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Monolithic cementless stems are indicated for use in partial or total hip arthroplasty and they are intended for press-fit (uncemented) use.

When used in total hip arthroplasty, monolithic cementless stems are with modular heads and compatible acetabular cups.

When used in partial hip arthroplasty, they are intended for use with 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 including osteoarthritis, avascular necrosis and dysplasia;

• rheumatoid arthritis;

· revisions in cases of good remaining femoral bone stock;

· treatment of femoral head and neck fractures.

The C2 femoral stem is intended for partial or total hip arthroplasty in cementless use in primary or revision cases. It is a monolithic collarless stem available in 14 sizes for both standard and lateralized versions and 8 sizes in revision version.

When used in total hip arthroplasty C2 femoral stems are coupled to previously cleared Limacorporate components:

• . Biolox Delta femoral heads or Limacorporate Femoral Heads articulating with Limacorporate Cemented Cups or
• Biolox Delta heads or Limacorporate Femoral Heads articulating with Delta TT ● Acetabular System.

When used in partial hip arthroplasty the C2 femoral stem is coupled to previously cleared Limacorporate Lock Bipolar Heads.

The C2 femoral stem is made of Ti6Al4V conforming to the specifications 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 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 C2 femoral stem is suitable for both first implant and revision versions. The first implant versions are available in standard and lateralized versions with different CCD angles (131° and 134°), offsets and stem lengths.

This document is a 510(k) premarket notification for a medical device called the "C2 femoral stem." It is a submission to the FDA to demonstrate substantial equivalence to previously marketed devices. Therefore, it does not describe an AI/ML powered device, an acceptance criteria table with reported device performance, or a study to prove an AI/ML device meets acceptance criteria.

The document details the device's intended use, description, and comparison to predicate devices, and refers to non-clinical testing for fatigue resistance as part of demonstrating substantial equivalence.

Here's the information that is available in the document, which primarily focuses on the regulatory submission process for a traditional medical device:

1. A table of acceptance criteria and the reported device performance:
* Not Applicable. This document is for a traditional medical device (a femoral stem implant), not an AI/ML powered device. Therefore, no acceptance criteria for AI/ML performance metrics (like sensitivity, specificity, AUC) are presented.
* The document mentions fatigue resistance tests according to ISO 7206-4 and ISO 7206-6. It states, "The tests results demonstrated the device's ability to perform under expected clinical conditions." However, no specific quantitative acceptance criteria or reported performance values (e.g., cycles to failure, load limits) are provided in this summary.

2. Sample size used for the test set and the data provenance:
* Not Applicable for an AI/ML test set. For the non-clinical fatigue testing, the document states, "All mechanical tests were performed on worst case components or constructs." The specific number of samples (e.g., number of stems tested) for these mechanical tests is not disclosed in this summary. Data provenance is not relevant in the context of these physical component tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Not Applicable. This is not an AI/ML device requiring expert-established ground truth.

4. Adjudication method for the test set:
* Not Applicable. This is not an AI/ML 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:
* Not Applicable. This is not an AI/ML device and therefore no MRMC study was conducted or is relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Not Applicable. This is not an AI/ML device.

7. The type of ground truth used:
* For the non-clinical fatigue testing, the "ground truth" would be the engineering specifications and ISO standards (ISO 7206-4, ISO 7206-6) for fatigue performance. Meeting these standards demonstrates the device's mechanical integrity.

8. The sample size for the training set:
* Not Applicable. This is not an AI/ML device, so there is no training set.

9. How the ground truth for the training set was established:
* Not Applicable. This is not an AI/ML device.

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The H-MAX S Femoral Hip System consists of the H-MAX S femoral stem, a modular femoral head, and an acetabular cup. In total hip arthroplasty, the H-Max S Stems are intended for use with modular CoCrMo femoral heads or Biolox Delta ceramic femoral heads and a compatible Limacorporate Cemented Cup or uncemented Delta TT acetabular cup.

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;
• osteoarthritis after femoral heads fractures;
• revisions in cases of good remaining femoral bone stock.

The Limacorporate Cemented Cup is intended for cemented use in hip arthroplasty where the acetabular socket needs reconstruction. The Limacorporate Delta TT Cup is intended for uncemented use.

The H-MAX S Femoral Hip System consists of the H-MAX S femoral stem, a modular femoral head, and an acetabular cup. In total hip arthroplasty, the H-Max S Stems are intended for use with modular CoCrMo femoral heads or Biolox Delta ceramic femoral heads and a compatible Limacorporate Cemented Cup or uncemented Delta TT acetabular cup.

