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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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(137 days)
The RESPONSE 4.5/5.0 and 5.5/6.0 Spine Systems are intended for immobilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.
When used for posterior non-cervical pediatic patients, the Response 4.5/5.0 and 5.5/6.0 Spine System implants are indicated as an adjunct to treat adolescent idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. The Response 4.5/5.0 and 5.5/6.0 Spine Systems are intended to be used with autograff and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The RESPONSE 4.5/5.0 Spine System and RESPONSE 5.5/6.0 Spine System (herein referred to as the RESPONSE Spine Systems) are pedicle screw spinal implant systems consisting 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. All implant components are manufactured from titanium alloy (6Al-4V-ELI; ASTM F-136), commercially pure titanium (ASTM F67), and cobalt-chromiummolybdenum alloy (ASTM F-1537). All system components and instruments are provided nonsterile.
The longitudinal members (rods) are provided in straight and pre-bent configurations. The anchors include a variety of hooks and pedicle screws. The interconnection components include rod-to-rod and anchor-to-rod connectors. The fasteners include set screws for all the pedicle screws, hooks and connectors. The system is implanted using general (Class I, 510(k) exempt) and specific (Class II) surgical instruments.
This submission adds additional rods, pedicle screws, anchor-to-rod connectors, and Class II instruments to the RESPONSE Spine Systems.
The provided text is a 510(k) summary for the RESPONSE™ Spine System. This document focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance, primarily through comparison of design, materials, and intended use, along with mechanical performance testing.
It does not contain information related to a study that establishes acceptance criteria for, or proves the device meets, performance characteristics typically measured for AI/ML-based medical devices (e.g., sensitivity, specificity, AUC). This type of device is a physical implant (pedicle screw system), and its "performance" is assessed through mechanical strength and durability testing, not through analysis of diagnostic accuracy or reader improvement.
Therefore, I cannot provide the requested information regarding:
- A table of acceptance criteria and reported device performance (in the context of diagnostic accuracy/AI performance).
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for the test set.
- MRMC comparative effectiveness study or human reader improvement with AI assistance.
- Standalone performance (algorithm only).
- Type of ground truth used (expert consensus, pathology, outcomes data).
- Sample size for the training set.
- How ground truth for the training set was established.
However, I can extract the information provided regarding the mechanical performance tests, which serve as the "study" proving the device's physical capabilities.
Study information related to the device's physical performance:
1. Acceptance Criteria and Reported Device Performance (as related to mechanical testing):
The document lists the types of mechanical performance testing conducted, implicitly indicating that meeting the standards of these tests would be the acceptance criteria for the physical device components. Specific numerical acceptance values or reported performance metrics (e.g., maximum force before failure) are not explicitly provided in this 510(k) summary, only that the tests were performed.
| Acceptance Criteria (Type of Mechanical Test) | Reported Device Performance (Implicitly met or passed) |
|---|---|
| Dynamic compression bend testing per ASTM 1717-15 | Performed, supporting substantial equivalence. |
| Axial grip testing per ASTM 1798-13 | Performed, supporting substantial equivalence. |
| Static compression bend testing per ASTM 1717-15 | Performed, supporting substantial equivalence. |
| Mechanical testing specific to reducer | Performed, supporting substantial equivalence. |
| User validation studies | Performed (no details on criteria/results provided). |
| Sterilization (leveraged from K181390 and K150600) | Leveraged, supporting substantial equivalence. |
| Biocompatibility per ISO 10993-1 (leveraged from K181390 and K150600) | Leveraged, supporting substantial equivalence. |
| Dynamic compression bend testing per ASTM 1717 (leveraged from K181390 and K150600) | Leveraged, supporting substantial equivalence. |
2. Sample size used for the test set and data provenance:
Not applicable as this is mechanical testing of physical implants, not data-driven testing. The "test set" would be the number of physical implants tested for mechanical properties. This specific number is not disclosed in the summary.
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 this context refers to the physical properties of the materials and constructs, established by engineering and material science standards (ASTM, ISO).
4. Adjudication method for the test set:
Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done:
No. This study type is for AI/human reader performance, not for physical implant performance.
6. If a standalone performance was done:
Not applicable in the context of AI/ML performance. Standalone performance here relates to the inherent mechanical properties of the devices themselves, which were tested.
7. The type of ground truth used:
Engineering and material science standards (e.g., ASTM, ISO guidelines for mechanical testing and biocompatibility).
