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The b-ONE® Total Hip System is intended for primary or revision total hip replacement in skeletally mature patients with a severely disabled hip joint and/or hip damage due to the following conditions: Osteoarthritis, traumatic arthritis, avascular necrosis of the femoral head, noninflammatory degenerative joint disease (NIDJD), slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis and congenital dysplasia: treatments of nonunion, acute traumatic fracture of the femoral head or neck; failed endoprosthesis, femoral osteotomy, or Girdlestone resection: and fracture-dislocation of the hip.

The b-ONE® Total Hip System KOSMO™ HA coated stems and Grit-Blasted stems are intended for cementless use only.

The b-ONE® Total Hip System KOSMO™ Stainless Steel stems are intended for cemented use only.

The b-ONE® Cement Restrictor is intended to restrict bone cement migration into the distal medullary canal and aid in cement pressurization during total hip arthroplasty.

b-ONE® Total Hip System components are not intended for use with other total hip systems.

b-ONE Total Hip System KOSMO Femoral Stem consists of cementless and cemented bone compacting stem options. The b-ONE KOSMO Femoral Stems Sizes are offered in 12 femoral stem sizes ranging from size 0 to 10 with half size of 4.5 for Cementless Collared Standard, High, and Proportional Offset families and 11 femoral stem sizes ranging from size 1 to 10 with half size of 4.5 for Cementless Collarless/Collared Coxa Vara families and Cemented Standard and Proportional Offset families.

The subject stems are laser marked with the catalog number, company logo, size, and material. The KOSMO Femoral Stem is composed of titanium alloy Ti-6A1-4V-ELI (ASTM F136) for cementless stems and Stainless Steel (ASTM F1586) for cemented stems. The cementless stems are offered as either HA coated or Grit-blasted.

The b-ONE Cement Restrictor is made from UHMWPE (ASTM F648/ISO 5834-1). The restrictor is offered in 7 different sizes with a major diameter of 9, 11, 13, 15, 17, 20, and 23mm and have a total length of 17mm. The cement restrictor is to be used for cement implantation. This b-One Cement Restrictor is intended to restrict bone cement migration into the distal medullary canal and aid in cement pressurization during total hip arthroplasty.

I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets acceptance criteria. The document is an FDA 510(k) clearance letter for the b-ONE® Total Hip System, which primarily discusses the substantial equivalence of the subject device to legally marketed predicate devices.

The content focuses on:

• The FDA's decision regarding the 510(k) submission (K240528).
• Regulatory information, classifications, and requirements for the device.
• Indications for Use for the b-ONE® Total Hip System.
• A comparison of technological characteristics with predicate devices.
• A list of non-clinical performance tests conducted, but not the acceptance criteria for these tests, nor the detailed results proving they were met.

Therefore, I cannot fulfill your request to create a table of acceptance criteria and reported device performance, or describe the study details (sample size, ground truth, expert qualifications, adjudication, MRMC, or standalone performance) because that information is not present in the provided text.

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The indications for the Corin Metalix Hip Stem as a total hip arthroplasty and, when used in combination with Corin hemi-arthroplasty femoral heads, as a hemi-arthroplasty, include:

• · Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
• · Rheumatoid arthritis
• · Correction of functional deformity
• · Treatment of non-union, femoral neck and trochanteric fractures of the proximal femur
• · Developmental dysplasia of the hip (DDH) or congenital dysplasia of the hip (CDH)
  The Corin Metafix Hip Stem is intended for cementless, single use only.

The Metafix Hip is a tapered stem manufactured from titanium (Ti6Al4V) with a layer of hydroxyapatite (HA) Coating applied. The Metafix™ Hip is available in a 135° standard offset (collared and collarless), 135° lateralized high offset (collarless), a 125° standard offset (collared and collarless), a 125° short neck (collared) and a 135° short neck (collared). The device is intended to be used with 12/14 modular taper heads.

This document is a 510(k) premarket notification for a medical device called the Corin Metafix Hip Stem. It's an FDA submission, not a study report. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria and a study proving device performance.

The document discusses the device's intended use, indications, and claims of substantial equivalence to previously marketed predicate devices. It mentions that non-clinical mechanical fatigue testing and range of motion analysis were performed, but no clinical testing was deemed necessary to establish substantial equivalence.

