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510(k) Data Aggregation
(27 days)
The Pre-Sutured Tendon is intended for use as a construct in anterior cruciate ligament and posterior cruciate ligament reconstruction.
The Pre-Sutured Tendon is for single patient use only.
The Pre-Sutured Tendon is a donated human nonbone tendon pre-sutured with sterile Ultra-high-molecular-weight polyethylene (UHMWPE) nonabsorbable sutures. The tendon is processed via the BioCleanse® Tissue Sterilization Process (The BioCleanse Process). The Pre-Sutured Tendon device is offered as a single strand and as a quadruple (quad) strand.
N/A
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(266 days)
Moldable Bone Void Filler and Moldable Bone Void Filler + CCC is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities and pelvis). These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. Moldable Bone Void Filler and Moldable Bone Void Filler + CCC can be used with autogenous bone marrow. Moldable Bone Void Filler and Moldable Bone Void Filler + CCC resorbs and are replaced with bone during the healing process.
Moldable Bone Void Filler and Moldable Bone Void Filler + CCC are for single patient use only.
Moldable Bone Void Filler and Moldable Bone Void Filler + CCC are bone void fillers composed of processed demineralized bone matrix (DBM), a synthetic macromer hydrogel, and cortical cancellous bone chips (CCC) for Moldable Bone Void Filler + CCC only. Both are provided with an accessory kit containing pre-measured hydrating solution and a spatula to mix the components.
After the implant is hydrated, the resultant putty can then be handled and placed in the appropriate bone voids or gaps. Moldable Bone Void Filler and Moldable Bone Void Filler + CCC gradually resorb and are replaced with new bone during the healing process. At the 12 week timepoint, animal study data demonstrated new bone formation averages of 16.21% in the Optecure group, 13.8% in the Optecure + CCC group, 15.75% in the Exactech Optecure + CCC predicate group, and 12.08 % in the empty defect negative control group.
The provided text is a 510(k) summary for a medical device (Moldable Bone Void Filler and Moldable Bone Void Filler + CCC). This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific performance acceptance criteria for an AI/ML algorithm.
Therefore, most of the requested information regarding acceptance criteria, test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training sets, and ground truth establishment for AI/ML algorithms is not applicable to this document.
However, I can extract information related to the device's performance data as presented in the context of demonstrating substantial equivalence.
Here's a breakdown of what can and cannot be answered based on the provided text:
What can be extracted:
- Acceptance Criteria (Implicitly based on Predicate Equivalence): The primary "acceptance criterion" for this 510(k) clearance is substantial equivalence to a predicate device. This is repeatedly stated throughout the document. The performance data presented (animal study results) are used to support this claim of equivalence, not to meet a pre-defined numerical performance threshold for a specific task like classification or detection.
- Reported Device Performance (Animal Study): The document provides quantitative results from an animal study regarding new bone formation.
What cannot be extracted (as it pertains to AI/ML acceptance criteria and studies):
- A table of explicit acceptance criteria for an AI/ML device.
- Sample size used for a test set (in the context of AI/ML).
- Data provenance for a test set.
- Number of experts and their qualifications used to establish ground truth for a test set.
- Adjudication method for a test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study, its effect size, or human reader improvement with AI assistance.
- Standalone (algorithm only) performance.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI/ML model.
- Sample size for a training set for an AI/ML model.
- How ground truth for a training set was established for an AI/ML model.
Information Extracted from the Provided Text:
1. A Table of Acceptance Criteria and the Reported Device Performance:
As this document is for a non-AI/ML medical device seeking 510(k) clearance, the "acceptance criteria" are intrinsically tied to demonstrating substantial equivalence to an existing predicate device. The performance data presented are used to support this claim, rather than meeting a specific numerical target for an AI/ML algorithm.
| Acceptance Criteria (Implicit for 510(k) Substantial Equivalence) | Reported Device Performance (Animal Study Data) |
|---|---|
| Devices are substantially equivalent to the predicate device with respect to indications for use, materials, biocompatibility, storage, and performance. This includes demonstrating comparable bone formation properties. | At the 12-week timepoint, animal study data demonstrated new bone formation averages of: - Optecure group (New Device): 16.21% - Optecure + CCC group (New Device): 13.8% - Exactech Optecure + CCC predicate group: 15.75% - Empty defect negative control group: 12.08% |
| Device does not raise any safety and effectiveness concerns as compared to the predicate device. | Non-clinical testing performed to support substantial equivalence and demonstrate safety and effectiveness included: Chemical and physical properties, Biocompatibility, Sterility, Shelf Life, and Animal Study. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- The document refers to an "animal study" which contains performance data used to support substantial equivalence. It does not explicitly state the sample size (number of animals or defects) used in this animal study.
