Search Results

Total hip replacement is indicated in the following conditions:

1. A severely painful and/or disabled joint from osteoarthritis, traumatio 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.
   EMPHASYS Acetabular Cups are indicated for cementless use only.

The EMPHASYS Acetabular System includes porous-coated acetabular shells in three configurations (No-Hole, 3-Hole and Multi-Hole) and AOX polyethylene liners in three configurations (Neutral, +4 Neutral and ELV).

This is a K (Premarket Notification) document for the EMPHASYS Acetabular System, a medical device. The document does not describe acceptance criteria for a diagnostic/AI device or a study proving that such a device meets acceptance criteria. Instead, it focuses on demonstrating substantial equivalence of the subject device (an acetabular system for hip replacement) to legally marketed predicate devices through various performance tests.

Therefore, I cannot extract the information requested as it is not present in the provided document. The document primarily deals with the mechanical and material performance of a hip implant, not an AI or diagnostic device that would involve a test set, ground truth, or expert review.

Ask a specific question about this device

Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatic arthritis or late stage avascular necrosis.
Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
Clinical management problems where arthrodesis or alternative techniques are less likely to achieve satisfactory results.
Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.
When used with MDM® Liners
Treatment of nonumion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Dislocation risks
When used with Constrained Liner
The Trident® Constrained Acetabular Insert is indicated for use in primary and revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability.
The Trident® II Acetabular Shells are indicated for cementless use only.

The Trident® II Acetabular Shells, 6.5mm Low Profile Hex Screws and dome hole plugs are sterile, single-use devices that are intended for cementless fixation into a prepared acetabulum for either primary or revision Total Hip Arthroplasty. The Trident® II Acetabular Shells are intended to be used with existing Trident® polyethylene inserts, Trident® Constrained Acetabular Inserts, MDM® liners and both new and existing surgical instruments. The purpose of this Special 510(k) is to add an additional dome hole plug option for use with the Trident® II Acetabular System.

This document is a 510(k) summary for the Stryker Orthopaedics Trident® II Acetabular System. It primarily focuses on demonstrating substantial equivalence to a predicate device for the addition of an acetabular dome hole plug option.

Based on the provided text, the device is a medical implant, not an AI/ML powered device, and therefore the request to describe acceptance criteria and associated studies for an AI/ML device is not applicable.

Here's the breakdown of why the requested information cannot be provided from this document:

• No AI/ML Component: The device described, the Trident® II Acetabular System, is a hip joint prosthesis. The document discusses its components (shells, screws, liners, dome hole plugs), intended use, indications for use, and a comparison to predicate devices, all of which are characteristic of traditional medical devices. There is no mention of artificial intelligence, machine learning, software algorithms for image analysis, or any computational diagnostic or prognostic functionality.
• Focus on Substantial Equivalence for a Physical Component: The primary purpose of this 510(k) filing is to add an "additional dome hole plug option." The entire "Non-Clinical Testing" section explicitly states "No new non-clinical testing was performed." Instead, it references analyses for "equivalence in dimensions and MR evaluation" and prior bacterial endotoxin testing. This is typical for a minor modification to an already cleared physical device, not for a new AI/ML product.

Therefore, the following information points from your request are not present because they relate to the evaluation of an AI-powered medical device:

1. A table of acceptance criteria and the reported device performance: Not applicable.
2. Sample size used for the test set and the data provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. Multi reader multi case (MRMC) comparative effectiveness study: Not applicable.
6. Stand-alone (i.e., algorithm only without human-in-the-loop performance) study: Not applicable.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

In conclusion, this document describes a physical medical device (hip implant components) and its regulatory clearance process, which does not involve the type of AI/ML performance evaluation criteria and studies you are inquiring about.

Ask a specific question about this device

Bencox Mirabo Cup Multi Hole of Bencox Total Hip System is intended for Cementless use in partial or total hip arthroplasty in primary or revision surgery for the following conditions:

a. Non-inflammatory degenerative joint disease, such as avascular necrosis, osteoarthritis, traumatic arthritis

b. Inflammatory degenerative joint disease, such as rheumatoid arthritis

c. Treatment of non-union, femoral neck fracture and trochantric fractures of the proximal femur with head involvement, unmanageable using other techniques

d. Patients with failed previous surgery where pain, deformity, or dysfunction persists

e. Revision of previously failed total hip arthroplasty

This submission consists of inclusion of additional variant to the existing devices Bencox Mirabo Cup System which is a cementless hip acetabular system (Metal on Poly Liner or Ceramic on Poly Liner) for hip arthroplasty. The subject device Bencox Mirabo Cup Multi Hole is similar to Bencox Mirabo Cup System cleared under K172806 and K162127 & K120924, with respect to material – Titanium alloy (ASTM F136), coating with pure Titanium powder (ASTM F1580), design, locking system, manufacturing, packaging and sterilization.

