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510(k) Data Aggregation
(103 days)
The LENSAR Laser System - fs 3D (LLS-fs 3D) is intended for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, laser phacofragmentation, and the creation of full and partial thickness single-plane and multi-plane arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure.
The predicate LENSAR Laser System is an ophthalmic surgical laser that has been cleared by the Agency for use in anterior capsulotomy and laser phaco fragmentation in cataract surgery performed individually or consecutively during the same surgery under K120214 (LENSAR Laser System - fs 3D). In K122829, the laser expands the Indication for Use to single-plane and multi-plane clear corneal cuts/incisions. This expansion of the Indication for Use is for partial as well as full thickness single-plane and multi-plane arc cuts/incisions in the cornea.
The current LLS-fs 3D uses the same laser and the same beam guidance system to deliver laser pulses to the eye as the predicate LENSAR device cleared via 510(k) K120214 and K 122829. Also, the patient interface device (PID), controlled force docking mechanism and moveable optical head to dock the laser to the stationary patient are unchanged from that 510(k) K120214 and K122829.
The LLS-fs 3D biometric system, which measures and constructs a three dimensional model of the optical surfaces within the eye, is unchanged from the predicate device except for software modifications to allow the system to analyze the shape and position of the peripheral cornea. To improve the accuracy of incision placement in the cornea, a new functionality called "Localized Imaging" has been added to the system. Localized Imaging is a process whereby the biometric camera is positioned to observe the corneal incision site and a very small laser mark (at low energy) is made at the center of the stroma. By imaging and measuring the position of the mark relative to the cornea anterior and posterior surfaces, the system mitigates any potential of incorrect laser beam placement due to eve movement. The corneal incision surgery is performed immediately after Localized Imaging and results in accurate incision depth in the cornea (<75 microns error).
The Indication for Use was expanded to include creation of the corneal incisions for entry to the eye in cataract surgery in K122829 and is now further expanded to include partial thickness corneal arc cuts/incisions.
Acceptance Criteria for LENSAR Laser System - fs 3D (LLS-fs 3D)
Based on the provided 510(k) summary, the acceptance criteria for the LLS-fs 3D, specifically regarding the new indication of partial thickness corneal incisions, revolve around demonstrating comparable or superior accuracy and safety compared to conventional manual techniques and the previously cleared predicate devices.
The primary performance metric evaluated for the new indication of partial thickness corneal incisions appears to be accuracy of incision depth. The goal was to show that laser-created partial thickness incisions (PTIs) achieved depths much closer to the target than manually-created PTIs, and that there was no significant difference in accuracy or variance between human and porcine eyes, and no detrimental effect on endothelial cells.
Here's a breakdown of the acceptance criteria and reported device performance:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance (as stated in the summary) |
|---|---|
| Accuracy of Incision Depth for Partial Thickness Corneal Incisions (PTIs): Laser PTIs must demonstrate superior or comparable accuracy to target depth compared to manual methods. (Target depth explicitly mentioned as 600 µm for testing) | "The accuracy of the depth of conventional manual versus laser-generated partial thickness corneal incisions (PTIs) was tested... A comparison of the depth accuracy of manual and laser PTIs demonstrated that the laser PTIs had measured depths much closer to the target 600 um depth than the manually-created PTIs." "The results showed that the mean errors in target accuracy were not different and the variance of the error in incision depth was also about the same [between porcine and human donor globes]." "Overall, the testing showed that PT's created by the LLS-fs 3D were more accurate and precise than those made using a diamond blade with the conventional manual technique." |
| Safety - Effect on Endothelial Cells: No significant loss of endothelial cell density due to laser PTIs. | "Evaluation of the effect of the laser partial thickness incisions on endothelial cells of ex vivo eyes showed that the laser method resulted in no loss of endothelial cell density when the residual corneal bed is maintained at >85um." |
| Safety - Absence of new hazards or acceptable probability/severity for existing hazards: The addition of partial thickness arc cuts/incisions should not introduce new, unacceptable hazards, or exacerbate existing ones to unacceptable levels. | "The addition of partial thickness arc cuts/incisions did not result in additional hazards although the probabilities and severities of some of the hazards identified for the predicate device were changed." (Implies these changes were within acceptable levels based on the overall conclusion of substantial equivalence). |
| Optical Radiation Hazard: Device must be eye safe under normal operating and fault conditions. | "An analysis of the optical radiation hazard to non-target tissue demonstrated that the current LLS-fs 3D femtosecond laser, biometric system scanning diode light source, and patient eye illumination (light emitting diodes) are eye safe under all normal operating and known fault conditions." |
| General Hazard Analysis: All potential hazards to patient, surgeon, and operators must have acceptable probability/severity. | "A hazard analysis of all potential hazards to the patient, surgeon and other system operators was performed to consider all changes between the current LLS-fs 3D and predicate LLS-fs 3D device. The hazard analysis demonstrates that all potential hazards have acceptable levels of probability/severity characteristics." |
2. Sample Sizes and Data Provenance
- Test Set Sample Sizes:
- Porcine ex vivo eyes: "The accuracy of the depth of conventional manual versus laser-generated partial thickness corneal incisions (PTIs) was tested using a porcine ex vivo eye model." (Specific number of eyes not quantified, but tested).
- Human donor globes: "The laser PTIs in porcine eyes were compared to a smaller number of laser PTIs in human donor globes." (Specific number of globes not quantified, but referred to as "smaller number").