- The data provenance (country of origin, retrospective/prospective) for this animal study is 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
- Not applicable. This is not an AI/ML device, and the ground truth for bone formation in an animal study would typically be established through histological analysis by trained pathologists or similar experts, but the number and qualifications are not provided.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. This is not an AI/ML device study involving human reader interpretation adjudication.
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. This is not an AI/ML device and no MRMC study was conducted or is relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a bone void filler, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the animal study: The ground truth for "new bone formation" would typically be established through histological analysis (a type of pathology) of tissue samples from the animal defects. The document mentions "animal study data demonstrated new bone formation averages."
8. The sample size for the training set
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device that requires a training set.
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(178 days)
The Pre-Sutured Tendon is intended for use as a construct in anterior cruciate ligament and posterior cruciate ligament reconstruction.
The Pre-Sutured Tendon is for single patient use only.
The Pre-Sutured Tendon is a donated human nonbone tendon pre-sutured with sterile Ultra-high-molecular-weight polyethylene (UHMWPE) nonabsorbable sutures. The tendon is processed via the BioCleanse® Tissue Sterilization Process (The BioCleanse Process). The Pre-Sutured Tendon device is offered as a single strand and as a quadruple (quad) strand.
This is a 510(k) summary for a medical device called the "Pre-Sutured Tendon." It does not contain information about acceptance criteria and a study proving a device meets these criteria in the context of an AI/ML medical device submission.
As such, I cannot extract the requested information regarding:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts and their qualifications for ground truth.
- Adjudication method for the test set.
- MRMC comparative effectiveness study or human reader improvement with AI.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This document describes a traditional medical device (a pre-sutured tendon for ligament reconstruction) and its regulatory clearance based on substantial equivalence to existing predicate devices, rather than an AI/ML-driven diagnostic or prognostic device requiring specific performance metrics related to diagnostic accuracy or reader studies. The "Performance Data" section briefly mentions bench testing and a human cadaver study to demonstrate feasibility and user needs, but these are not presented in the format of acceptance criteria for an AI/ML device study.
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(82 days)
When Fortilink-C is used as cervical interbody fusion (IBF) implants, these devices are indicated for use in skeletally mature patients with degenerative disease (DDD) of the cervical spine with accompanying radicular symptoms at one level or two contiguous levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These IBF devices are used to facilitate interbody fusion in the cervical spine and are placed via an anterior approach from C2-C3 to C7-T1 using autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The IBF devices are intended to be used with supplemental fixation cleared for the implanted level. Patients should have at least six (6) weeks of non-operative treatment with an interbody fusion device.
When Fortilink-TS and Fortilink-L are used as lumbar interbody fusion (IBF) implants, these devices are indicated for intervertebral body fusion of the spine in sketally mature patients with degenerative disc disease (DD) and up to Grade 1 spondylolisthesis of the lumbar spine at one level or two contiguous levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These IBF devices are used to facilitate interbody fusion in the lumbar spine from L1-L2 to L5-S1 using autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The IBF devices are intended to be used with supplemental fixation cleared for the implanted level. Patients should have at least six (6) months of nonoperative treatment prior to treatment with an interbody fusion device.
The interbody fusion (IBF) devices are designed to be inserted into the intervertebral body space of the spine, and are intended for intervertebral body fusion. These implants are manufactured from a radiolucent polymer (PolyEtherKetoneKetone (PEKK)) (ASTM F2820) which should support radiographic imaging inside the implant to evaluate fusion status and are assembled with radiographic markers composed of tantalum (ASTM F560) to facilitate proper implant position. The implants are provided sterile by gamma irradiation and are intended to be used with supplemental fixation cleared for the implanted level. The implants are supplied with instrumentation necessary to facilitate the insertion and removal of the implants, as well as general manual surgical instruments. These implants are provided in different footprints and varying heights to provide implant options best suited to an individual's pathology and anatomical condition. The following designs are included in the Fortilink IBF System : - Fortilink-C IBF System - Fortilink-TS IBF System - Fortilink-L IBF System
The provided text is a 510(k) premarket notification for a medical device, the Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D Technology. It details the device's characteristics, indications for use, and a summary of pre-clinical performance data.
