Search Results

The Cortical Fixation Systems are used for fixation of tendons and ligaments during orthopedic reconstruction procedures such as anterior cruciate ligament (ACL) reconstruction.

The Cortical Fixation Systems are available in two (2) models. The first one is the Cortical Fixation System (cortical button with fixed length loop). The second model is the Adjustable Cortical Fixation System (cortical button with adjustable length loop). These devices can be used with an Extended Plate which allows a larger surface of contact with the cortical bone. These products are anchor devices with titanium cortical button and are intended to be used as a soft tissue to bone fixation, especially for the ACL repair. The graft is passed through the loop and the titanium button ensures the tensioning and the fixation of the system.

The provided text describes the 510(k) summary for the Cousin Biotech Cortical Fixation Systems, which are used for fixation of tendons and ligaments during orthopedic reconstruction procedures such as anterior cruciate ligament (ACL) reconstruction. However, it does not contain a specific study that proves the device meets particular acceptance criteria in terms of clinical performance or diagnostic accuracy. Instead, it details the design verification and validation activities performed to ensure the device is safe, effective, and performs as intended, and that it is substantially equivalent to predicate devices.

The acceptance criteria described are largely related to manufacturing, sterility, biocompatibility, and mechanical performance, rather than clinical efficacy as might be found in a study for an AI/CAD product.

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

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)

This document describes a 510(k) submission for a medical device (surgical implant), not an AI/CAD system. Therefore, the concept of a "test set" in the context of diagnostic performance or AI algorithm evaluation is not applicable here. The performance testing refers to bench testing of the physical device, sterilization validation, shelf-life studies, and biocompatibility assessments. These types of tests do not typically involve patient "test sets" or data provenance in the way an AI study would.

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

Not applicable for this type of device and study. The "ground truth" for these tests would be the established scientific and regulatory standards themselves (e.g., a specific sterility assurance level, a validated packaging seal strength, or a measured material property).

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

Not applicable for this type of device and study. Adjudication methods are typically used in clinical trials or diagnostic studies where expert consensus is needed to establish a definitive diagnosis or outcome.

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 surgical device, not a diagnostic imaging or AI assistance system, so MRMC studies are not relevant.

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

Not applicable. This is a physical surgical device.

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

The "ground truth" for the verification and validation (V&V) activities described are the published national and international standards (e.g., ISO, ASTM, IEC) for sterilization, biocompatibility, packaging, and material properties, as well as the predetermined technical specifications of the device itself. These are objective engineering and scientific benchmarks, not clinical "ground truth" in the diagnostic sense.

8. The sample size for the training set

Not applicable. This is a physical surgical device, not an AI system that requires a "training set."

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

Not applicable. As above, this is a physical medical device.

Ask a specific question about this device

The ResCUBE System is a temporary implant for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and in the repair of bone fractures. The indications for use include the following applications:

1. Spinal trauma surgery, that can be treated with sublaminar, interspinous or facet wiring techniques.
2. Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as scoliosis, kyphosis and spondylolisthesis.
3. Spinal degenerative surgery, as an adjunct to spinal fusions.

The ResCUBE™ Ligament Fixation System (ResCUBE System) is a temporary spinal implant intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The ResCUBE System consists of the following components: a ligament allowing correction and stabilization of the levels, after tensioning; a malleable leader allowing guidance of the ligament during surgery and attached to the ligament by a PET sheath; and a low-profile connector holding the tension on the ligament.

The provided text is a 510(k) Summary for the ResCUBE™ Ligament Fixation System. It details information typically provided to the FDA for medical device clearance. However, it does not contain the specific type of acceptance criteria and study data related to AI/algorithm performance that you are asking for.

The document discusses performance testing for the ResCUBE System, but this refers to physical bench testing of the device's mechanical properties, not the performance of an AI or algorithmic component.

Therefore, most of the information requested in your prompt regarding acceptance criteria for AI, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, cannot be extracted from this document, as it appears the ResCUBE™ Ligament Fixation System is a physical medical implant, not an AI-powered device.

Here's what can be extracted based on the document's content:

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

2. Sample sized 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 as the testing refers to physical device performance and not data-driven AI performance.

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 provided as the ground truth for physical device testing is typically based on engineering specifications and direct measurements, not expert consensus on interpretations of data.

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

This information is not provided. This concept generally applies to human review of data, which is not the focus of this device's performance testing.

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

A MRMC study was not done, as this device is a physical implant and does not involve AI assistance for human readers.

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

This information is not applicable as the device is not an algorithm.

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

The ground truth for the performance testing mentioned (static and dynamic tension testing) is likely based on engineering specifications and direct physical measurements against established standards (IEC 62366: 2007, ISO 14630: 2012) and the manufacturer's own predetermined specifications.

8. The sample size for the training set

This information is not applicable as there is no training set for a physical implant device without AI components.

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

This information is not applicable as there is no training set for a physical implant device without AI components.

