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The Genesys Spine AIS-C Cervical Anchored Interbody System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one-disc level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The system is designed for use with supplemental fixation (i.e. cleared cervical plating system) and with autograft to facilitate fusion. These patients should have had six weeks of non-operative treatment.

The Genesys Spine AIS-C Cervical Anchored Interbody System includes PEEK interbodies and titanium interbodies, which utilize an integrated titanium alloy locking mechanism. Both PEEK interbodies and titanium interbodies are to be anchored to patient anatomy via two (2) titanium allov bone anchors. The Cervical Anchored Interbody System (AIS-C) was designed to provide additional biomechanical strength to traditional ACDF procedures through integrated fixation combined with supplemental fixation.

The provided text describes a 510(k) premarket notification for a medical device, the Genesys Spine AIS-C Cervical Anchored Interbody System. This document focuses on demonstrating substantial equivalence to predicate devices primarily through non-clinical (mechanical) testing. It does not contain information about a study involving human-in-the-loop performance, AI assistance, or the establishment of ground truth by medical experts for a diagnostic or AI-powered device. Therefore, many of the requested items (e.g., sample size for test/training sets, expert qualifications, MRMC studies, standalone AI performance) are not applicable or cannot be extracted from this document.

However, I can extract information related to the acceptance criteria and the (mechanical) study that proves the device meets those criteria.

Here's a breakdown of the available information:

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

The acceptance criterion for the mechanical tests was set as follows:

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: Not explicitly stated as a numerical sample size. The document mentions "all possible configurations of the AIS-C System constructs were analyzed in order to determine the worst case to be used for testing." This implies a selection of specific configurations for mechanical testing rather than a statistical sample size in the context of human data.
• Data Provenance: The data is from non-clinical mechanical testing, not human or patient data. Therefore, country of origin or retrospective/prospective classification is not applicable in the typical sense. The testing was conducted to U.S. standards (ASTM).

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 describes mechanical testing of a medical implant, not a diagnostic device or AI system that requires expert-established ground truth from medical images or patient data. The "ground truth" here is the physical performance against established industry standards and predicate device performance.

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

• Not Applicable. Pertains to human review of data, not mechanical testing.

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:

• No. This was not an MRMC study and did not involve human readers or AI assistance.

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

• No. This device is a physical 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 objective mechanical testing per established ASTM standards (F2077-11 for static and dynamic axial compression, compressive-shear, and torsion; F2267-04 for static subsidence; and ASTM draft standard F-04.25.02.02 for expulsion testing). The "truth" is whether the device meets or exceeds the mechanical performance of predicate devices.

8. The sample size for the training set:

• Not Applicable. This is not an AI or machine learning device.

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

• Not Applicable. This is not an AI or machine learning device.

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The Choice Spine Acapella Cervical Spacer System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease at one disc level from C2-T1. Degenerative Disc Disease (DDD) is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Choice Spine Acapella Cervical Spacer System is to be used with autogenous bone graft and supplemental fixation (i.e., an anterior cervical plate), and is implanted via an open, anterior approach.

The Choice Spine Acapella Cervical Spacer System is an anterior cervical interbody device consisting of a PEEK (polyetherethertone) implant cage with tantalum radiographic markers and two titanium alloy internal anchors. It is intended for use as an interbody fusion device and is offered in a variety of heights, footprints, and lordotic angles to accommodate varying anatomical conditions. The Choice Spine Acapella Cervical Spacer System is to be used with autogenous bone graft and supplemental fixation (i.e., an anterior cervical plate), and is implanted via an open, anterior approach. Acapella Cervical Spacer System implants are composed of PEEK Optima Grade LT1, Ti-6Al-4V, and tantalum. The body of the implant is composed of PEEK Optima Grade LT1 (ASTM 2026). The PEEK Optima Grade LT1 used in Acapella implants is manufactured using the same processes used to manufacture Acapella One implants (K132582). The material used to construct the anchors is titanium alloy Ti-6Al-4V per ASTM F136, which has a long history of safe and effective use in orthopedic implants. The radiographic markers are composed of tantalum per ASTM F560, which has a long history of safe and effective use in orthopedic implants. The locking pins are composed of nitinol per ASTM F2063, which has a long history of safe and effective use in orthopedic implants. The Acapella Cervical Spacer System is accompanied by a complete instrumentation system to assist the surgeon in the implantation of the device.

The provided document is a 510(k) premarket notification for the Acapella Cervical Spacer System, which is an intervertebral body fusion device. This type of regulatory submission typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical trial data with acceptance criteria for device performance in diagnosis or treatment.

Therefore, the document does not contain information about:

1. A table of acceptance criteria and reported device performance related to diagnostic accuracy or clinical outcomes.
2. Sample size used for the test set or data provenance for such a study.
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication method for a test set.
5. A multi-reader multi-case (MRMC) comparative effectiveness study.
6. A standalone (algorithm only) performance study.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. Sample size for a training set.
9. How the ground truth for the training set was established.

Instead, the performance data presented is focused on mechanical testing to demonstrate the structural integrity and equivalence of the device.

Here's the information that is available in the document regarding the device's technical performance:

Acceptance Criteria and Reported Device Performance (Mechanical Testing)

The document states: "The results of this non-clinical testing show that the strength of the Cervical Spacer System is substantially equivalent to the legally marketed predicate devices." This implies that the acceptance criteria for these mechanical tests were that the device's performance should be comparable or equivalent to the predicate devices. Specific numerical acceptance criteria are not provided, nor are the specific numerical results of the tests.

Study Details (Mechanical Testing):

• Type of Study: Non-clinical mechanical testing.
• Tests Performed:
  • Static axial compression per ASTM F2077-11
  • Static compressive shear per ASTM F (standard number incomplete in document)
  • Static torsion per ASTM F2077-11
  • Static subsidence per ASTM F2267-04
  • Static expulsion per ASTM F-04.25.02.02 (draft)
  • Dynamic axial compression bending per ASTM F2077-11
  • Dynamic compressive shear per ASMT F2077-11
  • Dynamic torsion per ASTM F2077-11
  • Custom static tension testing
• Sample Size: Not specified for each test.
• Data Provenance: Not applicable in the context of mechanical testing.
• Ground Truth: The "ground truth" for mechanical testing is established by the specified ASTM standards, which define the testing methodology and expected performance characteristics for such devices.
• Training Set: Not applicable as this is not an AI/algorithm-based device and no training set would be used for mechanical testing.
• Adjudication/Multi-reader/Standalone: Not applicable for mechanical testing.

In summary, this document demonstrates substantial equivalence through mechanical testing according to recognized standards, rather than through clinical studies involving diagnostic accuracy or clinical outcomes.

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