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EXULT Knee Replacement System is intended for the treatment of diseases as follows:

• Painful, disabling joint disease of the knee resulting from non-inflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis or avascular necrosis) or rheumatoid arthritis.
• Post-traumatic loss of knee joint configuration and function.
• . Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.
• . Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous arthroplasty procedure

EXULT Knee Replacement System is intended for cemented application only.

The purpose of the submission is a line extension of the EXULT Tibial Insert (CPS-type) to the EXULT Knee Replacement System (K192507). The CPS-type Tibial Inserts are designed based on the design of the other previously cleared Tibial Inserts of the EXULT Knee Replacement System (PS-type, CR-type and UC-type). The CPS-type, which is constrained posterior stabilized, has a thicker and wider post which provides additional constraint as compared to the PS-type insert. The CPS-type Tibial Insert matches with Femoral Components of one-size up and down. The CPS-type Tibial Insert is symmetrical and used in both the right and left knee. It is only used in combination with the Femoral component/Tibial baseplate of the predicate device (K192507).

The provided text does not contain information about acceptance criteria and a study that proves a device meets those criteria for software or AI/ML-driven medical device performance.

The document is a 510(k) premarket notification for the EXULT Knee Replacement System, a physical orthopedic device. It discusses the device's indications for use, technological characteristics, and non-clinical testing performed to establish substantial equivalence to predicate devices (other knee replacement systems).

The "Non-Clinical Testing" section lists various engineering tests (wear testing, fatigue testing, constraint testing, range of motion, surface roughness, disassembly) and references ISO and ASTM standards. These are traditional mechanical engineering tests for orthopedic implants, not performance studies for AI/ML algorithms.

Therefore, I cannot provide the requested information regarding:

• A table of acceptance criteria and reported device performance (for AI/ML).
• Sample size for the test set and data provenance.
• Number and qualifications of experts for ground truth.
• Adjudication method.
• MRMC comparative effectiveness study.
• Standalone performance study.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

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Total Knee components are indicated for rheumatic arthritis, osteoarthritis, osteoarthritis, or degenerative arthrius; failed osteotomies, unicoment, or total knee replacement. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior cruciate ligaments are incompetent and the collateral ligaments remain intact. Constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligament) are incompetent. Hinge knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligament) are absent or incompetent.

The Smith & Nephew, Inc. Cemented Round Patellae with JRNY Pegs are indicated for use with cement and are single use devices.

The subject of this Special 510(k) is the Cemented Round Patellae with JRNY Pegs. The subject Cemented Round Patella with JRNY Pegs are patella components, and a line extension of the GENESIS II Resurfacing Patellae cleared under the GENESIS II Total Knee System premarket notification K951987 (S.E. 8/22/1995). The subject devices were modified by incorporating the identical patella peg and cement pocket geometry from the JOURNEY BCS Resurfacing Patellae, cleared under Smith & Nephew, Inc. High Performance Knee premarket notification K042515 (S.E. 3/14/2005) respectively.

The subject Cemented Round Patellae with JRNY Pegs have a size range of 26, 29, 32, 35, 38, and 41mm with thicknesses range of 7.5mm and 9.0mm. The Cemented Round Patellae with JRNY Pegs are manufactured from Ultra-High Molecular Weight Polyethylene (UHMWPE), conforming to ASTM F648 (FDA Recognition Number 8-569), and 316 L Stainless Steel, conforming to ASTM F138 (FDA Recognition Number 8-542), identical to the predicate devices GENESIS II Resurfacing Patellae (K951987, S.E. 8/22/1995) and JOURNEY BCS Resurfacing Patellae (K042515, S.E. 3/14/2005).

The provided FDA 510(k) K221939 summary does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of device performance metrics often associated with AI/ML devices (e.g., sensitivity, specificity, accuracy).

Instead, this document is a 510(k) submission for a medical device (a knee implant component) seeking substantial equivalence to legally marketed predicate devices. The "performance testing" mentioned refers to mechanical testing to ensure the new device performs similarly to the predicate devices, not clinical performance or diagnostic accuracy.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, or details about sample size, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set information. These concepts are not applicable to the type of device and submission described in the provided text.

The "performance testing" section, briefly mentioned, indicates:

• Performance Testing: A review of leveraged mechanical data indicates that the subject Cemented Round Patellae with JRNY Pegs are substantially equivalent to previously cleared predicate devices.
• Evaluated Design Features:
  • Peg Geometry
  • Peg Location
  • Pocket Geometry
• Bacterial Endotoxin Testing: Representative worst-case device met acceptable endotoxin limits as stated in FDA Guidance and ANSI/AAMI ST72.

