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510(k) Data Aggregation
(105 days)
The Progressive Orthopaedic Company, LLC.
The Progressive Orthopaedic Company Total Knee System II is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthrius, osteoarthritis, primary and secondary traumatic arthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities. The Progressive Orthopaedic Company Total Knee System II may also be indicated in the salvage of previously failed surgical attempts if the knee can be satisfactorily balanced and stabilized at the time of surgery. The Progressive Orthopaedic Company Total Knee System II is designed for cemented use only.
The Progressive Orthopaedic Company Total Knee System II is a fixed bearing implant available in posteriorstabilized (PS) and cruciate-retaining (CR) configurations. It is a patellofemorotibial, polymer, semi-constrained, cemented knee prosthesis that consists of a femoral component, tibial tray and patellar component. The PS version has tibial inserts with posts and femoral components with cams that interact with the posts to help stabilize the knee after the posterior cruciate ligament is removed. The CR version of The Progressive Orthopaedic Company Total Knee System II has tibial inserts and femoral components without posts or cams, allowing the posterior cruciate ligament to be "retained" and provide stability to the knee joint. The femoral component articulates with the tibial insert component. The underside of the tibial insert component is flat and "snaps" into tibial baseplate component. The design and sizing of the femoral components correspond to the natural femoral anatomy, enhancing stress distribution and restoring original femoral dimensions and normal rotation, extension and flexion. Each femoral component has the same intercondylar distance and radius of curvature. Each tibial insert component is complimentarily shaped to conform to the femoral components. This allows any size femoral component to be matched with any size tibial component. The dome shape of each UHMWPE patellar component provides excellent contact with the femoral component and evenly distributes stresses. The dome shape of each patellar component also simplifies implantation by eliminating the need for rotational orientation.
The provided text is a 510(k) premarket notification and does not describe an AI medical device. It pertains to an orthopedic implant, specifically "The Progressive Orthopaedic Company Total Knee System II," a knee replacement prosthesis.
Therefore, the document does not contain the information needed to answer your questions about acceptance criteria for an AI device, including:
- A table of acceptance criteria and reported device performance for an AI model.
- Sample sizes for test and training sets, or data provenance.
- Number and qualifications of experts for ground truth establishment.
- Adjudication methods.
- Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone AI performance.
- Type of ground truth used (e.g., pathology, outcomes data).
- How ground truth for training data was established.
This document focuses on demonstrating substantial equivalence of a physical medical device (a knee implant) to a legally marketed predicate device, primarily through identical design features, materials, indications for use, and reliance on previously conducted preclinical performance testing of the predicate device (mechanical strength, fatigue, range of motion, etc.).
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(426 days)
The Progressive Orthopaedic Company, LLC
The Progressive Orthopaedic Total Hip System implant components are in cementless reconstruction of the articulating surface of femoral and acetabular portions of the hip that are severely disabled and/or very painful as a result of:
- · Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- · Rheumatoid arthritis or traumatic arthritis
- · Correction of functional deformity
- · Non-union femoral neck fracture
- · Trochanteric fractures of the proximal femur with head involvement which is unmanageable using other techniques.
The components can be used for primary hip arthroplasty or for revision of a failed total hip arthroplasty.
The present 510k The Progressive Orthopaedic additional screw sizes and apical hole plug are components to be used with the Progressive Orthopaedic Total Hip System, previously cleared via K143314.
| Screw Sizes | 6.5mm OD x 15-45mm Length |
|---|---|
| Material | Ti6Al4V per ASTM 1472 |
| Apical Hole Plug OD | Ø 8.52mm OD |
| Apical Hole Plug Thread | 5/16 X 24 UNF 2A |
| Material | Ti6Al4V |
This document is a 510(k) premarket notification for a medical device, specifically "The Progressive Orthopaedic Total Hip System." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical outcome studies. Therefore, the information you've requested regarding acceptance criteria, study details, and expert opinions for clinical performance is largely not applicable or not present in this document, as clinical testing was not required for this submission.
