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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 Duraloc® Option Acetabular Cup System is for total hip replacement.

A total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions:

• 1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
• Avascular necrosis of the femoral head. 2.
• Acute traumatic fracture of the femoral head or neck. 3.
• Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, 4. hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
• 5. Certain cases of ankylosis.

The acetabular cups are indicated for cementless application.

The Duraloc® Option Acctabular Cup System consists of a UHMWPE acetabular cup liner secured to a porous-coated Ti-6A1-4V acetabular shell. The acetabular system articulates with previously cleared 28mm fernoral heads, as well as with 22.225mm femoral heads internally documented by DePuy as line extensions to femoral heads cleared in K920317 and K980513.

The 28mm femoral heads were cleared in K920317 on March 19, 1992, K893872 on July 11, 1989, K883460 on October 11, 1998, K860701 on March 19, 1986, K891082 on June 9, 1989 and K011533 on January 28, 2002.

The acetabular cups are sized from 46mm to 66mm, in 2 mm increments. The liners are available in two styles: neutral and lipped. Liners with a 22,225mm inner diameter are offered in the outer diameter of 46mm. Liners with a 28mm inner diameter are offered in outer diameters of 48/50mm, 52mm, 54/56mm, 58/60mm, and 62/64/66mm.

The liner interlock allows the liner to be rotated to match the patient's anatomy. A locking ring, manufactured from Co-Cr-W-Ni alloy, is used to secure the liner.

The cups and liners are intended to be used in total hip arthroplasty to provide increased patient mobility and to reduce pain by replacing damaged hip joint articulation in patients where is evidence of sufficient sound bone to seat and support the components.

The acetabular cups are indicated for cementless application.

The provided text describes a 510(k) summary for a medical device, the Duraloc® Option Acetabular Cup System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving device efficacy through clinical studies with acceptance criteria in the way a new drug or novel medical device might.

The 510(k) summary does not include:

• Acceptance criteria in terms of performance metrics (like sensitivity, specificity, accuracy) for an AI/CADe device.
• Details of a study proving the device meets specific performance acceptance criteria.
• Information on sample sizes, ground truth establishment, expert qualifications, or adjudication methods for a diagnostic algorithm.
• Any mention of AI, CADe, or image analysis.
• Multireader multi-case (MRMC) studies or standalone performance studies.

Instead, the document focuses on:

• Substantial Equivalence: Comparing the Duraloc® Option Acetabular Cup System to previously cleared hip prosthesis devices (DePuy Pinnacle Acetabular System and DePuy Duraloc Cementless Acetabular Cup System).
• Device Description: Detailing the components and materials of the acetabular cup system.
• Intended Use and Indications: Specifying the conditions for which the device is intended, which are related to total hip arthroplasty to replace damaged hip joint articulation in various severe conditions like osteoarthritis, traumatic arthritis, avascular necrosis, etc.

Therefore, it is not possible to answer the detailed questions about acceptance criteria, study design, expert involvement, or AI performance based on the provided text. The document pertains to a hardware medical device (hip prosthesis) seeking 510(k) clearance, not a software/AI medical device that would have performance metrics like those requested in the prompt.

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The DePuy/Ace MMA Fracture Stem is indicated for cemented or press-fit cementless use as the femoral component in total hip arthroplasty (THA) for replacing the hip joints of patients whose hip joint has been damaged by fracture. The prosthesis may also be used for total hip arthroplasty for patients requiring total hip replacement for inflammatory or non-inflammatory degenerative joint disease or failure of a previous arthroplasty.

The DePuy/Acc MMA Fracture Stem is a cast Co-Cr-Mo hip stem with a bead blasted finish. The stem has a triangular proximal body, a rounded shoulder, a straight distal stem, and anterior and posterior grooves that extend from the distal tip up approximately 60% of the length of the stem. Five sizes are available, ranging from 9 to 16.5mm in diameter. The DePuy/Ace MMA Fracture Stem has an Articul-eze (12/14) taper and is only to be used with the DePuy Co-Cr-Mo or Zirconia Articul-eze taper modular femoral heads (cleared in K883460 and K952088).

This K964704 document describes a medical device, the DePuy/Ace MMA Fracture Stem, and its substantial equivalence to previously cleared devices. It does not contain information about acceptance criteria, device performance statistics from a study, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text. The document focuses on comparing the new device's design and intended use to existing, cleared devices to establish substantial equivalence, which is a regulatory pathway that often relies on demonstrating similar performance characteristics (e.g., fatigue strength in this case) rather than new clinical trials with detailed statistical performance metrics as might be found for AI-driven diagnostic devices.

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