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The R2P Radifocus Glidewire Advantage is designed to direct a catheter to the desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures. This device is not intended for neurovascular or coronary interventions.

The subject device, R2P Radifocus Glidewire Advantage, and the predicate device, Radifocus Glidewire (K152740), are both operated through a manual process. The subject device, R2P Radifocus Glidewire Advantage, and the predicate device, Radifocus Glidewire (K152740), exhibit some differences in design and construction. Terumo has confirmed that these differences don't introduce any new concerns in safety and performance compared to the predicate device.

The provided text is a 510(k) summary for a medical device (guide wire) and does not contain any information about an AI/ML-driven device or study results related to acceptance criteria for such a device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves an AI/ML-driven device meets those criteria based on this document. The document describes traditional performance and biocompatibility testing for a physical medical device.

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Advantage Ultra System and Advantage Fit Ultra System

The mesh implant is intended for use as a suburethral sling for the treatment of female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

The Advantage Ultra System and the Advantage Fit Ultra System delivery devices are intended for use as an aid in insertion, placement, fixation, and anchoring of the Advantage Ultra surgical mesh during urogynecological procedures.

Lynx Ultra System

The mesh implant is intended for use as a suburethral sling for the treatment of female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

The Lynx Ultra System delivery device is intended for use as an aid in insertion, placement, fixation, and anchoring of the Lynx Ultra surgical mesh during urogynecological procedures.

Advantage Ultra System and Advantage Fit Ultra System

The Advantage Ultra System and the Advantage Fit Ultra System are sterile, single-use systems each consisting of one delivery device and one blue mesh assembly. The mesh assembly is comprised of a polypropylene knitted mesh protected by two disposable polymer sleeves, two dilators, and one center tab. The sleeves and dilators are secured to the mesh by two polypropylene leader loops, and the center tab is secured to the mesh by a polyester lead. The two dilators at the distal ends of the mesh assembly are designed to be placed over the needle end of the delivery device.

The Advantage Ultra System and the Advantage Fit Ultra Systems are each packaged with their respective delivery device (Advantage Ultra or Advantage Fit Ultra delivery device). This is a single-use disposable delivery device that consists of a handle with a curved needle and a pusher component. The delivery device is designed to facilitate the passage of the mesh assembly through bodily tissues for retropubic placement.

The Advantage Fit Ultra System includes the same mid-urethral mesh implant as the Advantage Ultra System but differs in the design of the dilators and delivery devices. The needle portion of the Advantage Fit Ultra delivery device has a smaller outer diameter and a smaller bend radius and is offered to provide physicians with surgical options. The Advantage Fit Ultra dilators also have a smaller diameter to accommodate for the different needle size.

Lynx Ultra System

The Lynx Ultra System is a sterile, single-use system consisting of two delivery devices and one blue mesh assembly. The mesh assembly is comprised of a polypropylene knitted mesh protected by two disposable polymer sleeves, two dilators, and one center tab. The sleeves and dilators are secured to the mesh by two polypropylene leader loops, and the center tab is secured to the mesh by a polyester lead. At the distal ends of the mesh assembly there are association loops designed to be placed in the needle slot of the distal end of a delivery device.

This document is a 510(k) summary for the Advantage™ Ultra System, Advantage Fit™ Ultra System, and Lynx™ Ultra System, surgical mesh devices for treating female stress urinary incontinence. The core of this submission is to demonstrate that these devices are substantially equivalent to previously cleared predicate devices (K211223). The primary change in these new submissions is related to procedural steps in the electronic Instructions for Use (eIFU), specifically regarding the release and removal of disposable components of the mesh assembly.

Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context are focused on ensuring that the changes (eIFU modifications) do not negatively impact safety or effectiveness, and that the device remains substantially equivalent to its predicate. There isn't a traditional performance study proving clinical efficacy against a disease endpoint, as this is a 510(k) submission for substantial equivalence.

Here's an interpretation of your request based on the provided document:

Acceptance Criteria and Device Performance (in the context of a 510(k) for eIFU changes)

Since the document explicitly states "there are no changes to the intended use or indications for use, design, materials, sterilization, technological and performance characteristics, or principle of operation," the acceptance criteria are implicitly tied to demonstrating that the eIFU modifications do not introduce new safety or effectiveness concerns and allow the device to function as intended.

Table of Acceptance Criteria and Reported Device Performance

Study Details

The studies performed are "Performance bench testing" in the form of "Design Validation" and a "Summative Usability Evaluation."