The conclusion states that the device is substantially equivalent to the predicate devices based on similarities in function, intended use, indications for use, design, and material composition, and mechanical performance. Clinical data was not needed to support safety and effectiveness.

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The Legion Cones are intended to be used with the Legion Revision and Legion Hinge knee systems. The Legion Cones are indicated for the following:

1. Rheumatoid arthritis.

2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.

3. Failed osteotomies, unicompartmental replacement, or total knee replacement.

4. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.

5. Constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral collateral ligament) are incompetent.

6. Hinge knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral collateral ligament) are absent of incompetent.

These are single use implants and are intended for use with and without bone cement.

Subject of this Traditional premarket notification is the Smith & Nephew Legion™ Cone System. The Smith & Nephew Legion Cone System consists of porous coated tibial and femoral augments to address cavitary defects in the proximal tibia or distal femur. The system will also include the necessary instrumentation for the surgeon to prepare the tibia and femur for implantation of the augments.

The components of the Smith & Nephew Legion Cone System are as follows:

• Titanium alloy (Ti-6Al-4V) tibial cones of 2 heights and 7 sizes .
• · Titanium alloy (Ti-6Al-4V) hand-specific femoral cones of 1 height and 7 sizes

The Leqion Tibial and Femoral Cones are a one piece, conically shaped device with cannulation all the way through the cone which allows fixation to the Legion Revision and Legion Hinge tibial baseplates, femoral components, offset couplers, augments/wedges, and stem constructs.

The Legion Tibial and Femoral Cones are similar to the primary predicate Zimmer Trabecular™ Metal Tibial and Femoral Cone Augments cleared via premarket notification K053340. The Legion Tibial Cones will be available in heights of 25mm (short) and 40mm (long) and inner diameters (ID) of 18mm-30mm, in 2mm increments. The Legion Femoral Cones will be available in a height of approximately 35mm and inner diameters of 18mm-30mm, in 2mm increments. The Legion Femoral Cones will be provided in left and right orientations. The subject tibial and femoral cones are manufactured from forged titanium alloy (Ti-6Al-4V) that conforms to ASTM F 1472. The subject tibial and femoral cones also have an external asymmetric (Stiktite™) porous coating specification identical to the porous coating of the reference predicate Smith & Nephew SMF™ Hip Stems cleared via premarket notifications K080625. K103256, and K123012. The interior side of the subject cones has a grit-blasted surface specification for cement adhesion identical to the gritblasted surface of reference predicate Smith & Nephew Genesis II Total Knee System cement-on-augment devices cleared via premarket notification K951987.

The provided document is a 510(k) premarket notification for a medical device called the "Legion Cone System." This type of document is a submission to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. It typically does not contain information about acceptance criteria for a study proving device performance in the way that a clinical trial or a formal performance study for an AI/CADe device would.

Instead, for this type of device (knee prosthesis components), the "acceptance criteria" are generally met through mechanical testing and a comparison to predicate devices, demonstrating substantial equivalence in design, materials, and intended use. The "study" proving it meets acceptance criteria is primarily a series of mechanical tests and a predicate comparison.

Therefore, I will interpret your request in the context of this document type, focusing on the mechanical testing performed and the comparison to predicate devices, rather than a clinical study evaluating AI performance.

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

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

The document does not explicitly list "acceptance criteria" in a quantitative table with specific pass/fail values for each test. Instead, it states that a "mechanical evaluation" was conducted and that this evaluation "demonstrated that there are no new issues related to the safety or effectiveness of the subject devices." This implies that the results of these tests were considered acceptable when compared to established standards for such devices or to the performance of predicate devices.

Specific Mechanical Tests Conducted:

• Fatigue Strength
• Push-Out Strength
• Torsional Shear
• Tensile Attachment Strength

The document states, "A review of testing has demonstrated that there are no new issues related to the safety or effectiveness of the subject devices." This indicates the device passed these implied criteria by performing adequately in these mechanical tests.

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 provided in the document. The "tests" mentioned are mechanical tests on device components, not typically "data sets" in the context of AI/software or clinical trials. Therefore, concepts like country of origin or retrospective/prospective do not apply. The sample sizes for the mechanical tests (e.g., how many cones were tested for fatigue) are not disclosed.

