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510(k) Data Aggregation
(263 days)
The Multi-Drive Interference Screw System is intended for soft tissue reattachment, i.e. fixation of ligament and tendon graft tissue and tendon transfers in surgeries of the shoulder, elbow, knee, foot/ankle, and hand /wrist. Specifically:
Shoulder:
Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Sepair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Foot/Ankle:
Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus Transfer for Achilles Tendon Reconstruction, and Flexor Digitorum Longus Transfer for Posterior Tibial Tendon Reconstruction
Knee:
Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis
Elbow:
Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
Hand/Wrist:
Scapholunate Ligament Reconstruction, Unar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and repairs. Ligament Reconstruction and Tendon Interposition
The Multi-Drive Interference Screw System is a family of interference screws for the reattachment and fixation of tissue in surgeries of the shoulder, elbow, knee, foot/ankle, and hand /wrist. The interference screws are manufactured from HA Enhanced PEEK or titanium alloy in multiple lengths and diameters with key features including a threaded shank, cannulation hole, and multiple drive mating interface. The HA PEEK versions also incorporate tantalum pins for imaging visibility.
The provided text is a 510(k) summary for the Multi-Drive Interference Screw System. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study.
Therefore, many of the requested categories for a study proving acceptance criteria cannot be extracted from this document, as a clinical study with detailed performance metrics was not performed or described.
Here's an analysis based on the information available in the text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria for device performance. Instead, it relies on non-clinical testing to demonstrate substantial equivalence to predicate devices. The "performance" is implicitly that the device performs comparably to or within the established safety and effectiveness profile of the predicate devices.
| Acceptance Criteria Category | Reported Device "Performance" (demonstrates equivalence) |
|---|---|
| Mechanical Strength | - Insertion testing |
- Insertion/removal torque
- Static axial pullout
- Engineering analysis comparison of mechanical strength |
| Biocompatibility | - Pyrogenicity testing (LAL method), with
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(29 days)
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 Ø3.0mm (cannulated), Ø3.50mm (cannulated and non-cannulated) and Ø4.00mm (cannulated and non-cannulated) and in 0° angle. The system has K-wires, drill, taps, implant inserters, and sizers manufactured from medical grade stainless steel.
The provided text is a 510(k) summary for the VECTOR™ Hammertoe Correction System. It describes the device, its indications for use, and its equivalence to predicate devices, primarily through engineering analysis. This document does not contain information about an AI/ML powered device, nor does it present acceptance criteria or a study proving device performance in the context of AI/ML.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and data provenance
- Number of experts used to establish ground truth and their qualifications
- Adjudication method
- MRMC comparative effectiveness study results
- Standalone (algorithm only) performance data
- Type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established
The document explicitly states: "No FDA performance standards have been established for the Vector Hammertoe Correction System. The following was performed to demonstrate safety per methods of the previous submission: Engineering Analysis comparison of mechanical performance characteristics." This indicates that the safety and effectiveness were demonstrated through mechanical performance characteristics engineering analysis and comparison to predicates, not through clinical or AI/ML performance studies with human readers or AI algorithms.
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(78 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 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 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.
This document describes the Nvision Biomedical Technologies, Inc. Trigon HA Stand-Alone Wedge Fixation System, which is intended for internal bone fixation for bone fractures or osteotomies in the foot, specifically Cotton (opening wedge) osteotomies of the medial cuneiform and Evans lengthening osteotomies. It is not intended for use in the spine.
Here's an analysis based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
This 510(k) submission does not specify explicit quantitative acceptance criteria for device performance in the same way a clinical trial would for a new drug or diagnostic device. Instead, it relies on demonstrating substantial equivalence to predicate devices through non-clinical testing. The "acceptance criteria" are implicitly met if the test results demonstrate equivalence and do not raise new issues of safety or efficacy.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Compression performance: Demonstrate mechanical integrity and resistance to compression forces. | Testing performed per ASTM F2077. The submission states: "The results of these tests indicate that the Trigon™ HA Stand-Alone Wedge Fixation System is substantially equivalent to the predicate devices." (Page 5) The conclusion reiterates this: "Based on the testing performed, including compression, expulsion, and engineering analysis, it can be concluded that 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 for the proposed Trigon™ HA Stand-Alone Wedge Fixation System are assessed to be substantially equivalent to the predicate devices." (Page 5) |
| Expulsion performance: Demonstrate resistance to expulsion under relevant forces. | Testing performed (expulsion). The submission states the same conclusion as above, indicating equivalence with predicate devices. |
| Screw mechanical strength: Ensure the ancillary screws possess adequate strength. | Engineering analysis performed. The submission states the same conclusion as above, indicating equivalence with predicate devices. |
| Screw pullout strength: Ensure the ancillary screws maintain adequate fixation within the bone/wedge. | Engineering analysis performed. The submission states the same conclusion as above, indicating equivalence with predicate devices. |
| Material Equivalence (HA PEEK vs. PEEK): Demonstrate that the use of HA PEEK does not negatively impact equivalence compared to predicates made of standard PEEK. | "Trigon™ wedges are manufactured from HA PEEK while the primary predicate is manufactured from standard PEEK, however testing, analysis, and comparison to reference devices also manufactured from HA PEEK demonstrated that this does not negatively impact equivalence." (Page 5) This is a specific point of comparison where the "performance" is the demonstration that changing a material property does not lead to a negative impact on equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document describes non-clinical (bench) testing, not human studies or clinical trials with test sets involving patients.
- Sample size: The document does not specify the exact number of samples (e.g., number of wedges or screws) used for each non-clinical test (compression, expulsion, screw strength/pullout). It only lists the types of tests performed.
- Data provenance: Not applicable in the context of clinical data provenance (e.g., country of origin, retrospective/prospective) as these are bench tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is a 510(k) submission for a medical device cleared through substantial equivalence based on non-clinical (bench) testing, not a diagnostic algorithm requiring expert-established ground truth from patient data.
4. Adjudication Method for the Test Set
Not applicable for a non-clinical device submission based on bench testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This device is a mechanical implant, not an AI-assisted diagnostic tool where human reader performance would be evaluated.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a mechanical implant, it does not involve algorithms or AI.
7. The Type of Ground Truth Used
For the non-clinical tests, the "ground truth" is defined by the objective measurements and engineering standards (e.g., ASTM F2077 for compression) against which the device performance is measured to demonstrate substantial equivalence to predicate devices. It is thus engineering and mechanical testing standards.
8. The Sample Size for the Training Set
Not applicable. There is no concept of a "training set" in the context of this 510(k) submission for a mechanical implant.
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no training set, there is no ground truth for it. The submission focuses on demonstrating equivalence of the mechanical properties of a new device to existing predicate devices.
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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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