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The restor3d rTSA System is indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.

The restor3d rTSA System is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

Glenoid component with porous surface is indicated for uncemented biological fixation application only. The restor3d rTSA System glenoid baseplate components are intended for cementless application with the addition of screw fixation.

Humeral components with porous surface are indicated for either cemented or uncemented applications.

The restor3d Reverse Total Shoulder Arthroplasty System is intended for patients requiring a reverse shoulder replacement for patients with a functional deltoid muscle and with a deficient rotator cuff. The restor3d Reverse Total Shoulder Arthroplasty System consists of the glenoid baseplate, glenosphere intraoperatively affixed to the baseplate, humeral stem, and polymer bearing component affixed to the humeral stem. Additionally, the system includes supporting standard instrument trays and all required accessories (e.g., security screws, peripheral screws).

The provided text is a 510(k) clearance letter for a medical device: the restor3d Reverse Total Shoulder Arthroplasty System. This document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It explicitly states, "The restor3d Reverse Total Shoulder Arthroplasty System was subject to the following non-clinical performance tests to support the assertion of substantial equivalence."

Therefore, the document describes engineering and material performance testing, not a clinical study involving human patients or analysis of clinical images/data using an AI algorithm. The questions posed in your prompt (e.g., acceptance criteria for device performance/accuracy, sample size for test set/training set, number of experts for ground truth, MRMC study, standalone performance) are typically relevant for AI/ML-enabled medical devices or devices requiring clinical performance studies.

Since the provided text does not describe an AI/ML-enabled device or a clinical study that would generate "device performance" in terms of accuracy, sensitivity, specificity, etc., against a clinical ground truth, I cannot fill out the requested table or answer most of the specific questions.

Here's an explanation based on the provided text, highlighting why the requested information isn't present:

Context from the document:

• Device Type: Reverse Total Shoulder Arthroplasty System (a physical implant)
• Regulatory Pathway: 510(k) (seeking substantial equivalence to a legally marketed predicate)
• Testing Described: "Non-Clinical Testing" which includes:
  • Glenoid Baseplate Loosening per ASTM F2028
  • Glenoid Baseplate Fatigue and corrosion analysis
  • Morse Taper Disassembly Strength per ASTM F2009
  • Humeral Stem Fatigue and corrosion analysis
  • Bone Screw Testing per ASTM F543
  • Poly Liner Performance Tests per ASTM F1820
  • Range of Motion Analysis per ASTM F1378
  • Wear Analysis

These are all benchtop, mechanical, and material science tests designed to show that the new device performs similarly from an engineering standpoint to the predicate and meets established ASTM standards for orthopedic implants. They do not involve "device performance" in terms of clinical accuracy or an AI algorithm's predictive capability.

Therefore, I cannot fulfill your request as it pertains to acceptance criteria and studies typically associated with AI/ML or diagnostic devices that produce "performance" metrics against clinical ground truth.

However, if we interpret "acceptance criteria" and "device performance" within the context of mechanical/material testing as presented in the document, here's what could be inferred, though it won't directly answer your specific table columns:

The "acceptance criteria" for this device would be implicit in meeting the requirements of the cited ASTM standards, such as surviving a certain number of fatigue cycles at a given load, or meeting specific wear rates, or exhibiting particular disassembly strengths. The "reported device performance" would be the results from these bench tests, demonstrating that the device did indeed meet those standard specifications.

To directly address your prompts based on the absence of the requested information in the provided document:

Description of Acceptance Criteria and Study to Prove the Device Meets Them (Based on provided document)

The provided FDA 510(k) clearance letter for the restor3d Reverse Total Shoulder Arthroplasty System primarily relies on non-clinical bench testing to demonstrate substantial equivalence to a predicate device. This submission does not describe a clinical study of diagnostic or predictive performance, nor does it discuss AI model performance. Therefore, the requested information regarding AI/ML-specific acceptance criteria, test set details, expert involvement for ground truth, or MRMC studies is not present in this document.

The "acceptance criteria" for this device are implicitly tied to its ability to meet the performance requirements of established ASTM (American Society for Testing and Materials) standards for orthopedic implants, and to demonstrate comparable mechanical and material characteristics to its predicate device. The "study that proves the device meets the acceptance criteria" refers to a series of non-clinical benchtop tests.

