Search Results

Components of the Signature Orthopaedics hip replacement range are intended to replace a hip joint where bone stock is sufficient to support the implant. When a surgeon has selected prosthetic replacement as the preferred treatment, the devices are indicated for:

• Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis
• Inflammatory joint disease including rheumatoid arthritis
• Correction of functional deformity including congenital hip dysplasia & fracture non-union or mal-union
• Traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture
• Failed previous hip surgery including internal fixation or joint fusion, hemiarthroplasty, surface replacement, or total hip replacement
• Dislocation risks (when used with SignaSure Dual Mobility System)

Signature Orthopaedics' Longboard Revision Stem is intended for individuals undergoing revision surgery of the hip only.

Signature Orthopaedics' Origin, Origin TT, Aria, Remedy, Origin-NS, Pegasus, Spartan, World, Everglade and Longboard Hip femoral stems, SignaSure Cementless Cups, Logical and World Acetabular Cups are intended for cementless fixation only.

The Longboard Revision Stem is a femoral stem and a partially threaded distal locking screw intended for single use and cementless fixation for revision hip arthroplasties. The components are manufactured from titanium alloy as per ISO 5832-3 and ASTM F136 and the stem has a titanium alloy grit blast along the body. The Longboard Revision Stem is a symmetrical with a neck angle of 135°. The stem body is tapered and finned, while the distal tip is finless to allow for initial version adjustments. The stem neck features a 12/14 taper which allows for compatibility with Signature Orthopaedics' range of previously cleared femoral head components.

This FDA 510(k) Clearance Letter for the Longboard Revision Hip Stem describes a medical device (an orthopedic implant), not a software or AI/ML-based device. Therefore, the questions regarding acceptance criteria and study design for performance evaluation of algorithms and AI/ML systems (e.g., sensitivity, specificity, MRMC studies, ground truth establishment by experts) are not applicable to this document.

The document focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance testing for mechanical properties and material characteristics, as is standard for orthopedic implants.

Here's an analysis of the provided information relevant to the device's acceptance criteria and the study that proves it meets them, framed within the context of a physical medical device:

Acceptance Criteria and Study Proving Device Meets Acceptance Criteria

For physical medical devices like the Longboard Revision Hip Stem, acceptance criteria primarily revolve around:

1. Safety and Effectiveness: Ensuring the device is safe for its intended use and performs as expected.
2. Biocompatibility: Materials used must be compatible with the human body.
3. Mechanical Performance: The device must withstand anticipated physiological loads and stresses without failure for its expected lifespan.
4. Conformity to Standards: Compliance with established industry and regulatory standards.
5. Substantial Equivalence: Demonstrating that the device is as safe and effective as a legally marketed predicate device.

The study described to prove the device meets these criteria is the non-clinical performance testing and engineering evaluations.

1. Table of Acceptance Criteria and the Reported Device Performance

The document doesn't provide a precise "table" of numerical acceptance criteria in the format typically seen for AI/ML performance (e.g., "Sensitivity >= X%"). Instead, acceptance is inferred from the successful completion of specified engineering tests and adherence to industry standards, followed by a conclusion of substantial equivalence.

• ISO 21535 (Hip Joint Replacement Implants)
• ASTM F2996 (FEA for Hip Femoral Stems)
• ISO 7206-4 (Endurance of Stemmed Femoral Components)
• ISO 7206-6 (Endurance of Neck Region)
• ASTM F543 (Metallic Medical Bone Screws) |
  | Substantial Equivalence: The device is as safe and effective as existing legally marketed predicate devices. | "The Longboard Revision Hip Stem have the same intended use and same indications for use as the predicate devices. The subject devices use the same operating principle, incorporate the same basic design, and are manufactured using the same materials as the predicate devices. Any differences do not raise new questions of safety and effectiveness as established with performance testing. The subject devices are at least as safe and effective as the legally marketed predicate devices." |

Information Not Applicable/Provided for a Physical Device:

The following points are primarily relevant to software, AI/ML, or diagnostic devices, and therefore are not applicable to this 510(k) for a physical orthopedic implant:

2. Sample size used for the test set and the data provenance: Not applicable. Testing is primarily mechanical/physical on device samples, not on patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical implant is its physical behavior under load, measured by engineering methods, not expert consensus on images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 for diagnostic interpretation, not an implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm here.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable in the context of image interpretation. Ground truth for this device is mechanical integrity, material properties, and functionality under specified conditions, verified by laboratory testing.
8. The sample size for the training set: Not applicable as there is no training set for a mechanical device.
9. How the ground truth for the training set was established: Not applicable.

