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The ACCIN Total Knee System components are for use in total knee arthroplasty as a result of:
• Painful, disabling joint disease of the knee resulting from degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis;
• Post-traumatic loss of knee joint configuration and function
• Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability;
• Revisions of previous unsuccessful knee replacement or other procedure.
Additional indications for posteriorly stabilized components:
• Ligamentous instability requiring implant bearing surfaces with increased constraint;
• Absent or non-functioning posterior cruciate ligament.
These devices are single use only and are intended for implantation with bone cement.

The Accin™ total knee system consists of a series of cobalt chrome femoral components, a series of cobalt chrome tibial tray components and a series of UHMWPE modular tibial bearing components.

The provided text describes a 510(k) premarket notification for the "Accin™ total knee system," a medical device, and its comparison to predicate devices, rather than an AI/ML powered device. Therefore, the questions related to AI/ML specific criteria (such as AI improvement effect size, standalone algorithm performance, training set details, ground truth establishment for training set, and AI/ML acceptance criteria) are not applicable.

However, I can provide information based on the available text regarding the testing and comparison of the Accin™ total knee system to its predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with specific quantitative targets and the device's reported performance against those targets. Instead, it states that the device "meets the requirements of the current FDA Guidance documents on total knee arthroplasty product" and passed a series of tests. The "acceptance criteria" here implicitly refer to the requirements outlined in the FDA guidance documents and ASTM standards.

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

The document mentions "numerous tests were performed on the Accin™ total knee system" but does not specify the sample size (number of devices or components tested) for these tests.
The data provenance is not explicitly stated in terms of country of origin or whether the study was retrospective or prospective. Given the nature of a 510(k) submission for a physical medical device, the "tests" likely refer to mechanical and material property testing in a laboratory setting.

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

This question is not applicable as the submission pertains to a physical medical device (a knee implant) and its mechanical/material performance, not an AI/ML algorithm that requires expert-established ground truth from data for diagnostic or prognostic purposes.

4. Adjudication Method for the Test Set

This question is not applicable for the same reasons as point 3. Testing for medical device equivalence typically involves engineering and materials science analyses, not expert adjudication of clinical cases.

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 question is not applicable as the submission is for a physical medical device, not an AI/ML powered device.

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

This question is not applicable as the submission is for a physical medical device, not an AI/ML powered device.

7. The Type of Ground Truth Used

The "ground truth" for this medical device comes from established engineering and material science principles, FDA guidance documents, and ASTM standards for testing the mechanical properties, wear resistance, and biocompatibility of total knee arthroplasty devices. The equivalence is established by demonstrating that the new device meets these recognized standards and performs comparably to the predicate devices.

8. The Sample Size for the Training Set

This question is not applicable as the submission is for a physical medical device, not an AI/ML powered device. There is no "training set" in the context of an AI/ML algorithm.

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

This question is not applicable for the same reasons as point 8.

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The Accin™ Bipolar Head components are intended to be implanted to replace a portion of the hip for:

• Fractures of the proximal femur; .
• . Non-unions of proximal femoral neck fractures;
• Aseptic necrosis of the femoral head; .
• Osteo-rheumatoid and post traumatic arthritis of the hip with minimal . distortion of the acetabulum; and
• . Salvage of failed total hip arthroplasty.

The device is only for use where sufficient sound bone to seat the prosthesis is present and for use with the Accin Hip System components.

The Accin™ Bipolar Head System consists of a cobalt chrome femoral head with a preassembled polyethylene insert and a snap ring that locks the head into the insert.

This document is a 510(k) premarket notification for a medical device (Accin™ Bipolar Head System) and does not describe a study involving artificial intelligence or machine learning. Therefore, it is impossible to extract the requested information regarding AI acceptance criteria, performance, ground truth, or study methodology from the provided text.

