Search Results

This device is intended for use in total and hemi-hip arthroplasty. The device is intended for uncemented, press-fit use only in cases of:

1. Notably impaired hip joint due to osteoarthritis, rheumatoid arthritis, and/or post traumatic arthritis.
2. Previously failed hip surgery.
3. Proximal femoral neck fractures or dislocation.
4. Idiopathic avascular necrosis of the femoral head.
5. Non-union of proximal femoral neck fractures.
6. Treatment of fractures that are unmanageable using other forms of therapy.
7. Benign or malignant bone tumors, congenital dysplasia or other structural abnormalities where sufficient bone stock exists to properly seat the prosthesis.

The subject device is a set of smaller stems that extends the size range of the previously cleared Trivicta® stems (K233758).

Trivicta® is a single-piece, tapered, collared and non-collared, hydroxyapatite (HA) and sintered bead commercially pure (Cp) Titanium coated femoral hip stem designed for single use. The stem has a neck with a 12/14 trunnion taper for modular attachment to femoral heads. Trivicta® is manufactured from titanium alloy and device fixation is achieved through uncemented press-fit in the medullary canal and through the use of biocompatible HA coating and porous sintered bead coating.

The size range of the subject device is: lengths (97-101mm), horizontal offsets (36-43mm), vertical offsets (27-29mm), resection angle of 41°, and neck angle of 132°. The stem is offered with both standard (STD) and extended (EXT) offsets and with and without a collar.

Trivicta® is compatible with the following Ortho Development® devices: CoCr Femoral Heads, Biolox Delta Ceramic Femoral Heads, Solitude™ Unipolar Head, Escalade Acetabular Cup System, Legend® Acetabular Liner, Escalade Legend® Acetabular Shell, and Tri-plus™ DCM Liner.

The provided text is an FDA 510(k) clearance letter and associated summary for a hip stem device. This type of document describes the device, its indications for use, and a comparison to predicate devices, along with performance data to demonstrate substantial equivalence.

However, the information requested in your prompt regarding acceptance criteria for a software device, specifically around AI performance metrics like sensitivity, specificity, MRMC studies, ground truth establishment, training data, etc., is not contained within this FDA clearance document.

The document states under "Clinical Testing" (Page 7): "No clinical testing is required to establish the safety and effectiveness of Trivicta." This indicates that the clearance was based on non-clinical performance data (sterilization, shelf life, biocompatibility, mechanical testing) and comparison to predicate devices, not on a study involving AI performance or human-in-the-loop assessments as would be typical for medical AI devices.

Therefore, I cannot fulfill your request for the specific AI-related acceptance criteria and study details because the provided document is for a mechanical orthopedic implant, not an AI-powered diagnostic or therapeutic device.

Ask a specific question about this device

Z1 Hip System is intended for total or hemi hip arthroplasty and is indicated for the following conditions:

• · Advanced wear of the joint due to degenerative, post-traumatic or rheumatic diseases.
• · Failed previous hip surgery including joint reconstruction (osteotomy), arthrodesis, hemiarthroplasty or total hip replacement (THR).
• · Acute traumatic fracture of the femoral head or neck.
• · Avascular necrosis of the femoral head.
  Z1 Hip System is for cementless use only.

Z1 Hip System consists of femoral hip stems intended for use in total or hemi hip arthroplasty. The stem is designed for cementless implantation into the proximal femur and mates with compatible femoral heads and adapters for use in total or hemi hip arthroplasty through a 12/14 male taper connection. The stems are manufactured from a forged titanium alloy Ti-6Al-4V and have a wedge-shaped design, with a proximal-to-distal taper. Apart from the highly polished femoral neck region, the entire surface of the stem is grit-blasted and sprayed with a Ti-6Al-4V titanium alloy plasma coating followed by a hydroxyapatite (HA) overcoat. Offered in multiple sizes and neck lengths, the stems are available in Standard, High Offset, and Coxa Vara offsets and as collared or collarless stems in each offset to accommodate various patient anatomies. The hip stems are provided sterile and are for single use only. System-specific instrumentation is available to prepare the femur for implantation of the Z1 Hip System femoral stems. The Z1 Hip System is for use only with the Zimmer Biomet femoral heads and adapters, bipolar heads, and acetabular shells and liners identified in the package insert as compatible components.

This document describes the Z1 Hip System, a medical device for hip arthroplasty. However, the provided text does not contain any information regarding clinical studies with human subjects, acceptance criteria for such studies, or information about AI/algorithm performance. The document is a 510(k) premarket notification to the FDA, focusing on demonstrating substantial equivalence to a predicate device through non-clinical performance testing.

Therefore, I cannot provide details for most of your requested points, as they pertain to clinical trials and AI/algorithm performance, which are not present in this document.

Here's what can be extracted based on the provided text:

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

The document provides a summary of non-clinical performance testing performed according to various ISO and ASTM standards. The "acceptance criteria" discussed are related to the successful completion of these engineering tests, demonstrating that the device meets the requirements of the standards and is substantially equivalent to the predicate device. The document does not specify quantitative acceptance criteria with reported numerical values for each test in a comparative table format. Instead, it states that "All necessary testing has been performed... to assure substantial equivalence... All testing was performed on worst case implants or test coupons as dictated by the relevant performance standards." and "Based on the similarities of... the results of the non-clinical performance testing, the subject device is substantially equivalent to the legally marketed predicate device."

