Search Results
Found 6 results
510(k) Data Aggregation
(299 days)
PBJ
The KLS Martin CranioXpand Spring system is indicated for use in the treatment of cranial conditions such as craniosynostosis and congental deficiencies in which osteotomies and gradual bone distraction are indicated for the infant pediatric subpopulation (29 days of age). The CranioXpand implants are implantable single-use products intended for temporary stabilization of the bony cranial roof during and after surgery. This device is intended to be removed after bone consolidation.
The KLS Martin CranioXpand Spring System consists of implantable spring distractors and supporting instruments intended for temporary stabilization and distraction of the bony cranial roof during and after surgery through distraction osteogenesis. The CranioXpand Springs are offered in various sizes. The spring features include rounded atraumatic contours to ensure optimal embedding in soft tissue with curved ends to ensure the devices can securely anchor in the bone. Two springs are provided as part of the CranioXpand system for anterior and posterior placement on the osteotomies. The springs are removed after adequate bone formation or after the bone consolidation phase is complete. These devices are typically left in the implanted location for 3 - 6 months before explantation. The CranioXpand Instruments are accessories used to facilitate spring size selection, and spring insertion and positioning.
The provided text is a 510(k) Premarket Notification from the FDA, specifically concerning the KLS-Martin L.P. CranioXpand device. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets clinical performance acceptance criteria through the types of studies you've queried (e.g., MRMC studies, standalone AI performance, expert ground truth adjudication).
The CranioXpand device is a physical implant (spring system) used for cranial conditions in pediatric patients, not an AI or software-based diagnostic tool. Therefore, the types of studies and acceptance criteria you've asked about, which are common for AI-driven image analysis or diagnostic devices, are not applicable to the information contained within this 510(k) submission.
The "studies" conducted for this device are non-clinical performance bench testing and biocompatibility testing, designed to show that the CranioXpand is as safe and effective as its predicate device.
However, I can extract the information relevant to their acceptance criteria and performance studies for this type of medical device:
Here's a breakdown based on the provided document:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for the CranioXpand device, as reported in this 510(k), are focused on bench testing to demonstrate performance equivalence to the predicate device and biocompatibility.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993-1:2018 for long-term implants in contact with tissue/bone for the springs, and external communicating devices with limited contact for the instruments, covering endpoints such as cytotoxicity, sensitization, irritation, pyrogenicity, carcinogenicity, implantation, acute/subacute/subchronic/chronic toxicity. | The CranioXpand device and accessories were evaluated per FDA guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management Process" and found to comply with the requirements of ISO 10993-1:2018 thus are considered biocompatible. |
| Spring Testing (Performance Bench Test) | Force measurements during cyclical testing (compressing to 10mm, holding 5s, decompressing, repeated 6 times) must show performance comparable to the predicate device. The exact quantitative criteria for "comparable" are not explicitly stated, but the conclusion is a "Pass." | "A comparison of the performance of the subject and predicate springs via force measurements during cyclical testing was conducted... The acceptance criteria of the test were met, thus demonstrating that the performance of the subject device is substantially equivalent to that of the predicate device." Concluded: Pass |
| Insertion Instruments Testing | Instrument must appropriately open, close, and pick up the spring. Measurements to verify the instrument could compress spring legs sufficiently ( |
Ask a specific question about this device
(262 days)
PBJ
The DePuy Synthes CMF Distraction System is intended for use as a bone stabilizer and lengthening (and/or transport) device.
The DePuy Synthes CMF Distraction System is indicated for correction of congenital deficiencies or post-traumatic defects of the cranium, where gradual bone distraction is required in adults and pediatric patients.
Cranium
- . The 1.5 mm and 2.0 mm mesh and cloverleaf footplates and screws are intended for infants, children, adolescents, and adults.
DePuy Synthes Craniomaxillofacial (CMF) Distraction System is a modular distractor system intended for correction and reconstruction of the cranium in adults, adolescents, children, and infants. The distractor construct consists of the distractor body, footplates, extension arms, and bone screws, all of which are available in multiple configurations to meet patient and surgeon needs as detailed in the table below.