The document focuses on establishing substantial equivalence to a predicate device (Stelkast Bipolar Head System) based on material composition and intended use for a traditional medical implant. The determination of safety and effectiveness for this type of device is typically based on:

• Manufacturing standards: Adherence to established quality systems (e.g., ISO 13485).
• Biocompatibility testing: Ensuring the materials are safe for implantation.
• Mechanical testing: Demonstrating the device meets performance standards for strength, wear, and durability (though specific test results are not detailed in this summary).
• Clinical experience with the predicate device: The predicate device has a history of safe and effective use.

Without information on an AI-driven component or a study evaluating its performance, I cannot fulfill the request for details related to AI acceptance criteria and studies.

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The Accin™ Unipolar Head is intended to be implanted for use in the reconstruction of the femoral portion of severely disabled and / or very painful hip joints resulting from: Osteoarthritis; Rheumatoid Arthritis; Traumatic Arthritis; Avascular Necrosis; The device is only for use where sufficient sound bone to seat the prosthesis is present and for use with the Accin Hip Stems.

The Accin™ Unipolar Head System consists of a cobalt chrome modular endo prosthesis femoral head.

This document is a 510(k) premarket notification for a medical device called the "Accin™ Unipolar Head System." It seeks to demonstrate substantial equivalence to a predicate device, rather than proving a new device's absolute safety and effectiveness through clinical trials with established acceptance criteria and detailed performance studies.

Therefore, the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment is not available within this document. This type of information is typically found in clinical study reports, scientific publications, or more extensive premarket approval (PMA) submissions where a novel device's performance needs to be rigorously proven.

Here's a breakdown of why this information is absent in this context:

• 510(k) Premarket Notification: This regulatory pathway is for devices that are "substantially equivalent" to legally marketed predicate devices. The primary goal is to show similarity in intended use, technological characteristics, and safety and effectiveness profiles, not necessarily to re-prove efficacy or establish new performance benchmarks.
• Focus on Substantial Equivalence: The document explicitly states: "Testing has shown that the proposed device is equivalent to the predicate device." This "testing" would likely refer to bench testing (e.g., mechanical, material properties) to ensure it performs identically to the predicate, rather than human clinical studies comparing outcomes or algorithm performance.
• Device Type: The Accin™ Unipolar Head is a physical implant (a component of a hip prosthesis). Its performance is assessed through its mechanical properties, biocompatibility, and manufacturing quality, not through an algorithm's diagnostic accuracy or a human-AI collaboration.

Therefore, I cannot provide the requested table and study details as they are not pertinent to or present within this 510(k) submission document. The document's purpose is to establish equivalence to an already approved device, not to present a new performance study with acceptance criteria.

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The Accin™ Pedicle Screw System components are intended for noncervical and nonpedicle anterolateral fixation of: Degenerative disk disease (defined as back pain of discogenic origin with degeneration . of the disc confirmed by history and radiographic studies); Spondylolisthesis (grade 3 or 4); Trauma (i.e.: fracture or dislocation) ●; Spinal stenosis ●; Curvatures (i.e.: scoliosis, kyphosis, and/or lordosis) ●; Tumor; Pseudoarthrosis .; Failed previous fusion. ●. The Accin™ Pedicle Screw System components are intended for non-cervical pedicle fixation of: Spondylolisthesis (grade 3 or 4) .; Trauma (i.e .: fracture or dislocation) .; Spinal stenosis; Curvatures (i.e. scoliosis, kyphosis, and/or lordosis) .; Tumor ●; Pseudoarthrosis ; Failed previous fusion. . These components are single use only and are intended for use in skeletally mature patients.

The Accin™ Pedicle System consists of titanium alloy rods, cannulated, multi-axial and standard screws, locking caps, and cross-connector components. The surgeon uses the components to make a construct for spinal fixation.

Acceptance Criteria and Study for Accin™ Pedicle Screw System

This document outlines the acceptance criteria and the study conducted to demonstrate the safety and effectiveness of the Accin™ Pedicle Screw System.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes a mechanical performance study rather than a study with specific performance metrics like sensitivity, specificity, or accuracy, which are typical for diagnostic or AI-driven devices. Therefore, the "acceptance criteria" here refer to meeting the requirements of a recognized standard for mechanical testing of spinal implants.

