Search Results

The KeYi Total Hip System is designed for total hip arthroplasty. The indications for use are:
a. Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis.
b. Revision of failed femoral head replacement, cup arthroplasty or other hip procedures.
c. Proximal femoral fractures.
d. Avascular necrosis of the femoral head.
e. Non-union of proximal femoral neck fractures.
f. Other indications such as congenital dysplasia, arthrodesis conversion, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteoporosis, pseudarthrosis conversion, and structural abnormalities.
The Ke Yi femoral stems are indicated for cementless use. The KeYi acetabular shells are indicated for cemented or cementless use.

The KeYi Total Hip System is a porous-coated, semi-constrained, hip prosthesis designed for either primary or revision hip arthroplasty. The system is comprised of femoral stems and mating metal femoral heads; acetabular shells and mating acetabular liners; optional acetabular cancellous bone screws; and optional acetabular dome hole plug.
The KeYi Femoral Stems are forged titanium alloy, feature a proximal CP Titanium plasma porous coating, and are offered in a range of sizes. The KeYi Femoral Heads are polished cobalt chromium alloy and designed to mate with 12/14 taper of the femoral stem through taperlocking arrangement and to articulate with the acetabular liner. The heads are available in different sizes with various offsets.
The KeYi Acetabular Shells are manufactured from titanium alloy and feature a porous CP Titanium plasma porous coating. The shells feature a dome hole, are available with a two or three-hole pattern for supplemental bone screw fixation, and come in a range of outer diameter sizes. The KeYi Acetabular Liners are manufactured from ultrahigh molecular weight polyethylene (standard/non-crosslinked UHMWPE).
Optional components include threaded acetabular dome hole plugs and acetabular cancellous bone screws, all manufactured from titanium alloy.

The provided text is a 510(k) summary for the KeYi Total Hip System, a medical device. It describes the device's components, intended use, and a summary of non-clinical tests performed to demonstrate substantial equivalence to predicate devices.

However, the document does not contain any information regarding acceptance criteria, study methodologies, or performance data related to AI/algorithm-driven components, human reader performance, or comparative effectiveness studies involving AI assistance.

Therefore, based solely on the provided text, I cannot describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the manner requested. The questions asked, such as those about sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and training set details, are relevant to the evaluation of AI/ML-driven medical devices, which is not what this document addresses.

This document focuses on the mechanical and material performance of a physical orthopedic implant (hip replacement system) and its substantial equivalence to established predicate devices, a typical pathway for traditional medical devices.

Ask a specific question about this device

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.

Ask a specific question about this device

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.
2. Avascular necrosis of the femoral head.
3. Acute traumatic fracture of the femoral head or neck.
4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
5. Certain cases of ankylosis.

The subject devices are a line extension to the existing range of Articul/Eze 36mm Femoral Heads and represent additional taper sizes and offsets to allow surgeons more flexibility in the choice of femoral hip stem. Specifically, the tapers include 12/14 Articul/Eze taper with +15.5mm offset, 11/13 S-ROM taper with -3mm, 0mm, +3mm, +6mm, +9mm and 12mm offsets, and 14/16 taper with 0mm, +3mm, +5mm, +8mm and +11mm offsets. The tapers are designed to mate with femoral hip stems which have matching neck taper sizes. The offsets vary to allow the surgeon flexibility in lateralization of the hip joint.

There is no information in the provided text about acceptance criteria or a study proving that a device (in the context of AI or diagnostic algorithms) meets such criteria. The document is a 510(k) summary for DePuy M-Spec 36mm Femoral Heads, which are medical devices used in total hip arthroplasty (hip replacement), not a "device" in the sense of an AI/ML algorithm.

The document states that a dimensional analysis was conducted to demonstrate substantial equivalence to predicate devices, but this is a characteristic of the physical product, not a performance metric that would typically have "acceptance criteria" in the way an AI algorithm does (e.g., sensitivity, specificity thresholds).

Here's an analysis based on the provided text, highlighting what is and is not present:

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

• Not Applicable. The document describes a physical medical device (femoral heads) and its substantial equivalence to previously cleared devices. It does not contain acceptance criteria or performance metrics (like sensitivity, specificity, or AUC) typically associated with diagnostic AI or similar software devices. The "performance data" section only mentions "dimensional analysis" to show substantial equivalence.

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. There is no "test set" in the context of an AI/ML device. The "dimensional analysis" would involve measuring the physical characteristics of the femoral heads. Information on the number of units measured or their origin is not provided.

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. There is no "ground truth" establishment by experts because this is not an AI/ML device requiring such validation.

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

• Not Applicable. No adjudication method is described as it's not relevant for this type of device 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 is not an AI-assisted device, so 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 a physical medical implant, not an algorithm.

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

• Not Applicable. No ground truth, as typically defined for AI/ML devices, was used. The demonstration of substantial equivalence relied on a "dimensional analysis" comparing the new device's physical dimensions to those of predicate devices.

8. The sample size for the training set

• Not Applicable. There is no training set for a physical medical device like this.

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

• Not Applicable. There is no training set or ground truth for this type of device.

In summary: The provided text is a 510(k) summary for a physical medical device (femoral heads) and does not relate to an AI/ML device or software. Therefore, most of the requested information about acceptance criteria for AI performance studies is not present or applicable. The submission focused on demonstrating "substantial equivalence" through dimensional analysis rather than performance metrics typically associated with AI/ML algorithms.

Ask a specific question about this device

The DePuy aSphere M-Spec Head is indicated for use in the treatment of:

1. A severely painful and/or a severely disabled joint resulting from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia;
2. Avascular necrosis of the femoral head;
3. Acute traumatic fracture of the femoral head or neck;
4. Failed previous surgery, including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthoplasty, or other total hip replacement; and
5. Certain cases of ankylosis.
   The subject aSphere M-Spec Head is intended for use as part of the femoral component in a total hip arthroplasty.

The aSphere M-Spec Head is part of a modular prosthesis system for use in total hip replacement. It mates with DePuy femoral stems and articulates with DePuy acetabular inserts and cups.

The provided text details a 510(k) premarket notification for the "DePuy aSphere M-Spec Head," a modular femoral head for total hip replacement. However, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document outlines:

• Device Description: The aSphere M-Spec Head is part of a modular prosthesis system for total hip replacement, mating with DePuy femoral stems and articulating with DePuy acetabular inserts and cups.
• Indications for Use: Treatment of severely painful/disabled joints due to various arthritic conditions, avascular necrosis, acute femoral head/neck fractures, failed previous surgeries, and certain cases of ankylosis.
• Intended Use: As part of the femoral component in total hip arthroplasty.
• Basis of Substantial Equivalence: Similarities in intended use, indications for use, materials, design, method of manufacture, sterilization, and packaging methods to previously cleared DePuy M-Spec Heads (K980513, internal documentation to K851422, and K060031).

The FDA's letter (K082585) confirms the device's substantial equivalence to predicate devices, allowing it to be marketed. This 510(k) pathway for medical device approval primarily relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical studies with explicitly defined acceptance criteria for the new device's performance.

Therefore, I cannot provide the requested information in the table or answer the specific questions about acceptance criteria and a study proving their fulfillment, as this information is not present in the provided text. The document focuses on regulatory clearance based on equivalence, not on a detailed performance study with acceptance criteria.

Ask a specific question about this device

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.

Ask a specific question about this device