Search Results

The Balanced Knee System TriMax PS Plus Tibial Inset is in cemented total knee arthroplasty procedures with the following indications:

1. Loss of knee joint configuration and joint function.
2. Osteoarthritis of the knee joint.
3. Rheumatoid arthritis of the knee joint.
4. Post-traumatic arthritis of the knee joint.
5. Valgus, varus, or flexion deformities of the knee joint.
6. Revision procedures where other treatments or devices have failed.

The Balanced Knee® System (BKS) TriMax PS Plus Tibial Insert is a line extension of the TriMax PS Tibial Insert (K131337) that offers slightly more constraint than the original PS Insert. The PS post geometry is the only design difference between the previously cleared predicate device and the subject device. The change slightly modifies the post's shape to provide additional internal/external and varus/valgus constraint if the surgeon determines the need exists. The balance of the design is identical including the articulating surface, locking mechanism, as well as the PS post location and height. The PS Plus inserts are intended for use in primary and revision knee surgeries with the same indications for use as the predicate. This implant is used with existing BKS and BKS Revision (BKSR) tibial travs. TriMax femoral components and the BKSR modular femoral components. The material is identical as well as all manufacturing processes, cleaning, sterilization and packaging that were cleared under K131337.

This document describes a 510(k) premarket notification for a medical device called the "Balanced Knee® System TriMax PS Plus Tibial Insert." The submission is a "Special 510(k)" because it is a line extension of a previously cleared predicate device (K131337).

Since this is a Special 510(k) for a line extension of an existing device, and the primary change is a slight modification to the PS post geometry, the provided document does not contain information about a study proving the device meets acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to the predicate device through engineering analysis and verification testing.

Therefore, I cannot fulfill the request to provide:

1. A table of acceptance criteria and reported device performance (in the context of a clinical study or AI performance evaluation)
2. Sample size used for a test set and data provenance
3. Number of experts and their qualifications for ground truth
4. Adjudication method for a test set
5. MRMC comparative effectiveness study results or effect size
6. Standalone (algorithm-only) performance
7. Type of ground truth used
8. Sample size for the training set
9. How ground truth for the training set was established

The document describes the engineering and material performance evaluations conducted to demonstrate that the new device's design outputs meet the design inputs, similar to the predicate. The "performance data" section refers to:

• Sterilization: Stated adherence to ISO 11135-1 with a Sterilization Assurance Level (SAL) of 10-6.
• Shelf Life: Validation according to ASTM D4169:2016.
• Biocompatibility: Suitability for implantation verified per ISO 10993.

The comparison of technological characteristics mentions evaluations in the following areas, indicating what was assessed, but not specific acceptance criteria or performance numbers:

• Geometric Analysis
• Contact Area and Pressure
• Constraint
• Wear
• Range of Motion
• PS Post Fatigue

It concludes that "The results showed similar or identical performance indicating that the design outputs of the PS Plus Tibial Insert meet the design inputs." This is a general statement of engineering conformance, not a specific performance metric from a study as typically requested for AI/diagnostic device approvals.

In summary, this document is a 510(k) premarket notification for a mechanical orthopedic implant, not a software or AI-driven medical device. Therefore, the types of studies and acceptance criteria typically associated with AI/software performance evaluations (e.g., sensitivity, specificity, reader studies, ground truth establishment by experts) are not applicable to the content of this FDA letter.

Ask a specific question about this device

The Progen™ short trochanteric nail is indicated for fixation of various types of stable and unstable neck, intertrochanteric, and peritrochanteric fractures.

The Progen™ long trochanteric nail is intended for fixation of stable femoral fractures occurring from the base of the femoral neck extending distally to a point approximal to the intercondylar notch including fractures of the basilar neck, intertrochanteric fractures, subtrochanteric fracture, femoral shaft fractures, pathological fractures, impending pathological fractures, tumor resection, nonunion, and revisions.

The Progen™ long trochanteric nail is intended for fixation of stable and unstable femoral fractures occurring from the base of the femoral neck extending distally to a point approximately 10cm proximal to the intercondylar notch including fractures of the basilar neck, intertrochanteric fractures, peritrochanteric fractures, subtrochanteric fracture, femoral shaft fractures, pathological fractures, impending pathological fractures, tumor resection, nonunion, malunion, and revisions.