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The provided 510(k) summary only lists the types of tests performed and states they support substantial equivalence. It does not provide the specific numerical acceptance thresholds or the detailed numerical results from these non-clinical tests. This level of detail would typically be found in the full 510(k) submission not in the public clearance letter summary.

Regarding other specific questions (not applicable based on the document's content):

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

• Not applicable. The "test set" here refers to physical implant samples subjected to bench testing, not a dataset of clinical cases for an AI algorithm. The document does not specify the number of physical samples used for each test. Data provenance (country, retrospective/prospective) is not relevant for bench testing of a physical implant.

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

• Not applicable. Ground truth in this context is established by engineering standards (e.g., ASTM specifications, material properties) and physical measurements on the device, not by expert medical review of clinical data.

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

• Not applicable. This method applies to expert review of clinical cases, not mechanical 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:

• Not applicable. An MRMC study is for evaluating human performance (often with or without AI assistance) in interpreting clinical data. This document describes a physical implant, not an AI diagnostic tool.

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

• Not applicable. This refers to AI algorithm performance. No AI algorithm is described.

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

• Not applicable in the clinical sense. Ground truth for this device is based on engineering standards (ASTM), material specifications, and physical measurements demonstrating the device's mechanical and material properties are equivalent to the predicate and meet safety requirements.

8. The sample size for the training set:

• Not applicable. This refers to AI model training data. No AI model is described.

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

• Not applicable. This refers to AI model training data. No AI model is described.

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The iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis.

The Indications for Use include:

· Painful joint disease due to osteoarthritis, traumatic arthritis or osteonecrosis of the knee.

· Post traumatic loss of joint function.

· Moderate varus, valgus or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.

· Failed osteotomies, hemiarthroplasties, and unicondylar, patellofemoral or bicompartmental implants.

· Revision procedures provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans

This implant intended for uncemented use, but porous implants may be used with cement if desired by the surgeon.

The CS (cruciate sacrificing) insert option should be utilized when additional anterior-posterior constraint is desired.

The iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement System is a tricompartmental semi-constrained knee prosthesis composed of three components: a Femoral Component, a Tibial Component, and a Patellar Component. The product design incorporates a bone preserving approach for the treatment of severe pain and/or disability of a knee damaged by osteoarthritis or trauma. The joint restoring design provides for more natural kinematics by maintaining the patient specific femoral sagittal curves, preserving the patient specific femoral offset, preserving the medial and lateral joint lines and having a patient specific fit. It is intended for use in those patients whose condition cannot be appropriately or effectively addressed using a device that treats only one or two compartments of the knee (i.e. a unicompartmental, bicompartmental, or patellofemoral prosthesis).

Using patient imaging (CT scans), a patient-specific implant is designed that best meets the geometric and anatomic requirements of the specific patient. The treatment allows for the placement of an uncemented metallic device designed from the patient's natural bone geometry. The femoral component is additively manufactured from a cobalt chromium molybdenum ("CoCrMo") alloy. The tibial tray is additively manufactured from titanium ("Ti-6Al-4V") alloy. The tibial inserts are manufactured and offered in either ultra-high molecular weight polyethylene (iPoly®) or highly crosslinked ultra-high molecular weight Vitamin-E enriched polyethylene (iPoly® XE). The patellar component is manufactured and offered in ultra-high molecular weight polyethylene (iPoly®) with a porous Ti6Al4V metal backing. The femoral, tibial, and patellar implants are additively manufactured using proprietary TIDAL Technology™ which allows biological fixation without the need for bone cement. The iTotal® ldentity™ CR 3DP Porous KRS is designed for press-fit use without cement, but may be used with a cemented technique if desired.

The iTotal® Identity™ CR 3DP Porous KRS is supplied with disposable, patient-specific instrumentation (ilig®) designed for use with the system. These patient-specific guides are pre-navigated to fit the contours of the patient's femoral and tibial anatomies and to facilitate a simpler surgical technique. Each set of instruments is designed for one-time use, specifically for one patient. The iJig® instrument set is manufactured from biocompatible nylon material and supplied sterile along with the implants.

The provided text describes a medical device, the "iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement System," and its submission for FDA 510(k) clearance. However, it explicitly states that "No clinical testing was warranted for the subject device."

This means that the information you requested regarding acceptance criteria and the study that proves the device meets those criteria cannot be found in this document because a clinical study was not conducted or submitted for this particular clearance.

