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The Latitud™ Hip Replacement System is intended for use in total hip arthroplasty. Total hip arthroplasty is intended to provide patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where is an evidence of sufficient sound bone to fix and support the components.

Total hip replacement is indicated for the following conditions:

• Non-inflammatory degenerative joint diseases including osteoarthritis and avascular necrosis.
• Rheumatoid arthritis.
• Congenital hip dysplasia.
• Acute traumatic fracture of the femoral head or neck.
• Certain cases of Ankylosis.
• Dislocation of the hip.
• Correction of functional deformity.
• Revision of failed joint reconstruction or treatment.
• Treatment of non-union, femoral neck and trochanteric fractures of the proximal femur.

Note:

• · The Titanium coated Modular Shell is intended for press-fit, uncemented use only.
• · The Hydroxyapatite Coated Uncemented Femoral Stem is intended for press-fit, uncemented use only.
• · The Proximally Coated Uncemented Femoral Stem is intended for press-fit, uncemented use only.
• · The Cemented Femoral stem is intended for cemented use only.
• · The Modular Acetabular Liner is intended for use with Modular Acetabular Shell.

· The CoCr Modular Femoral Head is intended to articulate with Modular Liner to mate with uncemented stem or cemented stem.

• The Biolox® delta Modular Femoral Head is intended to articulate with Modular Liner and to mate with uncemented stem or cemented stem.

· The Bone Screw and Apical Hole Occluder are intended for use with Modular Acetabular shell.

• · The Centralizer and Cement Restrictor are intended for use with cemented stem only.

The Latitud™ Uncemented Femoral Stem is fabricated from Titanium alloy - ELI (Titanium-6 Aluminum-4 Vanadium Extra Low Interstitial). It has 12/14 taper at the top which mates with its 510(k) cleared Latitud™ Cobalt Chromium alloy and Biolox® delta Modular femoral head (Cleared under K172857). This stem is implanted without use of bone cement. Stem is coated with Hydroxyapatite (HA) by plasma spraying method. These stems are available in different sizes with neck angles of 135° standard, 135° lateral and 125° standard (Coxavera). Uncemented Femoral Stem is intended for press-fit uncemented use only.

The provided document is a 510(k) summary for the Meril Healthcare Pvt. Ltd. Latitud™ Hip Replacement System. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria in a clinical context.

The document primarily describes non-clinical performance data and biocompatibility testing to support the substantial equivalence claim. It does not include a multi-reader multi-case (MRMC) comparative effectiveness study, standalone algorithm performance, or details on ground truth establishment for a training set in the context of an AI/ML device. This is because the Latitud™ Hip Replacement System is a physical medical device (hip implant), not an AI/ML diagnostic or therapeutic system.

Therefore, many of the requested categories are not applicable to the content of this 510(k) summary. I will answer the applicable questions based on the provided text.

1. Table of acceptance criteria and the reported device performance

Since this is a physical medical device and not an AI/ML system, the "acceptance criteria" are related to mechanical and chemical properties, as well as biocompatibility, conforming to established ASTM and ISO standards. The document summarizes that the device was subjected to these tests and the results support its substantial equivalence. Specific quantitative acceptance criteria or detailed performance values are not explicitly listed in a comparative table within the summary.

Mechanical Tests:

Morphology Tests:

Chemical Tests:

Biocompatibility Tests: All tests were conducted according to ISO 10993 series standards (or USP General Chapter ). The conclusion states that the device is considered substantially equivalent, implying that these tests met the acceptance criteria.

*FDA guidance document- "510(k) Information needed for Hydroxyapatite coated orthopedic implants. February 1997"

Applicable Questions:

As this is a 510(k) for a physical medical device (hip implant) and not an AI/ML software, the following points are not applicable from the provided text:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
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
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
8. The sample size for the training set
9. How the ground truth for the training set was established

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The Opulent TiNbN Coated Knee is indicated for the following:

· Severe knee joint pain, loss of mobility, and disability due to: rheumatoid arthritis, traumatic arthritis, and polyarthritis.

· Correction of functional deformities.

· Post-traumatic loss of knee join contcularly when there is patellofemoral erosion, dysfunction, and/or prior patellectomy.

• · Moderate valgus, varus, or flexion trauma.
• · Knee fractures untreatable by other methods.
• · Revision surgery where sufficient bone and soft tissue integrity are present.

