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510(k) Data Aggregation
(59 days)
RESPONSE™ Navigation Instruments are intended to be used during the preparation and placement of Response 4.5/5.0 and 5.5/6.0 Spine System pedicle screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in open procedures. These instruments are designed for use with the Medtronic® StealthStation® S8 System (V1.2.0), which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
The OrthoPediatrics RESPONSE™ Navigation Instruments are reusable surgical instruments for use with the Medtronic® StealthStation® Navigation System to assist surgeons in precisely locating anatomical structures in open procedures for preparation and placement of pedicle screw system implants.
The RESPONSE™ Navigation Instruments include taps, probes, and drivers. The RESPONSE™ Navigation Instruments are to be used with the RESPONSE™ Spine System.
All instruments are made of stainless steel per ASTM F899. Taps range in size from Ø3mm to Ø8mm. The RESPONSE™ Navigation Instruments are not compatible with implants from other manufacturers and are designed for use only with Medtronic® StealthStation® Navigation System hardware and software.
The provided text describes a 510(k) premarket notification for the OrthoPediatrics RESPONSE™ Navigation Instruments. It does not present acceptance criteria or detailed study results in the format requested by the user.
The document states that the device was evaluated through:
- A detailed dimensional analysis and comparison with predicate devices.
- Testing per ASTM F2554-18, "Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems."
The specific parameters tested under ASTM F2554-18 are:
- Single point measurement accuracy
- Instrument axis rotation measurement accuracy
- Instrument angular position perpendicular to the system camera measurement accuracy
- Instrument angular position parallel to the system camera measurement accuracy
- Distance between points measurement accuracy
The conclusion states that "The results of this non-clinical testing together with the dimensional analysis and comparison show that performance of the RESPONSE™ Navigation Instruments is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."
Therefore, I cannot provide the requested information, specifically:
- A table of acceptance criteria and the reported device performance: While the tests performed (ASTM F2554-18 parameters) are listed, the specific acceptance criteria for each and the actual measured performance values are not disclosed in this document.
- Sample size used for the test set and the data provenance: No sample sizes or details on data provenance (e.g., country of origin, retrospective/prospective) are mentioned for the non-clinical testing. This type of device (surgical instruments) typically undergoes lab testing rather than human clinical trials for substantial equivalence for this specific type of 510(k). The "test set" here refers to the instruments themselves, not a dataset of patient images or outcomes.
- Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable, as this was non-clinical performance testing of physical instruments, not a study involving expert interpretation of medical images.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and effect size: Not applicable, as this is a navigation instrument, not an AI or imaging diagnostic device that would typically involve human readers.
- If a standalone performance study was done: Yes, the described non-clinical testing of the instruments against a standard (ASTM F2554-18) can be considered a form of standalone performance evaluation for the device's functional characteristics. However, "standalone" in the context of AI often implies algorithm-only performance without human input, which isn't the primary focus here.
- The type of ground truth used: The "ground truth" for this device's performance is established by the measurements and specifications defined in the ASTM F2554-18 standard for positional accuracy in computer-assisted surgical systems.
- The sample size for the training set: Not applicable, as this is not an AI/machine learning device requiring a training set.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document is a 510(k) clearance letter and summary for a physical medical device (surgical navigation instruments) and details non-clinical laboratory testing rather than clinical study data involving AI algorithms or human interpretation of medical images.
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(238 days)
The OrthoPediatrics Pediatric Nailing Platform|Femur is used for pediatric and small stature adult patients as indicated to stabilize fractures of the femoral shaft; subtrochanteric fractures; prophylactionalling of impending pathologic fractures; nonunions; fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity.
Additional indications includes simple long bone fractures; severely comminuted spiral, large oblique and segmental fractures; polytrauma and multiple fractures; reconstruction, following tumor resection and grafting; supracondylar fractures; bone lengthening and shortening; fixation of fractures that occur in and between the proximal and distal third of the long bones being treated.
The OrthoPediatrics Pediatric Nailing Platform|Femur is for single use only.
