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1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis
2. Rheumatoid arthritis
3. Correction of functional deformity
4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques
5. Revision of previously failed total hip arthroplasty

The subject devices, Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeves, are cylindrical components designed to slide onto the distal end of a cemented femoral stem prior to insertion into the femoral canal.

This submission proposes a new bioburden reduction manufacturing process that includes a new contact material for the Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve.

The provided document is a 510(k) summary for the Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving that a device meets specific acceptance criteria through a study with performance metrics in the way one might expect for a diagnostic AI or imaging device.

Therefore, the requested information, particularly regarding acceptance criteria performance, sample sizes for test/training sets, expert consensus, adjudication methods, MRMC studies, standalone performance, and ground truth types and establishment, is not applicable to this type of submission. This submission is for a physical medical device (a hip prosthesis component) and its substantial equivalence is based on technological characteristics and biocompatibility.

Here's a breakdown of what can be extracted and what is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: For this 510(k) submission, the "acceptance criteria" are not reported as specific performance metrics (e.g., sensitivity, specificity). Instead, they are implied by demonstrating substantial equivalence to a predicate device (K193546 Distal Centralizers). The criteria revolve around showing that the new device shares similar technological characteristics (intended use, indications for use, materials, design features, sterilization) and biocompatibility with the predicate.
• Reported Device Performance:
  • Non-Clinical Tests: A biocompatibility assessment was performed in accordance with ISO 10993-1. The data confirmed the biocompatibility of the candidate manufacturing process flow for the device in long-term contact with patient bone and tissues. No specific numerical performance metrics are provided, as this is a qualitative assessment of biocompatibility.
  • Clinical Tests: None were provided for this submission.

2. Sample Size Used for the Test Set and Data Provenance

• Not Applicable. This submission does not involve a "test set" in the context of evaluating an algorithm or AI. The biocompatibility assessment is a laboratory test on device materials, not a study on a human subject population with a test set of data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not Applicable. Ground truth in the context of expert consensus for diagnostics is not relevant here. Biocompatibility assessment relies on standardized testing procedures and interpretation by qualified laboratory personnel.

4. Adjudication Method for the Test Set

• Not Applicable. No test set or expert adjudication is involved.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• Not Applicable. This is a physical device, not an AI or diagnostic tool that would involve human readers.

6. If a Standalone Performance (Algorithm Only) Was Done

• Not Applicable. This is a physical device, not an algorithm.

7. The Type of Ground Truth Used

• Not Applicable. For the biocompatibility assessment, "ground truth" would be established by the results of the ISO 10993-1 tests themselves, interpreted against the standard's requirements. This is not "expert consensus," "pathology," or "outcomes data" in the typical sense applied to diagnostic performance.

8. The Sample Size for the Training Set

• Not Applicable. No training set is involved as this is not an AI/algorithm submission.

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

• Not Applicable. No training set is involved.

In summary, the provided document is a regulatory submission for a physical medical device, not a diagnostic or AI product. Therefore, most of the requested information about "acceptance criteria" and "studies" related to performance metrics, test/training sets, and expert evaluations is not applicable to this specific type of device and submission.

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1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
2. Rheumatoid arthritis
3. Correction of functional deformity
4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
5. Revision of previously failed total hip arthroplasty.

The subject devices, Distal Centralizers, are cylindrical components designed to slide onto the distal end of a cemented femoral stem prior to insertion into the femoral canal.

The provided text describes a 510(k) premarket notification for "Distal Centralizers" (K193546). This document is primarily focused on demonstrating substantial equivalence to a predicate device, specifically regarding a change in the bioburden reduction process. It is not a study proving device performance against acceptance criteria in the typical sense of a human-AI comparative study or a standalone algorithm performance study.

Therefore, many of the requested fields cannot be answered directly from this document because it's not a study about AI or human reader performance.

Here's an analysis based on the information available:

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

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

This document does not specify the sample size for the "Non-Clinical Tests" performed, nor does it provide information on data provenance. The tests are focused on the device itself (sterilization, shelf life, biocompatibility, geometry), not data from patients or users.

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. This is not a study requiring expert interpretation of results or establishment of ground truth in a clinical sense. The "ground truth" (or rather, the reference standards) for sterilization, biocompatibility, and geometric evaluations would be established through established scientific and engineering principles and testing protocols.

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

Not applicable. There is no mention of adjudication as this is not a study involving human interpretation or subjective assessment of clinical data.

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

No. An MRMC comparative effectiveness study was not done. The device (Distal Centralizers) is a physical medical implant, not an AI or imaging system.