The Opulent TiNbN Coated Knee is intended for cemented use only. This device is for single use only.

The Opulent TiNbN Coated Knee comprises of Femoral Component and Tibial Component as described below,

• Femoral Knee Component CR and PS (Left and Right) .
• . Tibial Component (Tibial Base Plate)

Each of these components is described below.

5.7.1 Femoral Component

The Femoral Component is fabricated from Cobalt-Chromium-Molybdenum (Co-Cr-Mo), coated with Titanium Niobium Nitride (TiNbN). The Femoral Component is available in two designs: Cruciate Retaining (CR) and Posterior Stabilized (PS). Each of these designs is further classified into Left and Right configurations. Each Left and Right configuration is available in eight different sizes (A to H) based on Anterior/Posterior (A/P) and Medial/Lateral (M/L) dimensions. Thus, a total of thirty two (32) models are available for the Femoral Component.

5.7.2 Tibial Component (Tibial Base Plate)

The Tibial Base Plate is fabricated from Cobalt-Chromium-Molybdenum coated with TiNbN. The tibial base plate is available in eight different sizes from 1 to 8 based on Anterior/Posterior (A/P) and Medial/Lateral (M/L) dimensions.

The provided text describes a medical device, the "Opulent TiNbN Coated Knee," and its submission for FDA clearance (K222816). However, the document does not contain information related to acceptance criteria, device performance metrics, sample sizes for test sets, data provenance, expert adjudication, MRMC studies, standalone performance, or ground truth establishment.

Instead, the document primarily focuses on:

• FDA Clearance Letter: Confirming the device's substantial equivalence to a predicate device.
• Indications for Use: Listing the medical conditions for which the device is intended.
• 510(k) Summary: Detailing the device information, predicate device comparison, manufacturing process, material, and non-clinical performance data (e.g., coating characteristics, wear resistance, biocompatibility testing).

The non-clinical performance data section lists the types of tests conducted (e.g., coating thickness, hardness, wear resistance, various biocompatibility tests), but does not provide specific acceptance criteria or the reported performance outcomes for these tests. Therefore, I cannot construct the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, or ground truth.

The document states:
"The subject device was subjected to following non clinical performance testing to evaluate device function and mechanical performance." (Page 6)
and lists tests like "Coating characteristics of TiNbN Coating," "Wear resistance," and "Biocompatibility testing." While these indicate the areas of evaluation, they do not provide the results or the criteria for acceptance.

In summary, the information required to answer your request is not present in the provided text.

Ask a specific question about this device

The Opulent TiNbN Coated Knee is indicated for the following:

· Severe knee joint pain, loss of mobility, and disability due to: rheumatoid arthritis, traumatic arthritis, and polyarthritis.

· Correction of functional deformities.

• · Post-traumatic loss of knee join contour, particularly when there is patellofemoral erosion, dysfunction, and/or prior patellectomy.
• Moderate valgus, varus, or flexion trauma.
• · Knee fractures untreatable by other methods.
• · Revision surgery where sufficient bone and soft tissue integrity are present.

The Opulent TiNbN Coated Knee is intended for cemented use only. This device is for single use only.

The Opulent TiNbN Coated Knee comprises of a Femoral Component and Tibial Component as described below,

• Femoral Knee Component CR and PS (Left and Right) ●
• Tibial Component (Tibial Base Plate) ●

Each of these components is described below. These components are compatible with previously cleared components of the Destiknee Total Knee System (e.g., patellae, tibial inserts).

I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets acceptance criteria. The document is an FDA 510(k) clearance letter and a 510(k) summary for a knee prosthesis called "Opulent TiNbN Coated Knee."

This type of document primarily focuses on demonstrating substantial equivalence to a predicate device, as opposed to a detailed clinical study demonstrating meeting specific performance acceptance criteria for a novel device. While it mentions non-clinical performance data and mechanical tests, it doesn't provide specific acceptance criteria values or the detailed results of a study designed to prove the device meets those criteria in the context of the questions you've asked (e.g., sample size for test/training sets, expert ground truth establishment, MRMC studies, effect sizes, standalone performance).