The Progen™ Trochanteric Nail System consists of temporary fixation intramedullary nails and their accompanying instrumentation designed for fracture fixation and stabilization of the femur. The implants are available in various lengths and diameters to accommodate a range of patient anatomy. Each of the intramedullary nails is secured by a sequence of screws that transect through holes in the proximal and distal sections of each nail.

The Progen™ Trochanteric Nail System consists of single-use intramedullary nails for stable and unstable neck, intertrochanteric, pertrochanteric, and subtrochanteric fractures and combinations of these fractures. The system consists of Nail, Lag Screw, Secondary Screw, Lag Cap, Locking Screws, Set Screws, and Nail End Cap. The nails and accompanying components are manufactured from titanium alloy (Ti-6Al-4V ELI). Additionally, the Nails and Lag Screws have a Type II anodized surface treatments.

The provided text describes the Progen™ Trochanteric Nail System, an intramedullary fixation rod system, and its substantial equivalence with predicate devices. However, this document does not contain information about acceptance criteria or a study proving that an AI/ML device meets acceptance criteria.

The information provided relates to a traditional medical device (an intramedullary nail system), and the performance data section focuses on sterilization, shelf-life, biocompatibility, and mechanical testing in accordance with ISO and ASTM standards. There is no mention of an AI/ML component, clinical testing, or any metrics related to AI/ML device performance such as sensitivity, specificity, or accuracy.

Therefore, I cannot provide the requested table or answer the questions related to AI/ML device performance, ground truth, expert qualifications, or MRMC studies based on the provided text.

Ask a specific question about this device

1. Non-inflammatory degenerative joint diseases (NIDJD), e.g., osteoarthritis, avascular necrosis
2. Traumatic arthritis
3. Previous tibial condyle or plateau fracture with loss of anatomy or function
4. Varus deformities
5. Revision of the tibial bearing insert of a previously implanted unicompartmental knee system provided that the tibial tray mechanism is not compromised, and femoral and tibial tray components remain well fixed and undamaged.

The BKS Uni is intended for unicompartmental knee arthroplasty procedures. The system is single-use and intended for implantation with bone cement.

The Balanced Knee® System (BKS®) Uni is a single compartment knee replacement. The BKS Uni is indicated for cemented use only.

Cobalt Chromium Femoral Component
The femoral components are cobalt chromium (Co-Cr-Mo). The femoral components are right and left specific and are intended for cemented use only.

Titanium Tibial Trays
The titanium tibial trays (Ti-6Al-4V ELI) are left and right specific and are for cemented use only.

Polyethylene Tibial Insert
The E-Vitalize tibial insert is manufactured from crosslinked Vitamin E Ultra High Molecular Weight Polyethylene. The inserts match the respective size of the tibial tray used.

The provided text describes a 510(k) premarket notification for a medical device called the Balanced Knee® System Uni. This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than on a study proving the device meets specific acceptance criteria in the context of AI/ML performance.

Therefore, many of the requested categories (such as sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment) are not applicable to this type of regulatory submission, as it pertains to a physical medical implant (a knee prosthesis) and not an AI/ML diagnostic or prognostic device.

Here's a breakdown of the information that is available based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a physical implant and not an AI/ML device, the "acceptance criteria" are related to mechanical performance, sterilization, shelf life, and biocompatibility, as confirmed through validation against established ISO and CFR standards.

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

Not applicable. This is for a physical device, and the "test set" refers to mechanical and material tests, not a dataset for an AI/ML model.

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

Not applicable. The ground truth for a knee prosthesis is established through mechanical and biocompatibility testing against defined industry standards, not expert evaluation of data.

4. Adjudication method 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 device is not an AI/ML diagnostic or prognostic tool. No MRMC study was performed.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used

The "ground truth" for this medical device is established by validated engineering and biological standards. This includes:

• Sterility Assurance Level (SAL) via ISO standards.
• Packaging integrity and shelf life via ISO standards.
• Biocompatibility via ISO standards.
• Mechanical performance metrics for range of motion, constraint, interlock strength, fatigue, contact area/stress, and wear.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable.

