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510(k) Data Aggregation
(256 days)
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(24 days)
The Spectrum Spine Expandable Titanium PLIF/TLIF System includes interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).
Spectrum Spine Expandable Titanium PLIF/TLIF System implants are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation.
The Spectrum Spine Expandable Titanium PLIF/TLIF System consists of lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. The Expandable Titanium PLIF/TLIF System implants are provided in various shapes to accommodate posterior lumbar interbody fusion (PLIF) and transforaminal lumbar interbody fusion (TLIF) surgical approaches. These implants can expand to a set height and lordosis as appropriate. The devices are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. The Expandable Titanium PLIF/TLIF System is to be filled with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion.
The Expandable Titanium PLIF/TLIF System is manufactured from titanium alloy per ASTM F136.
The system provides several footprints in multiple height and angle configurations. The cage's ability to be inserted at a nominal height and then expand to a set height and angle to fill the joint space once properly positioned minimizes damage to the bony end-plate caused by impaction.
The purpose of this special 510(k) is to gain clearance for modifications made to the Expandable Titanium PLIF/TLIF System.
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(189 days)
The Spectrum Spine Lumbar Cage System devices with roughened surface textured features, are indicated for use in skeletally mature patients with lumbar degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 – S1 whose condition requires the use of interbody fusion, confirmed by imaging studies (radiographs, CT, MRI). DDD is defined as discogenic pain with degeneration of the disc. DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). These patients should have had at least six months of nonoperative treatment. The Spectrum Spine Lumbar Cage System is indicated to be used with supplemental fixation cleared by the FDA for use in the lumbar spine and autograft bone, allograft bone comprised of cancellous and/or corticocancellous bone, demineralized allograft with bone marrow aspirate, or a combination thereof.
The Spectrum Spine Lumbar Cage System is composed of lumbar interbody fusion devices. The Spectrum Spine Lumbar Cage System is offered in multiple footprints with varying heights and lordotic angles designed to accommodate patient anatomy. Additionally, all interbody cages are offered with a smooth finish and a rough finish. The interbody devices also contain a large graft window through the body of the device to allow for placement of bone graft and facilitate fusion. All implant components are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136. The Spectrum Spine Lumbar Cage System also includes instruments to facilitate implantation of the subject implant devices. Instruments are manufactured from medical grade stainless steel.
The provided FDA 510(k) clearance letter for the Spectrum Spine Lumbar Cage System does not contain any information about a study proving the device meets acceptance criteria related to AI/ML device performance, human reader improvement with AI assistance, or the establishment of ground truth for such studies.
The document pertains to the clearance of an intervertebral body fusion device, which is a medical implant made of titanium alloy. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" described in the document relate solely to the mechanical and physical performance of the implant itself, not to the performance of an AI/ML algorithm.
Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving device performance in the context of AI/ML, as the provided text does not contain this information.
Based on the provided text, here's what can be extracted regarding the "acceptance criteria" and "study" for the physical device:
1. Table of Acceptance Criteria and Reported Device Performance (Mechanical/Physical Device):
| Acceptance Criterion (Test Type) | Standard Applied | Reported Device Performance Statement |
|---|---|---|
| Static Axial Compression | ASTM F2077-22 | "results have shown them to be substantially equivalent to the predicate interbody devices." |
| Dynamic Axial Compression | ASTM F2077-22 | "results have shown them to be substantially equivalent to the predicate interbody devices." |
| Static Compression Shear | ASTM F2077-22 | "results have shown them to be substantially equivalent to the predicate interbody devices." |
| Dynamic Compression Shear | ASTM F2077-22 | "results have shown them to be substantially equivalent to the predicate interbody devices." |
| Subsidence | ASTM F2267-22 | "results have shown them to be substantially equivalent to the predicate interbody devices." |
| Expulsion | Not explicitly stated | "results have shown them to be substantially equivalent to the predicate interbody devices." |
Note: The specific numerical performance values are not provided in this regulatory summary; only the conclusion of "substantial equivalence" is stated.
2. Sample Size and Data Provenance (Mechanical/Physical Device):
- Sample Size: Not specified in the document.
- Data Provenance: The tests are described as "Mechanical testing... performed on the subject Spectrum Spine Lumbar Cage devices." This implies laboratory testing on physical samples, not human or patient data.