- Endothelial cell study: "Evaluation of the effect of the laser partial thickness incisions on endothelial cells of ex vivo eyes..." (Source of ex vivo eyes not specified, but likely porcine or human donor as implied by other tests. Specific number not quantified).
- Data Provenance:
- The studies were "ex vivo," meaning performed on excised tissues, not live subjects.
- The origin (e.g., country) of the porcine or human donor eyes is not specified.
- The studies were likely retrospective in nature, as they utilize ex vivo samples for controlled measurements. They are presented as performance tests supporting a 510(k) submission, typical of pre-market validation.
3. Number of Experts and Qualifications for Ground Truth
- The document does not specify the number of experts used to establish ground truth for the test set.
- It also does not specify the qualifications of any experts involved in defining or adjudicating the ground truth. The ground truth ("measured depths") was established using an "optical coherence tomographer" which implies objective measurement, rather than expert interpretation of images.
4. Adjudication Method for the Test Set
- The document does not mention any adjudication method for the test set. The ground truth for incision depth was established through objective measurement using "an optical coherence tomographer," which typically involves automated or semi-automated measurement, reducing the need for human adjudication of subjective interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. The studies described were primarily technical performance evaluations (e.g., measuring incision depth accuracy), and safety assessments (e.g., endothelial cell integrity), rather than studies evaluating the impact of AI assistance on human reader performance. This device is not an AI-assisted diagnostic tool that would typically warrant such a study.
6. Standalone Performance Study (Algorithm Only)
- Yes, in essence, standalone performance was assessed for the laser's ability to create incisions. The studies evaluated the LLS-fs 3D's performance in creating incisions (accuracy of depth, effect on tissue) in ex vivo eyes, independent of a human surgeon's real-time interaction beyond initiating the procedure. The "Localized Imaging" functionality, which uses the biometric system to image and analyze laser marks to guide subsequent incisions, represents the device's internal "algorithm" controlling the laser's output. The accuracy reported for laser PTIs and the "Localized Imaging" feature ("<75 microns error") is a measure of this standalone algorithmic performance in achieving the intended result.
7. Type of Ground Truth Used
- The type of ground truth used was objective measurement data. Specifically, for incision depth, it was "measured depths using an optical coherence tomographer." For endothelial cells, it was the "loss of endothelial cell density," which would also be determined by objective counting and analysis.
- This is not an "expert consensus" or "outcomes data" in the clinical sense, but rather direct physical measurement of the device's output on tissue.
8. Sample Size for the Training Set
- The document does not specify a training set sample size. This is a medical device (laser system) with software modifications, not a machine learning/AI model in the contemporary sense that would explicitly have a distinct "training set" for model development. The "software modifications" are likely rule-based or algorithmic, rather than data-driven deep learning, meaning there isn't a "training set" in the typical AI/ML context.
9. How the Ground Truth for the Training Set Was Established
- Since there's no explicitly defined "training set" in the context of an AI/ML model, the concept of establishing ground truth for it is not applicable here. The "ground truth" for the device's design and software adjustments would be the desired physical outcome (e.g., precise incision depth) based on engineering specifications and preclinical data, which would then be validated in the performance tests described. The "Localized Imaging" system is described as using "self-correcting feedback," implying an internal calibration and adjustment loop rather than a trained AI.
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(136 days)
The LensAR Laser System - fs 3D (LLS-fs 3D) is indicated for anterior capsulotomy and laser phaco fragmentation during cataract surgery. The anterior capsulotomy and laser phaco fragmentation procedures may be performed either individually or consecutively during the same surgery.
The LensAR Laser System - fs 3D (LLS-fs 3D) employs a mode-locked Yb:YAG laser which generates a high frequency series of femtosecond, low energy pulses at a wavelength of 1030 nm. The system is technologically the same as the predicate device defined in K112098, i.e., designed to cut the lens and lens capsular tissue, with minimal collateral damage, by the mechanisms of plasma mediated ablation and photodisruption of targeted tissue at the beam focus. The precision capsulotomy and lens fragmentation incision patterns are generated by computer-controlled scanning of the position of the laser beam focus in three dimensions at the target location. The laser energy is delivered to the eye through a disposable, proprietary patient interface device (PID) that consists of a Suction Ring which is affixed to the eye, and a precision fused silica window, which when mounted onto a PID Arm, fixates the eye and allows the laser light to be coupled into the eye through a refractive index matching cell. The index matched light coupling allows the focused laser pulses to be accurately delivered to target locations within the patient's crystalline lens.
The provided text describes a 510(k) summary for the LensAR Laser System - fs 3D (LLS-fs 3D). This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a standalone clinical study with defined performance metrics, ground truth establishment, or expert consensus.
Therefore, much of the requested information, such as a table of acceptance criteria with reported performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or specific ground truth types for a performance study, is not explicitly detailed in this 510(k) summary.
