LOSPA II Knee System (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 of unsuccessful osteotomy, arthrodesis, or failure of previous arthroplasty procedure.

LOSPA II Knee System (EXULT Knee Replacement System) is intended for cemented application only.

The Additional components being added to the LOSPA II Knee Replacement System (EXULT Knee Replacement System) are:

• Revised Size 12 PS, CR Femoral Component -
• Additional Size 13 PS, CR Femoral Component -
• -Instrumentation

The subject LOSPA II Knee System (EXULT Knee Replacement System) components specification inclusions are a line extension of Femoral Components and Instrumentation system.

The provided text does not describe an AI/ML powered device, nor does it detail any clinical studies involving such technology.

The document is a 510(k) clearance letter from the FDA for a LOSPA II Knee System (EXULT Knee Replacement System), which is a traditional medical device (a knee replacement prosthesis). The clearance is for additional components to an already cleared system.

Therefore, I cannot provide answers to the questions regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment for an AI/ML device, as this information is not present in the provided text.

The "PERFORMANCE TESTING - BENCH" section refers to mechanical testing of the knee replacement components against established ASTM and ISO standards, not clinical studies for an AI/ML algorithm.

Ask a specific question about this device

LOSPA II 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.

LOSPA II Knee System is intended for cemented application only.

The subject LOSPA II Knee System components are similar to predicate devices,

• LOSPA Total Knee System components cleared under K110404, K121037 & . K130673 for subject devices - Femoral Components, Tibial Base plate, Tibial Insert, Patellar Components and related Instrumentation.
• LOSPA Modular Knee System cleared under K160157 for subject devices -. Stemmed Tibial Base Plate and Stem Plug and related Instrumentation

The subject components are a line extension to LOSPA Knee System and consists of following components,

A) LOSPA II Femoral Component (PS-tvpe and CR-type)

Femoral Components of LOSPA II Knee System are designed based on Femoral Components of LOSPA Knee System. Femoral component has two different types which match to Tibial Insert types: PS-type and CR-type. Each PS and CR-types have 12 sizes, from #01 to #12 for each right and left knee. The antero-posterior length ranges from 50 mm to 74 mm, and the medio-lateral length ranges from 59 mm to 77 mm. It is manufactured from cobalt-chromium-molybdenum alloy conforming to ASTM F75.

B) LOSPA II Tibial Insert (PS-type and CR-type)

Tibial Inserts of LOSPA II Knee System are designed based on Tibial Inserts of LOSPA Knee System, matching to Femoral Component types: PS-type and CR-type. Each PS and CR-types have 10 sizes, from #02 to #11. Tibial Insert is used at both right and left knee. The antero-posterior length ranges from 36 mm to 57 mm, and the medio-lateral length ranges from 57 mm to 86 mm. Tibial Inserts are recommended to match Femoral Components of two-size up and one-size down. The Tibial Inserts of LOSPA II have two material types: conventional UHMWPE and 7.5 Mrad crosslinked UHWMPE (XLPE) conforming to ASTM F648.

C) LOSPA II Tibial Baseplate (Standard and Stemmed)

Tibial Baseplate of LOSPA II Knee System has two different types: Standard and Stemmed. Standard base plate is designed based on our predicate device. LOSPA Knee System cleared under K110404/K121037. The Stemmed Tibial Baseplate is designed to add stem plug, or various types of stem extensions and based on our predicate device, LOSPA Modular Knee System cleared under K160157. Each Standard and Stemmed Baseplate has 10 sizes, from #02 to #11. The antero-posterior length ranges from 36 mm to 57 mm, and the medio-lateral length ranges from 57 mm to 86 mm. Each sizes exactly matches to same size of the Tibial Insert. It is manufactured from cobalt-chromium-molybdenum alloy conforming to ASTM F75.

D) LOSPA II Stem plug

LOSPA II Stem Plug is assembled with LOSPA II Stemmed Tibial Baseplate when the package is opened.. If Stem Extension is not used, the user can use it as it is assembled. Prior to use Stem Extension, the stem plug should be removed from the stem hole of the Tibial Baseplate. It is manufactured from cobalt-chromiummolybdenum alloy conforming to ASTM F1537.

LOSPA Stem Extensions cleared under K160157 and Patella Dome Type cleared under K110404 & K130673 is also compatible with LOSPA II Knee System.

The provided text is a 510(k) Summary for the LOSPA II Knee System. It details the device's indications for use, description, and claims of substantial equivalence to previously cleared predicate devices. However, this document does not contain the specific acceptance criteria or the study results for device performance in the context of diagnostic accuracy, sensitivity, specificity, or other performance metrics typically associated with studies proving a device meets acceptance criteria.

The "Performance Testing - Bench" section mentions various mechanical and material tests conducted according to ASTM and ISO standards (e.g., ASTM F1800; ASTM F1223; ASTM F2083; ASTM F1814, ISO 14243 and ISO 21536). It states that the device "performed either similar or better than comparable predicate devices." This refers to bench testing of physical characteristics like fatigue, wear, and strength, not clinical performance or diagnostic accuracy.

Therefore, I cannot provide the requested information regarding acceptance criteria and study details for device performance in the context of diagnostic or clinical effectiveness from this document. The information you're asking for typically relates to studies assessing the accuracy or clinical utility of a device, which is not present in this 510(k) summary for a knee replacement implant.

Ask a specific question about this device