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510(k) Data Aggregation
(231 days)
The 3D Printed PEEK Interbody System (ALIF) is intended for spinal fusion procedures in the lumbosacral spine at one or two contiguous levels from L2 to S1 in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral body fusion device. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). DDD patients may also have Grade 1 spondylolisthesis or retrolisthesis at the involved levels. The device must be used with supplemental fixation and is intended for use with autograft and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft. The device is to be implanted via an anterior approach.
The 3D Printed PEEK Interbody System (Cervical) is intended for spinal fusion procedures in the cervical spine at one or two contiguous levels from C2 to T1 in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment prior to treatment with an intervertebral body fusion device. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). The device must be used with supplemental fixation and is intended for use with autograft and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft. The device is to be implanted via an anterior approach.
The 3D Printed PEEK Interbody System devices are spinal fusion implants that are inserted into the intervertebral body space of the spine to act as disc spacers and hold bone graft. These devices are manufactured from PEEK OPTIMA™ LT1AMR5 with tantalum radiographic markers and are offered in multiple footprint, height, and lordotic angle options.
This document, a 510(k) Premarket Notification from the FDA, does not describe the acceptance criteria and study proving a software device meets acceptance criteria. Instead, it details the substantial equivalence of a physical medical device, the "3D Printed PEEK Interbody System," to existing legally marketed predicate devices.
Therefore, many of the requested points for describing an AI/software device's acceptance criteria and study (especially points 2, 3, 4, 5, 6, 7, 8, and 9) are not applicable to the information provided in this document. The document focuses on mechanical and physical properties rather than algorithmic performance.
However, I can extract the relevant information regarding the non-clinical testing performed for this physical device and structure it to the best of my ability, highlighting what is present and what is not.
Acceptance Criteria and Study for 3D Printed PEEK Interbody System (Physical Device)
This document describes the non-clinical testing performed to demonstrate the substantial equivalence of the "3D Printed PEEK Interbody System." The acceptance criteria are implicitly defined by meeting or exceeding the performance of the predicate devices according to established ASTM standards and internal lab protocols.
1. Table of Acceptance Criteria and Reported Device Performance:
The document broadly states that the non-clinical testing demonstrates the subject devices "have at least equivalent mechanical strength as the predicates and are as safe, as effective, and perform as well or better than these legally marketed devices." Specific numerical acceptance criteria and reported performance values are not provided in this summary. The tests performed are listed as follows:
| Test Name | Applicable Device(s) | Acceptance Criteria (Implicit) | Reported Device Performance (Summary) |
|---|---|---|---|
| Static and Dynamic Torsion per ASTM F2077 | Cervical devices | Meet or exceed performance of predicate devices per ASTM F2077. | "At least equivalent mechanical strength as the predicates... as safe, as effective, and perform as well or better." |
| Static and Dynamic Axial Compression and Compression Shear per ASTM F2077 | Cervical and ALIF devices | Meet or exceed performance of predicate devices per ASTM F2077. | "At least equivalent mechanical strength as the predicates... as safe, as effective, and perform as well or better." |
| Subsidence per ASTM F2267 | Cervical and ALIF devices | Meet or exceed performance of predicate devices per ASTM F2267. | "At least equivalent mechanical strength as the predicates... as safe, as effective, and perform as well or better." |
| Expulsion Testing | Cervical and ALIF devices | Prevent expulsion under defined conditions. | "At least equivalent mechanical strength as the predicates... as safe, as effective, and perform as well or better." |
| Impaction Testing per lab protocol | Cervical and ALIF devices | Meet performance requirements of internal lab protocol (and implicitly, predicate performance). | "At least equivalent mechanical strength as the predicates... as safe, as effective, and perform as well or better." |
Applicability Note: The questions below are typically relevant for AI/software medical devices and are largely not applicable to this 510(k) submission for a physical medical device. Where possible, I will state "Not Applicable" or explain why the information isn't present for a physical device.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in this 510(k) summary. For mechanical bench testing, sample sizes are typically defined by the relevant ASTM standards or internal validation plans, but these details are not disclosed in the public summary.
- Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable in the context of benchtop mechanical testing for a physical device. The testing is performed in a laboratory setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For mechanical testing, "ground truth" is established by the physical properties and performance metrics measured according to established engineering standards (ASTM). No human experts are used to interpret images or diagnose conditions for AI ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods are relevant for human interpretation of data, typically in AI studies or clinical trials, not for direct mechanical property testing.
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 physical device, not an AI device designed to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This question pertains to AI algorithm performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable directly. For mechanical testing, the "ground truth" refers to the quantitatively measured physical properties and performance values (e.g., strength, stiffness, deformation) obtained through validated test methods (ASTM standards, internal protocols). Comparative performance against predicate devices serves as a benchmark.
8. The sample size for the training set:
- Not Applicable. This device is a physical product, not a machine learning model; therefore, it does not have a "training set."
9. How the ground truth for the training set was established:
- Not Applicable. As there is no training set for a physical device, no ground truth needed to be established in this context.
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(192 days)
The EARP Nerve Cuff Electrode is used to perform localized stimulation of neural tissue and to locate, identify, and monitor spinal nerve roots during surgery.
The EARP Nerve Cuff Electrode conducts electrical signal as a component of intraoperative neuromonitoring. The EARP Nerve Cuff Electrode is used with commercially available neuromonitoring systems and does not stimulate or record signal itself. The standard connectors at the proximal end of the EARP Nerve Cuff Electrode interface with the neuromonitoring equipment and the distal cuff contacts the target tissue. The EARP Nerve Cuff Electrode is provided sterile packaged and is for single use only.
The provided text describes the 510(k) summary for the EARP Nerve Cuff Electrode, a surgical nerve stimulator/locator. It does not pertain to an AI/ML medical device, but rather a physical medical device. Therefore, many of the requested elements for describing the acceptance criteria and study proving an AI/ML device's performance are not present in this document.
However, I can extract the information related to the acceptance criteria and the study that proves the physical device meets these criteria, based on the provided FDA 510(k) summary.
Here's an attempt to answer as much as possible given the limitations of the provided text, recognizing that it's for a traditional medical device, not an AI/ML one:
Acceptance Criteria and Device Performance for the EARP Nerve Cuff Electrode
Since this is a physical medical device submission, the "acceptance criteria" are based on non-clinical performance and biocompatibility testing, demonstrating the device's safety and effectiveness in its intended use, and its substantial equivalence to predicate devices. The "study" refers to the non-clinical testing performed.
1. A table of acceptance criteria and the reported device performance
The document lists "Summary of Non-Clinical Testing" which serves as the "study" proving the device meets the acceptance criteria. The acceptance criteria are implied by the "Conclusion" column (e.g., "no evidence of causing cell lysis or toxicity" for cytotoxicity), and the "Pass/Fail" column indicates whether the device met these criteria.
| Acceptance Criteria (Implied) | Reported Device Performance (Conclusion) | Pass/Fail |
|---|---|---|
| Biocompatibility Testing: | ||
| Cytotoxicity (ISO 10993-5): No evidence of cell lysis or toxicity | The test article extract showed no evidence of causing cell lysis or toxicity. The test article extract met the requirements of the test since the grade was less than a grade 2 (mild reactivity). | Pass |
| Sensitization (ISO 10993-10): No delayed dermal contact sensitization | The test article extracts showed no evidence of causing delayed dermal contact sensitization in the guinea pig. The test article was not considered a sensitizer in the guinea pig maximization test. | Pass |
| Irritation (ISO 10993-23): Acceptable difference in mean scores | The test article met the requirements of the test since the difference between each test article extract overall mean score and corresponding control extract overall mean score was 0.0 and 0.1 for the SC and SO test article extracts, respectively. | Pass |
| Acute Systemic Toxicity (ISO 10993-11): No mortality or systemic toxicity | There was no mortality or evidence of systemic toxicity from the extracts injected into mice. Each test article extract met the requirements of the study. | Pass |
