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510(k) Data Aggregation
(77 days)
MEDICALCV, INC.
The ATRILAZE™ Surgical Ablation System is indicated for delivery of 810nm, 1064nm or 1083nm laser light to soft tissue to include cardiac tissue during surgical procedures. Indications include the incision, excision, dissection, vaporization, ablation, or coagulation of soft tissue.
The ATRILAZE™ Surgical Ablation System Accessories are intended for use in the support of the delivery of laser light to soft tissue to include cardiac tissue during surgical procedures.
The ATRILAZE™ Surgical Ablation System consists of a Laser Energy Generator, system cart, fluid delivery pump, fluid delivery tubing set and a fixed or flexible surgical ablation wand of various lengths. The wand is an intraoperative, sterile, single-use device designed to apply laser energy to cardiac tissue. The fluid delivery tubing set is a single-use device having a sterile fluid path designed for the delivery of sterile saline solution to the wand tip. The fluid delivery tubing may be provided together with the wand or as an accessory device. The fluid delivery pump and laser energy generator are sold separately. The wand includes a ridged metallic shaft or a flexible shaft of various lengths, and is equipped with a 905 SMA connector cable which attaches to the laser energy generator output connector. The emitted laser energy is directed toward the target tissue from the end of the optical fiber which rides within the flexible track.
The provided text describes a 510(k) submission for the ATRILAZE™ Surgical Ablation System, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical efficacy or the device's ability to "meet acceptance criteria" in terms of clinical outcomes with specific numerical performance metrics like sensitivity, specificity, or accuracy, as would be common for AI/ML devices.
Therefore, the requested information elements related to clinical performance metrics, sample sizes for test and training sets, ground truth establishment by experts, and MRMC studies are not applicable to this type of device and submission. The "acceptance criteria" here refer to demonstrating that the new device performs similarly and safely to the predicate device under specified laboratory conditions.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of a 510(k) for an ablation system, the "acceptance criteria" are implied to be that the device adheres to its specifications and produces similar lesion characteristics to the predicate device.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Adherence to specifications (functional and safety) | "Testing demonstrated that adherence to specifications was demonstrated." This indicates that the device met its design and functional requirements. |
| Lesion characteristics (substantially equivalent to predicate) | "the lesions obtained using the ATRILAZE™ wand with 1083nm laser light are substantially equivalent to those obtained with the currently cleared ATRILAZE™ Surgical Ablation System wavelengths." This is the key equivalence finding for the new 1083nm wavelength. |
| Sterility and fluid path integrity | Both the new device and the predicate are "provided sterile with a sterile fluid path for saline delivery at the laser tip." (This is a design feature, not a performance metric from the "Testing" section, but implies an underlying acceptance criterion). |
| Compatibility with existing laser energy generator and connectors | Both devices "utilize the same laser energy generator and are connected via an SMA 905 connector." (Implies compatibility was accepted). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document only states "Testing demonstrated that adherence to specifications was demonstrated." and that "lesions obtained using the ATRILAZE™ wand... are substantially equivalent." This implies a series of laboratory or bench tests were conducted, likely including tests on tissue phantoms or ex vivo tissue, but the specific number of tests or samples is not detailed.
- Data Provenance: Not specified. Given the nature of the device, it's highly probable that the testing was conducted in a laboratory or bench setting rather than using patient data from a specific country, and would be considered prospective for the specific tests performed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. For a device like a surgical ablation system, "ground truth" typically refers to physical measurements of ablation lesions (e.g., depth, width, morphology) rather than an expert's interpretation of images or clinical findings.
- Qualifications of Experts: Not applicable. The "ground truth" in this context would be derived from direct physical measurements and potentially histopathological analysis, which would be performed by qualified laboratory personnel or pathologists, but "experts" in the sense of clinical decision-makers are not involved in establishing this type of ground truth for substantial equivalence.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. Adjudication methods like 2+1 or 3+1 refer to resolving disagreements among multiple human readers for diagnostic tasks. This device demonstrates physical performance and substantial equivalence to a predicate, not diagnostic accuracy.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices to assess human reader performance with and without AI assistance. This device is a surgical tool.