The proposed OrthoPediatrics Pediatric Nailing Platform|Femur seeks to add sterile packaged nails for distribution. All subject components have previously been cleared as non-sterile implants. All other components of the OrthoPediatrics Pediatric Nailing Platform|Femur will remain non-sterile to be sterilized by end-user.
The OrthoPediatrics Pediatric Nailing Platform|Femur nails have a complex 3-dimensional geometry resulting in an anatomically appropriate design which with an advanced surgical technique. The smaller diameter of the nail allows it to be inserted in patients with a narrow medullary canal and allows for easier insertion without the need for excessive reaming.
The proposed nails are manufactured from stainless steel conforming to ASTM F138 and are available in child and adolescent configurations:
- The child nails are available in 7mm, 8mm, and 9mm diameters.
- The adolescent nails are available in 9mm, 10mm, 11mm, and 12mm diameters.
- These nails range in length from 20cm to 42cm, depending on the naildiameter.
- Surgeon preference dictates the appropriate nail size required to stabilize the fracture and allow for appropriate healing.
This document is a 510(k) premarket notification for a medical device called the "OrthoPediatrics Pediatric Nailing Platform|Femur". It is a submission to the FDA (Food and Drug Administration) for clearance to market the device.
The document discusses the device's indications for use, its technical characteristics, and compares it to a legally marketed predicate device (K172583 OrthoPediatrics' PediNail Intramedullary Nailing System).
However, this document does not contain information about acceptance criteria or a study proving the device meets those criteria, specifically in the context of an AI/algorithm-driven device or diagnostic.
The core of this submission is about demonstrating "substantial equivalence" to a predicate device, specifically regarding the addition of sterile packaged nails. It focuses on mechanical properties of the material after sterilization, not on software performance, diagnostic accuracy, or human-AI interaction.
Therefore, I cannot extract the requested information (acceptance criteria table, sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set information) from the provided text because it describes a hardware medical device clearance, not an AI/algorithm-based diagnostic or treatment planning system that would typically have the kinds of performance studies you are asking about.
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(125 days)
The OrthoPediatrics Titanium PediPlates® System is used for the express and sole purpose of redirecting the angle of growth of long bone(s). This is useful for gradually correcting angular deformities in growing children. Specific conditions/diseases for which the device will be indicated include: valgus, varus or flexion, extension deformities of the knee (femur and/or tibia), valgus, varus, or plantar flexion deformities of the ankle, valgus or varus deformities of the elbow (humerus), radial or ulnar deviation, flexion or extension deformities of the wrist (radius).
The OrthoPediatrics Titanium PediPlates® System consists of two and four-hole plates featuring a contoured mid-section and a low profile for pediatric use. There is a small provisional fixation hole in the center of the O and I-Plates to aid in accurate placement of the device relative to the growth plate. The plates are available in various sizes to accommodate variations in bone size and geometry. The plate is affixed to the bone using two to four screws (solid and cannulated), depending on which plate is selected.
This document is a 510(k) premarket notification for a medical device called the OrthoPediatrics Titanium PediPlates® System. It focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving performance against specific acceptance criteria for an AI/ML model. Therefore, much of the requested information regarding AI/ML device performance, such as test set sample size, expert ground truth establishment, MRMC studies, and training set details, is not applicable to this document.
However, I can extract the relevant information regarding the performance data provided:
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is a submission for a non-AI/ML medical device (bone fixation system) seeking substantial equivalence, there are no specific "acceptance criteria" in the sense of accuracy, sensitivity, or specificity for an AI model. Instead, the "acceptance" is based on demonstrating equivalence in performance to a predicate device.
The reported device performance is based on non-clinical tests comparing the subject device to the predicate. The "acceptance criteria" essentially boil down to performing equivalently to the predicate.
| Test Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Static Bend Testing | Performance equivalent to Orthofix Guided Growth System (K093442) | Concluded that the Titanium PediPlates® System will perform equivalently to the Orthofix Guided Growth System. |
| Torsional Testing | Performance equivalent to Orthofix Guided Growth System (K093442) | Concluded that the Titanium PediPlates® System will perform equivalently to the Orthofix Guided Growth System. |
| Four-Point Bend Testing | Performance equivalent to Orthofix Guided Growth System (K093442) | Concluded that the Titanium PediPlates® System will perform equivalently to the Orthofix Guided Growth System. |
| MR Environment Testing | MR Conditional | Determined to be MR Conditional. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated, but typically for mechanical testing of this nature, a certain number of samples per test type would be used to establish statistical significance. The document states "Testing concluded that the Titanium PediPlates® System will performed equivalently...", implying sufficient samples were used to draw this conclusion for the non-clinical tests.