The provided text is a 510(k) summary for a medical device called "Bencox Mirabo Cup Multi Hole." This document describes the device, its intended use, and its substantial equivalence to previously cleared devices. It does not contain information about acceptance criteria, a specific study proving the device meets those criteria, or the detailed aspects of a clinical or analytical study as requested in your prompt.

The document primarily focuses on demonstrating that the new device is "substantially equivalent" to existing predicate devices based on material, design, manufacturing, and performance testing data from the predicate devices. The only performance testing specifically mentioned for the subject device is "deformation testing as per ISO 7206-12," and it states that this testing showed the device is "expected to be safe and effective."

Therefore, I cannot fulfill your request for the tables and detailed study information as this data is not present in the provided text.

Based on the information available, I can only provide the following:

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

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

• Sample Size for Test Set: Not specified. The document refers to "engineering risk analysis & deformation testing as per ISO 7206-12" but does not detail the sample size for this testing.
• Data Provenance: Not specified, other than the manufacturer being Corentec Co., Ltd. based in the Republic of Korea.

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. This document refers to mechanical and sterilization testing, not expert-adjudicated clinical data or ground truth.

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

• Not applicable. This document does not describe results from a study requiring expert adjudication.

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 medical device (hip cup) submission, not an AI-assisted diagnostic tool.

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

• Not applicable. This is a medical device (hip cup) submission, not related to an algorithm's performance.

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

• For mechanical properties: Ground truth would be established by physical testing against recognized standards (e.g., ISO 7206-12) to ensure the device performs within acceptable mechanical limits.
• For sterilization: Ground truth is established by validation methods following international standards (ISO 11137-1 & 2) to demonstrate a specific Sterility Assurance Level.

8. The sample size for the training set:

• Not applicable. There is no mention of a "training set" as this is not an AI/machine learning submission.

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

• Not applicable.

Ask a specific question about this device

Trident Acetabular Component System:
Painful, disabling joint disease of the hip from: degenerative arthritis, rheumatoid arthritis, posttraumatic arthritis or late stage avascular necrosis.
Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
Clinical management problems where arthrodesis or alternative techniques are less likely to achieve satisfactory results.
Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.

Restoration ADM Acetabular Cup and MDM Liner Systems:
The indications for use for total hip arthroplasty include:

1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
2. Rheumatoid arthritis;
3. Correction of functional deformity;
4. Revision procedures where other treatments or devices have failed; and,
5. Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
6. Dislocation risks
   RESTORATION ADM HA Cups and MDM Liners are intended for cementless use only.

Accolade II Hip System:
The indications for use of the total hip replacement prostheses include:

1. noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
2. rheumatoid arthritis;
3. correction of functional deformity;
4. revision procedures where other treatments or devices have failed; and,
5. nonunions, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
   Additional indication specific to use of ACCOLADE II Femoral Stems with compatible Howmedica Osteonics Constrained Liners:
6. 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 intraoperative instability.
   ACCOLADE II Femoral Stems are intended for cementless use only and are intended for total and hemiarthroplasty procedures.

The subject X3 UHMWPE Acetabular Inserts for the Trident, Restoration ADM and MDM Liner systems are a modified version of their respective predicate devices. The subject device designs are identical to their respective predicates, but the subject devices will have a different method of terminal sterilization (ethylene oxide) and will be formed by consolidating Type 1 (GUR1020) resin via conventional methods which meet the specifications of ASTM F648.

The subject Accolade II Hip System is identical to the predicate Accolade II Hip System, with the exception that it has additional compatibility with new instrumentation which utilizes an addendum to the current surgical protocol.

The provided text is a 510(k) summary for joint replacement devices (Trident® X3® UHMWPE Acetabular Inserts, Restoration ADM® and MDM® X3® UHMWPE Acetabular Inserts, Accolade® II Hip System). It describes the devices, their intended use, and the non-clinical testing performed to establish substantial equivalence to predicate devices.