The information provided includes:

• Device Name: Opulent TiNbN Coated Knee
• Regulation Number: 21 CFR 888.3560 (Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis)
• Regulatory Class: Class II
• Product Code: JWH
• Predicate Device: Freedom® - TiNbN Coated Knee (K200912) from Maxx Orthopedics Inc., USA, and Destiknee Total Knee System (K160771 and K172936) from Meril Healthcare Pvt. Ltd.
• Device Description: Comprises Femoral and Tibial Components, made of Cobalt-Chromium-Molybdenum (Co-Cr-Mo) coated with Titanium Niobium Nitride (TiNbN).
• Indications for Use: Severe knee joint pain, loss of mobility, disability due to various arthritis types, correction of functional deformities, post-traumatic loss of knee joint contour, moderate valgus/varus/flexion trauma, knee fractures untreatable by other methods, and revision surgery. Intended for cemented use only, single use.
• Comparison of Technological Characteristics: Stated to be substantially equivalent to the predicate device with same indications, design, materials, packaging, surgical implantation technique, intended use, TiNbN coating, and sterilization method.
• Non-clinical Performance Data: Mentions mechanical tests performed on TiNbN coating (Wear Resistance, Coating Chemical Composition, Coating Thickness, Coating Hardness, Coating Adhesion Strength, Roughness, Metal Ion Analysis) and leveraged mechanical tests from predicate devices (Tibial-Femoral Contact Area Stress and Surface Stress Testing, Tibial-Femoral Constraint Testing, Range of motion analysis, Patello-Femoral Lateral Subluxation, Patello-Femoral Contact Area Stress and Surface Stress Testing, Tibial Tray Locking Mechanisms Testing, Finite Element Analysis of Tibial Tray, Tibial base plate component fatigue testing, Tibial Post Fatigue Strength).

Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria, ground truth, expert review, MRMC studies, or training data for a typical AI/software device evaluation, as this document pertains to a mechanical knee implant and a substantial equivalence review for a 510(k) clearance.

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The Latitud™ Hip Replacement System is intended for use in total hip arthroplasty. Total hip arthroplasty is intended to provide patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where is an evidence of sufficient sound bone to fix and support the components.

Total hip replacement is indicated for the following conditions:

• · Non-inflammatory degenerative joint diseases including osteoarthritis and avascular necrosis.
• · Rheumatoid arthritis.
• Congenital hip dysplasia.
• · Acute traumatic fracture of the femoral head or neck.
• · Certain cases of Ankylosis.
• Dislocation of the hip.
• · Correction of functional deformity.
• · Revision of failed joint reconstruction or treatment.
• · Treatment of non-union, femoral neck and trochanteric fractures of the proximal femur.

Latitud™ Hip Replacement System cleared under K172857 consists of modular acetabular cup system, femoral heads, femoral stems and related accessories.

Purpose of this 510(k) is to add following acetabular cup system and femoral stem under previously 510 (k) cleared Latitud Hip Replacement System (K172857).

• Latitud TM Triad Acetabular Cup System .
• Latitud™ Proximally coated Uncemented femoral stem .

Latitud™ Triad - Acetabular Cup System is a modular cup system. It includes Modular shells, Modular liners and Bone screws.

• . Modular Shell: Modular shells are intended for uncemented, press fit fixation with prepared acetabulum. They are designed for use with Modular liners. The Modular shells are fabricated from Ti-6Al-4V-ELI (Titanium-6Aluminum-4Vanadium Extra Low Interstitial). Modular shells are available in different sizes. The outer surface of the Modular shell is coated with commercially pure Titanium.
• Modular Liner: Modular liners are designed to be used with Modular shell. Modular liners . are intended to be articulated with a range of dedicated Cobalt chromium alloy or Biolox® delta Modular femoral heads previously cleared under K172857. Modular liners are fabricated from Highly Cross-Linked Polyethylene (HXLPE). It is available in different sizes.
• Bone Screw: Bone screw is used if additional fixation of Modular shell is required. Bone . screw is self tapping and is fabricated from Titanium alloy - ELI (Titanium-6Aluminum-4Vanadium Extra Low Interstitial). Bone screw is available in 6.5 mm diameter with different lengths.

The proximally coated uncemented femoral stem is fabricated from Titanium alloy - ELI (Titanium-6Aluminum-4Vanadium Extra Low Interstitial) and it is intended to be used with Femoral head (CoCr and Biolox Delta ceramic) previously cleared under K172857. The proximal portion of the stem is coated with commercially pure Titanium with plasma spray method. The proximal coated femoral stem is available in two designs (Standard i.e. full profile design and distally reduced design). Each design is available in different sizes with three neck angles (132° Standard, 132° Lateral, and 128° Standard).