8. The sample size for the training set:
Not applicable. The "training set" concept is for AI/ML models, not for physical device manufacturing.
9. How the ground truth for the training set was established:
Not applicable.
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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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(113 days)
OrthoPediatrics PediFoot Deformity Correction System is intended for fixation of fractures, nonunions, replantations, and fusions of small bone fragments. Examples include, but are not limited to, the hand, wrist, foot, and ankle.
The OrthoPediatrics PediFoot Deformity Correction System is a plate and screw system intended for the use in fracture fixation, osteotomies, and arthrodesis, primarily in the foot. The subject plates system will offer five different plate options – compression/neutral plates, reconstruction plates, wedge plates, clover plates and angle iron plates in various sizes to accommodate patient anatomy. All plates will be sized to allow their use in children and small statured adults. The plates are designed to accept the subject Ø2.7mm or Ø3.5mm cortical and/or variable angle locking screws. All subject plates and screws are manufactured from medical grade 316L stainless steel per ASTM F138 or ASTM F139. All instruments are manufactured from stainless steel per ASTM F899, cobalt chrome per ASTM F562, silicone, propylux, polyphenylsulfone, or aluminum per ASTM B209, B211, or B221.
This document describes the premarket notification (510(k)) for the OrthoPediatrics PediFoot Deformity Correction System. The primary purpose of this 510(k) is to demonstrate substantial equivalence to legally marketed predicate devices, not to prove clinical superiority or specific performance metrics against a predefined acceptance criterion in the context of an AI/ML device.
Therefore, many of the requested elements for an AI/ML device's acceptance criteria and study design are not applicable to this traditional medical device submission. This submission focuses on engineering and material equivalence, along with mechanical testing.
Here's an attempt to address the prompts given the available information, highlighting what is missing or not applicable:
Overview of Device and Submission Type:
The OrthoPediatrics PediFoot Deformity Correction System is a plate and screw system intended for fracture fixation, osteotomies, nonunions, replantations, and fusions of small bone fragments, primarily in the foot, hand, wrist, and ankle. This is a traditional orthopedic implant device, not an Artificial Intelligence/Machine Learning (AI/ML) powered device. Its 510(k) submission focused on demonstrating substantial equivalence to predicate devices through technical characteristics (materials, design, function, sterilization) and non-clinical mechanical testing, rather than clinical efficacy or diagnostic accuracy.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Not Explicitly Stated, Inferred from Predicate Equivalence) | Reported Device Performance (Summary of Non-Clinical Testing) |
|---|---|
| Mechanical Performance: - Torque to Failure (screws) - Driving Torque (screws) - Axial Pullout (screws) - Bone Plate Bend Strength - Variable Angle Screw/Plate Interface Performance (bending strength, push out strength) | Demonstrated Substantial Equivalence: - Testing demonstrated the subject device's mechanical properties (torque to failure, driving torque, axial pullout, bone plate bend strength, variable angle screw/plate interface performance) are equivalent to or better than the predicate devices (Synthes Modular Foot System K001941 and Synthes 2.4mm/2.7mm Variable Angle (VA)-LCP Forefoot/Midfoot System K100776). Specific numerical results for "acceptance" vs. "performance" are not provided in this summary but were likely part of the detailed submission. |
| Material Compatibility: - Biocompatibility - ASTM standards compliance (for materials) | Demonstrated Compatibility: - Plates and screws manufactured from medical grade 316L stainless steel per ASTM F138 or ASTM F139, identical to predicate materials. - Biocompatibility assessment completed (details not in summary). |
| MR Environment Compatibility: - MRI safety (if applicable) | MR Conditional: - Evaluated for use in an MR Environment and determined to be MR Conditional. |
Note: For this type of device (traditional orthopedic implant), "acceptance criteria" are typically rooted in demonstrating that the new device performs at least as safely and effectively as predicates with respect to mechanical properties, material properties, and intended use. Specific quantitative thresholds for "acceptance" are generally not disclosed in the 510(k) summary but are part of the full submission's engineering reports.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the provided summary. Mechanical testing typically involves a number of samples (e.g., 5-10 per test condition) to establish statistical significance for engineering properties.
