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510(k) Data Aggregation
(33 days)
Nvision Biomedical Technologies Inc
The SnapHammer Hammertoe Correction System is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe. Cannulated implants in the SnapHammer Hammertoe Correction System can be used with K-wires for the delivery of implants or the temporary stabilization of outlying joints (e.g. MTP Joint).
The SnapHammer Hammertoe Correction System is comprised of an additively manufactured titanium fixation device attached to a snap-off post. The snap-off post aids in a quick insertion and snaps off after implant has been threaded in. The implants are offered in Ø3.0mm and Ø3.50mm diameters and in lengths ranging from 12mm to 15mm. The system includes drills, implant inserters, and sizers manufactured from medical grade stainless steel.
The provided FDA 510(k) Clearance Letter for the "SnapHammer Hammertoe Correction System" describes a medical device, specifically a metallic bone fixation fastener. This document is a regulatory clearance for a physical medical device, not a software or AI-based medical device.
Therefore, the information requested in your prompt regarding acceptance criteria and studies for an AI/software medical device (e.g., sample size for test set, data provenance, number of experts, adjudication methods, MRMC study, standalone performance, ground truth, training set information) is not applicable to the provided document.
The document states:
- "No FDA performance standards have been established for the SnapHammer Hammertoe Correction System."
- The non-clinical testing performed focused on:
- "Engineering analysis comparing device characteristics including materials, intended use and processes (cleaning and sterilization methods)"
- "The steam sterilization process has been validated per ISO 17665-1 & 17665-2 to a sterility assurance level of 10⁻⁶"
- The basis for equivalence is that the device "maintain[s] the same features as the previously cleared devices, but steam sterilization is being added as an alternative sterilization method."
- "This modification does not change the intended use or performance of the device and does not raise additional questions of substantial equivalence."
In summary, this clearance is for a physical orthopedic implant and is based on demonstrating substantial equivalence to a predicate device, primarily by showing that a new sterilization method does not alter its safety or efficacy, rather than AI/software performance metrics.
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(231 days)
Nvision Biomedical Technologies, Inc.
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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(274 days)
Nvision Biomedical Technologies, Inc
The SnapHammer Hammertoe Correction System is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe. Cannulated implants in the SnapHammer Hammertoe Correction System can be used with K-wires for the delivery of implants or the temporary stabilization of outlying joints (e.g. MTP Joint).
The SnapHammer Hammertoe Correction System is comprised of an additively manufactured titanium fixation device attached to a snap-off post. The snap-off post aids in a quick insertion and snaps off after implant has been threaded in. The implants are offered in Ø3.0mm and Ø3.50mm diameters and in lengths ranging from 12mm. The system includes drills, implant inserters, and sizers manufactured from medical grade stainless steel.
This document is a 510(k) premarket notification for a medical device called the "SnapHammer Hammertoe Correction System." It aims to demonstrate the device's substantial equivalence to previously cleared predicate devices.
However, the provided text does not contain information about a study that proves the device meets specific acceptance criteria based on human-in-the-loop performance, nor does it provide a table of acceptance criteria and reported device performance directly related to an AI/Software as a Medical Device (SaMD) product.
Instead, this document describes a hardware medical device (a bone fixation fastener) and the non-clinical (mechanical) testing performed to demonstrate its safety and efficacy.
Therefore, I cannot fulfill the request to provide:
- A table of acceptance criteria and reported device performance for an AI/SaMD.
- Sample size used for a test set or data provenance for an AI/SaMD.
- Number of experts or their qualifications for establishing ground truth for an AI/SaMD test set.
- Adjudication method for an AI/SaMD test set.
- MRMC comparative effectiveness study results.
- Standalone performance for an AI/SaMD.
- Type of ground truth used for an AI/SaMD.
- Training set sample size or how its ground truth was established for an AI/SaMD.
The document discusses "non-clinical testing" for the orthopedic implant, which includes:
- Mechanical Performance: Torsion, driving torque, and axial pullout (per ASTM F543), as well as static and dynamic bending.
- Additive Manufacturing: Tensile testing per ASTM F3001 and residual powder removal (particle analysis per ASTM F1877).
