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.

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The Bencox Hip System is intended for cementless use in total or partial hip arthroplasty in primary or revision surgery for the following conditions:

a. Non-inflammatory degenerative joint disease, such as avascular necrosis, osteoarthritis, traumatic arthritis

b. Inflammatory degenerative joint disease, such as rheumatoid arthritis

c. Treatment of non-union, femoral neck fracture and trochantric fractures of the proximal femur with head involvement, unmanageable using other techniques d. Patients with failed previous surgery where pain, deformity, or dysfunction persists e. Revision of previously failed total hip arthroplasty

Bencox II Stem cleared under K103431 is modified at the proximal neck region. The other aspects of design / material / specification / manufacturing & sterilization / packaging are not altered and remain the same as discussed in K103431. The component is manufactured from Ti-6Al-4V alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401); Co-Cr-Mo alloy conforming to ASTM F1537 Standard Specification for Wrought Cobalt-28-Chromium-6-Molybdenum Alloys for Surgical Implants.

Bencox Metal Head is cleared under K103431 & K112019 with the neck lengths of small, medium and large. This submission includes extra large (XL) neck length as an inclusion to the existing specification. The other aspects of design / material / specification / manufacturing & sterilization/packaging are not altered and remain the same as discussed in K103431 & K112019. The component is manufactured from Co-Cr-Mo alloy conforming to ASTM F1537 Standard Specification for Wrought Cobalt-28-Chromium-6-Molybdenum Alloys for Surgical Implants.

Here's an analysis of the acceptance criteria and supporting study for the Bencox II Stem & Bencox Metal Head, based on the provided text:

Important Note: This document describes a modification to an existing medical device (hip prosthesis components). The acceptance criteria and performance data provided relate to demonstrating that the modified device performs similarly or better than the previously cleared predicate devices, particularly regarding fatigue strength and range of motion. This is a common approach for 510(k) submissions for device modifications, focusing on demonstrating equivalence rather than establishing de novo clinical performance benchmarks.

Acceptance Criteria and Study Details for Bencox II Stem & Bencox Metal Head (K122099)

1. Table of Acceptance Criteria and Reported Device Performance:

The provided 510(k) summary does not specify explicit numerical acceptance criteria in the typical sense for a diagnostic device (e.g., accuracy thresholds). Instead, for this orthopedic implant modification, the acceptance criteria are implicitly tied to demonstrating substantial equivalence to predicate devices through performance testing. The reported performance is comparative.

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

• Sample Size: The document does not specify exact sample sizes for the mechanical and sterilization tests, but refers to "a series of testing protocols." For such device modifications, testing typically involves a sufficient number of samples to statistically demonstrate compliance with standards and equivalence, but specific numbers are not provided.
• Data Provenance: The data is generated from laboratory testing (mechanical, sterilization, packaging) of the modified Bencox II Stem & Bencox Metal Head and comparison with the predicate devices. This is not patient-derived data. The manufacturing country is South Korea (Corentec Co., Ltd.). The data is prospective, generated specifically for this 510(k) submission.

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

• Not Applicable: For this type of submission involving mechanical and sterilization testing of an orthopedic implant component, "ground truth" is established by adherence to recognized international standards (ISO, ASTM) and established engineering principles, rather than expert clinical consensus on patient data. There is no mention of clinical experts being involved in establishing "ground truth" for these specific performance tests.

4. Adjudication Method for the Test Set:

• Not Applicable: As the "test set" consists of physical devices undergoing laboratory performance testing against engineering standards, there is no need for an adjudication method involving multiple human readers/experts. The tests produce quantifiable results compared to standard requirements and predicate device performance.

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

• No, not done. This 510(k) submission pertains to physical modifications of an orthopedic implant system and its mechanical and sterilization performance, not a diagnostic device requiring human-in-the-loop performance evaluation. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant and was not performed.

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

• No, not done. This product is a physical hip prosthesis component, not an algorithm or AI software. Therefore, an "algorithm only" performance study is not applicable.

7. Type of Ground Truth Used:

• Engineering Standards and Predicate Device Performance: The "ground truth" for the performance evaluation is based on established international engineering standards for orthopedic implants (ISO 7206-4, ISO 7206-6, ISO 21535, ISO 11137-1 & 2) and the demonstrated performance of the previously cleared predicate devices (K103431 & K112019). The goal is to demonstrate that the modified device meets or exceeds these established benchmarks.

8. Sample Size for the Training Set:

• Not Applicable: As this is a physical medical device (hip prosthesis components) and not an AI/ML algorithm, there is no "training set" in the context of machine learning. The design and manufacturing processes are informed by established engineering principles and prior device designs, but not through data-driven 'training' in the AI sense.

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

• Not Applicable: As there is no "training set" for an AI/ML algorithm, the concept of establishing ground truth for it does not apply. The performance evaluation is based on direct physical testing and comparison to engineering standards and predicate device performance.

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