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Found 37 results
510(k) Data Aggregation
(105 days)
Indications for Use (Describe)
Prescription Use
Collagen Wound Dressing is indicated for the management of exuding wounds including:
- Full thickness and partial thickness wounds
- Pressure and venous ulcers
- Ulcers caused by mixed vascular etiologies
- Diabetic ulcers
- Partial thickness burns
- Donor sites and other bleeding surface wounds
- Abrasions
- Traumatic wound healing by secondary intention
- Dehisced surgical incisions
Over-The-Counter Use
Intended for the management of minor cuts, minor scrapes, minor bruises, minor abrasions, minor lacerations, and minor burns.
Collagen Wound Dressing is a wound care device composed of pure freeze-dried cross-linked bovine collagen. It is a sterile, absorbent, white, porous, topical wound dressing. As a primary wound dressing that can be cut to any size or be used in multi-layers to fit wound. It can also be used in combination with either occlusive or semi-occlusive secondary dressing. The product is biodegradable. Please reapply the dressing as needed based on the patient's wound healing situation.
N/A
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(171 days)
The Collagen Wound Dressing is indicated for the management of exuding wounds including: Full thickness and partial thickness wounds Pressure and venous ulcers Ulcers caused by mixed vascular etiologies Diabetic ulcers Partial thickness burns Donor sites and other bleeding surface wounds Abrasions Traumatic wound healing by secondary intention Dehisced surgical incisions
Collagen Wound Dressing is an advanced wound care device composed of pure freezedried cross-linked bovine collagen. It is a sterile, absorbent, white, porous, topical wound dressing. As a primary wound dressing, it can be cut to any size or be used in multi-layers to fit wound. It can also be used in combination with either occlusive or semi-occlusive secondary dressing. The product is biodegradable.
The provided text does not describe a study that proves a device meets acceptance criteria for an AI/ML medical device. Instead, it is an FDA 510(k) clearance letter for a Collagen Wound Dressing, which is a physical medical device, not an AI/ML software.
The document discusses non-clinical data, performance tests (e.g., appearance, weight, absorption, pH, heavy metals, sterility, SEM, DSC, FTIR), biocompatibility, sterilization, and shelf-life studies. It explicitly states, "No clinical study is included in this submission."
Therefore, I cannot extract the information for an AI/ML medical device as requested, because the provided text is about a physical wound dressing and does not contain any details related to:
- Acceptance criteria for an AI/ML algorithm's performance (e.g., sensitivity, specificity, AUC)
- Sample sizes for test sets used in AI/ML validation
- Number/qualifications of experts for ground truth establishmen
- Adjudication methods
- MRMC studies
- Standalone algorithm performance
- Type of ground truth (e.g., pathology, outcomes data) in the context of an AI/ML model
- Training set details for an AI/ML model
The request's template is specifically designed for AI/ML device evaluations, which is not applicable to the content of this FDA clearance letter.
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(91 days)
The Collagen P.I.N. (Percutaneous Induction Needling system is indicated for use as a treatment to improve the appearance of facial acne scars in adults with Fitzpatrick Skin Types I - III, aged 22 years and older.
The Collagen P.I.N. consists of a handheld device that creates microinjuries into the skin, by virtue of a 1 A DC motor that rapidly reciprocates (7000 - 9000 rpm) an array of 35 gauge (SWG) stainless steel microneedles. The device handpiece motor body is comprised of aluminum alloy, with a dial mechanism that controls the depth of penetration of the microneedle array from 0.0 mm to a maximum of 3.0 mm. The Collagen P.I.N. disposable needle cartridge is designed in a single configuration - a 36-pin array in a radial arrangement. The needles, which are 3.0 mm long, are composed of medical grade stainless steel, with a 1.0 mm conical taper to needle array is housed in a cartridge housing that prevents liquids from entering the handpiece motor body via the inside lumen of the cartridge. The needle cartridge is composed of a polycarbonate outer shell and piston, which houses the microneedle array. The microneedle array is attached to the polycarbonate shell using a silicone boot, which acts as spring mechanism which facilitates the microneedling mode of action. Each lot of disposable microneedle cartridges are individually packaged and sterilized by ethylene oxide gas ("EtO"). The device contains a rechargeable lithium-ion battery. The device is to be operated only cordlessly, and not used while the device is plugged into the wall charging station.
This document describes a 510(k) premarket notification for the "Collagen P.I.N. (Percutaneous Induction Needling) System". This device is a microneedling system indicated for improving the appearance of facial acne scars. The provided text outlines the performance data, including non-clinical and clinical studies, to demonstrate substantial equivalence to a predicate device.
Based on the provided text, the device itself is a mechanical microneedling device, not an AI/algorithm-based device. Therefore, acceptance criteria, study design elements, and performance metrics typically associated with AI/ML-driven devices (like those in sections 1, 2, 3, 4, 5, 6, 7, 8, and 9 of your prompt, pertaining to AI performance, expert ground truth, multi-reader studies, training sets, etc.) are not applicable here.
The document primarily focuses on demonstrating the safety and efficacy of a medical device (microneedling system), not an AI algorithm. Its acceptance criteria and study designs are therefore geared towards verifying the mechanical function, sterility, biocompatibility, and clinical outcome for physical treatment, rather than the performance of an algorithm performing a diagnostic or predictive task.
However, I can extract the relevant performance data and acceptance criteria for this physical medical device as described in the document.
Here's a summary of the acceptance criteria and the study results for the Collagen P.I.N. device, focusing on what is available in the provided text:
Preamble:
The Collagen P.I.N. device is a microneedling system. The studies described are to demonstrate its safety and effectiveness for improving the appearance of facial acne scars, and to establish its substantial equivalence to a predicate device (Crown Aesthetics' SkinPen Precision System). There is no mention of AI or algorithmic components in this device or its testing. Therefore, the requested information pertaining to AI/ML device testing (e.g., sample size for test/training sets for AI, ground truth establishment for AI, MRMC studies, standalone AI performance) is not applicable here.