Regarding your other points (relevant to AI/ML devices), the document provides NO information:
- Number of experts used to establish ground truth: Not applicable/not mentioned.
- Adjudication method: Not applicable/not mentioned.
- MRMC comparative effectiveness study: Not applicable/not mentioned.
- Standalone (algorithm-only) performance: Not applicable/not mentioned.
- Type of ground truth used: Not applicable/not mentioned (for AI/ML devices).
- Sample size for training set: Not applicable/not mentioned.
- How ground truth for training set was established: Not applicable/not mentioned.
In summary, the provided FDA clearance letter is for a physical medical device (spinal implant) and its mechanical properties, not an AI/ML diagnostic or therapeutic device. Therefore, the details requested for AI/ML device validation are not present in this document.
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(64 days)
The Spectrum Spine Cervical Cage System devices including those with macro-, micro- and nano-roughened surface textured features are indicated for use for anterior cervical interbody fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 to T1. These patients should have had at least six weeks of nonoperative treatment. The Spectrum Spine Cervical Cage System is indicated to be used with supplemental fixation cleared by the FDA for use in the cervical spine and autograft bone, allograft bone comprised of cancellous and/or corticocancellous bone, demineralized allograft with bone marrow aspirate, or a combination thereof.
The Spectrum Spine Cervical Cage System is composed of cervical interbody fusion devices. The Spectrum Spine Cervical Cage System is offered in five footprints with varying heights and lordotic angles designed to accommodate patient anatomy. Additionally, all interbody cages are offered with a smooth finish and a rough finish. The interbody devices also contain a large graft window through the body of the device to allow for placement of bone graft and facilitate fusion. All implant components are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136.
The Spectrum Spine Cervical Cage System also includes instruments to facilitate implantation of the subject implant devices. Instruments are manufactured from medical grade stainless steel.
The provided text does not contain any information about acceptance criteria or a study that proves a device meets those criteria, specifically concerning a digital health device or AI/ML product.
The document is a 510(k) clearance letter from the FDA for a Spectrum Spine Cervical Cage System, which is a physical implant used for spinal fusion. The information provided relates to the physical and mechanical properties of this implant, not a software or AI device.
Therefore, I cannot provide the requested information, as these details are not present in the given text.
To address your request, here's what the provided text does include, which is relevant to the Spectrum Spine Cervical Cage System (a physical medical device):
- Device Name: Spectrum Spine Cervical Cage System
- Intended Use: Anterior cervical interbody fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, confirmed by imaging studies, resulting in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 to T1. Patients should have had at least six weeks of nonoperative treatment. To be used with supplemental fixation and specific bone graft materials.
- Performance Testing (Mechanical): Static and dynamic axial compression, static and dynamic compression shear, static and dynamic torsion per ASTM F2077-22, as well as subsidence per ASTM F2267-22 and expulsion. The results of these tests showed the device to be substantially equivalent to predicate interbody devices.
None of the requested points (acceptance criteria for digital device, sample size for test set, data provenance, expert ground truth, adjudication, MRMC study, standalone performance, ground truth type, training set size, training set ground truth establishment) are applicable or present in this document.
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(374 days)
The Spectrum Spine Expandable PLIF/TLIF Interbody Cage System is an interbody fusion device intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Expandable PLIF/TLIF implants are to be filled with autogenous bone graft material. The device are intended to be used with supplemental fixation.
The Spectrum Spine Expandable Titanium PLIF/TLIF System consists of lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. The Expandable Titanium PLIF/TLIF System implants are provided in various shapes to accommodate posterior lumbar interbody fusion (PLIF) and transforaminal lumbar interbody fusion (TLIF) surgical approaches. These implants can expand to the desired height and varying degrees of lordosis as appropriate. The devices are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. The Expandable Titanium PLIF/TLIF System is to be filled with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion. The Expandable Titanium PLIF/TLIF System is manufactured from titanium alloy per ASTM F136. The system provides several footprints in multiple height and angle configurations. The cage's ability to be inserted at a nominal height and then expand in both height and angle to fill the joint space once properly positioned minimizes damage to the bony end-plate caused by impaction.