- Effect Size of Human Readers with vs. without AI: Not applicable, as no MRMC study was conducted and the device is not an AI-assisted diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Not applicable. This device is a surgical tool, not an algorithm. Its performance is always predicated on human operation. The "testing" mentioned would be analogous to a standalone performance test for a mechanical or electrical device, verifying its functional specifications.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth for evaluating the "lesions obtained" would likely be based on physical measurements (e.g., macroscopic and/or microscopic assessment of lesion depth, width, volume) in tissue samples, potentially supported by histopathology to confirm cellular changes. For "adherence to specifications," the ground truth would be the specified engineering tolerances and performance parameters of the device itself.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is not an AI/ML device that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set Establishment: Not applicable, as there is no training set for this device.
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(289 days)
MEDICALCV, INC.
The MedicalCV SOLAR™ Surgical Ablation System is indicated for delivery of 810nm or 1064nm laser light to soft tissue, under direct visualization, during surgical procedures. Indications include the ablation, or coagulation of soft tissue.
The Solar™ Surgical Ablation System consists of a Laser Energy Generator, a Reciprocator Control unit, a fluid delivery tubing set and a flexible surgical ablation track. The Solar™ Orbital Track is an intraoperative, sterile, single-use device designed to apply laser energy to tissue. The fluid delivery tubing set is a single-use device having a sterile fluid path designed for the delivery of sterile saline solution to the ablation catheter. The Reciprocator Control unit is a motion generating device housing the fluid delivery pump and provides the means of monitoring the ablation process parameters. The laser energy Generator and Reciprocator Control Unit are sold separately. The Solar™ Orbital Track includes a ridged metallic shaft, a flexible track, and a guide lead and is equipped with a 905 SMA connector cable which attaches to the laser energy generator output connector. The emitted laser energy is directed toward the target tissue from the end of the optical fiber which rides within the flexible track.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Solar™ Surgical Ablation System:
The provided text focuses on demonstrating "substantial equivalence" of the Solar™ Surgical Ablation System to predicate devices rather than defining specific, quantifiable acceptance criteria for novel performance claims. The "study" described is primarily focused on demonstrating this equivalence through adherence to manufacturing specifications and qualitative/histological assessment of tissue lesions.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance to manufacturing specifications for Power Output | "Testing demonstrated that adherence to specifications was demonstrated..." |
| Compliance to manufacturing specifications for Fluid Flow | "Testing demonstrated that adherence to specifications was demonstrated..." |
| Visual and histology evaluation of lesions obtained on cardiac tissue compared to predicate device (Atrilaze™) to demonstrate substantial equivalence | "...the lesions obtained using the Solar™ flexible Orbital Trac are substantially equivalent to those obtained with the currently cleared Atrilaze™ Surgical Ablation System, which is to be expected since the energy source, the optical fiber, and application method used in both systems are identical." |
| Biocompatibility: Materials are non-toxic, non-hemolytic, non-pyrogenic | "The results of biocompatibility testing conducted on the disposable fiber optic delivery system and tubing set support that the materials used in the manufacture of the disposables are non-toxic, non-hemolytic, and non-pyrogenic." Consistent with predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The text mentions "lesions obtained on cardiac tissue" for visual and histology evaluation, but the number of tissue samples or experiments is not provided.
- Data Provenance: Not explicitly stated. The testing appears to be primarily laboratory-based ("biocompatibility testing," "Performance testing...included compliance to manufacturing specifications...along with visual and histology evaluation"). No mention of country of origin or whether it's retrospective or prospective human data. Given the context of a 510(k) submission and the nature of the testing, it's highly likely to be pre-clinical, laboratory-based testing rather than human study data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The "histology evaluation" implies evaluation by a histologist or pathologist, but no details are given.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/not specified. The testing described appears to be objective (manufacturing specifications) or qualitative/comparative (visual and histology) without indicating a need for expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study was not done. The submission focuses on demonstrating substantial equivalence to predicate devices, not on comparing the system's effectiveness with and without AI assistance or between different human readers. The device itself is a surgical ablation system, not a diagnostic imaging AI tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. The device is a surgical system that delivers laser energy, not an algorithm. The "performance testing" described is for the physical device's specifications and its ability to create tissue lesions, which inherently involves human operation and observation.