The evaluation focuses on the device's physical properties, biocompatibility, sterilization, and clinical outcomes based on human assessment.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a single, consolidated table of "acceptance criteria" alongside "reported device performance" for each criterion in the way an AI/ML device submission might. Instead, it describes various tests and their successful outcomes. I will synthesize this information into a table format based on the detailed performance data provided.
| Criterion Category / Test | Specific Acceptance Criteria | Reported Device Performance / Test Result | Conclusion |
|---|---|---|---|
| Biocompatibility - In Vitro Cytotoxicity (ISO 10993-5) | Qualitative: Grade < 2 (non-cytotoxic) Quantitative: > 70% viability (non-cytotoxic) | Qualitative: No change in morphology (Grade 0). Quantitative: Viability ranged from 91.30% - 97.95%. | PASS |
| Biocompatibility - Intracutaneous Reactivity (ISO 10993-10) | Avg Graded Score should be minimal/low (implied, as score of 0 was target). No mortality/morbidity. | Avg Graded Score = 0. No mortality or morbidity. Increase in body weight observed. Difference of mean skin reaction scores for test item extracts and vehicle control was zero. | PASS |
| Biocompatibility - Skin Sensitization (ISO 10993-10) | Positive control gives clear positive results. No response in negative control. No evidence of sensitization by test item. | No mortality or morbidity observed. All animals showed increase in body weight. No evidence of sensitization. | PASS |
| Biocompatibility - Acute Systemic Toxicity (ISO 10993-11) | No significantly greater biological reactivity than solvent control. No significant body weight loss in control. No mortality/abnormal behavior in control. | Control animals showed no biological reactions. All animals showed increase in body weight. No signs of ill health or overt toxicity. No animals dead/moribund. | PASS |
| Biocompatibility - Material Mediated Pyrogenicity (ISO 10993-11) | Control temperature variation < 1°C. Test animal temperature < 39.8°C. No individual body temperature increase of 0.5°C or more compared to control. | Control temperature variation < 1°C. Control temperatures < 39.8°C. No individual temperature increases of 0.5°C or more. | PASS |
| Cleaning/Disinfection Method Validation | 3-log10 (99.9%) reduction of specified microorganisms: S. aureus, P. aeruginosa, E. coli, K. pneumoniae, M. terrae. | Achieved microbial load reduction performance criteria for each microorganism (3-log10 reduction). | PASS |
| ETO Sterilization Validation (ISO 11135:2014) | Sterility Assurance Level (SAL) of 10^-6 (6-log10 reduction). EtO residuals below 0.5 µg/lens. ECH residuals below 2 µg/lens. | Achieved 6-log10 reduction. EtO residuals not detectable (<0.5 µg/lens). ECH residuals not detectable (<2 µg/lens). | PASS |
| Shelf Life Testing Validation | Conformance to specified packaging integrity standards (visual inspection, internal pressure/bubble test, seal strength, dye penetration) after accelerated aging. | All aged samples passed visual inspection, internal pressure, seal strength, and integrity-dye penetration tests at both 1-year and 2-year simulation time points. | PASS (2-year shelf life validated for microneedle cartridges) |
| Transport Simulation Testing (ISTA 2A, ISO 11607-1) | No adverse effects on device integrity/packaging after transport simulation (visual inspection, internal pressure/bubble test, seal strength, dye penetration). | No visible changes for conditioning/vibration. No irreversible changes for compression. Needle cartridges passed visual inspection, internal pressure, seal strength, and integrity-dye penetration tests. | PASS |
| In Vitro Study - Needle Length, Penetration, Cross-Contamination | Visible needle length within 3.0 mm specification. Max skin penetration depth within 2.5 mm specification. Max puncture duration within 0.180 seconds specification. No leakage or backflow. | Visible length: 1.959 mm to 2.833 mm (within 3.0 mm spec). Max penetration depth: 2.866 mm (±0.047) (within 2.5 mm spec). Max puncture duration: 0.180 seconds (within 0.180 sec spec). No evidence of leakage or backflow. | Meets specifications |
| Clinical Study - Efficacy (Clinician Global Aesthetic Improvement Assessment - CGAIS) | Proportion of subjects with "CGAIS success" (grade 1-3) at Visit 5 (Day 150). | Investigator (live assessment): 100% success for facial acne scars (n=23). Non-investigator panel (photographs): 47.8% (non-investigator 1) and 60.9% (non-investigator 2) success for facial acne scars (mITT population). | Met (Investigator), Varies (Panel) |
| Clinical Study - Subject-Reported Efficacy (SSIS, SGAIS, Satisfaction) | Improvement in appearance as reported by subjects. | SSIS: 91.3% reported at least 25% improvement at Day 150. SGAIS: 82.6% reported at least improvement at Day 150. Subject Satisfaction: 91.3% satisfied or very satisfied at Day 150. | Met |
| Clinical Study - Safety (Adverse Events) | Acceptable incidence and severity of Adverse Events (AEs), Treatment-Related AEs (TRAEs), Serious AEs (SAEs), Unexpected Adverse Device Effects (UADEs). | 11 (22%) subjects experienced TEAEs. 6 (24%) subjects with facial scars experienced TRAEs (all post-inflammatory pigment change, mild/mod severity, in Fitzpatrick skin type IV-VI). No SAEs, no UADEs. No study discontinuation due to AEs. | Acceptable safety profile |
| Clinical Study - Safety (Tolerability Assessments) | Acceptable levels of dryness, roughness, tightness, erythema, edema, itching, burning. | Most assessments (dryness, roughness, itching, burning) were none/mild for ≥ 94% post-treatment. Tightness: none/mild (60-84%), moderate (up to 38%), severe (2%). Erythema: none/mild (34-64%), moderate (up to 58%), severe (up to 11%). Edema: none/mild (62%), moderate (up to 38%), severe (up to 4%). | Acceptable tolerability profile with expected, mostly mild, transient skin responses. |
2. Sample size used for the test set and the data provenance
-
Clinical Study Test Set (Efficacy & Safety):
- Sample Size: 50 subjects initially entered the study. 47 (94%) completed the study.
- Primary Efficacy Population (mITT): 48 subjects (all who received at least one treatment and had at least one post-treatment evaluation).