This document describes the FDA's 510(k) clearance for the Spectrum Spine Expandable Titanium PLIF/TLIF System, an interbody fusion device. The focus of the provided text is on demonstrating the substantial equivalence of the new device to existing predicate devices, primarily through mechanical performance testing, rather than an AI/ML-based device requiring a study proving its performance against acceptance criteria for diagnostic or prognostic tasks.
Therefore, the requested information regarding acceptance criteria and a study proving the device meets these in the context of AI/ML performance (e.g., sensitivity, specificity, reader improvement, ground truth establishment) is not applicable to this submission.
The document primarily provides the following:
1. A table of acceptance criteria and the reported device performance:
This is described in terms of mechanical testing for intervertebral fusion devices, not diagnostic performance.
-
Acceptance Criteria (Testing Modes):
- Static axial compression per ASTM F2077
- Static compression shear per ASTM F2077
- Dynamic axial compression per ASTM F2077
- Dynamic compression shear per ASTM F2077
- Subsidence per ASTM F2267
-
Reported Device Performance:
"The results of this non-clinical testing show that the strength of the Expandable Titanium PLIF/TLIF System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."
(Specific numerical results are not provided in this summary, but the conclusion of substantial equivalence based on these tests is stated.)
The remaining points (2-9) are not relevant as this is not an AI/ML device that requires a diagnostic or prognostic performance study:
- Sample size used for the test set and the data provenance: Not applicable to a mechanical device.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a mechanical device is based on engineering standards and performance in stress tests, not expert interpretation of medical images or data.
- Adjudication method for the test set: Not applicable.
- 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 a physical implant, not a diagnostic AI tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's performance is its ability to withstand mechanical forces according to established ASTM standards, indicating its structural integrity and safety for its intended use, as compared to predicate devices.
- The sample size for the training set: Not applicable. No AI model involved.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document is a 510(k) clearance letter for a Class II medical device (surgical implant) based on substantial equivalence through mechanical testing, not an AI/ML device requiring clinical performance evaluation against specific diagnostic or prognostic metrics.
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(478 days)
The Spectrum Spine Expandable Cages (SSEC) are interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).
SSEC implants are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation.
The Spectrum Spine Expandable Cages (SSEC) are lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. The SSEC are provided in different shapes to accommodate a lateral surgical approach to the lumbar spine and can expand to the desired height and varying degrees of lordosis. The devices are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. These spacers are to be filled with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion. SSEC implants are manufactured from radiolucent PEEK (per ASTM 2026), titanium alloy (per ASTM F136), and tantalum markers (per ASTM F560).
The provided document is a 510(k) summary for a medical device called "Spectrum Spine Expandable Cages (SSEC)". This type of regulatory submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria based on a clinical study for AI performance.
Therefore, the document does not contain the information requested regarding acceptance criteria and study data for an AI-powered device. Specifically, it lacks:
- A table of acceptance criteria and reported device performance for an AI
- Sample size and data provenance for an AI test set
- Number and qualifications of experts for AI ground truth establishment
- Adjudication methods for AI test set
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study results
- Standalone AI performance
- Type of ground truth used for AI
- Training set sample size and ground truth establishment for AI
The information within the document pertains to mechanical and material testing of an intervertebral fusion device (implants), which are entirely different types of tests than those required for an AI-based medical device. The "Performance Data" section discusses:
- Static Axial Compression per ASTM F2077
- Static Compressive Shear per ASTM F2077
- Static Subsidence per ASTM F2267 and ASTM F2077
- Static Expulsion
- Dynamic Axial Compression per ASTM F2077
- Dynamic Compressive Shear per ASTM F2077
These are all mechanical tests to ensure the physical integrity and durability of the spinal implant, not performance metrics for an AI algorithm.
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(306 days)
The Spectrum SPINOUS PROCESS DEVICE is a posterior, non-pedicle supplemental fixation device, intended for use at a single-level in the non-cervical spine (T1-S1 inclusive). It is intended for plate fixation and attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain or discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation), and/or tumor. The Spectrum Spine SPINOUS PROCESS DEVICE is intended for use with bone graft, and is not intended for standalone use.
The Spectrum Spine Spinous Process Device is a permanent implant device with plates and rods made from Titanium Alloy per ASTM F136 and Commercially Pure Titanium per ASTM F67 and cages made from polyetheretherketone (Zeniva PEEK 500 per ASTM F2026-10, PEEK Polymer for surgical implant applications). It is a posterior, non-pedicle supplemental fixation device. The device provides plates, cages and connecting rods of various shapes and sizes to provide supplemental stabilization of the spinous process to support fusion.