However, based on the provided text, I can extract the following relevant information:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) submission, the primary "acceptance criterion" is often demonstrating substantial equivalence to a predicate device. The performance data presented focuses on verifying that the new device performs similarly or equivalently to the predicate devices and that any changes do not adversely affect safety or effectiveness. Specific quantitative acceptance criteria with reported performance values, as would be found in a clinical trial report, are not present.
| Acceptance Criterion (Inferred from 510(k) Summary) | Reported Device Performance |
|---|---|
| Accuracy and precision of biometric and beam delivery systems | Testing performed using ex vivo porcine and human donor eyes and custom artificial eyes. Further testing in acrylic plastic confirmed shot placement accuracy (individual shots, lines, rings) was the same as the predicate device. |
| Fit and function of enhanced Patient Interface Device (PID) and 3D-CSI system imaging | Demonstrated in an evaluation that confirmed performance as substantially equivalent to predicate devices. |
| Optical radiation hazard to non-target tissue | Analysis demonstrated that LLS-fs 3D femtosecond laser, biometric system scanning diode light source, and patient eye illumination (LEDs) are eye safe under all normal operating and known fault conditions. |
| Sterility and packaging of disposable PID | Sterilization and packaging testing using gamma radiation ensured a sterility assurance level of 10-6. Functional testing after gamma irradiation was demonstrated. Method of cleaning and autoclaving reusable PID Arm was validated. |
| Biocompatibility of disposable PID components | Testing on all parts of disposable Patient Interface Device (direct/indirect fluid contact with eye tissue) performed for: cytotoxicity, irritation, sensitization, and chemical/physical characteristics. No biocompatibility issues found. |
| Thermal and Acoustic effects | Unchanged from K102727 and K112098. |
| Laser tissue interaction characteristics and capsular tensile strength | LLS-fs 3D laser tissue interaction characteristics and capsular tensile strength remain unchanged from LLS-fs Laser (K112098). Tensile strength characteristics of anterior capsule button cut with LLS-fs are consistent with K090633. |
| Hazard analysis | Analysis performed for all potential hazards to patient, surgeon, and operators, considering changes between LLS-fs 3D and predicate LLS-fs. Demonstrates all potential hazards have acceptable levels of probability/severity characteristics. |
| Adjunctive use of ultrasound in cataract surgery | Adjunctive use of ultrasound for LLS-fs 3D was not significantly different from the LensAR Laser cohort (K112098) across cataract grades. Significant reduction in CDE required for Grade 2-4 nuclear cataracts compared to K102727 Control cohort (conventional procedures). Grade 5+ cataracts approximated K102727 Control for Grade 4. |
| Capsule complications | In cases with capsule complications, the event was documented to be associated with irrigation aspiration, ultrasound fragmentation, or IOL placement procedures, not with the laser procedures. |
2. Sample size used for the test set and the data provenance:
- Test Set Description: The "testing" referenced in the summary seems to involve various engineering and preclinical assessments rather than a single clinical "test set" in the traditional sense of a diagnostic device.
- Sample Size:
- Ex vivo eyes & artificial eyes: No specific number provided, only "ex vivo porcine and human donor eyes and custom built artificial eyes."
- Clinical observation for adjunctive ultrasound use: The study "Consistent with the predicate devices Indication for Use (K102727 and K112098), the LensAR Laser System - fs 3D was studied for the indication of anterior capsulotomy and laser phaco fragmentation during cataract surgery." refers to a patient cohort. However, the exact sample size for the LLS-fs 3D laser cohort is not specified. It is compared to "the LensAR Laser cohort" (from K112098) and the "Control Cohort in K102727" (conventional procedures), which implies patient data.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The mention of "ex vivo porcine and human donor eyes" suggests laboratory/pre-clinical setting. The clinical observation on adjunctive ultrasound implies prospective patient data, likely conducted as part of the predicate device studies or a limited follow-up for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the summary. The studies described are primarily engineering validations and comparisons to existing predicate device performance, not assessments against expert-established ground truth for diagnostic accuracy. Clinical observations on adjunctive ultrasound use would implicitly rely on surgical outcomes and clinician assessment, but no formal ground truth establishment by a panel of experts is mentioned.
4. Adjudication method for the test set:
This information is not provided in the summary.
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 is not applicable to this device. The LensAR Laser System - fs 3D is a surgical laser system for cataract surgery, not an AI-assisted diagnostic or imaging system for human readers. Therefore, an MRMC study and effects on human reader improvement are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device itself is a standalone surgical instrument that performs specific laser procedures (anterior capsulotomy and laser phaco fragmentation). Its performance is evaluated on its ability to execute these procedures precisely and safely. The summary details tests on the system's accuracy, precision, safety, and physical characteristics. Therefore, in a sense, the device's technical performance without human intervention (beyond initiating the procedure) is what's being assessed by the engineering and preclinical tests.
7. The type of ground truth used:
- Engineering/Physical Ground Truth: For tests on accuracy and precision, the ground truth would be precise measurements of shot placement in artificial materials (acrylic plastic) or ex vivo tissues. For biometric system accuracy, the ground truth would be known dimensions or established imaging standards.
- Clinical/Surgical Outcome Ground Truth: For the observation related to adjunctive ultrasound use and capsule complications, the "ground truth" would be the observed surgical metrics (e.g., CDE – Cumulative Dissipated Energy, which is a common metric in phacoemulsification, and documentation of complication causes). This is an outcomes-based assessment rather than an expert consensus on an image.
8. The sample size for the training set:
This information is not provided. The device uses "computer-controlled scanning of the position of the laser beam focus" and "software used to generate the custom incision patterns." It also has a "biometric system to measure and construct a three dimensional model of the optical surfaces within the eye." These systems would likely involve algorithms and models that were developed and validated, but the summary does not detail a specific "training set" of data as would be described for a machine learning algorithm.
