Search Results

General Indications:
The MobileLink® Acetabular Cup System is indicated for patients with mobility-limiting diseases, fractures or defects which cannot be treated by conservative or osteosynthetic procedures.

Indications:

• 1. Primary and secondary osteoarthritis
• 2. Rheumatoid arthritis
• 3. Correction of functional deformities
• 4. Avascular necrosis
• 5. Femoral neck fractures

6. Revision after implant loosening dependent on bone mass and quality

The MobileLink® Acetabular Cup System is a versatile cup system, designed to provide several options for surgeons and patients within one system. The cup system consists of press-fit metal shells made of a Ti6Al4V alloy. The system offers two designs, a cluster hole shell, with closing screws and a polar screw, and a multi hole shell. Both shells are available with two different coatings, either plasma sprayed coating (PlasmaLink®) or a double coating consisting of plasma spray plus calcium phosphate coating (TiCaP®). All shells are implanted cementless. The acetabular inserts are manufactured from conventional UHMWPE or Vitamin E highly crosslinked UHMWPE (E-Dur®). The inserts are available in six designs, neutral, offset, shouldered, offset/shouldered, 10° and 20° inclination. This premarket notification does not include the femoral components. The MobileLink® Acetabular Cup System is compatible with previously cleared femoral heads (K161840, K953653) and hip stems and neck segments (K161840, K151008, K142187, K953653) of Waldemar Link GmbH & Co. KG.

The provided text describes a 510(k) premarket notification for the "MobileLink Acetabular Cup System". This notification is a submission to the FDA to demonstrate that the device is substantially equivalent to legally marketed predicate devices, and therefore does not require a study proving the device meets specific acceptance criteria in the same way a novel device might.

Instead, the submission relies on non-clinical performance testing and analysis to demonstrate substantial equivalence to predicate devices. There is no mention of specific quantitative acceptance criteria or a dedicated study designed to prove the device meets such criteria with statistical significance.

Here's an breakdown of the information based on your request, structured to reflect what is actually present in the document:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission for substantial equivalence based on non-clinical testing, there isn't a table of specific, quantitative "acceptance criteria" for clinical performance. The "performance" is demonstrated through various bench tests and characterizations, aiming to show similarity to predicate devices.

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

• Test Set Sample Size: Not explicitly stated in the document. The testing described is bench testing, involving mechanical specimens rather than patient data.
• Data Provenance: Not applicable in the context of clinical data. The tests are bench tests conducted in a laboratory setting for the purpose of a 510(k) submission.

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

• Number of Experts & Qualifications: Not applicable. For bench testing, "ground truth" is typically established by engineering specifications, material standards (e.g., ASTM, ISO), and regulatory guidelines rather than expert clinical consensus.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. This is not a clinical study involving human interpretation of data where adjudication would be necessary. The tests are objective measurements against engineering 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

• MRMC Study: No. This device is a physical implant (acetabular cup system), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance is not relevant.

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

• Standalone Performance: Not applicable. This is not an algorithmic device.

7. The Type of Ground Truth Used

• Ground Truth: For bench testing, the "ground truth" refers to established engineering standards (e.g., ASTM, ISO), mechanical properties, material specifications, and performance expectations derived from predicate devices. The goal is to demonstrate that the device meets these engineering and material requirements.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This is not an AI/ML device that requires a training set of data.

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

• Ground Truth for Training Set: Not applicable. This is not an AI/ML device.

Ask a specific question about this device

The b-ONE® Total Hip System is intended for primary or revision total hip replacement in skeletally mature patients with a severely disabled hip joint and/or hip damage due to the following conditions:

Osteoarthritis, traumatic arthritis, avascular necrosis of the femoral head, noninflammatory degenerative joint disease (NIDJD), slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.

Hip components are also indicated for inflammatory degenerative joint disease including theumatoid arthritis and congenital dysplasia: treatments of nonunion, acute traumatic fracture of the femoral head or neck; failed endoprosthesis, femoral osteotomy, or Girdlestone resection; and fracture-dislocation of the hip.

The b-ONE® Total Hip System is intended for cementless use only.

b-ONE® Total Hip System components are not intended for use with other total hip systems.

The b-ONE® Total Hip System is an artificial hip replacement system comprised of femoral stems and mating femoral heads; acetabular shells and mating acetabular liners; and, optional 6.5mm acetabular screws. Acetabular Shell options include no-hole and multiple hole configurations.