However, the document does not contain information about acceptance criteria or a study that specifically proves the device meets those criteria in the context of an AI/human-in-the-loop system. The "Pre-Clinical Performance Data" section lists standard ASTM test methods for intervertebral body fusion devices, such as static and dynamic axial compression, static subsidence, and static expulsion/push-out. It also mentions evaluation for pyrogenicity using the Limulus Amebocyte Lysate (LAL) assay. These are mechanical and biological performance tests for the physical implant, not for an AI-driven or diagnostic system.
Therefore, I cannot populate the table or answer the specific questions related to AI system performance, ground truth, expert consensus, or MRMC studies, as this information is not present in the provided text. The document is for a physical medical implant, not an AI/software as a medical device (SaMD).
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(147 days)
The Fortilink-C interbody fusion devices are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one level or two contiguous levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radios. The Fortilink-C devices are used to facilitate interbody fusion in the cervical spine and are placed via an anterior approach from the C2-C3 disc to the C7-T1 disc using autogenous or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The Fortilink-C devices are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment with an interbody fusion device.
When used as a vertebral body replacement (VBR) device, Fortilink-C devices are for use in the thoracolumbar spine (TI-LS) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. VBRs are also indicated for treating fractures of the thoracic and lumbar spine. V BRs are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column, even in the absence of fusion for a prolonged period of time. The VBR device is intended to be used with autogenous or allogenic bone graft and must be used with supplemental internal fixation systems.
The Fortilink-C IBF/VBR implants are manufactured from radiolucent polyetherketoneketone (PEKK) material (ASTM F2820) in various footprints and sizes. Each implant includes radiographic marker pins from tantalum (ASTM F560) and a central graft containment window. Each implant has insertion slot features on the anterior face to mate with an insertion instrument. The Fortilink-C IBF/VBR implants includes both 0° (parallel) and 6° lordosis, and designs with and without teeth. Class II accessories and Class I (exempt) manual surgical instruments are available for use with the implants.
This document is a 510(k) Summary for the Fortilink™-C with TETRAfuse™ 3D Technology, an intervertebral body fusion (IBF) / vertebral body replacement (VBR) device. It describes the device, its indications for use, and the non-clinical testing performed to establish substantial equivalence to predicate devices.
Here's an analysis of the provided information, focusing on acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present "acceptance criteria" in a quantitative, measurable format with specific thresholds. Instead, it describes non-clinical testing performed to demonstrate "substantial equivalence" and "sufficient" mechanical strength. The "reported device performance" is a qualitative statement that the device met these objectives.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Strength (Static and Dynamic Axial Compression and Torsion): Demonstrate mechanical strength comparable to legally marketed predicate devices and sufficient for intended use, in accordance with ASTM F2077. | Mechanical testing showed that the mechanical strength of the subject system is substantially equivalent to the legally marketed predicate devices and sufficient for the intended use. |
| Subsidence Resistance (Static Subsidence): Demonstrate resistance to subsidence, in accordance with ASTM F2267. | Performed (results contributed to the conclusion of substantial equivalence and sufficient mechanical strength). Specific quantitative results are not provided in this summary. |
| Expulsion Resistance (Static Expulsion): Demonstrate resistance to expulsion, in accordance with Draft Standard Z8423Z (ASTM F-04.25.02.02). | Performed (results contributed to the conclusion of substantial equivalence and sufficient mechanical strength). Specific quantitative results are not provided in this summary. |
| Bacterial Endotoxin Levels: Meet requirements for bacterial endotoxin, in accordance with ANSI/AAMI ST-72. | Bacterial endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST-72. (Implied that it met the standard for acceptance). |
| Substantial Equivalence: Demonstrate that the device is substantially equivalent to previously cleared predicate devices in terms of indications for use, material composition, sterilization, packaging, technological characteristics, design features, and mechanical strength, with no significant differences that would affect safety and effectiveness. | This submission supports the position that the subject implants are substantially equivalent to previously cleared predicate devices. The subject and predicate devices are similar in terms of indications for use, material composition, sterilization, packaging, technological characteristics, design features, and mechanical strength. There are no significant differences between the subject and predicate devices that would affect the safety and effectiveness of the Fortilink-C system. Any differences were not considered significant based on mechanical performance, bench testing. |
2. Sample Size Used for the Test Set and the Data Provenance
This document describes non-clinical (bench) testing of mechanical properties and biocompatibility.
