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The Adaptive Wedge is intended to be used for internal bone fixation for small bone fractures or osteotomies in the ankle and foot such as:

• Opening wedge osteotomies of Hallux Valgus
• Evans lengthening osteotomies .
• · Cotton osteotomy

This device is intended for use with ancillary fixation and is not intended for use in the spine.

The Adaptive Wedge has a distinct design to help facilitate bony integration once implanted. It has angular teeth to prevent backing out. It is offered in varying widths and thicknesses to accommodate a variety of small bone applications.

Materials:
PEEK Optima LT1 per ASTM F2026. Titanium alloy per ASTM F136.

Function:
Used for angular correction of gaps and bony voids of small bones in the ankle and foot.

The provided text describes a 510(k) submission for the "Adaptive Wedge" bone fixation device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than de novo clinical studies with acceptance criteria in the traditional sense of AI/software performance.

Therefore, the requested information elements related to AI and software performance, such as sample sizes for test sets and training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types (pathology, outcomes data), are not applicable to this document as it pertains to a physical medical device.

The study presented here is a non-clinical study involving mechanical testing, not a clinical study on human subjects or an AI/software performance study.

Here's a breakdown of the applicable information:

1. Table of "Acceptance Criteria" and Reported Device Performance:

Since this is a substantial equivalence claim for a physical bone wedge, the "acceptance criteria" are implied by meeting the performance of the predicate devices. The performance is reported through mechanical tests.

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

• Sample Size for Test Set: Not specified in the document. The testing refers to mechanical properties of the device itself, not a test set of data.
• Data Provenance: Not applicable in the context of clinical or AI data. The "data" comes from engineering/benchtop mechanical testing of the device.

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

• Not Applicable. Ground truth, in the context of clinical or AI studies, refers to a definitive diagnosis or outcome. For a physical device, the "ground truth" for mechanical properties would be established through standardized engineering test methods and observed physical characteristics, not expert consensus on medical data.

4. Adjudication Method for the Test Set:

• None. Not applicable to mechanical testing of a physical device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No. No clinical studies, let alone MRMC studies, were performed.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:

• No. This is a physical bone wedge, not an algorithm.

7. Type of Ground Truth Used:

• Mechanical Test Results against Predicate Performance. The "ground truth" for demonstrating substantial equivalence was the performance of predicate devices in specific mechanical tests. The Adaptive Wedge's performance in these same tests was then compared to show equivalence.

8. Sample Size for the Training Set:

• Not Applicable. This is a physical device, not an AI model requiring a training set.

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

• Not Applicable. No training set was used.

Summary of Relevant Study Information from the Document:

• Study Type: Non-clinical (mechanical) testing.
• Purpose: To demonstrate substantial equivalence to predicate devices (BIOFOAM™ Bone Wedge, K073535 / K093950).
• Tests Performed:
  • Static compression testing
  • Dynamic compression testing
  • Determination of the coefficient of friction
  • Determination of subsidence and debris generation during static and dynamic compression-shear testing
• Conclusion: The tests indicated that the Adaptive Wedge is equivalent to the predicate devices in terms of mechanical safety and performance.
• Clinical Studies: None were performed.

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Fusion Advantage Cervical Cages are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radioular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Fusion Advantage Cervical Cages are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C3 to C7 disc levels using autograft bone. Fusion Advantage Cervical Cages are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

The Fusion Advantage Lumbar Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Fusion Advantage Lumbar Cage implants are to be used with autogenous bone graft and implanted via an open posterior, transforaminal or an lateral approach. The Fusion Advantage Lumbar Cages are to be used with supplemental fixation. Patients should have at least (6) months of non-operative treatment prior to treatment with an intervertebral cage. Patients with previous nonfusion spinal surgery at involved level may be treated with the device.

The Adaptive Specialty Fusion Advantage cervical cage was developed as an intercorporal implant for anterior cervical spondylodesis. The Fusion Advantage System was especially adapted to the local anatomy in order to secure the surgical result as well as possible. Its inferior and superior sides are flat with ridges on both surfaces to prevent migration. The implant is oval shaped with a large central graft space to help facilitate bony integration once implanted. In the lateral view, the implant has a 2.5° lordotic form.

The Adaptive Specialty Fusion Advantage Lumbar cage was developed as an implant for the posterior stabilization of the lumbar spinal column. The Adaptive Specialty Fusion Advantage implant has ridges on both its inferior and superior surfaces to prevent migration. It is a rectangular shape with a large rectangular graft space and lateral holes help facilitate bony integration once implanted.

Materials: PEEK-OPTIMA LT1 polymer (ASTM F2026 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications)

Function: To maintain disc space distraction in skeletally mature adults requiring intervertebral body fusion.

The provided text describes the Fusion Advantage Interbody Cages, a medical device for spinal fusion. However, it does not contain information about a study proving the device meets acceptance criteria in the context of AI/ML performance metrics, or clinical study data.

The relevant sections of the document are a 510(k) Summary and the FDA's clearance letter. These documents focus on demonstrating substantial equivalence to previously cleared devices based on non-clinical tests (mechanical strengths) and intended use, not on a study with acceptance criteria related to AI/ML or human reader performance.

Therefore, I cannot provide a table of acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, or details about MRMC or standalone studies, as this information is not present in the provided text.

The document primarily states:

• 7. Summary of Nonclincal Tests: "Tests performed according to ASTM F2077/F2267 indicate that the Interbody Fusion Advantage Interbody Cages meet required mechanical strengths."

This indicates that the acceptance criteria are related to mechanical strength tests defined by ASTM standards, and the device met these engineering standards. The document does not elaborate on specific numerical acceptance criteria or detailed results of these tests, beyond stating they were met.

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