- Data Provenance: Not specified, but likely from in-house testing or contracted testing laboratories. The data is retrospective in the sense that it was collected as part of the design verification and validation process prior to submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a mechanical device, not an AI/ML device requiring expert interpretation for ground truth. The "ground truth" for mechanical testing is derived from the physical properties and behavior of the materials and designs under controlled conditions.
4. Adjudication method for the test set:
- Not Applicable. As this is not an AI/ML device with human-in-the-loop assessment, there is no need for adjudication methods like 2+1 or 3+1.
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 not an AI/ML device. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an AI/ML device. No standalone algorithm performance was assessed.
7. The type of ground truth used:
- The "ground truth" for this device's performance is based on engineering and biophysical principles applied during mechanical testing. This includes:
- Material properties: Conformance to ASTM F136 for Ti-6Al-4V.
- Mechanical performance: Comparison of static bend, torsional, and four-point bend characteristics.
- MR compatibility standards.
8. The sample size for the training set:
- Not Applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established:
- Not Applicable. As no training set exists for this type of medical device, ground truth establishment for a training set is irrelevant.
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(41 days)
The OrthoPediatrics Locking Proximal Femur System Cortical Screws are intended for temporary internal fixation and stabilization of long bone fractures and osteotomies, mal-unions, and non-unions, in pediatric and small stature adults. Specific indications include: intertrochanteric derotation and Varus osteotomies, femoral neck and pertrochanteric fractures, and intertrochanteric valgus osteotomies.
The OrthoPediatrics Locking Proximal Femur System Cortical Screws are a line extension to expand the current offering to allow for longer cortical screws. The screws are part of one system that combines implants (plates and screws) and instruments. The additional cortical screw sizes include the following: 55mm, 60mm, 65mm, 70mm, 75mm, and 80mm.
The FDA 510(k) summary for the OrthoPediatrics Locking Proximal Femur System Cortical Screws (K162307) describes the device as a line extension to an existing system, adding longer cortical screws. The submission focuses on demonstrating substantial equivalence to a predicate device (K111086).
Based on the provided document, here's a breakdown of the acceptance criteria and the study conducted to prove the device meets these criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Intended Use | The proposed device's intended use must be the same as the predicate device: temporary internal fixation and stabilization of long bone fractures and osteotomies, mal-unions, and non-unions, in pediatric and small stature adults. | The proposed Locking Proximal Femur System Cortical Screws are intended for temporary internal fixation and stabilization of long bone fractures and osteotomies, mal-unions, and non-unions, in pediatric and small stature adults, which is the same as the predicate device. |
| Indications for Use | The proposed device's specific indications for use must be identical to the predicate device: intertrochanteric derotation and Varus osteotomies, femoral neck and pertrochanteric fractures, and intertrochanteric valgus osteotomies. | The proposed Locking Proximal Femur System Cortical Screws Indications for Use are identical to the predicate devices. |
| Material Equivalence | The proposed device's implant material must be identical to the predicate system's screws (medical grade BIODUR stainless steel meeting ASTM 2229-07 standard). | The proposed Locking Proximal Femur System Cortical Screws use the identical implant material as the predicate system's screws (medical grade BIODUR stainless steel which meets ASTM 2229-07 standard). |
| Design Features | The proposed device's design features must be similar to the predicate system's screws, accommodating differences like screw length and change from cannulated to solid. Safety and performance should remain equivalent. | The proposed Locking Proximal Femur System Cortical Screws incorporate similar design features as the predicate system's screws with the difference being the length of the screw and the change from cannulated to solid. The submission implies that these differences do not introduce new risks or reduce performance. |
| Sterilization | The proposed device's sterilization state must be identical to the predicate device (non-sterile). | The proposed Locking Proximal Femur System Cortical Screws are provided non-sterile, which is identical to the predicate device. |
| Performance (Non-Clinical) | Engineering analysis must demonstrate substantial equivalence between the subject device and the predicate device, implying that the mechanical performance (e.g., strength, durability, fixation capability) is maintained despite changes in length and cannulation. | Engineering analysis was performed to show substantial equivalence between the subject device and predicate device. The document does not provide specific metrics or results from this engineering analysis, but states that the activities were "verification activities." It also concludes "No new risks have been identified." |
| Clinical Performance | No clinical performance criteria were explicitly defined for this 510(k) as the submission claims substantial equivalence without new clinical data. The expectation is that clinical performance would be equivalent to the predicate. | Clinical Tests - None provided as a basis for substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable in the context of this 510(k). The submission relies on engineering analysis rather than a test set of data from patients or a defined clinical/biomedical dataset. No specific number of samples (e.g., implants tested) from the engineering analysis is provided in the summary.