Here's a breakdown based on the provided text, addressing your points where possible and noting when information is absent:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Non-Clinical) | Reported Device Performance (Non-Clinical) |
|---|---|
| Mechanical characterization | Equivalent to predicate devices |
| Torsion Resistance | Equivalent to predicate devices |
| Driving Torque | Equivalent to predicate devices |
| Pull Out Strength | Equivalent to predicate devices |
| Material Equivalence | Equivalent to predicate devices |
| Construction Equivalence | Equivalent to predicate devices |
| Performance Characteristics Equivalence | Equivalent to predicate devices |
Explanation:
The document states under "Non-Clinical Testing": "Mechanical testing has demonstrated the device's ability to perform under expected conditions. Testing included mechanical characterization testing, torsion, driving torque and pull out. In all testing, the subject device shows equivalent properties when compared to predicate products." It further elaborates: "Testing has determined that the device is substantially equivalent to the predicate device in material, construction, and performance characteristics."
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: Not specified in the document. Mechanical tests typically use a certain number of samples for each test type (e.g., torsion, pull-out), but these numbers are not detailed here.
- Data Provenance: Not specified, but generally, non-clinical bench testing data would be generated in a lab setting by the device manufacturer or a contract research organization. It would be prospective to the submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Not Applicable. This document pertains to mechanical and material equivalence, not diagnostic or clinical performance assessed by medical experts. "Ground truth" in this context refers to the measured physical properties and performance characteristics of the device, which are directly measured and compared against established engineering standards or predicate device performance.
4. Adjudication Method for the Test Set
- Not Applicable. As this is non-clinical mechanical testing, there is no "adjudication method" in the sense of expert consensus on clinical outcomes or diagnoses. The results are typically quantitative measurements compared to predefined criteria or predicate device 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 document is for a hip implant system, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies are irrelevant.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This document is for a hip implant system, not a standalone algorithm.
7. The Type of Ground Truth Used
- Instrumental Measurements/Benchmarking against Predicates: For the non-clinical testing, the "ground truth" would be the established mechanical properties and performance characteristics of the predicate devices and/or recognized engineering standards for hip implants. The subject device's performance is measured using calibrated instruments and compared directly to these benchmarks.
8. The Sample Size for the Training Set
- Not Applicable. This device did not involve machine learning or AI, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
- Not Applicable. As there is no training set for an AI/ML algorithm.
Summary of Device and Approval Context:
This 510(k) submission is for "The Progressive Orthopaedic Total Hip System," which consists of additional screw sizes and an apical hole plug for a previously cleared system (K143314). The approval is based on demonstrating substantial equivalence to predicate devices (Progressive Orthopaedic Total Hip System (K143314) and NovoSource NovoHip Total Hip System (K140701)).
The evidence for substantial equivalence primarily relies on non-clinical testing which confirmed that the device has equivalent material, construction, and performance characteristics (mechanical characterization, torsion, driving torque, and pull-out strength) when compared to the predicate devices. No clinical testing was required for this 510(k) submission.
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(90 days)
The Progressive Orthopaedic Company, LLC
The Progressive Orthopaedic Total Knee System is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, postraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities.
The Progressive Orthopaedic Total Knee System may also be indicated in the salvage of previously failed surgical attempts if the knee can be satisfactorily balanced and stabilized at the time of surgery. The Progressive Orthopaedic Total Knee System is designed for cemented use only.
The present 510k submission is for a cruciate retaining (CR) version of the Progressive Orthopaedic Total Knee System and a line extension of HC PS tibial inserts. The main predicate device (K142649) is a posterior stabilized (PS) version of the Progressive Orthopaedic Total Knee System. All implant components are the same between the two versions, except for the tibial inserts and the femoral components. The posterior stabilized version has tibial inserts with posts and femoral components with cams that interact with the posts to help stabilize the knee after the posterior cruciate ligament is removed. The cruciate retaining version of the Progressive Orthopaedic Total Knee System has tibial inserts and femoral components without posts or cams, allowing the posterior cruciate ligament to be "retained" and provide stability to the knee joint.