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

Not applicable. This is not an algorithm or AI device. The "standalone" performance here would refer to the physical and material performance of the centralizers themselves under the new manufacturing process, which was evaluated through non-clinical testing.

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

For the non-clinical tests described:

• Sterilization: Ground truth is established by validated sterilization protocols and tests (e.g., sterility testing, bioburden reduction validation) that adhere to international standards.
• Shelf life: Ground truth is established by accelerated aging or real-time shelf life studies using accepted methodologies.
• Biocompatibility: Ground truth is established by standard biocompatibility testing protocols (e.g., ISO 10993 series) against a known safe biological response.
• Geometric Evaluation: Ground truth is established by engineering specifications and design tolerances.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. This is not an AI/machine learning device that requires a training set.

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The Exeter® V40™ Femoral Stem Hip System is intended for use in total or hemi hip replacement. It is intended for cemented use only.

The Exeter® V40TM Femoral Stem Hip System is indicated for:

· noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;

• · rheumatoid arthritis:
• · correction of functional deformity;

· revision procedures where other treatments or devices have failed; and,

· treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

The Exeter® V40™ Femoral Stems/Orthinox Femoral Heads are sterile, single-use components intended for cemented total and hemi-hip arthroplasty. The femoral stems have a tapered distal portion with a V40™ neck taper. The stems are available in various offsets and body sizer. The Exeter Hip System continues to be manufactured from the same materials, the same design and the same manufacturing process as the previously cleared Exeter® V40™ femoral stems.

The provided text describes a submission for a medical device called the "Exeter® V40™ Femoral Stem Hip System" to the FDA, seeking a determination of substantial equivalence (510(k)). However, the document does not contain information about acceptance criteria or a study that specifically proves the device meets such criteria in terms of performance metrics like sensitivity, specificity, accuracy, or any comparative effectiveness with human readers.

The document focuses on demonstrating substantial equivalence to predicate devices primarily through:

• Intended Use and Indications: Stating that the new device has similar intended uses and indications as the predicate devices.
• Technological Characteristics: Asserting that the materials, design, and operational principles are similar or identical to predicate devices.
• Non-Clinical Testing: Listing various laboratory tests performed, such as Range of Motion Analysis, Femoral Stem Neck and Body Fatigue (according to ISO standards), Bacterial Endotoxin Testing, and Magnetic Resonance Imaging Analysis. These tests are performed to show adherence to established engineering and safety standards, and material properties, rather than diagnostic or clinical performance metrics.
• Clinical Testing: Explicitly stating that "Clinical testing was not required as a basis for substantial equivalence."

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance related to diagnostic accuracy, nor can I provide information about sample sizes for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, as these items are typically associated with performance evaluations of diagnostic or AI-driven devices, which is not the subject of this 510(k) submission.

The document's purpose is to show that a new version or extension of an existing hip implant system is substantially equivalent to previously cleared devices, meaning it doesn't raise new questions of safety or effectiveness. It does not describe a study to measure the performance of a diagnostic or therapeutic device against specific clinical or computational acceptance criteria.

If you have a different document that details such a study, I would be happy to analyze it.

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• 1. Joint impairment from arthritis (rheumatoid, osteo and post traumatic).
• 2. Revision of failed femoral head replacements.
• 3. When alternative reconstructive techniques are not viable.
• 4. . When arthrodesis is contraindicated.
• 5. Avascular necrosis or fracture of the femoral head.
• 6. Congenital defects that will allow adequate function of the system.

Progeny Forged CoCr Cemented Femoral Component

I am sorry, but the provided text is a decision letter from the FDA regarding a 510(k) premarket notification for a medical device (Progeny Forged CoCr Cemented Femoral Component).

This document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. It primarily indicates that the device has been found substantially equivalent to a legally marketed predicate device and can proceed to market.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

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Relief of pain and restoration of hip function following the effects of osteo, theumatoid and inflammatory arthritis, post-trauma disease, avascular necrosis, and total hip revision. These femoral stems are intended for use with bone cement.

The Taper-Fit Total Hip System consists of 4 sizes of stem. For each stem size there are 2 offsets 38 mm & 45 mm. A CDH stem is also available with a 36 mm offset. The modular stem is manufactured from Stainless Steel in accordance with BS 7251 Pt 9 -Specification for High Nitrogen Stainless Steel and is provided with a Polymethylmethacrylate Stem Centralizer. The devices are used to resurface femoral hip joints and reinstate function following the degenerative effects of osteo and theumatoid arthritis, post trauma disease, avascular neurosis and septic/aseptic total hip revision. The stem is double tapered, collarless and highly polished. The stem is used with a 316L Stainless Steel Modular Head. This stainless steel complying to BS 7252 Pt 1: 1997, ISO 5832-1:1997 Metallic Materials for Surgical Implants, Part 1. Specification for Wrought Stainless Steel.