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

   • Test Set Sample Size: The document does not specify the exact number of participants (users) or instances for the "Design Validation" and "Summative Usability Evaluation." It refers generally to "performance bench testing."
   • Data Provenance: Not specified, but "bench testing" typically implies laboratory or simulated environments, not patient data.

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

   • Not applicable in the sense of clinical "ground truth" (e.g., pathology, outcomes). The "ground truth" here is the successful and safe use of the device according to the eIFU. The design validation and usability studies themselves aim to verify this by testing user interaction and performance. The document does not specify the number or qualifications of evaluators/experts involved in conducting or assessing these bench tests.

3. Adjudication method for the test set:

   • Not explicitly stated. For bench testing and usability studies, adjudication might involve expert review of test results, error analysis, and user feedback, but no specific method like "2+1" or "3+1" is mentioned.

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

   • Not applicable. This is not an AI/imaging device. The study type is bench testing and usability evaluation for a surgical mesh delivery system with modified instructions for use.

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

   • Not applicable. This is a medical device (surgical mesh and delivery system), not an algorithm.

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

   • The "ground truth" for this submission's studies is the successful and safe operation of the device according to the updated eIFUs. This is assessed via controlled testing environments (bench testing) and usability studies, rather than clinical endpoints, pathology, or outcomes data, as this 510(k) specifically addresses changes to the instructions for use, not the fundamental device design or clinical performance.

7. The sample size for the training set:

   • Not applicable. This is not a machine learning/AI device, so there is no "training set."

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

   • Not applicable (as above).

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APOLLO ADVANTAGE Nitrile Examination Gloves are disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.

APOLLO ADVANTAGE Nitrile Examination Gloves are made of Nitrile rubber and are blue in color. The design of proposed device is addressing the standards as ASTM D6124, ASTM D5151 and ASTM D6319. The proposed device is non-sterile and powder free.

This document is primarily concerned with the 510(k) premarket notification for APOLLO ADVANTAGE Nitrile Examination Gloves, asserting its substantial equivalence to a predicate device. It details acceptance criteria and performance data for various physical and biocompatibility characteristics of the gloves.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

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The Advantage Lumbar System - ALIF, PLIF, TLIF is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who had six months of nonoperative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

The Advantage Lumbar – ALIF, PLIF, TLIF's implants are interbody fusion devices intended for use as an aid in spinal fixation. These hollow, rectangular implants are offered in a variety of widths, lengths, heights, and lordotic angles designed to adapt to a variety of patient anatomies. They have serrations on the superior and inferior surfaces designed for fixation, ergonomically shaped anterior edges, and flat posterior edges. Radiopaque markers have been embedded within the implants, which are designed to allow for visualization in radiographic images.

The provided document is a 510(k) summary for the Intelivation LLC's Advantage Lumbar System, which is an intervertebral body fusion device. The document explicitly states that no performance testing was required for this device.

The rationale provided is that the "subject and predicate devices are identical and therefore, no performance testing is required. Submission is only transferring names of systems that have already been cleared under K121567 and K131981."

Therefore, based on the provided text, it is not possible to describe acceptance criteria or a study that proves the device meets the acceptance criteria, as no such study was conducted or deemed necessary by the FDA for this particular 510(k) clearance due to the device's substantial equivalence to already cleared predicates.

All sections of your request related to acceptance criteria, device performance tables, sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be answered as the submission states no testing was required for this particular device.

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The Advantage-C PEEK Cervical Interbody Fusion Device is a cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disease (DDD) with / without radicular symptoms at one level from C2 - T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Advantage-C PEEK Cervical Interbody Fusion Device is intended for use with supplemental fixation systems and with autogenous bone graft.. The Advantage-C PEEK Cervical Interbody Fusion Device is supplied sterile and is intended for one-time use.

The proposed Intelivation Advantage-C Cervical Interbody Fusion Device is a sterile, single use implant grade polyetheretherketone (PEEK; ASTM F2026) device and Tantalum (ASTM F560), available in varied footprints and heights, designed for supplemental stabilization of the cervical spinal column in anterior cervical discectomy and fusion (ACDF) procedures. The device is intended for spinal fusion procedures at one level in skeletally mature patients with degenerative disc disease (defined as pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. The implant should be used with supplemental spinal fixation systems and with autogenous bone graft.

The provided text describes a 510(k) premarket notification for the "Advantage-C PEEK Cervical Interbody Fusion Device." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical efficacy studies typically required for a new device. Therefore, the information provided for acceptance criteria and studies will be geared towards non-clinical performance and biological compatibility.