Ask a specific question about this device

The Pisces Spinal System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion using autograft. This system is intended for posterior, non-cervical pedicle fixation of the thoracic, lumbar, sacrum and iliac spine (T1-Sacrum/Ilium) for the following indications:

1. Degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
2. Degenerative Spondylolisthesis with objective evidence of neurologic impairment
3. Trauma (fracture or dislocation)
4. Spinal tumor
5. Failed previous fusion (pseudarthrosis)
6. Spinal stenosis
7. Spinal deformities or curvatures such as scoliosis, kyphosis, or lordosis

The Pisces Spinal System is an implantable system intended to provide immobilization and stabilization of spine segments. The subject device is a modular pedicle screw assembly that consists of pedicle screws with solid and cannulated options, modular tulips in standard, reduction, and extended tab configurations, spinal rods, and set screws. All components are made of implantable-grade titanium.

The modular tulip is an assembly which consists of a tulip body, a saddle, and a locking ring. The top of the tulip body receives a locking set screw which secures the tulip body assembly to an ø5.5mm or ø6.0mm rod and pedicle screw when tightened.

The pedicle screw has a spherical head which the tulip assembly snaps onto either before or after surgical insertion. The 5.5mm or 6.0mm rod is inserted into the tulip assembly. After assembly of multiple pedicle screws, a set screw is inserted into the tulip and locked to a predetermined locking torque, immobilizing the construct. For the 20mm reduction and 90mm extended tab tulips, the guide tabs are removed from the construct following final lock. 20mm reduction tabs can be used to provide length for rod reduction while 90mm tab tulips facilitate minimally invasive surgeries (MIS). All implants are provided sterile for single use only.

This document describes the Pisces Spinal System and demonstrates its substantial equivalence to predicate devices, thus the acceptance criteria are based on mechanical and biological performance rather than diagnostic accuracy.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state sample sizes for each specific test (e.g., number of devices tested for mechanical performance, number of samples for bacterial endotoxin testing). However, it mentions "Validation results" for sterilization, shelf life, and biocompatibility, and "Mechanical testing" was performed on the device. All these tests are inherently prospective, meaning the data was generated specifically for the validation of this device. The provenance is internal to Ortho Development Corporation, as they conducted or commissioned these validation tests.

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

This information is not applicable. The acceptance criteria for this device are based on objective, quantifiable engineering and biological tests (e.g., sterility, mechanical strength, material compatibility), not on subjective expert consensus for establishing ground truth like in a diagnostic device.

4. Adjudication Method for the Test Set

Not applicable, as the acceptance criteria are based on objective physical and chemical testing, not expert interpretation requiring adjudication.

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

No MRMC study was done. This is a medical device for surgical implantation, not a diagnostic imaging device that would typically involve human readers or AI assistance in interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a physical implant, not an AI algorithm.

7. Type of Ground Truth Used

The ground truth is based on established engineering standards (ASTM and ISO), biological compatibility standards (ISO 10993-1, ANSI/AAMI ST72), and regulatory limits for sterility and endotoxins.

8. Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI algorithm requiring a training set.

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

Not applicable, as there is no training set for this type of device.

Ask a specific question about this device

The Gecko Spinal System is a temporary implant for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications:

1. Spinal trauma surgery, used in sublaminar or facet wiring techniques;

2. Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adult scollosis, kyphosis and spondylolisthesis;

3. Spinal degenerative surgery, as an adjunct to spinal fusions.

The Gecko Spinal System may also be used in conjunction with other Ortho Development's spinal rod systems made of similar metals whenever "wiring" may help secure the attachment of the other implants.

The Gecko Spinal System is an implantable device intended to provide immobilization and stabilization of spinal segments. The device consists of an implantable polyethylene terephthalate (PET) braided band with a stiffened guiding section at one end and a metal leader at the other (both removed before final implantation), an implantable grade titanium alloy clamp that mates with 5.5mm diameter rods, and an implantable grade titanium alloy nut that secures the band, clamp, and connecting rod together. All implants are provided sterile for single use only; the implant should not be re-used or re-sterilized under any circumstances.

This document is a 510(k) Premarket Notification from the FDA for a medical device called "The Gecko Spinal System." It is a regulatory approval document and does NOT contain information about a study proving the device meets acceptance criteria derived from AI/machine learning performance.