Therefore, I cannot provide the following information:

1. A table of acceptance criteria and the reported device performance: No clinical performance data is reported.
2. Sample size used for the test set and the data provenance: No clinical test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No clinical test set.
4. Adjudication method for the test set: No clinical test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not applicable as no clinical study was done.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable as this is a physical medical implant, not a software algorithm.
7. The type of ground truth used: No clinical ground truth established.
8. The sample size for the training set: No clinical training set.
9. How the ground truth for the training set was established: No clinical training set.

The document focuses on demonstrating substantial equivalence to previously cleared predicate devices through non-clinical performance evaluation, which includes various biomechanical and material tests. These non-clinical tests are listed, but their specific acceptance criteria and detailed results are not provided in this summary.

Non-Clinical Performance Evaluation (as listed in the document):

• Patella static tensile test
• Patella static shear test
• Patella shear fatigue test
• Tibial tray fatigue test
• Femoral fatigue test
• Tibial micromotion
• Tibiofemoral constraint test
• Tibiofemoral contact area, stress and wear test
• Tibial interlock test
• Patellofemoral subluxation, contact area and stress test
• Particle characterization
• Porous coating testing per FDA guidance on modified metallic surfaces
• Biocompatibility assessment

Conclusion from the document: "The results of the testing demonstrate that the subject device iTotal® Identity™ CR 3DP Porous KRS is as safe and effective and is substantially equivalent to the cleared predicates... and the differences between the subject and predicates do not raise different questions of safety or effectiveness."

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The TIDAL Fusion Cage System is intended to be used as part of a tibiotalocalcaneal fusion construct in a salvage procedure following failed ankle arthrodesis or failed ankle arthroplasty for patients at risk of limb loss. The TIDAL Fusion Cage System is intended for use as an accessory to the DynaNail TTC Fusion System. The TIDAL Fusion Cage System is not intended for standalone use. The TIDAL Fusion Cage System is intended for use with autograft and/or allogenic bone graft.

The subject TIDAL Fusion Cage System is a single-use, implant grade titanium alloy (Ti-6Al-4V) device, available in varying shapes, heights and diameters, designed to be used as an accessory to the DynaNail TTC System for ankle fusion.

The provided text describes a 510(k) premarket notification for a medical device called the "TIDAL Fusion Cage System." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical effectiveness through a traditional clinical study with acceptance criteria.

Therefore, the document does not contain the information requested regarding:

• A table of acceptance criteria and reported device performance: This is typically found in a clinical study report with predefined endpoints.
• Sample size used for the test set and data provenance: While a "retrospective, single arm, clinical evaluation" is mentioned, no specific sample size for a "test set" is provided.
• Number of experts used to establish ground truth and their qualifications: Ground truth establishment by experts is relevant for studies involving AI/image analysis, not for this type of device submission.
• Adjudication method: Not applicable.
• Multi reader multi case (MRMC) comparative effectiveness study: Not applicable.
• Standalone (algorithm only) performance: Not applicable, as this is a physical implant, not an AI algorithm.
• Type of ground truth used: Not applicable in the context of this 510(k) submission.
• Sample size for the training set: Not applicable, as this is about a physical device, not an AI algorithm.
• How ground truth for the training set was established: Not applicable.

What the document does provide regarding device performance:

The document states that the TIDAL Fusion Cage System was subject to various benchtop and clinical performance tests to support the assertion of substantial equivalence. These tests primarily focus on the mechanical and material properties of the implant, comparing them to the predicate device.

Table of Benchtop Performance Tests (from section H. Comparison of Non-Clinical Performance):

Regarding the "Clinical Performance Evaluation" (from section I):

The document mentions a "retrospective, single arm, clinical evaluation of the TIDAL Fusion Cage using an intramedullary (IM) nail for tibiotalocalcaneal (TTC) fusion."

• Study Design: Retrospective, single-arm clinical evaluation.
• Comparison: Clinical performance was "evaluated against an IM nail for TTC fusion" (though it's a single-arm study, this implies a comparison to known performance of IM nails).
• Effectiveness Endpoints: Joint salvage with the TIDAL Fusion Cage in place at last follow-up, perceived physical function, and deformity correction.
• Safety Outcomes: Absence of a subsequent secondary surgical intervention and device-related serious adverse events on the affected joints.
• Sample Size and Data Provenance: Not specified in the document.
• Ground Truth: The "ground truth" here would be the clinical outcomes (joint salvage, function, adverse events) as observed in the patient population studied. The method for establishing this (e.g., patient records review, clinical examination) is not detailed.