| Material-Mediated Pyrogenicity (USP<151>, ISO 10993-11): Acceptable rise in rabbit temperatures | The total rise of rabbit temperatures during the 3 hour observation period was within acceptable USP requirements. The test article met the requirements for the absence of pyrogens. | Pass |
| Other Non-Clinical Testing: | ||
| Dimensional characteristics, materials, function, intended use | Evaluated to ensure it performed as intended and supported substantial equivalence to predicate devices. (Specific performance values not detailed, but implied as 'Pass' overall.) | Pass |
| Tensile and flexural testing (mechanical integrity, continuity, isolation, visual appearance) | Evaluated to ensure it performed as intended and supported substantial equivalence to predicate devices. (Specific performance values not detailed, but implied as 'Pass' overall.) | Pass |
| Electrical safety testing (high potential and electrical leakage per ISO 14708-1) | Evaluated to ensure it performed as intended and supported substantial equivalence to predicate devices. (Specific performance values not detailed, but implied as 'Pass' overall.) | Pass |
| Electrode lead wire performance per 21 CFR 898.12 (IEC 60601-1) | Evaluated to ensure it performed as intended and supported substantial equivalence to predicate devices. (Specific performance values not detailed, but implied as 'Pass' overall.) | Pass |
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not specify the exact sample sizes (e.g., number of units, animals, or test replicates) for each test. It mentions "mice" and "guinea pig" for specific biocompatibility tests, implying the use of animal models according to the ISO standards.
- Data Provenance: The provenance is through laboratory testing conducted on the device components or extracts. The document does not specify the country of origin where the tests were performed, nor whether the data involved retrospective or prospective collection of patient data, as this is laboratory testing of a physical device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This concept is not applicable to the type of device described. "Ground truth" established by experts is typically relevant for interpretative devices like AI/ML products where human experts provide labels or diagnoses for comparison. For a physical medical device like an electrode, the "ground truth" is established by adherence to recognized performance standards (e.g., ISO, IEC, USP) and validated laboratory test methodologies. The "experts" would be the qualified personnel performing and interpreting these specific laboratory tests.
4. Adjudication method for the test set
This concept is not applicable as there is no "adjudication" of human interpretations for this type of device. The results are based on objective measurements from standardized laboratory tests.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This concept is not applicable as this is not an AI/ML device, and no human reader study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable as this is not an AI/ML device and does not involve an algorithm. The device's "standalone" performance is assessed through its physical characteristics and electrical/biocompatibility safety in laboratory settings.
7. The type of ground truth used
The "ground truth" for this physical device is established by:
- Established Performance Standards: Adherence to ISO, IEC, and USP standards for biocompatibility, electrical safety, and mechanical integrity.
- Objective Measurements: Laboratory measurements of physical, chemical, and electrical properties compared against pre-defined specifications derived from these standards or engineering requirements.
8. The sample size for the training set
This concept is not applicable as this is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
This concept is not applicable as this is not an AI/ML device that requires a training set.
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(44 days)
The Trigon HA Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as:
- · Cotton (opening wedge) Osteotomies of the Medial Cuneiform
- · Evans Lengthening Osteotomies
- · Subtalar Fusion
- · First Metatarsal-Cuneiform Lengthening Arthrodesis
- Calcaneocuboid Arthrodesis
The Trigon HA wedges are intended for use with ancillary fixation.
The Trigon HA Stand-Alone Wedge Fixation System is not intended for use in the spine.
The Trigon HA Stand-Alone Wedge Fixation System is a family of PEEK Optima HA Enhanced (HA PEEK) wedges with tantalum markers used for angular correction of small bones of the foot. The wedges incorporate two screw-receiving holes, surface teeth, and an area to contain grafting material. The wedges are designed in rectangular, kidney, circular oval and teardrop shaped footprints in a range of sizes and in multiple thicknesses. The associated 2.5mm diameter titanium screws are designed in lengths of 10 to 30mm.
When used with the provided screw fixation the Trigon wedges may be used with or without ancillary plating, except for the Lapidus and Calcaneocuboid Wedges which will require ancillary fixation not provided in the Trigon System. When used without the provided screws, Trigon wedges are intended for use with ancillary fixation.