- Facial Acne Scars Efficacy Sub-group: 25 subjects (from the mITT group, 23 with complete efficacy data (CGAIS)).
- Non-facial Scars Safety Sub-group: 25 subjects.
- Data Provenance: The document explicitly states "Induction Therapies sponsored a clinical study... single-arm, two-site study". The locations of the sites are not specified by country, but the submission is to the U.S. FDA, implying a U.S. or internationally accepted clinical trial. The study was prospective.
-
Non-Clinical Test Sets: Sample sizes vary by test (e.g., 1000 aged samples for shelf-life, with 900 being the 36-needle cartridge; 2 pig specimens for animal study, 8 skin samples; specific numbers for biocompatibility tests are standard for those protocols, but not explicitly stated as "sample size" in this summary).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
-
Clinical Study (CGAIS - for efficacy ground truth):
- Investigator Assessment (Live): Performed by the study Investigator. Their qualifications are not explicitly stated, but they are implied to be medical professionals conducting the study.
- Non-Investigator Panel Assessment (Photographs): A panel of 2 board-certified dermatologists (non-investigators) graded the CGAIS post-final visit using photographs. Their years of experience are not specified.
-
Animal Study (Histopathology):
- Morphological analysis performed by unstated "experts." No specific number or qualifications are given, but usually implies qualified pathologists.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Clinical Study - CGAIS by Non-Investigator Panel:
- The document states "graded by a panel of 2 board-certified dermatologists". It then reports separate success rates for "non-investigators 1 and 2" (47.8% and 60.9% respectively). This indicates that their assessments were reported individually and potentially averaged or reported as a range, rather than strict adjudication like 2+1 or 3+1 consensus. There is no mention of an explicit adjudication method if their assessments differed.
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 medical device (microneedling system), not an AI-assisted diagnostic or imaging device. The "readers" in this context (dermatologists) are providing a clinical assessment of a physical outcome, not interpreting images with or without AI assistance. Therefore, an MRMC comparative effectiveness study with AI assistance was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a physical microneedling system, not an algorithm. There is no "standalone algorithm" performance to report.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Clinical Study:
- Efficacy: Primarily expert assessment (investigator and independent dermatologists) based on visual appearance and photographic evidence (CGAIS), and patient-reported outcomes (SSIS, SGAIS, Subject Satisfaction).
- Safety: Clinician assessment of adverse events and tolerability (Investigator Tolerability Assessments), and patient-reported outcomes (Common Treatment Responses in Diaries).
- Animal Study: Pathology (histopathology from pig specimens) for morphological analysis.
- Non-Clinical Material Tests: Ground truth is established by universally accepted standardized test methods (ISO, ASTM standards), which define test conditions and expected results for material properties, sterility, and biocompatibility.
8. The sample size for the training set
- Not Applicable. This is a physical medical device, not an AI/ML algorithm. There is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established
- Not Applicable. As there is no AI/ML training set, there is no ground truth establishment for it.
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(67 days)
Collagentex RX-6 model is intended to emit light energy in the near infrared spectrum to provide non heating adjunctive use for temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin.
The Collagentex Rx-6 is a stand alone light device which emits polychromatic visible to near infrared light in the 580 to 1500 nanometer range. The light is non-collimating and non-pulsing. There are a total of 6 exposure areas, each set to receive 44.2miliWatt/sqcm or 2.6 Joule/minute at the minimum distance of 8 inches.
The device measures 96 inches long by 27.68 inches wide by 96 inches tall and is made up of 3 main sections. There are 2 vertical towers positioned 84 inches apart. The towers are made of metal and house the main electrical components for the device. A control console which includes a set timer, emergency stop button, oscillating on/off switch and a mechanical hour counter is mounted on left positioned tower.
In between the towers, positioned horizontally is a lamp module. The lamp module is made up of 6 individual lamp assemblies placed inline. The lamps are all 500w quartz type and each cover an exposure area of 23cm diameter. The height of the lamp module is adjustable via actuators positioned in the vertical columns. The actuators are controlled by a wired remote control. The device is to be mounted on the floor above a massage table provided by the device owner.
The document provided is a 510(k) summary for a medical device (Collagentex Rx-6). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical trial data or detailed performance metrics against specific acceptance criteria.
Therefore, the available information does not contain the following data for a typical clinical study evaluating device performance and acceptance criteria:
- A table of acceptance criteria and reported device performance.
- Sample size for a test set, its provenance, or retrospective/prospective nature.
- Number of experts for ground truth establishment or their qualifications.
- Adjudication method for a test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study results or effect sizes.
- Standalone (algorithm only) performance results.
- Type of ground truth used (e.g., pathology, outcomes data).
- Sample size for a training set.
- How ground truth for a training set was established.
However, based on the provided text, here's what can be extracted regarding the device's validation for substantial equivalence:
The "Performance Data" section primarily addresses safety and electrical compatibility standards compliance, not clinical efficacy acceptance criteria.
1. A table of acceptance criteria and the reported device performance:
The document doesn't provide a table of performance-based acceptance criteria related to efficacy (e.g., pain reduction percentage, visual analog scale score improvement) or specific reported performance against such criteria. Instead, it asserts substantial equivalence based on technical characteristics and compliance with safety standards.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
No clinical test set or data provenance is mentioned for establishing efficacy or performance against clinical acceptance criteria. The performance data refers to compliance with voluntary recognized standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable, as no clinical test set requiring expert-established ground truth is described for performance evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as no clinical test set requiring expert adjudication is described.
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. The device is an infrared lamp, not an AI-assisted diagnostic or therapeutic tool that would involve human "readers."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. The device is a physical infrared lamp, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable for clinical efficacy. The "ground truth" here is compliance with established safety and electrical standards.
8. The sample size for the training set:
Not applicable. The device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
Not applicable.
Summary of available "Performance Data" and "Conclusion" from the document regarding meeting safety and electrical standards (not clinical efficacy acceptance criteria):
The device (Collagentex Rx-6) was tested for and complied with the following recognized standards:
- IEC60601-1-2 3rd edition: Electromagnetic compatibility requirements.