Conclusion from section J:

"Based on the data submitted, any differences of the TIDAL Fusion Cage System do not raise any different questions of safety or effectiveness, therefore, demonstrates substantial equivalence to the predicate device." This statement implies that the conducted tests and evaluations were sufficient to meet the FDA's criteria for substantial equivalence, which is the primary "acceptance criterion" for a 510(k) submission.

In summary, the provided FDA clearance letter and 510(k) summary pertain to a physical medical device (implant) and do not describe an AI/software study involving ground truth, expert readers, or MRMC studies. The "acceptance criteria" here are demonstrating substantial equivalence through primarily benchtop testing and a limited clinical evaluation, not the performance metrics of a diagnostic algorithm.

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The Kinos Total Ankle System is indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. The Kinos Total Ankle System is additionally indicated for patients with failed previous ankle surgery. The Kinos Total Ankle System is intended for cement use only.

The subject Kinos Total Ankle System consists of implant and instrument components designed to preserve motion in patients with ankle arthritis or previously failed ankle surgery. The device is a fixed bearing and semi-constrained implant construct, intended for replacement of the articulating surfaces of the ankle that have been affected by a disease state or injury. The subject device provides limited mobility to a patient by restoring alignment of the articulating surfaces, reducing pain, and providing flexion- extension movement within the ankle joint. The tibial and talar implants are intended to be used with bone cement. The subject Kinos Total Ankle System consists of three implant components - a tibial implant affixed to the tibia, a bearing implant assembled to the tibial implant and a talar implant affixed to the talus. The tibial implant and bearing implant, assembled intraoperatively, function together and articulate with the talar implant to create a fixed bearing prosthesis, replacing the articulating surface of the tibiotalar joint. The subject line extension includes tibial segments which are assembled intraoperatively to the tibial base plate to enhance tibial fixation height in the tibia.

This document is a 510(k) Summary for the Kinos Total Ankle System. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria, particularly not in the context of an AI/ML-driven device.

The Kinos Total Ankle System is a physical medical device (an ankle prosthesis), and the submission is for an expansion of indications for use. The performance testing section specifically states: "No performance testing was performed to establish substantial equivalence of the subject device to the predicates." Instead, a "dimensional analysis comparison of device components and a surgical technique comparison" was conducted.

Therefore, I cannot provide the requested information, as the provided text relates to a traditional medical device and its regulatory submission, not a study validating an AI/ML device's performance against specific acceptance criteria.

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The r3 Tibial Implants of the Kinos Total Ankle System are indicated for revision total ankle arthroplasty. The Kinos Total Ankle System is intended for cement use only.

The subject line extension to the Kinos Total Ankle System are implant and instrument components designed to preserve motion in patients with ankle arthritis or previously failed ankle surgery. The device is a fixed bearing and semi-constrained implant construct, intended for replacement of the articulating surfaces of the ankle that have been affected by a disease state or injury. The subject device provides limited mobility to a patient by restoring alignment of the articulating surfaces, reducing pain, and providing flexion-extension movement within the ankle joint. The tibial and talar implants are intended to be used with bone cement. The subject Kinos Total Ankle System consists of three implant components - a tibial implant affixed to the tibia, a bearing implant assembled to the tibial implant and a talar implant affixed to the talus. The tibial implant and bearing implant, assembled intraoperatively, function together and articulate with the talar implant to create a fixed bearing prosthesis, replacing the articulating surface of the tibiotalar joint. The extension includes tibial segments which are assembled intraoperatively to the tibial base plate to enhance tibial fixation height in the tibia.

The provided document is an FDA 510(k) clearance letter for the Kinos Total Ankle System. This document focuses on the substantial equivalence of a new device (a line extension) to a previously cleared predicate device, rather than the performance of an AI/ML device.

Therefore, the information required to answer the prompt (acceptance criteria, study details for AI/ML device performance, sample sizes, expert involvement, ground truth, etc.) is not present in this document.

The document details the device's classification, indications for use, and a summary of performance testing primarily related to mechanical properties of the implant (e.g., fatigue testing, bone stability, assembly tests, porous surface characterization). This is typical for a medical device clearance that is a physical implant, not a software or AI/ML diagnostic tool.

In summary, this document does not contain the information requested in your prompt regarding AI/ML device acceptance criteria and performance study details.

