Search Results
Found 9 results
510(k) Data Aggregation
(126 days)
OSTEOBIOLOGICS, INC.
The OCT (Osteochondral Transplant) Comprehensive System is indicated for arthroscopic (Knee and Ankle) and open osteochondral grafting for the treatment of osteochondral (cartilage) defects.
The OCT (Osteochondral Transplant) Comprehensive System is a kit composed of several orthopedic surgical instruments. These instruments include Drill Sleeve Cap, Drills, Toothed Core Sleeve and Plunger, Obturators, Sizers, Drill Handle, Ruler and Drill Sleeves and Sterilization Tray. All instruments are composed of stainless steel and/or injection molded plastic. The instruments range in size from 3 to 11 mm.
This appears to be a 510(k) premarket notification for a medical device (OCT Comprehensive System) and not a study describing the device's performance against acceptance criteria. There is no information in the provided text about acceptance criteria or a study proving the device meets them.
The document is a communication from the FDA to OsteoBiologics, Inc., confirming that their device, the OCT (Osteochondral Transplant) Comprehensive System, is substantially equivalent to a previously cleared predicate device (Acufex "MosaicPlasty" Comprehensive System, K964215). This "substantial equivalence" determination is the basis for its clearance, not a performance study against specific acceptance criteria.
Therefore, I cannot provide the requested information because it is not present in the provided text.
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(388 days)
OSTEOBIOLOGICS, INC.
PolyGraft™ BGS Cement Restrictor is indicated for use as a bone cement flow restrictor plug in the femur, tibia, and/or humerus.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA regarding the PolyGraft™ BGS Cement Restrictor. It states that the device is substantially equivalent to legally marketed predicate devices for the indications for use stated in the enclosure. However, the document does not contain or reference any information about:
- Acceptance criteria for device performance.
- A study proving the device meets acceptance criteria.
- Specific performance metrics for the device.
- Clinical study details like sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.
The document primarily focuses on regulatory approval, specifically indicating a warning that the device is not intended for spinal indications and that its safety and effectiveness in the spine have not been established. It also outlines general FDA regulations and requirements.
Therefore, I cannot provide the requested information based on the given text.
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(52 days)
OSTEOBIOLOGICS, INC.
TruGraft™ BGS Syringe is indicated for the aspiration of fluids, such as autologous blood, plasma or other blood components with preloaded bone graft substitute.
The TruGraft™ BGS Syringe is a device that can be filled with OsteoBiologics, Inc. products: PolyGraft® BGS or PolyGraft® TCP (K030288 and K033707 respectively) or other bone graft substitute. The TruGrafTM BGS Syringe can be provided as a kit configuration. The convenience kit provides the TruGrafTM BGS Syringe loaded (filled) with a variety of bone graft substitutes.
The TruGrafi™ BGS Syringe is a standard piston syringe that consists of a barrel, plunger and removable end cap. The distal end of the barrel is threaded to allow connection to adapters. While without the attachment, the open end allows for filling of the bone graft material. A cap is available to seal the end of the barrel, enclosing the syringe contents. The piston/plunger assembly is used to expel contents or facilitate in the collection into the barrel of the syringe.
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance metrics, or a study that proves the device meets specific criteria. The document is a 510(k) summary for a medical device (TruGraft™ BGS Syringe) seeking substantial equivalence to predicate devices, not a performance study.
The text describes:
- The device's intended use and components.
- Its classification and product codes.
- The predicate devices it claims substantial equivalence to.
- Correspondence from the FDA confirming the 510(k) clearance.
It does not contain the following information typically found in a performance study:
- Acceptance criteria and reported device performance table: No specific performance metrics or thresholds are mentioned.
- Sample size, data provenance: No test sets, training sets, or data origin (country, retrospective/prospective) are discussed.
- Number/qualifications of experts for ground truth: There's no mention of experts or ground truth establishment.
- Adjudication method: Not applicable as no ground truth creation is described.
- MRMC comparative effectiveness study: No such study is mentioned or implied.
- Standalone (algorithm-only) performance: The device is a physical syringe, not an algorithm, so this is not applicable.
- Type of ground truth: Not applicable as no ground truth is discussed.
- Sample size for training set: No training set is mentioned.
- How ground truth for the training set was established: Not applicable.
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(340 days)
OSTEOBIOLOGICS, INC.
The PolyGraft™ BGS is to be used to fill bony voids or gaps caused by trauma or surgery that are not intrinsic to the stability of the bony structure. The PolyGraff™ BGS is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process. The PolyGraft™ BGS may be combined with autogenous blood products, such as platelet rich plasma, and/or sterile fluids, such as saline or Ringer's solution. The addition of these autogenous products does not alter the performance of the device.