9. How the ground truth for the training set was established:
This information is not provided. As above, the summary doesn't detail a specific "training set" or its ground truth establishment. The biometric system's ability to measure optical surfaces and the software's pattern generation are likely based on known physics, ophthalmological principles, and engineering validation rather than a distinct labeled "training set" as understood in modern AI/ML contexts.
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(89 days)
The LensAR-fs Laser System is indicated for anterior capsulotomy and laser phaco fragmentation during cataract surgery. The anterior capsulotomy and laser phaco fragmentation procedures may be performed either individually or consecutively during the same surgery.
The predicate LensAR Laser System is an ophthalmic surgical laser that has been cleared for use in anterior capsulotomy in cataract surgery (K090633) and anterior capsulotomy and laser phaco fragmentation performed individually or consecutively during the same surgery (K102727). In new laser device with modification to the pulse width of the laser (LensAR-fs Laser System) is intended for use in the same indication as cleared in K102727. The system employs a mode-locked Yb:YAG laser which generates a high frequency series of ultrashort (1500 femtosecond), low energy pulses at a wavelength of 1030, my The system is technologically the same as defined for the predicate device, i.e., designed to cut the lens and lens capsular tissue, with minimal collateral damage, by the mechanisms of plasma mediated ablation and photodisruption of targeted itssue at the beam focus. The precision capsulotomy and lens fragmentation is generated by computercontrolled scanning of the position of the laser beam focus in three dimensions at the target location. The laser energy is delivered to the eye through a disposable, patient interface device that consists of two separately packaged parts: a commercially wailable Suction Ring with Spring Loaded Syringe to fixate the eye and an Index Matching Eye Docking (IMED) device designed to match the refractive index of the comea to optimize beam targeting accuracy.
The LensAR-fs Laser System is an ophthalmic surgical laser indicated for anterior capsulotomy and laser phaco fragmentation during cataract surgery. The acceptance criteria and the study proving the device meets these criteria are detailed below:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Accuracy and Reproducibility of Capsulotomy Incisions (ex vivo) | The device produces anterior capsulotomy incision patterns that are accurate and predictable in size and shape. |
| Equivalence of Geographical Cutting Patterns (human donor ocular globes for phaco fragmentation) | Equivalence of the geographical cutting patterns to those established for the predicate LensAR Laser was established. The fs laser causes the lens to be divided, employing linear cuts, into a number of radial sections, similar in shape to those created by the conventional manual "phaco chop" surgical technique, and then further divided by applying a set of concentric cylindrical cuts through the radial sections. |
| Ocular Safety Equivalence | An optical radiation hazard analysis by Dr. Sliney confirms the continuing ocular safety equivalence to the predicate device detailed in 510(k) K102727. |
| Technological Characteristics Comparability (with predicate devices) | The pulse width, minor software and hardware changes are incorporated while remaining consistent with the technological characteristics of the predicate device LensAR Laser. The technical characteristics of the LensAR-fs Laser fall between those of the LensAR Laser and the LenSx Laser... and raise no new issues with respect to the safety and effectiveness of the device. The technology and mechanism of laser-tissue interaction are similar to other ultrashort pulse lasers identified in the table above. The differences are insignificant and do not affect safety or effectiveness. |
| Indication for Use Statement Consistency (with predicate devices) | The indication for use statement for anterior capsulotomy and laser phaco fragmentation for the LLS-fs is the same as that of the predicate devices. |
| Absence of New Issues of Safety or Effectiveness (compared to predicate devices) | The activities and information provided do not identify any new issues of safety or effectiveness. |
The study aimed to demonstrate substantial equivalence to predicate devices (LensAR Laser System K090633 and K102727, and LenSx 550 Laser System K094052 and K082947) by showing similar performance characteristics and no new safety or effectiveness concerns despite changes in pulse width and minor hardware/software modifications.
2. Sample Size and Data Provenance for the Test Set
- Ex vivo porcine eyes: The exact number is not specified, but the testing was done on "ex vivo porcine eyes."
- Human donor ocular globes: The exact number is not specified, but evaluations were done in "human donor ocular globes."
- Data Provenance: The studies were preclinical and conducted on ex vivo biological material (porcine eyes, human donor globes). The country of origin is not specified, nor is whether the data was retrospective or prospective, though preclinical studies of this nature are typically prospective in design.
3. Number of Experts and Qualifications for Ground Truth
The document does not explicitly state the number or qualifications of experts used to establish a "ground truth" for the test set in the traditional sense of clinical studies with expert image interpretation. The evaluation was primarily based on objective measurements and observations of the laser's physical effects.
- For Ocular Safety: An optical radiation hazard analysis was performed by Dr. Sliney. His specific qualifications are not detailed beyond "Dry Sliney confirms."
4. Adjudication Method for the Test Set
No explicit adjudication method (e.g., 2+1, 3+1) is mentioned, as the studies were preclinical and focused on physical and technical performance rather than subjective interpretation by multiple human readers.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done for this device. The submission explicitly states that "thus no new clinical evaluations were required," relying instead on pre-clinical data and comparison to predicate devices. Therefore, no effect size for human readers improving with AI vs. without AI assistance is provided or relevant to this submission.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)
The device is a laser system, not an AI algorithm. Its performance is inherent to its physical operation, and it is designed for use by a human surgeon. Therefore, a "standalone algorithm only" performance study is not applicable. The device's performance was evaluated based on the physical outcomes of its laser application.