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/not provided. The "ground truth" for a mechanical test is typically determined by the physics and engineering principles governing the test and measurement. There isn't an "expert" establishing ground truth in the way a clinical expert would for a diagnostic image. The "experts" involved would be the engineers and scientists conducting and analyzing the mechanical tests.

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

This information is not applicable/not provided. Adjudication methods like 2+1 are used in clinical studies, especially for ground truth establishment in ambiguous cases. This is not relevant for mechanical testing of an orthopedic implant.

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. An MRMC study or AI assistance is not relevant to the Legion Cone System, which is a physical implant component, not an AI/software device. The document explicitly states: "Clinical data was not needed to support the safety and effectiveness of the subject devices."

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

This information is not applicable. This refers to AI algorithm performance studies, which are not relevant to this physical orthopedic implant.

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

For the mechanical tests, the "ground truth" is established by the physical and engineering measurements against accepted standards and the performance of predicate devices. There is no biological "ground truth" like pathology or outcomes data from patients in this premarket notification for a mechanical device.

8. The sample size for the training set

This information is not applicable/not provided. There is no "training set" in the context of mechanical testing for a physical implant. This concept applies to machine learning models.

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

This information is not applicable/not provided. As there is no training set mentioned, the establishment of its ground truth is not relevant.

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Physica total knee system is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:

• · Non-inflammatory degenerative joint disease: including osteoarthritis, traumatic arthritis, or avascular necrosis;
• · Inflammatory degenerative joint disease including rheumatoid arthritis;
• · Correction of functional deformity;
• · Revision procedures where other treatments or devices have failed; and
• · Treatment of fractures that are unmanageable using other techniques.

Physica knee system is intended for cemented fixation.

The Physica KR Knee Replacement System is a total knee replacement system consisting of femoral, tibial plate, tibial liner, patella, and tibial stem components; the tibial stem and patella components are optional to be used as required for each individual patient. The Physica KR knee system devices are intended to be used with bone cement.

The femoral components are made of CoCrMo alloy according to the requirements of ISO 5832-4 and ASTM F75. The articulating surface is polished and has asymmetric condyles along the sagittal plane. Conformity between the inner surface of the components and the resected bone of the distal femur and two fixation pegs provide stability. Ten (10) sizes in left and right versions are available. The tibial plates are made of Ti6Al4V alloy meeting the specifications of ISO 5832-3 and ASTM F1472. The inferior aspect of the component has a keel and an optional modular tibial stem, manufactured from Ti6Al4V alloy, provide stability. A plug manufactured from standard UHMWPE (ISO 5834-2 / ASTM F648) is used to fill the female taper hole used to attach the optional stem; the plug is removed if a stem is used. The superior portion of the tibial plate is designed to lock the tibial liner through a snap-fit mechanism; the superior surface of the plate is polished to reduce back-side wear of the liner. Ten sizes of symmetric tibial plates are available.

Liners are made of standard UHMWPE (ISO 5834-2 / ASTM F648). They are characterized by a concave medial hemi-plateau along the sagittal plane while the lateral plateau is slightly convex. The articulating hemi-plateaus are both concave along the frontal plane. The liner is attached to the tibial plate through a snap-fit mechanism The anterior aspect of the liner is shaped to accommodate the patellar tendon during flexionextension movements of the knee. Ten (10) sizes, correspondently to the tibial plate sizes, in six (6) thicknesses, are available in versions for left and right knees.

Tibial stems, in three (3) lengths (20, 40, and 60mm), are made of Ti6Al4V alloy (ISO 5832-3 / ASTM F1472). They stems are 15.5mm in diameter and cylindrical in shape with longitudinal grooves intended to increase the torsional stability of the device and to facilitate the distribution of the bone cement on the device during its insertion. Three lengths are available.

The all-polyethylene patella components, in six (6) diameters (26, 29, 32, 35, 38, and 41mm), are made of standard UHMWPE (ISO 5834-2 / ASTM F648). The components have a biconvex surface to articulate with the trochlear groove of the femoral component. The inferior surface has three (3) pins / pegs and a cement pocket to aid in fixation.

This is a 510(k) premarket notification for the Physica KR knee system, a Class II medical device. The document states that clinical testing was not necessary to demonstrate substantial equivalence to predicate devices, meaning that no human clinical trials were conducted to establish efficacy or safety for this specific submission. The information provided focuses on non-clinical (mechanical) testing only.