The Progressive Orthopaedic Total Knee System is a Patellofemorotibia, polymer / metal / polymer, semi-constrained, cemented knee prosthesis, consisting of a femoral component, tibial insert, tibial tray and patellar component. The femoral component articulates with the tibial insert component. The underside of the tibial insert component is flat and "snaps" into the tibial baseplate component. Each femoral component has the same intercondylar distance and radius of curvature. Each tibial insert component is complimentarily shaped to conform to the femoral components. This allows a range of sizes of the femoral component to be matched with up to one size up/down of the tibial component. The dome shape of each UHMWPE patellar component provides excellent contact with the femoral component and evenly distributes stresses. The dome and sombrero shape of each UHMWPE patellar component provides contact with the femoral component.
This FDA 510(k) K150783 document is for a medical device called the "Progressive Orthopaedic Total Knee System", specifically a cruiciate retaining (CR) version. It is a knee replacement system. The document does not describe an AI/ML device or an algorithm. As such, the information requested in your prompt (e.g., acceptance criteria for an AI model, sample sizes for test and training sets, number of experts for ground truth, MRMC studies, etc.) is not applicable to this document.
The document focuses on demonstrating that the new CR version of the knee system is substantially equivalent to a previously cleared posterior stabilized (PS) version and another predicate device. This is done through a comparison of technological characteristics and performance testing of mechanical aspects of the device.
Here's the information gleaned from the document that is somewhat related to your request, but adapted to the context of a physical medical device (a knee prosthesis):
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Contact area between femoral and tibial insert components | Femoral/Tibial Insert Contact Area Test results indicate substantial equivalence. |
| Interlocking mechanism strength (anterior shear) | Anterior Shear Test results indicate substantial equivalence. |
| Interlocking mechanism strength (posterior shear) | Posterior Shear Test results indicate substantial equivalence. |
| Interlocking mechanism strength (medial/lateral shear) | Medial/Lateral Shear Test results indicate substantial equivalence. |
| Material composition (for device components) | CR version is manufactured from the same materials as the PS version. |
| Range of sizes available | Range of sizes for CR version is the same as the PS version. |
| Design similarity to predicate device | CR version design is substantially similar to the PS version system design. |
Explanation: The "acceptance criteria" here are not explicitly stated as numerical thresholds in the document. Instead, the document demonstrates "substantial equivalence" to a predicate device. The performance tests were conducted to show that the CR version performs similarly to the predicate device in terms of these mechanical properties, implying that the performance of the CR version is "acceptable" if it is equivalent to a device already on the market.
2. Sample size used for the test set and the data provenance:
Due to this being a mechanical device and not an AI/ML model, there is no "test set" in the sense of medical images or patient data. The "tests" performed are mechanical engineering tests on the device components. The sample sizes for these specific mechanical tests are not provided in this summary document. The "data provenance" is derived from in-vitro mechanical testing of the physical device components.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth as typically defined for AI/ML validation (e.g., expert consensus on medical images) does not apply to the mechanical testing of a knee prosthesis. Device performance is measured through objective physical tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This refers to consensus among human readers for medical image analysis, which is not relevant here.
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 AI/ML systems and their impact on human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This document pertains to a physical medical device, not an algorithm.
7. The type of ground truth used:
For the mechanical performance tests, the "ground truth" would be the objective measurements obtained from the mechanical testing, demonstrating the physical properties (e.g., contact area, shear strength) of the device components. The implicit "ground truth" for showing substantial equivalence is the established performance of the predicate devices.
8. The sample size for the training set:
Not applicable. This document is not about AI/ML.