- Sample Size: The document does not specify the exact number of devices or test samples used for each mechanical test (e.g., number of constructs for axial compression). ASTM standards typically require a minimum number of samples (e.g., n=6) for such tests, but this specific detail is not provided in the summary.
- Data Provenance: The data provenance is from bench testing conducted by RTI Surgical, Inc. (Pioneer Surgical Technology, Inc.), not from human clinical data. Therefore, concepts like "country of origin of the data" or "retrospective or prospective" do not directly apply in the context of human studies, as this is a device clearance based on substantial equivalence primarily supported by non-clinical performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This device clearance is based on non-clinical engineering and materials testing, not on clinical data requiring expert human review of diagnostic output or ground truth establishment in a clinical context.
4. Adjudication Method for the Test Set
Not applicable. This document describes non-clinical laboratory testing, not a study involving human readers or interpretation requiring adjudication.
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 a medical device clearance for an orthopedic implant, not an AI/CADe/CADx system. No MRMC study was conducted.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a medical device clearance for an orthopedic implant, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical testing was defined by the validated and recognized ASTM standards (ASTM F2077, ASTM F2267) and ANSI/AAMI standard (ANSI/AAMI ST-72). The performance of the Fortilink-C device was measured against the criteria and requirements set forth in these standards, and compared to the performance of the legally marketed predicate devices.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning study requiring a training set. This is a medical implant requiring mechanical and material testing.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, this is not an AI/machine learning study.
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(43 days)
CERVICAL INTERBODY FUSION DEVICE
When used as a cervical intervertebral body fusion implant, the Interbody Fusion (IBF)/ Vertebral Body Replacement (VBR) System ("IBF/VBR System") is indicated for intervertebral body fusion of the spine in skeletally mature patients. Cervical IBFs are intended for use at one level in the cervical spine, from the C2 to C3 intervertebral body space to the C7 to T1 intervertebral body space, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). Cervical IBFs are to be used in patients who have had six weeks of non-operative treatment. IBFs are designed for use with autogenous bone graft and/or allogenic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft to facilitate fusion. IBFs are intended to be used with supplemental spinal fixation cleared for the implanted level.
LUMBAR INTERBODY FUSION DEVICE
When used as a lumbar intervertebral body fusion implant, the Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System ("IBF/VBR System") is indicated for intervertebral body fusion of the spine in skeletally mature patients. Lumbar IBFs are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1 intervertebral body space, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Lumbar IBFs are to be used in patients who have had six months of non-operative treatment. IBFs are designed for use with autogenous bone and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. IBFs are intended to be used with supplemental spinal fixation cleared for the implanted level.
VERTEBRAL BODY REPLACEMENT
When used as a vertebral body replacement (VBR) implant, the Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System ("IBF/VBR System") is intended for use in the thoracolumbar spine, from T1 to L5, for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. VBRs are also indicated for treating fractures of the thoracic and lumbar spine. VBRs are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column, even in the absence of fusion for a prolonged period of time. The system is intended to be used with supplemental fixation cleared for the conditions listed above (i.e., tumor or trauma of T1 to L5). Additionally, the VBR implant is intended to be used with bone graft.
The system includes implantable devices manufactured from PEEK with tantalum or titanium alloy radiographic markers that are available in a variety of different shapes and sizes to accommodate varying patient anatomy and surgical approach. The IBF/VBR implants may be implanted via a variety or open or minimally invasive approaches, including anterior, lateral, posterior and oblique. Implant-specific and 510(k) exempt orthopedic manual surgical instruments, including the Clarity Retractor System, are also available for use with the system.
The provided text is a 510(k) premarket notification letter from the FDA regarding an Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) System. It details the device's indications for use and a summary of the submission. Crucially, this document explicitly states that "No new performance data was provided to support substantial equivalence" and "A literature analysis was performed and no new performance data was required to support substantial equivalence."
Therefore, I cannot extract the information required for acceptance criteria and the study that proves the device meets them from this document. The device in question was cleared based on its substantial equivalence to previously marketed predicate devices, with no new performance data submitted to demonstrate its own performance against specific acceptance criteria. The submission focused on expanding an indication for use for bone graft types and administrative changes, not on new performance studies of the device itself.
In summary, the document does not contain the information needed to answer your request about acceptance criteria and a study proving the device meets them, as no such new performance study was conducted or submitted for this particular 510(k) clearance.