- Data Provenance: Not applicable for a clinical or retrospective/prospective study. The provenance is from engineering analysis data generated by the manufacturer.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. There was no test set requiring expert ground truth establishment in a clinical or image-based context. The "ground truth" for the engineering analysis would be the established engineering and materials standards (e.g., ASTM 2229-07) and the performance characteristics of the predicate device.
4. Adjudication Method for the Test Set
Not applicable. No test set requiring adjudication was used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC comparative effectiveness study was not conducted nor mentioned. This device is a bone fixation screw, not an AI or diagnostic imaging device that would typically involve a multi-reader study.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No. This is not an algorithm or AI device. The "standalone" performance refers to the device's mechanical integrity as an implant. The engineering analysis conducted would assess this, but it's not described as a "standalone study" in the AI/algorithm sense.
7. Type of Ground Truth Used
The "ground truth" for this submission is based on:
- Engineering and Material Standards: Compliance with ASTM 2229-07 for material (BIODUR stainless steel).
- Predicate Device Characteristics: The known, legally marketed characteristics and performance of the K111086 OrthoPediatrics Locking Proximal Femur System, which serves as the benchmark for substantial equivalence.
- Design Specifications: The detailed design of the new screws compared to the predicate.
8. Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that involves a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/machine learning device.
Summary of the "Study" to Prove Acceptance Criteria:
The "study" conducted to prove the device meets acceptance criteria was an engineering analysis. This analysis compared the proposed Locking Proximal Femur System Cortical Screws (which are a line extension with longer screw sizes and a change from cannulated to solid design) to the predicate device (K111086).
The rationale for substantial equivalence was based on demonstrating similar:
- Intended Use
- Indications for Use
- Materials (medical grade BIODUR stainless steel meeting ASTM 2229-07 standard)
- Sterilization (provided non-sterile)
- Design Features (with considerations for the length and cannulation differences, implying these differences do not compromise performance).
The submission explicitly states:
- "Engineering analysis was performed to show substantial equivalence between the subject device and predicate device."
- "Clinical Tests - None provided as a basis for substantial equivalence."
The conclusion is that OrthoPediatrics believes the new screws are substantially equivalent to the predicate based on these similarities and the results of the verification activities (i.e., the engineering analysis), and that no new risks have been identified.
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(159 days)
OrthoPediatrics' PediLoc Fragment System is intended to provide temporary internal fixation and stabilization of long bones, short (small) bones, pelvis, and scapula. This includes fractures, osteotomies, mal-unions, and non-unions in all pediatric subgroups (except neonates), and small stature adults.
The OrthoPediatrics' PediLoc Fragment System combines implants and instruments in one convenient and comprehensive system. This System provides immediate stability and temporary fixation of bones during the healing process with conventional plating technology and fixation techniques.