7. Type of Ground Truth Used
The ground truth was established through:
- Objective Measurements/Observations: For capsulotomy incisions (e.g., accuracy, predictability in size and shape) and phaco fragmentation patterns (e.g., division into radial and concentric sections).
- Technical Comparability: Comparison of the device's technical characteristics (e.g., pulse width, laser-tissue interaction) with established predicate devices.
- Optical Radiation Hazard Analysis: Expert assessment of ocular safety.
8. Sample Size for the Training Set
This information is not applicable. The device is a physical laser system, not an artificial intelligence or machine learning model that requires a "training set" in the computational sense.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no training set for this type of device.
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(30 days)
ETHICON Mesh is indicated for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.
The proposed ETHICON Mesh is a sterile partially absorbable mesh implant, designed for repair of fascial structure of the pelvic floor in vaginal wall prolapse. The mesh implant is constructed of knitted filaments of equal parts of absorbable poliglecaprone-25 monofilament fiber and nonabsorbable polypropylene monofilament fiber.
The provided text, K082216, is a 510(k) premarket notification for a medical device (ETHICON Mesh) and does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way typically seen for AI/ML-driven devices or diagnostics.
Instead, this submission focuses on establishing substantial equivalence to previously marketed predicate devices for a surgical mesh. The "Performance Data" section is brief and refers to material biocompatibility and functional requirements, not clinical or diagnostic performance criteria as one would find for an AI algorithm.
Therefore, I cannot fulfill your request for a table of acceptance criteria, device performance, sample sizes, ground truth information, expert details, or MRMC study results because this document does not contain that type of information.
The relevant information from the document related to "performance" is:
- Performance Data Mentioned: "Biological reactivity of the materials has been assessed using methods specified in ISO 10993-1, and the material was found to be acceptable for its intended use. Results of functional performance testing indicate that the proposed device meets or exceeds all functional requirements."
- Conclusion Basis: Substantial equivalence to predicate devices (GYNECARE GYNEMESH® PS PROLENE® Soft Mesh and GYNECARE PROLIFT+M™ Pelvic Floor Repair Systems) based on similar technological characteristics.
This type of 510(k) submission generally relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, often through material characterization, mechanical testing, and comparison of technological characteristics, rather than extensive clinical performance studies with specific statistical endpoints that would be required for a novel device or a device making diagnostic claims.
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(54 days)
The TBD One-Step Ovulation Predictor Test is an at-home in vitro diagnostic use test to be marketed over-the-counter (OTC) to lay consumers. The test device product is intended for the detection of human luteinizing hormone (hLH) in urine as an aid in the prediction of ovulation.
The TBD One-Step Ovulation Predictor Test is a simple to use, plastic stick, in vitro device. The top of the stick is clear to allow the user to visualize the migration of the test reagents. The stick contains a chromatographic test strip which has all the necessary reagents to perform the test. An absorbent tip collects and delivers the urine sample to the reagents on the chromatographic strip. The test is performed by placing the absorbent tip into the urine stream for 5 seconds. Alternatively, the test may be performed by immersing the absorbent tip into a container of urine for 5 seconds. The urine sample from the absorbent tip migrates by capillary action along the chromatographic strip, reconstituting the reagents placed strategically along the strip. Visualization of the test results occurs when the appropriate reagents react producing one or two pink-purple lines which appear in a window in the hull of the test stick. The luteinizing hormone (LH) surge is indicated if the test line is similar to or darker than the reference line. If there is no test line or the test line is lighter than the reference line, then there has been no LH surge.
The provided text describes the TBD One-Step Ovulation Predictor Test and its similarity to a predicate device. However, it does not include detailed acceptance criteria or the specific study that would directly prove the device meets these criteria in the format requested.
Here's an analysis based on the information available in the text, highlighting what is missing for a complete answer to your request:
1. Table of Acceptance Criteria and Reported Device Performance:
The document broadly states that the TBD One-Step Ovulation Predictor Test was found to have "equivalent performance to that of the predicate device" in a direct laboratory comparison, and in consumer use studies, it was "at least as accurate as the predicate device with regard to consumers' accuracy in performing the test."
Missing Information:
- Specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds).
- Detailed quantitative performance metrics for the TBD One-Step Ovulation Predictor Test.
- Quantitative performance metrics for the predicate device to compare against.
2. Sample Size for the Test Set and Data Provenance:
The document mentions "direct laboratory comparison" and "consumer use studies."
Missing Information:
- Sample Size: The number of participants or samples used in these studies is not specified.
- Data Provenance: The country of origin of the data is not mentioned. It is implied that the studies were conducted by Carter-Wallace, Inc., an American company. The description refers to "consumer use studies," which suggests prospective data collection, but this is not explicitly stated. It's unclear if any retrospective data was used.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
The document does not mention the involvement of experts in establishing ground truth for the performance studies. Since it's an at-home ovulation predictor test intended for lay consumers, the "accuracy in performing the test" likely refers to the consumers' ability to correctly interpret the results based on the package inserts, rather than expert interpretation of complex clinical data.
Missing Information:
- Details on expert involvement in establishing ground truth are entirely absent.
