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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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EXULT Knee Replacement System is indicated 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 (UC-type) to the EXULT Knee Replacement System (K192507). The UC-type Tibial Inserts are designed based on the design of the other Tibial Inserts of the EXULT Knee Replacement System (PS-type and CR-type). The UC-type, which is ultra-congruent, has high conformity and increased anterior/posterior edge height, which limits anterior/posterior motion instead of a post structure, like the PS-type. The UC-type Tibial Insert matches Femoral Components of one-size up and down. The UC-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).

Here's an analysis of the provided text regarding acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Important Note: The document does not provide specific numerical acceptance criteria or numerical reported device performance values for any of these tests. It only states that the device was "evaluated to demonstrate substantial equivalence to the predicate devices" based on these tests.

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

This information is not provided in the document. The text mentions "non-clinical testing" but does not specify sample sizes for materials tested, nor does it refer to patient data (retrospective or prospective) or countries of origin.

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

This information is not applicable and therefore not provided in the document. The device is a knee replacement system (implant), not an AI/software device that requires expert-established ground truth for image interpretation or diagnosis. The tests described are mechanical and material performance tests.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided in the document. As noted above, this is a mechanical device, not an AI/software device involving human reader interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not applicable and therefore not provided in the document. This is a medical device (knee implant), not an AI-assisted diagnostic or treatment planning software.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable and therefore not provided in the document. This is a medical device (knee implant), not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical testing of this knee implant system would be the physical and mechanical properties of the device and its predicate, measured according to established international and ASTM standards. For instance, in wear testing, the "ground truth" is the actual material loss measured. In contact pressure testing, it's the measured pressure distribution.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided in the document. This is a medical device (knee implant), not a machine learning model that requires a training set.

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

This information is not applicable and therefore not provided in the document. As this is not an AI/ML device, there is no training set or ground truth in that context.

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LOSPA TKR System is intended for use in total knee arthroplasty surgery for the following indications:
· 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.
LOSPA TKR System is intended for cemented application only.

EXULT Knee 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 System is intended for cemented application only.

The subject devices in this special 510(k) are the surgical instruments for the LOSPA Modular Knee System and EXULT Knee System, and submitted as a line extension of optional instruments for Corentec's FDA-cleared reusable orthopedic knee joint replacement instruments. The subject instruments are part of Corenter' 510(k)-cleared knee product lines and are required to facilitate total knee arthroplasty procedures.

LOSPA Modular Knee System Instruments: Implant specific trials - the design of the connection part of the trials to the instrument has been revised due to customer's needs. Guide, alignment instruments - the design of the cutting guides and alignments instruments have been revised due to customer's needs.

EXULT Knee System Instruments: AP sizer external rotation instrument and cutting block instruments have been developed to facilitate to check in posterior access during the operation based on US surgeon's request.

The provided text does not contain information about the acceptance criteria or a study proving that a device meets acceptance criteria. The document is an FDA 510(k) clearance letter for Corentec Co., Ltd.'s LOSPA TKR System Instrumentation and EXULT TKR System Instrumentation. It primarily discusses the administrative details of the clearance, the indications for use of the devices, and a comparison to legally marketed predicate devices to establish substantial equivalence.

Specifically, the document states:

• No Clinical or Animal Testing: "No clinical or animal testing were required." (Page 6)
• Non-Clinical Testing: "The following non-clinical laboratory testing and/or engineering analysis were performed to determine substantial equivalence: ・ Dimensions measurement testing ・ Assembly testing" (Page 6)

Therefore, I cannot provide the requested information, which requires details about acceptance criteria, device performance studies, sample sizes, expert involvement, ground truth establishment, or multi-reader multi-case studies. The clearance was based on dimensional measurements and assembly testing, not on clinical performance metrics typically associated with acceptance criteria for device efficacy or diagnostic accuracy.

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LOSPA TKR System is intended for use in total knee arthroplasty surgery for the following indications:

· 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 of unsuccessful osteotomy, arthrodesis, or failure of previous arthroplasty procedure.

LOSPA TRK System is intended for cemented application only.

The Additional components being added to the LOSPA TKR System are:

Instrumentation (Tibial Insert Trial) -

The subject LOSPA TKR System components specification inclusions are a line extension of Instrumentation (Tibial Insert trial). The following is the additional components.

A) Instrumentation (Tibial Insert Trial)

A copy of a final tibial prosthesis designed to be used during total knee arthroplasty to determine the correct alignment, size, and fit of the final prosthesis. It is one of a set of trial knee prostheses that match the different anatomical structures of the knee joint, and may be used in conjunction with a knee femoral component trial prosthesis and a tibial baseplate trial prosthesis. This instrument is a reusable device that must be sterilized prior to use.