This document describes the acceptance criteria and the study conducted for the OrthoPediatrics' PediLoc Fragment System, as presented in the provided 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Study Type |
|---|---|---|---|
| Technological Characteristics | Fundamental scientific principles, intended use, material, general design, and sizes are the same as or similar to predicate devices. | The device's fundamental scientific principles, intended use, material, and general design, and sizes are reported to be the same as, or similar to, the predicate devices. | Comparison with Predicate Devices |
| Mechanical Performance | Performs as well as or better than predicate devices. | Performed as well as or better than the predicate devices. | Nonclinical (Bench) Testing |
| Static Testing | Meets established static performance standards. | Demonstrated satisfactory performance as per ASTM Standards. | Nonclinical (Bench) Testing |
| Dynamic Testing | Meets established dynamic performance standards. | Demonstrated satisfactory performance as per ASTM Standards. | Nonclinical (Bench) Testing |
| FEA Analysis | Results are comparable or superior to predicate devices. | FEA analysis along with comparisons demonstrated satisfactory performance. | Nonclinical (FEA Analysis) |
| Dimensional Comparison | Dimensions are comparable and supported by engineering rational. | Dimensional comparison review and analysis with engineering rational provided supportive data. | Nonclinical (Dimensional Review) |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not mention a "test set" in the context of clinical data or human subject studies. The nonclinical testing performed involved mechanical laboratory (bench) testing, FEA analysis, and dimensional comparisons. Therefore, there is no information about a sample size for a test set or data provenance in terms of country of origin or retrospective/prospective nature for human data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
There is no mention of experts or a ground truth establishment process for a human-related test set. The study detailed is entirely nonclinical (bench testing and analysis).
4. Adjudication Method for the Test Set
Not applicable, as there was no test set involving human data or expert review.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. The study presented is nonclinical and focuses on the physical and mechanical properties of the device compared to predicate devices.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
Not applicable. This device is a physical medical implant (fragment system), not a software algorithm or AI-driven system. Therefore, the concept of "standalone performance" in the context of algorithms does not apply.
7. The Type of Ground Truth Used
For the nonclinical studies, the "ground truth" was established based on:
- ASTM Standards: Recognized industry standards for mechanical testing of medical devices.
- Predicate Device Performance: The established performance characteristics of legally marketed predicate devices.
- Engineering Rational: Principles of engineering analysis and design for comparison of dimensions and performance.
8. The Sample Size for the Training Set
Not applicable. The device is not an AI/ML algorithm or system that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there was no training set for an algorithm.
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(142 days)
The OrthoPediatrics ACL Reconstruction System is intended for fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) Reconstruction.
The OrthoPediatrics ACL Reconstruction System is a two part fixation system for anchoring soft tissue grafts in ACL deficient patients. It is available in diameters of 6mm, 6.5mm, 7mm, 7.5mm, 8mm, 8.5mm, 9mm, & 10mm in order to accommodate differing anatomic requirements. The first system is a screw designed to work in conjunction with a sleeve that has been fitted into the graft tunnel within the bone. Both screw and sleeve components are made entirely of PEEK Optima. The second system consists of a titanium alloy implant intended to hook onto the looped portion of the soft tissue graft and then rest onto the cortex at the end of the graft tunnel.
The OrthoPediatrics ACL Reconstruction System's performance was evaluated through mechanical testing, specifically static pull-out testing and dynamic cyclic loading, to demonstrate substantial equivalence to predicate devices. The document does not provide specific numerical acceptance criteria or detailed device performance metrics beyond stating that the system "demonstrated substantial equivalence to predicate device performance."
Here's an overview of the information you requested, based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the provided text, but generally would involve specific thresholds for static pull-out strength and dynamic cyclic loading characteristics to ensure adequate fixation and durability. | The results demonstrated that the OrthoPediatrics ACL Reconstruction System is substantially equivalent to predicate device performance in static pull-out testing and dynamic cyclic loading. |
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: Not specified in the provided text.
- Data Provenance: Not specified in the provided text. Mechanical testing is typically laboratory-based, so "country of origin" would refer to the testing facility, which is not mentioned. The data would be prospective in the sense that the tests were specifically conducted for this submission.
