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Devine Spinal System is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. It provides stabilization and immobilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: (1) trauma (i.e. fracture or dislocation), (2) curvatures (scoliosis, kyphosis, and/or lordosis), (3) spinal tumor, (4) failed previous fusion (5) pseudarthrosis, (6) spinal stenosis. It is not intended for pedicle screw fixation above TS.

The proposed devices of Devine Spinal System is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. It provides stabilization and immobilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: (1) trauma (i.e. fracture or dislocation), (2) curvatures (scoliosis, kyphosis, and/or lordosis), (3) spinal tumor, (4) failed previous fusion (5) pseudarthrosis, (6) spinal stenosis.

It is made of Titanium Alloy (Ti-6AL-4V), which meet ASTM F136-02a, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, which are widely used for surgical implants with well known biocompatibility.

The proposed device includes three models, which are TL5.5, TL6.0 and TL6.35. All models use the same material, and same design principle. The only difference is the parts size which does not affect the design. There is no surface modified or coated.

The proposed device consists of the following components: FAS, Reduction FAS, Spine Hook, Rod and Crosslink Plate

The proposed devices are not provided sterile. It is required to be sterilized via autoclave method to reach a SAL of 100 by the hospital prior to surgery. The sterilization method is presented in the user manual, which was validated per 150 17665-1: 2006 Sterilization of health care products -- Moist heat - Part 1: Requirements for the development, validation, and routine control of a sterilization. process for medical devices.

The provided text describes a medical device, the "Devine Spinal System," and its submission for 510(k) clearance. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel effectiveness through clinical studies with acceptance criteria based on performance metrics like sensitivity or specificity.

Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes for test sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details cannot be fully provided from the given document.

The document details a non-clinical bench test study to demonstrate that the device meets design specifications and is substantially equivalent to a predicate device, not a study to prove acceptance criteria based on clinical performance metrics.

Here is what can be extracted and inferred based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

• Note: The acceptance criteria here are based on meeting the requirements of the ASTM F1717-09 standard for spinal implant constructs in a vertebrectomy model, not clinical performance metrics. The reported performance is a statement of compliance and substantial equivalence to a predicate device, not specific quantitative results for each test.

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

• The document describes bench tests conducted to verify mechanical performance, not a test set for assessing clinical performance using patient data. Therefore, the concept of "test set" in the context of clinical data provenance (country of origin, retrospective/prospective) is not applicable here.
• The sample sizes for the mechanical tests (e.g., number of implant constructs tested) are not specified in the provided text.

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

• This question is not applicable as the study described is a non-clinical bench test of mechanical properties, not an evaluation of a diagnostic or assistive device requiring expert consensus for ground truth on patient data.

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

• This question is not applicable as the study described is a non-clinical bench test of mechanical properties. Adjudication methods are typically used for establishing ground truth from expert interpretations of clinical data.

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, an MRMC comparative effectiveness study was not done. The device is an orthopedic implant (spinal system), not an AI-assisted diagnostic or imaging device.

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

• No, a standalone performance study in the context of an algorithm or AI was not done. The device is a physical spinal system.

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

• For the bench tests, the "ground truth" would be the physical properties and performance characteristics defined by the ASTM F1717-09 standard. The device's components were also made from Titanium Alloy (Ti-6AL-4V) meeting ASTM F136-02a, which serves as a material "ground truth" for biocompatibility and material properties.

8. The sample size for the training set

• This question is not applicable. There is no "training set" as this is a physical medical device undergoing mechanical bench testing, not an AI or machine learning model.

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

• This question is not applicable for the same reasons as point 8.

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