Additional Tibial Insert Trials are designed based on Tibial Insert Trials of predicate device cleared LOSPA TKR System Instrumentation under K110404 & K130673 & K160157 & K192507 & K200395. There is one eliminated size, 26T of each design (CR and PS), each for left and right sides. For both CR and PS designs, the ranges of dimensions are the same. The components have slightly modified height. Except for the differences of height, lengths are identical to the previously cleared Tibial insert trials. The subject LOSPA TKR System is available in nine proportional sizes.

This Tibial Insert Trials are made of Propylux conforming to ASTM D4101: Standard Classification System and Basic for Specification for Polypropylene Injection and Extrusion Materials.

The provided text describes a 510(k) premarket notification for the LOSPA TKR System, specifically focusing on the inclusion of new instrumentation (Tibial Insert Trial). It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of performance metrics like sensitivity, specificity, accuracy, or reader improvement.

The document is a regulatory submission for a medical device (knee joint prosthesis instrumentation) and details:

• Device Name: LOSPA TKR System
• Manufacturer: Corentec Co., Ltd.
• Regulatory Classification: Class II, Product Codes JWH, MBH
• Indications for Use: Total knee arthroplasty for specific conditions (osteoarthritis, rheumatoid arthritis, post-traumatic loss of function, moderate varus/valgus/flexion deformity, revision of unsuccessful procedures). Intended for cemented application only.
• Device Description: The submission is for additional instrumentation (Tibial Insert Trial) for the existing LOSPA TKR System. These trials are sized for correct alignment, size, and fit of the final prosthesis, are reusable, and made of Propylux.
• Substantial Equivalence: The device is being submitted as substantially equivalent to previously cleared LOSPA Total Knee System products (K110404, K130673, K160157, K192507, K200395).

The information requested in the prompt (acceptance criteria, study details, sample sizes, ground truth, expert qualifications, adjudication, MRMC studies, standalone performance, training set details) is typically associated with studies proving the clinical or analytical performance of diagnostic or AI-enabled devices. This document pertains to the modification of an existing mechanical prosthetic system, specifically the inclusion of new instrumentation (a trial component), not a diagnostic algorithm or a device requiring such performance studies.

Therefore, I cannot extract the requested information from the provided text because it does not contain data on:

1. Acceptance criteria and reported device performance: No specific performance metrics (e.g., sensitivity, accuracy) are mentioned for the Tibial Insert Trial.
2. Sample size, data provenance: Not applicable for this type of submission which is for mechanical instrumentation.
3. Number/qualifications of experts, adjudication method: Not relevant for this type of device.
4. MRMC study: Not relevant.
5. Standalone performance: Not relevant.
6. Type of ground truth: Not relevant.
7. Training set sample size/ground truth establishment: Not relevant, as this is not an AI/algorithmic device.

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The Acculoc Total Knee System is indicated in knee arthroplasty for relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, primary and secondary traumatic arthritis, avascular necrosis of the femoral condyle, posttraumatic loss of joint configuration. Moderate valgus, varus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability. This device may also be indicated in correction of unsuccessful osteotomy, arthrodesis, or failure of previous arthroplasty procedure. The Acculoc Total Knee System is designed for cemented use only.

The Acculoc Tibial tray is a component of "Acculoc Total Knee System" cleared under K170753 which consist of Femoral component, Tibial tray, Tibial Insert, Patella components and Instrumentation- Acculoc Total Knee Instrumentation System for use with the implants components. The current premarket notification is related to the addition of the Acculoc Tibial tray manufactured from CoCrMo alloy (Cobalt-chromium-molybdenum alloy), this is same size and same design with the predicate device tibial tray (K170753) and only the material is different. The Tibial tray AP and ML size ranges are exact same as the predicate device Tibial tray (K170753).

The provided text is a 510(k) premarket notification for a medical device called the "Acculoc Total Knee System." It specifically focuses on an update to this system, adding a new material (CoCrMo alloy) for the Tibial tray component.

This document does not contain information about acceptance criteria for device performance in the context of an AI/ML algorithm or a clinical study proving its performance against such criteria. Instead, it details:

• Device Name: Acculoc Total Knee System
• Regulatory Information: Product code, regulatory class, regulation number.
• Intended Use/Indications for Use: What the device is designed to do and for whom.
• Predicate Devices: Previously cleared devices that the current one is being compared against for substantial equivalence.
• Device Description: Information about the components and materials.
• Performance Testing: Refers to mechanical and pyrogenicity testing of the physical implant components against relevant ASTM/ISO standards, not clinical performance or performance of a diagnostic algorithm. This is typical for orthopedic implants to demonstrate safety and durability.

Therefore, I cannot answer the questions about acceptance criteria for an AI/ML device, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance because the provided text does not describe such a study or requirements. The "performance testing" mentioned is for the physical knee implant itself, not an AI or diagnostic device.