Therefore, many of the requested categories related to clinical study design, acceptance criteria based on human performance, expert ground truth, and patient data provenance cannot be extracted from this document as no such studies were performed for this submission.

Here is the information from the document regarding the non-clinical testing:

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

The document does not explicitly state numerical acceptance criteria. Instead, it indicates that "The testing results demonstrated the device's ability to perform under expected clinical conditions." For a 510(k) submission based on substantial equivalence, the performance is generally benchmarked against the predicate devices.

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 mentions "Mechanical testing was performed on worst case components or constructs." However, it does not specify the exact sample sizes (number of components or constructs) for each test. Data provenance is not applicable as this concerns mechanical bench testing, not human patient data.

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

Not applicable. This was mechanical bench testing, not a study requiring expert clinical assessment or ground truth establishment.

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

Not applicable. This was mechanical bench testing.

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. No clinical studies were conducted, and this is a physical medical device, not an AI/software product.

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

Not applicable. This is a physical medical device.

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

For mechanical testing, the "ground truth" would be established engineering standards, material properties, and expected biomechanical performance metrics (e.g., fatigue limits, wear rates, force limits) derived from predicate devices or established biomechanical principles. The document states the tests "demonstrated the device's ability to perform under expected clinical conditions," implying these standards were met.

8. The sample size for the training set

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

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

Not applicable. This is a physical medical device.

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Smith & Nephew's VISIONAIRE™ Disposable Instruments are intended to be used to further prepare the bone and assist in the positioning of total knee replacement components intraoperatively. Smith & Nephew VISIONAIRE™ Disposable Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Genesis II and Legion knee systems and their cleared Indications for Use.

The contraindications, potential adverse events, precautions, and warnings for the knee systems can be found in the Smith & Nephew Knee System package insert. The VISIONAIRE™ Patient Matched Cutting Blocks and Disposable instruments are intended for single use only. Do not reuse due to risks of breakage, failure or patient infection.

Per U.S. Food and Drug Administration (FDA) regulation, device-specific instruments are accessory devices and take on the classification of the device(s) with which they are used. Although these instruments are similar in design to 510(k)-exempt orthopaedic manual instruments classified under 21 CFR 888.4540, instruments which assist in the implantation of Class II Smith & Nephew Total Knee Systems and are classified as Class II devices are subject to pre-market notifications and regulations.

The Smith & Nephew Disposable Instruments include line additions to the Smith & Nephew Disposable Knee Instruments that were cleared in K123159. The subject devices are intended prepare the bone for Total Knee Arthroplasty.

The provided text does not contain information about the acceptance criteria or a study proving that a device meets those criteria, as it relates to a typical AI/ML device submission for medical imaging. The document is an FDA 510(k) clearance letter for VISIONAIRE™ Disposable Instruments, which are surgical instruments used for total knee replacement.

The clearance is based on substantial equivalence to predicate devices, not on meeting specific performance criteria through a study in the sense typically associated with AI/ML device evaluation (e.g., accuracy, sensitivity, specificity on a test set).

Here's a breakdown of why the requested information cannot be extracted and what information is available:

• Device Type: This is a physical surgical instrument, not an AI/ML software device.
• Approval Basis: The approval is based on "substantial equivalence" to existing legally marketed predicate devices, meaning it is similar in intended use, technological characteristics, and safety and effectiveness.
• Clinical Data: The document explicitly states: "Clinical data was not needed to support the safety and effectiveness of the subject devices." This further confirms that a performance study as would be done for an AI/ML device was not conducted or required for this clearance.

Therefore, I cannot populate the requested table and answer the specific questions about acceptance criteria, study design, ground truth, or expert involvement, as these elements are not relevant to the 510(k) clearance process for this type of medical device as described in the provided text.

The closest information available related to "performance" is:

• "Biocompatibility testing for the new colorants and materials was conducted per the recommendations of ISO 10993-1."
• "A review of the results indicates that the Disposable Instruments are equivalent to existing, legally marketed predicate instrumentation with regards to mechanical performance and that there are no new issues related to the safety and effectiveness of the subject devices."

This refers to engineering and material testing, not a clinical performance study using a test set against a ground truth as would be relevant for an AI/ML diagnostic or prognostic tool.

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The Smith & Nephew ANTHEM PS Total Knee System is intended for total knee arthroplasty.