4. Adjudication Method:
Given the nature of an at-home ovulation test, the concept of an adjudication method as typically applied to expert review of medical images or complex diagnoses is not directly applicable or described.
Missing Information:
- No adjudication method is mentioned or implied.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
An MRMC study is not relevant to this type of device (an at-home diagnostic test for a single user).
Missing Information:
- An MRMC study was not conducted or described.
6. Standalone Performance:
The "direct laboratory comparison" and "consumer use studies" would likely represent the standalone performance of the device as it would be used by consumers, without human-in-the-loop assistance beyond the consumer following instructions.
Missing Information:
- While implied, the term "standalone performance" isn't explicitly used, and specific metrics for this are absent (as noted in point 1).
7. Type of Ground Truth Used:
The ground truth for an ovulation predictor test would typically involve confirming actual ovulation, likely through other clinical methods (e.g., daily blood hormone levels, ultrasound). However, the document focuses on the prediction of the LH surge and refers to "consumers' accuracy in performing the test." This suggests the ground truth for consumer studies might be tied to how well users followed instructions and achieved a correct reading. For the "direct laboratory comparison," the ground truth for LH levels would be laboratory-measured LH concentrations.
Missing Information:
- The exact method for establishing ground truth (e.g., comparison against a gold standard lab assay, confirmation of actual ovulation through other means) for the performance studies is not explicitly detailed.
8. Sample Size for the Training Set:
The concept of a "training set" applies to machine learning algorithms. This device is a biochemical in-vitro diagnostic test, not an AI or machine learning product. Therefore, there wouldn't be a training set in that context.
Missing Information:
- Not applicable as this is not an AI/ML device.
9. How Ground Truth for the Training Set Was Established:
As above, this is not an AI/ML device, so a training set and its associated ground truth establishment are not applicable.
Missing Information:
- Not applicable as this is not an AI/ML device.
In summary, the provided text serves as a 510(k) summary demonstrating substantial equivalence to a predicate device, focusing on technological characteristics and overall performance claims ("equivalent performance," "at least as accurate"). It lacks the granular detail about specific study designs, acceptance criteria, and quantitative results that would be expected in a comprehensive study report to fulfill all aspects of your requested information.
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(20 days)
The MegaDyne reusable patient return electrode is to be used as a general purpose return electrode in any electrosurgical application in which a standard monopolar electrosurgical generator is used.
The MegaDyne reusable patient return electrode is constructed of a layer of conductive material, laminated between two sheets of dielectric plastic material. An insulated and strain-relieved two conductor cable connects the device to a standard monopolar electrosurgical unit (ESU). The capacitive patient return electrode is large enough to extend at least half the length and the full width of a typical patient torso. Sizes for both adult and pediatric patients are available. This device is not intended to be attached to the patient. In typical use, this device will lay on an operating room table with the patient laying on top, on the side labeled "patient side". A disposable plastic sheath is placed over the device, which is replaced after each procedure, to allow for easy clean up between patients and to provide a second layer of dielectric protection. A test wand is available as an accessory. The test wand is intended to be used for periodic electrode inspections. The test wand identifies electrical deficiencies in the return electrode outer dielectric laver.
This 510(k) summary describes a traditional medical device (patient return electrode), not a software as a medical device (SaMD) or an AI/ML-based device. Therefore, the requested information regarding acceptance criteria, study details, expert involvement, MRMC studies, standalone performance, training sets, and ground truth establishment is not applicable in the context of AI/ML evaluation.
The provided text focuses on the device's physical description, intended use, and safety information as per a 510(k) submission for a conventional electrosurgical accessory.
However, I can extract the safety information that acts as a performance criterion for this device:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Current density < 100 mA per square inch | Current density is designed to be less than 100 mA per square inch at an ESU output of 700 mA rms. |
| Conformance with AAMI HF-18/1993 | This device conforms with the applicable sections of AAMI HF-18/1993. |
Explanation:
The key performance criterion for this patient return electrode is to prevent patient burns by maintaining a low current density. The device is designed to meet this criterion. Additionally, compliance with the AAMI HF-18/1993 standard signifies that the device meets established safety and performance requirements for electrosurgical devices.
The remaining requested AI/ML-specific information is not present in the provided document and is not relevant to this type of device submission.
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(184 days)
The Irrigation/Aspiration/Coagulation Electrodes, ICE-311 and ICE-511, are indicated for electrosurgical fulguration (coagulation) of the uterine cervix as part of the procedure called Loop Excision of the Transformation Zone (LETZ®), or other loop electrosurgery procedures where simultaneous electrosurgical fulguration and small-volume fluid irrigation and/or aspiration is needed.
The device consists of a stainless steel spherical ball electrode attached to an ULTEM® irrigation and aspiration head that has PVC irrigation and aspiration tubes. The posterior end of the electrode shaft fits snugly into a standard electrosurgical pen which is connected to an electrosurgical generator that has been cleared for marketing by the FDA. The irrigation tube has a PVC female Luer fitting for connection to a fluid source and the aspiration tube has an ABS suction adapter for connection to a standard vacuum suction system.
The provided document is a 510(k) summary for a medical device called the "TBD Irrigation Aspiration Coagulation Electrode" (ICE). This summary describes the device and its substantial equivalence to previously cleared devices. However, it does not include a detailed study proving the device meets specific acceptance criteria in the format requested.