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The LOSPA Modular Knee 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.

The LOSPA Knee System is intended for cemented application only.

The LOSPA Modular Knee System components are similar to "LOSPA Total Knee System" cleared under K110404, K121037 & K130673 which consists of Femoral Components, Tibial Base plate, Tibial Insert, Patellar Components and related Instrumentation and are Patella Femoral Tibial Knee Prosthesis Systems, intended for cemented total knee arthroplasty, and all have same indications for use. The subject components, is a line extension to include extension stems with stem plugs and offset adaptors, distal and posterior femoral augments.

The provided text describes a 510(k) premarket notification for the LOSPA Modular Knee System. It does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria in relation to an AI system.

The document is a clearance letter from the FDA, a 510(k) summary, and indications for use for a medical device (a knee replacement system). The "Performance Testing - Bench" section describes mechanical tests performed on the physical knee implant components to demonstrate substantial equivalence to predicate devices, not performance criteria for an AI system.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving an AI device meets those criteria from this document.

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The Lospa Total Knee Replacement System is intended for use in total knee arthroplasty surgery for the following indications:

• 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.

The LOSPA Total Knee Replacement System is intended for cemented use only.

The LOSPA TKR System specification inclusions are components of "LOSPA Total Knee System" cleared under K110404 & K121037 which consists of Femoral Components, Tibial Base plate, Tibial Insert, Patellar Components and Instrumentation -LOSPA Total Knee Instrumentation for use with the system implant components.

The acceptance criteria and study proving they are met are described below based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance:

The document states, "Performance testing - Bench, was not required since engineering analysis showed that the inclusion of additional specification did not change the worst case configuration tested in both K110404 & K121037." This implies that the acceptance criteria for the new specifications (additional sizes of femoral components, tibial base plates, and patellar components) were met by demonstrating that they do not worsen the performance of the previously cleared predicate devices. The "reported device performance" is essentially that the new components maintain the same safety and effectiveness as the predicate devices, as determined by engineering analysis rather than new physical performance testing.

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

No explicit "test set" in the traditional sense of a clinical or bench performance test with a specific sample size is mentioned for this 510(k) submission. The decision was based on engineering analysis and comparison to predicate devices. Therefore, the concept of data provenance (e.g., country of origin, retrospective/prospective) related to a test set is not applicable here as no new performance data was generated.

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

Not applicable. As described, no new performance testing with a "test set" requiring ground truth establishment by experts was conducted for this specific submission. The assessment was based on engineering analysis and leveraging existing performance data from predicate devices.

4. Adjudication Method for the Test Set:

Not applicable. There was no "test set" in the traditional sense that would require an adjudication method.

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

No. The document explicitly states that "Performance testing - Bench, was not required." Therefore, no MRMC study, or any clinical study, was conducted to compare human reader performance with or without AI assistance, as AI is not mentioned as a component of this device.

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

No. The device is a total knee replacement system, which is a physical implant, not a software algorithm. Therefore, "standalone algorithm-only performance" is not applicable.

7. Type of Ground Truth Used:

The "ground truth" for proving the acceptance criteria was established through engineering analysis, essentially demonstrating that the design principles and materials of the new component sizes are consistent with and do not negatively impact the established safety and efficacy of the predicate devices. This relies on the established performance and safety profiles of the predicate devices and the understanding of material properties (ASTM standards) and manufacturing processes.

8. Sample Size for the Training Set:

Not applicable. The device is a physical knee replacement system, not a machine learning model, so there is no concept of a "training set" in this context.

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

Not applicable. As there is no training set for this device, the establishment of ground truth for such a set is not relevant.

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The intended use of the modified device [LOSPA Tibial Base Plate] has not changed as a result of the modification of the predicate device cleared under Lospa Total Knee System, K110404.

The LOSPA Tibial Base Plate which is a component of LOSPA Total Knee System is intended for use in total knee arthroplasty surgery for the following indications:
•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.

The LOSPA Tibial Base Plate is intended for cemented use only.

The LOSPA Tibial Base Plate is a component of "LOSPA Total Knee System" cleared under K110404 which consists of Femoral Components. Tibial Base plate, Tibial Insert, Patellar Components and Instrumentation - LOSPA Total Knee Instrumentation for use with the system implant components

The current premarket notification is related to the modification of LOSPA Tibial Base Plate design. The modification is specific to the KEEL and the design is similar to predicate device in K110404 and other approved device such as Stryker Scorpio 'NRG' Knee (K030978). Similar to predicate device the tibial base plates (or trays), are available in nine (9) sizes to provide optimal tibial coverage. The tibial base plates are designed for use in either the left or right side, and with either CR or PS femoral components or corresponding tibial inserts.

