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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.

The EXULT Knee Replacement System is intended for cemented use only.

The purpose of this submission is to introduce EXULT Tibial Insert UCR (Ultra Congruent & Cruciate Retaining) which is a line extension to the EXULT Knee Replacement System.

The EXULT Tibial Insert UCR is a modification to the PCL (Posterior Cruciate Ligament) notch of the EXULT Tibial Insert UC (K242046). This change allows the EXULT Tibial Insert UC to be used by surgeons who do not resect the PCL when implanting an EXULT Tibial Insert UC. Tibial Insert is used at both right and left knee. It is only used in combination with the same Femoral component and Tibial baseplate of the predicate device.

The provided FDA 510(k) clearance letter for the EXULT Knee Replacement System (K250889) does not contain any information about an AI/ML-driven medical device, nor does it include details about a study that assesses AI/ML performance against acceptance criteria.

This document pertains to a medical device (a knee replacement system) that is a physical implant made of materials like UHMWPE. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to engineering and biomechanical tests to ensure the mechanical integrity, wear characteristics, range of motion, and other physical properties of the knee implant.

Therefore, I cannot fulfill your request to describe the acceptance criteria and study for an AI/ML device based on this input. The provided text does not contain any of the required information regarding AI/ML performance, sample sizes for AI/ML test sets, expert ground truth adjudication, MRMC studies, standalone AI performance, or training set details.

The "Non-Clinical Testing" section on Page 7 lists the following mechanical/physical tests:

• Contact area/pressure per ASTM F2083
• Interlocking test per ASTM F1814
• Wear of articular surface per ISO 14243-2/3
• Range of Motion analysis per ISO 21536
• Constraint analysis per ASTM F1223
• Endurance and deformation under high flexion per ASTM F2777

These are standard tests for orthopedic implants and are not related to AI/ML performance. The "Clinical Testing" section explicitly states: "Clinical data was not needed to support the safety and effectiveness of the subject device." This further confirms that no clinical study involving human readers or AI assistance was conducted for this device.

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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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BENCOX Delta Option Heads of BENCOX Total 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 trochanteric 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

The BENCOX Delta Option Head consists of a delta ball head and a titanium sleeve (Ti6Al4V). The ball heads are made of the BIOLOX® delta ceramic material, which is a high-purity alumina composite material according to ISO 6474-2 Type X, and come in various outer diameters.

The ceramic BIOLOX® delta ball head is assembled with the corresponding titanium sleeve and is then placed over the titanium alloy tapers of an in-situ hip stem prosthesis. The titanium sleeve has an inner taper which fits the dimensions of a metallic hip stem prosthesis, and the BIOLOX® delta ball head has a taper which fits to the dimensions of the outer diameter of the titanium sleeve.

This document is a 510(k) premarket notification for a medical device (BENCOX Delta Option Heads, a hip joint prosthesis component). It is a regulatory submission to the FDA demonstrating substantial equivalence to a legally marketed predicate device.

Crucially, this document is NOT a study describing the performance of an AI/ML medical device. It details the engineering and material properties of a physical orthopedic implant. Therefore, the questions related to AI/ML device performance, such as "effect size of how much human readers improve with AI vs without AI assistance," "standalone (i.e. algorithm only without human-in-the-loop performance)," "sample size for the training set," and "how the ground truth for the training set was established," are not applicable to this document.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the non-clinical (bench) testing performed to demonstrate the device's safety and effectiveness compared to predicate devices, rather than clinical performance or AI/ML algorithm validation.

Here's a breakdown of the requested information based on the provided document:

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

The document does not provide a table with specific acceptance criteria values and the device's reported performance against those criteria. It lists the types of non-clinical tests performed to demonstrate substantial equivalence. These tests are implicitly conducted against established engineering and material standards for orthopedic implants.

8. The sample size for the training set

Not applicable. This is a physical orthopedic implant, not an AI/ML medical device.

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

Not applicable. This is a physical orthopedic implant, not an AI/ML medical device.

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BENCOX Mirabo Z Cup Cortinium of BENCOX Total Hip System is intended for Cementless use in total 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

The subject BENCOX Mirabo Z cup Cortinium shares key design features, materials, Indications for Use statements, geometry, and compatibility with other Corentec acetabular components marketed under the brand names BENCOX Mirabo Cup System and BENCOX Mirabo Z Cup Cortinium.