Acceptance Criteria and Study for Craniomaxillofacial Distraction System (CMFD)
The provided document describes the Craniomaxillofacial Distraction System (CMFD) and its demonstration of substantial equivalence to predicate devices. The "acceptance criteria" here refers to the performance benchmarks demonstrated through non-clinical testing to ensure the device is safe and effective and comparable to existing devices, especially given some technological differences.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Name | Acceptance Criteria (Implicit from Test Method/Predicate Comparison) | Reported Device Performance |
|---|---|---|
| Reversing Prevention | The device should not reverse unintentionally under conditions where the previous design of CMFD reversed. | The subject device does not reverse unintentionally under the same conditions where the previous design of CMFD reversed. |
| Construct Bending Strength | The CMFD construct should be at least as strong as the predicate KLS Arnaud distractor, and design changes should not weaken it. | The CMFD construct is stronger than the predicate KLS Arnaud distractor, and the design changes relative to the previous design in K060138 do not affect the strength of the distractor construct. |
| Torque Input/Force Output and Construct Torsional Strength | The device must be capable of outputting the force required to distract bone in the cranium without failing. | The device is capable of outputting the force required to distract bone in the cranium without failing. |
| Extension Arm Interface Tensile Strength | The interface between the distractor and extension arm must withstand a tensile force based on a human factors benchmark applicable to the previous CMFD design. | The redesigned CMFD meets the same human factors benchmark as the previous design of CMFD. |
| Biocompatibility | Materials should be biocompatible, either by using previously cleared materials or demonstrating biocompatibility for new materials. | For modified distractor bodies (new material, Cobalt Chromium), a risk-based assessment per ISO 10993-1 was conducted with supporting biocompatibility testing. Results demonstrated that the material change does not raise new questions of safety or efficacy with respect to biocompatibility. Other components use materials cleared in predicate K060138. |
| Steam Sterilization Validation | Must achieve a Sterility Assurance Level (SAL) of 10^-6 via steam sterilization using previously validated parameters. | The devices may be effectively steam sterilized by the proposed parameters, which are the same parameters as the previous design of CMFD. The sterilization parameters were validated using the "overkill" method as referenced in Annex D of ANSI/AAMI/ISO 17665-1 to assure an SAL of 10^-6. |
| Endotoxin Testing | Maximum endotoxin levels for finished devices must be met (e.g., 2.15 EU/device). | The subject devices meet the maximum endotoxin testing limit of 2.15 EU/device (quantified using a Kinetic Turbidimetric method). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify sample sizes for the individual non-clinical tests (e.g., how many constructs were tested for bending strength, how many devices for reversing prevention). The tests are described generally, without providing specific numbers of units or repetitions.
The provenance of the data for these non-clinical tests would be the device manufacturer's (DePuy Synthes) internal testing laboratories or contracted labs, likely in the US (where the company is based). These are prospective tests performed specifically to support this regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable to the type of study presented. The studies described are non-clinical (mechanical, materials, sterilization, endotoxin) which rely on objective measurements and engineering standards, not expert interpretation of results to establish ground truth in the way a clinical study with image interpretation would.
4. Adjudication Method for the Test Set
This section is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving human interpretation or subjective assessments, where disagreements among experts need a resolution process. The tests performed here are objective engineering and laboratory tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This submission focuses on demonstrating substantial equivalence through non-clinical performance testing and comparison to predicate devices, along with a literature review of the previous device. There is no mention of human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable as the device is a mechanical surgical implant (Craniomaxillofacial Distraction System), not an algorithm or AI software, so there is no standalone algorithm performance to evaluate.
7. The Type of Ground Truth Used
For the non-clinical performance tests, the "ground truth" is established by:
- Engineering Standards and Specifications: For mechanical tests like bending strength, torsional strength, and tensile strength, the ground truth is defined by established engineering principles, material properties, and predetermined performance thresholds derived from predicate devices or clinical requirements.
- Biocompatibility Standards: ISO 10993-1 provides the framework for biocompatibility assessment.
- Sterilization Standards: ANSI/AAMI/ISO 17665-1 defines the "overkill" method for sterilization validation, setting the SAL of 10^-6 as the ground truth for sterility.