All tibial base plate components are manufactured from cobalt-chromium-molybdenum alloy conforming to ASTM F75, Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075).

The AP width ranges from 36 mm, and the ML width ranges from 55 mm to 84 mm. The underside of the base plate features a central keel and stem; the length of the stem is either 35 mm or 40 mm. The stem with keel design is intended to improve the initial stability. In addition, the posterior slope of the keel and stem helps to increase rotational resistance. The base plate is designed to fully capture and lock the polyethylene insert. The surface of the tibial base plate that interfaces with the polyethylene insert includes a ground finish to minimize back side wear of tibial inserts.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the LOSPA Tibial Base Plate:

It's important to note that the provided document is a 510(k) summary for a Special 510(k) submission, which focuses on device modification and demonstrating substantial equivalence to a predicate device. Therefore, it does not contain the typical acceptance criteria and detailed study data found in submissions for novel devices or comprehensive clinical trials. Instead, the performance testing described is primarily to demonstrate that the modified device performs similarly to the predicate device and does not raise new safety or efficacy concerns.

Here's a breakdown based on your requested information, with acknowledgements of what is not present in this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

   Acceptance Criterion	Reported Device Performance
   Fatigue/Endurance (Mechanical)	Performed similar to the predicate device (K110404) based on ASTM F1800/ISO14879-1 and ISO 21536 standards.
   Modified Instrument Validation (Tibial Keel Punch)	Tested and validated.
   Substantial Equivalence (Overall)	Demonstrated based on similar intended use, fundamental scientific technology, operating principles, and materials compared to predicate devices (K110404 and K030978). No new issues of safety or efficacy raised.

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

   • Sample Size for Test Set: Not explicitly stated. For mechanical testing, sample sizes are typically determined by the relevant ASTM/ISO standards (e.g., a certain number of samples for fatigue testing). The exact number is not provided in this summary.
   • Data Provenance: Not specified, but mechanical testing is typically performed in a laboratory setting, not on patient data.
   • Retrospective or Prospective: Not applicable, as this refers to mechanical bench testing, not clinical 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. "Ground truth" in this context would refer to expert medical diagnoses or outcomes in a clinical study. The performance testing here is mechanical in nature, comparing the physical properties of the device to established engineering standards and a predicate device.

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

   • Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies for resolving discrepancies in expert interpretations (e.g., imaging reads). This submission describes 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

   • No. An MRMC study is a clinical study involving human readers (e.g., radiologists) interpreting cases, often with and without AI assistance. This document describes a mechanical device and its bench testing.

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

   • Not applicable. This is a physical medical device (a tibial base plate), not a software algorithm.

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

   • The "ground truth" for the mechanical testing is based on established engineering standards (ASTM F1800, ISO14879-1, ISO 21536) and the performance characteristics of the legally marketed predicate device (K110404). The goal is to show that the modified device's mechanical properties are equivalent or better and meet these standards.

8. The sample size for the training set

   • Not applicable. There is no "training set" in the context of mechanical bench testing for a physical implant. Training sets are relevant for machine learning algorithms.

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

   • Not applicable, as there is no training set.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study described is primarily a mechanical performance study designed to demonstrate substantial equivalence of the modified LOSPA Tibial Base Plate to its predicate device (Lospa Total Knee System, K110404) and another approved device (Stryker Scorpio 'NRG' Knee, K030978).

The key components of this study included:

• Mechanical Testing: Specifically, fatigue (endurance) testing was performed on the tibial base plate.
• Standards: The testing was carried out using methods described in recognized international and national standards:
  • ASTM F1800 (Standard Practice for Cyclical Fatigue Testing of Static and Articulated Internal Spinal Fixation Devices) / ISO14879-1 (Implants for surgery — Knee joint prostheses — Part 1: Determination of endurance properties of knee tibial trays)
  • ISO 21536 (Non-active surgical implants — Joint replacement implants — Specific requirements for knee-joint prostheses)
• Comparison: The results of the mechanical testing showed that the LOSPA Tibial Base Plate "performed similar to the predicate device submitted under K110404." This similarity in performance, along with shared design principles, materials, and intended use, formed the basis for the substantial equivalence determination.
• Instrument Validation: The modified instrument, the tibial keel punch, was also "tested and validated." The specific methods or acceptance criteria for this validation are not detailed but imply functional verification.

The underlying "acceptance criteria" not explicitly listed in a bolded table (as would be typical for a clinical study) are implicitly met by demonstrating compliance with the referenced ASTM/ISO standards and achieving performance levels similar to the predicate device. This approach is standard for Special 510(k) submissions focusing on modifications that do not fundamentally alter the device's mechanism of action or safety/efficacy profile, thus relying on established performance benchmarks for similar devices.

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