Note: The FDA also determined substantial equivalence to predicate devices (Vertebron PSS System - K033352, K043152, K051716 and K071376) as a key "acceptance criterion" for market clearance. This implies that the device's design, materials, and intended use are similar enough to a device already deemed safe and effective.

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

• Sample Size for Test Set: The document does not specify the exact number of samples (e.g., screws, constructs) tested. It states, "Tests were performed on the pedicle screw system," implying that a sufficient number were tested to satisfy the requirements of ASTM F1717.
• Data Provenance: The data is generated from laboratory mechanical testing of the device components, not from clinical patient data. Therefore, concepts like "country of origin of the data" or "retrospective/prospective" studies are not applicable in this context.

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

• Not Applicable. This study is a mechanical engineering test on an orthopedic implant, not a clinical study involving human assessment or expert review for diagnostic ground truth. The "ground truth" is defined by the physical properties and performance characteristics measured against the ASTM standard.

4. Adjudication Method for the Test Set

• Not Applicable. As this is a mechanical test conducted against a defined standard, there is no need for expert adjudication of results in the way one would for clinical image interpretation or diagnosis. The pass/fail criteria are objectively defined by the ASTM F1717 standard.

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

• Not Applicable. This is a mechanical device performance study, not a study evaluating human reader performance with or without AI assistance.

6. Standalone Performance Study

• Yes, a standalone study was done. The study described is a standalone performance test of the Accin™ Pedicle Screw System itself, evaluating its mechanical properties (static and fatigue) against a standard (ASTM F1717). This is an "algorithm only" equivalent in the sense that the device's inherent physical performance is being assessed without human intervention in the 'reading' or 'interpretation' of the device's function in a clinical scenario.

7. Type of Ground Truth Used

• Mechanical Specifications/Standard Conformance: The "ground truth" for this study is defined by the objective, quantifiable requirements and test methodologies outlined in the ASTM F1717 standard for spinal implant constructs in a vertebrectomy model. The device's performance (e.g., strength, fatigue life) must meet the minimum thresholds or performance profiles specified by this standard.

8. Sample Size for the Training Set

• Not Applicable. This is not a machine learning or AI-driven device, so there is no training set in the conventional sense. The device's design and manufacturing processes are likely informed by engineering principles and prior knowledge from predicate devices, but not by a formal "training set" of data for an algorithm.

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

• Not Applicable. Since there is no training set for an AI algorithm, there is no "ground truth" to establish for such a set. The design and manufacturing process would refer to established biomechanical principles and material science, along with the performance of predicate devices.

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The Accin™ Cervical Plate System is intended for anterior interbody fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with degenerative disk disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); trauma (including fracture); tumor; deformity (defined as kyphosis, lordosis or scoliosis); pseudoarthrosis; and/or failed previous fusions. The Accin™ Cervical Plate System can be implanted in the sub-axial cervical spine from C3 through C7.

The Accin™ Cervical Plate System consists of titanium cervical plates and both self-tapping and self-drilling screw components. The surgeon uses the components to make a construct that is placed anteriorly for spinal fixation. The construct is used for temporary fixation which allows for fusion of the cervical spine

The provided FDA 510(k) submission for the Accin™ Cervical Plate System does not describe a study involving an AI/Machine Learning device or software. Instead, it concerns a traditional medical device classification. Therefore, the questions related to AI device performance, sample sizes for test and training sets, ground truth establishment, expert adjudication, or MRMC studies are not applicable to this submission.

The acceptance criteria and the study performed relate to the mechanical and material equivalence of the Accin™ Cervical Plate System to its predicate devices.

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

Summary of the Study:

The study conducted was a bench testing comparison study, not a clinical trial or an AI/ML performance study. The primary goal was to demonstrate substantial equivalence to legally marketed predicate devices (Vertebron SCP and SSP Cervical Plate Systems) based on material composition and mechanical performance.