Based on the provided text, the following information can be extracted regarding acceptance criteria and the study that proves the device meets the acceptance criteria:

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

The document explicitly states: "The subject device designs are identical to their respective predicates... The subject Accolade II Hip System is identical to the predicate Accolade II Hip System..." and "The subject X3 UHMWPE Acetabular Inserts are identical in intended use, indications, design, and operational principles to the predicate devices."

The performance is implicitly compared to the performance of the legally marketed predicate devices. The acceptance criteria for the new devices are that their performance, after modifications (sterilization method and instrumentation compatibility), remains equivalent to the predicate devices. The non-clinical tests serve to confirm this equivalence.

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

• Sample Size for Test Set: Not explicitly stated in terms of a "test set" for a diagnostic algorithm. The document refers to "non-clinical laboratory testing." For these tests (e.g., material testing, mechanical testing), typical sample sizes would be based on statistical power analyses for the specific test, but these details are not provided.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable in the context of this submission. The tests are laboratory-based and non-clinical.

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

This information is not applicable. The submission is for orthopedic implants and relies on engineering and biological testing, not expert interpretation of diagnostic images or clinical data to establish a ground truth.

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

This information is not applicable, as there is no diagnostic test set or human interpretation involved to warrant an adjudication method.

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 is not applicable. The device is a medical implant (hip replacement components), not an AI diagnostic tool or software-as-a-medical device, therefore no MRMC study was performed.

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

This is not applicable as the device is a medical implant, not an algorithm.

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

The "ground truth" for this device's performance is established by engineering standards (e.g., ASTM F648, ISO/DIS 14242-1, ISO 11135:2014) and regulatory guidance (e.g., FDA Guidance for UHMWPE, ISO 10993 for biocompatibility). The performance of the modified device is compared against these established standards and the known performance characteristics of the legally marketed predicate devices to demonstrate substantial equivalence.

8. The sample size for the training set:

This is not applicable as the submission is for a medical implant and not an AI/ML algorithm that requires a training set.

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

This is not applicable.

Ask a specific question about this device

Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, posttraumatic arthritis or late stage avascular necrosis.
Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.
When used with MDM Liners:
Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Dislocation risks
When used with Constrained Liner:
The Trident Constrained Acetabular Insert is indicated for use in primary and revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability.
The Trident® II Tritanium Acetabular Shells are indicated for cementless use only.

The Trident® II Tritanium® Acetabular Shell and 6.5mm Low Profile Hex Screws are sterile, single-use devices that are intended for cementless fixation into a prepared acetabulum for either primary or revision Total Hip Arthroplasty. The Trident® II Tritanium® Acetabular Shell is an extension of the Trident System product line and features the same locking mechanism as the current Trident® Tritanium® product line. The Trident® II Tritanium® Acetabular Shell is intended to be used with existing Trident® polyethylene inserts, MDM® liners and existing surgical instruments.
The subject device is manufactured from Ti-6Al-4V ELI alloy. The implant consists of a unique configuration of both solid and porous structures that are simultaneously built using a Laser Rapid Manufacturing (LRM) method of additive manufacturing, applying Stryker's proprietary Tritanium® In-Growth Technology.
There are three designs of Trident® II Tritanium® Acetabular Shells:
Solidback (sizes 42A-66H)
Clusterhole (sizes 42A-66H)
Multihole (sizes 42A-72J)
The new compatible 6.5mm Low Profile Hex Screws feature a hex geometry and are manufactured from wrought Ti-6Al-4V ELI. The new screws range in lengths from 15-80mm.

The provided document is a 510(k) premarket notification for a medical device called "Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex Screws." This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than detailing a study that proves the device meets specific acceptance criteria in the context of an AI/ML-driven medical device.

Therefore, most of the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is not present in this document as it pertains to AI/ML device validation, which is not the subject of this 510(k) submission.

However, I can extract the following relevant information based on the typical requirements for a 510(k) submission for a non-AI/ML device:

1. Acceptance Criteria and Reported Device Performance:
   The document states that "performance testing show that the Trident® II Tritanium® Acetabular Shell and 6.5mm Low Profile Hex Screw are substantially equivalent to the predicates in terms of intended use, indications, design, materials, performance characteristics and operational principles." This implies that the acceptance criteria are met if the device's performance is comparable to the predicate devices. The performance is assessed through various non-clinical laboratory tests.

