Search Results

· Painful, disabling joint disease of the hip from: degenerative arthritis, theumatoid 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.
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 Restoration Anatomic Shell is indicated for cementless use only.

The Restoration Anatomic Shell is a sterile, single-use device that is intended for cementless fixation into a prepared acetabulum for either primary or revision Total Hip Arthroplasty. The subject device substrate is manufactured from Ti-6Al-4V ELI alloy and has a porous CP-Ti coating. The materials, design features and screw hole locations of the subject Restoration Anatomic Shell are identical to the predicate device cleared via premarket notifications K153345, K151264, and K142462.

The provided text is a 510(k) summary for the Restoration Anatomic Shell, a hip joint prosthesis. It does not describe any acceptance criteria or a study that proves the device meets those criteria from a performance or clinical standpoint.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device based on material, design, and intended use, with the only changes being to the packaging configuration.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details, as this information is not present in the provided text.

Here's a breakdown of what the document does say regarding testing, which relates to the packaging change:

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

• Acceptance Criteria: The document mentions that packaging configuration changes necessitated specific testing. The criteria for these tests would be defined within the referenced standards.
• Reported Device Performance: The document states that a "ship test study was completed on the subject device to qualify the proposed packaging configuration." It also mentions "Product bioburden and cytotoxicity testing were executed as the proposed packaging configuration constitutes a change in packaging materials that contact the product after final cleaning."
  • Packaging Performance: "Testing was completed per ISO 11607-1, ASTM F1886, ASTM D4169, ASTM F2825, ASTM F88/F88M, and ASTM F2096, and ASTM F2097." The outcome is implicitly positive, as the device received 510(k) clearance, suggesting the packaging met the requirements of these standards.
  • Bioburden Performance: "Bioburden testing was completed per ISO 11737-1."
  • Cytotoxicity Performance: "Cytotoxicity testing was completed per ISO 10993-5."
  • Results: The conclusion that "The proposed modifications do not affect safety or effectiveness" implies these tests were passed, but specific performance metrics are not detailed in the provided text.

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 provided in the document as it did not involve clinical or performance studies for the device itself, only packaging validation.

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 as there was no test set requiring expert ground truth establishment for clinical performance.

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

• This information is not applicable as there was no test set requiring adjudication for clinical performance.

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 as this is a hip joint prosthesis, not an AI-assisted diagnostic device, and no MRMC study was conducted or required.

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

• This information is not applicable as this is a hip joint prosthesis, not an algorithmic diagnostic device, and no standalone performance study was conducted or required.

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

• This information is not applicable as there was no clinical performance study for the device described. The "ground truth" for the packaging validation would be the physical and biological integrity after testing, as per the specified ISO and ASTM standards.

8. The sample size for the training set

• This information is not applicable as no training set was involved (no AI or analytical model development for device performance was described).

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

• This information is not applicable for the reasons mentioned above.

Ask a specific question about this device

CancelleX Porous Titanium Lumbar Interbody System devices are intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non- fusion spinal surgery at the involved spinal level(s). The device is intended to be used with supplemental fixation systems that have been cleared for use in the lumbrosacral spine (e.g. posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). Hyperlordotic interbody devices (≥20° lordosis) must be used with at least anterior supplemental fixation. The device is intended to be used with autogenous bone graft. Patients must have undergone a regimen of at least six months of non-operative treatment prior to being treated with the CancelleX device.

CancelleX Porous Titanium Lumbar Interbody System devices are being added to the Lumbar Interbody System. The CancelleX Porous Titanium Interbody devices are generally box shaped with surface teeth and a central channel for packing autogenous bone. These implants are available in a range of shapes and sizes to accommodate variations in patient anatomy. The devices are manufactured from Commercially Pure (Unalloyed) Titanium (ASTM F1580). The system also includes instruments manufactured using polyacrylamide (PARA-IXEF-GY51) polymer and stainless steel per ASTM F899.

The provided text describes the regulatory clearance of the CancelleX Porous Titanium Lumbar Interbody Device. It does not contain information about the acceptance criteria or a study proving the device meets said criteria in the context of AI/ML device performance.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance data (bench testing and biocompatibility). It explicitly states that animal and clinical performance data were not required to determine substantial equivalence.