The document primarily focuses on demonstrating substantial equivalence based on technological characteristics and functional comparisons with predicate devices, rather than presenting a performance study with defined acceptance criteria.
Here's a breakdown of the information that can be extracted or inferred from the provided text, and what is missing:
Information that can be extracted/inferred:
- Device Performance Reported: The document reports that:
- "Laboratory tests of the UMP ICE and the MMP #0055 have demonstrated that the irrigation fluid flow differs by less than 4% and that the aspiration capability differs by less than 8%."
- "The coagulation capabilities of the UMP ICE and the UMP ACE are equivalent since they are based on the same UMP DBL electrodes."
Information that is missing or not explicitly detailed in the provided text:
- A table of acceptance criteria: Specific, quantifiable acceptance criteria are not explicitly defined in the document as "acceptance criteria." Instead, the performance metrics mentioned above (e.g., <4% difference in irrigation flow, <8% difference in aspiration capability) act as implicit performance targets based on comparison to predicate devices.
- Sample size used for the test set and the data provenance: The document mentions "Laboratory tests" but does not specify the sample size (e.g., number of devices tested, number of measurements taken) or the provenance of the data (country of origin, retrospective/prospective).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for these tests would be the measured performance of the predicate device. Expert consensus is not a factor for these types of engineering/laboratory tests.
- Adjudication method: Not applicable, as expert adjudication is not relevant for these types of laboratory tests comparing physical attributes.
- Multi-reader multi-case (MRMC) comparative effectiveness study: No, this type of study is not mentioned or described. The device is a surgical tool, and the focus is on its physical performance rather than diagnostic accuracy or human interpretation of images.
- Standalone (i.e., algorithm only without human-in-the-loop performance) study: No, this is not applicable as the device is a physical electrosurgical tool, not an AI algorithm.
- Type of ground truth used:
- For irrigation flow and aspiration capability: The "ground truth" was the measured performance of the predicate device (MMP #0055).
- For coagulation capabilities: The "ground truth" was the performance of the UMP ACE electrodes, as the ICE electrodes use the "same UMP DBL electrodes."
- Sample size for the training set: Not applicable, as this is a physical medical device, not an AI model that requires a training set.
- How the ground truth for the training set was established: Not applicable for the same reason as above.
Attempt to present the information in the requested format, acknowledging missing details:
Acceptance Criteria and Device Performance Study for Utah Medical Products Inc.'s ICE electrodes
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Irrigation Fluid Flow | Difference of less than 4% compared to predicate (MMP #0055) | Differed by less than 4% compared to predicate (MMP #0055) |
| Aspiration Capability | Difference of less than 8% compared to predicate (MMP #0055) | Differed by less than 8% compared to predicate (MMP #0055) |
| Coagulation Capabilities | Equivalent to predicate devices (UMP ACE, based on UMP DBL electrodes) | Equivalent to UMP ACE electrodes (as they use the same UMP DBL electrodes) |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the document. The text only refers to "Laboratory tests."
- Data Provenance: Not specified. It can be inferred that these were internal laboratory tests conducted by Utah Medical Products, Inc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. The ground truth for these engineering tests was based on direct measurement of physical properties of the predicate devices.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set
- Adjudication Method: Not applicable. Expert adjudication is not relevant for objective laboratory measurements of device performance.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done
- No, an MRMC comparative effectiveness study was not done. The device is a surgical instrument, not a diagnostic imaging or AI-driven system that would typically undergo such a study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, a standalone (algorithm-only) performance study was not done. The device is a physical electrosurgical tool, not an AI algorithm.
7. The type of ground truth used
- Ground Truth Type: For irrigation fluid flow and aspiration capability, the ground truth was the measured performance of the identified predicate device (MegaDyne Medical Products, Inc.'s All-In-One Hand Control #0055). For coagulation capabilities, the ground truth was the performance of Utah Medical Products, Inc.'s ACE-311 and ACE-511 Aspiration/Coagulation Electrodes, as the ICE electrodes use the same core coagulating components (UMP DBL electrodes).
8. The sample size for the training set
- Sample Size: Not applicable. The device is a physical medical device, not an AI model that requires a training set.
9. How the ground truth for the training set was established
- Ground Truth Establishment: Not applicable.
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(84 days)
Not Found
an intramedullary rod which addresses humeral fractures. The nail is 8 mm in diameter and is available in a lengths of 200 mm, 240 mm, 260 mm, 280 mm, and 300 mm. It is used in conjunction with 3.5 mm interlocking screws. The Acumed Retrograde Humeral Nail is manufactured from titanium per ASTM F 136. This device is provided pre-sterile. Sterlity is achieved by gamma radiation.
This document is a 510(k) summary for a medical device called the "Acumed Retrograde Humeral Nail." It is a pre-market notification to the FDA. The submission focuses on demonstrating substantial equivalence to a predicate device, not on presenting a study with acceptance criteria and a device's performance against them.
Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes, expert qualifications, ground truth, and study types is not available in the provided text.
The document describes the device, its material, sterilization method, and states its similarity to a predicate device ("Smith & Nephew Richards' Russell-Taylor Humeral Interlocking Nail") in design, function, indications, and surgical technique, implying that it is expected to perform as well, but it does not provide data from a study to prove this.
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(54 days)
The Acumed Supracondylar Nail is an intramedullary rod which addresses supracondylar fractures.
