Search Results

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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, traumator 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 iNSitu Total Hip Replacement System is an artificial total hip replacement system includes femoral stems manufactured from forged Ti 6Al-4V ELI material, femoral heads manufactured from CoCr alloy and BIOLOX® delta ceramic, acetabular cups (additively manufactured from Ti), acetabular liners manufactured from Vitamin E polyethylene, acetabular bone screws, screw hole covers for the screw holes in the acetabular cups, and apical hole covers for the apical hole in the acetabular cups manufactured from Ti 6Al-4V ELI material.

The provided text is a 510(k) summary for the iNSitu Total Hip System, a medical device for total hip replacement. It demonstrates substantial equivalence to a predicate device and includes information about performance testing.

However, the provided document does not contain information about a study proving that an AI/device meets acceptance criteria, or any of the detailed information requested in the prompt regarding AI model performance, ground truth establishment, sample sizes for training/test sets, expert adjudication, or MRMC studies.

Therefore, I cannot extract the requested information from the provided text. The document describes a physical medical device (hip replacement system) and its performance testing as per FDA regulations for 510(k) clearances, which typically involves mechanical and material properties, not AI algorithm performance.

Ask a specific question about this device

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, 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

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 iNSitu Total Hip Replacement System is an artificial hip replacement system. The system includes femoral stems, femoral heads, acetabular cups (additively manufactured), acetabular liners (Vitamin E polyethylene), acetabular bone screws, screw hole covers for the scetabular cups, and apical hole covers for the apical hole in the acetabular cups.

This document describes the pre-market notification for the iNSitu Total Hip System, a medical device. The provided text, however, focuses on demonstrating substantial equivalence to predicate devices through performance testing, rather than establishing acceptance criteria and proving an AI device meets them.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies for an AI/algorithm-based device because the provided document does not describe an AI or algorithm-based device. It pertains to a physical medical implant system (a total hip replacement system).

The document describes the following for the iNSitu Total Hip System:

• Intended Use: Total hip replacement due to osteoarthritis, rheumatoid arthritis, avascular necrosis, congenital hip dysplasia, acute traumatic fracture, or failed previous hip surgery. The femoral stem and acetabular cup are intended for cementless fixation.
• Technological Characteristics: Manufactured from titanium alloy, packaged and sterilized using similar processes to predicate devices.
• Performance Testing (Preclinical): Extensive mechanical testing was conducted to evaluate the device and demonstrate substantial equivalence to predicate devices. This testing included:
  • Modular acetabular component disassembly (liner push-out, offset pull-out, torsional testing on worst-case sizes).
  • Torsional and fixation strength and removal torque of acetabular bone screws.
  • Characterization of physical, mechanical, thermal, cross-link, and oxidation properties of the highly cross-linked vitamin E stabilized UHMWPE.
  • Hip wear simulator testing on worst-case components.
  • Impingement testing on worst-case components.
  • Range of motion evaluation (flexion/extension, abduction/adduction, internal/external rotation).
  • Characterization of porous structured titanium (in accordance with FDA Guidance "Guidance Document for Testing Orthopedic Implants with Surfaces Apposing Bone or Bone Cement").
  • Physical and mechanical properties of the AM titanium alloy solid implant substrate (non-porous base material).
  • Unsupported fatigue test on the acetabular cup.
  • Mechanical and fatigue testing of ceramic femoral heads.
  • Disassembly testing of the femoral head/femoral taper (with CoCr and ceramic femoral heads).
  • Fatigue testing of the worst-case femoral hip stem.
  • Fatigue testing of the neck region of the worst-case femoral hip stem.
  • Bacterial Endotoxins Test (BET), chromogenic kinetic method.

Conclusion stated in the document: The described performance testing demonstrates that the iNSitu Total Hip System is substantially equivalent to the predicate systems based on its indications for use, design features, and technological characteristics.

To elaborate on why the specific questions in the prompt cannot be answered with the provided text:

• AI/Algorithm Device: The iNSitu Total Hip System is not an AI or algorithm-based device. It is a physical implant. Therefore, concepts like "AI assistance," "human-in-the-loop performance," "training set," "test set," "ground truth," and "experts establishing ground truth" are not applicable in this context.
• Acceptance Criteria for AI Performance: The document provides performance testing results for mechanical properties and biocompatibility of the hip implant, not diagnostic or predictive performance metrics of an AI.
• Sample Size for Test Set/Data Provenance/Ground Truth: These are AI/algorithm-specific concepts. For a physical device, testing involves material science and mechanical engineering principles, often using specialized test fixtures and standardized protocols rather than patient data sets in the way AI devices do.
• MRMC Study/Effect Size: These are relevant for AI-assisted diagnostic tools where human performance with and without AI is compared. This is not applicable to a hip implant.
• Standalone Performance: For a physical device, this would refer to its performance characteristics (e.g., strength, wear resistance) independent of surgical technique, which is covered by the mechanical testing. However, it's not the "standalone (algorithm only)" concept implied by the question.

In summary, the provided text describes a medical device clearance based on mechanical and material testing to demonstrate substantial equivalence, not an AI device validation study.

Ask a specific question about this device