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The restor3d Kinos Axiom Total Ankle System is indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. The restor3d Kinos Total Ankle System is additionally indicated for patients with failed previous ankle surgery. The restor3d Kinos Axiom Total Ankle System is intended for cement use only.

The subject restor3d Kinos Axiom Total Ankle System is an implant and instrument system designed to preserve motion in patients with ankle arthritis or previously failed ankle surgery. The device is a fixed bearing and semi-constrained implant construct, intended for replacement of the articulating surfaces of the ankle that have been affected by a disease state or injury. The device provides limited mobility to a patient by restoring alignment of the articulating surfaces, reducing pain, and providing flexion-extension movement within the ankle joint. The device is intended to be used with bone cement. The subject restor3d Kinos Axiom Total Ankle System consists of three implant components - a tibial implant affixed to the tibia, a bearing implant assembled to the tibial implant and a talar implant affixed to the talus. The tibial implant and bearing implant, assembled intraoperatively, function together and articulate with the talar implant to create a fixed bearing prosthesis, replacing the articulating surface of the tibiotalar joint.

The additively manufactured r3 talar dome and Vitamin E, cross-linked ultra-high molecular weight polyethylene (UHMWPE) r3 bearing component, subject of this 510(k), are compatible with:

• All Kinos Axiom Total Ankle System Tibial Tray Components and associated . instrumentation cleared via K192778
• All Kinos Axiom Total Ankle System X-Stem Tibial Components and associated . instrumentation cleared via K232595

This document is a 510(k) Summary for the restor3d Kinos Axiom Total Ankle System, which is a medical device. It does not describe an AI/ML-based device or a study involving human readers and AI assistance. The performance testing mentioned (ASTM F2665, engineering analyses) pertains to the mechanical and physical properties of the ankle implant, not to the performance of a software algorithm.

Therefore, most of the requested information (e.g., acceptance criteria for AI performance, sample size for test set/training set, ground truth establishment for AI, expert consensus, MRMC studies) is not applicable to this document.

The document discusses:

• Device Name: restor3d Kinos Axiom Total Ankle System
• Regulation Number: 21 CFR 888.3110 (Ankle Joint Metal/Polymer Semi-Constrained Cemented Prosthesis)
• Regulatory Class: Class II
• Product Code: HSN
• Indications for Use: Patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis, or failed previous ankle surgery. Intended for cement use only.
• Predicate Devices: Primarily INFINITY Total Ankle System (K123954) and SALTO TALARIS Total Ankle Prosthesis (K182878).
• Device Description: An implant and instrument system designed to preserve motion in patients with ankle arthritis or previously failed ankle surgery. It's a fixed bearing and semi-constrained implant construct, consisting of a tibial implant, a bearing implant (Vitamin E, cross-linked UHMWPE), and a talar implant (additively manufactured r3 talar dome).
• Performance Testing:
  • Contact Area Testing per ASTM F2665
  • Constraint Testing per ASTM F2665
  • Range of Motion Testing per ASTM F2665
  • Locking Mechanism Fatigue Strength Analysis per ASTM F2665
  • Implant Strength Engineering Analysis per ASTM F2665
  • Wear Engineering Analysis per ASTM F2665
• Conclusion: The device is substantially equivalent to predicate devices, and changes (additively manufactured talar component, Vitamin E cross-linked UHMWPE bearing component, design/size changes) do not raise new safety or effectiveness concerns.

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The restor3d lumbar cages are intended to be used as an intervertebral body fusion device with bone graft for use in lumbar spine. They are indicated for use in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels from L2-S1. DDD patients may also have up to grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Implants are used to facilitate fusion in the lumbar spine using autograft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. The device is intended to be used with supplemental fixation systems that have been cleared for use in the lumbar spine.

The restor3d TiDAL Lumbar Interbody Fusion System are additively manufactured Titanium Alloy (Ti-6AL-4V per ASTM F2924) implants, designed for use as a lumbar interbody fusion device. They are provided sterile-packed. The system is comprised of various sizes to accommodate individual patient anatomy as well as multiple designs to support several surgical techniques (PLIF, ALIF, OLIF, LLIF). Each approach includes several offerings that vary by footprint (width and depth/length), height, and lordotic angle. All sizes have a large central window(s) for packing autogenous bone graft and/or allogenic bone graft. The inferior and superior faces have endplate surface lattices as well as teeth to resist migration when placed in between the vertebral bodies.