The provided text is a 510(k) Summary for the Latitud™ Hip Replacement System. This document details the device's design, indications for use, and a comparison to predicate devices to demonstrate substantial equivalence. However, it does not describe an AI medical device or a study proving its performance against acceptance criteria. It focuses solely on the mechanical and material performance of a hip replacement system.

Therefore, I cannot provide a detailed response to your request, as the information regarding acceptance criteria, device performance, sample sizes, expert involvement, multi-reader multi-case studies, or ground truth establishment for an AI device is not present in the provided text.

Based on the information available, here's what can be extracted, although it doesn't align with your request for an AI medical device:

Device: Latitud™ Hip Replacement System
Device Type: Hip Joint Metal/Ceramic/Polymer Semi-Constrained Cemented Or Nonporous Uncemented Prosthesis (Class II)
510(k) Number: K183532
Applicant: Meril Healthcare Private Limited

Non-clinical Performance Data (similar to "studies" for this type of device):

The document lists various non-clinical tests conducted to evaluate device function/mechanical performance and demonstrate substantial equivalence to predicate devices, including:

• Locking Strength: per ASTM F1820-13
• Wear test: (ASTM F1877-05, ISO 14242-3-2009)
• Impingement Test: (ASTM F2582-14)
• Evaluation of torsion properties, pull out properties, driving torque, and self tapping performance of Bone Screw: per ASTM F543-13e
• Proximal fatigue test: (ISO 7206-6:2013)
• Distal fatigue test: (ISO 7206-4:2010)
• Range of motion test: (ISO 21535-2007/Amd 1:2016)
• Axial pull-off test: (ISO 7206-10:2003)
• Fretting corrosion: (ASTM F1875-98; Reapproved 2014)
• Evaluation of Ceramic femoral head (includes Burst test, Post fatigue burst test, Pull-off test and Torque test): (ISO 7206-10:2003, ASTM F1820-13)
• Ti coating adhesion (shear) test: (ASTM F1044-05; Reapproved 2017)
• Material Characterization of HXLPE: (ASTM F2565-13, ASTM F2759-11, ASTM F648-14, ASTM F2003-15, ISO 5834-3 and ISO 5834-2)
• Endotoxin testing

Conclusion from the document: Based on performance testing results and similarities in intended use, device design/technological characteristics, materials, and sterilization method, the Latitud™ Hip Replacement System is considered substantially equivalent to the previously cleared predicate devices.

Missing Information (Relevant to your request for an AI device but not present in this document):

The document does not contain any of the following information pertinent to an AI medical device study:

• A table of acceptance criteria and reported device performance for an AI
• Sample sizes used for a test set (beyond the components tested in mechanical studies)
• Data provenance (country of origin, retrospective/prospective)
• Number of experts used to establish ground truth
• Qualifications of experts
• Adjudication method
• Multi-reader multi-case (MRMC) comparative effectiveness study results
• Standalone (algorithm only) performance
• Type of ground truth used (expert consensus, pathology, outcome data)
• Sample size for a training set
• How ground truth for a training set was established

Therefore, I cannot fulfill your request as it pertains to an AI medical device study based on the provided text.

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The Latitud™ Hip Replacement System is intended for use in total hip arthroplasty. Total hip arthroplasty is intended to provide patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where is an evidence of sufficient sound bone to fix and support the components.

Total hip replacement is indicated for the following conditions:

• · Non-inflammatory degenerative joint diseases including osteoarthritis, post-traumatic arthritis and avascular necrosis.
• · Rheumatoid arthritis.
• Congenital hip dysplasia.
• · Acute traumatic fracture of the femoral head or neck.
• · Certain cases of Ankylosis.
• Dislocation of the hip.
• · Correction of functional deformity.
• · Revision of failed joint reconstruction or treatment.
• · Treatment of non-union, femoral neck and trochanteric fractures of the proximal femur.

Note:

• · The Titanium coated Modular Shell is intended for press-fit, uncemented use only.
• · The Hydroxyapatite coated Uncemented Femoral Stem is intended for press-fit, uncemented use only.
• · The Cemented Femoral stem is intended for cemented use only.
• The Modular Acetabular Liner is intended for use with Modular Acetabular Shell.
• · The CoCr Modular Femoral Head is intended to articulate with Modular Liner to mate with uncemented stem or cemented stem.
• The Biolox® delta Modular Femoral Head is intended to articulate with Modular Liner and to mate with uncemented stem or cemented stem.
• · The Bone Screw and Apical Hole Occluder are intended for use with Modular Acetabular shell.
• · The Centralizer and Cement Restrictor are intended for use with cemented stem only.