PolyGraft™ BGS is manufactured using a blend of poly(D,L-lactide-coglycolide), calcium sulfate, polyglycolide fibers and surfactant. The PolyGrafi™ BGS will be provided in a variety of shapes and sizes ranging from small, porous granules to preformed cylindrical plugs.
The provided text describes the PolyGraft™ BGS, a resorbable bone void filler, and its 510(k) summary (K040047). However, the document does not contain the specific information required to complete all sections of your request, such as a table of acceptance criteria, detailed device performance metrics, or information about AI/algorithm performance. The device described is a physical medical device, not an AI/algorithm-based diagnostic tool.
Therefore, many of the requested fields related to AI/algorithm performance, ground truth establishment for AI, sample sizes for test/training sets in an AI context, and expert adjudication are not applicable or cannot be extracted from this document.
Here's a breakdown of the information that can be gleaned from the provided text, addressing your questions to the extent possible:
1. Table of Acceptance Criteria and Reported Device Performance
The submission states that the PolyGraft™ BGS is "substantially equivalent in design, function and performance to the PolyGraft™ BGS cleared as K030288." This implies that the acceptance criteria are met by demonstrating equivalence to a predicate device.
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (as per Study) |
|---|---|
| Biocompatibility (materials used) | Demonstrated biocompatibility by independent certified laboratories. |
| Degradation rate in simulated body fluid | Showed degradation rate substantially equivalent to predicate devices. |
| Bone formation (in vivo) | Histologically showed bone formation similar to the predicate device (PolyGraft™ BGS alone) at different endpoints, particularly when combined with autogenous blood products. |
| Performance when combined with autogenous blood products | Demonstrated that the addition of autogenous blood products (like platelet rich plasma) does not alter the performance of the device and supported expanded indications. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document mentions a "rabbit metaphyseal defect study." However, the exact number of rabbits or lesions used in this study is not specified.
- Data Provenance: The study was an "in vivo comparison" using rabbits, which is a prospective animal study. The country of origin of the data is not specified, but the applicant is based in San Antonio, Texas, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document mentions "histologically showed bone formation" but does not specify the number or qualifications of experts who assessed these histological results.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method. It notes "histologically showed bone formation similar to the predicate device," implying a comparative assessment, but not a formal adjudication process amongst multiple readers/experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study conducted was an in vivo animal study comparing a device variant to a predicate device. This is not applicable to a physical bone graft substitute.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, this device is a physical bone void filler, not an algorithm or AI. Standalone algorithm performance is not applicable.
7. The Type of Ground Truth Used
The ground truth was established through histological analysis of bone formation in a rabbit model.
8. The Sample Size for the Training Set
This product is a physical medical device, not an AI algorithm. Therefore, the concept of a "training set" in the context of machine learning does not apply. The studies were for performance and safety demonstrations.
9. How the Ground Truth for the Training Set was Established
As above, the concept of a "training set" is not applicable for this type of medical device. The "ground truth" for the performance studies was established through histological assessment in the animal model.
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(264 days)
OSTEOBIOLOGICS, INC.
The PolyGraft™ TCP is to be used to fill bony voids or gaps caused by trauma or surgery that are not intrinsic to the stability of the bony structure. The PolyGraft™ TCP is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.
PolyGraft™ TCP is manufactured using a blend of poly(D,L-lactide-coglycolide), tricalcium phosphate, polyglycolide fibers and surfactant. The PolyGraff™ TCP will be provided in a variety of shapes and sizes ranging from small, porous granules to preformed cylindrical plugs.
The provided text is a 510(k) summary for the PolyGraft™ TCP device. It describes the device, its intended use, and claims substantial equivalence to a predicate device (PolyGraft™ BGS, K030288).
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state specific acceptance criteria (e.g., a certain percentage of degradation, specific mechanical strength thresholds). Instead, the acceptance is based on demonstrating substantial equivalence to a predicate device.
| Acceptance Criteria (Implicit) | Reported Device Performance (Summary) |
|---|---|
| Biocompatibility | Demonstrated biocompatibility of materials by independent certified laboratories. |
| Degradation rate | Degradation testing in simulated body fluid at 37°C showed the degradation rate is substantially equivalent to predicate devices. |
| Design, Function, Intended Use | Substantially equivalent to PolyGraft™ BGS (K030288). |
2. Sample Size and Data Provenance for Test Set
- Sample Size: The document does not specify a distinct "test set" in the context of clinical or performance data for the PolyGraft™ TCP device itself. The evidence presented focuses on in vitro testing for degradation and biocompatibility.