The provided text describes the Spectrum Spine SPINOUS PROCESS DEVICE and its 510(k) summary for FDA clearance. However, it does not include information about acceptance criteria or a study that specifically proves the device meets such criteria in terms of diagnostic performance or clinical outcomes.
The "Performance Data" section solely refers to mechanical testing of the device: "Performance data for the Spectrum Spine SPINOUS PROCESS DEVICE included static and dynamic compression bend, static torsion, locking screw torque strength, axial push off strength from simulated bone and rod dissociation strength. Most testing was completed per ASTM 1717-12 and ASTM F1798-97."
This type of testing is to ensure the device's structural integrity and physical properties meet established standards for medical implants, not to evaluate diagnostic accuracy or compare its performance against a ground truth.
Therefore, I cannot populate the requested table or answer the questions related to acceptance criteria for diagnostic performance, sample sizes for test sets, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details from the provided text.
The document indicates that the device was deemed "substantially equivalent" to predicate devices based on:
- Indications for Use
- Materials
- Means of fixation
This implies that the lack of new performance studies concerning diagnostic accuracy or extensive clinical outcomes was acceptable because the device was not presenting a novel diagnostic function or significantly different mechanism of action that would necessitate such studies for substantial equivalence.
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(110 days)
The SS Fenestrated Facet Screw System (FFS) is indicated for the posterior surgical treatment at L1-S1 (inclusive) spinal levels for the following: Spondylolisthesis; Spondylolysis; Pseudarthrosis or failed previous fusions which are symptomatic; Degenerative Disc Disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies and/or degenerative disease of the facets with instability. The system is intended for use with only autogenous bone graft material.
The SS Fenestrated Facet Screw System (FFS) is a permanent implant device made from Cobalt Chrome Alloy Per ASTM 1537. It is to be implanted from the posterior approach. The device is provided in one diameter and multiple lengths to accommodate the various anatomy of the spine. The device is intended to provide mechanical support and stability to the implanted level until biologic fusion is achieved. The SS Fenestrated Facet Screw System is cannulated and fenestrated which allows it to be used as a delivery system for bone graft. The system is not to be used with bone cement.
The provided text describes the regulatory submission for a medical device called the "SS Fenestrated Facet Screw System." It does not contain information about a study involving software or AI. Therefore, I cannot extract details about acceptance criteria or a study proving device performance in the context of AI.
The document discusses the substantial equivalence of the SS Fenestrated Facet Screw System to predicate devices based on performance testing for mechanical properties. However, this is for a physical implantable device, not an AI software.
Here's a breakdown of what is present in the document related to performance and testing for the physical device:
Device: SS Fenestrated Facet Screw System (FFS)
Acceptance Criteria and Reported Device Performance (for the physical device):
The document states:
- "Testing of the FFS to demonstrate substantial equivalence included static and dynamic 3-point bending, screw axial pullout, and torque to failure."
- "The testing standards utilized were, ASTM F543-07 'Standard Specification and Test Methods for Metallic Medical Bone Screws', F2193-02, 'Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System,' and ASTM F1264-03 'Standard Specification and Test Methods for Intrameduliary Fixation Devices.'"
While the specific numerical acceptance criteria and reported performance values are not detailed in the provided text, the successful 510(k) clearance implies that the device met the requirements outlined in these ASTM standards and was deemed substantially equivalent to its predicate devices in terms of safety and effectiveness.
Regarding your specific questions related to AI/Software:
- A table of acceptance criteria and the reported device performance: This information is not present for an AI/software device. The document describes mechanical testing of a physical implant.
- Sample sized used for the test set and the data provenance: Not applicable for an AI/software study.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for an AI/software study.
- Adjudication method: Not applicable for an AI/software study.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable for an AI/software study.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for an AI/software study.
- The type of ground truth used: Not applicable for an AI/software study.
- The sample size for the training set: Not applicable for an AI/software study.
- How the ground truth for the training set was established: Not applicable for an AI/software study.
In summary, the provided text is a 510(k) summary for a physical medical implant (a facet screw system) and does not describe an AI or software device, nor does it contain the type of study data you are asking for regarding AI acceptance criteria and performance.