The BENCOX Mirabo Z cup Cortinium is similar to the predicate devices BENCOX Mirabo Z Cup Cortinium cleared under K210614 and Bencox Mirabo Cups cleared under K220468, K172806, K162127, K120924 with respect to material - Titanium alloy (ASTM F136), and coated by pure titanium powder (ASTM F1580) through an additive manufacturing process, design, locking system, manufacturing (without coating processes), packaging and sterilization. This submission is only for the inclusion of specification of BENCOX Mirabo Z Cup Cortinium with external diameter 50mm.

The manufacturing process including additive manufacturing is identical to the predicate. The subject 50mm acetabular shell is thinner than the predicate 50mm shells but it is not thinner than other sized shells in the predicate submission. Otherwise, the geometry of the features is identical to the predicate.

The subject devices operate using the same fundamental scientific technology, have the same intended use and design features, employ the same materials of construction, are offered in the same product size scopes, and are implanted using a similar surgical technique and the same or similar instrumentation to legally marketed device cleared under K120924, K162127, K172806, K220468 and K210614.

The provided text describes a 510(k) submission for a hip joint prosthesis, not an AI/ML medical device. Therefore, it does not contain information about acceptance criteria or a study proving that an AI/ML device meets those criteria.

The document is a clearance letter from the FDA for a new size (50mm diameter acetabular cup) of an existing hip implant device, the BENCOX Mirabo Z Cup Cortinium. The submission focuses on demonstrating substantial equivalence to previously cleared devices through non-clinical testing of the physical properties and performance of the implant.

Consequently, I cannot extract the information required in your request regarding acceptance criteria and a study for an AI/ML device. The document mentions tests like "Wear Testing as per ISO 14242-1 and 14242-2," "Cup Deformation as per ISO 7206-12," and "Shell Fatigue Testing as per ASTM F3090," which are standard tests for orthopedic implants. However, these are mechanical and material tests, not performance metrics for an AI/ML algorithm.

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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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BENCOX Mirabo Z Cup Cortinium of BENCOX Total Hip System is intended for cementless use in total 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

The BENCOX Mirabo Z Cup Cortinium is a porous coated non hemispherical outer shell made of Ti-6Al-4V alloy (ASTM F136) via machining processes and coated by pure titanium powder (ASTM F1580) through an additive manufacturing process. The device design allows for the cementless use of cross-linked polyethylene liners into the shell and incorporates screw holes for fixation.

The provided text is a 510(k) premarket notification for the BENCOX Mirabo Z Cup Cortinium. It describes the device, its intended use, and claims substantial equivalence to previously marketed predicate devices. However, it does not contain information about acceptance criteria, detailed study results proving a device meets acceptance criteria, sample sizes for test or training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or how ground truth was established.

This document focuses on regulatory compliance through substantial equivalence, primarily based on design and material similarities, and a set of non-clinical bench tests comparing the device to existing standards and predicate devices.

Therefore, I cannot fulfill your request for this specific information based on the provided text. The document states "Device Comparisons and performance testing indicate that the BENCOX Mirabo Z Cup Cortinium is substantially equivalent to the predicates in terms of intended use, indications, design, materials, performance characteristics and operational principles," and lists the nonclinical testing performed (e.g., Cup Fatigue Testing per ASTM F3090-20, Porous Structure Characterization per various ASTM and DIN EN ISO standards). These tests are typically performed to demonstrate that the device meets existing standards and is comparable to previously cleared devices, rather than establishing specific acceptance criteria and proving performance against them in a clinical study format.

In summary, the provided document does not contain the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement for a clinical performance study.