- Data Provenance:
- Country of Origin: Not specified for the in vitro testing.
- Retrospective or Prospective: The in vitro degradation testing is inherently prospective laboratory testing. Biocompatibility assessment would also be laboratory-based.
3. Number of Experts and Qualifications for Ground Truth (Test Set)
- Number of Experts: Not applicable. The document describes in vitro laboratory tests (biocompatibility, degradation) rather than human-interpreted data requiring expert consensus for ground truth.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. This concept is relevant for studies involving human interpretation or clinical endpoints requiring expert review, which is not described here.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done: No. An MRMC comparative effectiveness study is not mentioned. This type of study is typically used for diagnostic or screening devices where human readers interpret medical images or data. The PolyGraft™ TCP is a resorbable bone void filler.
- Effect Size: Not applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)
- Standalone Performance Done: Yes, in a sense. The described testing (biocompatibility, degradation rate) is performed directly on the device material itself, without human intervention as part of its function to deliver a diagnostic or interpretive result. The "performance" here is the material's inherent properties and behavior.
7. Type of Ground Truth Used
- Type of Ground Truth: For the in vitro studies, the "ground truth" is established by standard laboratory methods and control conditions.
- Biocompatibility: Established by "independent certified laboratories" according to recognized standards.
- Degradation: Established by in vitro testing in a "simulated body fluid at 37 ℃" with comparison to predicate devices.
8. Sample Size for the Training Set
- Sample Size: Not applicable. This device is not an AI/ML algorithm that requires training data in the conventional sense. The "training" for this type of device involved formulation development and manufacturing processes.
9. How the Ground Truth for the Training Set was Established
- Ground Truth Establishment: Not applicable. No "training set" or "ground truth" in the context of AI/ML algorithms is mentioned for this device. The development process would have involved material science principles and iterative testing to achieve the desired properties, but not in the framework of machine learning.
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(34 days)
OSTEOBIOLOGICS, INC.
The IMMIX™ PlastiFilm is to be used wherever temporary wound support is required, to reinforce soft tissue where weakness exists, or for the repair of hernia or other fascial defects that require the addition of a reinforcing, or bridging material to obtain the desired surgical result. This includes, but is not limited to the following procedures: vaginal prolapse repair, colon and rectal prolapse repair, reconstruction of the pelvic floor and sacral colposuspension.
The IMMIX™ PlastiFilm is manufactured using poly(D,L-lactide-coglycolide) polymer and triethyl 2-acetylcitrate or tributyl 2-acetylcitrate. The device will be provided in sheets of 10 mm x 10 mm to 120 mm x 120mm. Other shapes and sizes will be provided as needed for particular surgical procedures. Additionally, the device can be cut with scissors to obtain desired shapes and sizes.
The thickness of the IMMIX™ PlastiFilm will range from 50 to 300 microns, according to the region to be treated, and will be provided with and without macroporous holes. The holes will range from 100 microns to 1000 microns in diameter. The holes may be aligned, offset, or random patterns. The borders of the sheets may be aligned with the holes to attach suture material.
The provided text describes a 510(k) premarket notification for a medical device called IMMIX™ PlastiFilm. This document details the device's composition, intended use, and the testing conducted to support its clearance. However, it does not contain any information regarding acceptance criteria or a study that uses acceptance criteria in the context of device performance metrics often associated with AI/ML devices (e.g., sensitivity, specificity, accuracy, F1-score).
The regulatory context of this document (510(k) clearance in 2003) predates the common requirements for AI/ML device performance studies and acceptance criteria as they are understood today. The "Testing" section focuses on material properties and biocompatibility, not on a machine learning algorithm's performance.
Therefore, I cannot provide the requested information for acceptance criteria and a study proving the device meets them because the provided text does not contain such details. The device described, IMMIX™ PlastiFilm, is a polymeric surgical mesh, not an AI/ML diagnostic or prognostic device that would typically have performance metrics and associated acceptance criteria as requested in your prompt.
Here's why the requested information cannot be extracted:
- No AI/ML Component: The device is a physical surgical mesh, not an AI/ML algorithm.
- No Performance Metrics: There are no metrics like sensitivity, specificity, or accuracy reported.
- No Test/Training Sets: There's no mention of data sets used to train or test an algorithm.
- No Ground Truth Establishment: The concept of establishing ground truth for an AI model is not applicable here.