The Latitud™ Hip Replacement System consists of following components:
Acetabular Cup System

• Modular Shell / Cup

• Modular Liner

• Cobalt Chromium Modular Femoral Head

• Biolox® delta Modular Femeral Head
  Femoral Stem

• Uncemented Femoral Stem

• Cemented Femoral Stem
  Accessories (Sub components)

• Bone Screw

• Apical Hole Occluder

• Centralizer

• Cement Restrictor

Acetabular cup system is a modular acetabular replacement system consisting of a range of Modular Shells, Modular Liners, Cobalt chromium alloy and Biolox® delta Modular Femoral Heads. The Modular Shells are designed for use with dedicated sizes of Modular Liners articulating with a range of dedicated Cobalt chromium alloy and Biolox® delta Modular Femoral Heads.

Modular Shell: Modular Shell is intended for uncemented, press fit fixation with prepared acetabulum. They are designed for use with Modular liners. The Modular shell is fabricated from Ti-6Al-4V-ELI (Titanium-6Aluminum-4Vanadium Extra Low Interstitial). Modular shell is available in different sizes. The outer surface of the Modular shell is coated with commercially pure Titanium. Two/Three screw holes are provided in Modular shell for additional immediate fixation with bone by means of Bone screws. A threaded apical hole is provided to attach instruments for surgical insertion. After fixation of Modular shell, apical hole will occlude by Occluder.

Modular Liner: Modular liner is designed to be used with Modular shell and articulate with a range of dedicated Cobalt chromium alloy or Biolox® delta Modular femoral heads. Modular liner is fabricated from Highly Cross-Linked Polyethylene (HXLPE). It is available in different sizes.

Cobalt chromium Modular Femoral Head: Modular femoral head fabricated from cobalt chromium alloy is designed to mate with 12/14 taper of femoral stem through taper-locking arrangement and to articulate with Modular liner. It is available in different sizes with different offsets.

Biolox® Delta Modular Femoral Head: Modular femoral head fabricated from ceramic material (Biolox® delta, by CeramTec. Germany) is designed to mate with 12/14 taper of femoral stem through taper-locking arrangement and to articulate with Modular liner. It is available in different sizes with different offsets.

Uncemented Femoral Stem: The Uncemented femoral stem is fabricated from Titanium alloy - ELI (Titanium-6Aluminum-4Vanadium Extra Low Interstitial). It has 12/14 taper at the top which mates with Cobalt chromium alloy and Biolox® delta Modular femoral head. This stem is implanted without use of bone cement. Stem is coated with Hydroxyapatite (HA) by plasma spraying method. These stems are available in different sizes with three different neck angles. Uncemented femoral stem is intended for press-fit uncemented use only.

Cemented Femoral Stem: Cemented femoral stem is fabricated from High Nitrogen Stainless Steel (HNSS). It has 12/14 taper trunnion at the top which mates with Cobalt chromium alloy and Biolox® delta Modular femoral head. This stem is implanted with use of bone cement. These stems are available in different sizes with two different offsets. Cemented stem is intended for cemented use only.

Accessories (Subcomponents):
Bone Screw: Bone screw is used if additional fixation of Modular shell is required. Bone screw is self tapping and is fabricated from Titanium alloy - ELI (Titanium-6Aluminum-4Vanadium Extra Low Interstitial). Bone screw is available in 6.5 mm diameter with different lengths.

Apical Hole Occluder: Apical hole occluder is provided to occlude the apical hole after fixation of the Modular shell in acetabulum. Apical hole occluder is fabricated from Titanium alloy - ELI (Titanium-6Aluminum-4Vanadium Extra Low Interstitial). Apical hole occluder is available in one size.

Centralizer: Centralizer is used for correct positioning of Cemented stem in medullary canal of femur. Centralizer is fabricated from Ultra High Molecular Weight Polyethylene (UHMWPE). Centralizer is designed to be used with Cemented stem only. Centralizer is offered in two sizes.