- Endotoxin Limits: Established limits (e.g., 2.15 EU/device) are the ground truth for endotoxin testing.
- Predicate Device Performance: Performance of the predicate devices implicitly sets a benchmark for acceptable "ground truth" performance for comparison.
8. The Sample Size for the Training Set
This section is not applicable. This is a submission for a mechanical medical device, not a machine learning or AI algorithm, so there is no concept of a "training set" in the context of device development or testing mentioned here.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the same reasons as #8.
Ask a specific question about this device
(163 days)
PBJ
Internal Distraction - Sterile includes devices intended as bone stabilizers and lengthening (and or transport) devices for correction of congenital deficiencies or post traumatic defects of the cranial bones that require gradual distraction.
Internal Distraction - Sterile consists of sterile internal distraction devices intended for the correction of cranial bones that are comprised of several different designs and components intended for bone stabilization and elongation through distraction osteogenesis. It is composed of multiple sizes and shapes of distractor footplates and either fixed or detachable activator arms. The devices are positioned internally with a connected activation arm extending through the soft tissue for external activation. Some devices, due to their anatomical positioning, are directly activated using a patient activation driver, eliminating the need for attaching an activation arm to the device. The distractor footplates are fixated to the bone on either side of the osteotomy using previously cleared bone screws (K943347, K944561, K944565, K971297, K060177). Distraction is achieved by rotating the distractor threaded drive screws with the patient driver, often with an activation arm, which causes a separation of the distractor footplates and induces the body to grow bone and expand soft tissue as a response. Various lengths of distractor drive screws are available to achieve the desired distraction length. Upon completion of distraction and consolidation of the bone, the screws are removed from the footplates and the distractor is explanted.
This document is a 510(k) premarket notification for the "Internal Distraction - Sterile" device. The acceptance criteria and supporting studies are based on demonstrating substantial equivalence to a predicate device, the "Zurich Distraction System (K010139)".
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Intended Use | The device is intended as a bone stabilizer and lengthening/transport device for correction of congenital deficiencies or post-traumatic cranial bone defects requiring gradual distraction. | The "Internal Distraction - Sterile" device has the same intended use as the predicate device, specifically for cranial bones. |
| Materials/Biocompatibility | Materials (Titanium Alloy (Ti-6Al-4V) and CP Titanium) should meet biocompatibility requirements as per FDA Blue Book Memo #G95-1 (ISO 10993 Part 1). | The device uses the same materials (Titanium Alloy (Ti-6Al-4V) and CP Titanium) as the previously cleared predicate device, with identical chemical composition, manufacturing processes, and body contact duration. Therefore, no new biocompatibility testing was needed or performed. |
| Sterilization & Pyrogenicity | Device must be in sterile packaging and meet pyrogenicity limits. | Bacterial Endotoxins testing was conducted (ANSI/AAMI ST72:2011, USP , EP 2.6.14). Results demonstrate conformity to required endotoxin units per device and meet pyrogen limit specifications. The device will be provided sterile via gamma irradiation. |
| Mechanical Performance | Mechanical properties (axial resistance, torsional loading, material properties, manufacturing tolerances) must be sufficient to withstand anatomical loads and allow for effective and safe bone movement. | Axial load testing, bending torsion testing, axial-torsion testing, and transverse shear testing were performed. All devices passed design requirements for material properties, manufacturing tolerances, axial resistance, and torsional loading, demonstrating sufficient capability to withstand anatomical loads and allow effective/safe boney movement. |
| Substantial Equivalence | The device must be substantially equivalent to the predicate device in intended use, design, function, manufacturing process, and materials, such that any differences do not raise new questions of safety or effectiveness. | The device is similar to the predicate in intended use, design, function, manufacturing process, and materials. Differences (sterile packaging, cranial-specific indication, ratcheting mechanism, detachable activators) were deemed not to raise new questions of safety or effectiveness. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily relies on non-clinical performance data (bench testing) and comparison to the predicate device.
- Biocompatibility: No new testing was performed; it relied on the predicate device's clearance.
- Pyrogenicity: The sample size for Bacterial Endotoxins testing is not specified.