The content focuses on:

• Regulatory approval: 510(k) clearance, substantial equivalence to predicate devices.
• Device description: Components, materials, intended use, indications for use.
• Performance data (non-clinical): Sterilization (gamma radiation), shelf life (packaging), biocompatibility, and mechanical testing (static and dynamic band tension, axial grip, torsional grip, axial compression). These are standard engineering and material science tests for implantable medical devices, not performance metrics for an AI/ML algorithm.
• Absence of clinical testing: "None provided for basis of substantial equivalence." This explicitly states that no clinical trials were conducted or submitted for this specific 510(k) clearance.

Therefore, I cannot extract the requested information regarding acceptance criteria for an AI-powered device, study details for AI performance, sample sizes for test/training sets, expert involvement, adjudication methods, MRMC studies, standalone AI performance, or ground truth establishment for AI. This information is simply not present in the provided text.

Ask a specific question about this device

These devices are intended for use in total knee arthroplasty procedures for the following conditions:

1. Loss of joint configuration and joint function.
2. Osteoarthritis of the knee joint.
3. Rheumatoid arthritis of the knee joint.
4. Post-traumatic arthritis of the knee joint.
5. Valgus, varus, or flexion deformities of the knee joint.
6. Revision procedures where other treatments or devices have failed.
   The BKS Revision is indicated in the salvage of previously failed surgical attempts where bone loss may require the use of augments, sleeves, cones or stem extensions.
   The BKS Revision System Trabecular Tibial Cone Augments are for cemented or cementless use.

The Balanced Knee® Revision System (BKS® Revision) Trabecular Tibial Cone Augments are an addition to the Balanced Knee® Revision System to provide optional single-use modular cone augment implants used in revision knee surgery. The subject device provides additional support to the tibial implant and reinforcement to the proximal tibia when bone voids are present. The subject device is designed for cemented or uncemented fixation with the bone.

The provided text describes a 510(k) premarket notification for the "Balanced Knee Revision System Trabecular Tibial Cone Augments." This is a medical device (knee joint prosthesis component) and not an AI/ML-driven device or an imaging device.

Therefore, the requested information regarding acceptance criteria and study details for an AI/ML device (e.g., test set sample size, data provenance, expert ground truth, MRMC studies, standalone performance, training set details) is not applicable to this document.

The document discusses the substantial equivalence of the device to existing predicate devices based on technological characteristics and non-clinical performance testing.

Here's an assessment of the provided information relative to the device type described:

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

The document lists the following non-clinical tests that were conducted and "successfully met the predetermined acceptance criteria." However, the specific numerical acceptance criteria and reported performance values are not detailed in this 510(k) summary. It only states that the tests met the criteria.

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 applicable as this is a physical medical device, not an AI/ML imaging device. The "test set" here refers to physical specimens subjected to biomechanical and material tests, not a dataset for AI model evaluation. No data provenance in terms of country of origin or retrospective/prospective collection is relevant in this context.

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 is not applicable. Ground truth establishment by experts in the context of radiology or clinical interpretation is not relevant for this physical device's mechanical and material testing. The "ground truth" for these tests are the established ASTM and ANSI/AAMI standards.

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

This is not applicable. Adjudication methods are relevant for ambiguous or challenging cases in AI/ML performance evaluation, usually involving human experts. For mechanical testing, the results are objectively measured against predefined standards.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This is not applicable. MRMC studies are specific to imaging devices and AI/ML aids that influence human reader performance. This device is a prosthetic component.

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

This is not applicable. Standalone performance refers to an algorithm's output without human intervention, which is not relevant for a physical implant.

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

The ground truth for this device's performance evaluation lies in the established industry standards (ASTM, ANSI/AAMI) for mechanical, material, and biocompatibility testing. There is no "pathology" or "outcomes data" specifically mentioned for establishing ground truth for the premarket clearance of this component.

8. The sample size for the training set:

This is not applicable as this is not an AI/ML device.

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

This is not applicable as this is not an AI/ML device.

In summary: The provided document is a 510(k) summary for a physical orthopedic implant. The requested information pertains to an AI/ML or imaging device, which is a different category of medical product. Therefore, most of the specific questions are not applicable to the content of this document. The device's acceptance criteria are based on meeting established national and international standards for mechanical properties and biocompatibility.