7. The Type of Ground Truth Used
- Manufacturing Specifications: For power output and fluid flow.
- Histology/Visual Evaluation: For assessing the characteristics of the lesions on cardiac tissue. This would be considered a form of expert assessment or pathology ground truth, though the details of the assessment are limited.
- Biocompatibility Standards: For the disposable components.
8. The Sample Size for the Training Set
- Not applicable. This device is a physical surgical tool and does not employ AI/machine learning, therefore there is no "training set" in the context of AI.
9. How the Ground Truth for the Training Set was Established
- Not applicable, as there is no training set.
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(27 days)
MEDICALCV, INC.
The Medical CV Atrilaze™ Surgical Ablation System is indicated for delivery of 810nm or 1064nm laser light to soft tissue to include cardiac tissue during surgical procedures. Indications include the incision, dissection, vaporization, ablation, or coagulation of soft tissue.
The Altrilaze Surgical Ablation System consists of a generator designed for the delivery of 810nm or 1064nm laser light and a hand held fiber optic light delivery device (probe) fitted with a standard SMA 905 connector at the proximal end. The system may be used in conjunction with surgical treatment for hemostasis, incision, coagulation and vaporization of tissue as required by the clinician.
Here's a breakdown of the acceptance criteria and study information for the Atrilaze™ Surgical Ablation System, based on the provided text:
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Power Output (Manufacturing Specs) | Not explicitly stated as a numerical acceptance criterion, but "compliance to manufacturing specifications for Power Output" was a performance test. The results generally indicate compliance as substantial equivalence to the predicate device was found. |
| Lesion Characteristics (Visual) | Not explicitly stated as a numerical acceptance criterion, but visual evaluation of lesions obtained using the 1064nm wavelength on cardiac tissue was performed. |
| Lesion Characteristics (Histology) | Not explicitly stated as a numerical acceptance criterion, but histology evaluation of lesions obtained using the 1064nm wavelength on cardiac tissue was performed. |
| Substantial Equivalence | Testing demonstrated that lesions obtained using the Nd:YAG laser at 1064nm wavelength are substantially equivalent to those obtained with the currently cleared laser at 810nm wavelength (the predicate device K040744 & K052495). This is the overarching acceptance criterion for the modification to the device (new wavelength). |
| Biocompatibility | For the fiber optic delivery systems (probes), the acceptance criteria (and results from prior submissions K040744 & K052495) were that the materials are non-toxic, non-hemolytic, and non-pyrogenic. Since there was no change to the probe design, packaging, or sterilization, additional testing was not required for the current submission. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document mentions "visual and histology evaluation of the lesions obtained using 1064nm wavelength on cardiac tissue" but does not specify the number of lesions or tissue samples.
- Data Provenance: Not explicitly stated, but given the nature of the device (surgical ablation system) and the testing (cardiac tissue), it is highly likely to be pre-clinical/laboratory testing on ex vivo or in vivo animal models, rather than human data. The document does not specify country of origin.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not explicitly stated.
- Qualifications of Experts: Not explicitly stated, though it can be inferred that the visual and histology evaluations would be performed by qualified professionals such as pathologists or biomedical researchers.
4. Adjudication Method for the Test Set
- Adjudication Method: Not explicitly stated. Given the context of visual and histology evaluation, single or multiple expert assessments would be expected, but no specific adjudication process (e.g., 2+1, 3+1) is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not performed. The study focused on technical performance and substantial equivalence of the device's output (lesion characteristics) when using a new wavelength, not on human reader performance with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study
- Not applicable. This device is a physical surgical laser system, not an AI algorithm. Therefore, a standalone (algorithm only) performance study would not be relevant.
7. Type of Ground Truth Used
- Direct Measurement/Observation and Expert Evaluation:
- Histology: Provides microscopic examination of tissue, considered a high-fidelity ground truth for tissue effects.
- Visual Evaluation: Direct observation of the lesions.
- Power Output Compliance: Measured against manufacturing specifications.
8. Sample Size for the Training Set
- Not applicable. This device is a physical surgical laser system and does not involve a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. (See point 8)
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(29 days)
MEDICALCV, INC.