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

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

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

Notes on Acceptance Criteria: For some tests (like subsidence), a "characterization" is performed, implying that the results are within expected limits for the material and design, even if an explicit "Pass" is not stated in the summary. The core acceptance criterion for a 510(k) is often "substantial equivalence" to a predicate device, which these non-clinical tests help to demonstrate.

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

• Sample Size for Test Set: Not explicitly stated for any of the non-clinical tests. The document refers to "the proposed device" and "this testing" which implies standard sample sizes for each test method as per the referenced ASTM and ISO standards would have been used, but specific numbers are not given.
• Data Provenance: The studies are non-clinical (laboratory tests). No country of origin is mentioned for the data, but the submitter is Intelivation, LLC, based in Saint Simons Island, Georgia, USA. The studies are prospective in the sense that they were conducted specifically for this submission.

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

This question is not applicable to the non-clinical performance and sterilization tests described. Ground truth, in the clinical sense, is not established for these types of engineering and material property tests. The "ground truth" for these tests is defined by the objective measurement criteria and methodologies specified in the referenced ASTM and ISO standards.

4. Adjudication method for the test set:

Not applicable. The tests are objective, laboratory-based physical and chemical evaluations following standardized protocols. There is no human adjudication process involved as there would be with clinical image interpretation or diagnosis.

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 physical interbody fusion implant, not an AI-assisted diagnostic or therapeutic tool. No MRMC study was conducted or is relevant for this product.

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

Not applicable. This device is an implantable medical device, not an algorithm or software.

7. The type of ground truth used:

For the non-clinical tests, the "ground truth" is based on the objective measurements and performance specifications defined by the referenced industry standards (ASTM, ISO). For example, for strength tests, the ground truth is the measured yield/ultimate force or fatigue resistance compared against a predefined standard. For wear particle analysis, it's the measured size, shape, and distribution. For sterilization, it's the achievement of a specific sterility assurance level (SAL).

8. The sample size for the training set:

Not applicable. There is no concept of a "training set" for physical medical device performance testing in this context. The manufacturing process and quality control would involve internal testing, but not a "training set" in the machine learning sense.

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

Not applicable, as there is no "training set" for these non-clinical tests.

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The mesh implant is intended for use as a suburethral sling for the treatment of female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

The Advantage Ultra System is a sterile, single-use system consisting of one delivery device and one mesh assembly. The mesh assembly is comprised of a polypropylene knitted mesh protected by two disposable polymer sleeves, two dilators, and one center tab. The sleeves and dilators are secured to the mesh by two polypropylene leader loops, and the center tab is secured to the mesh by a polyester lead. The two dilators at the distal ends of the mesh assembly are designed to be placed over the needle end of the delivery device. The Advantage Ultra System is packaged with the Advantage™ System Delivery Device previously cleared via K172565. This is a single-use disposable delivery device that consists of a handle with a curved needle and a pusher component. The delivery device is designed to facilitate the passage of the mesh assembly through bodily tissues for retropubic placement.

The Advantage Fit Ultra System is a sterile, single-use system consisting of one delivery device and one mesh assembly. The mesh assembly is comprised of a polypropylene knitted mesh protected by two disposable polymer sleeves, two dilators, and one center tab. The sleeves and dilators are secured to the mesh by two polypropylene leader loops, and the center tab is secured to the mesh by a polyester lead. The two dilators at the distal ends of the mesh assembly are designed to be placed over the needle end of the delivery device. The Advantage Fit Ultra System is packaged with the Advantage Fit™ System Delivery Device previously cleared via K172565. This is a single-use disposable delivery device that consists of a handle with a curved needle and a pusher component. The delivery device is designed to facilitate the passage of the mesh assembly through bodily tissues for retropubic placement.

The Lynx Ultra System is a sterile, single-use system consisting of two delivery devices and one mesh assembly. The mesh assembly is comprised of a polypropylene knitted mesh protected by two disposable polymer sleeves, two dilators, and one center tab. The sleeves and dilators are secured to the mesh by two polypropylene leader loops, and the center tab is secured to the mesh by a polyester lead. At the distal ends of the mesh assembly there are association loops designed to be placed in the needle slot of the distal end of a delivery device. The Lynx Ultra System is packaged with two Lynx System Delivery Devices previously cleared via K172565. Each is a single-use disposable delivery device that consists of a handle with a curved needle with a needle slot for connection to the mesh assembly. The needle is designed to facilitate the passage of the mesh assembly through bodily tissues for suprapubic placement.

