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The Minima S System is indicated for use in partial or total hip arthroplasty and is intended for press-fit (uncemented) use. When used in total hip arthroplasty, the Minima S Stems are intended for use with compatible femoral heads and acetabular components. When used in partial hip arthroplasty, the Minima S stems are intended for use with Lock Bipolar Heads. Hip arthroplasty is intended for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

• non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis and hip dysplasia;
• rheumatoid arthritis;
• treatment of femoral head and neck fractures; .
• revisions in cases of good remaining femoral bone stock.

The Minima S System is intended for partial or total hip arthroplasty in cementless use. It is a monolithic collarless stem available in 9 sizes (#4-#12) in standard and lateralized versions.
When used in total hip arthroplasty Minima S stems are coupled to:

• Biolox Delta femoral heads (object of this submission) or Limacorporate Femoral Heads (K112158) articulating with Limacorporate Cemented Cups (K112158) or
• Biolox Delta heads (object of this submission) or Limacorporate Femoral Heads (K112158) articulating with Delta TT Acetabular System (K112898).
  When used in partial hip arthroplasty the Minima S femoral stem is coupled to Lock Bipolar Heads (Limacorporate K112158).
  The Minima S stem is made of Ti6Al4V and it has a plasma sprayed titanium coating in the proximal area (ASTM F1472 - ISO 5832-3). The stem is characterized by a 12/14 conical taper to be coupled to Limacorporate Femoral Heads, Biolox Delta femoral heads or Lock Bipolar Heads. In addition necks are lowered to reduce accidental contact between stem and acetabular cups and they are mirror-polished to reduce abrasion of the UHMWPE cups in case of abnormal contact. The stem has a rectangular section and is characterized by a "V" shaped A-P profile to improve adaptability to the most common bone morphologies and to facilitate insertion of the stem in the canal.
  The Minima S System stems is available in standard and lateralized versions with different CCD angles (131° and 134°), offsets and stem lengths.
  Biolox Delta Heads devices are used by surgeons to replace the head of the femur during total or partial hip surgery. They are characterized by a spherical shape and are coupled with the acetabular cup (K112158, K112898) inserted in the acetabulum, in total hip replacement, or with Lock Bipolar Heads (K112158) in partial hip replacement.
  Biolox Delta heads are coupled with the Minima S stems by means of a 12/14 Morse taper. Biolox Delta heads are made of Biolox Delta ceramic and are available with 28, 32 and 36 mm of diameters and in sizes (offsets) S, M, L and XL (XL size available only for head size 36).

This document is a 510(k) premarket notification for the Minima S System, a hip replacement device. It primarily focuses on demonstrating substantial equivalence to previously marketed devices rather than presenting the results of a primary clinical study for the Minima S System itself. As such, information regarding acceptance criteria, device performance, and study design elements typically found in a clinical trial report is not present in this document for the Minima S System.

However, the document does describe non-clinical testing performed to demonstrate substantial equivalence. Based on the provided text, here's an analysis of the relevant sections, acknowledging that many requested fields cannot be filled due to the nature of this submission:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document states that the non-clinical tests demonstrated the devices' ability to perform under expected clinical conditions, implying that the acceptance criteria for these tests were met. However, the specific quantitative pass/fail criteria (e.g., maximum deflection, number of cycles survived, minimum pull-out force values, specific burst pressure) are not detailed in this summary.

Information Not Available or Not Applicable Based on the Provided Document:

The following information is specifically requested for "the study that proves the device meets the acceptance criteria." Since this document details a 510(k) submission based on substantial equivalence and non-clinical testing, and explicitly states "Clinical testing was not necessary," most of the requested fields related to clinical studies, human reader performance, and ground truth establishment from patient data are not applicable and are therefore left blank or marked as "N/A."

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

   • Sample Size: Not specified for the non-clinical tests. Non-clinical mechanical tests typically use a smaller number of physical samples (e.g., n=3 or n=6 per test condition) rather than a "test set" of patient data.
   • Data Provenance: N/A (Non-clinical mechanical testing).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (No clinical test set requiring expert ground truth in this document).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A (No clinical test set requiring adjudication in this document).

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 refers to a hip replacement system, not an AI diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This document refers to a hip replacement system, not an AI diagnostic device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): N/A. For the non-clinical tests, the "ground truth" would be the engineering specifications and performance limits defined by the referenced ISO standards and FDA guidance documents.

8. The sample size for the training set: Not applicable. This document refers to non-clinical testing for a physical medical device, not a machine learning model.

9. How the ground truth for the training set was established: Not applicable. This document refers to non-clinical testing for a physical medical device.