The Acumed Supracondylar Nail is an intramedullary rod which addresses supracondylar fractures. The nail is available in six different sizes with diameters of 11 mm, 12 mm, and 13 mm and lengths of 150 mm and 220 mm. The nail is used in conjunction with 5 mm interlocking screws. The Acumed Supracondylar Nail is manufactured from titanium per ASTM F 136. This device is provided pre-sterile. Sterility is achieved by gamma radiation. Validation of sterility is maintained on site. Sterility level is 106. Information regarding implantation, packaging, and labeling have been provided.
Based on the provided text, there is no information about acceptance criteria, device performance, or any studies conducted on the Acumed Supracondylar Nail.
The document is a 510(k) summary for a medical device (Acumed Supracondylar Nail) and focuses on describing the device, its materials, sterilization, and its substantial equivalence to a predicate device (Smith & Nephew Richards' Intramedullary Supracondylar Nail System) for regulatory approval purposes.
Therefore, I cannot provide the requested information in the format of the table or answer the specific questions about studies, sample sizes, ground truth, or expert involvement, as this data is not present in the provided text.
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(29 days)
The TBD Pregnancy Test is a simple-to-use, at-home pregnancy test marketed over-the-counter (OTC) to lay consumers. The test device product is intended for the detection of human chorionic gonadotropin (hCG) in urine as an aid in the detection of early pregnancy.
The TBD Pregnancy Test is a Class II in vitro diagnostic medical device product that functions by way of an immunochemical chromatographicchromogenic method in detecting the presence of hCG in the urine as an aid in the early diagnosis of pregnancy. It consists of a plastic stick, housing an absorbent material that collects and delivers urine to reagents on a chromatographic strip contained within the device. The test is performed by dipping the device into a container of urine for 20 seconds. The absorbent section of the strip allows the urine sample to move chromatographically along the reagent strip reconstituting the diffusible reagents placed strategically along the strip and delivering them to the appropriate capture zones for visualization of the test results. The detection of hCG in the urine sample (pregnant) is indicated by the appearance of two pink lines in the result window. If there is no hCG (not-pregnant) in the urine, one pink line will appear.
The provided text describes a 510(k) summary for the "TBD Pregnancy Test," an at-home pregnancy test. However, it does not contain detailed acceptance criteria, a comprehensive study report that proves the device meets those criteria, or the specific information requested in your prompt (e.g., sample sizes for test/training sets, number/qualifications of experts, adjudication methods, details on MRMC studies, or specific ground truth methodologies beyond general statements).
The document mentions several studies but only describes their general purpose. It lacks the quantitative results and methodologies needed to populate the requested tables and answer the questions thoroughly.
Therefore, many of the requested details cannot be extracted from the provided text.
Here's an attempt to answer the questions based only on the provided text, highlighting what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Laboratory Accuracy | Conducted studies to determine performance in comparison to predicate device. (Specific results/metrics not provided) |
| Sensitivity | Evaluated and confirmed in a third laboratory study. (Specific sensitivity values not provided) |
| Lay Consumer Performance | Evaluated in two separate studies. (Specific metrics for ease of use/interpretation not provided) |
| Lay Consumer Interpretation | Evaluated in two separate studies. (Specific metrics for accuracy of interpretation by lay users not provided) |
| Substantial Equivalence to Predicate Device | Declared substantially equivalent to CLEARBLUE™ Easy One-Step Pregnancy Test. (Specific data supporting this claim not provided) |
| Detection of hCG in urine | Functions by immunochemical chromatographic-chromogenic method. (Specific detection limits/assay range not provided) |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not specified in the provided text.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The text only mentions "laboratory studies" and "separate studies" for consumer evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not specified in the provided text. The term "experts" or "qualified personnel" is not used in the context of ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified 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
- No, an MRMC comparative effectiveness study was not explicitly mentioned or implied. The device is an at-home pregnancy test, not an AI-assisted diagnostic tool for human readers. The studies focused on laboratory performance and lay consumer performance/interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, in essence. The "TBD Pregnancy Test" is an in-vitro diagnostic device designed to operate "stand-alone" in terms of its chemical reaction and visual readout. The "standalone performance" is covered by the "laboratory accuracy" and "sensitivity" studies mentioned. However, the term "algorithm" is not applicable as this is a chemical-based test, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Implied Ground Truth: For the "laboratory accuracy" studies, the ground truth would typically be established by a reference method for hCG detection, or by using known positive and negative hCG samples. For the "sensitivity" study, it would involve known concentrations of hCG. For "lay consumer performance/interpretation," the ground truth for pregnancy status would likely be established by a laboratory reference test. However, the specific methodology (e.g., reference lab results, clinical diagnosis) is not detailed.
8. The sample size for the training set
- Not specified in the provided text. The concept of a "training set" typically applies to machine learning algorithms, which is not directly applicable to this chemical-based diagnostic device. The studies described are performance evaluations, not algorithm training.
9. How the ground truth for the training set was established
- N/A, as an AI/algorithm training set is not applicable to this device.
Summary of Missing Information:
The provided text from the 510(k) summary is a high-level overview. It describes the device, its intended use, technological characteristics, and that performance studies were conducted. However, it lacks the detailed quantitative data, specific methodologies, and statistical information typically found in a full study report that would allow for a complete answer to your prompt. Specifically, all requested sample sizes, exact performance metrics for acceptance criteria, details on expert involvement, and adjudication methods are absent.
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