The provided text describes the 510(k) summary for the Advantage™ Ultra System, Advantage Fit™ Ultra System, and Lynx™ Ultra System, which are surgical meshes for treating female stress urinary incontinence. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study or a standalone algorithm performance study.

Therefore, the information required for "a table of acceptance criteria and the reported device performance" and the details of a study proving those criteria are not explicitly present in the provided text in the way one might expect for a typical performance validation study with specific metrics like sensitivity, specificity, or accuracy for an AI/CADe device.

However, based on the provided text, the closest interpretations for acceptance criteria and the "study" demonstrating their fulfillment are related to performance testing to ensure the device functions as intended and meets specifications compared to its predicates.

Here's an analysis based on the available information:

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

The document does not provide a table with specific quantitative acceptance criteria (e.g., minimum tensile strength value) explicitly alongside reported performance results. Instead, it broadly states that performance testing was conducted, and the results "demonstrate that the proposed products function as intended and meet specification requirements."

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

The document does not specify the sample sizes for the performance tests (dimensional, tensile, functional, user evaluations, packaging, sterility, biocompatibility). It also does not mention the data provenance in terms of country of origin or whether a retrospective or prospective study was conducted for establishing clinical performance (as this submission is focused on substantial equivalence based on materials and design, not clinical outcomes from a trial). The "samples" referred to are likely physical devices or components of the device itself (non-aged and accelerated aged for shelf life testing).

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 and not provided in the document. The performance tests described (dimensional, tensile, functional, biocompatibility, sterility) are technical evaluations of the device's physical properties and safety, not assessments requiring expert "ground truth" in a clinical diagnostic sense. "User evaluations" are mentioned, which would involve experts (e.g., surgeons or medical professionals) interacting with the device, but the number and qualifications are not detailed.

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

This information is not applicable and not provided. Adjudication methods are typically used in clinical studies or studies involving human interpretation (e.g., radiology reads) to establish ground truth or handle discrepancies, neither of which is described as part of the performance testing for this surgical mesh.

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 is not applicable as the device is a surgical mesh, not an AI/CADe system for diagnostic imaging interpretation. Therefore, no MRMC study or AI-related effectiveness details are provided.

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

This is not applicable as the device is a surgical mesh, not an algorithm.

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

For the performance testing, the "ground truth" would be the established engineering specifications, material standards (e.g., ISO 10993-1:2018 for biocompatibility), and regulatory requirements for sterility and packaging integrity. These are objective measures and standards rather than clinical "ground truth" derived from patient data or expert consensus on a diagnosis.

8. The sample size for the training set

This is not applicable as the device is a physical surgical mesh, not an AI model requiring a training set.

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

This is not applicable as the device is a physical surgical mesh, not an AI model.

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The RibFix Advantage System is indicated for the fixation, and fusion of rib fractures and osteotomies of normal and osteoporotic bone.

The RibFix Advantage System consists of bridges (with locking posts) and locking caps for the thoracoscopic fixation and stabilization of ribs. These implants are manufactured from commercially pure titanium (per ASTM F67) and titanium alloys (Ti-6A1-7Nb per ASTM F1295 and Ti-6Al-4V per ASTM F136 or ASTM F1472). The system is comprised of the following implants:

• . Titanium alloy RibFix Advantage Bridge with threaded locking posts
• . Commercially pure titanium locking caps
• . Commercially pure titanium washers (optional)
  When fully assembled, the bridge is placed on the underside of the rib, the threaded locking posts extends through pre-drilled holes in the rib, and the locking caps are fixed to the locking post on the anterior side of the rib. Washers may be placed on the posts prior to assembling with locking caps. The combined threaded locking post/locking cap provides for fixation of the bridge. The devices are sold non-sterile and intended to be sterilized by the user prior to implantation. The system also includes reusable instrumentation to aid in implantation of the devices.

This document (K203474) describes a 510(k) premarket notification for the "Biomet Microfixation RibFix Advantage System." This system is for the fixation and fusion of rib fractures and osteotomies. The FDA determined the device is substantially equivalent to legally marketed predicate devices.

Acceptance Criteria and Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device (K183317, AdvantageRib System) and provides non-clinical performance data related to MR safety. It does not present acceptance criteria in the typical format of accuracy, sensitivity, or specificity commonly used for AI/software devices. Instead, the acceptance criteria are implicitly that the device performs equivalently or better than the predicate device in relevant non-clinical tests.

