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The CASCADIA implants are indicated for use with autogenous bone graft as intervertebral body fusion devices in skeletally mature patients. The implants are intended for use at either one level or two contiguous levels, from L2 to S1, for the treatment of degenerative disease (DDD) with up to Grade 1 spondvlolisthesis or retrolisthesis at the involved levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar implants are intents who have had six months of non-operative treatment.

For all the above indications the CASCADIA implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including K2M Pedicle Screw and K2M Spinal Plate Systems.

The subject submission describes the Cascadia Interbody System. The implants consist of hollow tube structures made of titanium alloy. The devices are available in a variety of different sizes and heights to match more closely the patient's anatomy. The purpose of the subject submission is for a line addition to the lumbar intervertebral body fusion devices previously cleared in the K2M Aleutian Intervertebral Body Fusion System, to include implants additively manufactured from titanium alloy.

Function: The system functions as an intervertebral body fusion device to provide support and stabilization of the lumbar segments of the spine.

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that a device meets those criteria. The document is an FDA 510(k) clearance letter for the Cascadia Interbody System, which focuses on demonstrating substantial equivalence to previously marketed predicate devices rather than providing detailed performance data against specific acceptance criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on this document.

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The Camber Spine Technologies TLS 5.0 Interbody 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. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Camber Spine Technologies TLS 5.0 Interbody Cage is to be used with autologous bone graft and implanted via an open transforaminal or posterior approach.
Camber Spine Technologies TLS 5.0 Interbody Cage implants are to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

Camber Spine Technologies, TLS 5.0 Interbody Cage is a device for interbody fusion of the anterior column of the spine. These cages are hollow so that bone can grow through the device, fusing the adjacent bony surfaces.
Camber Spine Technologies, TLS 5.0 Interbody Cage is a hollow device with texture on two opposing convex sides, and is offered in various lengths, widths, heights and shapes. Camber Spine designed the Camber Spine Technologies, TLS 5.0 Interbody Cage to be placed through a transforaminal or posterior approach and to address vertebrae in the lumbosacral region of the spine.

The provided text describes the Camber Spine Technologies TLS 5.0 Interbody Cage, a medical device, and its regulatory submission. It does not describe an AI or algorithm-based device. Therefore, many of the requested details, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set information, are not applicable or cannot be extracted.

However, the document does contain information regarding acceptance criteria and the studies performed to demonstrate equivalence.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

• Not Applicable. This document describes the non-clinical testing of a physical medical device (interbody cage) for mechanical and material properties, not an AI or algorithm. The "test set" for this context would refer to the physical units of the device subjected to the aforementioned tests. The document does not specify the number of units tested for each non-clinical test.
• Data Provenance: Not applicable in the context of AI/algorithm data provenance (country of origin, retrospective/prospective clinical data). The data provenience refers to the results of engineering and material science tests.

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

• Not Applicable. This is a physical device, and the ground truth for its performance is established through standardized ASTM tests and ISO sterilization validation, which have objective physical outcomes (e.g., force at failure, wear rates, sterilization efficacy). This does not involve expert interpretation or consensus as would be required for labeling medical images for AI.

4. Adjudication Method for the Test Set

• Not Applicable. As per point 3, the "test set" for this device's evaluation involved objective, standardized engineering tests, not subjective interpretations requiring adjudication.

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

• No. The document explicitly states: "No clinical tests were performed." Therefore, no MRMC study was conducted. Details about human reader improvement with AI assistance are not relevant here.

6. Standalone (Algorithm Only) Performance Study

• No. This is a physical interbody cage, not an algorithm or AI device. Therefore, a standalone algorithm performance study is not applicable.

7. Type of Ground Truth Used

• For the non-clinical tests (mechanical properties, wear, expulsion) and sterilization validation: Objective physical measurements and engineering standards (ASTM and ISO).
• For the overall substantial equivalence: The "ground truth" used for regulatory submission is the performance and indications for use of legally marketed predicate devices. The device's performance against the acceptance criteria (derived from standards and predicate device performance) serves as the basis for demonstrating substantial equivalence.

8. Sample Size for the Training Set

• Not Applicable. This is a physical device, not an AI/ML algorithm. There is no "training set" in this context. The "design process" for such a device would involve engineering design, material selection, and manufacturing process development, not machine learning training.

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

• Not Applicable. As per point 8, there is no training set mentioned or implied for this device.

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