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TheRay Collared and Collarless Total Hip System is indicated for use in skeletally mature individuals undergoing surgery for total hip replacement due to:
• A severely painful and/or disabled joint from osteoarthritis, theumatoid arthritis, avascular necrosis, or congenital hip dysplasia;
· Acute traumatic fracture of the femoral head or neck;
· Failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty or total hip replacement.

TheRay Collared and Collarless Total Hip System femoral stems are intended for cementless fixation. The acetabular cup is intended for cementless fixation. The porous structured surfaces on the acetabular cup provide biological fixation in a cementless application.

The iNSitu Bipolar Hip System is intended for use in combination with the iNSitu Total Hip System Femoral Stem or TheRay Collared or Collarless Femoral Stem for uncemented primary or revision hemiarthroplasty 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 devices or treatments for these indications have failed.

TheRay Collared and Collarless Hip System includes the new subject femoral stems, along with previously cleared femoral heads (K161184, K220336), acetabular cups (additively manufactured – K161184 and K191936), acetabular liners (vitamin E polyethylene – K161184), acetabular bone screws (K161184), screw hole covers for the screw holes in the acetabular cups (K161184), and apical hole covers for the acetabular cups (K161184). The subject femoral stem implant features a forged triplaner Ti-6Al-4V ELI substrate and an applied dual coating comprised of plasma-sprayed commercially pure titanium (CPTi) and hydroxyapatite (HA). The collared version of the subject TheRay Femoral Stem features a collar on the medial aspect of the stem above the coating that is designed to seat on the native resected calcar. The collarless version of the subject TheRay Femoral Stem is identical to the collared version, less the medial collar.

The iNSitu Bipolar Hip System has been previously cleared for use in K191297 and consists of a factory assembled UHMWPE (ASTM F648) liner in a cobalt chrome (ASTM F75) outer shell, and UHMWPE (ASTM F648) retention ring with a Ti-6Al-4V ELI (ASTM F136) spring. These Bipolar Heads include outer diameters ranging from 38 to 60 mm, in 1 mm increments, to properly fit the patient anatomy. The smaller Bipolar Heads (38 to 43 mm) have an inner diameter that mates with a 22mm diameter Femoral Head; the larger Bipolar Heads (44 to 60 mm) have an inner diameter that mates with a 28 mm diameter Femoral Head. The iNSitu Bipolar Hip System may be used in conjunction with the subject TheRay Collared and Collarless Hip System Femoral Stems.

The provided text describes a medical device, "TheRay Collared and Collarless Femoral Stem," and its submission for FDA clearance. However, it does not include information about acceptance criteria or a study proving the device meets them in the context of an AI/ML enabled device.

The document is a 510(k) summary for a hip implant (a physical medical device), not a software device or an AI/ML product. The performance testing mentioned (Range of Motion, Distal stem fatigue, Neck fatigue, Femoral head disassembly, Biocompatibility) are standard tests for orthopedic implants, ensuring their mechanical integrity and safety for human implantation.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI device meets them because the document describes a traditional medical device, not an AI/ML-enabled one.

To directly answer your request based on the absence of the information in the provided text:

1. A table of acceptance criteria and the reported device performance: Not applicable. The document describes a physical hip implant, not an AI/ML device, and therefore does not have performance metrics like sensitivity, specificity, or F1-score with corresponding acceptance criteria typically associated with AI.
2. Sample size used for the test set and the data provenance: Not applicable. This information is relevant for AI/ML validation datasets. The document mentions "Extensive preclinical performance testing" but does not detail sample sizes in the context of data for an AI model.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. "Ground truth" in this context usually refers to expert-labeled data for AI model training/validation. The document does not describe such a process.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This refers to methods for resolving discrepancies in expert labeling for AI ground truth. The document does not describe such a process.
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: Not applicable. This type of study is specific to AI-assisted diagnostic or decision-making tools to evaluate human performance with and without AI. The device described is a physical hip implant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This refers to the performance of an AI algorithm on its own. The device described is a physical hip implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. "Ground truth" here refers to data labeling for AI. For a hip implant, "ground truth" would relate to real-world clinical outcomes and mechanical performance, which are evaluated through different types of studies (e.g., clinical trials, bench testing per ISO standards).
8. The sample size for the training set: Not applicable. This refers to the dataset used to train an AI model.
9. How the ground truth for the training set was established: Not applicable. This refers to the process of creating labeled data for AI model training.

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The iNSitu Bipolar Hip System is intended for use in combination with the iNSitu Total Hip System Femoral Stems for uncemented primary or revision hemiarthroplasty 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;
• . Revisions procedures where other devices or treatments for these indications have failed

The iNSitu Bipolar Hip System consists of a factory assembled UHMWPE (ASTM F648) liner in a cobalt chrome (ASTM F75) outer shell, and UHMWPE (ASTM F648) retention ring with a Ti-6Al-4V ELI (ASTM F136) spring. These Bipolar Heads include outer diameters ranging from 38 to 60 mm, in 1 mm increments, to properly fit the patient anatomy. The smaller Bipolar Heads (38 to 43 mm) have an inner diameter that mates with the subject 22mm diameter Femoral Head; the larger Bipolar Heads (44 to 60 mm) have an inner diameter that mates with the previously cleared 28 mm diameter Femoral Head. The iNSitu Bipolar Hip System may be used in conjunction with an iNSitu Total Hip System Femoral Stem (K161184/K172501) for hemiarthroplasty.