Ask a specific question about this device

The NAJA System is a temporary implant for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications:

1. Spinal trauma surgery, used in sublaminar or facet wiring techniques.
2. Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, kyphosis and spondylolisthesis.
3. Spinal degenerative surgery, as an adjunct to spinal fusions.
   The NAJA System may also be used in conjunction with other medical grade implants made of titanium or cobalt chrome alloy whenever "wiring" may help secure the attachment of the other implants.

The NAJA™ Ligament Correction System (NAJA System) is a temporary implant intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The NAJA implant consists of a titanium alloy connector and a polyethylene terephthalate (PET) woven band. The NAJA System allows the spine to be secured to a rod construct without the use of a bone screw, and acts as an alternative to sublaminar wires and hooks.

This document is a 510(k) Premarket Notification from the FDA regarding Cousin Biotech S.A.S.'s NAJATM Ligament Correction System. It details the device, its intended use, a comparison to predicate devices, and the performance testing conducted to demonstrate substantial equivalence.

Here's an analysis of the provided information concerning acceptance criteria and the study proving the device meets them:

Overall Summary:
The NAJA™ Ligament Correction System is a temporary implant used in orthopedic surgery for stabilization and aid in fracture repair. The submission focuses on demonstrating "substantial equivalence" to existing predicate devices (K110348 - Zimmer Spine - Universal Clamp Spinal Fixation System and K922952 - Pioneer Surgical Technology - Songer Cable System) rather than proving de novo clinical effectiveness through large-scale human outcome studies. The performance testing is primarily bench-top (mechanical) and compliance with relevant ISO standards for sterilization, biocompatibility, and packaging. This is typical for Class II devices seeking 510(k) clearance, where substantial equivalence to a legally marketed predicate can be demonstrated through non-clinical data.

Key Findings Related to Acceptance Criteria and Study Proof:

1. Table of acceptance criteria and reported device performance:

   Acceptance Criteria/Study Area	Standard/Criteria	Reported Device Performance/Findings
   Packaging Shelf Life	ISO 11607-1: 2006 (Packaging for terminally sterilized medical devices – Part 1: requirements for materials, sterile barrier systems and packaging systems) & ISO 11607-2: 2006 (Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes).	"Validation results indicate that the packaging for the NAJA System complies with the standards."
   Biocompatibility	ISO 10993-1: 2009 (Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process).	"Verification results indicated that the NAJA System patient contact materials comply with the standard."
   Mechanical Performance (Bench Testing)	Static and dynamic band tension testing. Static axial grip and static torsional grip testing per ASTM F1798-13. Dynamic axial compression testing per ASTM F1717-15.	"Test results demonstrate that the NAJA System has substantially equivalent mechanical performance as compared to the predicates listed." (Specific numerical results are not provided in this summary, but the conclusion of equivalence is stated.)
   Sterilization Assurance Level (SAL)	Sterility assurance level of 10-6. ISO 11137-1: 2006, Am1: 2013 (Sterilization of health care products – Requirements for validation and routine control – Radiation sterilization) & ISO 11137-2: 2013 (Sterilization of health care products Radiation – Part 2: Establishing the sterilization dose).	"Validation results indicate that the NAJA System complies with the standards" for gamma radiation sterilization to a SAL of 10^-6.
   Substantial Equivalence (Overall Conclusion)	The device is as safe and as effective as the predicate devices.	"The results of these activities demonstrate that NAJA System is as safe and as effective as the predicate devices. Therefore, the NAJA System is considered substantially equivalent to the predicate devices." (This is the overarching "acceptance criterion" for 510(k) clearance, deemed met by the sum of the other tests.)

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

   • Test Set Sample Size: The document does not specify exact sample sizes for the mechanical tests (e.g., how many devices or test specimens were tested for ASTM F1798-13 or F1717-15). It states "The following mechanical tests were performed..." but doesn't quantify the number of units tested. For the sterilization and biocompatibility, testing is typically performed on representative samples of the device or its materials as per the specific ISO standards.
   • Data Provenance: The studies were conducted by the manufacturer, Cousin Biotech S.A.S., located in Wervicq-Sud, France. The data appears to be prospective in nature, as it's generated specifically for the regulatory submission to demonstrate compliance with standards for a new device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   This section is not applicable in the context of this 510(k) submission. This is a medical device (hardware) and not an AI/software device requiring human expert consensus for "ground truth" establishment on medical images or clinical outcomes. The "ground truth" for this device's performance is established by objective, verifiable engineering standards and laboratory measurements (e.g., tensile strength, biocompatibility assays, sterilization efficacy).

4. Adjudication method for the test set:
   This section is not applicable. Since the testing is bench-top and objective (mechanical properties, chemical properties, microbiological sterility), there is no human interpretation or subjective assessment that would require an adjudication method. The results are typically quantitative measurements compared against predetermined acceptance limits derived from the relevant standards.