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(74 days)
CERVICAL INTERBODY FUSION DEVICE
When used as a cervical intervertebral body fusion device (C-Plus), the Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System ("IBF/VBR System") is indicated for intervertebral body fusion of the spine in skeletally mature patients. Cervical IBFs are intended for use at one level in the cervical spine, from the C2-C3 disc to the C7-T1 disc, for the treatment of cervical disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is to be used in patients who have had six weeks of non-operative treatment. IBFs are designed for use with autogenous bone graft and/or allogenic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft to facilitate fusion. IBFs are intended to be used with supplemental spinal fixation cleared for the implanted level, such as Streamline OCT, SlimFuse, Cequence, PAC, or Aspect Systems.
LUMBAR INTERBODY FUSION DEVICE
When used as a lumbar intervertebral body fusion device (Rotate, Bullet-Tip, T-Plus, Contact, CrossFuse, and CrossFuse II), the Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System ("IBF/VBR System") is indicated for intervertebral body fusion of the spine in skeletally mature patients. Lumbar IBFs are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Lumbar IBFs are to be used in patients who have had six months of non-operative treatment. IBFs are designed for use with autogenous bone graft to facilitate fusion. IBFs are intended to be used with supplemental spinal fixation cleared for the implanted level, such as Quantum, Streamline TL, Contact ALP, Streamline MIS Systems, or Lat-Fuse Lateral Plate System.
VERTEBRAL BODY REPLACEMENT
When used as a vertebral body replacement (VBR) device (C-Plus, Rotate, Bullet-Tip, T-Plus, Contact, CrossFuse, and CrossFuse II), the Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System ("IBF/VBR System") is intended for use in the thoracolumbar spine (TI-L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. VBRs are also indicated for treating fractures of the thoracic and lumbar spine. VBRs are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column, even in the absence of fusion for a prolonged period of time. The system must be used with supplemental fixation cleared for the conditions listed above (i.e., tumor or trauma of TI-L5) such as the Streamline TL Spinal Fixation System. Streamline MIS Spinal Fixation System or Quantum Spinal Fixation System. Additionally, the VBR device is intended to be used with bone graft.
The system includes implantable devices manufactured from PEEK with tantalum or titanium alloy radiographic markers that are available in a variety of different shapes and sizes to accommodate varying patient anatomy and surgical approach. The IBF/VBR implants may be implanted via a variety or open or minimally invasive approaches, including anterior, lateral, posterior and oblique.
This document is a 510(k) premarket notification for the "Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System". It concerns the clearance for the use of allogenic bone graft with the existing C-Plus cervical intervertebral body fusion device.
1. A table of acceptance criteria and the reported device performance
This document does not provide a table of acceptance criteria or specific device performance metrics in numerical form. Instead, the basis for clearance is substantial equivalence to a predicate device (Pioneer IBF/VBR System K133455) and a literature analysis. The "performance" in this context refers to demonstrating that the expanded indication (use of allogenic bone graft) poses no new risks and is equivalent to the established performance with autogenous bone graft.
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 for the test set: Not applicable and not explicitly stated. The submission relies on a "literature analysis of published clinical data" rather than a new test set generated for this 510(k). The literature analysis would have encompassed various studies, each with its own sample size.
- Data provenance: Not specified in terms of country of origin or whether the individual studies in the literature analysis were retrospective or prospective. The submission only states it's "published clinical data."
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. This submission relies on a literature analysis, not a new study with a ground truth established by experts specifically for this submission. The "ground truth" (clinical outcomes) would have been established within the original published studies by the researchers and clinicians involved.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No new test set or adjudication process was 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 a spinal implant device, not an AI/imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a spinal implant device, not an AI/imaging device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" implicitly referred to in the literature analysis would be the clinical outcomes data from previously published studies on cervical interbody fusion devices using allogenic bone graft. This would include fusion rates, pain reduction, adverse events, etc.
8. The sample size for the training set
Not applicable. No new algorithm or model was trained for this submission. The device is a physical implant.
9. How the ground truth for the training set was established
Not applicable. No new algorithm or model was trained for this submission.
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(89 days)
The device is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. Indications for use include the repair of hernias and /or body wall defects which require the use of reinforcing or bridging material to obtain the desired surgical outcome. The device is intended for reinforcement of soft tissues in plastic and reconstructive surgery.
The device is intended for single patient use only.