- Data Provenance: The data is from non-clinical (bench) testing performed by the manufacturer, OrthoPediatrics, Corp. This is not patient data; it's laboratory test data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Not Applicable: This is a mechanical device submission, not an AI/ML diagnostic or prognostic tool. "Ground truth" in the context of expert consensus on patient data (e.g., radiologists interpreting images) is not relevant to demonstrating substantial equivalence for an orthopedic implant. Ground truth for mechanical testing is established by the test methods and equipment calibration.
4. Adjudication Method for the Test Set
- Not Applicable: Adjudication methods (e.g., 2+1, 3+1) are used for reconciling expert opinions on clinical data, which is not relevant here. Mechanical test results are objective measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No: An MRMC study is relevant for evaluating the impact of AI on human reader performance for diagnostic tasks. This device is an orthopedic implant, not a diagnostic imaging tool.
6. If a Standalone (Algorithm Only) Performance Was Done
- Not Applicable: This is not an algorithm or AI device.
7. The Type of Ground Truth Used
- Engineering Specifications and Mechanical Test Standards: The "ground truth" for this device's performance demonstration lies in meeting established mechanical performance standards (e.g., ASTM F543, F382) and demonstrating comparable or superior performance to the predicate devices in these tests. The properties measured (e.g., torque, bend strength, pullout force) are the "ground truth" for the device's mechanical integrity.
8. The Sample Size for the Training Set
- Not Applicable: This device does not involve training data as it is not an AI/ML algorithm.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable: No training set or associated ground truth for an AI/ML algorithm development.
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(142 days)
Small Cannulated Screws (2.5mm - 4.0mm diameter) are intended for fixation of fractures and non-unions of small bones and small bone arthrodeses. Examples include, but are not limited to scaphoid and other carpal and phalangeal fusions, osteotomies, and bunionectomies.
Large Cannulated Screws (4.5mm – 7.5 mm diameter) are intended for fracture fixation of large bones and large bone fragments. Diameters 6.5 mm and larger are intended for large bone fragments such as slipped capital femoral epiphyses; pediatric femoral neck fractures; tibial plateau fractures; SI joint disruptions; intercondylar femur fractures; subtalar arthrodesis and fixation of pelvis and iliosacral joint.
The OrthoPediatrics Cannulated Screw System is a cancellous screw system intended for the use in the fixation of bone fragments. The subject Cannulated Screw System is composed of cannulated screws offered in a variety of sizes and options to accommodate patient anatomy, as well as washers and associated instrumentation to facilitate or aid in placement of the subject screws. The cannulated design of these screws allows them to be used in combination with a guide wire, also included in this system, for precise placement into bone. The included Bone Screw Washers provide optional increased stabilization between the screw head and cortical bone. All subject screws and washers are manufactured from medical grade stainless steel per ASTM F138. All instruments are manufactured from stainless steel per ASTM F899, with the exception of the guide wires, which are manufactured from cobalt chrome per ASTM F562.
This document does not describe an AI/ML powered device, therefore, the requested information elements related to AI/ML device performance and testing are not applicable.
The document describes the OrthoPediatrics Cannulated Screw System, a medical device for bone fixation. The provided text outlines the regulatory submission, intended use, device description, and a summary of technological characteristics compared to predicate devices to establish substantial equivalence.
Here's a breakdown of the requested information based on the provided text, indicating where information is not available due to the nature of the device (not an AI/ML product) or the submission type (510(k)):
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Non-Clinical Tests (Mechanical Properties) | The subject device was tested for mechanical properties relevant to bone screws. The specific acceptance criteria (e.g., minimum torque values, maximum pullout forces) are not explicitly stated in the summary. However, the reported performance indicates that: "Testing demonstrated the subject device to be substantially equivalent to predicate Synthes Cannulated Screws (K963172 and K012945) devices." This implies that the device met the performance levels expected to be equivalent to the predicate devices. Testing included: - Torque to Failure per ASTM F543 - Driving Torque per ASTM F543 - Axial Pullout per ASTM F543 |
| MR Environment Compatibility | "The OrthoPediatrics Cannulated Screw System was evaluated for use in an MR Environment and were determined to be MR Conditional." (This indicates it met the criteria for MR Conditional labeling, though the specific criteria are not detailed in this summary.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document does not specify the sample size for the non-clinical mechanical tests. It only mentions the types of tests performed.
- Data Provenance: The mechanical testing data would typically be generated in a lab setting, likely in the country of manufacture or a designated testing facility. The specific country or whether the data is retrospective/prospective is not mentioned. Given it's pre-market testing for a physical device, it would be considered prospective testing for the device's design.