In summary: The clearance of the Longboard Revision Hip Stem relies on non-clinical, laboratory-based mechanical and materials testing of physical device samples against established industry standards and comparison to predicate devices, to demonstrate its safety and effectiveness for its intended use, rather than on clinical data or AI/ML performance metrics.

Ask a specific question about this device

The Signature Orthopaedics Freedom Cervical Screw and Rod System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients (C1 to C7) as an adjunct to fusion in the treatment of the following acute and chronic instabilities and deformities of the cervical spine:

• traumatic spinal fractures and/or traumatic dislocations
• instability or deformity; failed previous fusions (e.g. pseudarthrosis)
• degenerative disease, including neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability, and
• short term stabilization of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom expectancy is of insufficient duration to permit achievement of fusion.

The Freedom™ Posterior Cervical Screw System consists of screws, longitudinal rods and cross connectors in a variety of sizes to accommodate differing anatomic requirements. The cervical screws are inserted into adjacent vertebrae, then rods are clamped into the tulip of the pedicle screw using the cap screw, thus immobilising the instrumented vertebrae. The cross-connector may then be attached between rods to improve stability. The system components are made of Ti6Al4V alloy and are supplied sterile.

The provided FDA 510(k) clearance letter pertains to the Freedom Posterior Cervical Screws, which is a medical device and not an AI/ML-driven software system. As such, the information you've requested regarding acceptance criteria, study details, sample sizes, ground truth, and human reader performance is not applicable to this type of device submission.

The FDA clearance for this device is based on demonstrating substantial equivalence to a legally marketed predicate device, primarily through non-clinical performance testing and engineering evaluations. These tests focus on the physical and mechanical properties of the screws to ensure they are safe and effective for their intended use as a spinal implant.

Here's a breakdown of the relevant information provided in the document concerning the device's performance:

1. Table of Acceptance Criteria and Reported Device Performance

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

• The document states that "worst-case sizes of the subject cervical screws" were tested.
• Sample size: Not explicitly quantified with a specific number of units, but implied it was a representative selection of "worst-case sizes."
• Data provenance: The tests were "non-clinical testing and engineering evaluations" conducted by the manufacturer, Signature Orthopaedics Pty Ltd, in Australia. This is a form of prospective testing done specifically for regulatory submission.

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

• Not applicable. This is a hardware device where "ground truth" is established through engineering principles and physical testing against established ASTM standards, not through expert human interpretation or diagnosis.

4. Adjudication method for the test set:

• Not applicable. This involves objective mechanical testing, where results are measured directly against predefined acceptance criteria from engineering standards. There is no subjective adjudication process for establishing a "ground truth" as would be the case for image interpretation or diagnostic performance.

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 surgical implant, not an AI-assisted diagnostic tool. Therefore, no MRMC studies or human reader performance evaluations were conducted or are relevant.

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

• Not applicable. This is a physical product, not a software algorithm.

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

• The "ground truth" for this device's performance is derived from established mechanical and material engineering standards (ASTM standards). The device's components must meet or exceed the performance specifications (e.g., strength, fatigue resistance) outlined in these standards to be deemed safe and effective for their intended surgical purpose.

8. The sample size for the training set:

• Not applicable. This refers to a dataset used to train an AI model. This device is hardware and does not involve a training set.

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

• Not applicable. As above, there is no training set for this type of medical device submission.