Here's an interpretation based on the non-clinical tests mentioned:

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

This document discusses non-clinical performance testing (mechanical, material, sterilization, etc.) on implants or test coupons, not clinical data from human subjects. Therefore, the concepts of "test set," "data provenance," "country of origin," "retrospective or prospective," and "sample size" in the context of human data are not applicable here. The document refers to "worst case implants or test coupons" for testing.

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)

This is not applicable as the document describes non-clinical engineering and material testing, not human-read clinical data requiring expert ground truth establishment.

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

This is not applicable, as there is no clinical test set or adjudication process 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

There is no mention of an MRMC study or AI assistance in this document. The device is a physical hip implant (Z1 Hip System).

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

This is not applicable, as the document refers to a physical hip implant and not an algorithm or AI product.

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

For the non-clinical testing, the "ground truth" is defined by the specifications and requirements of the referenced ISO and ASTM standards (e.g., a specific fatigue load cycle, a particular coating thickness range, sterility assurance level). The device's performance is compared against these engineering and material standards.

8. The sample size for the training set

This is not applicable, as there is no training set mentioned for an algorithm or AI.

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

This is not applicable, as there is no training set mentioned for an algorithm or AI.

Ask a specific question about this device

Hip Arthroplasty Indications:
· Painful, disabling joint disease of the hip resulting from: noninflammatory degenerative joint disease (including osteoarthritis or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis.

• · Revision of previous unsuccessful femoral head replacement, hip arthroplasty or other procedure.
  · Correction of functional deformity
  · Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

Additional indication specific to use of Insignia Hip Stems with compatible Howmedica Osteonics Constrained Liners:
· When the stem is to be used with compatible Howmedica Osteonics Constrained Liners, the device is intended for use in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability.

Additional indication specific to use of Insignia Hip Stems with compatible ADM and MDM Acetabular Components:
· When the stem is to be used with compatible Howmedica Osteonics ADM and MDM Acetabular Components, the device is indicated for Dislocation risks

Insignia Femoral Stems are intended for cementless use only and are intended for total and hemiarthroplasty procedures.

The Insignia Hip Stem is a sterile, single-use device that is intended for cementless fixation into a prepared femoral canal for either primary or revision total or hemi hip arthroplasty. The basic design of the Insignia Hip Stem is similar to other commercially distributed hip stems, such as the Accolade II and Omnifit HFx hip stems. The Insignia Hip Stem is manufactured from Ti-6Al-4V ELI alloy, features a collar, commercially pure titanium plasma sprayed proximal surface, and plasma sprayed hydroxyapatite coating.

The Insignia Hip Stem includes 12 sizes ranging from Size 0 through 11. Each stem size is offered in a Standard Offset and a High Offset option at a single 132 degree neck angle. The stem is designed only for use with compatible V40 Howmedica Osteonics femoral heads, sleeves, and cemented or uncemented acetabular components.

This is a medical device submission for the Insignia Hip Stem, which is a physical implant, not a software device or AI algorithm. Therefore, the questions regarding acceptance criteria and studies related to AI or algorithm performance are not applicable to the provided text.

The document discusses the mechanical and material performance of the hip stem rather than the diagnostic or predictive performance of an AI system. No information about AI acceptance criteria, training sets, test sets, expert adjudication, or MRMC studies for AI devices is present in the provided text.

Ask a specific question about this device

Total hip replacement or hip arthroplasty is indicated in the following conditions:

1. A severely painful and/or disabled joint from osteoarthritis, rheumatoid arthritis, or congenital hip dysplasia.
2. Avascular necrosis of the femoral head.
3. Acute traumatic fracture of the femoral head or neck.
4. Certain cases of ankylosis.

Partial hip replacement or hip hemi-arthroplasty is indicated in the following conditions:

1. Acute fracture of the femoral head or neck that cannot be appropriately reduced and treated with internal fixation.
2. Fracture dislocation of the hip that cannot be appropriately reduced and treated with internal fixation.
3. Avascular necrosis of the femoral head.
4. Non-union of femoral neck fractures.
5. Certain high subcapital and femoral neck fractures in the elderly.
6. Degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement.
7. Pathology involving only the femoral head/neck and/or proximal femur that can be adequately treated by hip hemi-arthroplasty.

The ACTISTM DUOFIX™ Hip Prosthesis is indicated for cementless use only.

The ACTIS Duofix™ Hip Prosthesis is identical to the previously cleared ACTIS Duofix™ Hip Prosthesis (K150862 & K160907). The ACTIS Duofix™ Hip prostheses are manufactured from forged titanium alloy (Ti6Al4V), have a sintered commercially pure titanium bead porous coating (Porocoat ®), and thin layer of plasma-sprayed hydroxyapatite (HA) coating. The stem consists of a wide range of stem neck designs and sizes allowing an anatomical match for each patient. The stems are compatible with both unipolar and bipolar heads intended for hip hemi-athroplasty and with modular metal or ceramic femoral heads intended for total hip arthroplasty.