This document describes the regulatory clearance of a medical device, specifically the iNSitu Bipolar Hip System. It refers to performance testing done for a predicate device to establish substantial equivalence. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML powered device.

The provided text is a 510(k) summary for a traditional medical device (a hip prosthesis), not an AI/ML device. Therefore, the questions related to AI/ML device performance (like sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable to this document.

The document focuses on demonstrating substantial equivalence to a previously cleared predicate device (the BioPro Bipolar Head) based on identical design, materials, indications for use, and manufacturing methods.

Here's a breakdown of the relevant information provided, adapted to the context of a traditional device:

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

The document does not explicitly state "acceptance criteria" in the way one would for an AI/ML algorithm's performance metrics (e.g., sensitivity, specificity). Instead, it relies on the mechanical and functional equivalence to a predicate device.

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

• Test set sample size: Not specified. The "testing" refers to mechanical and functional tests of the physical device components, not a "test set" of data as in AI/ML.
• Data provenance: Not applicable in the context of mechanical device testing.

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 as typically defined for AI/ML (e.g., expert consensus on medical images) is not relevant for the mechanical testing of a hip prosthesis. The "ground truth" here is adherence to mechanical and material standards and performance comparable to a predicate device.

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

Not applicable. This concept is for resolving disagreements in expert labeling of data, which is not part of this device's evaluation.

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

Not applicable. This is not an AI/ML device, so no MRMC study would be conducted for human reader improvement with AI assistance.

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

Not applicable. This is not an AI/ML algorithm.

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

The "ground truth" for this medical device's performance is adherence to established material specifications (e.g., ASTM F75 for cobalt chromium, ASTM F648 for UHMWPE, ASTM F136 for Ti-6Al-4V) and demonstrated mechanical performance comparable to a legally marketed predicate device as determined through physical testing.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no training set.

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

Not applicable. There is no training set for this type of device.

In summary: The provided document is for a traditional hip implant, not an AI/ML powered device. The "acceptance criteria" are implied to be the successful demonstration of mechanical and material properties that are substantially equivalent to a cleared predicate device, as confirmed by physical performance testing. The questions regarding AI/ML specific aspects (sample sizes, experts, adjudication, MRMC, standalone performance, training sets, etc.) do not apply to this submission.

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The iNSitu Total Hip System is indicated for use in skeletally mature individuals undergoing surgery for total hip replacement due to:

· A severely painful and or disabled joint from osteoarthritis, theumator arthritis, avascular necrosis, or congenital hip dysplasia;

· Acute traumatic fracture of the femoral head or neck;

· Failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty or total hip replacement

The iNSitu Total Hip System femoral stem is intended for cementless fixation. The iNSitu Total Hip System acetabular cup is intended for cementless fixation. The porous structured surfaces provide biological fixation in a cementless application.

The subject device of this 510(k) notification is the Blade Femoral Stem, which is a line extension to the iNSitu Total Hip System. The Blade Femoral Stem is a collarless dual-tapered for biologic fixation. The neck is polished and narrowed in the anterior-posterior dimension to reduce the potential for impingement with the liner and to increase the range of motion (ROM), while maintaining flexural rigidity. The proximal portion of the stem possesses a porous structured commercially pure (CP) titanium coating for biologic fixation with bone. The hip stem has a smooth satin finish. There is a range of sizes that proportionally increase in diameter, stem length, and neck offset to accommodate a range of human hip anatomy. The range of stem sizes is offered in both standard and lateralized neck configurations. The Blade Femoral Stem is made from titanium alloy conforming to ASTM F136.

The iNSitu Total Hip System includes a family of femoral stems (including the predicate iNSitu Femoral Stems and the subject Blade Femoral Stems), femoral head components, UHMWPE acetabular cups, acetabular hole covers, optional acetabular screws, instruments, and sterilization cases. With the extension Blade Femoral Stem, all other components of the subject device are identical to the predicate devices cleared in K161184 and K172501. The implants are packaged in single use, sterile packages with a 5-year shelf life and the re-usable instruments are contained in sterilization cases intended for steam sterilization.

This is a 510(k) premarket notification for a medical device, not an AI/ML device. Therefore, the provided document does not contain information about acceptance criteria or studies related to AI/ML device performance. The information requested in the prompt, such as sample size for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, or ground truth establishment methods, is not applicable to this submission.

The document describes a line extension (Blade Femoral Stem) to an already cleared total hip system. The acceptance criteria and the study for this type of device focus on mechanical and material performance, as well as substantial equivalence to previously cleared predicates.

Here's the relevant performance information from the document:

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

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

This information is not explicitly stated in the document. For mechanical testing, samples typically refer to manufactured devices (or components) subjected to specific test conditions, not data sets in the AI/ML context.

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, as this is a mechanical device, not an AI/ML diagnostic tool.

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

Not applicable, as this is a mechanical device, not an AI/ML diagnostic tool.

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

Not applicable, as this is a mechanical device, not an AI/ML diagnostic tool.

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

Not applicable, as this is a mechanical device, not an AI/ML diagnostic tool.

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

The "ground truth" for this device would be its ability to withstand mechanical stresses and fatigue as per established engineering standards for orthopedic implants, and to demonstrate substantial equivalence to its predicate devices. This is typically verified through laboratory-based mechanical testing, not clinical "ground truth" in the diagnostic sense.

8. The sample size for the training set

Not applicable, as this is a mechanical device, not an AI/ML device that requires a training set.

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

Not applicable, as this is a mechanical device, not an AI/ML device.

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