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The Ring-Lok™ Modular Bi-Polar System is intended for use in combination with other previously cleared femoral components including the Rig-Fix™ Hip Stem (K072101), C-fit Performa (K923898) or the Stability Hip Stem (K915787 and K934457) for uncemented primary or revision hemi-arthroplasty of the hip. This prosthesis may be used for the following conditions, as appropriate:

• Femoral neck and trochanteric fractures of the proximal femur .
• Osteonecrosis of the femoral head .
• Revision procedures where other treatments or devices or these indications have failed.

The Ring-Lok™ Modular Bi-Polar System is intended for use in combination with the previously cleared femoral components including Rig-Fix™ Hip Stem (K072101), C-fit Performa (K923898) or the Stability Hip Stem (K915787 and K934457)). The Ring-Lok™ Modular Bipolar System consists of a factory assembled UHMWPE liner in a cobalt chrome outer shell, and UHMWPE retention ring. These bipolar heads include outer diameters ranging from 38 to 62 mm, in 1mm increments, to properly fit the patient anatomy. The inner diameter mates with a 22.225, 26 or 28 mm diameter femoral head.
Implant International supplies Ring-Lok™ Bi-Polar Instrumentation for use with the Ring-Lok™ Modular Bi-Polar System.

Here's a breakdown of the acceptance criteria and study information for the Ring-Lok™ Modular Bipolar System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that the testing was "to written protocols with pre-defined acceptance criteria," but it does not explicitly list the quantitative acceptance criteria for each test beyond requiring substantial equivalence to predicate devices. The reported performance consistently states that the criteria were met.

2. Sample Size for Test Set and Data Provenance

• Sample Size: "worst case component size and option/design." The exact number is not specified, but it implies a focused selection of the most challenging configurations for testing.
• Data Provenance: The testing was conducted by Implant International Limited, based in the UK. Therefore, the data provenance is likely UK-based, non-clinical (laboratory), and prospective (as it was part of design verification for this specific device).

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

This information is not provided in the document. The testing described is non-clinical performance testing (mechanical/engineering tests), not clinical studies involving human patients or expert interpretation of clinical data. Therefore, the concept of "ground truth" established by medical experts for a test set in the usual sense does not apply here.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. As explained above, the tests are non-clinical engineering evaluations, not clinical data requiring adjudication by experts.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study described is a non-clinical performance test comparing the device to predicate devices through engineering evaluations.

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

This concept is not applicable to this medical device. The "Ring-Lok™ Modular Bipolar System" is a physical implant (a hip prosthesis component), not an AI algorithm or software. Therefore, there's no "algorithm only" or "human-in-the-loop" performance to evaluate in this context. The standalone performance refers to the device itself performing its intended biomechanical function without direct human intervention during its operation in the body.

7. Type of Ground Truth Used

The "ground truth" in this context is the performance of established predicate devices (Medacta Bi-Polar Head K091967 and BioPro Bi-Polar Head K082705) in similar non-clinical tests, and the engineering specifications/standards that these types of devices are expected to meet. The aim was to demonstrate "substantial equivalence" to these predicates.

8. Sample Size for the Training Set

This information is not applicable/not provided. There is no "training set" in the context of this device's non-clinical performance testing. Training sets are relevant for machine learning algorithms, which is not what this device is.

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

This information is not applicable/not provided for the reasons stated in point 8.

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Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions:

1. Severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
2. Avascular necrosis of the femoral head.
3. Acute traumatic fracture of the femoral head or neck.
4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthro-plasty, or total hip replacement.
5. Certain cases of ankylosis.

The Titan Porocoat® Hip Stem is indicated for cementless use and fixation by biological tissue ingrowth into the porous coating.

The Titan Porous Hip is a collarless, titanium, tapered, press-fit femoral stem. The hip stem is manufactured from Titanium (Ti-6Al-4V) and has a sintered commercially pure titanium bead porous coating (Porocoat®) applied to the stem. The hip stem consists of 11 body sizes ranging in diameter from 6mm to 18mm with each body size having two offset options.

Based on the provided 510(k) summary for the Titan™ Porocoat® Hip Prosthesis, it is important to note that this document describes a medical device (a hip implant), not an AI/software device. Therefore, many of the typical acceptance criteria and study methodologies relevant to AI/software performance (e.g., sample size for test/training sets, ground truth by experts, MRMC studies, standalone performance) are not applicable or described in this type of submission.

510(k) submissions for medical devices like hip implants primarily focus on demonstrating substantial equivalence to a predicate device already on the market, rather than proving performance against specific acceptance criteria for diagnostic or algorithmic accuracy. The "study" here is the comparison to predicate devices and the design/materials of the new device itself.

However, I will extract the relevant information and indicate where typical AI/software device information is not available in these types of physical device submissions.

Acceptance Criteria and Device Performance (for a physical medical device)

2. Avascular necrosis of the femoral head.
3. Acute traumatic fracture of the femoral head or neck.
4. Failed previous hip surgery (various types).
5. Certain cases of ankylosis.
6. Indicated for cementless use and fixation by biological tissue ingrowth into the porous coating. | "The Titan Porocoat Hip Prosthesis has the same intended use and basic design as the predicate devices and is therefore substantially equivalent." The indications are explicitly stated as identical to the predicate devices. The hip stem is manufactured with a sintered commercially pure titanium bead porous coating (Porocoat®) specifically for cementless fixation and tissue ingrowth, aligning with the stated indication. |
   | Design Characteristics | Collarless, titanium, tapered, press-fit femoral stem. Manufactured from Titanium (Ti-6Al-4V). Sintered commercially pure titanium bead porous coating (Porocoat®). 11 body sizes (6mm to 18mm) with two offset options per size. | The document describes the device's design and materials (titanium, porous coating), which are directly presented as its characteristics. The claim of "substantial equivalence" is based on these features being comparable to the predicate devices. For mechanical devices, performance is typically demonstrated through bench testing (e.g., fatigue, static strength, wear) to show that the new device meets established standards or performs comparably to the predicate, although these specific test results are not detailed in this high-level summary. The similarity in "basic design" to predicate devices (UNI-ROM Femoral Hip Stem K974331, Stability Hip Femoral Component K934457 with Porocoat, Vision AML Hip Prosthesis K953694) serves as the primary "performance" metric in a 510(k) for substantial equivalence. |
   | Material | Titanium (Ti-6Al-4V) and sintered commercially pure titanium bead porous coating (Porocoat®). | Materials are explicitly stated. The choice of these materials is likely consistent with, or justified as equivalent to, the predicate devices. |

Information Not Applicable or Not Provided for this Physical Medical Device 510(k) Summary:

Since this is a submission for a physical medical implant (hip prosthesis) and not an AI/software device, the following points as requested in your prompt are not applicable or not typically included in this type of 510(k) summary document. The "study" for such devices often involves bench testing, material characterization, and comparison to design principles of predicate devices, rather than clinical studies focused on algorithmic performance.

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for a physical device like a hip implant. There isn't a "test set" of data in the sense of an algorithmic evaluation. Device performance is typically evaluated through mechanical testing, material analysis, and comparison to predicate device specifications.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an implant isn't established by experts in the same way it would be for an image-based diagnosis.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
4. 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, as this is not an AI-assisted diagnostic or decision support device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For an implant, "ground truth" relates to its physical and biocompatible properties meeting specifications and performing as intended (e.g., mechanical strength, wear resistance, successful osseointegration). This is established through engineering and biological testing, not expert consensus on data cases.
7. The sample size for the training set: Not applicable. There is no AI model being trained.
8. How the ground truth for the training set was established: Not applicable.

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