Ask a specific question about this device

These devices are intended for use in total knee arthroplasty procedures for the following conditions:

1. Loss of joint configuration and joint function.
2. Osteoarthritis of the knee joint.
3. Rheumatoid arthritis of the knee joint.
4. Post-traumatic arthritis of the knee joint.
5. Valgus, varus, or flexion deformities of the knee joint.
6. Revision procedures where other treatments or devices have failed.

The BKS Revision is indicated in the salvage of previously failed surgical attempts where bone loss may require the use of augments, sleeves or stem extensions.

The BKS Revision is indicated for cemented application only. The porous-coated metaphyseal sleeves are intended for cemented and uncemented biological fixation application.

The BKS® Revision Sleeves System expands the capabilities of the Balanced Knee® System (BKS®) Revision through the introduction of femoral and tibial sleeves, a tapered junction box, locking bolt, and a sleeve specific tibial tray. All new implants are a single-use modular system used in revision knee surgery to accommodate metaphyseal bone defects and provide rotational stability. The system is designed for cemented or uncemented fixation with the bone. The porous-coated femoral sleeve is affixed to the modular femoral component via a tapered junction box. The porous-coated tibial sleeve is affixed to a sleeve tibial tray.

This document describes a 510(k) premarket notification for the "BKS Revision Sleeves System." This is a medical device submission, and the focus is on demonstrating substantial equivalence to previously cleared predicate devices, rather than proving a specific clinical performance metric against acceptance criteria in the way a diagnostic AI device would.

Therefore, the requested information about acceptance criteria, study design, ground truth, and human reader performance is not applicable in the context of this device submission. The primary "study" conducted here is non-clinical mechanical testing to ensure the device meets engineering standards and performs similarly to existing devices.

Here's a breakdown of what the document provides, and why the requested information is not present:

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

• Acceptance Criteria (Non-Clinical): The document states that the following non-clinical tests were conducted and "successfully met the predetermined acceptance criteria":
  • Static Disassembly per ASTM F-1814 and ASTM F-2083
  • Cyclic fatigue per ASTM F1800, ASTM F1814, and ASTM F2083
  • Bacterial endotoxin testing using LAL pyrogen testing methodology per ANSI/AAMI ST72:2011
• Reported Device Performance (Non-Clinical): The document simply states that the tests were "successfully met," indicating compliance with the standards. It does not provide specific numerical results or performance metrics like sensitivity, specificity, or accuracy, which would be relevant for a diagnostic device.

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

• Not applicable. This device is an orthopedic implant, not a diagnostic or AI-driven system that uses data in this manner. The "test set" consists of physical devices subjected to mechanical and biological safety tests. The document doesn't specify the number of individual sleeve components tested for each mechanical test, but it would be a small number of physical samples, not a dataset of patient information.

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. Ground truth in this context refers to the engineering standards themselves (e.g., ASTM standards) and the established methods for bacterial endotoxin testing. These are defined by scientific and engineering bodies, not established by individual experts reviewing a test set for clinical accuracy.

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

• Not applicable. No adjudication method is described or required for this type of non-clinical testing. The tests are designed to objectively measure physical properties or biological safety against defined standards.

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:

• No, not applicable. This device is an implant, not an AI-assisted diagnostic tool. No MRMC studies were performed.

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

• No, not applicable. This device is an implant, not an algorithm.

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

• Ground Truth (Non-Clinical): The "ground truth" for this submission is adherence to established engineering standards (ASTM) for mechanical properties and biological testing standards (ANSI/AAMI ST72:2011) for pyrogenicity. The device's performance is compared against these predetermined, objective standards rather than expert consensus on clinical cases or pathology.

8. The sample size for the training set:

• Not applicable. There is no "training set" as this is not a machine learning or AI device.

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

• Not applicable. See point 8.

In summary: The BKS Revision Sleeves System is an orthopedic implant. Its "acceptance criteria" and "study" are focused on demonstrating mechanical integrity, biocompatibility, and substantial equivalence to existing devices through non-clinical testing against established engineering and biological safety standards. Clinical studies or AI-specific performance metrics (like those for diagnostic devices) were not part of this 510(k) submission, and the document explicitly states: "No clinical studies were performed."