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The EXp Acetabular Shell Liner is intended for use in reconstruction of the articulating surface of the acetabular portion of the hip that is severely disabled and/or very painful resulting from:

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.
5. Revision of previously failed total hip Arthroplasty.
   Cemented and Uncemented Applications

The EXp Acetabular Shell Liner is made of polyethylene to which Vitamin E has been added. It is available in both hooded and non-hooded options. The liner is part of a complete total hip system and will be used in conjunction with an acetabular shell, femoral head and femoral stem in total hip arthroplasty. The femoral heads which are to be mated with the EXp Liner are made of Biolox forte, Biolox Delta, or CoCr alloy.

The provided text describes a 510(k) summary for the EXp Acetabular Shell Liner. This documentation focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing rather than conducting a controlled clinical study with acceptance criteria often seen in AI/ML device submissions. Therefore, many of the requested elements for AI/ML device evaluation (like sample sizes for test sets, expert ground truth, MRMC studies, training set details) are not applicable or present in this specific type of submission.

However, I can extract and structure the information related to the performance claims and the studies that support them.

Acceptance Criteria and Study for EXp Acetabular Shell Liner

The submission details several claims regarding the oxidative stability and mechanical performance of the EXp material and the EXp liners, which can be interpreted as the performance goals or "acceptance criteria" for the device to be deemed substantially equivalent. The "reported device performance" are the results of the non-clinical tests conducted to support these claims.

1. Table of Acceptance Criteria and Reported Device Performance

• Maximum ASTM F2102 oxidation index for EXp: increased from 0.1 ± 0.02 to 0.2.
• Maximum ASTM F2102 oxidation index for conventional GUR1050: increased from 0.1 ± 0.04 to 3.8 ± 0.2.
• Ultimate load for EXp (ASTM F2183): remained constant (63.3 ± 8.9 N non-aged, 73.1 ± 5.2 N 4-week-aged).
• Ultimate load for conventional GUR1050: decreased from 71.5 ± 3.0 N (non-aged) to an embrittled condition (no sample could be machined after 4 weeks; 45.7 ± 5.9 N after 2 weeks). |
  | Morphology of EXp UHMWPE is consistent with conventional UHMWPE.
  Criteria: No consolidation defects or voids when imaged at high magnification under scanning electron microscopy. | Freeze fracture analysis and scanning electron microscopy showed both EXp UHMWPE and 25kGy GUR 1050 material demonstrated no consolidation defects or voids at high magnification. |
  | Vitamin E blended into EXp UHMWPE does not elute from the material.
  Criteria: No Vitamin E detected in hexane or isopropanol (IPA) extracts using GC-MS and LC-MS. | GC-MS and LC-MS analysis confirmed no Vitamin E was extracted from EXp material when refluxed in hexane at 74°C for 24 hours (detection limits: 50-250 ppb) or soaked in IPA at room temperature for 18 hours (detection limits: 1000 ppm). |
  | EXp liners remain resistant to oxidation after 5 million cycles of wear testing and artificial aging.
  Criteria: Resistance to oxidation (per ASTM F2102) after wear testing (ISO 14242-1) followed by accelerated aging (ASTM F2003). | After 5 million cycles of wear testing (ISO 14242-1) and subsequent 4 weeks of oxidative aging (ASTM F2003):
• Maximum oxidation index (ASTM F2102) for EXp liners: increased from 0.1 ± 0.02 (non-aged EXp material) to 0.2 ± 0.02 (4-week-aged EXp material). |
  | EXp liners experience no failures from dynamic impingement testing.
  Criteria: Resistance to rim fracture under fatigue loading conditions to 1.0 MC (million cycles) per ASTM F2582, with no failure of the locking mechanism. | Dynamic impingement testing per ASTM F2582:
• Three (3) artificially aged EXp liners were loaded to engage the rim with the femoral neck at 4.6 Nm (70% of static peak dislocation moments).
• All three samples reached run-out (1.0 MC) with no fractures observed and no failure of the locking mechanism. |

Regarding the other requested information, which is more relevant to AI/ML device studies:

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. This submission is for a physical medical device (acetabular liner) and relies on non-clinical, in vitro, and mechanical bench testing, not data analysis from patient studies. The "samples" refer to physical specimens of the material or device.

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. Ground truth in this context is established by standardized physical, chemical, and mechanical testing protocols (e.g., ASTM, ISO standards), not human expert consensus on images or clinical data.

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

• Not applicable. Adjudication methods are typically for subjective assessments or discrepancy resolution in clinical or image-based studies. This submission relies on objective physical measurements.

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 is a physical device, not an AI/ML diagnostic or assistive tool.