Ask a specific question about this device

Components of the Signature Orthopaedics range of soft tissue fixation devices are intended to reattach ligament, tendon or soft tissue to bone. Specifically, the BI-ON Screw and Anchor, BI-ON Bio-screw and Bio-anchor, Vector Knotted, ATOK, Vortex Anchor, Dynaloc Anchor and Shoulder Suture Anchor are indicated for use in the shoulder, including:

Shoulder

• Capsular stabilization
  • Bankart Repair
  • Anterior shoulder instability
  • SLAP lesion repairs
  • Capsular shift or capsulolabral reconstructions
• Acromioclavicular separation repairs
• Deltoid repairs
• Rotator cuff tear repairs
• Biceps tenodesis

The Shoulder Soft Tissue Anchor System consists of a range of implants for soft tissue fixation to bone in the shoulder joint. The soft tissue anchors are manufactured from PEEK OPTIMA LT1 (ASTM F2026) or a PEEK/Hydroxyapatite composite and are available as knotted and knotless variants. Several of the soft tissue anchor variants are supplied preloaded with sutures and preassembled onto a driver. The UHMWPE (HS fibre) sutures are finished devices externally supplied by RiverPoint Medical and previously cleared through 510(k) K10006. All components are intended for single use only.

The following variants are included in the range of Shoulder Soft Tissue Anchors:

• Turbine Anchor
• Mini Incision Anchor
• Turbine OP Anchor
• Vortex Anchor
• Vector Anchor
• DynaLoc Anchor
• BI-ON Bio Anchor
• Arthroscopic Transosseous Knotless (ATOK) Anchor

The provided 510(k) clearance letter is for a medical device (Shoulder Soft Tissue Anchors), not an AI/software device. Therefore, the questions regarding acceptance criteria, study design for AI models, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, and standalone algorithm performance do not apply to this document.

This document describes the process for clearing a physical medical device (soft tissue anchors) through the FDA's 510(k) pathway, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through non-clinical performance testing.

However, based on the information provided, I can extract the following relevant details about the device and its testing:

1. Acceptance Criteria and Reported Device Performance:

The document states that the "results of non-clinical testing show that the strength of the Signature Orthopaedics Shoulder Soft Tissue Anchor System is sufficient for their intended use and substantially equivalent to legally marketed predicate devices."

While specific numerical acceptance criteria (e.g., minimum pull-out strength in Newtons) and corresponding reported performance values are not detailed in this public clearance letter, the overall conclusion indicates that the device met the established performance thresholds for mechanical strength. The "acceptance criteria" for a physical device like this would typically be defined as meeting or exceeding the performance of the predicate device(s) or generally accepted engineering standards for comparable devices, often expressed as quantitative values for specific mechanical tests.

The relevant performance tests conducted were:

• Anchor insertion testing
• Anchor pull-out testing
• Anchor torque to failure testing
• Anchor fatigue testing

These tests were performed using ASTM F543 as a guide. This ASTM standard provides guidance for "Standard Practice for Metallic Medical Bone Screws," which would be appropriately adapted for bone anchors.

Therefore, a table of specific numerical acceptance criteria and reported device performance cannot be generated solely from this document. The document only provides the conclusion that the device met these criteria through testing.

The remaining questions are not applicable to the content of this 510(k) clearance letter for a physical implantable device.

Ask a specific question about this device

Components of the Signature Orthopaedics hip replacement range are intended to replace a hip joint where bone stock is sufficient to support the implant. When a surgeon has selected prosthetic replacement as the preferred treatment, the devices are indicated for:

• Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis
• Inflammatory joint disease including rheumatoid arthritis
• Correction of functional deformity including congenital hip dysplasia
• Traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture
• Failed previous hip surgery including internal fixation or joint fusion, reconstruction, hemiarthroplasty, surface replacement, or total replacement

Signature Orthopaedics' Origin, Origin TT, Aria, Remedy, Origin-NS, Pegasus, Spartan, World and Everglade Hip femoral stems, SignaSure Cementless Cups, Logical and World Acetabular Cups are intended for cementless fixation only.

Signature Orthopaedics' Evolve, Cemented TSI (both CoCr and HNSS variants), and Origin Cemented femoral stems and SignaSure Cemented Cups are intended for cemented fixation only.

Signature Orthopaedics' SignaSure Logical/World Metal Insert is indicated for use with a cementless Signature Orthopaedics' Logical/World Acetabular Cup to provide dual mobility articulation.

Signature Orthopaedics' constrained liner components are indicated particularly for patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability.