- No Expert Adjudication/MRMC Study: These are specific to AI/ML software evaluations.
The "Testing" section mentions:
- Biocompatibility assessment: Performed by an independent certified laboratory.
- Degradation testing: Performed in a physiological buffered saline solution at 37 ℃, showing full resorbability over months.
- Suture pullout testing: Performed by OsteoBiologics on a family of PlastiFilm products, demonstrating the films could withstand "substantial loads and deformations."
These are physical and chemical property tests, not performance studies for an AI/ML algorithm.
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(170 days)
OSTEOBIOLOGICS, INC.
The PolyGraft™ BGS is to be used to fill bony voids or gaps caused by trauma or surgery that are not intrinsic to the stability of the bony structure. The PolyGraft™ BGS is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.
PolyGraft™ BGS is manufactured using a blend of poly(D,L-lactide-coglycolide), calcium sulfate, polyglycolide fibers and surfactant. The PolyGraft™ BGS will be provided in a variety of shapes and sizes ranging from small, porous granules to preformed cylindrical plugs.
The provided text is a 510(k) summary for the PolyGraft™ BGS device, which is a resorbable bone void filler. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria for an AI/algorithm-based device.
Therefore, the requested information elements (acceptance criteria, study details for AI performance, sample sizes for test/training, expert ground truth, MRMC study, standalone performance) are not applicable to this document because it describes a physical medical device (bone graft substitute) and not an AI or algorithm-based device.
The "Testing" section describes the studies conducted to show substantial equivalence to predicate devices, which are:
- Biocompatibility assessment: Performed by independent certified laboratories to demonstrate material compatibility.
- Degradation testing: Performed in a simulated body fluid at 37 ℃ to show substantially equivalent degradation rate to predicate devices.
- Rabbit metaphyseal defect study: An in vivo study comparing bone formation and biomechanical properties of PolyGraft™ BGS to predicate devices at six weeks, demonstrating similar histological bone formation and equivalent biomechanical properties.
These studies serve to justify the substantial equivalence claim, which is the basis for 510(k) clearance for this type of device, rather than meeting specific performance metrics typically associated with AI device acceptance criteria.
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(84 days)
OSTEOBIOLOGICS, INC.
The IMMIX™ Thin Film is to be used wherever temporary wound support is required, to reinforce soft tissue where weakness exists, or for the repair of hernia or other fascial defects that require the addition of a reinforcing, or bridging material to obtain the desired surgical result. This includes, but is not limited to the following procedures: vaginal prolapse repair, colon and rectal prolapse repair, reconstruction of the pelvic floor and sacral colposuspension.
The IMMIX™ Thin Film is manufactured using poly(D,L-lactide-coglycolide) polymer and will be provided in sheets of 10 mm to 120 mm x 120mm. Other shapes and sizes will be provided as needed for particular surgical procedures. Additionally, the device can be cut with scissors to obtain desired shapes and sizes.
The thickness of the IMMX™ Thin Film will range from 50 to 300 microns, according to the region to be treated, and will be provided with and without macroporous holes. The holes will range from 100 microns to 1000 microns in diameter. The holes may be aligned, offset, or random patterns. The borders of the sheets may be aligned with the holes to attach suture material.
The provided document describes a medical device called IMMIX™ Thin Film (K024199), a polymeric surgical mesh. This 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance metrics for a novel AI/software device. Therefore, many of the requested data points (related to AI performance, sample sizes for AI training/testing, expert ground truth, MRMC studies, etc.) are not applicable to this submission.
However, I can extract the relevant information regarding the device's performance as presented in the submission.
1. Table of acceptance criteria and the reported device performance
The submission does not explicitly state quantitative "acceptance criteria" in the way one might for a diagnostic AI device (e.g., target specificity, sensitivity). Instead, the performance is demonstrated through studies showing the physical and biocompatible properties of the material, and its equivalence to a predicate device. The implicit acceptance criteria are that the device is biocompatible, biodegradable, and strong enough for its intended use, performing comparably to an already cleared device.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Biocompatibility | Biocompatibility assessment performed by an independent certified laboratory demonstrated the biocompatibility of the materials used for this device. |
| Degradation/Resorbability | Degradation testing performed in a physiological buffered saline solution at 37 ℃ showed that the device is fully resorbable over a period of months. |
| Mechanical Strength (Suture Pullout) | OsteoBiologics performed suture pullout testing on a family of thin film products, which are identical in material composition. The results demonstrated that the films could withstand substantial loads and deformations before its physical integrity is compromised, therefore supporting the suitability of the IMMIX™ Thin Film for use in a clinical situation. |
| Substantial Equivalence to Predicate Device (MacroPore Surgi-Wrap (TS), K012025) | The IMMIX™ Thin Film is substantially equivalent in design, function and intended use to the MacroPore Surgi-Wrap (TS), cleared as K012025 on December 3, 2001. |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of an algorithm's performance. The studies mentioned are laboratory tests:
- Biocompatibility: No sample size specified, likely performed on material samples according to standard protocols for medical devices.