The porous coating is applied over the proximal region of the stem. A thin coating of hydroxyapatite (HA) of uniform thickness is sprayed over the porous and distal stem areas via a plasma spray process. The HA powder used in the plasma spray process conforms to ASTM F1185-88 and ISO 13779-6 Hydroxyapatite (Ca5(PO4)3OH) ceramic. The plasma spray process used to apply the HA coating to the ACTIS Duofix™ Stem is the same process used to coat the SUMMIT Duofix™ Stem which was cleared in K193398. The HA material used for the ACTIS Duofix™ Stem is the same as the HA material used on the SUMMIT Duofix™ Stem. Thirteen sizes of prostheses are provided to allow high resolution of fit within host femora. Each size is offered in standard and high offset neck options, desired recreation of patient biomechanics in combination with head and liner combinations.

This document describes a 510(k) premarket notification for the ACTIS Duofix Hip Prosthesis, not an AI/ML powered device. Therefore, the requested information regarding acceptance criteria, study details, ground truth, and human reader performance with AI assistance is not applicable.

The submission focuses on demonstrating substantial equivalence to previously cleared predicate devices through:

• Manufacturing changes: Adding DePuy Ireland as an alternate manufacturing facility for the HA coating process and DePuy Orthopaedics Inc. Warsaw IN as an alternate site for grit-blasting.
• Non-clinical performance data:
  • Biological safety per ISO 10993-1.
  • Characterization testing of Hydroxyapatite Coating per FDA Guidance.
  • Performance Bench Testing - Body (Distal) Fatigue Testing per ISO 7206-4 2010.

No clinical tests were conducted as part of this submission, nor are there any indications of an AI/ML component in the 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, 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, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
5. Certain cases of ankylosis.

Hemi hip replacement is indicated in the following conditions:

1. Acute fracture of the femoral head or neck that cannot be appropriately reduced and treated fixation.
2. Fracture dislocation of the hip that cannot be appropriately reduced and treated with internal fixation.
3. Avascular necrosis of the femoral head.
4. Non-union of femoral neck fractures.
5. Certain high subcapital and femoral neck fractures in the elderly.
6. Degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement.
7. Pathology involving only the femoral head/neck and/or proximal femur that can be adequately treated by hemi-hip arthroplasty.

The SUMMIT POROCOAT Porous, SUMMIT DuoFix Porous, and SUMMIT Basic Press Fit stems are indicated for uncemented use only.
The SUMMIT Cemented and SUMMIT Basic Cemented stems are indicated for cemented use only.

The Summit Hip System is series of tapered femoral hip stems which may be used in either total or hemi-hip arthroplasty procedures in conjunction with DePuy hip arthroplasty devices.
The Summit Porous Hip Prosthesis is a series of collarless, titanium, tapered, press fit femoral stems The hip stem is manufactured from titanium alloy (Ti-6Al-4V) and has a sintered commercially pure titanium bead porous coating (Porocoat) applied to the stem. There are 10 body sizes ranging in diameter from 7mm (Size 1) to 18mm (Size 10) with each body size having two offset options. These stems are intended for uncemented use only.
The Summit DuoFix Porous Hip Prosthesis is a series of collarless, titanium alloy, tapered, press-fit femoral stems. The hip stem is manufactured from titanium alloy (Ti-6Al-4V) and has a sintered commercially pure titanium bead porous coating (Porocoat) applied to the stem with a thin layer of hydroxyapatite (HA) coating. There are 10 body sizes ranging in diameter from 7mm (Size 1) to 18mm (Size 10) with each body size having two offset options. These stems are intended for uncemented use only.
The Summit Cemented Hip Prosthesis is series a flanged, collared tapered Cobalt-Chromium femoral stems with a smooth finish. There are seven proportional body sizes with a standard offset, and six proportional body sizes with a high offset. Distal and proximal PMMA centralizers help assure the stem is centered in the femoral canal. These stems are intended for cemented use only.
The Summit Basic Cemented Hip Prosthesis is a series of flanged, collared, tapered Cobalt-Chromium-Molybdenum femoral stems with a smooth surface finish. There are seven total sizes with a constant offset. Only six of the seven sizes are available in the high offset option. A distal PMMA centralizer helps assure that the stem is centered in the femoral canal. These stems are intended for cemented use only.
The Summit Basic Press Fit Hip Prosthesis is a series of collared, tapered Titanium femoral stem with a grit-blasted finish. There are seven sizes with a constant offset and a distal centralizer to assure that the stem is centered in the femoral canal. These stems are intended for uncemented use only.

This is a 510(k) summary for the Summit Hip System, which is a medical device. This document does not describe acceptance criteria for an AI/ML device, nor does it contain information about a study proving such a device meets acceptance criteria. Instead, it describes non-clinical tests conducted to demonstrate substantial equivalence of the Summit Hip System to predicate devices.

Therefore, I cannot answer your request based on the provided text as it does not contain the information you are looking for.

Ask a specific question about this device