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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 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 MTP Implant is intended for use as a hemi-arthroplasty implant for the first metatarsophalangeal joint, for the treatment of degenerative and post-traumatic arthritis, hallux rigidus, and an unstable or painful metatarsophalangeal (MTP) joint. The device is a single use implant intended to be press fit with optional use of bone cement.

The restor3d MTP Implant is a sterile, single use implant grade metal device, available in varied articulating surface coverages. The restor3d MTP implant is designed to replace damaged articulating surface of the first metatarsal distal head. The device is intended for the treatment of patients with degenerative and post-traumatic arthritis in the first metatarsal joint in the presence of good bone stock and integrity of the first metatarsal head. This implant can also be used in the following clinical conditions: hallux valgus or hallux limitus, hallux rigidus, and an unstable or painful metatarsal/phalangeal (MTP) joint. The implant is a single use product intended to be press fit, with optional use of bone cement.

The restor3d MTP Implant is comprised of a single laser powder bed fusion (LPBF) printed cobalt-chromium alloy (Co28Cr6Mo) part. The external surface of the implant that is intended to be in contact with the phalanx is mirror polished.

The provided document is a 510(k) premarket notification for a medical device called the "restor3d MTP Implant". It focuses on establishing substantial equivalence to a predicate device rather than describing an AI/ML powered device or a comparative effectiveness study involving human readers. Therefore, much of the requested information regarding acceptance criteria, study details for AI/ML performance, sample sizes for test/training sets, expert involvement, and ground truth establishment is not present in this document.

However, I can extract the information related to the device's performance testing to support its substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a typical "Pass/Fail" format. Instead, it describes a set of performance tests conducted to demonstrate substantial equivalence to a predicate device. The implied acceptance is that the restor3d MTP Implant performs similarly to or meets the standards demonstrated by the predicate device for the specified tests.

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

This document does not describe tests related to AI/ML or diagnostic performance based on data sets. The tests mentioned are mechanical and material property tests of the physical implant. Therefore, "sample size for the test set" in the context of image data or patient data, and "data provenance" (country of origin, retrospective/prospective) are not applicable or mentioned.

3. 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 physical medical device (implant) and the document describes mechanical/material testing, not diagnostic performance evaluated by experts.

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

Not applicable. Adjudication methods are typically used for reconciling expert opinions in diagnostic studies, which is not the subject of this submission.

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 document is for a physical orthopedic implant, not an AI/ML-powered diagnostic tool.

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

Not applicable. This document is for a physical orthopedic implant, not an AI/ML algorithm.

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

For the mechanical and material tests described, the "ground truth" would be established by adherence to recognized engineering standards and test methods. For example, material properties are verified against industry standards for cobalt-chromium alloys, and mechanical tests (compression, bending, shear, fatigue, abrasion) would be assessed against benchmarks derived from the predicate device's performance or industry-accepted performance criteria for such implants. The document does not specify these detailed standards but implies compliance with generally accepted testing methodologies for orthopedic implants.

8. The sample size for the training set

Not applicable. There is no mention of an AI/ML component or a training set.

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

Not applicable. There is no mention of an AI/ML component or a training set.

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The restor3d Utility Wedges are intended to be used for internal bone fractures or osteotomies in the ankle and foot, such as:

• · Opening wedge osteotomies of the foot including osteotomies for Hallux Valgus
• · Opening wedge of Medial Cuneiform or Cotton osteotomies
• · Lateral Column Lengthening (Evans Lengthening Osteotomy or Calcaneal Z Osteotomy)
• · Metatarsal Cuneiform osteotomies
• · Nonunion of arthrodesis of the Midfoot including Metatarsal Cuneiform osteotomies (TMT or Lapidus)
• · Hindfoot osteotomies such as Ankle fusion and Subtalar fusion

The restor3d Utility Wedges are intended for use with supplemental fixation. The restor 3d Utility Wedges are not intended for use in the spine.

The proposed Utility Wedge is a sterile, single use medical grade titanium alloy (Ti-6Al-4V) device, available in varied footprints and heights, designed for opening and lengthening osteotomy procedures of the foot, including Lapidus and Subtalar.

The provided text is a 510(k) Summary for the restor3d Utility Wedge. It describes the device, its intended use, and its substantial equivalence to predicate devices, supported by benchtop performance testing. However, it does not contain the detailed information necessary to answer all parts of your request, particularly regarding acceptance criteria and study details that would typically be found in a clinical study report or a more comprehensive validation summary for a device involving AI or human interpretation.

Based on the provided text, here's what can be extracted and what information is missing:

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

The document mentions three benchtop performance tests:

• Static Compressive Strength
• Dynamic Compressive Strength
• Expulsion

It states, "No new questions of safety or effectiveness were identified during device testing." However, specific acceptance criteria (e.g., minimum compressive strength in Newtons, or maximum displacement under dynamic load) and the reported device performance against these criteria are not provided in this summary.

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

This information is not provided. The summary refers to "benchtop performance tests" rather than tests involving patient data.

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 as the summary describes benchtop tests, not tests involving expert interpretation or medical imaging.

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

This information is not applicable as the summary describes benchtop tests, not tests involving expert interpretation or medical imaging.

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

There is no mention of a multi-reader multi-case (MRMC) study, AI assistance, or human readers. This device is a physical implant, not an AI-enabled diagnostic tool.

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

This information is not applicable as this is a physical medical device (an osteotomy wedge), not an algorithm or AI system.

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

For the benchtop tests, the "ground truth" would be the engineering specifications and relevant testing standards (e.g., ASTM or ISO standards for mechanical testing of implants), but these specific standards or criteria are not detailed in this summary.

8. The sample size for the training set

This information is not applicable as this is a physical medical device, not an AI model requiring a training set.

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

This information is not applicable as this is a physical medical device, not an AI model.

In summary: The provided document is an FDA 510(k) summary for a physical orthopedic implant. It outlines the device's indications for use and states that substantial equivalence was supported by benchtop mechanical testing. However, it does not provide the detailed acceptance criteria, specific performance results, or study methodologies that would be relevant for an AI/software device or a clinical study involving human interpretation. The questions regarding AI, human readers, ground truth establishment for training/test sets, and expert qualifications are not applicable to the information contained within this specific 510(k) summary.

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