Signature Orthopaedics' Evolve UniPolar Head and BiPolar Head are intended for hemi-hip arthroplasty only, where the natural acetabulum does not require replacement. The Evolve UniPolar Head and BiPolar Head are indicated for bone fractures or pathologies involving only the femoral head/neck and/or proximal femur, such as:

• Acute femoral head or neck fracture
• Fracture dislocation of the hip
• Avascular necrosis of the femoral head
• Non-union of femoral neck fractures
• Certain high subcapital and femoral neck fractures in the elderly
• Degenerative arthritis involving only the femoral head

Signature Orthopaedics' Origin™ Cemented Hip Stems are manufactured from nitrogen stainless steel per ASTM F1568 and ISO 5832-9. The subject stem is straight and tapered with a lateral chamfer. The Cemented Origin™ stem is polished and intended for cemented use in total hip arthroplasty. It features a 12/14 taper which allows for compatibility with Signature Orthopaedics' range of previously cleared femoral head components including the Signature CoCr Femoral Heads (K121297 and K163081), Signature Ceramic Femoral Heads (K190704), Signature BiPolar Head (K133370 and K163081) and Evolve UniPolar Head (K143184). Compatible acetabular cups and liners including the Logical Cup (G-Series K121297, PX-Series K121297 and C-Series K153131) and the Logical Liners (Neutral and 10º Hooded, Lateralised K121297), Logical Liners (20º Hooded, Lateralised 20º Hooded K153131), Logical Constrained Liners (K153131) and Logical Liners Vit-E (Neutral and 10º Hooded, Lateralised, 20º Hooded, Lateralised 20º Hooded, High Wall, 10º Face Changing (K241690).

Based on the provided FDA 510(k) Clearance Letter for the Origin™ Cemented Hip Stem, there is no information present regarding acceptance criteria or a study proving that the device meets specific acceptance criteria in the context of an AI/human reader performance study.

This document is a 510(k) clearance for a physical medical device (a hip stem), not a software or AI-enabled device that would typically involve acceptance criteria related to accuracy, sensitivity, specificity, or human reader performance. The "Performance Testing" section refers to non-clinical mechanical and fatigue testing of the physical hip stem, not a clinical or human-in-the-loop study as described in your request.

Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria, sample sizes for test sets, expert involvement, adjudication, MRMC studies, standalone performance, or ground truth establishment for AI/human reader studies.

If you have a document related to an AI/software device, please provide that, and I would be happy to analyze it against your criteria.

Ask a specific question about this device

Components of the Signature Orthopaedics hip replacement range are intended to replace a hip joint where bone stock is sufficient to support the implant. When a surgeon has selected prosthetic replacement as the preferred treatment, the devices are indicated for:

• · Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis
• · Inflammatory joint disease including rheumatoid arthritis
• · Correction of functional deformity including congenital hip dysplasia
• · Traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture
• Failed previous hip surgery including internal fixation or joint fusion, reconstruction, hemiarthroplasty, surface replacement, or total replacement

Signature Orthopaedics' Origin TT, Aria, Remedy, Origin-NS, Pegasus, Spartan, World and Everglade Hip femoral stems, SignaSure Cementless Cups, Logical and World Acetabular Cups are intended for cementless fixation only.

Signature Orthopaedics' Evolve, Cemented TSI (both CoCr and HNSS variants), Origin Cemented femoral stems and SignaSure Cemented Cups are intended for cemented fixation only.

Signature Orthopaedics' SignaSure Logical/World Metal Insert is indicated for use with a cementless Signature Orthopaedics' Logical/World Acetabular Cup to provide dual mobility articulation.

Signature Orthopaedics' constrained liner components are indicated particularly for patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability.

Signature Orthopaedics' Evolve UniPolar Head and BiPolar Head are intended for hemi- hip arthroplasty only, where the natural acetabulum does not require replacement. The Evolve UniPolar Head are indicated for bone fractures or pathologies involving only the femoral head/neck and/or proximal femur, such as:

• · Acute femoral head or neck fracture
• · Fracture dislocation of the hip
• · Avascular necrosis of the femoral head
• · Non-union of femoral neck fractures
• · Certain high subcapital and femoral neck fractures in the elderly
• · Degenerative arthritis involving only the femoral head

The Signature Orthopaedics Origin™ TT Stem is intended for single use and cementless fixation. It is manufactured from titanium alloy as per ISO 5832-3 and has a proximal plasma spray coating of titanium as per ASTM F1580 and hydroxyapatite as per ISO 13779-2. It features a 12/14 taper and is compatible for use with Signature CoCr Femoral Heads (K121297 and K163081), Ceramic Femoral Heads (K190704), Logical™ PX, G and C Series Acetabular Cups (K121297 and K153131), Logical™ Liners (K121297, K153131 and K241690), Logical™ Constrained Liners (K153131), BiPolar Heads (K133370 and K163081) and Evolve™ UniPolar Heads (K143184).

