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Total hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabiliating hips damaged as a result of trauma, inflammatory joint disease such as theumatoria arthritis, or noninflammatory degenerative joint, disease (NIDID) or any of its composite diagnoses swater disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular not disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular ne transmatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic ... traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the remote of the manaly inpped capital stated hip, fracture of the pelvis; diastrophic variant; remote osteomyelitis with an extended drainage free period; nonunion; femoral ne trochanteric fractures of the proximal femur with head involvement that are unmanded fracture and other techniques; femoral osteolomy, or Girdlestone resection; fracture dislocation of the high other techniques; femoral osteotomy, or Girdlestone resection; fracture disloc correction of deformity.

The 28 mm. long Biolox Alumina Ceramic Femoral Head is manufactured from aluminum oxide (Al2O3), and it is designed for use with both titanium and cobalt chromium alloy femoral components with a 12/14 taper.

This document describes the 510(k) summary for the 28 mm. Long Biolox Alumina Ceramic Femoral Head.

Here's an analysis of the provided text to answer your questions regarding acceptance criteria and the study proving the device meets them:

1. Table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance

The document does not explicitly state the sample size for the mechanical testing or the specific data provenance (e.g., country of origin). It only mentions "Mechanical testing was performed according to the requirements in the ceramic femoral head draft guidance document." This implies the testing was conducted on a sufficient number of samples as dictated by the guidance, but the exact number isn't provided. The context suggests that the testing would have been conducted on new prototypes of the 28mm long Biolox Alumina Ceramic Femoral Head.

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

This information is not applicable to this type of device submission. The "ground truth" for a mechanical implant like a femoral head is established through objective engineering tests (e.g., fatigue, fracture toughness, wear) against established international standards and regulatory guidance documents. It doesn't involve human expert evaluation in the same way an AI diagnostic tool would.

4. Adjudication method for the test set

This is not applicable. Mechanical testing results are objective measurements (e.g., load at failure, displacement) and do not require human adjudication in the context of interpretation, unlike for diagnostic image analysis.

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

This is not applicable. This is a medical device for orthopedic implantation, not an AI diagnostic tool. No human readers or AI assistance are involved in its primary function or evaluation for market clearance.

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

This is not applicable. This is a physical medical implant, not a software algorithm.

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

The "ground truth" for this device's performance is based on objective mechanical testing against established industry standards and regulatory guidance documents (e.g., for strength, fatigue, wear resistance) to demonstrate its ability to withstand in vivo loading without failure and its equivalence to predicate devices.

8. The sample size for the training set

This is not applicable. There is no "training set" in the context of a mechanical medical device submission like this. The device performance is assessed through direct physical testing, not machine learning.

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

This is not applicable as there is no training set for this type of device.

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Total hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic variant; old, remote osteomyelitis with an extended drainage-free period; nonunion; femoral neck fracture and trochanteric fractures of the proximal femur with heads involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity.

The Biolox Alumina Ceramic Femoral Head is designed for single use only.

The Biolox Alumina Ceramic Femoral Head is manufactured from aluminum oxide, Al2O3 and is designed for use with both titanium and cobalt chromium alloy femoral components with a 12/14 taper. The 28 long size will not be marketed in the USA for use with a Co-Cr-Mo taper.

The provided text describes the "Biolox Alumina Ceramic Femoral Head" device and its 510(k) submission. However, it does not include detailed information about acceptance criteria, the specific study proving the device meets those criteria, sample sizes for test/training sets, expert qualifications, or adjudication methods in the way typically expected for a medical device performance study, especially for AI/algorithm-driven devices.

The text focuses on demonstrating substantial equivalence to a predicate device based on material characteristics and mechanical testing according to a "ceramic femoral head draft guidance document."

Here's an attempt to extract and synthesize the information based on the provided text, acknowledging where information is missing for your specific request points:

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

The document states that "Mechanical testing was performed according to the requirements in the ceramic femoral head draft guidance document," and "All of the test results indicate that the Biolox Alumina Ceramic Femoral Head is equivalent to devices currently on the market and capable of withstanding without failure."

This implies the acceptance criteria were defined by the "ceramic femoral head draft guidance document" for mechanical properties, and the device met them by demonstrating "equivalence" and "withstanding without failure." However, the specific numerical criteria or performance metrics are not detailed in the provided text.

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

The text mentions "mechanical testing," which typically involves physical samples. It does not specify the number of femoral heads tested (sample size) or any "data provenance" in terms of clinical trial data or patient demographics, as this is a materials/mechanical performance submission, not a clinical efficacy study with 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)

This information is not applicable and not present in the document. The "ground truth" for mechanical testing would be the physical properties and failure points observed, not expert interpretation.

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

This is not applicable and not present. Adjudication methods are typically used for subjective assessments (e.g., image interpretation), not for objective mechanical testing.

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

This is not applicable. The device is a physical ceramic femoral head, not an AI-driven diagnostic or assistive tool for human readers.

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

This is not applicable. The device is a physical ceramic femoral head, not an algorithm.

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

The "ground truth" implicitly used for this device's performance assessment is mechanical engineering principles and established standards for material strength and wear resistance, as outlined in the "ceramic femoral head draft guidance document." It's based on objective physical measurements, not expert consensus or biological outcomes in this context.

8. The sample size for the training set

This is not applicable. The device is not an AI/ML model that requires a training set.

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

This is not applicable. The device is not an AI/ML model.

Ask a specific question about this device