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BENCOX Mirabo Cup System of Bencox Total Hip System is intended for Cementless use in partial or total 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

The Bencox Mirabo Cup System is a Cementless hip acetabular system (Poly Liner) intended to be used with femoral components including either metal or ceramic heads and femoral stems to form a total hip system for hip arthroplasty. This submission consists of the following line extension components:

• Acetabular Cup Bencox Mirabo Cup
• . Acetabular Liner - Bencox Mirabo PE Liner

Acetabular Cup: Bencox Mirabo Cup

The Bencox Mirabo Cup Spec. Inclusion is similar to Bencox Mirabo Cup cleared under K162127 & K120924 with respect to material - Titanium alloy (ASTM F136), coating with pure Titanium powder (ASTM F1580), design, locking system, manufacturing, packaging and sterilization. This submission is only for the inclusion of specification of acetabular cups with external diameter 50 mm.

Acetabular Liner: Bencox Mirabo PE Liner

The Bencox Mirabo PE Liner specification inclusion is similar to Bencox Mirabo PE Liner cleared under K162127 & K150007, with respect to material, conforming to ASTM F648, Type 2 (GUR 1050), and irradiated with average dose of 10.0 Mrad of gamma radiation, design, locking system, manufacturing, packaging and sterilization. This submission is only for the inclusion of specification of Liner with head size, 28/42, 32/42, 36/42 mm.

This FDA 510(k) submission for the BENCOX Mirabo Cup System is for a medical device (hip joint prosthesis components), not an AI/ML software. Therefore, the information typically requested regarding acceptance criteria and studies for AI/ML performance (such as test set sample sizes, data provenance, expert ground truth, MRMC studies, or training set details) is not applicable to this document.

The document discusses mechanical testing and biocompatibility studies, which are relevant to the safety and effectiveness of a physical medical implant. Here's a summary of the non-clinical testing referenced for this device, which serves as the "study that proves the device meets the acceptance criteria" for a physical implant:

Acceptance Criteria and Reported Device Performance (Non-Clinical Testing for Physical Device)

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

· non-inflammatory degenerative joint disease, such as avascular necrosis, osteoarthritis, traumatic arthritis;

· Inflammatory degenerative joint disease, such as rheumatoid arthritis;

· Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques;

· patients with failed previous surgery where pain, deformity, or dysfunction persists;

· revision of previously failed total hip arthroplasty.

The Additional components being added to the BENCOX THR System are:

• Instrumentation (Head trial, Bencox Hybrid PE Liner Trial - STD/ELV, Bencox Mirabo PE Liner Trial - STD/ELV, Shell Trial, Bipolar Cup Trial, Bipolar Cup Trial Ring, Head Impacting Part, Liner Impacting Part)

The Bencox Hip Instrumentation is a set of accessories to be used with Bencox Hip Implants. The instruments are designed to be simple, conventional, and accurate and all parts of which are used for their respective procedures by qualified orthopedic surgeons. The parts of the instruments are made of Propylux and/or SUS along with colorants which are biocompatible and used in medical industry for decades and cleared for use in previous premarket notifications of Corentec.

The Trials are used to match the different anatomical structures of the hip joint and the Impacting Parts are used to combine the components together. These instruments are reusable devices that must be sterilized prior to use.

The trials and impacting parts of this submission are made of Propylux and/or SUS conforming to ASTM D4101: Standard Classification System and Basis for Specification for Polypropylene Injection and Extrusion Materials, and ASTM F899:

Standard Specification for Wrought Stainless Steels for Surgical Instruments, respectively.

The provided document is a 510(k) premarket notification for a medical device, the BENCOX THR System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device's performance against specific acceptance criteria through a clinical study.

Therefore, the document does not contain the following information:

• A table of acceptance criteria and reported device performance.
• Sample size used for a test set or its data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for a test set.
• Information on a multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
• Information on standalone (algorithm-only) performance.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for a test set.
• Sample size for a training set.
• How ground truth for a training set was established.

Explanation from the document:

The document states under "Non-Clinical Testing":
"The designs, dimensions and function of additional instruments are similar with predicate devices under K162127. Additional performance testing is unnecessary since the trial is not implanted."

And under "Clinical Testing":
"Clinical testing for BENCOX THR System Instrumentation were not required as a basis for substantial equivalence."

This explicitly indicates that no clinical performance studies, which would typically involve testing against acceptance criteria, were conducted or required for this 510(k) submission. The basis for clearance is the demonstrated substantial equivalence to predicate devices through technical characteristics and non-clinical engineering analysis (e.g., dimensions).

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