The provided text describes the regulatory review for a medical device called the "Origin™ TT Stem," which is a femoral hip prosthesis. However, the document does not contain any information regarding acceptance criteria, study methodologies for device performance, sample sizes, expert involvement, ground truth establishment, or multi-reader multi-case studies.

The document primarily focuses on:

• Regulatory classification and product codes for the device.
• Indications for Use of the hip replacement system, including various components beyond just the Origin™ TT Stem.
• Comparison to predicate devices to establish substantial equivalence.
• Non-clinical performance testing (Range of Motion, Stem and Neck Fatigue FEA, Stem and Neck Fatigue Testing) conducted according to established ISO and ASTM standards to demonstrate the strength and safety of the device.

Therefore, I cannot provide the requested table or answer the specific questions about the study that proves the device meets acceptance criteria, as this information is not present in the provided text.

The document states:

• "Non-clinical testing and engineering evaluations were conducted to verify that the performance of the Signature Orthopaedics Origin™ TT Stem is adequate for anticipated in-vivo use."
• "The results of non-clinical testing show that the strength of the Signature Orthopaedics Origin™ TT Stem is sufficient for their intended use and substantially equivalent to the legally marketed predicate device."

This indicates that internal testing was performed, but the details of the "acceptance criteria" and the specific data from these tests are not provided in the 510(k) summary. The document focuses on demonstrating that the device meets existing standards (ISO, ASTM) and is substantially equivalent to predicate devices, rather than presenting a clinical study with detailed performance metrics against specific acceptance thresholds.

Ask a specific question about this device

Components of the Signature Orthopaedics hip replacement range are intended to replace a hip joint where bone stock is sufficient to support the implant. When a surgeon has selected prosthetic replacement as the preferred treatment, the devices are indicated for:

· Non-inflammatory degenerative ioint disease including osteoarthritis or avascular necrosis

• · Inflammatory joint disease including rheumatoid arthritis
• · Correction of functional deformity including congenital hip dysplasia
• · Traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture

· Failed previous hip surgery including internal fixation or joint fusion, reconstruction, hemiarthroplasty, surface replacement, or total replacement

Signature Orthopaedics' World Cup components are intended for cementless fixation only.

The primary purpose of this Special 510(k) Device Modification to devices cleared as part of the World Cup System (K201278 and K241690) is to notify the FDA of additional geometrical variants of the World liner available in crosslinked UHMWPE (XLPE) and Vitamin-E Stabilized, 100kGy crosslinked UHMWPE (Vit-E HXLPE) material options.

The World Liners are compatible with World Acetabular Cups and are available in neutral, and hooded, lateralised, high wall, face changing and eccentric variants. The liners are designed to sit within an acetabular shell and articulate with a femoral head.

The provided document is an FDA 510(k) clearance letter for a medical device called "World Liner," which is a component of a hip replacement system. It primarily details the regulatory clearance process, the device's indications for use, and a comparison to predicate devices, emphasizing that the new "World Liner" variants are substantially equivalent to previously cleared versions.

However, this document does not contain any information about acceptance criteria, specific study designs (like MRMC or standalone performance studies), sample sizes for test or training sets, expert qualifications, or ground truth establishment methods as would be expected for an AI/ML-based device submission.

The "Performance Testing" section is extremely brief and only mentions "Engineering evaluations" and "Range of Motion assessment per ISO 21535." These are typical for mechanical devices to demonstrate physical performance and compatibility, not for evaluating the performance of an AI/ML algorithm.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance: This information is not present.
• Sample sizes used for the test set and data provenance: Not mentioned.
• Number of experts used to establish ground truth and qualifications: Not mentioned, as there is no apparent AI/ML ground truth evaluation.
• Adjudication method: Not mentioned.
• MRMC comparative effectiveness study details: Not mentioned.
• Standalone performance details: Not mentioned.
• Type of ground truth used: Not mentioned.
• Sample size for the training set: Not mentioned.
• How ground truth for the training set was established: Not mentioned.