The MedicalCV, Inc. Atrilaze™ Surgical Ablation System is Indicated for delivery of 810nm laser light to soft tissue to include cardiac tissue during surgical procedures. Indications include the incision, excision, dissection, vaporization, ablation, or coagulation of soft tissue.
The Altrilaze Malleable S-2 Disposable Probe is used with the Atrilaze™ Surgical Ablation System which consists of a generator designed for the delivery of 8 l 0nm laser light and a hand held fiber optic light delivery device (probe) fitted with a standard SMA 905 connector at the proximal end. The system may be used in conjunction with surgical treatment for hemostasis, incision, ablation, coagulation and vaporization of tissue as required by the clinician
The provided text does not describe an AI/ML powered device and therefore lacks the detailed information required to fulfill the request. The document describes a traditional medical device, the Atrilaze™ Malleable S-2 Disposable Probe, which is a surgical laser instrument.
Based on the provided text, here's what can be extracted about the device's performance and testing, but it will not fully address the detailed requirements for AI/ML acceptance criteria and studies:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (General) | Reported Device Performance (Summary) |
|---|---|
| Biocompatibility | Non-toxic, non-hemolytic, non-pyrogenic. Material change (stainless steel to nitinol) had no impact on previously gathered test results (K040744). |
| Manufacturing Specifications | Compliance to manufacturing specifications for Power Output, Tip Pull-Off, Pressure, and Flow. |
| Substantial Equivalence | Demonstrated to be substantially equivalent to predicate devices. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified for any of the tests.
- Data Provenance: The document does not specify country of origin or whether the tests were retrospective or prospective. It only mentions that biocompatibility testing was conducted under Good Laboratory Practices per 21 CFR Part 58.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable to a traditional device performance study as described here. "Ground truth" in the context of expert consensus is typically relevant for diagnostic AI/ML devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as this is a traditional device performance study, not one requiring expert adjudication of results.
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, as this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable, as this is not an AI/ML device. The "device" itself is a probe that delivers laser light, and its performance is measured against physical specifications.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The ground truth for this device's testing would be based on engineering specifications and established laboratory testing protocols for biocompatibility and physical performance (Power Output, Tip Pull-Off, Pressure, Flow). It's not a diagnostic device where pathology or expert consensus would establish ground truth for a condition.
8. The sample size for the training set:
- Not applicable, as this is not an AI/ML device. There is no "training set."
9. How the ground truth for the training set was established:
- Not applicable, as this is not an AI/ML device. There is no "training set" or corresponding ground truth to establish.
In summary, the provided document details the regulatory submission for a physical surgical laser probe, not an AI/ML-powered device. Therefore, most of the requested information pertinent to AI/ML device validation is not present.
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(252 days)
MEDICALCV, INC.
The MedicalCV, Inc. Atrilaze™ Soft Tissue Ablation System is indicated for delivery of 810nm laser light to soft tissue to include cardiac tissue during surgical procedures. Indications include the incision, dissection, vaporization, ablation, or coagulation of soft tissue.
The Altrilaze Soft Tissue Ablation System consists of a generator designed for the delivery of 810nm laser light and a hand held fiber optic light delivery device (probe) fitted with a standard SMA 905 connector at the proximal rond. The system may be used in conjunction with surgical treatment for hemostasis, incision, ablation, coaeglytion and vaporization of tissue as required by the clinician.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Biocompatibility: | Non-toxic, non-hemolytic, non-pyrogenic |
| Materials used in the disposable probe must be biocompatible. | |
| Manufacturing Specifications Compliance: | Compliance to manufacturing specifications for: |
| - Power Output | - Power Output |
| - Tip Pull-Off | - Tip Pull-Off |
| - Pressure (for fiber optic delivery device) | - Pressure |
| - Flow (for fiber optic delivery device) | - Flow |
| Visual Evaluation of Lesions on Cardiac Tissue: | Lesions obtained using the Atrilaze System on cardiac tissue were visually evaluated. |
| Substantial Equivalence: | Demonstrated substantial equivalence to predicate devices (Biolitec/Ceramoptec Ceralas D10-25 and CardioFocus Diode Laser System) for the incision, dissection, vaporization, ablation or coagulation of soft tissue. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify a sample size for a test set in the context of an algorithm or diagnostic device. This document describes a traditional medical device (a surgical laser system), and the testing performed is related to its physical and functional characteristics, not an AI or diagnostic algorithm applied to data.