- Degradation testing: No sample size specified, likely performed on material samples.
- Suture pullout testing: Performed on "a family of thin film products," but specific sample sizes are not provided.
- Data Provenance: The studies were performed by OsteoBiologics (suture pullout, degradation) and an "independent certified laboratory" (biocompatibility). The origin of this data is therefore in-house/contracted lab testing, not human patient data, and it's inherently prospective (experimental testing).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a physical surgical mesh, not a diagnostic or AI-driven device requiring expert ground truth for a test set.
4. Adjudication method for the test set
Not applicable for the reasons stated above.
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, not an AI or diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device.
7. The type of ground truth used
For the laboratory tests:
- Biocompatibility: Ground truth is established by standard biological assays and observation of cellular responses, as interpreted by expert toxicologists/biocompatibility specialists.
- Degradation: Ground truth is a direct measurement of material degradation over time under controlled conditions.
- Suture Pullout Testing: Ground truth is the direct measurement of force and deformation until failure using standardized mechanical testing equipment.
8. The sample size for the training set
Not applicable. There is no AI algorithm involved, and thus no "training set" in this context.
9. How the ground truth for the training set was established
Not applicable. There is no AI algorithm involved, and thus no "training set."
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(87 days)
OSTEOBIOLOGICS, INC.
The ACTAEON™ Probe arthroscopic cartilage stiffness tester is indicated for an arthroscopic in vivo point measurement of articular cartilage stiffness in humans. The ACTAEON™ Probe can be used arthroscopically or in open joint procedures.
The ACTAEON™ Probe is a hand-held device which when activated by the user measures the reaction force (resistance) of articular cartilage against a known rate and force of indentation applied by the disposable indenting tip of the device.
This document does not contain the detailed information necessary to complete all sections of your request. The provided text is a 510(k) summary for the ACTAEON™ Probe, which focuses on regulatory approval based on substantial equivalence to a predicate device, rather than a detailed study report describing acceptance criteria and device performance.
Here's what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
Unfortunately, the provided text does not include a table of acceptance criteria or specific reported device performance metrics. The summary states that "The ACTAEON™ Probe is designed to meet and comply with all sections of IEC 60601," which refers to electrical safety standards, not performance criteria for measuring cartilage stiffness.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not available in the provided text. A 510(k) summary primarily focuses on demonstrating substantial equivalence, and often such detailed clinical study information is not included in this document type unless a specific performance study was required.
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 information is not available in the provided text.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not available in the provided text.
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
The ACTAEON™ Probe is described as an "arthroscopic cartilage stiffness tester," which is a physical measurement device, not an AI or imaging diagnostic tool that would typically involve "human readers" or "AI assistance" in the sense of image interpretation. Therefore, an MRMC study as you've described it is not applicable to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable to this device. The device is a physical probe that measures stiffness; it's not an algorithm operating in a standalone capacity. The human user operates the device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not available in the provided text. For a device measuring stiffness, ground truth would typically come from comparative mechanical measurements or correlation with pathological findings, but the document does not elaborate on this.
8. The sample size for the training set
This information is not available in the provided text. Since this is not an AI/machine learning device, the concept of a "training set" for an algorithm, as commonly understood in modern AI development, is not applicable here. If "training set" refers to calibration or development data for the physical probe, that information is not provided.
9. How the ground truth for the training set was established
This information is not available in the provided text and is not applicable in the context of AI/ML training as defined by your request.
Summary of what is available from the document:
- Device: ACTAEON™ Probe, an arthroscopic cartilage stiffness tester.
- Intended Use: For arthroscopic in vivo point measurement of articular cartilage stiffness in humans, usable arthroscopically or in open joint procedures.
- Predicate Device: Artscan 200 Arthroscopic Cartilage Stiffness Tester from Artscan Oy. Helsinki. Finland.
- Regulatory Basis: Substantial equivalence to the predicate device.
- Stated Compliance: Designed to meet and comply with all sections of IEC 60601 (electrical safety).
The provided text serves as a regulatory summary for device clearance, not a detailed technical report of a performance study.
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