- NRTL, CSA, ANSI: Electrical safety standards.
- ANSI/IESNA RP-27.1-05: Photobiological safety standards for the device.
- ANSI/IESNA RP-27.3-07: Photobiological safety standards for eye protection.
The conclusion states that the Collagentex RX-6 model is substantially equivalent to its predicate device (K162022, Collagentex RX-1) because it uses:
- The same technology (Quartz Lamp with filter)
- Outputs the same wavelength spectrum (580nm to 1500nm)
- Has the same irradiation intensity (44.2 miliWatt/sqcm or 2.6 Joule/minute)
- Has the same treatment time (20 minutes per site/per patient)
- Identical testing (referring to the listed safety and electrical standards compliance).
- Also notes the same skin surface temperature rise (1.8°C max).
The primary evidence presented is the technical equivalence to a predicate device which itself has been cleared for marketing, and compliance with relevant safety and electrical performance standards. There isn't a study proving the device meets clinical efficacy acceptance criteria provided in this 510(k) summary; rather, it hinges on substantial equivalence for the stated indications for use.
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(85 days)
The Ivy Sports Medicine Collagen Meniscus Implant (CMI) is intended for use in surgical procedures for the reinforcement and repair of soft tissue injuries of the medial meniscus. In repairing medial meniscal defects, the patient must have an intact meniscal rim and anterior and posterior horns for attachment of the mesh. In addition, the surgically prepared site for the CMI must extend at least into the red/white zone of the meniscus to provide sufficient vascularization.
The CMI reinforces soft tissue and provides a resorbable scaffold that is replaced by the patient's own soft tissue. The CMI is not a prosthetic device and is not intended to replace normal body structure.
The Ivy Sports Medicine Collagen Meniscus Implant XL (CMI XL) is a resorbable collagen matrix comprised primarily of bovine type I collagen. The CMI is provided in a semi-lunar shape with a triangular cross section to be used to reinforce weakened soft tissue and provide a resorbable scaffold that is replaced by the patient's own tissue. The surgeon trims the device to the size necessary for repair of the damaged or weakened soft tissue. The CMI XL is provided sterile for single use only.
The provided text describes a 510(k) premarket notification for a medical device called the Ivy Sports Medicine Collagen Meniscus Implant XL (CMI XL). It asserts substantial equivalence to a predicate device, the ReGen Collagen Scaffold (K082079).
Based on the provided document, here's a breakdown of the requested information:
1. Table of acceptance criteria and the reported device performance
The document states: "Testing performed on the Collagen Meniscus Implant XL demonstrated that all of the predetermined acceptance criteria were met with passing results." However, it does not explicitly list the specific acceptance criteria or the numerical performance results against those criteria. It only makes a general statement about meeting them.
2. Sample size used for the test set and the data provenance
The document does not provide details on the sample size used for the test set or the data provenance. It mentions "Design verification testing" and "Bench performance test data" but no specifics on how many devices were tested or where the components/data originated.
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 as the document indicates "Clinical evaluation is not required for this device." The testing performed appears to be bench testing rather than clinical studies requiring expert ground truth for interpretation.
4. Adjudication method for the test set
This information is not applicable as the document indicates "Clinical evaluation is not required for this device" and the testing described is bench performance testing.
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 information is not applicable. The device is a physical collagen implant, not an AI-assisted diagnostic or interpretative tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical collagen implant, and there is no algorithm or human-in-the-loop component described.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Since clinical evaluation was not required and the testing was described as "Design verification testing" and "Bench performance test data," the ground truth would likely be established by engineering specifications, material science standards, and comparison to the predicate device's established performance. The document implicitly suggests that the ground truth for performance relied on the predicate device's characteristics.
8. The sample size for the training set
This information is not applicable. The device is a physical implant, not an AI model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable. The device is a physical implant, not an AI model that requires a training set.
In summary, the document focuses on demonstrating substantial equivalence through bench testing, asserting that the new device meets predefined, unlisted, acceptance criteria based on the predicate device's performance, and explicitly stating that clinical evaluation was not required.
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(154 days)
Collagentex RX-1 model is intended to emit light energy in the near infrared spectrum to provide non heating adjunctive use for temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin.
Collagentex RX-1 model is a stand alone device of a single quartz lamp, emitting polychromatic visible to near infrared light from 580nm to 1500nm, non-collimating, non pulsing in order to offer exposure to the user where directed at a distance of 8" and farther from the body, non topical light therapy in order to relieve minor pain temporarily. The unit can be mounted on a table top or rolled on a base with casters. Narrow band filter and acrylic shield are designed to eliminate any emission of ultraviolet or wavelength shorter than 480nm wavelengths. The lamp replacement life is 500hrs. The exposure dosage is controlled by a user set timer. Exposure area is set to receive 44.2miliWatt/sqcm or 2.6 Joule/minute of exposure at the minimum distance. The device runs on AC power of 120 Volt 60 Hz or 220 Volt 50 Hz by plugging to main power.
The provided text is a 510(k) summary for the Collagentex RX-1 device, which is an infrared lamp intended for temporary relief of minor chronic neck and shoulder pain. The document focuses on demonstrating substantial equivalence to a predicate device, rather than providing details of a study with specific acceptance criteria and performance metrics in the way one might expect for an AI/ML device.
Therefore, many of the requested elements for describing acceptance criteria and a study demonstrating device performance cannot be found in this document, as the submission is not based on a clinical efficacy study with quantitative performance measures against a ground truth.
Here's an attempt to answer the questions based only on the provided text, indicating where information is unavailable.