This submission describes a medical device, the Trigon™ HA Stand-Alone Wedge Fixation System, and its claim of substantial equivalence to predicate devices. However, the provided document does not contain information regarding acceptance criteria or a study proving that the device meets such criteria.
The document is a 510(k) Premarket Notification from the FDA, which focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than on demonstrating performance against specific clinical acceptance criteria through new clinical studies.
Therefore, I cannot provide the requested information for points 1 through 9.
Summary of missing information specifically related to acceptance criteria and performance studies:
- No acceptance criteria tables: The document does not specify any quantitative acceptance criteria for device performance.
- No reported device performance data: While there is a mention of "Engineer analysis comparing device characteristics," no specific performance metrics or data are provided.
- No clinical study details: There is no mention of a test set, sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance studies, or ground truth types and their establishment.
- No training set details: Information on training set size or how ground truth was established for a training set is not present.
The document focuses on comparing the proposed device's characteristics (materials, intended use, processes) to those of previously cleared predicate devices to establish substantial equivalence. It explicitly states, "No FDA performance standards have been established for the Trigon HA Stand-Alone Wedge Fixation System." and "The following was performed to demonstrate safety per methods of the previous submission: Engineering analysis comparing device characteristics including materials, intended use and processes (cleaning and sterilization methods)". This indicates a non-clinical, comparative assessment rather than a clinical performance study against defined acceptance criteria.
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(262 days)
The EARP Interbody System is intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radios. These patients should have had six months of non-operative treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis at involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is implanted via a posterolateral approach.
EARP implants are intervertebral body fusion devices used in the lumbar spine following discectomy. All devices are manufactured from PEEK Optima LT1 per ASTM F2026 and include tantalum markers per ASTM F560 for radiographic visualization. The devices have multiple footprints to adapt to the general shape of the vertebral endplates and have a hollow center to accommodate bone graft. Each footprint is available in multiple heights to accommodate patient variability and there are anti-migration features on the superior and inferior surfaces designed to improve fixation, stability, and prevent back out and migration.
This document is not about an AI or software device. It describes the EARP Interbody System, a medical implant used for spinal fusion. Therefore, the requested information regarding acceptance criteria and studies that prove the device meets them, especially in the context of AI/software performance, human reader improvement, and ground truth establishment, is not applicable.
The document primarily focuses on the device's mechanical performance and substantial equivalence to previously cleared predicate devices, as demonstrated through engineering analysis and comparison of technological characteristics.
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(253 days)
The Quantum Anterior Cervical Plate is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical fusion in patients with:
·degenerative disc disease (as defined by neck pain of discogenic origin with
degeneration of the disc confirmed by patient history and radiographic studies),
· spondylolisthesis,
- · trauma (i.e. fractures or dislocations),
- · tumors.
- · deformity (defined as kyphosis, lordosis, or scoliosis),
- · pseudarthrosis.
- · failed previous fusion,
- · spinal stenosis.
The Quantum Anterior Cervical Plate is a titanium alloy plate, conforming to ASTM F3001, intended for anterior screw fixation of the plate to the cervical spine. The fixation construct consists of a cervical plate that is attached to the vertebral body of the cervical spine with selfdrilling and self-tapping bone screws using an anterior approach. Plates are available in a variety of lengths (08 mm - 110 mm), addressing multiple levels of fixation (one to five). The plate incorporates graft visualization holes on the longitudinal center line for intraoperative visualization. Bone screws are available in three diameters (3.75 mm. and 4.75 mm) and a variety of lengths (10 mm - 20 mm). Screws are made from titanium alloy per ASTM F136.
This document is a 510(k) Premarket Notification from the U.S. Food & Drug Administration (FDA) for a medical device called the "Quantum Anterior Cervical Plate." It details the device's characteristics, intended use, and the rationale for its substantial equivalence to previously marketed predicate devices.
Based on the provided text, there is NO information regarding Acceptance Criteria or any study testing AI/ML-driven device performance. This document pertains to a physical medical implant (a cervical plate) and its mechanical testing, not a diagnostic or prognostic AI/ML system.
Therefore, I cannot provide the requested information as it is not present in the provided text. The questions posed in your prompt (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) are relevant to the evaluation of AI/ML-based medical devices, which this document does not describe.