9. How the ground truth for the training set was established:
Not applicable. This document is not about AI/ML.
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(188 days)
The Progressive Orthopaedic Company, LLC
The Progressive Orthopaedic Total Knee System is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities.
The Progressive Orthopaedic Total Knee System may also be indicated in the salvage of previously failed surgical attempts if the knee can be satisfactorily balanced and stabilized at the time of surgery. The Progressive Orthopaedic Total Knee System is designed for cemented use only.
The Progressive Orthopaedic Total Knee System is of the fixed bearing type with a posterior stabilized design. It is a Patellofemorotibia, polymer/metal/polymer, semi-constrained, cemented knee prosthesis, that consists of a femoral component, tibial tray and patellar component. The femoral component articulates with the tibial insert component. The underside of the tibial insert component is flat and "snaps" into tibial baseplate component. The design and sizing of the femoral components correspond to the natural femoral anatomy, enhancing stress distribution and restoring original femoral dimensions and normal rotation, extension and flexion. Each femoral component has the same intercondylar distance and radius of curvature. Each tibial insert component is complimentarily shaped to conform to the femoral components. This allows any size femoral component to be matched with any size tibial component. The dome shape of each UHMWPE patellar component provides excellent contact with the femoral component and evenly distributes stresses. The dome shape of each patellar component also simplifies implantation by eliminating the need for rotation.
The provided text does not contain detailed acceptance criteria or extensive study data for the Progressive Orthopaedic Total Knee System. The document is essentially a 510(k) summary for a medical device, which focuses on establishing substantial equivalence to a predicate device rather than presenting a comprehensive performance study with specific acceptance criteria and detailed results.
However, based on the information provided, here's what can be inferred and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance (Summary) |
|---|---|
| Mechanical Performance: | |
| - Fatigue performance of tibial tray (to withstand expected in vivo loading without failure) | "Test results indicate that the Progressive Orthopaedic Total Knee System performs as well as the U2 Total Knee System and is capable of withstanding expected in vivo loading without failure." (Implies the fatigue performance criteria were met, likely by demonstrating equivalence to the predicate's known performance or by meeting industry standards). |
| - Interlock mechanism strength (between tibial insert and tibial baseplate) | "Test results indicate that the Progressive Orthopaedic Total Knee System performs as well as the U2 Total Knee System and is capable of withstanding expected in vivo loading without failure." (Implies the interlock strength criteria were met, likely by demonstrating equivalence to the predicate). |
| - Shear fatigue strength of tibial insert post (to withstand expected in vivo loading without failure) | "Test results indicate that the Progressive Orthopaedic Total Knee System performs as well as the U2 Total Knee System and is capable of withstanding expected in vivo loading without failure." (Implies the shear fatigue strength criteria were met, likely by demonstrating equivalence to the predicate). |
| - Contact pressures and areas (to be comparable to predicate for proper articulation) | "Test results indicate that the Progressive Orthopaedic Total Knee System performs as well as the U2 Total Knee System and is capable of withstanding expected in vivo loading without failure." (Implies acceptable contact pressures and areas, likely comparable to the predicate). |
| Functional Performance: | |
| - Lateral subluxation of patellar component (to ensure stability) | "Test results indicate that the Progressive Orthopaedic Total Knee System performs as well as the U2 Total Knee System and is capable of withstanding expected in vivo loading without failure." (Implies lateral subluxation was within acceptable limits, likely comparable to the predicate). |
| - Range of motion performance (to ensure adequate knee movement) | "Test results indicate that the Progressive Orthopaedic Total Knee System performs as well as the U2 Total Knee System and is capable of withstanding expected in vivo loading without failure." (Implies acceptable range of motion, likely comparable to the predicate). |
| Substantial Equivalence: | |
| - Same intended use and indications for use as predicate | Met: The document explicitly states, "The Progressive Orthopaedic Total Knee System has the same intended use and indications as the U2 Total Knee system." |
| - Manufactured from the same materials as predicate | Met: "The Progressive Orthopaedic Total Knee System is manufactured from the same materials as the U2 Total Knee system." |
| - Same range of sizes as predicate | Met: "The range of sizes available for the Progressive Orthopaedic Total Knee System is the same as the range of sizes cleared for the U2 Total Knee system." |
| - Design substantially similar to predicate | Met: "The Progressive Orthopaedic Total Knee System design is substantially similar to the U2 Total Knee system design." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify sample sizes for mechanical testing or details on the test set. It mentions "Performance Testing" which is typically conducted on device prototypes or specific components, not clinical data. Therefore, the concept of "data provenance" (country of origin, retrospective/prospective) does not apply in the context of this 510(k) summary, as it's not a clinical study report.