1. A table of acceptance criteria and the reported device performance
The concept of "acceptance criteria" and "reported device performance" in the context of this 510(k) is heavily focused on demonstrating substantial equivalence to a predicate device (Bioptron Pro Light Therapy System and Bioptron Compact III Light Therapy System, K032216). There are no specific quantitative clinical performance metrics (e.g., accuracy, sensitivity, specificity for a diagnostic device) with defined acceptance thresholds. Instead, the acceptance criteria are implicitly that the device's technical characteristics and intended use are similar to the predicate device, and that it meets relevant safety and electromagnetic compatibility standards.
| Characteristic / "Acceptance Criterion" Implicit in Substantial Equivalence | Collagentex RX-1 (Reported Performance) |
|---|---|
| Indications for Use | Temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin (same as predicate) |
| Light Source | Quartz Lamp (same as predicate) |
| Light Source Power | 500 W (predicate: 90 W) - note: different, but acceptable in context of safety & efficacy |
| Emitted light wavelength (effective) | 580nm to 1500nm (predicate: 590nm to 1550nm) |
| Emitted light intensity | 44.2 miliWatt/sqcm (2.6 Joule/minute) (predicate: 40 miliWatt/sqcm, 2.4 Joule/minute) |
| Skin Surface Temperature | Under 42 C (same as predicate) |
| Treatment Time | 20 minutes (same as predicate) |
| Patient Contact | No contact to human body (same as predicate) |
| Electrical Safety | Complied with NRTL, CSA, ANSI (predicate: CE) |
| Electromagnetic Compatibility | Complied with IEC60601-1-2 3rd edition (predicate: CE) |
| Photobiological safety of device | Complied with IESNA/ANSI RP-27.1-05 (predicate: CE) |
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 provided in the document. The submission relies on technical characteristics comparison and compliance with standards rather than a clinical human subject test set for efficacy.
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 applicable/provided. No clinical test set requiring expert-established ground truth is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided. No clinical test set is described.
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 information is not applicable/provided. The device is an infrared lamp, not an AI/ML diagnostic or assistive tool, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/provided. The device is an infrared lamp, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable/provided in the context of a clinical performance study. The "ground truth" for this submission is the established safety and efficacy of the predicate device and compliance with recognized standards.
8. The sample size for the training set
This information is not applicable/provided. The device is an infrared lamp, not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable/provided. The device is an infrared lamp, not an AI/ML algorithm requiring a training set.
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(286 days)
Collagen Dental Wound Dressings are indicated for the management of oral wounds and sores, including:
- Denture sores
- Oral ulcers (non-infected or viral)
- Periodontal surgical wounds
- Suture sites
- Burns
- Extraction sites
- Surgical wounds
- Traumatic wounds
Collagen Dental Wound Dressings are absorbent, porous, collagen matrices engineered from purified collagen derived from bovine dermis tissue. The Collagen Dental Wound Dressings are applied directly to the wound and protect the wound and delicate new tissue. Collagen Dental Wound Dressings can be removed, replaced or left in situ. If left in situ the dressings will be essentially resorbed in 30 days. Collagen Dental Wound Dressings are available in tape, sponge and plug form, and are supplied sterile, non-pyrogenic and for single use only.
The provided text describes a 510(k) premarket notification for "Collagen Dental Wound Dressings" (K152600). This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a comparative effectiveness study or a comprehensive study with human readers.
Here's an analysis of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Strict "acceptance criteria" as would be set for a clinical trial with specific performance metrics (e.g., sensitivity, specificity for diagnostic devices, or specific clinical outcomes for therapeutic devices) are not explicitly stated in this 510(k) summary. Instead, the focus is on demonstrating "substantial equivalence" of the Collagen Dental Wound Dressings to its predicate devices by comparing technical characteristics and showing similar in vitro and in vivo performance in non-clinical tests.
The criteria for demonstrating substantial equivalence are implicitly that the new device performs comparably to the predicate devices in various tests.
| Parameter | Acceptance Criteria (Implied: Similar to Predicate) | Reported Device Performance (Collagen Dental Wound Dressings) |
|---|---|---|
| Material | Purified Collagen (similar to predicate) | Purified Collagen |
| Collagen Source | Bovine Dermis (similar to K142712 predicate) / Porcine Tendon (K122115) | Bovine Dermis |
| Form | Porous Collagen Matrix (similar to predicate) | Porous Collagen Matrix |
| Color | White to off-white (similar to predicate) | White to off-white |
| Shapes | Rectangular and Cylindrical (similar to predicate) | Rectangular and Cylindrical |
| Sizes | Specific sizes (25x75x1mm, 20x40x3mm, 10mm(ID) x 20mm(L)) (similar) | Specific sizes (25x75x1mm, 20x40x3mm, 10mm(ID) x 20mm(L)) |
| Absorbency | Absorbs local wound fluids upon application (similar) | Absorbs local wound fluids upon application |
| Biocompatibility | Biocompatible (similar to predicate) | Biocompatible |
| Pyrogenicity | Non-pyrogenic (similar to K122115 predicate) | Non-pyrogenic |
| Cytotoxicity | Non-cytotoxic (similar to predicate expectations) | Non-cytotoxic |
| Sensitization | No evidence of causing delayed dermal contact sensitization | No evidence of causing delayed dermal contact sensitization |
| Intracutaneous Reactivity | No erythema or edema from the extract injected intracutaneously | No erythema or edema from the extract injected intracutaneously |
| Residues | Within acceptable limits (similar to predicate expectations) | Within acceptable limits |
| pH | pH similar to predicate device | pH similar to predicate device |
| Hydrothermal Transition Temp. | Hydrothermal transition temperature similar to predicate device | Hydrothermal transition temperature similar to predicate device |
| Viral Inactivation | Viral inactivation demonstrated (similar to predicate expectations) | Viral inactivation study performed |
| Resorption | Resorption profile comparable to predicate device (in animal model) | Resorption study conducted in rat model |
2. Sample Size Used for the Test Set and Data Provenance
The "test set" in this context refers to the samples used in the non-clinical tests (e.g., materials for in vitro characterization, animals for biocompatibility and resorption studies). The document does not specify exact sample sizes for each test. For example:
- In vitro characterization: The number of samples for each test (Composition, Dimensions, Thickness, Density, Weight, Absorbency, pH, Hydrothermal transition temperature) is not specified.
- Biocompatibility:
- Cytotoxicity: Not specified.
- Sensitization: "Guinea Pig Maximization" – typically involves a group of guinea pigs, but the exact number is not stated.
- Intracutaneous Reactivity: "Intracutaneous Study in Rabbits" – typically involves a group of rabbits, but the exact number is not stated.