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(28 days)
The Trigon™ HA Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as:
- Cotton (opening wedge) osteotomies of the medial cuneiform
- . Evans lengthening osteotomies
The Trigon HA wedges are intended for use with ancillary fixation.
The Trigon HA Stand-Alone Wedge Fixation System is not intended for use in the spine.
The Trigon HA Stand-Alone Wedge Fixation System is a family of PEEK Optima HA Enhanced (HA PEEK) wedges with tantalum markers used for angular correction of small bones of the foot. The wedges incorporate two screw-receiving holes, surface teeth, and an area to contain grafting material. The wedges are designed in rectangular and kidney shaped footprints in a range of sizes (16x16mm to 20x22mm) and in multiple thicknesses (5 to 12mm). The associated 2.5mm diameter titanium screws are designed in lengths of 10 to 30mm.
When used with the provided screw fixation the Trigon wedges may be used with or without ancillary plating. When used without the provided screws Trigon wedges are intended for use with ancillary fixation.
The provided text describes a 510(k) premarket notification for the "Trigon HA Stand-Alone Wedge Fixation System" but does not contain information about acceptance criteria or a study proving that the device meets those criteria. The submission focuses on demonstrating substantial equivalence to a predicate device, primarily through engineering analysis comparing device characteristics (materials, intended use, processes) and the addition of steam sterilization as an alternative method.
Therefore, for aspects related to acceptance criteria, device performance, sample size, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, the requested information is not provided in the given text.
The text does mention:
- Summary of Non-Clinical Testing: An engineering analysis was performed comparing device characteristics including materials, intended use, and processes (cleaning and sterilization methods). No FDA performance standards have been established for this device.
- Conclusion: Based on the comparison of device characteristics, the subject device does not raise new issues of safety or efficacy compared to the predicate devices. The similar indications for use, technological characteristics, and performance characteristics are assessed to be substantially equivalent.
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(14 days)
The nvª, nvª, and nv are intended for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis or retrolisthesis at involved levels. The device systems must be used with supplemental fixation and autograft to facilitate fusion and are implanted via an anterior, posterior, or transforaminal approach. Hyperlordotic interbody devices (>20° lordosis) must be used with at least anterior supplemental fixation or anterior buttress plate with posterior supplemental fixation.
The nv4, nvP, and nvb are intervertebral body fusion devices used in the lumbar spine following discectomy. All devices are manufactured from PEEK Optima LT1 per ASTM F2026 or PEEK Optima HA Enhanced and include tantalum markers per ASTM F560 for radiographic visualization.
The devices have multiple footprints to adapt to the general shape of the vertebral endplates and have a hollow center to accommodate bone graft. The devices are implanted via a variety of approaches including anterior, posterior, or transforaminal. Each footprint is available in multiple heights to accommodate patient variability and there are anti-migration features on the superior and inferior surfaces designed to improve fixation, stability, and prevent back out and migration.
The provided text describes a medical device, the nvª, nvP, and nvb intervertebral body fusion devices, and their 510(k) premarket notification to the FDA. However, it does not contain information about acceptance criteria, device performance from a clinical study, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment relevant to AI/ML device testing.
This document pertains to the regulatory clearance of a physical medical implant (intervertebral body fusion device) based on its substantial equivalence to previously cleared predicate devices, primarily through non-clinical engineering analysis of mechanical performance.
Therefore, I cannot provide the requested information regarding acceptance criteria and study details as they would apply to an AI/ML device, because this document is about a physical medical device and its mechanical performance, not an AI/ML algorithm.
The document explicitly states:
- "No FDA performance standards have been established for the nv4, nv7, and nv1." (Page 4)
- "The following was performed to demonstrate safety per methods of the previous submission: Engineering analysis comparison of mechanical performance in compression/ compression shear, subsidence, and expulsion (reference ASTM F2077 and F2267). The results of the engineering analysis indicate that the nv3, nvP and nv system is substantially equivalent to the predicate devices." (Page 4)
This indicates that the safety and effectiveness were demonstrated through engineering analysis and comparison to predicate devices, not through a clinical study involving human or AI evaluation with performance metrics like sensitivity, specificity, etc.