Therefore, I cannot provide a table of acceptance criteria and reported device performance related to AI/ML or answer most of the requested questions.

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

1. Table of Acceptance Criteria and the Reported Device Performance (as much as applicable):

The following questions cannot be answered based on the provided document as they relate to AI/ML device performance, which is not discussed:

• 2. Sample sized used for the test set and the data provenance
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
• 4. Adjudication method for the test set
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
• 7. The type of ground truth used
• 8. The sample size for the training set
• 9. How the ground truth for the training set was established

Summary of what the document does indicate:

The device's clearance was based on its substantial equivalence to previously cleared predicate devices, supported by non-clinical (biocompatibility and bench) testing. No AI/ML components or associated studies are mentioned.

Ask a specific question about this device

· Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NID) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.

· Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, atthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection: fracture-dislocation of the hip; and correction of deformity.

REDAPT™ Augments are intended for single use only and are to be implanted with bone cement to the mating acetabular shell and without bone cement to the bone interface

Augments are intended to be used in primary and revision surgeries where the acetabulum has the deficiencies of the acetabular roof, anterior or posterior pillar, medial wall deficiency, and / or protrusion as a result of the indications listed previously.

Subject of this Traditional premarket notification are the REDAPT® Augments. The subject devices are acetabular augment hip components to be used to fill bone voids where significant bone loss is present and a cup alone cannot fill the void.

This document is a 510(k) Premarket Notification from the FDA regarding the "Smith & Nephew, Inc. REDAPT Augments." It describes the device, its intended use, and the pre-clinical testing performed to establish substantial equivalence to legally marketed predicate devices.

Summary of Acceptance Criteria and Study:

The document focuses on substantiating the equivalence of the REDAPT Augments to predicate devices, primarily through engineering analysis and mechanical testing, rather than an AI/ML-based study with specific acceptance criteria for algorithm performance. Therefore, many of the requested points related to AI/ML performance, ground truth, expert review, MRMC studies, and training data are not applicable to this 510(k) submission.

The "acceptance criteria" in this context are implicitly the successful completion of the described pre-clinical tests and the demonstration that the results are equivalent to or better than the predicate devices, thereby ensuring safety and effectiveness.

Here's a breakdown of the requested information based on the provided text, with "N/A" for sections not covered by this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and the Data Provenance:

• Sample Size for Test Set: The document refers to "worst-case products" and "representative samples" for testing. Specific numerical sample sizes for each mechanical or chemical test are not provided in this summary.
• Data Provenance: N/A for this type of testing (not clinical data or image data). The tests were conducted on manufactured device samples.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

• N/A. This is pre-clinical engineering and laboratory testing, not a study requiring human expert interpretation of data for ground truth establishment in the context of AI/ML.

4. Adjudication Method for the Test Set:

• N/A.

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:

• N/A. This is not an AI/ML device, nor is it a clinical study comparing human reader performance.

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

• N/A. This is a medical implant device, not an algorithm.

7. The Type of Ground Truth Used:

• The "ground truth" for these tests is based on established engineering principles, material science standards, and in vitro testing methodologies. For example, "successful completion" of fatigue testing means the device withstood the specified cyclical loads without failure or excessive deformation, as defined by the test protocol and industry standards. Comparison to predicate device performance also serves as a benchmark.

8. The Sample Size for the Training Set:

• N/A. This product does not involve machine learning or a "training set."

9. How the Ground Truth for the Training Set was Established:

• N/A.

Additional Context from the Document:

• Clinical Data: The summary explicitly states: "Clinical data was not needed to support the safety and effectiveness of the subject devices."
• Substantial Equivalence: The overarching goal of this 510(k) submission is to demonstrate "substantial equivalence" to predicate devices based on intended use, indications, and performance characteristics, primarily through the pre-clinical engineering and laboratory testing described.
• Technological Characteristics: The augment devices use the same titanium alloy, sterilization method, porous structure, and manufacturing as previous cleared devices. Key differences identified are geometry, size offering, and additive manufacturing method (Ti-6Al-4V).

Ask a specific question about this device