Cement Restrictor: Cement restrictor is used to occlude and seal intramedullary canal in order to generate sufficient pressure to enhance cement penetration and to prevent distal cement leakage. Cement restrictor is designed to be used with Cemented stem only. Cement restrictor is fabricated from Ultra High Molecular Weight Polyethylene (UHMWPE). Cement restrictor is provided in two sizes.

The provided text is a 510(k) Summary for the Latitud™ Hip Replacement System. This document focuses on demonstrating substantial equivalence to predicate devices based on design, materials, and mechanical performance testing, rather than presenting a clinical study with acceptance criteria and device performance as one might find for a novel diagnostic or therapeutic device.

Therefore, the requested information elements related to clinical study design (sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, training set details) are not applicable to this type of submission.

However, I can extract information related to the non-clinical performance data and the conclusion on substantial equivalence.

Here's the relevant information that can be extracted:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally established by the referenced ASTM and ISO standards for mechanical testing of orthopedic implants. The document states that the system "was subjected to following nonclinical performance testing to evaluate device function/mechanical performance." The implication is that the device met the requirements of these standards. Specific numerical acceptance criteria and precise performance values are not detailed in this summary; rather, the successful completion of these tests serves as the proof of meeting criteria for substantial equivalence.

1. A table of acceptance criteria and the reported device performance
See table above. The "reported device performance" is implied by the statement "subjected to following nonclinical performance testing to evaluate device function/mechanical performance" and the overall conclusion of substantial equivalence. For 510(k) submissions based on mechanical testing, specific numerical results are often contained in the full submission, but the summary confirms successful completion against established standards.

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

• Sample Size for Test Set: Not specified in the summary document. Mechanical testing for these types of devices typically involves a specified number of samples per test condition as dictated by the respective ASTM/ISO standards.
• Data Provenance: Not explicitly stated as "country of origin of the data." The applicant is Meril Healthcare Private Limited, based in Gujarat, INDIA. The testing was non-clinical (laboratory/mechanical testing), not human data.
• Retrospective or Prospective: Not applicable, as this is non-clinical performance data (material and mechanical testing).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is a 510(k) for an orthopedic implant, where "ground truth" is established by adherence to recognized mechanical and materials testing standards, not by expert medical interpretation of clinical data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This describes non-clinical testing, not a clinical study requiring adjudication of expert opinions.

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 510(k) for an orthopedic implant, not an AI or imaging diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a 510(k) for an orthopedic implant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this submission are the established specifications and performance requirements outlined in the referenced ASTM and ISO consensus standards for orthopedic implants. Successful demonstration of meeting these standards through mechanical and material testing serves as the basis for substantial equivalence.

8. The sample size for the training set
Not applicable. This is a 510(k) for an orthopedic implant based on non-clinical performance and substantial equivalence to predicate devices, not a machine learning or AI device that requires a training set.

9. How the ground truth for the training set was established
Not applicable. See point 8.

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ARMAR™ / ARTIS™ Small Fragment and Calcaneal Plates & MBOSS™/FIXION™ Screws are indicated for temporary internal fixation and stabilization of osteotomies and fractures, such as:

• comminuted fractures
• supracondylar fractures
• extra-articular fractures
• fractures in osteopenic bone
• nonunions
• malunions
  Smaller-sized ARMAR™ / ARTISTM plates are used for small bones and small fragments of the hands and feet.
  ARMARTM / ARTIS™ Calcaneal plates are indicated for temporary internal fixation and stabilization of osteotomies and fractures of the calcaneous.

ARMAR™ / ARTIS™ Humerus and Olecranon plates & MBOSSTM/FIXIONT™ Screws are intended for fractures and fracture dislocations, osteotomnies, and non-unions of the distal and proximal humerus, olecranon, and ulna in adult, particularly in osteopenic bone.
Specifically, distal humerus plates are indicated for intra-articular fractures, comminuted supracondylar fractures, osteotomies, malunions and non-unions of the distalhumerus. Olecranon and Proximal ulna plates are indicated for fractures, osteotomies, malunions and non-unions of the olecranon and proximal ulna.

ARMARTM / ARTISTM Tibia and Buttress Plates & MBOSS™/FIXION™ Screws are intended for fixation of the ankle in adults. Specifically,

• Anterolateral Distal Tibia Plates are intended for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal tibia.
• Medial Distal and Proximal Tibia Plates are intended for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal tibia,
• L Buttress and T Buttress Plates are intended to buttress partial articular fractures and bone fragments of the distal tibia, and
• Proximal Lateral Tibia Plates are intended for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal tibia, a Distal Tibia T Plates and Distal Tibia L Plates are intended to buttress partial articular fractures and bone fragments of the distal tibia.

