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The Blustone Synergy cervical (Slate Lavaflow) implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of carcellous bone graft when used as an adjunct to fusion in patients with cervical disc disease (DDD) at one level or two contiguous levels from C2 to T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six weeks of non-operative treatment. The Blustone Synergy cervical implants are also to be used with supplemental fixation.

The Blustone Synergy lumbar (Lavaflow) implants are intervertebral body fusion devices indicated for use with autograff and/or allogenic bone graft comprised of cancellous bone graft when used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of non- operative therapy. Additionally, the Blustone Synergy lumbar implants can be used as an adjunct to fusion in patients diagnosed with degenerative scolosis. The Blustone Synergy lumbar implants are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.

The Blustone Synergy Interbody Fusion System is composed of cervical and lumbar interbody fusion devices. The BluStone Synergy Slate Lavaflow System is a Titanium Plasma Coated cervical interbody fusion system comprised of parallel and 6° lordotic cages in two footprints with varying heights designed to accommodate patient anatomy, and may be implanted as a single device via an anterior approach. The Blustone Synergy Lumbar Interbody Lavaflow System is a Titanium Plasma Coated lumbar interbody fusion system comprised of various device configurations based on surgical approach and patient anatomy, and may be implanted via one of the following approaches: bi-laterally in pairs via a posterior (PLIF) approach; as a single device via a transverse (T-PLIF) approach; as a single device via a transforaminal (TLIF) approach; or as a single device via a lateral (LLIF) approach.

All Blustone Synergy Interbody Fusion System implant components are made of polyether-ether-ketone (Zeniva ZA-500 PEEK) that conforms to ASTM F2026. Additionally, the devices contain tantalum markers (ASTM F560) to assist the surgeon with proper placement of the device.

This Traditional 510(k) submission seeks to expand the sizes offered for the MAGMA LLIF cages as well as add commercially pure (CP) titanium plasma coating per ASTM F1580 to the subject new MAGMA cages as well as all previously cleared cervical and lumber interbody fusion devices. Plasma-coated implant options will be denoted as the LAVAFLOW subfamily. Finally, this submission seeks to offer all implants as sterile devices via sterilization by ethylene oxide (EO) in addition to the previously cleared non-sterile, non-coated options.

The provided text is a 510(k) summary for the Blustone Synergy Interbody Fusion System. It describes the device, its indications for use, and a comparison to predicate devices to establish substantial equivalence. However, it does not contain information about specific acceptance criteria or a detailed study proving the device meets those criteria with statistical data, sample sizes, ground truth establishment, or expert involvement as requested in the prompt.

The document primarily focuses on demonstrating substantial equivalence to previously cleared devices through:

• Comparison of Indications for Use, Materials, and Geometry: Stating that these aspects are "all-inclusive of the subject device" compared to predicates.
• Performance Testing: Mentioning that mechanical testing (expulsion, dynamic compression per ASTM F2077, and wear debris analysis per ASTM F1877) has been performed and "the results have shown them to be substantially equivalent to the predicate interbody devices." It also notes an "engineering rationale" for new MAGMA small IBDs.

Therefore, I cannot fulfill your request for a table of acceptance criteria, reported device performance, sample sizes, data provenance, expert ground truth details, adjudication methods, MRMC study information, or standalone algorithm performance, as this information is not present in the provided text.

The document concludes that "Based on the test results and the comparison to the predicate devices, the subject device is determined to be substantially equivalent to the predicate devices," which is the central finding of a 510(k) submission. However, the specifics of these "test results" in terms of statistical metrics against predefined acceptance criteria are not detailed.

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The Synthes Radial Head Prosthesis System is intended for:

1. The replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with
   a. Joint destruction and/or subluxation visible on x-ray
   b. Resistance to conservative treatment
2. Primary replacement after fracture of the radial head.
3. Symptomatic sequelae after radial head resection
4. Revision following failed radial head arthroplasty.

The Synthes Radial Head Prosthesis is a two-piece modular system comprised of titanium alloy stem and cobalt chrome head components with an integral screw and side-loading application to allow for in situ assembly. The system consists of a range of lengths and diameters for the stem in both straight and curved configurations as well as heads in a range of diameters and heights to accommodate the surgical need.