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

• Sample Size: The document does not specify the exact number of devices or components tested. It only states, "Tests were performed on the cervical plate system." For bench testing, sample sizes are typically determined by statistical methods for materials science or engineering, but this detail is not provided.
• Data Provenance: The data comes from laboratory bench testing performed by or for Accelerated Innovation, LLC. There is no information on the country of origin of the data beyond the submitter being in Clifton, NJ, USA. The study is a prospective test in the sense that the testing was performed on the new device (Accin™) specifically to support its 510(k) submission.

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

• Not applicable. This was bench testing against a standard (ASTM F1717) and comparison to a predicate device's established performance, not a study requiring expert clinical ground truth assessment.

4. Adjudication method for the test set:

• Not applicable. This was mechanical testing, not a subjective assessment requiring adjudication. The results would be quantitative measurements of physical properties.

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 study does not involve human readers or AI.

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

• Not applicable. This study does not involve an algorithm or AI.

7. The type of ground truth used:

• The "ground truth" in this context is the established mechanical performance characteristics and material composition of the predicate devices, as well as the requirements outlined in the ASTM F1717 standard and the FDA guidance document "Spinal System 510(k)s." The device's performance was compared directly to these objective benchmarks.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML study, so there is no training set.

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

• Not applicable. There is no training set.

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The Accin™ Hip System components are for use in total hip arthroplasty as a result of: Hip arthritis caused by rheumatoid disease, non-inflammatory degenerative joint disease, osteoarthritis, and arthritis resulting from biologic or mechanical trauma to the hip Correction of functional deformity Avascular Necrosis Treatment of non-unions, femoral neck and trochanteric fractures of the proximal femur Difficult clinical management problems involving persistent pain and physical impairment where conventional arthodesis is not likely to achieve satisfactory results These components are single use only and are intended for implantation without bone cement.

The Accin™ Hip System consists of plasma spray coated titanium alloy femoral component, a cobalt chrome femoral head, a plasma spray coated titanium alloy acetabular shell, bone screws and a polyethylene acetabular insert.

The provided document, K073068, describes the Accin™ Hip System, a medical device. This document is a summary of safety and effectiveness, indicating the device's comparison to predicate devices and the testing performed. However, it does not contain detailed information regarding acceptance criteria and a study that proves the device meets those criteria in the format requested.

Specifically, the document states:

• "Testing has shown that the proposed device meets the requirements of the current FDA Guidance documents on total hip arthroplasty product and the proposed device is equivalent to the predicate device."
• "Tests were performed on the Hip System. The tests performed can be found in the guidance documents entitled 'Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements;' 'Class II Special Controls Guidance Document: Hip Joint Metal/Polymer Constrained Cermented or Uncom of the Prosthesis;' and 'Guidance for Industry and FDA Staff - Non-clinical Information for Femoral Stem Prostheses.'"

This indicates that testing was conducted to demonstrate equivalence to predicate devices and adherence to FDA guidance documents, which serve as the implicit acceptance criteria for this type of device. However, the document does not provide:

1. A specific table of acceptance criteria and reported device performance. It only generally states that the device meets requirements and is equivalent.
2. Sample size used for the test set or data provenance. The document only states "Tests were performed on the Hip System."
3. Number of experts, their qualifications, or adjudication methods. These are not applicable as the tests described are mechanical/material performance tests, not clinical studies involving expert interpretation or ground truth establishment in a diagnostic context.
4. Information on any Multi Reader Multi Case (MRMC) comparative effectiveness study. This type of study is not relevant for a hip implant's mechanical and material safety/effectiveness demonstration.
5. Standalone algorithm performance. This is not applicable as the device is a physical hip implant, not an AI algorithm.
6. Type of ground truth used. The document refers to FDA guidance documents and predicate device equivalence as the basis for evaluation, implying engineering and material standards rather than expert consensus, pathology, or outcomes data in a clinical trial sense.
7. Sample size for the training set or how ground truth was established for it. These concepts are not relevant for the type of device and testing described.

Therefore, based only on the provided text, I cannot complete the requested tables and information. The document focuses on regulatory approval through substantial equivalence to predicate devices and adherence to existing guidance for materials and mechanical testing, rather than a detailed clinical study report with the specified metrics.

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