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 section is not applicable. The NAJATM Ligament Correction System is a physical implant, not an AI or imaging diagnostic device. Therefore, MRMC studies involving human readers are irrelevant to its performance assessment as described here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   This section is not applicable. As stated above, this is a physical medical device, not an algorithm or software. Standalone performance as typically defined for AI/software devices is not relevant. The "standalone performance" of this device is its mechanical properties and biological inertness as demonstrated by the bench tests.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   The "ground truth" for this device's performance is defined by:

   • Engineering Standards: Predetermined, scientifically established performance specifications and testing methodologies outlined in ISO and ASTM standards (e.g., ISO 11607, ISO 10993, ISO 11137, ASTM F1798, ASTM F1717).
   • Physical Measurements: Test results (e.g., force, torque, sterility culture results, chemical analysis) demonstrating compliance with the quantitative and qualitative requirements of these standards.
   • Comparison to Predicates: The ultimate "ground truth" for substantial equivalence in a 510(k) is that the device performs as safely and effectively as legally marketed predicate devices, which is demonstrated through a combination of engineering comparisons and the aforementioned bench testing.

8. The sample size for the training set:
   This section is not applicable. As a physical medical device, there is no "training set" in the machine learning sense. The device's design and manufacturing processes are developed through traditional engineering principles, not machine learning.

9. How the ground truth for the training set was established:
   This section is not applicable for the same reasons as #8.

Ask a specific question about this device

PREMIUM are surgical meshes that are indicated for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

PREMIUM medical devices are surgical meshes with light polypropylene. They are non resorbable parietal reinforcement implants.

The provided document describes a 510(k) premarket notification for a medical device called "PREMIUM", which is a surgical mesh. The document details the device's characteristics, intended use, and a summary of performance data to demonstrate substantial equivalence to a legally marketed predicate device.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria in a table format. Instead, it refers to conformance with a special control "Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh." The reported device performance is that it "conforms to the special control" and the testing "demonstrates that PREMIUM is as safe, as effective, and performs as safety and effectively as its predicate devices."

The specific tests performed are listed, with the implicit acceptance being that the results are comparable or equivalent to the predicate device.

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

The document states: "No clinical data has been presented." This means that the testing was non-clinical. Therefore, there is no test set in the sense of patient data. The "test set" likely refers to the samples of the PREMIUM surgical mesh used for the physical and mechanical property testing.

• Sample Size: Not specified for each test (Tensile strength, Stiffness, etc.).
• Data Provenance: Not applicable as no clinical data was used. The testing was laboratory-based, likely performed by the manufacturer (Cousin Biotech).

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

Not applicable. Since "No clinical data has been presented," there was no need for experts to establish ground truth on a patient test set. The ground truth for the non-clinical performance tests would be established by validated test methods and reference standards, interpreted by engineers or technicians.

4. Adjudication Method for the Test Set

Not applicable. As no clinical data was used, there was no need for an adjudication method by medical experts for a test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This device is a surgical mesh, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human reader performance with or without AI assistance is irrelevant and was not conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

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

7. The Type of Ground Truth Used

The ground truth used for this non-clinical submission is based on physical and mechanical property measurements of the device (PREMIUM surgical mesh samples). The performance is compared against the known properties and established safety/effectiveness profile of the predicate device (PROLENE SOFT), which presumably has its own performance data and regulatory history. The "acceptance criteria" are implied by conformance to a specific FDA guidance document for surgical meshes, which outlines the required non-clinical tests.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI or machine learning model. Therefore, there is no "training set" in the context of data used to train an algorithm. The "training" for the manufacturing process would refer to quality control and process validation, which is not detailed here.

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

Not applicable, as there is no training set for an algorithm.

Ask a specific question about this device

BIOMESH® CA.B.S.'Air® Composite is intended for use in all forms of hernia repair requiring reinforcement with nonabsorbable support material.

BIOMESH® CA.B.S.'Air® Composite medical devices are parietal prosthesis with inflatable expansion balloon and fixation threads.

The provided text is a 510(k) summary for the BIOMESH® CA.B.S.'Air® Composite device. It states the purpose of the submission is to demonstrate substantial equivalence to predicate devices. However, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or effectiveness studies (MRMC or standalone).

The relevant section, "Performance data," simply states: "BIOMESH® CA.B.S.'Air® Composite conforms to the special control 'Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh'." This indicates that the device met the general requirements for surgical mesh, but no specific performance metrics or studies are detailed in the provided text.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance: This information is not present.
2. Sample sized used for the test set and the data provenance: This information is not present.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present.
4. Adjudication method for the test set: This information is not present.
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 present, and the device described is a surgical mesh, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This information is not present, and the device described is a surgical mesh, not an AI diagnostic tool.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): This information is not present.
8. The sample size for the training set: This information is not present.
9. How the ground truth for the training set was established: This information is not present.

Ask a specific question about this device

Ask a specific question about this device