This document is a 510(k) Summary for the Synthes Radial Head Prosthesis System. It is focused on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and conducting a study to prove performance against those criteria in the way one might for a novel diagnostic or AI device.

Therefore, many of the specific questions regarding acceptance criteria, device performance metrics (e.g., sensitivity, specificity), sample sizes, ground truth establishment, expert qualifications, and MRMC studies are not directly applicable or explicitly detailed in this type of submission for a medical implant device.

However, I can extract the relevant information regarding the performance testing and the approach to demonstrating substantial equivalence.

Here's an analysis based on the provided text, addressing the applicable points and explaining why others are not present:

Context: The Synthes Radial Head Prosthesis System is a medical implant (a modular radial head prosthesis) intended for the replacement of the radial head in specific orthopaedic conditions. The 510(k) submission aims to demonstrate that this new device is "substantially equivalent" to existing, legally marketed predicate devices. This means it has the same intended use, fundamental technological characteristics, and similar materials, and that performance testing shows it is as safe and effective as the predicates.

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

The document does not explicitly present a table of quantitative acceptance criteria for performance metrics typical of, for example, diagnostic accuracy (like sensitivity, specificity, AUC). Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to predicate devices through various tests and analyses.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: The document does not specify a "sample size" in terms of patients or anatomical specimens as one would for a clinical trial or diagnostic study. The "test set" here refers to the actual physical devices (or components thereof) that underwent in vitro performance testing and surface analysis. The number of such devices or samples tested is not disclosed in this summary.
• Data Provenance: The tests are described as "in vitro performance testing," "Macro Surface Analysis," "Scanning Electron Microscopy (SEM)," and "X-Ray Photoelectron Spectroscopy (XPS)." These are laboratory-based studies, not clinical studies involving patient data from specific countries or populations. The data provenance is controlled laboratory conditions.

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 to this type of device submission. The "ground truth" for a mechanical implant is its physical and mechanical properties, not expert-derived diagnostic labels. The performance is assessed through engineering and materials science testing, not clinical diagnosis by experts.

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

• This question is not applicable. Adjudication methods are typically used to resolve discrepancies in expert interpretations of clinical data or images. This submission focuses on the objective physical and mechanical properties of an implant.

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 question is not applicable. The device is a physical implant, not a diagnostic imaging or AI algorithm that would involve human readers or AI assistance.

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

• This question is not applicable. The 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 established by engineering and materials science standards and measurements. This includes:
  • Mechanical properties: The ability to withstand clinical loads.
  • Material properties: Chemical composition and physical and macro/micro surface characteristics.
  • Peer-reviewed literature: Used to demonstrate how these material and surface characteristics relate to physiological responses.

8. The sample size for the training set

• This question is not applicable. There is no concept of a "training set" in the context of this 510(k) submission for a physical implant. The design and manufacturing processes are based on engineering principles and prior knowledge from predicate devices, rather than machine learning training.

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

• This question is not applicable, as there is no training set. The "ground truth" for the device's design and material selection would be established through established engineering principles, materials science, and conformity to relevant ASTM/ISO standards (though specific standards are not named in this summary).

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The Endoskeleton® TT IBD is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device must be used with supplemental fixation. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone.

The Endoskeleton® TT IBD is comprised of a variety of implant sizes to accommodate various patient anatomy and pathology, and associated instrumentation. All implantable components are manufactured from medical grade titanium alloy (Ti6A14V-ELI),

While the provided document is a 510(k) summary for the Endoskeleton® TT IBD, it does not contain the type of detailed information typically found in an AI/Software as a Medical Device (SaMD) study for performance evaluation.

This document describes a medical device (an intervertebral fusion device) which is a physical implant, not an AI software. The "Performance Testing" mentioned refers to pre-clinical testing for the physical device's adequacy (likely mechanical, biocompatibility, etc.), not a clinical study involving human readers or AI algorithms as would be the case for a SaMD.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details from this document. These types of details are specific to the evaluation of AI or software-based medical devices.

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