This document is a 510(k) premarket notification for a medical device called the "restor3d TiDAL Lumbar Interbody Fusion System." It's essentially an application to the FDA to market a new device by demonstrating that it's "substantially equivalent" to an already legally marketed device (the predicate device).

The request asks about acceptance criteria and a study that proves the device meets those criteria, typically found in the context of AI/ML-driven medical devices or diagnostic tools. However, the provided text describes a spinal implant (a physical device for interbody fusion in the lumbar spine), not an AI/ML-driven diagnostic or assistive technology. As such, the concepts of "acceptance criteria" and a "study that proves the device meets acceptance criteria" for AI performance metrics (like accuracy, sensitivity, specificity, expert consensus, MRMC studies, etc.) are not applicable to this type of medical device as described in the provided document.

Instead, for a physical implant like the restor3d TiDAL Lumbar Interbody Fusion System, "acceptance criteria" are related to mechanical properties, biocompatibility, sterilization, and manufacturing quality. The "study that proves the device meets acceptance criteria" would involve performance testing (e.g., mechanical testing to prove strength and durability, sterilization validation, cleaning validation, and biocompatibility testing).

Let's break down what is provided and why the requested information isn't directly present in the context of an AI/ML device:

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

• Not applicable in the AI/ML sense. For this implant, "acceptance criteria" would relate to standards for its material properties, manufacturing tolerances, and mechanical performance (e.g., compression strength, fatigue life). The document states that performance testing was conducted:
  • Cleaning per ISO 17664-1, AAMI TIR30, and ASTM F565.
  • Sterilization per ISO 17665-1, ISO 17665-3, AAMI TIR 12, ISO 11737-1, ISO 11737-2, and ASTM F565.
  • Biocompatibility per ISO 10993-1.
• The reported device performance is implicitly that it met the requirements of these standards, allowing the FDA to determine substantial equivalence. The document doesn't provide specific numerical results from these tests (e.g., actual measured compression strength in Newtons) but rather states the standards followed.

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

• Not applicable in the AI/ML sense. There isn't a "test set" of images or patient data for an algorithm. The testing involves physical prototypes of the implant. The sample size for mechanical testing (e.g., how many implants were tested) is not specified in this summary but would be detailed in the full submission.

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

• Not applicable. This relates to clinical or image-based ground truth for AI. For an implant, ground truth is established through adherence to engineering standards and material science.

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

• Not applicable. This refers to consensus reading for AI ground truth.

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 type of clinical study for diagnostic devices (often AI-assisted). This document is for a physical implant.

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

• Not applicable. No algorithm is being assessed.

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

• For a physical implant, the "ground truth" for performance is defined by established international and national standards (e.g., ISO, ASTM, AAMI) for mechanical properties, material safety, and manufacturing quality. Meeting these standards serves as the "ground truth" for device safety and effectiveness.

8. The sample size for the training set:

• Not applicable. No AI algorithm is being trained.

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

• Not applicable. No AI algorithm is being trained.

Summary with respect to the provided document:

The provided document is a 510(k) summary for a physical medical implant (lumbar interbody fusion system), not a software or AI-driven device. Therefore, most of the questions, which are tailored to evaluating AI/ML medical devices, are not applicable.

The "acceptance criteria" for this device are the successful completion of various performance tests according to recognized standards as listed in Section G:

• Cleaning: ISO 17664-1, AAMI TIR30, ASTM F565
• Sterilization: ISO 17665-1, ISO 17665-3, AAMI TIR 12, ISO 11737-1, ISO 11737-2, ASTM F565
• Biocompatibility: ISO 10993-1

The "study that proves the device meets the acceptance criteria" is the performance testing described in Section G. The outcome of these tests is stated indirectly by the FDA's decision of "substantial equivalence" based on "comparison to the predicate device" and confirmation that the additional components (disc preparation instruments) do "not raise any additional questions of safety and effectiveness."

No details on sample sizes for these physical tests are provided in this summary, nor are specific numerical results, as these are typically part of a more extensive technical file submitted to the FDA rather than the public 510(k) summary.

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The Kinos Axiom Total Ankle System is indicated for patients with ankle joints damaged by severe rheumatoid, posttraumatic, or degenerative arthritis. The Kinos Total Ankle System is additionally indicated for patients with failed previous ankle surgery. The Kinos Axiom Total Ankle System is intended for cement use only.