This document is for a mechanical medical device (hip liner), not an AI/ML-driven device. As such, the type of performance data and evaluation criteria you are asking about (which are relevant for AI/ML) are not applicable or present in this context.

Ask a specific question about this device

The patient should be skeletally mature to receive a knee replacement. The Rx Knee System is indicated for temporary use (maximum 180 days) as an adjunct to total knee replacement (TKR) in patients undergoing a two-stage procedure due to a septic process and where gentamicin is the most appropriate antibiotic based on the susceptibility pattern of the infecting micro-organism(s). The device is intended for use in conjunction with systemic antimicrobial therapy (standard treatment approach to an infection).

The device is intended for use with the gentamicin-loaded cement. Palacos® G.

The Rx Knee System is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g., resection arthroplasty, fusion etc.).

The device is only indicated for patients who will consistently use traditional mobility assist devices (e.g., crutches, walkers, canes) throughout the implantation period, allowing basic joint mobility.

The Rx Knee System is a temporary knee device consisting of femoral, all polyethylene tibial and patellar components, with femoral and tibial augments and a tibial or universal stem to accommodate for variants in patient anatomy. The femoral component is available in posterior stabilised and cruciate retaining variants intended for use with corresponding all polyethylene tibia variants that have been previously cleared as part of Signature Orthopaedics' World Knee System via K181530. The femoral and tibial components have been previously cleared as part of Signature Orthopaedics' World Knee System via K181530, K220737 and K223062. All Rx Knee System components are intended for use with FDA-cleared gentamicin-loaded bone cement.

The device is intended to be used for patients undergoing a two-stage revision procedure for infection of a total knee implant. The Rx Knee System components are sterile, single-use devices intended for temporary use as a total knee replacement.

Materials: Cast Cobalt Chromium (CoCr) alloy (ASTM F75 and ISO 5832-4) for the femoral component, Wrought Titanium-6Aluminium-4Vanadium ELI Alloy (Ti6Al4V ELI, ASTM F136-13) for femoral and tibial augment components, tibial stem, stem extension adapter and locking screw, Ultra-High-Molecular-Weight Polyethylene (UHMWPE) or Vit-E HXLPE for the femoral and tibial components and All-poly tibial components previously cleared as part of predicate World Knee System, and titanium nitride (TiN) diamond-like carbon (DLC) for coating femoral components which is the subject of FDA device master file no. 1647.

This document is an FDA 510(k) Premarket Notification review for a medical device, the "Rx Knee System". It details the device's description, indications for use, comparison to predicate devices, and performance testing conducted to demonstrate substantial equivalence.

However, the document does not contain specific acceptance criteria, or details of a study that proves the device meets those criteria, in the format typically used for studies validating AI/ML medical devices. The performance testing outlined here is primarily engineering evaluations and comparisons to existing predicate devices, not clinical studies with human participants against a defined ground truth for a diagnostic or predictive AI/ML model.

Therefore, I cannot extract the requested information regarding acceptance criteria, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to an AI/ML device validation.

The information provided pertains to a traditional medical device (knee prosthesis), and the "performance testing" described focuses on mechanical performance, biocompatibility, sterility, and antibiotic elution to demonstrate substantial equivalence to existing devices, which is the standard for 510(k) clearances. It does not describe a study that validates an AI/ML algorithm's performance against a clinical "ground truth".

Ask a specific question about this device

Logical Liner and World Liner: Components of the Signature Orthopaedics hip replacement range are intended to replace a hip joint where bone stock is sufficient to support the implant. When a surgeon has selected prosthetic replacement as the preferred treatment, the devices are intended for:
· Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis
· Inflammatory joint disease including rheumatoid arthritis
· Correction of functional deformity including congenital hip dysplasia
· Traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture
· Failed previous hip surgery including internal fixation or joint fusion, reconstruction, hemiarthroplasty, surface replacement, or total replacement

World Knee System: Patients should be skeletally mature to receive a knee replacement. Patients should have adequate bone stock and size to support and accept the prosthesis. The patient's need for knee replacement should be due to one or more of the following conditions: · Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis. · Inflammatory degenerative joint disease including rheumatoid arthritis. - · Functional deformity such as varus, valgus or flexion deformities. - · Revision procedures where other treatments or devices have failed. - · Fractures that are unmanageable using other techniques. Signature Orthopaedics' World Knee replacement components may be intended for cemented or cementless use.

