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510(k) Data Aggregation
(22 days)
Medussa-PL Cage
The Medussa-PL Cage 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 Medussa-PL Cage is an interbody fusion device utilized to facilitate the fusion process in the lumbar spine. The Medussa-PL Cage is additively manufactured from Titanium Alloy (Ti-6Al-4V) according to the ASTM F3001 and is available in a range of sizes to accommodate different patient anatomies, and pathologies.
I am sorry, but based on the provided text, I cannot provide the requested information. The document is a 510(k) clearance letter for a medical device (Medussa-PL Cage) and does not contain details about:
- Acceptance criteria and reported device performance: The document mentions "engineering analysis and the performance testing result" but does not provide specific acceptance criteria or quantitative performance data.
- Study design details: There is no mention of sample sizes, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, or standalone algorithm performance.
- Ground truth information: While it states the device is for Degenerative Disc Disease (DDD) confirmed by "patient history and radiographic studies," it doesn't elaborate on how ground truth was established for any assessment studies, nor does it specify training set details.
The document primarily focuses on establishing substantial equivalence to a predicate device based on general similarities in design, materials, function, and indications for use, rather than presenting a detailed clinical or performance study with quantified acceptance criteria.
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(135 days)
Medussa-PL Cage
The Medussa-PL Cage 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 1 spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone.
The Medyssey, Medussa-PL Cage is an interbody fusion device utilized to facilitate the fusion process in the lumbar spine. The cage is additively manufactured from titanium alloy (ASTM F136 and ASTM F3001) and is available in a range of sizes to accommodate different patient anatomies and pathologies.
The provided document is a 510(k) summary for the Medussa-PL Cage, an intervertebral body fusion device. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific acceptance criteria based on performance studies with human readers or clinical outcomes.
Therefore, many of the requested sections (2, 3, 4, 5, 6, 7, 8, 9) regarding study design, sample sizes, expert involvement, multi-reader studies, and ground truth establishment cannot be answered from the provided text, as this information is not typically part of a 510(k) summary for a spinal implant device unless specific clinical or performance studies were required.
Here's the information that can be extracted or deduced from the document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in terms of clinical performance metrics like sensitivity, specificity, or inter-reader agreement, which are common for AI/diagnostic devices. Instead, for this type of implantable medical device, the "acceptance criteria" are implicitly related to demonstrating substantial equivalence to a previously cleared predicate device. This is primarily done through engineering analysis comparing design, materials, function, and performance.
| Criterion Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Substantial Equivalence | The subject device must be substantially equivalent to the predicate device in terms of indications, design, materials, function, and performance. | "The subject Medussa-PL Cage is substantially equivalent to the primary predicate, the Medussa-PL Cage (K170341), with respect to indications, design, materials, function, and performance." |
| Engineering Performance | Based on accepted engineering principles and testing (e.g., mechanical testing, material characterization, CAD analysis). | "Engineering CAD analyses including a comparison of device dimensions and materials concluded that based on the similarities in device design, the subject and predicate devices are substantially equivalent with respect to performance since both products have the same dimensions, material, area and bone graft lumen capacity." (Note: The document implies these analyses were performed and support the equivalence claim, but doesn't detail the specific results numbers). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is not a study involving a "test set" of patient data for evaluating diagnostic performance. The evaluation is based on engineering analyses and comparison to a predicate device.
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. No ground truth for a test set was established in the context of a diagnostic performance study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set requiring expert adjudication was used.
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. The device is a spinal implant, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The evaluation is based on engineering and material standards, and comparison to a predicate device, not on clinical efficacy measured against a ground truth from patient outcomes or pathology, which would typically be part of a PMA (Premarket Approval) submission rather than a 510(k). For a 510(k), the "truth" is established by demonstrating equivalence to a legally marketed device.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/machine learning device.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The study that "proves" the device meets the acceptance criteria (i.e., is substantially equivalent to a predicate) is described as Engineering CAD analyses and a comparison of device dimensions and materials. This analysis concluded that the subject device (Medussa-PL Cage) and the predicate device (Medussa-PL Cage K170341) have the "same dimensions, material, area and bone graft lumen capacity." This demonstration of equivalence across key design and material components, along with the same Indications for Use, is considered sufficient for 510(k) clearance for this type of implantable device.
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(272 days)
Medussa-PL Cage
The Medussa-PL Cage 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 1 spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone.
The Medussa-PL Cage is comprised of a variety of implant sizes and instrumentation to accommodate various patient anatomy and pathology. All implantable components are manufactured with an additive manufacturing technology from medical grade titanium alloy Ti6Al4V-ELI per ASTM F136 and ASTM 3001. The cages are intended to be implanted via a Posterior Lumbar Intervertebral (PLIF) approach. Implants are single use and the system is provided sterile.
The provided text describes a medical device, the "Medussa-PL Cage," and its 510(k) premarket notification to the FDA. The submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria for a novel algorithm or AI.
Therefore, the requested information regarding acceptance criteria, study details (sample size, data provenance, expert ground truth, adjudication, MRMC study, standalone performance), training set specifics, and specific performance metrics for an AI/algorithm-based device cannot be extracted from this document.
This document outlines the regulatory approval process for an intervertebral body fusion device and its physical performance testing, not the performance of an AI application.
Here's an explanation of why the requested information is not available in the provided text:
- Type of Device: The "Medussa-PL Cage" is an intervertebral body fusion device, a physical implant used in spinal surgery. It is not an AI or algorithm-based software device.
- Regulatory Pathway: The document describes a 510(k) premarket notification, which is a pathway for devices that are "substantially equivalent" to legally marketed predicate devices. This process primarily involves demonstrating that the new device has the same intended use, indications for use, technological characteristics, and safety/effectiveness profiles as an already approved device. It does not typically involve defining and testing against specific acceptance criteria for an AI's diagnostic or predictive performance.
- Performance Data Provided: The "Performance Data" section details mechanical testing such as static and dynamic axial compression, compression shear, static torsion, subsidence, expulsion, and abrasion. These tests are relevant to the physical properties and structural integrity of an implant, not the accuracy or reliability of an AI algorithm.
- Ground Truth and Experts: The concepts of "ground truth," "experts," "adjudication," and "human-in-the-loop performance" are specific to the evaluation of AI/algorithm performance. They are not applicable to the physical testing of an implant.
Therefore, I cannot fulfill the request for a table of acceptance criteria and device performance as it pertains to AI, nor any of the other AI-specific study details, because the provided document is not about an AI device.
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