The proposed device is an implantable surgical mesh comprised of non-crosslinked porcine dermis that has been processed, terminally sterilized and is stored hydrated and ready to use. The proposed device is designed to perform as a scaffold that allows for neovascularization and permits replacement of the device with host tissue. The device in its unopened, undamaged package is sterile.
This document is a 510(k) premarket notification for the Fortiva™ porcine dermis and Tutoplast® porcine dermis surgical meshes. The purpose of this submission is to demonstrate that the proposed device is substantially equivalent to a legally marketed predicate device (K123356). The document describes the device's indications for use, technological characteristics, and performance data supporting its substantial equivalence.
Here's an analysis of the acceptance criteria and study information provided:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a numerical or target-based format. Instead, it demonstrates equivalence to a predicate device through various tests. Equivalence is the de-facto acceptance criteria in this context for a 510(k) submission.
| Characteristic / Test | Acceptance Criteria (Implied: Equivalence to Predicate K123356) | Reported Device Performance (Fortiva™ porcine dermis, Tutoplast® porcine dermis) |
|---|---|---|
| Intended Use | Equivalent to predicate (Surgical mesh scaffold to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes) | Proposed device is equivalent to predicate in intended use. |
| Material | Equivalent to predicate (Porcine Dermis) | Proposed device is equivalent to predicate in material. |
| Design | Equivalent to predicate (Terminally sterilized sheets in various sizes) | Proposed device is equivalent to predicate in design. |
| Function | Equivalent to predicate (Scaffold for soft tissue repair) | Proposed device is equivalent to predicate in function. |
| Processing | Equivalent to predicate (Proprietary tissue sterilization process) | Proposed device is equivalent to predicate in processing. |
| Chemical composition | Equivalent to predicate (Not applicable to these devices) | Proposed device is equivalent to predicate in chemical composition. |
| Energy Source | Equivalent to predicate (Not applicable to these devices) | Proposed device is equivalent to predicate in energy source. |
| In vitro Biomechanical Properties | Equivalent to predicate for: - Tensile maximum load - Burst strength - Suture pullout strength | Unimplanted tensile maximum load, burst strength and suture pullout strength were equivalent for the proposed and predicate devices. |
| Viral Inactivation | Demonstrated ability of process to inactivate model viruses with a wide range of characteristics. | Results demonstrate the ability of the process to inactivate viruses with a wide range of characteristics (enveloped and non-enveloped, RNA and DNA, low resistance and high resistance). |
| Pyrogenicity | Device did not elicit a pyrogen response in rabbit test; Endotoxin level <20 EU per device. | The device did not elicit a response in the rabbit pyrogen test. All device lots will be tested to ensure the endotoxin level is <20 EU per device. |
| Biocompatibility Testing | Passed all applicable FDA Blue Book Memorandum G95-1 and ISO 10993-1 testing. | The device passed all applicable FDA Blue Book Memorandum G95-1 and ISO 10993-1 testing. |
| Implantation Study (Structural & Functional Properties) | Equivalent to predicate for: - Maximum tensile strength at graft-host interface - Burst strength - Clinical and gross pathology - Local effects of implantation | Structural and functional properties of the proposed and predicate devices were equivalent for the evaluated implantation study. Results were equivalent. |
2. Sample size used for the test set and the data provenance
The document does not specify a distinct "test set" in the context of human subject data, as this is a 510(k) submission based on in-vitro and animal studies demonstrating substantial equivalence to a predicate, not a new clinical trial.
- For biomechanical properties (in vitro): The sample size for each test (tensile maximum load, burst strength, suture pullout strength) is not explicitly stated.
- For viral inactivation: The sample size involved testing "porcine dermis at the stage in the chemical processing applicable to the chemical being evaluated." Specific numbers are not given.
- For pyrogenicity: The standard rabbit pyrogen test involves a specific number of rabbits (typically 3, with provisions for additional rabbits if initial results are equivocal). The document states "the rabbit pyrogen test," implying adherence to a standard protocol, but doesn't give the exact number of rabbits used.
- For biocompatibility (ISO 10993-1 testing): This standard typically involves a battery of tests (e.g., cytotoxicity, sensitization, irritation, acute systemic toxicity), each with its own sample size, often using various cell lines or animal models. Specific sample sizes are not provided.
- For the implantation study (animal study): The sample size (number of animals or implants) is not explicitly stated. The provenance is animal data.
Data Provenance: The data comes from in-vitro lab testing and animal studies ("animals studies demonstrate that the proposed device is biocompatible"). There is no mention of human retrospective or prospective data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The studies performed are not clinical studies relying on expert interpretation of images or symptoms to establish ground truth.