- Pyrogenicity: "USP (151) Rabbit Pyrogen Study" – typically involves a few rabbits (e.g., 3-8), but the exact number is not stated.
- Resorption study: "rat subcutaneous model" – typically involves a group of rats, but the exact number is not stated.
- Viral inactivation study: Not specified how many samples/batches were tested.
Data Provenance: The data comes from non-clinical laboratory studies (in vitro and in vivo animal models). The document does not mention any human data (retrospective or prospective) for these tests. The country of origin for these specific tests is not stated but implied to be part of the manufacturer's R&D process, likely within the USA given the submission to the FDA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the document describes non-clinical testing. "Ground truth" established by human experts (e.g., radiologists, pathologists) is relevant for studies involving human data or diagnostic imaging. The "results" of these non-clinical tests are determined by standard laboratory methods and validated interpretations of those methods.
4. Adjudication Method for the Test Set
This information is not applicable for non-clinical laboratory testing. Adjudication methods (e.g., 2+1, 3+1) are used in clinical studies or studies evaluating diagnostic performance where independent reviewers assess cases, and discrepancies are resolved. The tests described here have objective outputs determined by the experimental protocols.
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. This type of study assesses the performance of human readers, sometimes with and without AI assistance, on a set of cases. The document describes a medical device (wound dressing) and its non-clinical characteristics, not a diagnostic or AI-enabled device requiring such a study.
6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) Was Done
No, this refers to a medical device, not an algorithm or AI system. Therefore, the concept of "standalone performance" for an algorithm is not applicable.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical tests is established by the results of the standardized scientific tests themselves (e.g., an in vitro lab test concludes "Non-cytotoxic," an animal study shows "No evidence of causing delayed dermal contact sensitization"). These are objective measurements and observations determined by established methodologies rather than expert consensus, pathology reports (from human patients), or clinical outcomes data.
8. The Sample Size for the Training Set
This refers to a training set for machine learning models. Since this document is for a physical medical device (collagen wound dressings) and not an AI/ML product, the concept of a "training set" is not applicable.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for an AI/ML model, this question is not applicable.
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(238 days)
Collagen Dural Regeneration Matrix is intended for use as a dura substitute for the repair of dura mater.
Collagen Dural Regeneration Matrix is a white, non-friable, resorbable and biocompatible type I collagen matrix made from purified bovine Achilles tendon. Collagen Dural Regeneration Matrix is a porous, sponge-like collagen matrix with one smooth surface that conforms to the contours of the defect site. It is supplied sterile, non-pyrogenic, in various sizes, and for single use only.
This document is a 510(k) premarket notification for a medical device called "Collagen Dural Regeneration Matrix." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness or clinical superiority. Therefore, the information provided is geared towards comparing the new device to an existing one.
Here's an analysis of the acceptance criteria and supporting studies, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" for performance in a quantitative manner as one might find for a diagnostic device. Instead, it demonstrates substantial equivalence by comparing various parameters of the new device to its predicate. The "results" in the tables below effectively serve as the device performance against the implicit acceptance criteria of being "similar to predicate device" or "adequate."
| Parameter | Acceptance Criteria (Implied) | Reported Device Performance (Collagen Dural Regeneration Matrix) |
|---|---|---|
| General Characteristics (from Section 6) | ||
| Indications for Use | Same as predicate | Intended for use as a dura substitute for the repair of dura mater. |
| Collagen Source | Bovine Achilles tendon | Bovine Achilles tendon |
| Form | Porous Collagen Matrix | Porous Collagen Matrix |
| Color | White to off-white | White to off-white |
| Physical Integrity | Non-friable | Non-friable |
| Sizes | Variety of sizes | Variety of sizes |
| Conformability | Conformable | Conformable |
| Biocompatibility | Biocompatible | Biocompatible |
| In Vivo Stability | Gradual resorption | Gradual resorption |
| Sterility | Sterile, SAL 10-6 | Sterile, SAL 10-6 |
| Pyrogenicity | Non-pyrogenic | Non-pyrogenic |
| Single Use/Reuse | Single use only | Single use only |
| Packaging | Double blister | Double blister |
| In Vitro Characterization (from Section 7) | ||
| Dimensions | Similar to predicate | Dimensions similar to predicate device |
| pH | Similar to predicate | pH similar to predicate device |
| Tensile strength | Similar to predicate | Tensile strength similar to predicate device |
| Conformability | Similar to predicate | Conformability similar to predicate device |
| Hydrothermal transition temperature | Similar to predicate | Hydrothermal transition temperature similar to predicate device. |
| Liquid Permeability | Minimally permeable; similar to predicate | Minimally permeable; similar to predicate |
| Burst strength | Adequate for cerebrospinal fluid (CSF) pressure | Adequate for cerebrospinal fluid (CSF) pressure |
| Biocompatibility (from Section 7) | ||
| Cytotoxicity | Non-cytotoxic | Non-cytotoxic |
| Sensitization | No sensitization response | No sensitization response |
| Intracutaneous Reactivity | No erythema and no edema (for polar extract); No to very slight erythema or edema (for non-polar extract) | Met criteria |
| Acute Systemic Toxicity | No mortality or evidence of systemic toxicity | No mortality or evidence of systemic toxicity |
| Genotoxicity (Bacterial Reverse Mutagenic) | Non-mutagenic | Non-mutagenic to Salmonella typhimurium and Escherichia coli |
| Genotoxicity (Mouse Lymphoma Assay) | Non-mutagenic | Non-mutagenic (no two-fold or greater increase in mean mutant frequency) |
| Pyrogenicity | Non-pyrogenic | Non-pyrogenic |
| Muscle Implantation | Not significant macroscopic reaction; Non-irritant (microscopically vs. control); Slight irritant (microscopically vs. negative control) | Achieved |
| Subchronic Toxicity | No evidence of systemic toxicity or adverse findings | No evidence of systemic toxicity or adverse findings attributed to the test article when compared with the predicate control. |
| Chronic Toxicity | No evidence of systemic toxicity or adverse findings | No evidence of systemic toxicity or adverse findings attributed to the test article; non-irritant when compared to the predicate control at 26 weeks. |
2. Sample Size Used for the Test Set and Data Provenance
This is not applicable in the context of this 510(k) premarket notification in the way it would be for an AI/diagnostic device.