3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts
This information is not applicable. The 510(k) summary describes mechanical performance testing of the device components, not a clinical study involving diagnosis or interpretation by experts to establish ground truth.
4. Adjudication Method for the Test Set
This information is not applicable, as it pertains to clinical studies often involving expert interpretation, which is not described here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence through design, materials, and mechanical performance testing, not clinical effectiveness studies comparing human readers with and without AI assistance. This device is a physical knee implant, not an AI-powered diagnostic tool.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable. The device is a physical knee implant and does not involve an algorithm or AI.
7. The Type of Ground Truth Used
The "ground truth" for the mechanical performance tests would be established through engineering standards, material specifications, and validated biomechanical testing methods. For example, for fatigue performance, the ground truth is the point at which the component fails or exceeds a predefined deformation limit, which is then often compared to the expected in-vivo loads. It's not based on expert consensus, pathology, or outcomes data in the traditional clinical sense.
8. The Sample Size for the Training Set
This information is not applicable. This device is a physical implant and does not involve a "training set" in the context of machine learning or algorithm development.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
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(100 days)
The Progressive Orthopaedic Company, LLC
The Progressive Orthopaedic Total Hip System implant components are in cementless reconstruction of the articulating surface of femoral and/or acetabular portions of the hip that are severely disabled and/or very painful as a result of:
- · Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- · Rheumatoid arthritis or traumatic arthritis
- · Correction of functional deformity
- · Non-union femoral neck fracture
- · Trochanteric fractures of the proximal femur with head involvement which is unmanageable using other techniques.
The components can be used for primary hip arthroplasty or for revision of a failed total hip arthroplasty.
The present 510k submission is for a non-cemented primary hip prosthesis that consists of a 4part total hip replacement system including femoral Head, acetabular poly liner, and acetabular metal (or shell) components. The femoral head component articulates within the poly acetabular component. The poly acetabular component snaps into the metal acetabular component. The design and sizing of the components correspond to natural hip anatomy to restore normal rotation, extension, and flexion.
The femoral stem component is made from forged Ti 6AL 4V, with a Ti plasma spray coating. The uni-polar femoral head component is made from CoCr, or BIOLOX® delta ceramic, in 28, 32, and 36 mm sizes.
The acetabular poly liner component is made of standard UHMWPE polyethylene in both hooded and non-hooded options. The acetabular poly liner component is offered with different inner and outer diameter combinations to accept various size uni-polar femoral heads and acetabular metal components.
The acetabular metal (or shell) component is made from forged Ti 6AL 4V with a Ti porous coating. It is available in no-hole, cluster-hole, and revision multi-hole styles.
The provided document is a 510(k) summary for a medical device called "The Progressive Orthopaedic Total Hip System". This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific acceptance criteria for performance as would typically be seen for AI/Software as a Medical Device (SaMD).
Therefore, the information requested for AI/SaMD performance studies is largely not applicable to this submission. This document details non-clinical laboratory testing to prove mechanical and material equivalence.
However, I can extract the relevant information from the document as it pertains to the type of acceptance criteria and the testing done to meet regulatory requirements for this specific device.