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(90 days)
The Trigon™ Ti Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures or osteotomies in the foot, such as:
- Cotton (opening wedge) osteotomies of the medial cuneiform
- Evans lengthening osteotomies
The Trigon Ti wedges are intended for use with ancillary fixation.
The Trigon Ti Stand-Alone Wedge Fixation System is not intended for use in the spine.
The Trigon Ti Stand-Alone Wedge Fixation System is a family of additively manufactured titanium wedges used for angular correction of small bones of the foot. The wedges incorporate an organized lattice structure and two screw-receiving holes. The system rectangular and kidney shaped wedges may or may not include a window for containing grafting material. The wedges are designed in rectangular and kidney shaped footprints in a range of sizes (16x16mm to 20x22mm) and in multiple thicknesses (5 to 12mm). The associated 2.5mm diameter screws are designed in lengths of 10 to 20mm.
When used with the provided screw fixation the Trigon wedges may be used with or without ancillary plating. When used without the provided screws Trigon wedges are intended for use with ancillary fixation. Windowless wedge designs that do not allow for graft placement should only be used with ancillary plating.
The provided text describes a medical device, the Trigon™ Ti Stand-Alone Wedge Fixation System, and its 510(k) premarket notification. However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML algorithm or software.
The document primarily focuses on:
- Regulatory review: The FDA's substantial equivalence determination for the device.
- Device description: Physical characteristics, materials, and intended use of the bone wedge system.
- Predicate devices: Identification of similar devices already on the market.
- Non-clinical testing: Mechanical testing (compression, compression shear, expulsion, screw strength/pullout) to demonstrate substantial equivalence to predicates.
Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study proving the device meets those criteria, as it relates to AI/ML performance, because that information is not present in the provided text.
Specifically, the document does not mention or provide data for any of the following:
- AI/ML algorithm performance.
- Test sets, training sets, or data provenance.
- Experts establishing ground truth.
- Adjudication methods.
- Multi-reader multi-case (MRMC) studies.
- Standalone algorithm performance.
- Types of ground truth (beyond mechanical test results for a physical device).
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(30 days)
The nv is intended for spinal fusion procedures at one level, from C2-T1, in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine. DDD is defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. One device is to be used per intervertebral space. Patients should receive six weeks of non-operative treatment prior to treatment with an intervertebral body fusion device. The nv- devices must be used with supplemental fixation and are designed for use with autograft bone to facilitate fusion. The devices are to be implanted via an anterior approach.
The nv& is an intervertebral body fusion device used in the cervical spine following discectomy. All devices are manufactured from PEEK Optima LT1 per ASTM F2026 and include tantalum markers per ASTM F560 for radiographic visualization.
The devices have multiple footprints to adapt to the general shape of the vertebral endplates and have a hollow center to accommodate bone graft. The devices are implanted via an anterior approach. Each footprint is available in multiple heights to accommodate patient variability and there are anti-migration features on the superior and inferior surfaces designed to improve fixation, stability, and prevent back out and migration.
This document is a 510(k) premarket notification from the FDA, classifying the medical device "nv°" an "Intervertebral Body Fusion Device." The document reviews the device's indications for use, device description, and comparison to predicate devices, but it does not contain information about software or AI/ML-driven components. Therefore, the requested information about acceptance criteria and a study proving the device meets those criteria, particularly regarding AI/ML performance metrics, cannot be extracted from this document.
The document discusses the substantial equivalence of the "nv°" device to previously cleared devices based on non-clinical testing such as engineering analysis of mechanical performance (compression, shear, torsion, subsidence, expulsion). The conclusion states that the device is substantially equivalent based on design control activities, identical indications for use, and similar technological characteristics, implying that no new clinical studies were required or conducted to demonstrate safety and efficacy compared to the predicate devices.
Therefore, I cannot provide the detailed information requested in your prompt regarding acceptance criteria, study design, sample sizes, expert involvement, or AI/ML specific performance metrics, as these are not relevant to the content of this 510(k) premarket notification for this specific medical device.
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