ARMAR™ / ARTISTM 2.4mm Plates & MBOSS™/FIXION™ Screws are intended for Fixation of complex intra- and extra-articular fractures and osteotomnies of the distal radius and other small bones in adults.

ARMARTM / ARTISTM Clavical Hook Plate & MBOSS™/FIXION™ Screws is intended for fixation of lateral clavicle fractures and dislocations of the acromioclavicular joint.

ARMARTM / ARTISTM Metaphyseal Plate & MBOSS™/FIXION™ Screws indicated for fractures, osteotomies, and non-unions of the radius and other small bones. Additionally, the Metaphyseal Plate is intended for pelvic and acetabular reconstructive surgery and fracture fixation of the distal humerus, clavicle, and scapula.

ARMARTM / ARTISTM Calcaneal Plate & MBOSS™/FIXION™ Screws is intended for fixation of complex extra-articular and intra-articular fractures and osteotomies of the calcaneus.

The Meril Healthcare Trauma System utilizes screws and plates of various lengths and designs to accommodate a variety of patient anatomies. The Trauma System utilizes medical grade stainless steel and titanium. Trauma System implant are provided clean and non-sterile with instructions for steam sterilization. The instruments are provided non-sterile and are reusable. The implants are provided nonsterile and are single use only.

This document is a 510(k) premarket notification decision letter from the FDA regarding a medical device, specifically bone plates and screws. It does not contain information about an AI/ML device, AI acceptance criteria, or a study proving an AI device meets acceptance criteria.

Therefore, I cannot extract the requested information regarding AI device performance, acceptance criteria, sample sizes, expert ground truth, MRMC studies, or training/test set details from this document. The document describes the substantial equivalence of bone fixation appliances to existing predicate devices based on technological characteristics and mechanical performance data (e.g., static four-point bending, dynamic four-point bending, static torsion, static axial pullout).

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The DestikneeTM Total Knee System is indicated for patients with severe knee pain and disability due to:

· Severe knee joint pain, loss of mobility, and disability due to: rheumatoid arthritis, traumatic arthritis, polyarthritis.

· Correction of functional deformities.

· Post-traumatic loss of knee joint contour, particularly when there is patellofemoral erosion, dysfunction, or prior patellectomy.

· Moderate valgus, varus, or flexion trauma.

· Knee fractures untreatable by other methods.

The Destiknee™ Total Knee System is intended for cemented use only. This device is for single use only.

The Destiknee™ Total Knee System is a system of components intended to replace the Femoral, Tibial and Patella articular surfaces of the knee joint. The components are available in many styles and sizes and are manufactured from metallic and non-metallic materials.

The Destiknee TM Total Knee System was originally cleared under 510(k): K160771. The purpose of current submission is to add Tibial Base Plate (size 7 and size 8) and All Poly Patella (size 37mm and 40mm) in Destiknee™ Total Knee System.

The provided text is a 510(k) summary for the Destiknee™ Total Knee System, a medical device. It describes the device, its indications for use, and a comparison to a predicate device. However, it does not contain information about formal acceptance criteria, studies proving the device meets those criteria, or details regarding Artificial Intelligence (AI) algorithms as requested in the prompt.

The document focuses on demonstrating substantial equivalence to a previously cleared device (K160771) based on non-clinical performance data which includes:

• Fatigue test of Tibial Base Plate (ASTM F1800-12; ISO 14879-1:2000)
• Endotoxin testing (to confirm manufacturing process does not introduce endotoxins)
• 14-day USP sterility testing

The document explicitly states that the purpose of the current submission is "to add Tibial Base Plate (size 7 and size 8) and All Poly Patella (size 37mm and 40mm) in Destiknee™ Total Knee System." This indicates a modification or expansion of an existing device rather than a new AI-powered diagnostic device.

Therefore, I cannot fulfill the request for information related to AI device acceptance criteria, study details (sample size, ground truth, expert qualifications, MRMC studies, standalone performance), or training set information, as this document does not describe such a device or studies. The information provided is for a total knee replacement system and its mechanical and biological safety performance.

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