- Biomechanical tests: Ground truth is established by physical measurement according to validated test methods.
- Viral inactivation: Ground truth is established by laboratory assays measuring viral reduction.
- Pyrogenicity: Ground truth is established by physiological response (temperature change) in rabbits.
- Biocompatibility: Ground truth is established by standardized biological assays and observation in animal models.
- Implantation study: Ground truth is established by physical measurements (tensile strength, burst strength) and histological/pathological examination of animal tissues.
4. Adjudication method for the test set
This information is not applicable as there is no mention of human readers or subjective assessments requiring adjudication in the context of a "test set" for this type of 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 a 510(k) submission for a surgical mesh, not an AI-powered diagnostic device. An MRMC study is not relevant to demonstrating substantial equivalence for this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm.
7. The type of ground truth used
The ground truth used for the various studies includes:
- Physical Measurements: For biomechanical properties (tensile strength, burst strength, suture pullout strength).
- Laboratory Assays: For viral inactivation (measuring viral reduction) and endotoxin levels.
- Physiological Response: For pyrogenicity (rabbit temperature response).
- Pathological/Histological Examination: For the implantation study, assessing clinical and gross pathology, as well as local effects of implantation in animal models.
- Validated Biocompatibility Tests: According to FDA Blue Book Memorandum G95-1 and ISO 10993-1 standards.
8. The sample size for the training set
Not applicable. This device does not involve machine learning or AI, and therefore does not have a "training set." The studies performed are for device characterization and equivalence to a predicate.
9. How the ground truth for the training set was established
Not applicable, as there is no training set.
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(201 days)
The device is indicated as a dura substitute for the repair of dura mater.
The proposed device is composed of bovine pericardium processed through a proprietary tissue preservation and sterilization process which includes gamma irradiation. The proposed device is composed of collagenous connective tissue with three-dimensional intertwined fibers and can be fixed regardless of the direction of the device. Collagenous connective tissue with multidirectional fibers retains the mechanical strength and elasticity of the native tissue, while providing the basic structure to support replacement by new endogenous tissue. The proposed device in its unopened, undamaged package is sterile.
The provided document describes the K132850 submission for a Bovine Pericardium Suturable Dural Graft, Tutopatch™ DM Graft, or Tutoplast® Bovine Pericardium DM. The submission focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel acceptance criteria with a specific study framework for entirely new performance standards.
Here's a breakdown based on the information provided, tailored to your request but highlighting the context of a 510(k) submission:
1. Table of Acceptance Criteria and Reported Device Performance
In a 510(k) submission for substantial equivalence, "acceptance criteria" are typically defined by demonstrating performance comparable to legally marketed predicate devices, rather than predefined absolute thresholds for a novel device. The document uses predicate device performance as the benchmark for "substantial equivalence."
| Test Category | Test | Acceptance Criteria (Implicit by Equivalence to Predicate) | Reported Device Performance | Conclusion (Device meets criteria) |
|---|---|---|---|---|
| Biocompatibility | Cytotoxicity - Inhibition of Cell Growth Assay | No leachable materials released in cytotoxic concentrations (comparable to predicate) | No leachable materials were released in cytotoxic concentrations from the device. The proposed device is non-cytotoxic. | Substantially equivalent |
| Pyrogenicity (LAL Assay) | Endotoxin level < 2.15 EU per device (comparable to predicate, and for subsequent device lots) | The device did not elicit a response. All device lots will be tested to ensure the endotoxin level is <2.15 EU per device. | Substantially equivalent | |
| Mechanical Properties | Suture Pull out (N) | Max load comparable to the DuraMatrix predicate device. | The proposed device suture pull-out max load is comparable to the DuraMatrix predicate device. | Substantially equivalent |
| Burst Strength (N) | Burst strength comparable to/not inferior to the DuraMatrix predicate device. | The proposed device burst strength is greater than the DuraMatrix predicate device. | Substantially equivalent | |
| Shrink temperature (°C) | Shrink temperature comparable to the Lyoplant predicate device. | The shrink temperature of the proposed device is comparable to the Lyoplant predicate device. | Substantially equivalent | |
| Max Load (N) (presumably ultimate tensile strength) | Maximum load at failure comparable to the DuraMatrix predicate device. | The maximum load at failure of the proposed device is comparable to the DuraMatrix predicate device. | Substantially equivalent | |
| Functional Properties | Pre-clinical Implantation Study | Performed as well as a similar dura substitute, with comparable clinical and gross pathology, cerebrospinal fluid leakage, and local effects of implantation. | The proposed device performed as well as a similar dura substitute, demonstrating moderate resorption and marked integration at end time point. | Substantially equivalent |
| Clinical Outcomes (Sabatino et. al., 2014) | Adequate performance with no evidence of adverse health effects, similar to autologous galea-pericranium. | Performed adequately with no evidence of adverse health effects. | Substantially equivalent | |
| Clinical Outcomes (Filipi et. al., 2000) | Easily sutured, formed a watertight seal, "excellent material implantation characteristics and favorable clinical outcome." | Easily sutured, formed a watertight seal, provided "excellent material implantation characteristics and favorable clinical outcome." | Substantially equivalent |
2. Sample Size Used for the Test Set and Data Provenance
- In-vitro tests (Cytotoxicity, Suture Pull-out, Burst Strength, Shrink Temperature, Max Load, Pyrogenicity): The document does not specify the exact sample sizes (n-numbers) for these in vitro tests. This is common in 510(k) summaries where detailed raw data is often in the full submission, not the summary.
