. The device is provided as sterile for single patient use only.

The provided text describes a medical device, the RIGIDLOOP™ Adjustable Cortical Fixation System, and its 510(k) summary for FDA clearance. This document type (510k summary) typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study results with acceptance criteria.

Based on the provided text, the following information can be extracted regarding acceptance criteria and the "study" that proves the device meets them:

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

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. The document only states "Fixation strength testing (bench-top) was conducted." This implies an engineering test, not a clinical study with human subjects.
• Data Provenance: Not specified, but likely laboratory/bench testing data rather than human subject data.

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

• This information is not applicable to the type of testing described. The "ground truth" for bench testing would be measured physical properties, not expert consensus on medical images or clinical outcomes.

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

• This information is not applicable as the described testing is bench-top, not a clinical study requiring adjudication of expert 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:

• This information is not applicable. The RIGIDLOOP™ system is a medical device for orthopedic surgery, not an AI-powered diagnostic or assistive tool. No MRMC study was conducted or is relevant to this device's clearance.

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

• This information is not applicable. The RIGIDLOOP™ system is a physical surgical device, not an algorithm.

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

• For the fixation strength testing, the "ground truth" would be direct physical measurements of load, displacement, and failure points, consistent with engineering and biomechanical bench-top testing standards. For biocompatibility, it would be results from standardized biocompatibility assays.

8. The sample size for the training set:

• This information is not applicable. There is no "training set" as this is not an AI/machine learning device. The "training suture" mentioned in the description is for surgical training, not algorithm training.

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

• This information is not applicable for the same reason as above (not an AI/machine learning device).

Ask a specific question about this device

The Healix Advance Knotless Anchors are indicated for use in the following procedures for reattachment of soft tissue to bone:

Shoulder

Rotator Cuff .
. Biceps Tenodesis

The proposed Healix Advance Knotless Anchor is a one piece implantable cannulated, threaded anchor designed to secure soft tissue to bone. The anchor is provided loaded on a disposable inserter driver device. The proposed anchors will be offered in a 6.5 mm size. The proposed 6.5 mm Healix Advance Knotless PEEK Anchor is manufactured from PEEK (Polyetheretherketone) material.

The DePuy Mitek HEALIX ADVANCE KNOTLESS PEEK ANCHOR (6.5mm) is a medical device designed for reattachment of soft tissue to bone. This submission (K131683) is for a larger version (6.5mm) of previously cleared predicate devices (4.75mm and 5.5mm Healix Advance Knotless PEEK Anchors).

Acceptance Criteria and Device Performance Study:

Since this FDA submission is a Special 510(k) based on substantial equivalence to predicate devices, formal acceptance criteria and a single study proving the device meets them in the traditional sense (e.g., a clinical trial with specific performance endpoints) are not presented in the provided documents. Instead, the submission focuses on demonstrating that the new device has the same design, technological characteristics, and safety/performance profile as the predicate devices, despite the size change.

The "Substantial Equivalence" framework in 510(k) submissions relies on showing that the new device is as safe and effective as a legally marketed predicate device. The "acceptance criteria" here can be inferred as showing that the new device performs equivalently or comparably to the predicate in non-clinical tests relevant to its function.

1. Table of Acceptance Criteria and Reported Device Performance:

Explanation: The "acceptance criteria" are implied by the need to demonstrate substantial equivalence to the predicate devices (4.75mm and 5.5mm Healix Advance Knotless PEEK Anchors). The non-clinical testing performed (Insertion Torque, Torque to Failure, Anchor Pullout) aimed to show that the 6.5mm anchor's mechanical performance is comparable to the predicate devices, thus meeting the "acceptance criteria" for safety and effectiveness in the context of a Special 510(k).

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "Product Design Verification and Design Validation activities," but does not detail the number of samples used for each test (Insertion Torque, Torque to Failure, Anchor Pullout).
• Data Provenance: The testing was "Non-clinical Testing" performed by the manufacturer, DePuy Mitek. The country of origin of the data is not specified, but it would have been generated in a controlled laboratory setting by the company. It is retrospective in the sense that the testing was conducted prior to submission to demonstrate equivalency.

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

• Not applicable in this context. The "ground truth" for non-clinical mechanical testing is derived from the physical properties and performance characteristics of the devices themselves, measured through established engineering and biomechanical methods. No human experts are used to interpret the "ground truth" of these test results; rather, engineers and scientists conduct and analyze the tests against predetermined specifications or predicate performance.

4. Adjudication Method for the Test Set:

• Not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or image-based diagnostic evaluations where human interpretation of outcomes is involved. For non-clinical mechanical testing, results are quantitative and objective, and thus do not require an adjudication process.

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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of images or data (e.g., radiologists reading mammograms with and without AI assistance). The Healix Advance Knotless PEEK Anchor is an implantable surgical device, and its performance is evaluated through biomechanical testing and clinical outcomes, not through human reader interpretation of data.

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

• No, a standalone (algorithm only) study was not done. This type of study is specifically for evaluating the performance of AI algorithms. The device described is a physical surgical implant, not an algorithm.

7. Type of Ground Truth Used:

• The "ground truth" for the non-clinical testing was based on objective, quantitative mechanical measurements (e.g., torque values, force measurements for pullout strength). These measurements establish the intrinsic performance characteristics of the device. The comparison of these measurements to the predicate device's known performance serves as the basis for the substantial equivalence claim.

8. Sample Size for the Training Set:

• Not applicable. This device is a physical product, not an AI/ML algorithm that requires a training set. The concept of a "training set" is relevant to machine learning models.

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

• Not applicable, as there is no training set for this device.

Ask a specific question about this device

ORTHOCORD Suture is indicated for use in general soft tissue approximation, and/or ligation, including orthopaedic procedures.

Orthocord® Suture is a synthetic, sterile, braided, composite suture composed of dyed (D&C Violet #2 or D&C Blue #6) absorbable polydioxanone (PDS) and un-dyed non-absorbable polyethylene. The partially absorbable suture is coated with a copolymer of 90% caprolactone and 10% glycolide.

The provided text does not contain a study or detailed performance data that would allow for a complete answer to your request. The document is a 510(k) summary for a medical device (Small Size Orthocord® Suture) seeking substantial equivalence to previously cleared devices.

Instead of a detailed study with acceptance criteria and performance metrics, it states that:

• "The determination of substantial equivalence for this device was based on a detailed device description, and conformance to consensus and voluntary standards."
• "Non-clinical laboratory testing was performed demonstrating that the device conformed to the USP monograph for absorbable sutures, except for oversized diameter."

This indicates that the device's equivalence and safety/performance were established primarily through comparison to existing predicate devices and adherence to general standards, rather than a novel clinical or non-clinical study with specific acceptance criteria and reported device performance as you've requested for AI/software-based devices.

Therefore, I cannot populate the table or answer most of your detailed questions because the information is not present in the provided text.

However, I can extract the following limited information:

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

2. Sample sized used for the test set and the data provenance: Not applicable. No specific "test set" or data provenance (country of origin, retrospective/prospective) is described for a study 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. Ground truth establishment by experts is not mentioned for this type of submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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 suture, not an AI/imaging diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this device's performance would be its physical and mechanical properties conforming to established standards and predicate device performance, not clinical ground truth in the AI sense.

8. The sample size for the training set: Not applicable.

9. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device