- Mechanical Performance: The sample size for axial load, bending torsion, axial-torsion, and transverse shear testing is not specified. This was bench testing, not clinical data, so provenance like "country of origin" or "retrospective/prospective" is not applicable in the typical sense for patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The study is a 510(k) submission based on non-clinical bench testing and demonstration of substantial equivalence to a predicate device. There was no test set requiring expert ground truth for clinical cases.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set or adjudication for diagnostic ground truth was performed or required.
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 device is a medical implant (internal distraction system), not an AI-assisted diagnostic or therapeutic tool. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device, not an algorithm, so the concept of standalone performance does not apply.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable in the context of clinical ground truth for diagnostic accuracy. The "ground truth" for this submission is based on:
- Predicate Device Equivalence: The safety and effectiveness profile of the legally marketed predicate device (Zurich Distraction System, K010139).
- Engineering Standards: Compliance with recognized standards for biocompatibility (ISO 10993-1), pyrogenicity (ANSI/AAMI ST72:2011, USP , EP 2.6.14), and mechanical performance through bench testing against design requirements.
8. The sample size for the training set
Not applicable. This is a medical device clearance, not an AI model. There is no concept of a "training set" for the device itself.
9. How the ground truth for the training set was established
Not applicable. See point 8.
Ask a specific question about this device
(156 days)
PBJ
The RxG Distraction System includes devices intended for use in bone stabilization and elongation (lengthening) in the correction of congenital or developmental defects in cranial reconstruction for the pediatric and adult populations.
The RxG Distraction System consists of implantable devices used to lengthen or increase the dimension of cranial bones through distraction osteogenesis. It is composed of multiple sizes and shapes of RxG footplates and a threaded drive screw connected to an activation arm. The device is positioned internally with the connected activation arm extending through the soft tissue for external activation. The RxG footplates are secured to the bone on either side of the osteotomy with SonicPins RxG. Distraction is achieved by turning the activation arm with the patient activation driver, causing the plates to separate. Various lengths of drive screws are available to achieve up to 40 mm of distraction. Upon completion of distraction and consolidation of the bone, the drive screw is detached from the RxG footplates and removed, while the RxG footplates and SonicPins RxG remain implanted and are resorbed in 12-14 months.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Performance Bench | The RxG distractor should exhibit less deformation than the LactoSorb distractor. | The RxG Distraction System exhibited less deformation and achieved greater distraction distance than the LactoSorb distractor. The results showed substantial equivalence to the primary predicate. |
| Biocompatibility | Biocompatibility requirements met as per FDA Blue Book Memorandum #G95-1. | The RxG Distraction System patient-contacting materials are previously cleared, have the same chemical composition, manufacturing processes, body contact, and sterilization methods as the reference device. The biocompatibility requirements have been met. |
| Sterility | Achieve a Sterility Assurance Level (SAL) of 10⁻⁶. | The subject device undergoes the same sterilization methods as the reference devices and achieved an SAL of 10⁻⁶. |
| Packaging & Shelf-Life | Packaging suitable for sterilization and capable of maintaining sterility for shelf life. | The packaging & shelf-life for the subject device is identical to a reference device. The packaging is suitable for the intended sterilization process and can maintain sterility during the intended shelf life period of 5 years. |
2. Sample Size Used for the Test Set and Data Provenance
The document only describes non-clinical testing.
- Performance Bench: The test involved comparing the RxG distractor to the LactoSorb distractor. The sample size for this comparative mechanical testing is not specified in the provided text.
- Data Provenance: The tests are described as non-clinical (bench testing), so there's no patient data or country of origin to report.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. The tests are non-clinical (bench testing) and do not involve human expert interpretation for ground truth.
4. Adjudication Method for the Test Set
Not applicable. The tests are non-clinical (bench testing) and do not involve human 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 device is a medical implant system, not an AI-powered diagnostic tool. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a medical implant system, not an algorithm. No standalone performance study (in the context of AI) was done.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical tests was based on:
- Performance Bench: Direct measurements of deformation and distraction distance during simulated osteotomy in a controlled laboratory setting.
- Biocompatibility: Adherence to FDA-recognized international standards (ISO 10993).