The document states: "Testing identified in this summary has all passed acceptance criteria established by the predicate device where applicable."

Here's a table based on the provided information, interpreting "acceptance criteria" as meeting the standards set for safe operation in an MRI environment:

Study Details:

1. Sample sizes used for the test set and the data provenance:

   • The document primarily refers to non-clinical testing on the device itself for MR safety. It does not describe a clinical study or a test set of patient data.
   • For the MR safety evaluations, the "sample" would refer to the physical devices tested. The document does not specify the number of devices or components tested, but implies that a sufficient number were tested to satisfy the ASTM standards.
   • Data provenance: Not applicable in the context of clinical data. The non-clinical tests were conducted in a lab setting.

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

   • Not applicable as this is a non-clinical device clearance. Ground truth is established by the accepted ASTM standards for MR compatibility, which are developed by expert committees in their respective fields (e.g., engineers, physicists, medical professionals specializing in MRI safety).

3. Adjudication method for the test set:

   • Not applicable. The adjudication method relates to resolving disagreements among human reviewers on ground truth, which is not relevant for non-clinical engineering tests.

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

   • No. This is a physical medical device (implants for rib fixation), not an AI/software device. Hence, an MRMC study is not relevant, and there's no "human readers improve with AI" component.

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

   • No. This is a physical medical device. Not applicable to standalone algorithm performance.

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

   • The "ground truth" for demonstrating device safety and equivalence is based on established engineering standards (ASTM) for material properties, mechanical performance, and MR compatibility. For substantial equivalence, it's also based on the established safety and efficacy profile of the predicate device.

7. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device requiring a training set.

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

   • Not applicable.

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The K-Shield Advantage Port Access Infusion Set (PAIS) is a safety port access device used to administer solutions to surgically implanted port.

The K-Shield Advantage Port Access Infusion Set (PAIS) is a safety port access device used to administer solutions to a surgically implanted port. This device is designed utilizing a non-coring Huber needle to access the implanted port. The K-Shield Advantage PAIS has an integral safety device intended to protect against accidental needle stick injuries and infection caused by blood borne pathogens. Upon removal from the port, the anti-needlestick protector (ANSP) covers the needle tip protecting against accidental needle stick injuries. The devices are disposable ethylene oxide sterilized medical devices which are constructed from non-coring needle (Huber needle), wing, tubing (either micro bore or standard bore), clamp, female conical fitting and locking cap. The device has optional injection site (needle injection, needleless access connector (NAC), or no injection site) and anti-needle stick protector (ANSP).

The K-Shield Advantage Port Access Infusion Set (PAIS) is a safety device used to administer solutions to surgically implanted ports. The device was modified from a previously cleared version (K123344), with minor enhancements to strengthen the safety device feature, improve the gripping point for easy cannulation, and reduce the bulkiness of the needle cap.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size and Data Provenance (Test Set):

• Needle Cap Evaluation: N=30 for each cap type (straw cap and T-cap). The data provenance is not explicitly stated but is implicitly from bench testing conducted by Kawasumi Laboratories, Inc.
• Simulated Use Testing: N=599 "effective samples." Data provenance is from simulated use testing conducted by Kawasumi Laboratories, Inc.

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

This information is not provided in the document. The tests performed are primarily bench and simulated use tests based on established international and in-house standards, not expert assessments of performance.

4. Adjudication method for the test set:

This information is not applicable as the tests are objective measurements against defined criteria, not subjective human assessments requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This device is a physical medical device (infusion set), not an imaging or diagnostic AI device that would typically involve human readers.

6. Standalone (algorithm only without human-in-the-loop performance) study:

No, a standalone study was not done. This refers to algorithmic performance, which is not relevant for a physical medical device. The "standalone" concept applies to AI/software as a medical device (SaMD).

7. Type of ground truth used (test set):

The "ground truth" for the test set is established by objective technical standards and in-house criteria for physical performance characteristics (e.g., tensile strength, leak test, cap removal force) and functional activation (ANSP). For the simulated use testing, the ground truth is the observable proper activation of the ANSP.

8. Sample size for the training set:

This information is not applicable. This device is a physical product, not an AI/machine learning model that requires a training set.

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 medical device.

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The AdvantageRib System is intended for the fixation, stabilization, and fusion of rib fractures and osteotomies of normal and osteoporotic bone.