Here's a breakdown of why this document cannot provide the requested information:

• Acceptance Criteria & Reported Performance: These are typically quantitative metrics set for a medical device's performance, often established in clinical trials or specific engineering tests. This document doesn't provide such a table.
• Sample Size (Test Set) & Data Provenance: This refers to the number of patients or samples used in a study to evaluate the device's performance. Since no clinical study was conducted for this submission, this information is not present.
• Number of Experts & Qualifications: This is relevant for studies where expert opinion is used to establish ground truth or evaluate outcomes. Not applicable here.
• Adjudication Method: Also relevant for studies involving human interpretation of data. Not applicable here.
• MRMC Comparative Effectiveness Study: This is a specific type of clinical study comparing human reader performance with and without AI. The device described, a hip stem, is a physical implant, not an AI or imaging device, so this type of study is irrelevant.
• Standalone Performance (Algorithm only): This refers to the performance of an AI algorithm without human involvement. Not applicable to a physical hip stem.
• Type of Ground Truth: This refers to the definitive determination of a condition or outcome in a study. Since no clinical study is presented, no ground truth is established in this document.
• Sample Size (Training Set) & Ground Truth for Training Set: This is relevant for AI/machine learning models where data is used to 'train' the algorithm. Not applicable to a physical hip stem.

In summary, this document is a regulatory submission for a hip implant, not a clinical or AI performance study. It does not contain the detailed information you requested about acceptance criteria and study data.

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The Corail AMT Hip Prosthesis is intended for use in total hip arthroplasty and is intended for press fit (uncemented) use. 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. A 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 arthroplasty, or total hip replacement.
5. Certain cases of ankylosis.
   The non-porous Corail AMT Hip Stem is indicated for cementless use only.

The Corail AMT Hip Prosthesis is a collarless, hydroxyapatite coated titanium alloy femoral stem. The Corail AMT Hip Prosthesis is similar to the previously cleared Corail AMT Hip Prostheses but has a shorter stem length, shorter neck length and smaller cross-section. The Corail AMT Hip Prostheses is contraindicated in patients weighing more than 84 lbs.

The provided text is a government regulatory document (510(k) premarket notification summary) for a medical device, the DePuy Corail AMT Hip Prosthesis. This type of document focuses on establishing substantial equivalence to a previously cleared device, rather than providing a detailed study demonstrating performance against specific acceptance criteria.

Therefore, the document does not contain the kind of information typically found in a clinical study report that would establish acceptance criteria and prove a device meets them in the way the request implies (e.g., using metrics like sensitivity, specificity, or reader improvement with AI).

Here's an breakdown based on the provided text, highlighting what is (and isn't) present:

Acceptance Criteria and Device Performance (Not directly addressed in this document)

This document does not present a table of acceptance criteria and reported device performance in the form of a clinical study outcome. Instead, it relies on the concept of substantial equivalence. The "acceptance criteria" here implicitly refer to demonstrating that the new device is as safe and effective as a legally marketed predicate device.

The "reported device performance" is not quantified in the way a clinical trial would (e.g., success rates, complication rates from a new study). Rather, it's inferred from the design similarities and in vitro testing (fatigue testing mentioned implicitly).

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

As stated above, this document does not contain such a table. The "acceptance" is regulatory clearance based on substantial equivalence.

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

• Not applicable / Not provided. This document does not describe a clinical "test set" in the context of typical AI/medical device performance studies. The basis for substantial equivalence is primarily design similarity, materials, manufacturing methods, and in vitro fatigue testing, not human or patient data.

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 / Not provided. Ground truth establishment by experts is not a component of a 510(k) submission based on substantial equivalence for a hip prosthesis, unless there were specific clinical studies that are not detailed here.

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

• Not applicable / Not provided. Adjudication methods are relevant for studies where multiple observers interpret data; this is not the nature of the evidence presented for this device.

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. This is a hip prosthesis, not an AI-assisted diagnostic device. Therefore, no MRMC study or AI-related effectiveness is discussed.

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

• No. This is a physical medical device, not an algorithm.

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

• Not applicable in the typical sense. For this device, the "ground truth" for demonstrating safety and effectiveness implicitly relies on the long-term clinical performance and regulatory clearance of the predicate device. The demonstration of substantial equivalence focuses on showing that the new device (Corail AMT Hip Prosthesis) is similar enough to the predicate (previously cleared Corail AMT Hip Prostheses and DePuy S-Rom Femoral Hip Stem) in design, materials, manufacturing, and intended use as to raise no new questions of safety and effectiveness. The in vitro fatigue testing serves as a basis to show mechanical performance.

8. The sample size for the training set

• Not applicable / Not provided. This is not an AI/machine learning device.

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

• Not applicable / Not provided. This is not an AI/machine learning device.

Summary Regarding the Provided Document:

The provided text, a 510(k) summary, demonstrates the device meets regulatory requirements by establishing substantial equivalence to existing, legally marketed devices. This process does not typically involve the kind of rigorous clinical studies with explicit acceptance criteria, ground truth establishment by experts, or sample sizes for test/training sets as one would expect for an AI/diagnostic device or a PMA submission for a novel device. The "study" mentioned is primarily a comparison to predicate devices and in vitro fatigue testing to support the claim of equivalence.

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