Indications for Use:

1. Rheumatoid arthritis.
2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.
3. Failed osteotomies, unicompartmental replacement, or total knee replacement.
4. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.

The ANTHEM PS Total Knee System is indicated for use only with cement and is a single use device.

The subject ANTHEM PS Total Knee System is a posterior stabilized implant design that includes cobalt chromium (ASTM F75) femoral components and titanium (ASTM F1472) tibia baseplate components that are intended to be used with existing GENESIS II components to complete the total knee construct. The femoral components are based on the LEGION Narrow PS (K112941) and GENESIS II PS (K951987) designs, and are available in two categories: ANTHEM Standard (Sizes: 3-8; left and right options) and ANTHEM Narrow (Sizes 1-6; left and right options). The ANTHEM Tibia Baseplates are leveraged from the GENESIS II Tibia Baseplate (K951987) design, with a modification to the stem, and provided in sizes 1-8 with left and right options. All of the implants are gamma sterilized single-use prescription devices intended to be used under the guidance of a physician at a healthcare facility.

This document is a 510(k) Premarket Notification for a medical device (ANTHEM PS Total Knee System) and focuses on demonstrating substantial equivalence to previously cleared predicate devices. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way a clinical study would for an AI/software device.

Therefore, the requested information elements related to AI device performance evaluation, such as sample size, ground truth, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, are not present in this document.

However, I can provide the available information regarding the "study" that proves the device meets requirements, which in this context refers to preclinical bench testing to establish substantial equivalence.

Here's a breakdown of the available information:

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

This document does not provide a table of acceptance criteria with specific quantitative performance metrics. Instead, it relies on demonstrating substantial equivalence to predicate devices through biomechanical testing. The "acceptance criteria" here is implicitly that the device performs comparably to the predicate devices in the described tests.

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: Not explicitly stated in terms of number of devices tested, but the testing was "non-clinical bench (mechanical) testing" done on "the proposed femoral and tibial components." This typically involves a set number of test samples for each device variant and test type, as per ASTM standards, but specific numbers are not detailed here.
• Data Provenance: The testing was conducted as part of the regulatory submission process for Smith & Nephew, Inc., located in Memphis, TN, USA. This is preclinical (bench) data, not clinical data from patients.

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

Not applicable. This is a mechanical device, and "ground truth" for mechanical testing is established by the test setup, calibration, and adherence to ASTM standards by engineers and technicians, not clinical experts for diagnostic accuracy.

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

Not applicable. This is a mechanical device; there's no "adjudication" in the clinical sense for determining ground truth.

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 pertains to a total knee system, not an AI or software device.

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

Not applicable. This document pertains to a total knee system, not an AI or software device.

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

For this mechanical device, the "ground truth" used for testing aligns with established ASTM (American Society for Testing and Materials) standards for orthopaedic implants. These standards define the methodology and expected performance characteristics for evaluating factors like contact area and constraint. The "truth" is whether the device's mechanical performance conforms to these scientific/engineering benchmarks and is comparable to predicate devices.

8. The sample size for the training set:

Not applicable. This document pertains to a mechanical device, not an AI/ML algorithm that requires a training set.

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

Not applicable. No training set is involved for this type of device submission.

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Smith & Nephew Disposable Fin Punch is an accessory device and is intended to be used to assist in the implantation of Smith & Nephew Total Knee Systems including Legion and Genesis II Knee Systems and their cleared Indications for Use.

Indications for Total Knee Replacement

1. Rheumatoid arthritis.
2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity level are compatible with an adequate long-term result.
3. Failed osteotomies, unicompartmental replacement, or total knee replacement.
4. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
5. Constrained knee systems are designed for use in patients in primary and revision surgery. where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligament) are absent or incompetent.

The Smith & Nephew Disposable Fin Punch is a line addition to the Smith & Nephew Disposable Knee Instruments that were cleared in K123159. The subject device is intended to cut the bone to prepare the tibia to accept the tibial base implant.

The provided text is related to a 510(k) premarket notification for a medical device called the "Smith & Nephew Disposable Fin Punch." This document is a regulatory submission for a device, not a study report proving the device meets specific acceptance criteria through a clinical or algorithmic performance study in the way typically associated with diagnostic AI/ML products.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies is not applicable to this type of regulatory submission.

The document primarily focuses on demonstrating substantial equivalence to predicate devices through technical characteristics, intended use, and materials, rather than a performance study with defined numerical acceptance criteria for diagnostic accuracy.