The subject Kinos Axiom Total Ankle System is an implant and instrument system designed to preserve motion in patients with ankle arthritis or previously failed ankle surgery. The device is a fixed bearing and semi-constrained implant construct, intended for replacement of the articulating surfaces of the ankle that have been affected by a disease state or injury. The device provides limited mobility to a patient by restoring alignment of the articulating surfaces, reducing pain, and providing flexion-extension movement within the ankle joint. The device is intended to be used with bone cement. The subject Kinos Axiom Total Ankle System consists of three implant components - a tibial implant affixed to the tibia, a bearing implant assembled to the tibial implant and a talar implant affixed to the tibial implant and bearing implant, assembled intraoperatively, function together and articulate with the talar implant to create a fixed bearing prosthesis, replacing the articulating surface of the tibial-talar joint. The subject line extension tibial implant is additively manufactured from Ti-6A1-4V (ASTM F2924) and features a modified stem for fixation into the tibia.

The provided text is a 510(k) Summary for the Kinos Axiom Total Ankle System. It describes the device, its intended use, and its substantial equivalence to predicate devices, but does not contain information about acceptance criteria or specific study results that prove the device meets acceptance criteria.

Specifically, the document lists "Performance Testing" with bullet points for:

• Strength Testing per ASTM F2665
• Bone Stability Testing
• Porous Surface Characterization
• Biocompatibility per ISO 10993-1:2018

However, it does not provide:

• A table of acceptance criteria and reported device performance. It only lists the types of tests conducted.
• Sample sizes used for any test sets.
• Data provenance for any test sets.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication methods.
• Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or effect sizes.
• Information on standalone algorithm performance.
• Type of ground truth used.
• Sample size for any training set.
• How ground truth for a training set was established.

Therefore, I cannot fulfill your request for this information based on the provided text. The document is a regulatory submission demonstrating substantial equivalence, not a detailed report of clinical or performance study results.

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The Extremity Staple System is indicated for use in fracture, osteotomy fixation and joint arthrodesis as well as fixation of bone fragments (i.e., small fragments of bone which are not comminuted to the extent that preclude staple placement). The device is intended for use in short, long, or flat bones. The Extremity Staple System is intended for single use only.

The Extremity Staple System, which consists of the Extremity Staple and associated instruments, is intended for use for fixation and compression and supports several surgical techniques (e.g., fracture, osteotomy, joint arthrodesis, and fixation of bone fragments). The staples are made of implant-grade Nitinol and are designed to exhibit superelastic properties at room temperature. This allows for continued compression to be applied across bone segments, thus enhancing long-term stability and promoting fusion. Each staple is pre-loaded on an inserter for implantation and sterile packed. The staples are available in multiple sizes, varying by bridge length and leg length, to accommodate individual patient anatomy. Disposable Instrumentation is provided to assist in the surgical placement of the Extremity Staple.

The provided text describes a medical device, the "Extremity Staple," and its regulatory review for substantial equivalence to existing predicate devices. However, this document does not contain any information regarding acceptance criteria, device performance metrics, or details of a study involving AI or human reader performance.

The document solely focuses on:

• Regulatory Clearance: A letter from the FDA confirming substantial equivalence (K231458).
• Device Description: What the Extremity Staple is, its material (Nitinol), and its intended use (fracture, osteotomy fixation, joint arthrodesis, fixation of bone fragments).
• Predicate Devices: Identification of similar devices already on the market (BME Speed™ Implant and BioPro Memory Staple).
• Comparison to Predicates: Discussion of similarities and differences in material, design, technological characteristics, and intended use.
• Performance Testing (Mechanical): A list of mechanical tests conducted (ASTM F564-17 for static/dynamic bend and pull-out, ASTM F2129-19a for cyclic corrosion) to demonstrate mechanical performance for its intended use and support substantial equivalence.

Therefore, I cannot provide the requested information about acceptance criteria, reported device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, as these details are not present in the provided text.

The document explicitly states: "The results of this non-clinical testing demonstrate that the mechanical performance of the Extremity Staple is sufficient for its intended use and no new questions of safety or effectiveness were identified during device testing; therefore, the Extremity Staple is considered substantially equivalent to the BME Speed™ predicate device." This indicates that the mechanical tests were used to support substantial equivalence, but it does not provide specific performance metrics or acceptance criteria in the format requested.

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