The H-MAX S femoral stem is a monolithic, cementless stem made from Ti6Al4V (ISO 5832-3. ASTM F1472). The external surface has a macro-roughened surface and a layer of hydroxyapatite is applied along the length of the stem. The H-MAX S stem is manufactured in 11 sizes for each of two configurations, standard and lateralizing, that vary in the CCD angle.

The Biolox Delta ceramic head is a modular femoral ceramic head with a female 12/14 taper for coupling to the male 12/14 taper of the H-Max S femoral stem. The Biolox Delta ceramic heads are available in diameters of 28, 32, and 36 mm in three (3) neck lengths (S, M, L); the 36 mm diameter head is also available with a XL neck length.

The Delta TT Cup is a hemi-spherical, 2-piece modular cup consisting of a metal shell and a polyethylene liner. The metal shell is manufactured using an EBM (Electron Beam Melting) process with titanium alloy powder (Ti6Al4V, ASTM F1472 - ISO 5832-3) producing a non-porous bulk interior surface with a Trabecular Titanium porous structure on the external surface. A polar threaded hole is used for attachment of an introducer instrument; the hole mates with the polar peg of the polyethylene liner when the liner is inserted into the cup. Three threaded holes in lateral positions allow additional fixation of the cup using bone screws; polyethylene plugs are used to fill the holes when bone screws are not required. The Delta TT Cup metal shell is coupled with a liner made of either conventional or cross-linked ultra high molecular weight polyethylene (UHMWPE) by means of a taper coupling. The Delta TT Cup metal shell is available in external diameters of 44, 46 and 48 mm, for use with Small liners; 50 and 52 mm, for use with Medium liners; and 54, 56, 58, 60, 62, 64, 66, 68, 70, 72, 74 and 76mm mm for use with Large liners. The polyethylene liners are available in three (3) sizes, Small, Medium and Large, with inner diameters of 28, 32, and 36mm.

Femoral head devices are used by surgeons to replace the head of the femur during total hip surgery. They are characterized by a spherical shape and are coupled with the acetabular cup inserted in the acetabulum.

The femoral heads are coupled with the H-Max S stems by means of a 12/14 Morse taper. Modular heads are made of CoCrMo (ASTM F1537) and are available in diameters of 28, 32 and 36 mm and in S. M. L and XL offsets.

Cemented cups are used to completely replace the acetabular cavity, using cement as the fixation agent. Cemented acetabular cups are manufactured entirely from UHMWPE (ASTM F648, ISO 5834-2). An AISI 316-L stainless steel ring is inserted in the equatorial region to allow the evaluation of the device position through radiography.

The acetabular cups are available in two different versions:

• standard
• protruded

The standard version is completely hemispherical and is designed for use in deep acetabula. The protruded version has a lateral portion which provides greater coverage of the femoral head to resist dislocation. The cemented cups are available with articular diameters of 28 and 32 mm.

The provided document is a 510(k) premarket notification letter from the FDA regarding a medical device, the H-MAX S Femoral Hip System. This type of document focuses on establishing substantial equivalence to existing legally marketed devices rather than presenting detailed clinical trial data for acceptance criteria.

Therefore, the information typically required to fill out the requested table regarding acceptance criteria and the study that proves the device meets them, including sample sizes, ground truth establishment, expert qualifications, and MRMC studies, is not present in this document.

Here's what can be inferred or stated based on the document's content:

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

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

• Sample Size for Test Set: Not applicable. No new test set data from a clinical or independent performance study is presented. The substantial equivalence relies on comparison to predicate devices and their existing clearances.
• Data Provenance: Not applicable in the context of new device performance data. The "data" here refers to pre-existing information and clearance of predicate devices, which would have their own provenance from previous submissions.

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

• Not applicable. No new test set requiring expert ground truth establishment is described. The FDA's review process involves internal experts, but the document does not detail this.

4. Adjudication method for the test set:

• Not applicable. No new test set requiring adjudication is described.

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 device is a mechanical implant (hip system), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study or evaluation of human reader improvement with AI assistance is entirely irrelevant and was not performed.

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

• No. Similar to point 5, this is a mechanical device, not an algorithm. Standalone algorithm performance is not applicable.

7. The type of ground truth used:

• Not applicable for new device performance in this context. The "ground truth" for substantial equivalence is effectively the established safety and effectiveness of the identified predicate devices, as determined by the FDA in their prior clearances.

8. The sample size for the training set:

• Not applicable. No training set is mentioned as this is not an AI/machine learning device.

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

• Not applicable.

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