Data Provenance: Not applicable in the context of an AI/diagnostic device. The testing involved biocompatibility testing and performance testing of the physical laser system.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the device is a surgical laser system, not an AI or diagnostic algorithm that relies on expert interpretation of "ground truth" for a test set. The visual evaluation of lesions on cardiac tissue would likely involve medical professionals (e.g., surgeons, pathologists), but the number and specific qualifications are not detailed.
4. Adjudication Method for the Test Set
This information is not applicable as the device is a surgical laser system, not an AI or diagnostic algorithm that requires adjudication of expert opinions for a test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of AI-assisted diagnostic tools where human readers interpret cases, and is not applicable to a surgical laser device described here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone performance study as would be understood for an algorithm was not done. The device is a surgical laser system, and its performance is inherently tied to its use by a clinician.
7. The Type of Ground Truth Used
The "ground truth" in this context refers to the verifiable outcomes of the testing performed on the physical device. This includes:
- Laboratory-established standards for biocompatibility: Demonstrating non-toxicity, non-hemolysis, and non-pyrogenicity.
- Manufacturing specifications: Compliance with objective measurements of power output, tip pull-off strength, pressure, and flow.
- Visual evaluation of tissue effects: Observation of lesions on cardiac tissue, likely compared against expected outcomes for surgical lasers.
- Predicate device performance: The ability to perform equivalently to established predicate devices for soft tissue incision, dissection, vaporization, ablation, and coagulation.
8. The Sample Size for the Training Set
This information is not applicable. The device is a surgical laser system, not an AI or machine learning algorithm that requires a "training set."
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 medical device.
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(253 days)
MEDICALCV, INC.
The MedicalCV, Inc. Northrup Universal Annuloplasty System is indicated as a reinforcement for repair of the human cardiac mitral or tricuspid valves damaged by acquired or congenital disease, or as a replacement for a previously implanted annuloplasty ring. The annuloplasty ring should be used only in cases where visual inspection confirms that the valve is repairable and does not require replacement.
The Northrup Universal Annuloplasty System consists of an annuloplasty ring mounted on a holder assembly for implantation in the mitral or tricuspid position. A complete set of instrumentation is available separately to properly size the annulus.
The provided text describes the Northrup Universal Annuloplasty System™, a medical device, and its approval process by the FDA. However, the text does not contain information about acceptance criteria for device performance, nor does it describe a study proving the device meets specific performance criteria.
The document is a "Summary of Safety and Effectiveness" (K033685) for a 510(k) submission, which focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive performance study with acceptance criteria.
Therefore, I cannot fulfill your request for a table of acceptance criteria, reported device performance, study details, sample sizes, ground truth establishment, or human-in-the-loop study results, as this information is not present in the provided text.
The text primarily details:
- Device Description: An annuloplasty ring for mitral or tricuspid valve repair.
- Intended Use: Reinforcement for repair of damaged cardiac valves (acquired or congenital disease), or replacement of a previously implanted ring, for repairable valves.
- Technological Comparison: Compared to predicate devices like CarboMedics AnnuloFlex Annuloplasty System (K992056), Edwards Lifesciences Cosgrove-Edwards Annuloplasty System (K923367), and Baxter Carpentier-Edwards Physio Annuloplasty Ring (K926138).
- Testing: Mentions biocompatibility testing (non-toxic, non-hemolytic, non-pyrogenic under GLP) and suture retention testing, which demonstrated "more than adequate retention force as compared to the predicate device." It concludes the device is "substantially equivalent" to predicate devices.
- FDA Approval: A letter from the FDA confirming substantial equivalence for the stated indications for use, allowing the device to be marketed.
In summary, the provided document focuses on regulatory approval (510(k) clearance) based on substantial equivalence, and not on detailed performance metrics, acceptance criteria, or clinical study results as you've requested.
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