   Acceptance Criteria (Implied: Substantially Equivalent to Predicate)	Reported Device Performance (Summary)
   Mechanical strength and fixation (e.g., push-out, lever-out, torque-out, fatigue, plastic deformation)	Device demonstrated acceptable performance in all listed non-clinical tests (e.g., Push out (ASTM F1820), Lever out (ASTM F1820), Torque out (ASTM F1820), Fatigue, Plastic Deformation) ensuring substantial equivalence to predicate.
   Bone screw performance	Demonstrated acceptable performance based on Bone Screw Testing (ASTM F543).
   Porous surface characteristics	Porous surface meets requirements outlined in FDA guidance documents ("Guidance Document for Testing Orthopedic Implants With Modified Metallic Surfaces Apposing Bone Or Bone Cement").
   Biocompatibility / Pyrogenicity	Achieved acceptable endotoxin limit as specified in ANSI/AAMI ST72:2011 via Bacterial endotoxin testing (BET).
   Range of Motion	Acceptable Range of Motion Analysis was performed.
   Fretting Evaluation (for MDM liner)	Acceptable Fretting Evaluation of the MDM liner was performed.
   Material Chemistry	Acceptable Material Chemistry evaluations were performed.

2. Sample size used for the test set and the data provenance: Not applicable to this type of device submission. The tests are laboratory-based, often using a small number of physical samples (e.g., implants, screws) for mechanical testing to destruction or specific load cycles.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical performance is typically established through adherence to standardized test methods (e.g., ASTM standards) and material science principles, interpreted by engineers and material scientists.

4. Adjudication method for the test set: Not applicable. Performance data from laboratory tests do not involve human adjudication in the way clinical or image-based studies do.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, an MRMC study was not done as this is a physical medical implant, not an AI/ML diagnostic or assistive device.

6. If a standalone performance study was done: The non-clinical laboratory testing represents the standalone performance evaluation of the device's physical and mechanical properties.

7. The type of ground truth used: The "ground truth" for this device's performance is defined by established engineering and materials science principles, standard test methodologies (e.g., ASTM standards), and regulatory guidance documents for orthopedic implants. For example, for mechanical strength tests, the ground truth is often a failure point or a resistance level under specific applied loads. For biocompatibility/pyrogenicity, it's the defined acceptable endotoxin limit.

8. The sample size for the training set: Not applicable. This device is not an AI/ML product developed using a training set.

9. How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) document is for a traditional medical device (hip implant) and therefore lacks the detailed information typically requested for AI/ML device validation studies. The "study" mentioned here refers to the battery of non-clinical laboratory tests performed to demonstrate that the device is substantially equivalent to legally marketed predicate devices.

Ask a specific question about this device

The Stryker Orthopaedic Acetabular Shells for use with the Total Hip Instruments are intended for use in total hip arthroplasty and are intended for either primary or revision total hip arthroplasty. The Stryker Orthopaedic Hip Implant Stems for use with the Total Hip Instruments are intended for use in total or hemi-arthroplasty of the hip and are intended for either primary or revision procedures. The Direct Superior Approach does not change the intended use of the subject devices.

Indications for Use (Trident PSL Shell, Tritanium Shell, Trident Hemispherical Shells):

• Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, posttraumatic arthritis or late stage avascular necrosis.
• Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
• Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
• Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.
  The Trident shells are intended for cementless fixation within the prepared acetabulum.

Indications for Use (Tritanium Acetabular Shell System):

• Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, posttraumatic arthritis or late stage avascular necrosis.
• Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
• Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
• Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.
  The Tritanium Acetabular Shell System is intended for cementless use only.

Indications for Use (Accolade II Femoral Stem):
The indications for use for total hip arthroplasty with stems include:

• Noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis:
• Rheumatoid arthritis;
• Correction of functional deformity;
• Revision procedures where other treatments or devices have failed; and,
• Nonunions, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
  Additional indication specific to use of the Accolade II Femoral 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.
  Accolade II Femoral Stems are intended for cementless use only and are intended for total and hemiarthroplasty procedures.

Indications for Use (Secur-Fit Advanced Hip Stem):
The indications for use for total hip arthroplasty with stems include:

• Noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis:
• Rheumatoid arthritis;
• Correction of functional deformity;
• Revision procedures where other treatments or devices have failed; and,
• Nonunions, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
  Additional indication specific to use of the Secur-Fit Advanced 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.
  Secur-Fit Advanced Hip Stems are intended for cementless use only and are intended for total and hemiarthroplasty procedures.

