(22 days)
The HA Taperloc® Porous Femoral Stem & HA Taperloc® Porous Lateralized Femoral Stem are indicated for use for 1) Non-inflammatory 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; and 5) Revision procedures where other treatments or devices have failed.
The HA Taperloc® Porous Femoral Stems & HA Taperloc® Porous Lateralized Femoral Stems are the same as the predicate Taperloc® Femoral Stem (K921301), except for the additions of Hydroxyapatite Coating and additional sized femoral stems.
The provided text is a 510(k) premarket notification for a medical device (HA Taperloc® Porous Femoral Stems & HA Taperloc® Porous Lateralized Femoral Stems).
This document explicitly states there was NO clinical testing performed to establish substantial equivalence for this device.
Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies is not applicable or cannot be extracted from this document, as a clinical study was not conducted.
Here's what can be extracted based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated as this was a 510(k) submission primarily relying on substantial equivalence to a predicate device, not performance against predefined clinical criteria.
- Reported Device Performance: No clinical performance data is reported as no clinical testing was performed. The non-clinical testing focused on mechanical properties and deemed the device substantially equivalent to the predicate.
2. Sample size used for the test set and the data provenance:
- Not Applicable: No clinical test set was used because no clinical testing was performed.
- Non-Clinical Testing: "Mechanical Testing with an Engineering Justification" was performed, but specific sample sizes for these tests are not provided in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable: No clinical test set and thus no ground truth established by experts for a clinical comparison. Mechanical testing would have involved engineers and a review by the FDA.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable: No clinical test set.
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 device is a prosthetic hip joint stem, not an AI-assisted diagnostic or imaging device. There was no MRMC study conducted, and no AI component is described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable: This device is a prosthetic hip joint stem, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable: For the purposes of demonstrating substantial equivalence for this medical device, the "ground truth" was established through comparison of materials, design, sizing, and indications to a legally marketed predicate device (Taperloc® Femoral Stem K921301), and mechanical testing to ensure no new risks. No clinical ground truth (like pathology or outcomes data) was used in a clinical study.
8. The sample size for the training set:
- Not Applicable: No clinical study involving a training set was performed for this 510(k) submission.
9. How the ground truth for the training set was established:
- Not Applicable: No clinical study involving a training set was performed.
Summary of the basis for substantial equivalence for this device:
The "HA Taperloc® Porous Femoral Stems & HA Taperloc® Porous Lateralized Femoral Stems" achieved substantial equivalence based on:
- Device Description: Being "the same as the predicate Taperloc® Femoral Stem (K921301), except for the additions of Hydroxyapatite Coating and additional sized femoral stems."
- Indications for Use: Being the same as the predicate device.
- Summary of Technologies: Materials, design, sizing, and indications are "similar or identical to the predicate devices."
- Non-Clinical Testing: "Mechanical Testing with an Engineering Justification determined that the HA Taperloc® Porous Femoral Stems & HA Taperloc® Porous Lateralized Femoral Stems' components presented no new risks and were, therefore, substantially equivalent to the predicate device."
- Lack of Clinical Testing: Explicitly stated, "No clinical testing was provided as a basis for substantial equivalence."
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.