- Sterility: Adherence to international standards for sterilization validation (ISO 11137, ISO 11737).
- Packaging & Shelf-Life: Adherence to international standards for packaging integrity (ISO 11607) and real-time stability testing.
8. The Sample Size for the Training Set
Not applicable. This device is a medical implant system, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This device is a medical implant system, not an AI model.
Summary of the Study that Proves the Device Meets the Acceptance Criteria:
The KLS-Martin RxG Distraction System demonstrated substantial equivalence through a series of non-clinical laboratory tests. These tests compared the subject device to its primary predicate (LactoSorb Distraction, K002083) and referenced other cleared devices (RxG Distraction System, K133304; Resorb-X G, K121606) to demonstrate that the new device does not raise new issues of safety or effectiveness.
The key studies and their findings were:
- Performance Bench Testing: Comparative mechanical testing was conducted between the RxG distractor and the LactoSorb distractor. The devices were affixed to sawbone blocks, simulating an osteotomy, and placed in a Ringer's solution waterbath. After a 48-hour latency period, distraction and consolidation were simulated over 52 days, with deformation measurements taken at regular intervals. The RxG Distraction System met the acceptance criterion by exhibiting less deformation and achieving greater distraction distance than the predicate device.
- Biocompatibility Testing: The biocompatibility of the materials (Resorb xG, Ti-6Al-4V, and Stainless Steel) was assessed according to FDA Blue Book Memorandum #G95-1, encompassing toxicology, cytotoxicity, and chemical analysis. The materials in the subject device were deemed to have met biocompatibility requirements as they are identical to those previously cleared in reference devices, with the same chemical composition, manufacturing processes, body contact, and sterilization methods.
- Sterility Testing: Validation of the gamma sterilization process was performed in accordance with ISO 11137-1, -2, and ISO 11737-1, -2. The tests included bioburden assessment and dose verification. The sterilization methods achieved an SAL of 10⁻⁶, meeting the acceptance criteria.
- Packaging & Shelf-Life Testing: Validation of package integrity was conducted per ISO 11607-1, -2, and real-time stability testing was performed for the Resorb xG implants. The packaging and shelf-life were found to be identical to a reference device, confirming its suitability for sterilization and maintenance of sterility for a 5-year shelf life.
Clinical testing was explicitly stated as "not necessary for the determination of substantial equivalence." This indicates that the non-clinical data was considered sufficient by the FDA to demonstrate that the RxG Distraction System is as safe and effective as existing legally marketed devices.
Ask a specific question about this device
(167 days)
PBJ
The OsteoMed smartflex Cranial Spring Distraction System is intended for use in the treatment of cranial conditions such as syndromic craniosynostosis and congenital deficiencies in which osteotomies and gradual bone distraction are indicated. This device is intended to provide temporary stabilization and gradual lengthening of the cranial bones. This device is intended to be removed after consolidation. The OsteoMed smartflex Cranial Spring Distraction System is intended for single patient use only.
The OsteoMed smartflex Cranial Spring Distraction System is a distraction osteogenesis system consisting of distractors in various sizes. The distractor is anchored to the cranium by the distractor foot plate. The distractor gradually distracts the bone segments by applying a continuous force to the bones of the skull facilitating remodeling to expand the prematurely closed suture. The distractors are removed after consolidation. The instruments used with the system are pliers, benders, plate cutters and other instruments to facilitate the placement and removal of the OsteoMed smartflex cranial spring distractors. The OsteoMed smartflex Cranial Spring Distractors are made from Medical Grade Stainless Steel per ASTM F-138.