Ask a specific question about this device

This device is intended for use in total knee arthroplasty procedures for the following conditions:

1. Loss of joint configuration and joint function.
2. Osteoarthritis of the knee joint.
3. Rheumatoid arthritis of the knee joint.
4. Post-traumatic arthritis of the knee joint.
5. Valgus, varus, or flexion deformities of the knee joint.
6. Revision procedures where other treatments or devices have failed.

The Offset Junction Box is part of the Balanced Knee® Revision System and is a single use modular device used in revision knee surgery to provide an attachment point between a modular femoral component and a stem extension.
The Offset Junction Box is available in four size options: 0mm and 5mm offset configurations with either a 5° or 7° valgus angle.

This document describes a medical device, the "Balanced Knee Revision System - Offset Junction Box," and its FDA 510(k) clearance. This is a traditional medical device approval, not related to AI/ML software. Therefore, the questions regarding acceptance criteria and studies that prove the device meets these criteria in the context of an AI/ML device cannot be fully answered from the provided text.

The provided text details the device's indications for use, its classification, and the basis for its substantial equivalence to a predicate device (K060569). It mentions mechanical tests conducted but does not provide specific acceptance criteria or detailed results in a comparative table format as requested for AI/ML devices.

However, I can extract the information provided about the non-clinical mechanical tests and state that, based on the document, these tests were used to demonstrate the device's safety and effectiveness in line with established standards for knee joint prostheses.

Here's an attempt to structure the available information, noting the absence of AI/ML-specific details:

Regarding the specific questions for AI/ML devices:

1. A table of acceptance criteria and the reported device performance: As seen above, specific quantitative acceptance criteria or performance metrics (like sensitivity, specificity, AUC) for an AI/ML algorithm are not provided because this is a physical medical device. The "performance" is described in terms of meeting mechanical and biological safety standards.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for this physical device. The testing involved mechanical tests of the device itself, not analysis of a data set.

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 an AI/ML model is not relevant here. The ground truth for device performance would be established by physical testing standards and expert engineering evaluation, but the specifics are not detailed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for a physical device.

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 not an AI/ML device involving human readers or interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the mechanical tests, the ground truth would be defined by the ASTM standards (ASTM F-1814 for static torsion, static axial and shear, cyclic fatigue) and regulatory requirements for bacterial endotoxin testing. These standards define acceptable performance limits.

8. The sample size for the training set: Not applicable. There is no training set for a physical device.

9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) clearance letter for a physical knee implant component. It addresses the device's substantial equivalence through mechanical testing against established standards, not through AI/ML model performance evaluation. Therefore, most of the questions tailored for AI/ML devices cannot be answered from this specific text.

Ask a specific question about this device

This device is intended for use in total hip arthroplasty. The device is intended for uncemented, press-fit use only in cases of:

• Notably impaired hip joints due to osteoarthritis, rheumatoid arthritis and/or post traumatic arthritis.
• Previously failed hip surgery.
• Fractures of the femoral neck or head.
• Avascular necrosis of the femoral head.
• Congenital dysplasia or other structural abnormalities where sufficient bone stock exists to prosthesis.

The proposed subject device is a line extension to the acetabular cup system previously cleared in K103384. The predicate is a modular system intended for the replacement of the natural articular surface of the hip joint in total hip replacement surgery. The system consists of acetabular shells, liners, bone screws, apical screw hole cover, and femoral heads.

The subject and predicate acetabular liners are both made of highly cross-linked polyethylene and are hemispherical in shape with positive locking, liner stabilization, and anti-rotation features.

The Legend Acetabular Liners (subject device) differ from the predicate device, cleared in K103384, through the addition of new sizes. Other components of the system have not been modified and are not a part of this submission other than by reference.

This document is a 510(k) premarket notification for the Legend® Acetabular Liners. It is a submission for a medical device and, as such, does not involve studies related to AI, image interpretation, or human-in-the-loop performance. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to non-clinical performance testing of a physical medical device.

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

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

The document does not specify the sample size for the non-clinical tests (impingement performance and bacterial endotoxin testing). It also does not explicitly state the country of origin of the data or whether it was retrospective or prospective, though for non-clinical lab testing of a physical device, these provenance details are less commonly reported in summary documents.