The AdvantageRib System consists of bridges (with locking posts) and locking caps for the thoracoscopic fixation and stabilization of ribs. These implants are manufactured from commercially pure titanium and titanium alloys (Ti-6Al-7N per ASTM F1295 and Ti-6Al-4V per ASTM F136 or ASTM F1472). The system is comprised of the following implants:

• Titanium alloy AdvantageRib Bridge with threaded locking posts
• Commercially pure locking caps
  When fully assembled, the bridge is placed on the underside of the rib, the threaded locking posts extends through pre-drilled holes in the rib, and the locking caps are fixed to the locking post on the anterior side of the rib. The combined threaded locking post/locking cap provides for fixation of the bridge.

The provided FDA 510(k) summary for the AdvantageRib System does not contain the detailed information required to describe acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML-driven medical device.

The document discusses a medical device for bone fixation (rib fractures) and its equivalence to a predicate device. It focuses on mechanical testing, material specifications, and sterilization validation for a physical implant, not a software algorithm.

Therefore, I cannot extract the following information from the provided text:

• Table of acceptance criteria and reported device performance related to an AI/ML algorithm.
• Sample size and data provenance for a test set (as no AI/ML test set is mentioned).
• Number and qualifications of experts for ground truth (as no AI/ML ground truth is mentioned).
• Adjudication method (as no AI/ML ground truth is mentioned).
• MRMC comparative effectiveness study or effect size of human improvement with AI (as no AI is discussed).
• Standalone algorithm performance (as no algorithm is discussed).
• Type of ground truth used (as no AI/ML ground truth is mentioned).
• Sample size for the training set (as no AI/ML training set is mentioned).
• How ground truth for the training set was established (as no AI/ML training set is mentioned).

The document describes the non-clinical testing performed for the AdvantageRib System as follows:

Non-Clinical Testing Information Provided:

Sterilization: The sterilization process must achieve a Sterility Assurance Level (SAL) of $10^{-6}$. (This is a standard acceptance criterion for sterilization validation). |
| Reported Device Performance | Mechanical Performance: "Dynamic and static testing was performed on the bridge, locking post, locking cap construct demonstrating that neither the material or dimensional changes introduced a new worst case." (Specific quantitative results not provided in summary).

Sterilization: "Sterilization validation was performed on the subject device per ISO 14937:2009... to establish SAL of $10^{-6}$." (This confirms the acceptance criterion was met). |

Additional Context from the Document:

• Device Name: AdvantageRib System
• Intended Use: Fixation, stabilization, and fusion of rib fractures and osteotomies of normal and osteoporotic bone.
• Predicate Device: MatrixRIB Endo Thorascopic Rib Plating System (K141241)
• Modifications vs. Predicate: Includes option for different titanium alloys, optional washer, increased lengths of locking posts and locking caps with an internal X-drive feature (vs. external hex), and ability for all implants to be steam sterilized (vs. predicate's gamma radiation for some components).
• Conclusion: "The conclusions drawn from the nonclinical testing demonstrates that the device is as safe and as effective as the identified predicate."

In summary, the provided document is a 510(k) summary for a physical medical implant device, not an AI/ML diagnostic or therapeutic algorithm. Therefore, the specific details requested regarding AI/ML performance, ground truth, and study design are not present. The acceptance criteria and performance discussed relate to the mechanical and sterilization properties of the physical implant.

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The AdvantageRib Anterior System is intended for the fixation, and fusion of rib fractures and osteotomies of normal and osteoporotic bone.

The AdvantageRib Anterior System is composed of commercially pure titanium locking bone plates per ASTM F67 and titanium alloy locking and non-locking screws per ASTM F1472 that provide rigid fixation in instances of fractures and osteotomies in normal and osteoporotic bone. The implant and associated screws are provided to the end user in non-sterile packaging, in a variety of sizes and lengths.

I am sorry, but the provided text does not contain the acceptance criteria and study details as requested. The document is a 510(k) premarket notification letter from the FDA regarding the "AdvantageRib Anterior System." It states that clinical testing is not necessary to demonstrate substantial equivalence and refers to performance evaluation in accordance with ASTM standards and engineering/geometric analysis.

The document does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number or qualifications of experts for ground truth.
4. Adjudication method for a test set.
5. Information on a multi-reader multi-case (MRMC) comparative effectiveness study.
6. Information on a standalone (algorithm only) performance study.
7. The type of ground truth used.
8. Sample size for a training set.
9. How ground truth for a training set was established.

Instead, it focuses on demonstrating substantial equivalence to predicate devices based on intended use, materials, design features, dimensions, function, surgical technique, labeling, and adherence to specific ASTM standards (F382, F543, F2193) through engineering and geometric analysis.

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