The therapeutic effect is replacement of the diseased joint with artificial components to restore joint function. Compatibility of the femoral head to the stem is only claimed for the b-ONE® Total Hip System. There is no allowed interchangeability with systems manufactured by other companies.

The Tapered Wedge Stem, Acetabular Shells, and Acetabular Bone Screws are made from Ti-6AI-4V-ELI. Stem and shell coatings include CPTi Plasma Porous Spray with or without HA. Femoral heads are made from CoCr or Ceram Tec Biolox® delta. Acetabular Shell Liners are made from conventional UHMWPE and UHMWPE with Vitamin E.

All system components are supplied sterile and are single use devices.

This FDA 510(k) summary describes the b-ONE® Total Hip System, a total hip replacement device. It does not contain information about a study based on AI/ML. There is no mention of acceptance criteria or details of a study proving the device meets said criteria in the context of AI/ML performance.

The document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices through bench testing and comparison of technological characteristics.

Therefore, the requested information regarding acceptance criteria and study details for an AI/ML device is not applicable to this document. I cannot fill in the table or provide answers to the specific questions as they relate to AI/ML performance.

However, I can extract the information provided about the device's performance testing for its substantial equivalence claim, which is based on traditional engineering and biocompatibility testing:

Device Performance Information from the Provided Document (Not AI/ML related):

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of "acceptance criteria" and "reported device performance" in the way one might expect for an AI/ML product (e.g., sensitivity, specificity, AUC). Instead, it lists various non-clinical performance tests conducted to demonstrate the device's safety and effectiveness compared to predicate devices. The implicit "acceptance criterion" for each test is that the b-ONE® Total Hip System performs comparably to or within acceptable limits for a device of its kind, thereby not raising new questions of safety or effectiveness relative to the predicates. The "reported device performance" is the successful completion of these tests.

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

Not applicable. The tests listed are non-clinical, bench-top tests, and material characterization studies, not studies involving patient data or AI/ML test sets.

3. Number of Experts and Qualifications for Ground Truth:

Not applicable. This information is relevant for AI/ML performance evaluation based on expert-labeled data, which is not described in this document.

4. Adjudication Method:

Not applicable. Adjudication methods are typically used for establishing ground truth in clinical or image-based studies, not for the type of bench testing described here.

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

No. An MRMC study is not mentioned as this document describes a traditional medical device (hip implant), not an AI/ML device or software for interpretation.

6. Standalone (Algorithm Only) Performance:

Not applicable. There is no algorithm or software component mentioned that would have standalone performance.

7. Type of Ground Truth Used:

For the mechanical and material tests, the "ground truth" is defined by established industry standards (e.g., ASTM, ISO guidelines) and regulatory requirements for orthopedic implants, ensuring the device meets specific physical and chemical properties and performs as intended under simulated physiological conditions. Biocompatibility is assessed against recognized standards.

8. Sample Size for the Training Set:

Not applicable. There is no AI/ML training set.

9. How the Ground Truth for the Training Set was Established:

Not applicable. There is no AI/ML training set.

In summary, the provided document is a 510(k) summary for a physical medical device (an orthopedic implant) and does not describe an AI/ML-driven device or study. Therefore, most of the questions related to AI/ML acceptance criteria and study design are not relevant to this content.

Ask a specific question about this device

The Klassic® Knee System is intended for prosthetic replacement in treatment of the following:

• Patient conditions of non-inflammatory degenerative joint disease (NIDJ): . avascular necrosis and osteoarthritis
• Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis ●
• Patients with failed previous surgery where pain, deformity, or dysfunction . persists
• . Correctable varus-valgus deformity and moderate flexion contracture
• Revision of a previously failed knee arthroplasty .
• . Patients who require a total knee replacement

The Klassic® Knee System is indicated for cemented use only, except for the Klassic Femur, Porous, and the Klassic Tibial Baseplate, Porous, which are indicated for cementless use.

The purpose of this 510(k) is to add Klassic® Knee CR/Congruent Tibial Inserts with E-Link®, Ultra-PS® Tibial Inserts with E-Link®, Sombrero Patellae with E-Link® and Domed Patellae with E-Link® ("E-Link® Knee Components") to the Klassic® Knee System. These components are manufactured from E-link®, a Vitamin E blended UHMWPE crosslinked by gamma irradiation. The E-Link® Knee Components are available in various sizes and thicknesses to match patient anatomy.