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(146 days)
The Spectrum Spine Laminoplasty Plating System is intended for use in the lower cervical and upper thoracic spine (C3-T3) after a laminoplasty has been performed. The Spectrum Spine Laminoplasty Plating System holds the allograft in place in order to prevent the allograft from expulsion or impinging on the spinal cord.
The Spectrum Spine Laminoplasty Plating System is comprised of various sized, pre-bent plates that are designed to fit the anatomy of the vertebral arch (i.e., between the pedicle and spinous process). The plates have screw holes located at both ends of the plate to allow for attachment to the bone. The screws intended for use with the plates are available in a variety of lengths and diameter and are designed to match the anatomical requirements.
The provided text describes the Spectrum Spine Laminoplasty Plating System and its performance data for a 510(k) submission. However, it does not contain specific acceptance criteria, reported device performance in those terms (apart from passing certain ASTM standards), or details about a study that would address most of the requested information.
The document primarily focuses on demonstrating substantial equivalence to predicate devices through technical characteristics and mechanical testing according to established ASTM standards. It does not describe a clinical study or a study comparing the device's performance against specific, quantifiable acceptance criteria in a clinical context.
Therefore, for many of your requested points, the information is not available in the provided text.
Here is the information that can be extracted or deduced from the provided text, and where the information is not available, it is stated as such:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Performance: | |
| Static Axial Pullout (screws per ASTM F543-07) | Tested and met the standard (implied, as conclusion states substantial equivalence) |
| Static Four-Point Bend (system per ASTM F2193-02) | Tested and met the standard (implied, as conclusion states substantial equivalence) |
| Dynamic Four-Point Bend (system per ASTM F2193-02) | Tested and met the standard (implied, as conclusion states substantial equivalence) |
| Material Composition: | |
| Plates and screws manufactured from titanium alloy (ASTM F136) | Manufactured from titanium alloy (ASTM F136) |
| Indications for Use: | |
| Intended for use in lower cervical and upper thoracic spine (C3-T3) after laminoplasty to hold allograft and prevent expulsion/impingement on spinal cord. | Indicated for use in lower cervical and upper thoracic spine (C3-T3) after laminoplasty to hold or buttress allograft and prevent expulsion/impingement on spinal cord. |
| Technical Characteristics: | |
| No new technical characteristics compared to predicate devices. | No new technical characteristics introduced. |
Note on "Reported Device Performance": The document states that the device "was tested" according to specific ASTM standards and that the data "lead to the conclusion that Spectrum Spine Laminoplasty Plating System is substantially equivalent to the predicate devices." This implicitly means the device met the requirements of these tests, but the specific numerical results or thresholds (acceptance criteria) for those tests are not detailed in this summary.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The testing described is mechanical (physical hardware testing), not clinical or involving human subjects/cases in the traditional sense of a "test set" for performance evaluation.
- Data Provenance: The "performance data" refers to mechanical testing.
- Country of origin: Not specified, but likely performed in a certified lab in the USA, given the FDA submission.
- Retrospective or Prospective: Not applicable, as this refers to mechanical bench testing, not clinical data collection.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not applicable. The "ground truth" for this device's performance evaluation is based on established engineering standards (ASTM F543-07 and ASTM F2193-02) and material specifications (ASTM F136), not expert consensus from clinical cases. There's no mention of experts establishing a ground truth in the context of device performance as one would for an AI/diagnostic device.
4. Adjudication Method for the Test Set
- Not applicable. This concept typically applies to clinical studies where expert reviewers independently assess cases and then reconcile discrepancies. The reported testing is mechanical bench testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. An MRMC study is not relevant for this type of mechanical implant device. This type of study is typically performed for diagnostic or AI-assisted interpretation devices.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not applicable. This device is a mechanical surgical implant, not an algorithm or AI system.
7. The Type of Ground Truth Used
- Engineering Standards and Material Specifications: The ground truth for evaluating the device's safety and effectiveness for a 510(k) submission is based on adherence to established ASTM standards for mechanical properties (e.g., strength, durability) and material composition (titanium alloy as per ASTM F136), demonstrating substantial equivalence to previously marketed devices.
8. The Sample Size for the Training Set
- Not applicable. This device is a mechanical surgical implant. There is no training set in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. See point 8.
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