Here's how the available information relates to your request:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable in the context of a diagnostic AI/ML device.

The "acceptance criteria" discussed in this document are primarily related to mechanical safety and biocompatibility, not diagnostic performance. The document states:

• "Mechanical testing has been conducted to address the intraoperative impact loads expected to be experienced by the fin punch."
• "Biocompatibility testing for the black Polyetherimide (PEI) material was conducted per the recommendations of ISO 10993-1."
• "A review of the results indicates that the Disposable Fin Punch is equivalent to existing, legally marketed predicate instrumentation with regards to mechanical performance and that there are no new issues related to the safety and effectiveness of the subject devices."

There are no specific numerical performance metrics (like sensitivity, specificity, AUC) reported in this document that would typically be found for an AI/ML diagnostic device study against defined acceptance criteria. The "performance" here refers to the device's ability to withstand mechanical stresses and be biocompatible.

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

Not applicable. This document describes mechanical and biocompatibility testing for a surgical instrument, not a test set of data points for an algorithm. Therefore, there's no "test set" in the sense of patient data, nor data provenance (country of origin, retrospective/prospective). The "testing" refers to lab-based mechanical and material evaluations.

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

Not applicable. There is no "ground truth" in the context of expert consensus on patient data for this device. Mechanical and biocompatibility tests are assessed against established engineering standards and material properties, not expert clinical interpretations.

4. Adjudication Method for the Test Set

Not applicable. (See point 3).

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, an MRMC comparative effectiveness study was not done. This is a surgical instrument, not an AI diagnostic tool that human readers would use.

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

Not applicable. This is a physical surgical instrument, not an algorithm.

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

For mechanical testing, the "ground truth" would be engineering specifications and established mechanical properties of the materials and design, verified through physical testing. For biocompatibility, the "ground truth" is adherence to ISO 10993-1 standards for material safety.

8. The Sample Size for the Training Set

Not applicable. This is a physical surgical instrument, not an AI/ML algorithm. There is no training set mentioned or implied.

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

Not applicable. (See point 8).

In summary: The provided document is a 510(k) clearance letter and summary for a surgical instrument (Smith & Nephew Disposable Fin Punch), not a study demonstrating the performance of a diagnostic AI/ML device. The "acceptance criteria" and "testing" referred to are for mechanical properties and biocompatibility, not for diagnostic accuracy evaluated against patient data or expert ground truth.

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Total knee components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis; failed osteotomies, unicompartmental replacement, or total knee replacement. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact. The Journey II Total Knee system components are indicated for use only with cement and are single use devices.

Subject of this Abbreviated Premarket Notification are the Journey II Knee system. This 510(k) was prepared in accordance with the Agency's, "Draft Guidance for the Preparation of Premarket Notifications (510(k)s) for Cemented, Semi-Constrained Total Knee Prostheses," dated April 1993. The subject device is a cruciate retaining (CR) total knee system which provides the ability for greater flexion to those patients who have the anatomical capability to allow a greater flexion range. Components of this premarket notification include the following components: Cruciate retaining femoral components which will initially be available in sizes 1-10 in right and left designs in OXINIUM material. Cruciate retaining femoral components which will initially be available in sizes 1-9 in right and left designs in cobalt chrome material Cruciate retaining articular inserts which will initially be available in sizes 1-2, 3-4, 5-6, and 7-8 in right and left designs. Journey II CR articular inserts will be offered in 9-21 mm thicknesses and manufactured from cross-linked polyethylene or UHMWPE. The Journey II CR Knee system will use existing cemented Journey tibial tray and patellar components currently used with the Journey BCS Knee System (K042515), Journey II Deep Dished articular insert components (K113482), and existing patellar components of the Genesis II Knee System (K951987)

The provided text describes a 510(k) premarket notification for the "Journey II CR Knee System." The core of this submission is to demonstrate substantial equivalence to previously cleared predicate devices, rather than conducting a de novo study against explicit acceptance criteria for device performance. Therefore, the information requested regarding acceptance criteria, performance metrics, sample sizes for test and training sets, expert involvement, and ground truth establishment, as typically found in studies for novel algorithms or AI devices, is not applicable in this context.

Here's an analysis based on the provided document:

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

• Not Applicable. This submission is based on demonstrating substantial equivalence to predicate devices, not on meeting specific, predefined performance acceptance criteria for a novel device. The "performance" assessment here is a comparison of design and mechanical characteristics to existing products.