The provided text is a 510(k) summary for the Klassic® Knee System. It does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML-enabled device. The document is for a traditional medical device (knee replacement system) and focuses on substantial equivalence based on engineering analyses and bench testing, rather than performance metrics related to diagnostic or predictive accuracy.

Therefore, I cannot provide the requested information. The document does not describe any AI/ML model.

Ask a specific question about this device

The Trident® Tritanium® PST® Acetabular Shell System is in skeletally mature individuals undergoing surgery for total hip replacement due to:

· A severely painful and/or disabled joint from osteoarthritis, theumatoid arthritis, avascular necrosis, or congenital hip dysplasia;

· Acute traumatic fracture of the femoral head or neck;

· Failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty or total hip replacement.

The Trident® Tritanium® PST® Acetabular Shell is intended for cemented fixation. The porous structured surface provides biological fixation when used in a cementless application.

The subject Trident® Tritanium® PST® Acetabular Shell is the predicate PST® Acetabular Shell, which has been modified to incorporate the acetabular bearing mating features of the predicate Trident® Tritanium®, Trident® PSL®, and Trident® Hemispherical Shells, to allow compatibility with existing Stryker Orthopaedics acetabular bearings including the Trident polyethylene and Modular Dual Mobility (MDM) bearing families.

The subject Trident® Tritanium® PST® Acetabular Shells are manufactured from titanium alloy and feature a porous structured surface. The subject shells feature a dome hole, and are available either in a solid shell (no screw holes) configuration, or in a cluster screw hole configuration for optional supplemental bone screw fixation. The subject Tritanium® PST® Acetabular Shells are compatible with the optional predicate PST Acetabular Shell system bone screws (titanium alloy), with the optional predicate Stryker Orthopaedics Torx head acetabular dome hole occluder (CP titanium), and with an optional new hex head acetabular dome hole occluder (titanium alloy).

The provided text is a 510(k) Summary for the Trident® Tritanium® PST® Acetabular Shells. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way an AI/software device would.

This document describes a medical device (an acetabular shell for hip replacement), not a software or AI product. The "Performance Testing" section refers to comparisons of materials, manufacturing methods, design features, and disassembly testing per ASTM F1820 (including push-out, and torsional testing) to demonstrate substantial equivalence to predicate devices.

Therefore, most of the requested information (related to AI performance, sample sizes for test/training sets, experts for ground truth, MRMC studies, standalone performance, etc.) is not applicable to this type of regulatory submission for a physical medical device.

I can only extract the following relevant information:

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

Based on the document, specific acceptance criteria and reported device performance in terms of quantifiable metrics like sensitivity, specificity, accuracy, etc., are not applicable as this is a physical medical device, not an AI/software device with such performance metrics.

The performance testing mentioned is mechanical in nature, focused on demonstrating substantial equivalence to predicate devices.

• Comparison of manufacturing methods: Same manufacturing methods as predicate PST® Acetabular Shells.
• Comparison of design features: Same outer profile and porous structured surface as predicate PST® Acetabular Shells.
• Disassembly Testing: Per ASTM F1820, including push-out and torsional testing (for worst-case style and size of compatible Stryker Orthopaedics acetabular bearings). |
  | Compatibility | - Incorporates acetabular bearing mating features of predicate Trident® Tritanium®, Trident® PSL®, and Trident® Hemispherical Shells.
• Compatible with existing Stryker Orthopaedics acetabular bearings, including Trident polyethylene and Modular Dual Mobility (MDM) bearing families. |
  | Sterilization | Same sterilization methods as predicate PST® Acetabular Shells. |
  | Packaging | Similar packaging to predicate PST® Acetabular Shells. |

2. Sample size 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 to this device. The testing described is mechanical performance (e.g., disassembly testing per ASTM F1820) of physical components, not data analysis or clinical studies in the typical sense of AI/software device evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable. Ground truth, in the context of expert review for AI/software, is not relevant for the mechanical testing of a physical implant.

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

This information is not applicable. Adjudication methods are typically for resolving discrepancies in expert interpretations for ground truth establishment, 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

This information is not applicable. MRMC studies are for evaluating human performance with and without AI assistance for tasks like image interpretation, which is not relevant for an orthopedic implant.

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

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

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

This information is not applicable. The "ground truth" for a physical device is its adherence to specified material properties, mechanical strength characteristics, and design specifications as evaluated through engineering tests, not clinical or pathological outcomes in the context of expert consensus as described for AI/software.