- Test Set: The "test set" here refers to the actual Collagen Dural Regeneration Matrix devices and components subjected to various in vitro and in vivo tests. The exact number of samples used for each bench test is not specified in the summary, but it would typically involve replicates to ensure statistical validity.
- Data Provenance:
- In Vitro Characterization: Laboratory internal testing data.
- Biocompatibility: Laboratory testing following ISO standards.
- Animal Efficacy Study: Conducted using a rabbit model.
- Retrospective/Prospective: The testing described is prospective, in that samples of the new device were specifically manufactured and tested for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This is not applicable for a device like a dural regeneration matrix. Ground truth for its performance is established through physical, chemical, and biological testing as outlined in the tables, rather than expert interpretation of images or clinical data.
- For the animal study, the assessment of dura repair and resorption would typically be conducted by veterinary pathologists or qualified researchers. No specific number or qualifications are given in this summary.
4. Adjudication Method for the Test Set
- Not applicable as the ground truth is established through objective laboratory and animal testing, not human readers or consensus.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI Improvement
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that analyze images or data for human interpretation, often involving AI. The Collagen Dural Regeneration Matrix is a physical implant, not a diagnostic tool incorporating AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No, a standalone algorithm performance study was not done. This is not an AI device.
7. The Type of Ground Truth Used
The ground truth for the device's performance and safety was established through:
- Physical and Chemical Properties: Measured quantitatively (e.g., pH, tensile strength, burst strength, dimensions, permeability, hydrothermal transition temperature) and qualitatively (e.g., conformability, color, physical integrity).
- Biocompatibility Endpoints: Based on standardized in vitro and in vivo assays (e.g., cytotoxicity, sensitization, systemic toxicity, genotoxicity, pyrogenicity, implantation responses).
- Animal Study Outcomes: Observation and assessment of dura repair and resorption in a rabbit model.
8. The Sample Size for the Training Set
- Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for this device.
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(52 days)
Collage is a software application intended for viewing of 3D medical image files from scanning devices, such as CT, MRI, or 3D Ultrasound as well as 2D patient images, such as patient photographs, intraoral photographs, and dental x-rays. Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. It is intended for use by doctors, clinicians, and other qualified individuals utilizing standard PC hardware. This device is not indicated for mammography use.
Collage is an interactive imaging software used for the visualization, storage, and management of 3D medical image files from scanning devices, such as CT, MRI, or 3D Ultrasound as well as 2D patient images, such as patient photographs, intraoral photographs, and dental x-rays. Doctors, dental clinicians, and other qualified individuals can retrieve, process, render, review, store and print images, utilizing standard PC hardware. The software runs in Windows operating systems and visualizes medical imaging data on the computer screen. The Collage software is intended as a platform bridging different sets of patient data for comprehensive studies. With Collage software, doctors can manage all of their patient images, including both 2D and 3D image data, in a single software.
Here's an analysis of the provided text regarding the acceptance criteria and study for the "Collage" device:
The provided text does not contain explicit acceptance criteria or a detailed study proving the device meets those criteria, as typically understood for AI/ML medical devices.
Instead, the document is a 510(k) premarket notification summary for a Picture Archiving and Communication System (PACS) software, "Collage." The evaluation focuses on demonstrating substantial equivalence to a predicate device (OsiriX MD, K101342) through software development quality assurance measures and bench testing.
Here's an attempt to answer your questions based on the available information, noting where information is absent:
-
A table of acceptance criteria and the reported device performance
The document does not specify formal, measurable "acceptance criteria" for clinical performance. The evaluation is based on demonstrating the software functions as intended and is comparable to a predicate device.
Acceptance Criteria (Implied) Reported Device Performance Software is stable and operating as designed. "Testing confirmed that the software is stable and operating as designed." Risk associated with the software is reduced to acceptable levels. "Testing also confirmed that the software has been evaluated for hazards and that risk has been reduced to acceptable levels." Ability to render and manage 2D and 3D medical images. "Bench testing of the software with predicate software was performed by evaluation of images rendered by Collage and predicate software. This testing and evaluation included testing of rendering both 2D and 3D images... This testing confirms that Collage is as effective as its predicate in its ability to perform its essential functions of rendering and managing medical images." -
Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document mentions "Bench testing of the software with predicate software was performed by evaluation of images rendered by Collage and predicate software." It does not specify the sample size of images used for this bench testing, nor does it provide information on the provenance (country of origin, retrospective/prospective) of these images.
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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)
"Bench testing... was evaluated by an expert in the field of radiology." Only one expert is mentioned. Their specific qualifications (e.g., years of experience) are not detailed beyond "an expert in the field of radiology."
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Adjudication method (e.g., 2+1, 3+1, none) for the test set
Given that only "an expert" evaluated the bench testing results, there was no adjudication method mentioned or implied (like 2+1 or 3+1 consensus).
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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 MRMC comparative effectiveness study was done. The device "Collage" is a PACS software for viewing and managing images, not an AI-assisted diagnostic tool. Therefore, there's no mention of how human readers improve with AI assistance.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is described as "a software application intended for viewing...images." "Diagnosis is not performed by this software but by doctors, clinicians and other qualified individuals." It is a tool for clinicians, not a standalone diagnostic algorithm. Therefore, no standalone (algorithm-only) performance was assessed in the context of diagnostic accuracy, as it's not its intended function. The "standalone" performance assessed was its ability to render and manage images as a PACS system.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the bench testing described, the "ground truth" was essentially the visual evaluation and comparison of rendered images by a radiology expert against images rendered by the predicate device, to ensure "Collage" performs its essential functions effectively. It's not a diagnostic "ground truth" derived from pathology or outcomes, but rather a functional ground truth for image display.
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The sample size for the training set
The document describes "Collage" as an imaging software, not an AI/ML model that would typically have a distinct "training set." Therefore, no sample size for a training set is mentioned. The software development followed standard quality assurance measures, but this is different from machine learning model training.