It concludes that based on these tests, the device does not raise new issues of safety or efficacy compared to the predicate devices. This implies that the acceptance criteria for these mechanical tests were met, demonstrating equivalence. However, the specific quantitative acceptance criteria or results for these mechanical tests are not detailed in this publicly available summary.
In summary, this document is about a physical medical device (hardware) and its mechanical testing, not a software or AI-based medical device. Therefore, the requested information regarding AI/SaMD acceptance criteria and study design is not present.
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(192 days)
Nvision Biomedical Technologies, Inc.
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, 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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(362 days)
Nvision Biomedical Technologies, Inc
The Integral Titanium Cervical Interbody 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 back 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 Integral Titanium Cervical Interbody 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 Integral Titanium Cervical Interbody is an intervertebral body fusion device used in the cervical spine following discectomy. All devices are additively manufactured using titanium alloy per ASTM F3001.
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 (ACIF) surgical 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.
This document is a 510(k) Summary for the Integral Titanium Cervical Interbody and does not contain any information regarding clinical studies, acceptance criteria, or performance data related to AI/algorithm performance.
The document describes a medical device, an intervertebral body fusion device, and the non-clinical testing performed to demonstrate its substantial equivalence to predicate devices. The listed tests are engineering and mechanical tests (e.g., static and dynamic compression, subsidence, expulsion) to assess the physical properties and safety of the implant itself, not its diagnostic or decision-making performance.
Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for a device's performance, as this information is not present in the provided text. The document focuses solely on the substantial equivalence of a physical medical implant based on its design, materials, and mechanical testing results.
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(44 days)
Nvision Biomedical Technologies, Inc.
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)
Nvision Biomedical Technologies, Inc.
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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(30 days)
Nvision Biomedical Technologies, Inc
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 Ssteotomies
- Subtalar Fusion
- First Metatarsal-Cuneiform Lengthening 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 and oval 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 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.
The provided text is a 510(k) Premarket Notification from the FDA for a medical device called the "Trigon HA Wedge Fixation System." This document primarily focuses on demonstrating the substantial equivalence of the new device to existing predicate devices, rather than presenting a study to prove the device meets specific acceptance criteria for AI performance or diagnostic accuracy.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be found within this document. This type of information is typically found in clinical trial reports or performance validation studies for devices that rely on algorithms or AI for diagnostic or prognostic purposes.
The document states:
- "No FDA performance standards have been established for the Trigon HA Stand-Alone Wedge Fixation System."
- "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)."
- "The results of this comparison indicate that the Trigon HA Stand-Alone Wedge Fixation System is substantially equivalent to the predicate devices."
This indicates that the "study" demonstrating the device meets requirements was an engineering analysis to show equivalence to existing devices, not a performance study as would be done for an AI-powered diagnostic tool. The device is a physical implant, not a software-driven diagnostic or treatment planning system that would require the kind of performance metrics you've asked about.
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(180 days)
Nvision Biomedical Technologies, Inc
The Radian MS Bunion System is intended for fixation of osteotomies and corrective procedures of the hallux and associated disorders such as hallux valgus.
The Radian MIS Bunion System is a single-use bone fixation device intended to be permanently implanted. The system consists of a titanium alloy plate and screws that provide fixation for the first metatarsal in the correction of a bunion. The plate has 4 screw-receiving holes. It is designed to allow for intramedullary insertion of the 2 proximal screws and medial insertion of the 2 distal screws. The plate is provided in 1 size and 1 configuration that can be used across all patient anatomy. The locking 3.0mm diameter titanium screws are designed in lengths of 14mm to 30mm in increments of 2mm. The system is provided non-sterile.
The provided text is a 510(k) Premarket Notification from the FDA regarding "The Radian MIS Bunion System". This document focuses on the regulatory clearance of a medical device (a bone fixation system) based on its substantial equivalence to previously cleared predicate devices.
The document does not describe any acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML algorithm's performance.
Instead, it details the physical and mechanical performance testing of the Radian MIS Bunion System hardware (plate and screws), which are orthopedic implants, to demonstrate their safety and efficacy for their intended use.
Therefore, I cannot extract the information required to populate the fields related to an AI/ML study, as no such study is mentioned or relevant to this specific FDA clearance.