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)
This question is not applicable. The study involved mechanical performance testing of a physical device, not interpretation of data by human experts to establish ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This question is not applicable as the study involved mechanical testing, not expert 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
This question is not applicable. The study was a mechanical performance evaluation of a medical device, not a human reader study involving AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The study was a mechanical performance evaluation of a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for mechanical testing is established by standardized test methods (e.g., ASTM standards) that define how force is applied and how displacement/failure is measured. The "ground truth" would be the direct measurements of mechanical properties (e.g., peak load, stiffness, cycles to failure) observed during these tests.
8. The sample size for the training set
This question is not applicable. The study did not involve a training set as it was a mechanical performance evaluation, not a machine learning model.
9. How the ground truth for the training set was established
This question is not applicable for the same reason as above.
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(57 days)
The Response Spine System is intended for posterior, non-cervical fixation (pedicle screw fixation T1-S2/ilium and hook fixation (T1-L5)) in pediatric patients is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The device is intended to be used with autograft and/or allograft.
The Response Spine System consists of longitudinal members (rods), anchors (hooks and screws), interconnection components (rod-to-rod and anchor-to-rod connectors) and fasteners in a variety of sizes, including fixed angled screws, to accommodate differing anatomic requirements.
The OrthoPediatrics Response Spine System (K130655) relies on substantial equivalence to predicate devices rather than a standalone clinical study to demonstrate its safety and effectiveness. The acceptance criteria and the "study" proving it meets those criteria are articulated through mechanical testing designed to show equivalence.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Set by ASTM F1717 Standard and Equivalence to Predicates) | Reported Device Performance (as stated in the 510(k) Summary) |
|---|---|
| Mechanical Performance: - Static Compression Bending - Dynamic Compression Bending - Static Torsion (Demonstrates that the device's mechanical strength and durability are comparable to predicate devices and meet established standards for spinal implant constructs.) | "Static and dynamic compression bending tests and static torsion tests, performed according to ASTM F1717, demonstrated the device to be substantially equivalent to the predicate devices." |
Note: The specific numerical acceptance values for these tests are not provided in the summary but would be detailed in the full test report, confirming that the Response Spine System's results fell within acceptable ranges or were comparable to the predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as the evaluation focuses on mechanical testing of devices rather than patient data. The "sample" here refers to the number of devices (rods, screws, hooks, connectors) tested under various mechanical loads.
- Data Provenance: Not applicable in the traditional sense of patient data. The testing would have been conducted in a laboratory setting, likely in the US, by the manufacturer or a contracted testing facility. This is a retrospective comparison to existing predicate device data and established ASTM standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable in the context of mechanical testing. "Ground truth" for mechanical testing is established by the ASTM F1717 standard itself, which is developed by a consensus of engineering and medical experts in the field of spinal implants. The results are physical measurements.
- Qualifications of Experts: The "experts" in this context are the engineers and material scientists who designed and conducted the tests, and those who developed the ASTM F1717 standard.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. Mechanical testing results are objective measurements against a standard. There is no human adjudication of "truth" in the way there is for clinical interpretations. The results either meet the standard/equivalence or they don't.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No. This device is a surgical implant undergoing mechanical performance testing, not an imaging or diagnostic device requiring human interpretation of results. Therefore, an MRMC study is not relevant.
6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)
- Standalone Performance: Not applicable. This is a physical medical device, not a software algorithm. Its "performance" is its mechanical integrity under specified loads, which is evaluated directly in a lab.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth for this evaluation is based on:
- Established ASTM F1717 Standard: This standard dictates the methodology and acceptable criteria for static and dynamic testing of spinal implant constructs.
- Performance of Predicate Devices: The measured mechanical properties (e.g., stiffness, fatigue life) of the Response Spine System are compared to those of the legally marketed predicate devices (OrthoPediatrics' OP Spine System and Medtronic CD Horizon) to establish substantial equivalence.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This is a physical device being evaluated for mechanical equivalence, not a machine learning model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no training set for this type of device evaluation.
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(55 days)
The OP Spine System is intended for posterior, non-cervical fixation (pedicle screw fixation T1-S2/ilium and hook fixation (T1-L5) in pediatric patients is indicated as an adjunct to fusion to treat adolescent idiopathic scollosis. The device is intended to be used with autograft and/or allograft.
