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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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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 NextStep Arthropedix Total Hip Replacement System includes a family of femoral stems, femoral head components, acetabular UHMWPE liners, acetabular cups (including solid, 3-holed, and the subject multiholed), acetabular hole covers, optional acetabular screws, instruments, and sterilization cases (K161184/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 for steam sterilization.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the iNSitu Total Hip System:

The provided text is a 510(k) summary for a medical device (iNSitu Total Hip System) that is seeking clearance as substantially equivalent to existing devices. In this context, "acceptance criteria" and "study" are interpreted in terms of demonstrating substantial equivalence, rather than directly measuring performance against predefined clinical metrics like sensitivity or specificity for a diagnostic algorithm.

Specifically, this submission is to add a multi-holed acetabular cup to an already cleared total hip system. Therefore, the "acceptance criteria" revolve around showing that the new component does not raise new questions of safety or effectiveness and performs comparably to the previously cleared predicate device.

Acceptance Criteria and Reported Device Performance

| Acceptance Criteria Category | Specific Criteria (Implied) | Reported Device Performance |
| Intended Use Equivalence | The new multi-holed acetabular cup must have the same indications for use as the predicate device. | "The iNSitu Total Hip System multi-holed acetabular cup has the indications for use as the iNSitu Total Hip System acetabular cup predicate device." This explicitly states that the intended use is the same. |
| Technological Characteristics Equivalence | The materials, manufacturing processes, and design features of the new multi-holed component must be comparable to the predicate, with consideration given to the impact of the added holes. Changes should not introduce new safety concerns. | "The multi-holed acetabular cups are manufactured from the same materials and processes as the family of acetabular cups in the original iNSitu Total Hip System (K161184/K172501). All iNSitu Total Hip System components...are cleaned, packaged and sterilized using the same processes as previously described..." "The subject multi-holed acetabular cup is equivalent to the original acetabular cup based on comparisons of intended use, design features, and technological characteristics." |
| Performance (Mechanical) Equivalence | The mechanical performance of the multi-holed acetabular cup, particularly regarding fatigue strength, must be demonstrated to be equivalent or superior to the predicate, especially considering the new holes for fixation. | "2-point fatigue testing was performed on the multi-holed acetabular cup to show substantial equivalence to the predicate device." (It explicitly states the test was performed to show substantial equivalence). |
| Sterilization Equivalence | The sterilization process must effectively sterilize the new component, and the introduction of the multi-holed design should not create a new worst-case scenario that invalidates the existing sterilization validation for the system. | "Risk based EO sterilization was performed to document that the newly introduced iNSitu Multi-Holed Acetabular Cup did not present a new worst-case scenario, and therefore included into the documentation for the existing sterilization process for the predicate device (K161184/K172501)." |
| Overall Substantial Equivalence (Conclusion) | The cumulative evidence from intended use, technological characteristics, and performance testing must demonstrate that the device is substantially equivalent to legally marketed predicate devices and does not raise new questions of safety or effectiveness. | "A comparison of technological characteristics and performance testing demonstrates that the NextStep Arthropedix iNSitu Total Hip System multi-holed acetabular cup is substantially equivalent to the predicate system (K161184/K172501)." |

Study Details (for demonstrating Substantial Equivalence of a Physical Device)

It's crucial to understand that the "study" described here is for a physical orthopedic implant, not an AI/Software as a Medical Device (SaMD). Therefore, many of the typical questions for AI/SaMD (like "number of experts," "adjudication," "MRMC," "ground truth type," "training set size") are not applicable in this context. The "study" involves engineering and biocompatibility testing of the material and design.

Here's an analysis based on the provided text, recognizing the nature of the device:

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: The document does not specify a numerical sample size for the "2-point fatigue testing" or "Risk based EO sterilization." For physical device testing, sample sizes are typically determined by relevant ISO or ASTM standards (e.g., a certain number of units or specimens). The text implies sufficient samples were tested to demonstrate substantial equivalence, but the exact number isn't stated.
   • Data Provenance: Not explicitly stated, but typically these tests would be performed in a controlled laboratory environment by the manufacturer or a third-party testing facility. The data is prospective in the sense that the tests were specifically conducted for this submission.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not Applicable. For a physical implant, "ground truth" is established through engineering and material science standards (e.g., ISO, ASTM) and physical measurements. There isn't a "ground truth expert" in the same way there would be for image interpretation. The "ground truth" is the established mechanical properties required for the device or established sterility assurance levels.

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

   • None. Adjudication methods are relevant for subjective interpretations (like medical image reading). For physical device testing, results are typically quantitative measurements against predefined pass/fail criteria from engineering standards.

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. This is a physical orthopedic implant, not an AI-assisted diagnostic or therapeutic device. No human-in-the-loop performance or reader studies were conducted or are relevant for this type of device.

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

   • Not Applicable. This is a physical orthopedic implant. There is no algorithm.

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

   • Engineering Standards and Measurements. The "ground truth" for the performance tests (fatigue, sterilization) would be derived from:
     • Mechanical Properties: Compliance with established ISO/ASTM standards for orthopedic implants (e.g., fatigue limits for hip components).
     • Sterilization: Achievement of a specified Sterility Assurance Level (SAL) (e.g., 10^-6) as per ISO 11135 for EO sterilization.
     • Biocompatibility: Adherence to ISO 10993 for material safety. (Though not explicitly detailed as a test in this summary, it would have been part of the initial K161184/K172501 clearance).

7. The sample size for the training set:

   • Not Applicable. This is a physical device, not a machine learning model. There is no "training set."

8. How the ground truth for the training set was established:

   • Not Applicable. As there is no training set, this question is not relevant.

In summary: K191936 is a 510(k) submission for a change to an existing physical medical device. The "acceptance criteria" discussed are largely met by demonstrating (through materials characterization, design comparison, and specific engineering tests like fatigue and sterilization validation) that the new component is as safe and effective as the previously cleared predicate device. The framework for evaluating AI/SaMD does not directly apply here.

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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, 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.

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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, 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.

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