The primary purpose of this Special 510(k) Device Modification to devices cleared as part of the Logical Cup, World Hip, and World Knee System, is to notify the FDA of the the change in materials used to manufacture the polyethylene components (Logical Liner, World Liners and World Knee Patella) to Vitamin-E Stabilized, 100 kGy crosslinked UHMWPE (Vit-E HXLPE) that is the subject of Masterfile MAF 2795. This 510(k) also notifies the FDA of minor design updates to the implants and reusable instruments. The Logical Acetabular System consists of an Acetabular Shell and a highly cross-linked polyethylene Acetabular Liner that is available in neutral, hooded and lateralized variants. The liner is designed to sit within an acetabular shell and articulate with a femoral head. The World Liners are compatible with World Acetabular Cups and are available in neutral, and hooded variants. The liners are designed to sit within an acetabular shell and articulate with a femoral head. The World Knee Patella is available in symmetrical and asymmetrical variants, with pegs. It is part of the World Knee System, which is a modular knee system consisting of a femoral component, meniscal inert, a patella and a tibial component.

The provided text does not contain information about acceptance criteria or a study proving that a device meets specific acceptance criteria in the context of an AI/ML medical device. Instead, it is a 510(k) premarket notification for orthopedic implants (hip and knee replacement components).

Therefore, I cannot provide a response with the requested information as it is not present in the input.

Reasoning for the absence of requested information:

• Device Type: The 510(k) is for physical orthopedic implants (Logical Liner, World Liner, World Knee Patella), not an AI/ML software device.
• Performance Metrics: The performance testing described focuses on material properties, mechanical integrity, and wear resistance relevant to physical implants (e.g., density, mechanical properties, melting point, fatigue crack propagation, oxidation challenge, ESR testing, wear for 5 million cycles). These are not the types of metrics typically associated with AI/ML diagnostic or prognostic performance (e.g., sensitivity, specificity, AUC).
• No AI/ML Components: There is no mention of algorithms, machine learning models, training data, ground truth establishment by experts, or any other elements common to AI/ML device evaluations.

Since the input is not about an AI/ML device, the questions regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth for AI models are not applicable.

Ask a specific question about this device

The VerteLoc Spinal System is indicated for use as a cervical vertebral body replacement (VBR) fusion device in the cervical spine (C3-C7) in skeletally mature patients for partial or total replacement of diseased, collapsed or unstable vertebral body due to tumour, trauma (i.e., fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues.

The VerteLoc Spinal System is to be used with bone graft material. The Vertel.oc Spinal System is intended for use with supplemental internal fixation that has been cleared by the FDA.

The Verteloc Spinal System is a modular vertebral body replacement (VBR) system intended to replace a diseased, collapsed, damaged or unstable cervical vertebral body following partial or total corpectomy. The VerteLoc device comprise of three components; two end bodies and one mid body, which when used in combination is used to replace a measured deficit in the patient's spine. The VerteLoc device is offered in a variety of footprints and heights to accommodate the needs of patients. When assembled, the central portion of the end and mid bodies create an inner hollow for the placement of autograft and/or autograft bone graft material. The VerteLoc device is manufactured from unreinforced PEEK OPTIMA LT1 as per ASTM F2026 with titanium pins as per ASTM F136 and ISO 5832-3 as well as tantalum marker beads as per ASTM F560 and ISO 13782.

The VerteLoc Spinal System VBR is to be used in conjunction with supplemental fixation systems.

I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets the acceptance criteria. The document is an FDA 510(k) clearance letter for the "VerteLoc Spinal System," which describes the device, its indications for use, and a summary of technological characteristics compared to predicate devices. It also mentions non-clinical testing conducted, but it does not detail specific acceptance criteria, reported device performance against those criteria, or the methodology of an in-depth study to prove acceptance.