The OP Spine System consists of longitudinal members (rods), anchors (hooks and screws), interconnection components (rod-to-rod and anchor-to-rod connectors) and fasteners in a variety of sizes to accommodate differing anatomic requirements.
This document describes the OrthoPediatrics (OP) Spine System, a spinal fixation device intended for pediatric patients. It's a Special 510(k) submission, which means it's claiming substantial equivalence to a previously cleared predicate device.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from predicate device) | Reported Device Performance (OP Spine System) |
|---|---|
| Torsional grip performance (based on ASTM F1798) | Demonstrated equivalence to the predicate device. |
| Dynamic compression bending performance (based on ASTM F1717) | Demonstrated equivalence to the predicate device. |
Note: Since this is a Special 510(k) claiming substantial equivalence to an existing device (OP Spine System [K120291]), the acceptance criteria for the new device are directly tied to demonstrating performance equivalent to the predicate. The document states that the fundamental scientific principles, technological characteristics, intended use, material, general design, and sizes are the same as the predicate device.
2. Sample Size and Data Provenance
The document does not specify the sample size used for the performance tests.
The data provenance is not explicitly stated. However, given that it's a submission to the FDA for a US medical device, the testing would typically be conducted according to internationally recognized standards (ASTM in this case), and the results presented to the FDA. The nature of the tests (mechanical testing) suggests a laboratory setting, not patient data.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. This submission concerns mechanical performance testing of a physical device, not an AI or imaging system requiring expert interpretation or ground truth establishment by medical professionals.
4. Adjudication Method
Not applicable. Mechanical testing does not involve adjudication.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not an AI-assisted diagnostic or therapeutic device that would involve human readers.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This is a physical medical device (spine system), not an algorithm.
7. Type of Ground Truth Used
The "ground truth" in this context refers to the established mechanical testing standards (ASTM F1798 and ASTM F1717) and the performance characteristics of the predicate device. The performance of the new device is compared directly to these established benchmarks.
8. Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that involves training data.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
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(76 days)
The OP Spine System is intended for posterior, non-cervical fixation (pedicle screw fixation T1-S2/flium and hook fixation (T1-L5)) in pediatric patients is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The device is intended to be used with autograft and/or allograft.
The OP Spine System consists of longitudinal members (rods), anchors (hooks and screws), interconnection components (rod-to-rod and anchor-to-rod connectors) and fasteners in a variety of -sizes to accommodate differing anatomic requirements.
The provided text describes a medical device submission (K120291) for the OrthoPediatrics (OP) Spine System. However, it does not include information about acceptance criteria, device performance metrics, or study details in the format requested.
The document is a 510(k) summary and subsequent FDA determination letter, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed clinical study results or acceptance criteria as would be found for a novel device requiring such proof for market clearance.
Here's a breakdown based on the provided text, highlighting what's missing in relation to your request:
Information not available in the provided text:
- Acceptance Criteria Table and Reported Device Performance: This document does not specify quantitative acceptance criteria or report device performance against them. It states that "Static and dynamic compression bending tests and static torsion tests, performed according to ASTM F1717, demonstrated that the device performs as well as or better than the predicate devices," but no specific metrics or thresholds are provided.
- Sample size and data provenance for test set: Not applicable as no specific test set (for performance evaluation against acceptance criteria) is described.
- Number of experts and qualifications for ground truth: Not applicable.
- Adjudication method for test set: Not applicable.
- Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable.
- Standalone (algorithm only) performance: Not applicable as this is a physical medical device, not an AI algorithm.
- Type of ground truth used: Not applicable.
- Sample size for training set: Not applicable.
- How ground truth for training set was established: Not applicable.
Information that is available (though not directly answering your questions in the requested format):
The document indicates "PERFORMANCE DATA: Static and dynamic compression bending tests and static torsion tests, performed according to ASTM F1717, demonstrated that the device performs as well as or better than the predicate devices. Published clinical results for similar devices supported the safety and effectiveness of the device."
