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Biolox® delta Option Ceramic Heads are indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components in cases of:

1. Non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis and traumatic arthritis.
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 by other techniques.
5. Revision procedures where other treatment or devices have failed.

Specific indications for compatible components that can be used with the above modular heads include:

Salvage/Oncology Hip and Total Femur System components are also indicated for cases of ligament deficiency, tumor resection, trauma and revision of unsuccessful osteotomy or arthrosis. (K974558, K002757, K021380, K033871)

Interlocking hip stems are indicated for non-cemented application in cases of revision, trauma, fracture, oncology or other situations where severe proximal bone loss may compromise the fixation and stability of a standard-type hip replacement prosthesis. (K990830, K042774)

The Biolox® delta Option component is a modular ceramic head with a Type I or 12/14 adapter sleeve, indicated for primary or revision hip arthroplasty. The material for the device is Transition-Toughened-Platelet Alumina (TTPA) 75% Alumina, 24% Zirconia and 1% Platelet. The highly polished spherical surface articulates with a polyethylene liner acetabular component. The modular head attaches to any Biomet metallic femoral stem with a Type 1 taper or a 12/14 taper, using the associated adapter sleeve. There have been no changes in design or part numbers since the original submission in K082996 and K093549 (size 44mm).

The scope of this submission is to incorporate Biomet's entire Biolox® deta Option Ceramic Heads under unified part numbers, Indications and Contraindications, Instructions for Use, labeling and packaging.

The provided document is a 510(k) premarket notification for a medical device, specifically Biolox® delta Option Ceramic Heads. It primarily focuses on establishing substantial equivalence to previously marketed predicate devices rather than proving the device meets specific acceptance criteria through a new clinical or non-clinical study for the current submission.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets them in the way a de novo or PMA submission might.

Here's a breakdown of why this information is not present and what the document does state:

1. A table of acceptance criteria and the reported device performance: This is not available. The document states "No additional mechanical testing was conducted since there are no design changes to the device since clearance, K082996 and K093549." This means new acceptance criteria and performance data for this submission were not generated because the device itself hasn't changed. The substantial equivalence is based on prior clearances.

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. No new test set data was generated for this submission.

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. No new test set data was generated for this submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No new test set data was generated for this submission.

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 pertains to a ceramic hip implant component, not an AI-assisted diagnostic or therapeutic device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This document pertains to a ceramic hip implant component, not an AI or algorithmic device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. No new clinical or performance data was generated for this submission.

8. The sample size for the training set: Not applicable. This document does not describe the development or testing of an algorithmic or AI device with a training set.

9. How the ground truth for the training set was established: Not applicable.

What the document does indicate regarding device performance and safety:

• Reliance on Predicate Devices: The core argument for substantial equivalence is that the Biolox® delta Option Ceramic Heads are technologically identical to previously cleared devices (K082996 and K093549).
• No Design Changes: The document explicitly states: "There have been no changes in design or part numbers since the original submission in K082996 and K093549 (size 44mm)." And later, "The technological characteristics of the Biolox® delta Option Ceramic Heads are the predicates. K082996 and K093549. There have been no changes to the devices since their original clearance..."
• No New Mechanical Testing: "No additional mechanical testing was conducted since there are no design changes to the device since clearance, K082996 and K093549."
• No Clinical Testing: "None provided as a basis for substantial equivalence."
• Minimal Changes: The only modifications mentioned for this specific submission are the addition of "traumatic arthritis" to the Indications for Use and a change in packaging to conform with K131684.
• Conclusion of Substantial Equivalence: Because there are no design changes and only minor labeling/packaging updates, the submission concludes: "thus no new risks of safety or efficacy have been introduced. The Biolox® delta Option Ceramic Heads remain substantially equivalent to the predicates and raise no new issues of safety or efficacy."

In summary, this 510(k) submission is a "me too" submission, where the manufacturer is seeking clearance for a device that is essentially the same as one already cleared. Therefore, the detailed performance data and acceptance criteria that would typically be associated with a novel device or significant modification are not part of this specific document. The "proof" of meeting acceptance criteria relies on the previous clearances of the predicate devices.

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