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 is not applicable as the device is a physical bone screw system, not an AI/ML diagnostic or predictive tool that requires expert-established ground truth for its performance evaluation in the context of this 510(k) submission. Mechanical testing relies on standardized test methods (e.g., ASTM standards) rather than expert consensus on data interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for a physical device undergoing mechanical performance testing. Adjudication methods are relevant for studies involving human interpretation of data, such as in imaging or clinical trials.
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 medical device (cannulated screw system), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the mechanical performance data, the "ground truth" is established by adherence to standardized testing methods (e.g., ASTM F543) and quantifiable physical properties. There is no expert consensus, pathology, or outcomes data used as "ground truth" for the performance evaluation of the device itself in this submission. The "ground truth" for substantial equivalence lies in demonstrating that the mechanical properties are comparable to legally marketed predicate devices.
8. The sample size for the training set
Not applicable. This is a physical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of device.
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(112 days)
The Response Spine System (Response 4.5/4.0 & Response 5.5/6.0 Spine Systems) is intended for immobilization and stabilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, or lordosis), tumor, pseudoarthrosis, and/or failed previous fusion.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Response Spine System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Response Spine System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The Response Spine System is a pedical screw spinal implant system consisting of longitudinal members (rods), anchors (hooks and screws), interconnection components (rod-to-rod and anchorto-rod connectors) and fasteners in a variety of sizes to accommodate differing anatomic requirements.
Here's an analysis of the provided text regarding the OrthoPediatrics Response Spine System's acceptance criteria and studies:
The provided FDA 510(k) clearance document for the Response Spine System does not contain information about the acceptance criteria or a study proving the device meets those criteria in the context of an AI/human-in-the-loop diagnostic device.
Instead, this document is for a medical implant (spinal system) and the "acceptance criteria" and "study" refer to mechanical bench testing to demonstrate performance compared to a predicate device. The information requested in your prompt (e.g., sample size for test sets, expert ground truth, MRMC studies, standalone algorithm performance) is typically relevant to AI/diagnostic imaging devices, not spinal implants.
Therefore, many of your requested fields cannot be filled based on this specific document. However, I will answer the fields that are addressed by the document, focusing on the mechanical testing context.
Acceptance Criteria and Device Performance for OrthoPediatrics Response Spine System (K181390)
The provided document details the clearance of the Response Spine System, a medical implant, primarily based on demonstrating substantial equivalence to a predicate device through mechanical bench testing. It does not involve AI or diagnostic performance.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Bench Testing) | Reported Device Performance (Response 4.5/5.0 Spinal System) |
|---|---|
| Static yield (comparable to cleared, predicate systems) | Has static yield comparable to cleared, predicate systems. |
| Stiffness (comparable to cleared, predicate systems) | Has static stiffness comparable to cleared, predicate systems. |
| Dynamic compression bending runout properties (comparable to cleared, predicate systems) | Has dynamic compression bending runout properties comparable to cleared, predicate systems. |
| Overall properties (comparable to or better than other commercially available, adult-indicated posterior pedicle screw devices) | Overall, the results show the Response 4.5/5.0 Spinal System to have properties comparable to or better than other commercially available, adult-indicated posterior pedicle screw devices. |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the exact number of test samples or constructs used for the mechanical tests. It refers to "worst case line extension Response 4.5/5.0 Spinal System pedicle screw constructs."
- Data Provenance: The testing was bench-top mechanical testing performed by the manufacturer, OrthoPediatrics, Corp. This is not clinical data, so country of origin or retrospective/prospective distinctions are not applicable in the usual sense.
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 a diagnostic one requiring expert interpretation of images or clinical data to establish ground truth. "Ground truth" for mechanical testing is based on engineered specifications and comparison to predicate device performance.
4. Adjudication method for the test set:
- Not Applicable. As this involves mechanical testing of a medical implant, adjudication methods like 2+1 or 3+1 are not relevant. Performance is determined by physical measurements against established engineering standards and predicate device performance.
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. An MRMC study was not done. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an AI algorithm.
7. The type of ground truth used:
- The ground truth for the mechanical testing was the established mechanical performance characteristics of the predicate device (Response 5.5/6.0 Spine System, K150600) and general industry standards for thoracolumbosacral pedicle screw systems, as well as the intrinsic mechanical properties measured during testing.
8. The sample size for the training set:
- Not Applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established:
- Not Applicable. No training set was used.
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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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