Here's a breakdown of what is available regarding the device (not an AI algorithm):
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Performance: | |
| Static bending (per ASTM F382) | Results indicate substantial equivalence to predicate devices. |
| Dynamic bending (per ASTM F382) | Results indicate substantial equivalence to predicate devices. |
| Engineering analysis to evaluate screw mechanical strength | Results indicate substantial equivalence to predicate devices. |
| Material Composition: | |
| Implants (plate and screws): Titanium alloy | Manufactured using Titanium. |
| Instruments: Medical grade Stainless Steel | Manufactured using medical grade Stainless Steel. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified for the mechanical tests, but these would typically involve a set number of physical devices/components for destructive and non-destructive testing.
- Data Provenance: Not applicable in the context of patient data. The tests were laboratory-based mechanical tests.
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. "Ground truth" in this context refers to the physical properties and performance of medical hardware, not interpretation of data by human experts for diagnostic purposes. These properties are established by standardized testing methods (e.g., ASTM F382) and engineering principles.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are used for resolving disagreements in expert interpretations or labels, which is not relevant to mechanical testing of hardware.
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, not specified and not applicable. This type of study is for evaluating diagnostic performance, typically of AI tools, and is not mentioned for this orthopedic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No, not applicable. This document is about a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Not applicable in the AI/ML sense. For mechanical testing, the "ground truth" is defined by the physical behavior of the materials and constructs under tested conditions as measured by calibrated equipment and compared against established engineering standards (e.g., ASTM F382) and the mechanical performance of predicate devices.
8. The sample size for the training set:
- Not applicable. There is no AI/ML algorithm discussed that would require a training set.
9. How the ground truth for the training set was established:
- Not applicable. There is no AI/ML algorithm discussed.
Summary of the Study Discussed (Mechanical Testing):
The "study" described in the 510(k) summary is a set of non-clinical mechanical tests performed on the Radian MIS Bunion System.
- Tests performed:
- Static bending (per ASTM F382)
- Dynamic bending (per ASTM F382)
- Engineering analysis to evaluate screw mechanical strength
- Purpose: To demonstrate that the Radian MIS Bunion System is "substantially equivalent" to predicate devices in terms of safety and efficacy, particularly regarding its mechanical performance.
- Conclusion: The tests indicate that the device does not raise new issues of safety or efficacy and is substantially equivalent to the predicate devices.
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(30 days)
Nvision Biomedical Technologies, Inc
The Vector Hammertoe Correction System is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.
The Vector Hammertoe Correction System is comprised of a sterile PEEK (polyetheretherketone) HA (hydroxyapatite) fixation device. The implants are offered in Ø3.00mm, Ø3.50mm and Ø4.00mm and in 0° angle. The system has K-wires, drill, taps, implant inserters, and sizers manufactured from medical grade stainless steel.
The provided text does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria, as it relates to performance metrics of a device, particularly an AI/imaging device. The document is an FDA 510(k) clearance letter for a medical device called the "Vector® Hammertoe Correction System," which is a bone fixation system, not an imaging or AI-driven diagnostic device.
Therefore, I cannot provide the requested information from the given text.
The document discusses:
- Device Name: Vector® Hammertoe Correction System
- Regulation Number: 21 CFR 888.3040 (Smooth Or Threaded Metallic Bone Fixation Fastener)
- Regulatory Class: Class II
- Indications for Use: Fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.
- Device Description: Sterile PEEK (polyetheretherketone) HA (hydroxyapatite) fixation device, K-wires, drill, taps, implant inserters, and sizers manufactured from medical grade stainless steel.
- Predicate Devices: K201850 (Nvision Biomedical's Vector Hammertoe Correction System), K183055 (Nvision Biomedical's Vector Hammertoe Correction System), and K193645 (Nvision Biomedical's nva, nvt).
- Non-Clinical Testing: Primarily engineering analysis comparing device characteristics (materials, intended use, cleaning, sterilization) to predicate devices. It states no FDA performance standards have been established for this device and that the results indicate substantial equivalence. The key modification mentioned is the addition of steam sterilization as an alternative method.
None of the information required for explaining acceptance criteria for an AI/imaging device, such as sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment, is present in this regulatory document.
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