Indications for Use (Anato Hip Stem):
The indications for use for total hip arthroplasty with stems include:

• Noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
• Rheumatoid arthritis;
• Correction of functional deformity;
• Revision procedures where other treatments or devices have failed; and,
• Nonunions, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
  Additional indication specific to use of the Anato Hip Stem 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.
  The Anato Hip Stem is intended for cementless use only and is intended for total and hemiarthroplasty procedures.

The devices covered by this submission include Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments. The Instruments consist of Retractors, Cup Impactors, U-Joint Bolt Driver, Alignment Guide, Angled Reamer Handle, Instrument Trays and a Case. All instruments are hand-held surgical instruments used during orthopaedic surgery and are nonsterile, reusable devices. All Class II devices in this submission have been previously determined substantially equivalent in prior 510(k) submissions and are commercially available. The acetabular shells and femoral stems are manufactured from the following materials: titanium (Ti-6Al-4V) alloy, commercially pure (CP) titanium plasma spray, commercially pure titanium and PureFix® hydroxylapatite (HA).

This document is a 510(k) premarket notification from Stryker Orthopaedics to the FDA for their Acetabular Shells, Femoral Stems, and Total Hip Instruments for use with the Direct Superior Approach.

It is important to note that this submission is for a labeling modification to introduce a new surgical approach (Direct Superior Approach) for existing devices, not for a new device requiring extensive performance studies. Therefore, the details requested for acceptance criteria and studies proving device performance (like sample sizes, expert qualifications, etc., which are typically associated with evaluating a new device's diagnostic or predictive performance) are largely not applicable in the context of this specific regulatory submission.

Here's an attempt to address your request based on the provided document, highlighting what is (and isn't) present:

1. Table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria or report on device performance based on a study, because the submission is for a labeling modification of already cleared and marketed devices. The core of the submission is to demonstrate that the new surgical approach (Direct Superior Approach) does not fundamentally change the intended use, safety, or effectiveness of the previously cleared devices.

Instead of performance metrics, the document focuses on demonstrating substantial equivalence to predicate devices. This means that the new labeling (for the Direct Superior Approach) does not raise new questions of safety or effectiveness and that the devices, when used with this new approach, are as safe and effective as existing legally marketed predicate devices.

The "performance" in this context is the general safety and efficacy of the existing devices, which was established in their original 510(k) clearances.

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. No specific test set to evaluate device performance for a new device was used. The submission focuses on the surgical approach for existing devices.

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 for a diagnostic or predictive device was involved. The safety and effectiveness of the devices themselves were established in prior 510(k)s.

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

Not applicable. There was no test set requiring ground truth adjudication.

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/diagnostic device submission.

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

Not applicable. This is not an AI/diagnostic device submission.

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

Not applicable in the sense of a new performance evaluation for a new device. The "ground truth" for this submission is the established safety and efficacy of the predicate devices.

8. The sample size for the training set

Not applicable. No new device or algorithm requiring a training set was involved.

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

Not applicable. No new device or algorithm requiring a training set was involved.

Summary of the Study (as per the document):

The document explicitly states:

• Non-Clinical Testing: "Performance testing was not required in support of this submission because this submission covers a labeling modification to introduce an additional surgical protocol, Direct Superior Approach."
• Clinical Testing: "Clinical testing was not required as a basis for substantial equivalence."

Conclusion of the Study:

The "study" in this case is the review of the modified labeling and comparison to predicate devices, rather than experimental testing of the device itself.

The conclusion is that the Stryker Orthopaedics Acetabular Shells, Femoral Stems, and Total Hip Instruments for use with the Direct Superior Approach are substantially equivalent to the predicate devices identified in the premarket notification. This substantial equivalence is based on:

• The intended use and indications for the implants with the Direct Superior Approach being identical to those of the cleared predicate devices.
• The materials, design features, and functionality for the components being substantially equivalent to previously cleared predicate devices.
• The fundamental scientific technology of the modified device (i.e., the surgical instruments for the new approach) not having changed relative to the predicate devices.
• The material and design of the Total Hip Surgery Instruments for use with the Direct Superior approach being identical to those of the predicate devices cleared for use with other approaches (Posterolateral Approach and Direct Anterior Approach), and their operational principles being similar.

In essence, the "study" for this submission was a comparative analysis of design, materials, intended use, indications for use, and operational principles between the proposed devices (with the new approach) and their already cleared predicates, confirming that no new safety or effectiveness concerns were raised by adding the Direct Superior Approach to the labeling.

