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The Half Dome Posterior Lumbar Intervertebral body fusion body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L1-L2 to L5-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 at the involved level(s). Half Dome implants are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

The Half Dome Posterior Lumbar Interbody devices are implants developed for the substitution of the classical autogenous bone graft blocks They are available in a range of footprints and heights to suit the individual pathology and anatomical conditions of the patient. The implants have a hollow center to allow placement of autogenous bone graft. The Half Dome cages are designed to be used in conjunction with supplemental spinal fixation instrumentation.

This document describes the Half Dome Posterior Lumbar Interbody System, a medical device, and does not provide information about an AI/ML powered device. Therefore, the questions related to AI/ML specific criteria (such as AI performance, training/test sets, ground truth establishment by experts, adjudication, or MRMC studies) are not applicable.

The acceptance criteria and study information provided pertain to the non-clinical testing performed to demonstrate substantial equivalence to predicate devices, as is typical for 510(k) submissions of this nature where clinical studies are not performed.

Here's the information based on the provided text, focusing on the device's substantial equivalence:

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

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

• Test Set Sample Size: Not explicitly stated in terms of a "sample size" for a clinical or AI test set. Non-clinical testing typically involves a set number of physical samples for each test (e.g., several implants for compression testing). The document does not specify the number of implants tested for each mechanical test.
• Data Provenance: The data is derived from non-clinical bench testing (mechanical tests) performed by the manufacturer, Astura Medical. There is no information on country of origin for this testing, nor is it retrospective or prospective in the clinical sense.

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. The ground truth for this device's acceptance is established through compliance with established ASTM standards for mechanical testing and comparison to legally marketed predicate devices, not through expert consensus on interpretation of data like in an AI/ML context.

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

• Not Applicable. Adjudication methods are relevant for clinical studies or expert consensus, which were not performed for this 510(k) submission.

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:

• Not Applicable. This is not an AI-powered device, and no MRMC study was performed.

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

• Not Applicable. This is not an AI-powered device.

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

• For the non-clinical tests, the "ground truth" is defined by the performance requirements and methodologies outlined in the specified ASTM standards (e.g., ASTM F2077, ASTM F2267) and the performance characteristics of the identified predicate devices. The substantial equivalence argument posits that if the new device performs within acceptable limits established by these standards and similar to the predicate devices, it is safe and effective for its intended use.

8. The sample size for the training set:

• Not Applicable. This is not an AI-powered device.

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

• Not Applicable. This is not an AI-powered device.

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The Endoskeleton® TL IBD is indicated for use in spinal fusion procedures 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 with the devices. This device is intended for use supplemental fixation systems cleared for use in the lumbar spine. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). Patients with non-fusion spinal surgery at the involved level(s) may be treated with the device. It is indicated to be used with autograft bone.

The Endoskeleton® TL Interbody Fusion Device (IBD) implants are available in a various sizes with a variety of lordotic angles (0, 7 or 12 degrees), to accommodate patient anatomy. Lengths range from 40 to 60mm, widths from 18 to 26m and heights range from 8 to 16mm. Endoskeleton® TL IBD implants are intended for treatment in Lateral Lumbar Interbody Fusion used in single placement treatment placed across the disc space, and are designed with a farge hollow region in the center to house bone graft material. The new bone formation through the implant is intended to provide long-term structural support and biologic fusion at the implanted disc space. The design incorporates "windows" through the implant to permit visualization of the graft material and over time formation of new bone. The superior and inferior surfaces are acid etched to improve fixation to the adjacent bone. An implant holding feature has been incorporated into the trailing surface of the implant to mate with the implant holder, and to facilitate placement of the interbody space. All implantable components are manufactured from medical grade titanium alloy (Ti-6Al-AV-ELI).

Here's an analysis of the provided text regarding the Endoskeleton® TL Interbody Fusion Device, focusing on acceptance criteria and supporting studies:

It's important to note that this document is a 510(k) Summary for a medical device seeking clearance, not a detailed research paper. Therefore, the depth of information regarding clinical studies, ground truth establishment, and expert qualifications is much less than what would be found in a peer-reviewed publication. The focus of a 510(k) is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to prove absolute safety and effectiveness through extensive clinical trials for a novel device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify a "test set" in the context of human subjects or clinical data. The performance testing described (mechanical testing) likely used device prototypes or manufactured samples. The number of samples for each mechanical test is not provided.
• Data Provenance: Not applicable in the context of a clinical test set. The mechanical testing was performed in vitro, presumably by Titan Spine, LLC or a contracted lab. There is no mention of country of origin for clinical data, as no clinical study is detailed.
• Retrospective/Prospective: Not applicable, as no clinical study is described. The mechanical tests are inherently retrospective in the sense that they are performed on manufactured devices.

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

• This information is not provided in the document. For mechanical testing, the "ground truth" is typically defined by the test standards (ASTM F2077, ASTM F2267) and the performance of the predicate device. There were no human experts establishing a clinical ground truth for this type of submission.

4. Adjudication Method for the Test Set

• This information is not provided and is not applicable to the type of mechanical performance testing described. Adjudication methods are typically used in clinical studies for interpreting ambiguous findings, which is not the case here.

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. This device is a physical intervertebral fusion device, not an AI software or diagnostic imaging tool that would involve human readers or AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• No, a standalone performance study was not done. This refers to AI algorithms. The device is a physical implant.

7. The Type of Ground Truth Used

• For the mechanical testing, the "ground truth" was established by established ASTM standards (F2077, F2267) and the performance characteristics of the legally marketed predicate devices. The goal was to demonstrate that the subject device met or exceeded the performance of the predicates under these standardized conditions.

8. The Sample Size for the Training Set

• This information is not applicable. "Training set" refers to data used to train machine learning models. This device is a physical implant, and the submission does not involve AI or machine learning.

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

• This information is not applicable. As there is no AI component, there is no training set or associated ground truth.

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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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