8. The sample size for the training set

This information is not applicable. There is no "training set" as this is not an AI/software device.

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

This information is not applicable. There is no "training set."

Ask a specific question about this device

The Klassic HD™ Acetabular Insert with E-Link™ Poly, for use within the Klassic HD™ Hip System, is intended for prosthetic replacement without bone cement in treatment of the following:

• . Patient conditions of non-inflammatory degenerative joint disease (NIDJD): avascular necrosis, osteoarthritis, ankylosis, protrusio acetabuli and painful hip dysplasia.
• Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis. ●
• . Those patients with failed previous surgery where pain, deformity or dysfunction persists.
• Revision of a previously failed hip arthroplasty. ●
• o Patients who require a total hip replacement.

The Total Joint Orthopedics Klassic HD™ Acetabular Insert with E-Link™ Poly ("Insert with E-Link'') is a permanently implanted device for use as an acetabular bearing surface in total hip arthroplasty ("THA"). The Insert with E-Link is fully compatible for use with the previously cleared Klassic HD™ Hip System and is manufactured from Vitamin E blended UHMWPE crosslinked by gamma irradiation. The Insert with E-Link is sterilized by ethylene oxide gas and intended for single-use only.

The provided FDA 510(k) summary for the "Klassic HD™ Acetabular Insert with E-Link™ Poly" does not contain the type of acceptance criteria and study details commonly associated with AI/ML medical devices. This document describes a traditional medical device (an acetabular insert for hip replacement) and focuses on demonstrating substantial equivalence to predicate devices through non-clinical bench testing.

Therefore, many of the requested items related to AI/ML device performance (like sample size for test sets, expert ground truth, MRMC studies, standalone performance, training set details) are not applicable or cannot be extracted from this document.

However, I can extract the information that is present and indicate where information is not provided.

Here's the analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not specified. The document states "Non-clinical bench testing was conducted," implying physical samples of the device were tested, but the number of samples for each test type is not detailed.
• Data Provenance: Not applicable in the context of clinical data provenance (e.g., country of origin, retrospective/prospective). This refers to bench testing performed on manufactured devices.

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

• Number of Experts: Not applicable. Ground truth for non-clinical bench testing is established by recognized standards (ASTM, ISO) and laboratory measurements of physical properties, not by human expert interpretation.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

• Adjudication Method: Not applicable. Bench testing results are typically evaluated against pre-defined specifications or predicate device performance, not adjudicated by a panel of human reviewers.

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

• MRMC Study: No. This is a traditional medical device, not an AI/ML device, so MRMC studies are not relevant.
• Effect Size of AI Improvement: Not applicable.

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

• Standalone Study: No. This is not an AI/ML algorithm.

7. The type of ground truth used

• Type of Ground Truth: For the non-clinical testing, the "ground truth" (or reference against which performance was assessed) was established by:
  • Recognized Standards: When available (e.g., ASTM, ISO standards for material properties, sterility, mechanical strength).
  • "Non-recognized standards from ASTM and ISO" used as a guide: For tests where no directly recognized standard existed.
  • Established Specifications: The document states that the device "meets the established specifications necessary for consistent performance during its intended use."
  • Predicate Device Performance: Comparison of technological characteristics and performance to legally marketed predicate devices to demonstrate substantial equivalence.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. This is not an AI/ML device.

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

• Training Set Ground Truth Establishment: Not applicable. This is not an AI/ML device.

Ask a specific question about this device

PIPELINE Total Hip System is indicated for use in skeletally mature individuals undergoing surgery for total hip replacement due to:

• A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis, or congenital hip dysplasia:
• Acute traumatic fracture of the femoral head or neck;
• Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty or total hip replacement.

The PIPELINE Tapered Femoral Stem and PIPELINE PST™ Acetabular Shell are intended for cementless or cemented fixation. The porous structured surface provides biological fixation when used in a cementless application.

The PIPELINE PST™ Acetabular Shell with HA is intended for cementless fixation. The porous structured surface with HA provides biological fixation.