This suggests that the "acceptance criteria" were implied by meeting or exceeding the performance of the predicate devices in these specific mechanical tests, as per the ASTM F1717 standard. The "study" that proves this involves these mechanical tests. However, no specific numerical results are given.
The "ground truth" equivalent in this context for mechanical testing is adherence to the ASTM F1717 standard and comparison with known performance characteristics of predicate devices.
In summary, the provided document is a 510(k) submission for substantial equivalence based on materials, design, and mechanical testing against predicate devices, not a clinical trial report with specific acceptance criteria and detailed performance metrics.
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(110 days)
OrthoPediatrics PediLoc™ Tibia Plates are indicated for fractures, osteotornies, and non-unions of the pediatric and small stature adult tibia.
The OrthoPediatrics PediLoc™ Tibial Plates are machined metallic plates that offer screw to plate locking designed for various fracture modes of the distal end of the tibia and other small bones.
The provided submission describes a medical device, the OrthoPediatrics PediLoc™ Tibial Plate System, and its substantial equivalence to previously cleared predicate devices. It does not contain information about a study proving the device meets specific acceptance criteria in the context of AI/ML performance, nor does it include details on clinical studies with defined endpoints, statistical analysis, or ground truth establishment relevant to AI/ML device evaluations.
Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth for an AI/ML device is not applicable or cannot be extracted from this document.
However, based on the document's content, here's what can be inferred about the "acceptance criteria" and "study" in the context of this 510(k) submission:
Acceptance Criteria and Device Performance (in the context of 510(k) for a traditional medical device)
| Acceptance Criteria (Inferred from 510(k) process) | Reported Device Performance |
|---|---|
| Technological Characteristics Substantial Equivalence: Device shares indications for use, similar materials, and similar technological characteristics with predicate devices. | "Components comprising OrthoPediatrics PediLoc™ Tibial Plate (and screws) System are similar to the predicate devices listed above in that they share indications for use, are made from similar materials, and incorporate similar technological characteristics." |
| Performance Characteristics (Strength): Device's mechanical strength is comparable to predicate devices. | "Engineering (strength) calculations were included demonstrating these devices are as strong as the devices cleared through K080522." (K080522 is Synthes LCP Distal Tibia T-Plates, a predicate device). |
| Materials: Device is manufactured from materials meeting established standards. | "The devices are manufactured from 316L stainless steel which meets the ASTM-F138 standard." |
| Intended Use: The intended use aligns with the predicate devices and is appropriate for the device design. | "OrthoPediatrics PediLoc™ Tibial Plates are indicated for fractures, osteotomies, and non-unions of the pediatric and small stature adult tibia." This is compared to and found similar to predicate devices. |
Study Information (in the context of 510(k) for a traditional medical device)
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. This 510(k) relies on engineering calculations and comparison to predicate devices, not a test set of data in the AI/ML sense. Mechanical testing (implied by "engineering (strength) calculations") would involve a sample of manufactured devices, but the specific number is not provided, and it's not a "test set" of patient data.
- Data Provenance: Not applicable in the context of patient data. The "data" here refers to engineering and material specifications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. Ground truth, in the AI/ML sense, is not established for patient data in this submission. The "ground truth" for a mechanical device would be the physical properties and performance measured against engineering standards. The FDA reviewers and the manufacturer's engineers are the "experts" involved in assessing this.
4. Adjudication method for the test set
- Not Applicable. There is no "test set" of patient data 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 not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Engineering Specifications and Material Standards: The "ground truth" for this device's performance is its adherence to mechanical engineering principles, material science standards (e.g., ASTM-F138 for 316L stainless steel), and comparison of its design and intended use to legally marketed predicate devices.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device, so there is no training set.
9. How the ground truth for the training set was established
- Not Applicable. This is not an AI/ML device, so there is no training set or associated ground truth establishment.
In summary: This document is a 510(k) premarket notification for a traditional surgical implant. The "study" predominantly refers to engineering calculations and a comparison to known predicate devices to establish substantial equivalence, rather than a clinical trial or AI/ML performance evaluation study against specific acceptance criteria.
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