Acceptance Criteria and Device Performance (Not applicable in the typical AI/SaMD sense as this is a mechanical prosthesis):
The document states that "All devices met the required performance specifications for testing and are considered equivalent to the predicate devices." The acceptance criteria are implicitly tied to the performance of the predicate device and established standards for hip prostheses, but specific numerical thresholds are not detailed in this summary.
Here's a table based on the non-clinical tests performed:
| Test Performed | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Fatigue Performance Test for Progressive Orthopaedic Stem | Meet established standards for hip stem fatigue and predicate | Met required performance specifications |
| Fatigue Performance Test for the Neck Portion of the Stem | Meet established standards for neck fatigue and predicate | Met required performance specifications |
| Disassembly Force Test for Neck Taper/Femoral Head Interface | Meet established standards for interface integrity and predicate | Met required performance specifications |
| Range of Motion Test for Total Hip System | Achieve functional range of motion and predicate | Met required performance specifications |
| Burst Strength Test for Ceramic Femoral Heads (Static) | Withstand static compression forces and predicate | Met required performance specifications |
| Cyclic Fatigue Test for Ceramic Femoral Heads (Cyclic) | Withstand cyclic compression forces and predicate | Met required performance specifications |
| Post-Cyclic Fatigue Burst Test for Ceramic Femoral Heads (Static) | Withstand static compression after cyclic loading and predicate | Met required performance specifications |
| Pull-Off Test for Ceramic Femoral Heads | Demonstrate adequate pull-off strength and predicate | Met required performance specifications |
| Rotational Stability Test for Ceramic Femoral Heads | Demonstrate adequate rotational stability and predicate | Met required performance specifications |
| Torsional Properties Test for Bone Screws | Meet established standards for screw torsion and predicate | Met required performance specifications |
| Driving Torque Test for Bone Screws | Meet established standards for screw driving torque and predicate | Met required performance specifications |
| Axial Pull-Out Strength Test for Bone Screws | Meet established standards for screw pull-out and predicate | Met required performance specifications |
| Lever-Out Test for Acetabular Shell/Liner Assembly | Demonstrate resistance to lever-out forces and predicate | Met required performance specifications |
| Torque-Out Test for Acetabular Shell/Liner Assembly | Demonstrate resistance to torque-out and predicate | Met required performance specifications |
| Push-In Test for Acetabular Shell/Liner Assembly | Demonstrate appropriate push-in forces and predicate | Met required performance specifications |
| Push-Out Test for Acetabular Shell/Liner Assembly | Demonstrate appropriate push-out forces and predicate | Met required performance specifications |
Additional Information (Specific to AI/SaMD, but N/A for this device):
- Sample size used for the test set and the data provenance: Not applicable. This device is a mechanical prosthesis, not a software device relying on a test set of data. The "samples" would be the physical devices or components tested in the lab.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is established by physical measurements and engineering standards, not expert consensus on data.
- Adjudication method for the test set: Not applicable.
- 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-assisted diagnostic or therapeutic device.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For this device, ground truth is based on established engineering standards (e.g., ISO standards for implant testing), material specifications, and performance data from the legally marketed predicate device (NovoSource NovoHip Total Hip System).
- The sample size for the training set: Not applicable. This device is not developed using machine learning that requires a training set.
- How the ground truth for the training set was established: Not applicable.
Summary based on the provided document:
The Progressive Orthopaedic Total Hip System underwent a series of non-clinical, in-vitro laboratory tests, including fatigue, strength, stability, and disassembly tests for its various components (stem, femoral head, acetabular shell/liner, bone screws). The acceptance criteria were implicitly defined by relevant engineering standards for orthopedic implants and by demonstrating equivalence to the predicate device, NovoSource NovoHip Total Hip System (K132158). The document states that all devices met the required performance specifications for testing, leading to the conclusion that the device is substantially equivalent to the predicate. No clinical testing was required for this 510(k) submission.
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