This document describes the OsteoMed smartflex Cranial Spring Distraction System and its comparison to predicate devices for 510(k) clearance. The study presented is not a diagnostic device study, but rather a mechanical performance verification and clinical data comparison for a surgical implant. Therefore, several of the requested categories are not directly applicable or are interpreted differently in this context.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally based on demonstrating "substantial equivalence" to predicate devices in terms of safety and effectiveness. This is achieved through engineering tests and comparison to clinical outcomes of similar devices.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Stress on Infant Cranial Bone (below yield strength) | Finite Element Analysis showed stress on cranial bone was 80% below the stress of the predicate Cranial Distractor. |
| Maximum Distraction Distance (safe and effective range) | Maximum possible distraction distance of 55mm was identified as safe. 91 clinical cases with similar devices showed 31 cases reaching 55mm and 60 cases going beyond 55mm with only one skin infection and 3 spring repositioning complications. |
| Distraction Rate (comparable to clinical practice for similar devices) | Average distraction rate of 1.39mm per day (over a six-week duration) was obtained from clinical data and compared to the predicate's 1mm per day (0.5mm twice a day). |
| Spring Geometry and Force Targets (as described in literature/design specification) | Spring geometry was verified using an optical comparator. Force was measured during compression between footplates to simulate initial implantation force, verifying targets were met. |
| Biocompatibility (Medical Grade Stainless Steel per ASTM F-138) | Stated as "Biocompatible" and comparable to the predicate device OsteoMed External Mandibular Distraction System (K063792) which uses similar material. |
| Sterility (Provided Sterile) | Stated as "Provided Sterile (Gamma)" and comparable to predicate device K922211 for sterility method. |
| Overall Safety and Effectiveness (comparable to predicate devices) | "In conclusion, the device is safe and effective and performs as well as the OsteoMed Cranial Distraction System and the KLS-Martin predicate devices." Substantiated by similarities in intended use, indications for use, function, performance, operational principle, and materials. |
2. Sample Size Used for the Test Set and Data Provenance
- Finite Element Analysis: The sample size is not explicitly stated beyond "Cranial Vault Distractor Predicate and the OsteoMed SmartFlex Cranial Spring Distractor were created," implying a comparison of two models. Data provenance is implied to be simulated data based on infant skull properties.
- Distraction Distance and Rate Clinical Data:
- Sample Size: 91 clinical cases.
- Data Provenance: Clinical data obtained by surgeons, with cranial spring devices similar to the device, manufactured by a physician. No country of origin is specified, but it's referred to as "clinical data," suggesting retrospective human patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Finite Element Analysis: Not applicable in the context of expert ground truth. The "ground truth" here would be established by engineering principles and validated models.
- Distraction Distance and Rate Clinical Data: The data was obtained by "surgeons." The number of surgeons is not specified. Their qualifications are implicitly that they are "a physician in cranial distraction," suggesting expert practitioners in the field.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method in the traditional sense of multiple experts reviewing and reaching consensus on an output, as this is not a diagnostic study. For the clinical data, the "ground truth" appears to be the observed clinical outcomes as recorded by the treating surgeons. There is no mention of independent expert review or adjudication of these historical clinical outcomes for the purpose of this submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The study compares the performance of the new device to predicate devices and existing clinical data, but not in a multi-reader, human-AI assisted vs. human-only paradigm.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is a physical surgical implant, not an algorithm or AI system. Therefore, the concept of "standalone" algorithm performance is not applicable. The performance described relates to mechanical characteristics and clinical outcomes of the physical device.
7. The Type of Ground Truth Used
- Finite Element Analysis: Engineering models and "infant skull properties" as established physical parameters.
- Distraction Distance and Rate: Clinical outcomes data (observed distraction distances and rates, and complications) from actual patient cases.
8. The Sample Size for the Training Set
The document does not describe a "training set" in the context of machine learning. The clinical data on 91 cases mentioned for distraction distance and rate appears to be the primary observational data used for performance comparison and justification, not a "training set" for an algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no explicitly defined "training set" for an algorithm in this submission. The 91 clinical cases' outcomes were established by the treating surgeons and their medical records.
Ask a specific question about this device
(113 days)
PBJ
The OsteoMed Cranial Distraction System is intended for use in the treatment of cranial conditions such as syndromic craniosynostosis and congenital deficiencies in which osteotomies and gradual bone distraction are indicated. This device is intended to provide temporary stabilization and gradual lengthening of the cranial bones. This device is intended to be removed after consolidation. The OsteoMed Cranial Distraction System implants are intended for single use only.