Ask a specific question about this device

The Trident® Tritanium® PST® Acetabular Shell System is in skeletally mature individuals undergoing surgery for total hip replacement due to:

· A severely painful and/or disabled joint from osteoarthritis, theumatoid arthritis, avascular necrosis, or congenital hip dysplasia;

· Acute traumatic fracture of the femoral head or neck;

· Failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty or total hip replacement.

The Trident® Tritanium® PST® Acetabular Shell is intended for cemented fixation. The porous structured surface provides biological fixation when used in a cementless application.

The subject Trident® Tritanium® PST® Acetabular Shell is the predicate PST® Acetabular Shell, which has been modified to incorporate the acetabular bearing mating features of the predicate Trident® Tritanium®, Trident® PSL®, and Trident® Hemispherical Shells, to allow compatibility with existing Stryker Orthopaedics acetabular bearings including the Trident polyethylene and Modular Dual Mobility (MDM) bearing families.

The subject Trident® Tritanium® PST® Acetabular Shells are manufactured from titanium alloy and feature a porous structured surface. The subject shells feature a dome hole, and are available either in a solid shell (no screw holes) configuration, or in a cluster screw hole configuration for optional supplemental bone screw fixation. The subject Tritanium® PST® Acetabular Shells are compatible with the optional predicate PST Acetabular Shell system bone screws (titanium alloy), with the optional predicate Stryker Orthopaedics Torx head acetabular dome hole occluder (CP titanium), and with an optional new hex head acetabular dome hole occluder (titanium alloy).

The provided text is a 510(k) Summary for the Trident® Tritanium® PST® Acetabular Shells. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way an AI/software device would.

This document describes a medical device (an acetabular shell for hip replacement), not a software or AI product. The "Performance Testing" section refers to comparisons of materials, manufacturing methods, design features, and disassembly testing per ASTM F1820 (including push-out, and torsional testing) to demonstrate substantial equivalence to predicate devices.

Therefore, most of the requested information (related to AI performance, sample sizes for test/training sets, experts for ground truth, MRMC studies, standalone performance, etc.) is not applicable to this type of regulatory submission for a physical medical device.

I can only extract the following relevant information:

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

Based on the document, specific acceptance criteria and reported device performance in terms of quantifiable metrics like sensitivity, specificity, accuracy, etc., are not applicable as this is a physical medical device, not an AI/software device with such performance metrics.

The performance testing mentioned is mechanical in nature, focused on demonstrating substantial equivalence to predicate devices.

• Comparison of manufacturing methods: Same manufacturing methods as predicate PST® Acetabular Shells.
• Comparison of design features: Same outer profile and porous structured surface as predicate PST® Acetabular Shells.
• Disassembly Testing: Per ASTM F1820, including push-out and torsional testing (for worst-case style and size of compatible Stryker Orthopaedics acetabular bearings). |
  | Compatibility | - Incorporates acetabular bearing mating features of predicate Trident® Tritanium®, Trident® PSL®, and Trident® Hemispherical Shells.
• Compatible with existing Stryker Orthopaedics acetabular bearings, including Trident polyethylene and Modular Dual Mobility (MDM) bearing families. |
  | Sterilization | Same sterilization methods as predicate PST® Acetabular Shells. |
  | Packaging | Similar packaging to predicate PST® Acetabular Shells. |

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

This information is not applicable to this device. The testing described is mechanical performance (e.g., disassembly testing per ASTM F1820) of physical components, not data analysis or clinical studies in the typical sense of AI/software device evaluation.

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 information is not applicable. Ground truth, in the context of expert review for AI/software, is not relevant for the mechanical testing of a physical implant.

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

This information is not applicable. Adjudication methods are typically for resolving discrepancies in expert interpretations for ground truth establishment, which is not relevant here.

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 information is not applicable. MRMC studies are for evaluating human performance with and without AI assistance for tasks like image interpretation, which is not relevant for an orthopedic implant.

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

This information is not applicable. This describes a physical medical device, not an algorithm.

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

This information is not applicable. The "ground truth" for a physical device is its adherence to specified material properties, mechanical strength characteristics, and design specifications as evaluated through engineering tests, not clinical or pathological outcomes in the context of expert consensus as described for AI/software.

8. The sample size for the training set

This information is not applicable. There is no "training set" as this is not an AI/software device.

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

This information is not applicable. There is no "training set."

Ask a specific question about this device