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

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

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

• The "ground truth" for the performance claims is derived from standardized physical and chemical measurements according to established industry standards (e.g., ASTM F2183, ASTM F2003, ASTM F2102, ISO 14242-1, ASTM F2582).

8. The sample size for the training set

• Not applicable. This device does not involve a "training set" in the context of AI/ML or statistical modeling. The material properties are inherent to its manufacturing process and composition.

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

• Not applicable. As above, no training set is described for this physical device.

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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 or noninflammatory degenerative joint disease (NiDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, 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, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia, treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.

Subject of this Traditional Premarket Notification are Biolox Delta Ceramic Femoral Head line additions. The subject devices are ceramic femoral head components which are intended to be used in conjunction with existing Smith & Nephew 12/14 taper hip stems, and they are intended to articulate against appropriately sized, existing XLPE acetabular liners. The Biolox Delta Ceramic Femoral Heads are manufactured from Biolox delta ceramic material and will be offered in sizes 40 and 44mm with offsets of 0, +4, and +8mm.

Biolox Detta Ceramic Femoral Heads in smaller sizes (28, 32, and 36mm) have previously been cleared for market via premarket notification K083762. The only difference between the subject Biolox Delta Ceramic Femoral Heads and those cleared via K083762 is the size offering: the subject devices are offered with a larger diameter than the predicate devices. All other design features, including material choice, taper design, and articular surface finish, are identical. Additionally, Biolox Delta Ceramic Femoral Heads in the same size range have previously been cleared for market via K082844.

Here's an analysis of the provided text regarding the Biolox Delta Ceramic Femoral Heads, structured to address your specific questions.

It's important to note that this document is a 510(k) Premarket Notification summary for a medical device (femoral heads), not an AI/ML medical device. Therefore, many of the questions related to AI/ML specific concepts (like multi-reader multi-case studies, ground truth establishment for a training set, sample sizes for test/training sets in an AI context) are not applicable. The device's "performance" in this context refers to its mechanical and material properties, not diagnostic accuracy or predictive power.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states: "A review of the testing has demonstrated that there are no new issues related to the safety or effectiveness of the subject devices." This implicitly means the device met the acceptance criteria derived from the referenced guidance documents. Specific numerical acceptance criteria or detailed test results are not provided in this summary, which is typical for a 510(k) summary. The acceptance criteria would be defined within the full test reports, per the cited FDA guidance documents.

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

• Sample Size: Not explicitly stated. The document refers to "Performance testing has been conducted" and evaluates various mechanical properties (burst, fatigue, wear, etc.). These tests typically involve a specific number of samples for each test type, based on engineering standards and statistical power requirements, but these numbers are not disclosed in this summary.
• Data Provenance: The data is from in-vitro mechanical and material performance testing conducted by Smith & Nephew, Inc. at their facilities, or by contract labs following established test methods. This is not patient data; it's device performance data.

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

• This question is not applicable to this type of device and study. "Ground truth" in the context of this device refers to the physical and mechanical properties being measured, compared against established engineering standards and predicate device performance. It doesn't involve expert consensus on diagnoses or interpretations of medical images. The "experts" would be the engineers and technicians performing and reviewing the materials and mechanical testing.

4. Adjudication method for the test set

• This question is not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical studies or expert review processes, typically for evaluating diagnostic accuracy or clinical outcomes. This document describes mechanical performance testing, not a clinical trial or expert review of clinical cases.

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 question is not applicable. This device is a ceramic femoral head (joint implant), not an AI/ML software device for diagnostic assistance. Therefore, an MRMC study related to human readers and AI assistance is irrelevant.

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

• This question is not applicable. This device is a physical implant, not an algorithm or software. "Standalone performance" in this context would refer to the device's mechanical integrity under simulated physiological conditions, which is what the performance testing ("femoral head burst, femoral head fatigue, wear performance," etc.) evaluated.

7. The type of ground truth used

• The "ground truth" for this device's performance is based on accepted engineering standards, material specifications, and the performance of legally marketed predicate devices.
  • Expert Consensus: Not in the sense of clinical experts, but rather consensus within the engineering community on test methods and material properties.
  • Pathology: Not applicable.
  • Outcomes Data: Not directly used as "ground truth" for the device performance tests described (which are primarily mechanical). Clinical outcomes would be observed post-market or in clinical trials, but this 510(k) relies on non-clinical performance data and substantial equivalence to predicates.

8. The sample size for the training set

• This question is not applicable. The device is a physical product, not an AI/ML model that requires a "training set" of data.

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

• This question is not applicable for the same reasons as point 8.

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