The OsteoMed Cranial Distraction System is comprised of distractors, spacers, screws and instrumentation. The distractor is an internal distraction device for bone elongation of cranial bones. The distractor is anchored between the osteotomy with 1.2mm standard or 1.2mm AutoDrive screws previously cleared under K924138 and K023260, respectively. The distractor is activated using a distractor tool via the distraction rod. The distraction rod is preassembled within the distractor device. The non-threaded portion of the distractor rod can be removed during the consolidation period. The distractors, spacers, and screws are removed after consolidation. The instruments include distractor tool, drills, plate bending forceps, plate cutters and screwdrivers to facilitate the placement of screws and modification of the distractor assembly plates. A distractor rod removal tool is also available to partially remove the distractor rod leaving the distracted device in place. The distractor assembly is made from Titanium (ASTM F-67) and Titanium Allov (ASTM F-136), and the spacer is made from Titanium (ASTM F-67). The screws are made from Titanium Alloy (ASTM F-136). The instrumentation is made from various grades of surgical grade stainless steel, anodized aluminum, and/or medical grade plastic.
The provided text describes the OsteoMed Cranial Distraction System and its clearance via a 510(k) submission. However, the document does not contain a study that proves the device meets specific acceptance criteria in terms of performance metrics like sensitivity, specificity, accuracy, or any similar quantitative measures that would be found in a study about a software algorithm or diagnostic device.
Instead, the document focuses on demonstrating substantial equivalence to a predicate device (KLS-Martin, K003883) based on inherent characteristics and verification testing.
Therefore, many of the requested categories for a study are not applicable or cannot be extracted from this document, as it's not a performance study of a device against specific diagnostic or algorithmic metrics.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Performance (implied): The device should function as an internal distractor for bone elongation. | The OSTEOMED Cranial Distraction System performed equivalently to the KLS predicate device based on verification testing. Verification testing consisted of mechanical testing and comparisons against the KLS predicate device. |
| Materials Biocompatibility (implied): Materials used should be biocompatible. | Materials used for the distractor (Titanium/Titanium Alloy) are the same as the predicate devices and are biocompatible. |
| Intended Use Equivalence: The device's intended use should be equivalent to the predicate device. | Intended use is equivalent to the KLS and OsteoMed predicate devices. The device is intended for use in the treatment of cranial conditions such as syndromic craniosynostosis and congenital deficiencies in which osteotomies and gradual bone distraction are indicated, for temporary stabilization and gradual lengthening of cranial bones, and to be removed after consolidation. |
| Safety and Effectiveness (overall): The device should be safe and effective. | "In conclusion, the device is safe and effective and performs as well as the predicate device." |
| No New Safety/Effectiveness Issues: The device should not raise new safety or effectiveness issues compared to the predicate. | "Due to the similarity of materials and design to the predicate device, OsteoMed believes that the OsteoMed Cranial Distraction System does not raise any new safety or effectiveness issues." |
Regarding the "study that proves the device meets the acceptance criteria," the document states:
- "Verification testing consisted of mechanical testing and comparisons against the KLS predicate device."
- "Clinical Testing is not required to support substantial equivalence."
This indicates that the "study" was a non-clinical verification testing phase, primarily mechanical in nature, comparing the OsteoMed device to the KLS predicate device to ensure similar performance characteristics.
Here's a breakdown of the other requested information, highlighting what is not applicable (N/A) or not provided in the document for the reasons explained above:
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified for the mechanical verification testing. It would likely refer to the number of device units tested.
- Data Provenance: N/A as it's mechanical testing, not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. This does not apply to mechanical verification testing of a distraction system. Ground truth, in the context of diagnostic performance, is not relevant here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. This is for assessment of diagnostic findings, not mechanical 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:
- N/A. This device is a mechanical cranial distraction system, not an AI-powered diagnostic tool. No MRMC study was conducted or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This device is a mechanical system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- N/A. For mechanical testing, the "ground truth" would be established engineering specifications derived from the predicate device's performance, as well as general engineering principles and material standards (e.g., ASTM standards cited for materials).
8. The sample size for the training set:
- N/A. This is for machine learning models; this document describes a mechanical device.
9. How the ground truth for the training set was established:
- N/A. This is for machine learning models; this document describes a mechanical device.
Ask a specific question about this device
Page 1 of 1