Therefore, I cannot provide the requested table or answer the specific questions about sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, or training set details.

Ask a specific question about this device

The Signature Orthopaedics PEEK RCI, Bio-Composite and SignaLoc Screws intended for use in fixation of soft tissue including ligament or tendon to bone for cruciate ligament reconstruction surgeries of the knee. The screws are also intended for use in the following procedures:

• · ACL repairs
• · PCL repairs
• · Extra-capsular repairs
  • · Medial collateral ligament
  • Lateral collateral ligament
  • · Posterior oblique ligament
• · Patellar realignment and tendon repairs
  • Vastus medialis obliquus advancement
• · Illiotibial band tenodesis

The PEEK RCI, Bio-Composite and SignaLoc Screws are interference screws which provide compression of the graft or tendon to the bony wall for biological fixation of the ligament, tendon or soft tissue to bone. The screws feature an internal cannulation to accept a guide wire and have the same drive feature. The screws have an external variable thread along the length of the tapered shape and a rounded head. Each screw is provided individually packaged sterile for single use. The PEEK RCI is manufactured from unreinforced PEEK and the SignaLoc and Bio-Composite is manufactured from a PEEK/Hydroxyapatite composite.

The provided document is a 510(k) premarket notification decision letter from the FDA for the PEEK RCI, Bio-Composite, and SignaLoc Screws. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, primarily through non-clinical performance testing. It does not describe a study involving an AI device or human-in-the-loop performance.

Therefore, the requested information regarding acceptance criteria and study details for an AI-powered device, multi-reader multi-case studies, standalone algorithm performance, and ground truth establishment for AI training sets is not applicable to this document.

However, I can provide the acceptance criteria and study information related to the non-clinical performance of the PEEK RCI, Bio-Composite, and SignaLoc Screws as detailed in the document.

Acceptance Criteria and Device Performance for PEEK RCI, Bio-Composite, and SignaLoc Screws (Non-Clinical)

The document primarily states that "Non-clinical testing and engineering evaluations were conducted to verify that the performance of the PEEK RCI, Bio-Composite and Signaloc Screws are adequate for anticipated in-vivo use." The acceptance criteria for these tests are implied to be meeting the requirements and performance characteristics of the referenced ASTM and ISO standards, and demonstrating substantial equivalence to the predicate devices. Specific quantitative acceptance values are not explicitly stated in this FDA letter but would have been part of the manufacturer's detailed testing report.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size for Test Set and Data Provenance:

• Sample Size: Not specified in the provided document. Non-clinical testing typically involves a sufficient number of samples to ensure statistical validity per the relevant standards, but exact numbers are not disclosed here.
• Data Provenance: The tests are non-clinical (laboratory/bench top) and engineering evaluations performed by the manufacturer, Signature Orthopaedics Pty Ltd. The country of origin for the data generation would be Australia (where the manufacturer is based) or potentially related testing facilities. The data is prospective in the sense that it was generated specifically for this submission to support the device's performance.

3. Number of Experts and Qualifications for Ground Truth:

• Not applicable. This document describes non-clinical performance testing of medical screws, not an AI device or a study requiring human expert ground truth for image interpretation or diagnosis.

4. Adjudication Method for Test Set:

• Not applicable. As this is non-clinical bench testing, there is no "adjudication method" in the context of expert consensus or dispute resolution. The results are typically determined by calibrated equipment and adherence to standard protocols.

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

• No. An MRMC study was not done as this is for a physical medical device (screws) and not an AI-assisted diagnostic or interpretative system.

6. Standalone (Algorithm Only) Performance:

• Not applicable. This device is a physical medical implant, not a software algorithm.

7. Type of Ground Truth Used:

• Not applicable in the context of expert consensus or pathology for clinical conditions. For non-clinical testing, the "ground truth" is established by the specifications and performance requirements defined in the referenced industry standards (ASTM, ISO, AAMI) and the properties of the predicate devices. The screws' ability to meet these specified physical and biological material properties serves as the ground truth.

8. Sample Size for Training Set:

• Not applicable. This device is not an AI algorithm that requires a training set.

9. How Ground Truth for Training Set was Established:

• Not applicable. This device is not an AI algorithm.

Ask a specific question about this device