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

• Not Applicable. No human or animal test sets are mentioned. The "testing" referred to is mechanical testing of the device components.

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. No test set with ground truth established by experts is mentioned.

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

• Not Applicable. No test set requiring expert adjudication for ground truth is mentioned.

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

• Not Applicable. This is a mechanical device submission, not an AI/software device. No MRMC study was conducted.

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

• Not Applicable. This is a mechanical device submission, not an AI/software device.

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

• Not Applicable. For a mechanical device submission demonstrating substantial equivalence, the "ground truth" is typically the established performance and safety profiles of the predicate devices and the results of various mechanical tests performed on the new device (e.g., patellofemoral contact area, tibiofemoral constraint). The document states: "A review of the mechanical data indicates that the Journey II CR Knee System is capable of withstanding expected in vivo loading without failure."

8. The sample size for the training set

• Not Applicable. This is a mechanical device submission, not a machine learning or AI device.

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

• Not Applicable. This is a mechanical device submission, not a machine learning or AI device.

Summary of the Study and "Acceptance Criteria" (in the context of a 510(k) for a mechanical device):

The "study" conducted for the Journey II CR Knee System was primarily a mechanical testing and comparison study to demonstrate substantial equivalence to previously cleared predicate devices. The "acceptance criteria" are implied by the regulatory requirements for substantial equivalence, meaning the device must be as safe and effective as a legally marketed predicate device.

Device Performance Measures (Mechanical Testing):

The document explicitly states that the following mechanical testing was performed to demonstrate the device's capability of withstanding expected in vivo loading:

• Patellofemoral Contact Area Analysis
• Tibiofemoral Contact Area Analysis
• Patellofemoral Resistance to Lateral Subluxation
• Tibiofemoral Constraint Testing

The report concludes: "A review of this testing has demonstrated that there are no new issues related to the safety and effectiveness of the subject devices."

Table of "Acceptance Criteria" (Substantial Equivalence Aspects) and Reported Device "Performance" (Comparison):

Missing Information & Key Points:

• No specific numerical acceptance criteria for the mechanical tests are provided in the document. The conclusion is a qualitative statement of "no new issues." This is typical for a 510(k) where the primary goal is to show similarity to an already cleared device, implying that if the new device performs within the established range of the predicate, it is deemed acceptable.
• No clinical data was required or presented to support the safety and effectiveness, as explicitly stated in the document ("Clinical data was not needed to support the safely and effectiveness of the subject devices"). This reinforces that the submission relies on substantial equivalence through material and design similarity, and mechanical testing.

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Smith & Nephew Total Knee Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Total Knee Systems and their cleared Indications for Use.

Indications for Cruciate Retaining Cemented Knee Replacement:

1. Rheumatoid arthritis.
2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.
3. Failed osteotomies, unicompartmental replacement, or total knee replacement.
   Cruciate Retaining Cemented Knee components are indicated for use with cement and are single use devices.

Indications for Cruciate Retaining Cementless Knee Replacement:

1. Rheumatoid arthritis.
2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.
3. Failed osteotomies, unicompartmental replacement, or total knee replacement.
   Cruciate Retaining Cementless Knee components are indicated for use without cement and are single use devices.

Indications for Posterior Stabilized Cemented Knee Replacement:

1. Rheumatoid arthritis.
2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.
3. Failed osteotomies, unicompartmental replacement, or total knee replacement.
4. Primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
   Posterior Stabilized Cemented Knee components are indicated for use with cement and are single use devices.

Indications for Posterior Stabilized Cementless Knee Replacement:

1. Rheumatoid arthritis.
2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.
3. Failed osteotomies, unicompartmental replacement, or total knee replacement.
4. Primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
   Posterior Stabilized Cementless Knee components are indicated for use without cement and are single use devices.

Indications for Constrained Total Knees:

1. Rheumatoid arthritis.
2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.
3. Failed osteotomies, unicompartmental replacement, or total knee replacement.
4. Constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligament) are incompetent.
   Constrained Total Knee components are indicated for use with cement and are single use devices.

Indications for Hinged Total Knees:

1. Rheumatoid arthritis.
2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.
3. Failed osteotomies, unicompartmental replacement, or total knee replacement.
4. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
5. Hinge knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligament) are absent or incompetent.
   Hinged Total Knee components are indicated for use with cement and are single use devices.