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. The "ground truth" in this context refers to the performance standards set by ASTM and ANSI/AAMI for the physical properties of the device, not expert interpretation of data.

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

Not applicable. This is a physical device performance test, not an interpretive one requiring adjudication.

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

No. This is a medical device, specifically an orthopedic implant, not an AI-powered diagnostic or interpretive tool. Therefore, MRMC studies are not relevant.

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

No. This device is not an algorithm.

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

The "ground truth" for the device's performance is established by the specified industry standards and methodologies: ASTM F-2582 for Impingement Performance and ANSI/AAMI ST72:2011 for Bacterial Endotoxin Testing. These are objective engineering and microbiological performance standards.

8. The sample size for the training set

Not applicable. This device is not an AI algorithm and does not have a "training set."

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

Not applicable. This device is not an AI algorithm.

Ask a specific question about this device

This device is intended for use in total and hemi-hip arthroplasty. The device is intended for uncemented, press-fit use only in cases of:

1. Notably impaired hip joint due to osteoarthritis, rheumatoid arthritis, and/or post traumatic arthritis.
2. Previously failed hip surgery.
3. Proximal femoral neck fractures or dislocation.
4. Idiopathic avascular necrosis of the femoral head.
5. Non-union of proximal femoral neck fractures.
6. Treatment of fractures that are unmanageable using other forms of therapy.
7. Benign or malignant bone tumors, congenital dysplasia or other structural abnormalities where stock exists to properly seat the prosthesis.

Entrada™ hip stem is a single-piece, tapered, collared and non-collared, hydroxyapatite (HA) coated femoral hip stem designed for single use. The stem has a neck with a 12/14 trunnion taper for modular attachment to femoral heads. Entrada™ hip stem is manufactured from titanium alloy and device fixation is achieved through uncemented press-fit in the medullary canal and through the use of biocompatible HA coating. The stem has a variety of sizes to accommodate the majority of patients encountered: lengths (95-160mm), horizontal offsets (35-55mm), vertical offsets (29-34mm), resection angle of 45°, and neck angle of 132°. The stem is offered with both standard (STD) and extended (EXT) offsets and with and without a collar.

This document describes the Entrada™ Hip Stem, a hip arthroplasty device, and its acceptance criteria for substantial equivalence to legally marketed predicate devices. The information provided is from a 510(k) Premarket Notification to the FDA.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

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

Unfortunately, the provided document does not explicitly state specific numerical acceptance criteria for the mechanical tests. It only lists the types of tests performed and generally concludes that the device "met the predetermined acceptance criteria" and that "The mechanical test results demonstrate that Entrada™ hip stem is safe and effective."

2. Sample size 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: The document states that mechanical tests were "conducted on the worst-case configurations of Entrada™ hip stem." However, it does not specify the numerical sample size for these tests (e.g., number of stems tested for fatigue).
   • Data Provenance: This was a non-clinical study involving mechanical testing of the device itself. Therefore, concepts like country of origin for patient data or retrospective/prospective clinical data do not apply. The data was generated in a laboratory setting.

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 question is not applicable as the studies performed were non-clinical mechanical tests, not clinical studies requiring expert ground truth for interpretation of patient data. The "ground truth" for mechanical testing is adherence to established engineering standards and performance targets.

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

   This question is not applicable as there were no clinical studies or human interpretation of diagnostic data that would require an adjudication method.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

   This question is not applicable. No clinical studies, and specifically no MRMC studies involving human readers or AI assistance, were performed.

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

   This question is not applicable. This device is a physical hip stem, not an algorithm or AI software. Therefore, there is no standalone algorithm performance to evaluate.

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

   For the non-clinical mechanical tests, the "ground truth" is based on established engineering standards, biomechanical principles, and the performance characteristics of predicate devices. The tests aim to demonstrate that the Entrada™ Hip Stem meets performance criteria consistent with devices already on the market and considered safe and effective.

8. The sample size for the training set

   This question is not applicable. As this device is a physical hip stem and the studies were non-clinical mechanical tests, there is no concept of a "training set" like there would be for an AI algorithm.

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

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

Ask a specific question about this device