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How the ground truth for the training set was established
As there is no mention of a training set for an AI/ML model, this question is not applicable based on the provided text.
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(214 days)
Collagen Dura Membrane is intended for use as a dura substitute for the repair of dura mater.
Collagen Dura Membrane is a white, nonfriable, conformable, membrane matrix consisting of highly purified collagen derived from bovine dermis. It is flexible and conforms to the contours of the defect site. The product's mechanical strength allows the membrane matrix to be sutured in place. Collagen Dura Membrane is supplied sterile, non-pyrogenic, in various sizes, and for single use only.
The Collagen Dura Membrane is a dura substitute for the repair of dura mater. The acceptance criteria and supporting study are described below, based on the provided FDA 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally framed as demonstrating "similarity to predicate device" or "not considered sensitizing," etc., in comparison to established standards and the predicate device (Durepair® Dura Regeneration Matrix).
| Test Parameter | Acceptance Criteria (Implied from comparison) | Reported Device Performance (Collagen Dura Membrane) |
|---|---|---|
| Material Properties | ||
| Dimensions | Similar to predicate device | Dimensions similar to predicate device |
| Suture Pullout Strength | Similar to predicate device | Suture strength similar to predicate device |
| Tensile Strength | Similar to predicate device | Tensile strength similar to predicate device |
| Conformability | Similar to predicate device | Conformability similar to predicate device |
| Hydrothermal Transition | Similar to predicate device | Hydrothermal transition temperature similar to predicate device. |
| Porosity/Permeability | Similar to predicate device | Permeability similar to predicate device |
| Biocompatibility | ||
| Cytotoxicity | Non-cytotoxic (as per ISO 10993-5) | Non-cytotoxic. |
| Sensitization | Not considered sensitizing (as per ISO 10993-10) | Not considered to be sensitizing. |
| Intracutaneous Reactivity | No erythema and no edema (as per ISO 10993-10) | No erythema and no edema from the test extract injected intracutaneously into the rabbits. |
| Acute Systemic Toxicity | No mortality or significant systemic toxicity (as per ISO 10993-11) | No mortality or evidence of significant systemic toxicity. |
| Genotoxicity | Non-mutagenic (as per ISO 10993-3) | Non-mutagenic to Salmonella typhimurium tester strains TA98, TA100, and TA1537, and to Escherichia coli strain WP2uvrA. None of the test article treatments induced substantial increases in the number of revertant colonies. Non-mutagenic (Mouse Lymphoma Assay). Levels of micronucleated cells within normal negative ranges. Non-mutagenic (In Vivo Mouse Micronucleus Assay). |
| Pyrogenicity | Non-pyrogenic (as per USP (151)) | The test article was judged as nonpyrogenic. |
| Implantation | Minimum tissue reaction up to 4 weeks, no adverse reaction (as per ISO 10993-6) | Minimum tissue reaction up to 4 weeks of implantation and no adverse tissue reaction to the host. |
| Subchronic Systemic | No evidence of systemic toxicity or adverse findings | There was no evidence of systemic toxicity or adverse findings attributed to the test article at 13 week time point. |
| Toxicity | at 13 weeks (as per ISO 10993-11) | |
| Chronic Toxicity | No evidence of systemic toxicity or adverse findings | There was no evidence of systemic toxicity or adverse findings attributed to the test article at 26 week time point. |
| at 26 weeks (as per ISO 10993-11) | ||
| Device Performance | ||
| Dura Repair & Resorption | Performance similar to predicate device | Subject device performed as well as the predicate device. |
| Resorption Profile | Verification of design criteria | Resorption profile verified design criteria. |
| Handling/Implantability | Handles as well as predicate device with typical surgical technique | Subject device handles as well as the predicate device using typical surgical technique for implantation. |
2. Sample size used for the test set and the data provenance
The document does not specify a separate "test set" in the context of clinical or independent evaluation using human readers. Instead, the study uses various in vitro and in vivo models for comparison to the predicate device and established standards.
- Animal Studies:
- Rabbit dural defect repair model: Used for dura repair and resorption comparison. Specific sample size not stated.
- Rat subcutaneous model: Used for resorption profile. Specific sample size not stated.
- Canine craniectomy model: Used for handling and implantability. Specific sample size not stated.
- Biocompatibility Studies: Specific animal numbers for each test (e.g., rabbits for intracutaneous reactivity, mice for systemic toxicity and micronucleus assay) are not explicitly detailed in this summary, but would have been part of the full study protocols.
- Data Provenance: The studies are non-clinical (in vitro, animal studies). The country of origin of the data is not specified but would typically be from the manufacturing or testing facilities commissioned by Collagen Matrix, Inc. All data is prospective, generated specifically 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 applicable. The studies performed are non-clinical, involving laboratory testing and animal models. There is no mention of human experts establishing ground truth for a "test set" in the context of diagnostic performance or clinical outcomes in the summary provided. Expert interpretation would primarily relate to pathologists or researchers evaluating animal tissues, but their number and specific qualifications are not detailed.
4. Adjudication method for the test set
Not applicable, as there is no mention of a "test set" requiring adjudication by human readers in this non-clinical submission 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
Not applicable. This device is a physical dura substitute, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance is not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical dura substitute, not an algorithm or software.
7. The type of ground truth used
The "ground truth" for the non-clinical studies was established through:
- Comparative measurements: Direct measurements of physical properties (dimensions, strength, conformity, temperature, permeability) compared to those of the predicate device.
- Standardized biological assays: Results from in vitro and in vivo biocompatibility tests were evaluated against established criteria from ISO 10993 series and USP standards (e.g., "non-cytotoxic," "not sensitizing," "no mortality or significant systemic toxicity").
- Histopathological evaluation: For implantation and animal efficacy studies, the "ground truth" would be the pathological assessment of tissue reaction, new dura formation, resorption, and overall device integration in the animal models.
- Direct observation: For handling and implantability, the "ground truth" was based on surgical observation during the canine model study.
8. The sample size for the training set
Not applicable. The device is a physical implant, not a machine learning algorithm requiring a "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
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