Subject of this Traditional 510(k) Premarket Notification are the Smith & Nephew, Inc. Total Knee System Instruments. The subject devices are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Total Knee Systems and their cleared Indications for Use. Smith & Nephew Total Knee System Instruments can be organized into instrument families which are categorized as follows: Trials, Cutting Instruments and Cutting Guides; Cutting Blocks, Alignment and Sizing Instruments, Impactors and Handles, Clamps, Extraction, Torque, Instrument Guides, and Covers and Protectors.

This document is a 510(k) Summary of Safety and Effectiveness for the Smith & Nephew Total Knee System Instruments. It explicitly states that these instruments are "accessory devices" used to assist in the implantation of Smith & Nephew Total Knee Systems.

The document does not contain any information regarding acceptance criteria or a study proving the device meets those criteria, nor does it provide details about any AI-related performance metrics.

The content is focused on:

• Device classification and regulatory information.
• Listing predicate devices (previously cleared knee systems).
• Device description (types of instruments).
• Intended use and Indications for Use for various knee replacement types (Cruciate Retaining, Posterior Stabilized, Constrained, Hinged).
• FDA clearance letter.

Therefore, I cannot provide the requested information. The document is for mechanical surgical instruments, not an AI/Software as a Medical Device (SaMD) that would typically involve performance studies with ground truth and expert reviews for diagnostic accuracy.

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Total knee components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis; failed osteotomies, unicompartmental replacement, or total knee replacement. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact. Smith & Nephew, Inc. Journey II BCS Knee components are indicated for use only with cement and are single use devices.

Subject of this Abbreviated Premarket Notification is the Journey II BCS Knee system. The Journey II BCS Knee System is a posterior stabilized total knee system which provides the ability for greater flexion (155°) to those patients who have the anatomical capability to allow a greater flexion range. Components of this premarket notification include:

• Posterior stabilized femoral components which will initially be available in sizes 1-10 in right . and left designs in OXINIUM material.
• Posterior stabilized femoral components which will initially be available in sizes 1-9 in right . and left designs in cobalt chrome material
• Posterior stabilized articular inserts which will initially be available in sizes 1-2, 3-4, 5-6, and . 7-8 in right and left designs. Journey II BCS articular inserts will be offered in 9-21 mm thicknesses and manufactured from cross-linked polyethylene (XLPE) material and conventional non-cross-linked Ultra-High Molecular Weight Polyethylene (UHMWPE) material.
  The Journey II BCS Knee system will use existing cemented Journey tibial tray and patellar components currently used with the Journey BCS Knee System (K042515) and may also be used with existing patellar components of the Genesis II Knee System (K951987).

The provided text is a 510(k) Premarket Notification for a medical device, the Journey II BCS Knee System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a de novo clinical study with a full-fledged acceptance criteria and performance study as might be done for a novel device.

Therefore, many of the typical questions regarding acceptance criteria, study design, expert ground truth, and training sets from an AI/imaging device perspective are not applicable to this document. The "study" here refers to mechanical testing for equivalence, not a clinical trial or AI model validation.

Here's a breakdown based on the information provided and addressing the non-applicability:

1. 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)

• Sample Size: Not applicable in the context of clinical data for this 510(k) submission. The "test set" here refers to mechanical testing of device components. The document does not specify the number of components tested for each mechanical analysis, but it's not a human patient "test set."
• Data Provenance: Not applicable for clinical data. The mechanical testing would have been performed 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)

• Not applicable. Ground truth in this context is established through engineering and mechanical testing standards and comparison to predicate devices, not expert human interpretation of data for diagnostic purposes.

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

• Not applicable. Adjudication methods are typically used for establishing ground truth in clinical studies involving human interpretation or uncertain outcomes. Mechanical testing relies on measurable physical properties and 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

• Not applicable. This document is for a knee prosthesis, a physical implant. It does not involve AI or human readers for diagnostic interpretation. The submission explicitly states: "Clinical data was not needed to support the safety and effectiveness of the subject devices."

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 (expert consensus, pathology, outcomes data, etc)

• The "ground truth" for this device's performance demonstration is based on mechanical engineering principles and standards, comparison to predicate device performance, and the absence of new safety/effectiveness issues revealed by those mechanical tests.

8. The sample size for the training set

• Not applicable. This is a physical medical device; there is no "training set" in the context of an AI/machine learning model.

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

• Not applicable. As there is no training set for an AI model, this question is not relevant.

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