The predicate Pipeline Total Hip System (K112802) and PBP Total Hip System (K122802) are artificial hip replacement systems that include femoral stems (titanium alloy and CP titanium), femoral heads (cobalt chromium or alumina ceramic), acetabular shells (titanium alloy, porous structured technology (PST™)), acetabular liners (ultrahigh molecular weight polyethylene, standard and highly crosslinked Vitamin E), acetabular bone screws (titanium alloy) and dome hole covers (titanium alloy) for the holes in the acetabular shells. This subject 510k adds the following components to the existing hip systems:

• A smaller, size 1 femoral stem; .
• The option of hip stems (all sizes) with 3 tantalum beads, to allow the surgeon to . perform radiostereometric analysis(RSA) to measure implant migration; and
• . The option of acetabular screw hole occluders provided either separately (for assembly by the surgeon), or pre-assembled to the acetabular shells.

The provided text describes a 510(k) summary for a hip replacement system, which details its components, intended use, and substantial equivalence to predicate devices, but does not contain information related to a "device" in the context of an AI/ML algorithm or medical imaging diagnostic device.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies because the provided document is for a mechanical orthopedic implant, not a diagnostic or AI-powered device.

The questions in the prompt (e.g., "Number of experts used to establish the ground truth," "Adjudication method," "MRMC comparative effectiveness study," "standalone algorithm performance") are specific to the evaluation of AI/ML or diagnostic imaging devices, which are not relevant to the Pipeline Total Hip System.

The "Performance Testing" section in the document refers to:

• Hip Stem Fatigue Testing: Conducted according to ISO 7206-4:2010 to determine endurance properties.
• Stem Neck Fatigue Testing: Conducted according to ISO 7206-6:1992 and ASTM F2068-03.
  These are mechanical engineering tests to ensure the structural integrity and durability of the implant under physical stress, not a study to prove diagnostic accuracy or AI performance.

Ask a specific question about this device

The Pipeline Total Hip System is indicated for use in skeletally mature individuals undergoing surgery for total hip replacement due to:

• A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis, or congenital hip dysplasia.
• Acute traumatic fracture of the femoral head or neck.
• Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty or total hip replacement.
  The Tapered Hip Stem and PST™ Acetabular Shell are intended for cementless or cemented fixation. The porous structured (PST™) surface provides biological fixation when used in a cementless application.
  The Pipeline Total Hip System HA porous structured acetabular shells are intended for cementless fixation. The HA porous structured surface provides biological fixation.

This 510(k) addresses the addition of the following components (already cleared under 510(k) #K122158) to the Pipeline Total Hip System:

• . HA-coated Acetabular Shells feature a thin HA coating applied over the porous structured (PST) shells in a range of sizes,
• . Biolox® delta Ceramic Femoral Heads available in a range of diameters and extension options,
• . 40mm CoCr Femoral Heads, and
• . 40mm inner diameter Highly Crosslinked Vitamin E UHMWPE Acetabular Liners.
  These components are compatible with the total hip system determined substantially equivalent as the Pipeline Total Hip System in 510(k) #K112802 and as the PBP Total Hip System in 510(k) #K122158.

The provided text describes a Special 510(k) Premarket Application for a line extension to the "Pipeline Total Hip System." This type of submission claims substantial equivalence to previously cleared devices. Therefore, the "acceptance criteria" and "study" described are not for a de novo device, but rather the justification for substantial equivalence.

Here's how the information aligns with your request:

1. Table of Acceptance Criteria and Reported Device Performance

The core acceptance criterion for this 510(k) is substantial equivalence to predicate devices. The reported "performance" is that the new components are identical to those already cleared.

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

This submission does not involve a "test set" in the traditional sense of clinical or performance data for a new device. Instead, the "test" is a comparison to existing, cleared devices on the market. The submission asserts that the components are identical to those previously cleared. Therefore, there's no independent sample size or data provenance to report for a specific "test set." The "provenance" for the predicate devices would be based on the information provided in their respective 510(k) submissions (K112802 and K122158), which is not detailed here.

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

Not applicable. This is a claim of identicality to cleared devices, not a study requiring expert-established ground truth for a new device's performance. The "ground truth" here is the prior FDA clearance of the identical components.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" requiring adjudication in this type of submission.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a mechanical hip replacement system, not an AI-assisted diagnostic or imaging tool.

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

Not applicable. This device is a mechanical hip replacement system.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" in this context is the prior FDA clearance and determination of substantial equivalence for the identical components under 510(k) #K122158. The submission argues that since the new components are identical to those previously cleared, their safety and effectiveness are established by the predicate's clearance.

8. The Sample Size for the Training Set

Not applicable, as this is a mechanical device, not a machine learning algorithm.

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

Not applicable, as this is a mechanical device, not a machine learning algorithm.

Ask a specific question about this device