- Pre-clinical Implantation Study (Animal Model): The sample size for the animal model is not specified. The data provenance is "animal model" (prospective, experimental).
- Sabatino et al. (2014):
- Sample Size: Not explicitly stated how many patients received the proposed device, but it was a "prospective cohort study" comparing the proposed device (Tutopatch) to autologous galea-pericranium.
- Data Provenance: The study was published in "Clin. Neuro and Neurosurgery," indicating it was a clinical study. It appears to be prospective data, and the device was marketed as "Tutopatch" in the European market.
- Filipi et al. (2000):
- Sample Size: 32 patients.
- Data Provenance: Retrospective evaluation of patients who received Tutoplast bovine pericardium dural grafts (the proposed device as marketed in ex-US countries). The study was published in "Neurosurg Rev."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information (number and qualifications of experts for ground truth) is typically relevant for diagnostic or AI-based devices where human interpretation is the "ground truth." For a dural graft product like this, the "ground truth" is established by:
- Biomechanical properties: Objective measurements from standardized laboratory tests.
- Biocompatibility: Established by standardized cytotoxicity and pyrogenicity assays.
- Animal study: Assessment by veterinary pathologists/researchers.
- Clinical studies: Assessment by neurosurgeons or clinicians involved in the patient follow-up, observing outcomes like CSF leakage, adverse events, surgical handling, etc. The studies cited (Sabatino et al., Filipi et al.) describe methodologies where clinical outcomes are observed and reported by medical professionals, implicitly establishing the "ground truth" for clinical performance. The number and specific qualifications of the adjudicating experts for these clinical studies are not detailed in this 510(k) summary.
4. Adjudication Method for the Test Set
As this is not a diagnostic device or imaging-based assessment where consensus reads are common:
- In-vitro tests: No adjudication method as these are objective measurements.
- Animal study: Adjudication is typically part of the pathology review process, but not explicitly described here.
- Clinical studies (Sabatino et al., Filipi et al.): No formal "adjudication method" like 2+1 or 3+1 is typically used for overall clinical outcomes in these types of surgical device studies. Clinical outcomes are recorded by treating physicians or study investigators, and significant events might undergo review, but not in the sense of a consensus ground truth reading.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC comparative effectiveness study is designed for evaluating the impact of a diagnostic tool (often AI) on human reader performance for diagnostic tasks. This device is a surgical implant (dural graft). The clinical studies cited evaluate the performance of the graft itself, not its impact on human reader accuracy.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable. This device is a passive surgical implant, not an algorithm or AI system.
7. The Type of Ground Truth Used
- Biomechanical properties: Objective measurements (e.g., N for force, °C for temperature).
- Biocompatibility: Results of standardized biological assays (e.g., cell culture, LAL assay).
- Animal study: Gross pathology, histopathology, and clinical observation data.
- Clinical studies (Sabatino et al., Filipi et al.): Clinical outcomes data (e.g., absence of CSF leakage, adverse events, ease of use, material integration, resorption, overall clinical judgment by surgeons).
8. The Sample Size for the Training Set
This question is not applicable as this is not an AI/ML device that requires a training set. The data presented are for evaluating the performance of the physical dural graft.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there is no training set for an AI/ML device.
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