The provided text describes a 510(k) submission for the Corin Taper-Fit Total Hip System, a medical device. However, it does not contain information about acceptance criteria, device performance metrics, or the details of any study conducted to prove the device meets specific criteria.

The document details:

• The device's name and manufacturer.
• A description of the device components (stem, offsets, material).
• The intended use (relief of pain and restoration of hip function due to various conditions like arthritis, trauma, avascular necrosis, and total hip revision).
• The FDA's substantial equivalence determination, allowing the device to be marketed.
• Regulatory classifications and requirements.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance or details about a study to prove acceptance criteria, as this information is not present in the provided text. The document is a regulatory approval letter, not a performance study report.

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The Exactech AuRA Calcar Replacement Femoral Stem is indicated for use in skeletally mature patients in whom the calcar region is missing due to a failed previous total hip replacement as a result of osteoarthritis, osteonecrosis , rheumatoid arthritis or congenital hip dysplasia. It is also potentially indicated for use in post-traumatic degenerative problems. FOR CEMENTED USE ONLY

The collar of the calcar replacement stem differentiates itself from all other cemented femoral components in that it provides a horizontal and vertical collar type platform for the best load transfer in a compromised femoral situation. A cemented primary or long stem device typically has a collar designed at some angle to the femoral centerline whereby a bone loading platform can be established at the optimum resection location. In many instances, this ideal position has been compromised and an implant surface that is horizontally perpendicular to and vertically parallel to the femoral centerline is preferred for optimal axial load transfer to the bone and appropriate trochanteric fixation can be achieved. The surface finish is dominated by an overall satin, glass bead blast everywhere except on the taper. A secondary grit blast is performed on portions of the proximal region of the implant. A complete instrumentation and trial system is available to assist in accurate implantation of the AuRATM Calcar Replacement Femoral Stem.

The provided text describes a medical device, the AuRA™ Hip System Calcar Replacement Femoral Stem, and its regulatory submission (K962002). However, it does not contain information regarding an acceptance criteria table, device performance data, or a study specifically designed to compare against acceptance criteria.

The document focuses on demonstrating substantial equivalence to pre-amendment devices and other legally marketed devices, primarily through:

• Device Description and Design Rationale: Highlighting features like material, surface finish, and collar design.
• Similarities/Dissimilarities to a Predicate Device (Howmedica hnr Hip System): Comparing material, design elements, and sizes.
• Material Specifications: Referring to ASTM standards for forged cobalt chrome.
• Mechanical Testing: Stating that forged cobalt chromium exhibits specific mechanical properties and that "fatigue testing results have been favorable for this type of device."
• Biocompatibility: Citing ASTM F799-95 for evaluation of biocompatibility and corrosion resistance.
• Sterilization: Describing the sterilization method (gamma irradiation) and adherence to AAMI guidelines.
• Utilization of Implantation, Indications, and Contraindications.

Therefore, I cannot fulfill your request for: "A table of acceptance criteria and the reported device performance," nor can I provide details about the specific study that proves the device meets those criteria, as this information is not present in the provided text.

The document's intent is to establish substantial equivalence based on material, design, and general mechanical properties, rather than present a study with specific performance metrics against defined acceptance criteria for a new, novel AI or diagnostic device.

To directly answer your specific numbered questions based on the lack of this information in the provided text:

1. A table of acceptance criteria and the reported device performance: Not provided in the text.
2. Sample size used for the test set and the data provenance: Not applicable, as no such test set or study is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no such test set or study is described.
4. Adjudication method for the test set: Not applicable, as no such test set or study is described.
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 document is about a hip implant, not an AI or diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This document is about a hip implant, not an AI or diagnostic device.
7. The type of ground truth used: Not applicable, as no such test is described. The "ground truth" for a hip implant's equivalence relies on material properties, design comparison, and clinical history of similar devices.
8. The sample size for the training set: Not applicable, as no "training set" in the context of an AI/diagnostic algorithm is relevant to this device submission.
9. How the ground truth for the training set was established: Not applicable, as no "training set" or "ground truth" in the context of an AI/diagnostic algorithm is relevant to this device submission.

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