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510(k) Data Aggregation
(29 days)
NovoSorb BTM is indicated for use in the management of wounds including: partial and full thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic and vascular ulcers, surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, and skin tears) and draining wounds.
The NovoSorb BTM device has been modified to expand the available thickness of the foam component from 2 mm to 2-6 mm. Sizes are limited to a maximum volume of 160 cm³. The device continues to be a porous, biodegradable, polyurethane foam, adhered to a fenestrated transparent sealing membrane. The sealing membrane is designed to physiologically close the wound limiting evaporative moisture loss during integration of the foam. The sealing membrane is to be removed and discarded when appropriate, leaving only the foam layer to biodegrade in patients.
NovoSorb BTM is a terminally sterilized, single use device intended for deep partial and full thickness wounds. Each NovoSorb BTM is packed in a transparent polymer pouch, enclosed in an aluminized pouch. A product label is placed on the pouch. The aluminized pouch together with an instruction for use is individually packaged in a cardboard envelope and a product label is placed on the envelope.
It appears there might be a misunderstanding of the provided FDA 510(k) clearance letter. The document is for a medical device called "NovoSorb BTM," which is a wound dressing. This device is a physical medical device (a porous, biodegradable, polyurethane foam), not an AI/software-based medical device.
Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance) is not applicable to this submission.
The 510(k) summary clearly states:
- "No clinical tests were performed; determination of substantial equivalence was not based on an evaluation of clinical performance data."
- "PolyNovo believes the modified NovoSorb BTM device is substantially equivalent to the legally marketed predicate devices NovoSorb BTM (K172140) and NovoSorb MTX (K242149), because no differences in technological characteristics exist between different foam thicknesses as there is no change to the foam density for different foam thicknesses."
The "acceptance criteria" for this device, as described in the non-clinical tests section, relate to physical and mechanical properties of the wound dressing, not diagnostic performance based on AI.
Below is a brief summary of how the device met its acceptance criteria, based only on the provided document, without attempting to fit it into an AI study framework:
Acceptance Criteria and Study for NovoSorb BTM (Physical Medical Device)
The NovoSorb BTM is a physical wound dressing device, not an AI or software-based diagnostic tool. Therefore, the acceptance criteria and supporting studies are based on the physical, mechanical, and biological properties of the material and its substantial equivalence to previously cleared predicate devices, rather than AI performance metrics.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicitly Met by Substantial Equivalence Claim) | Reported Device Performance (Summary from Document) |
|---|---|---|
| Physical Characteristics | Consistency in material properties (e.g., polyurethane composition, porosity, density, foam structure). | "modified to expand the available thickness of the foam component... Device continues to be a porous, biodegradable, polyurethane foam... properties of the foam component, including average pore size, porosity, and density, remain unchanged compared to both predicate devices." |
| "Sealing membrane adhered to the foam; constructed from the same synthetic biodegradable polyurethane material." | "Same as Predicate Device" | |
| Mechanical Strength | Ability to withstand typical handling and application, maintaining structural integrity (e.g., tensile strength, tear resistance). | "Verification performance testing demonstrates that the proposed NovoSorb BTM will consistently meet established functional and performance requirements. These requirements include physical characteristics, mechanical strength, and durability." |
| Durability | Resistance to degradation beyond intended bioabsorption timeframe, maintenance of integrity during use. | "Verification performance testing demonstrates that the proposed NovoSorb BTM will consistently meet established functional and performance requirements... include physical characteristics, mechanical strength, and durability." |
| Biocompatibility | Non-toxic and safe for contact with human tissue. | (Implied by substantial equivalence to predicate devices using same materials and manufacturing processes) |
| Sterility | Achievement and maintenance of desired sterility assurance level. | "sterilized using gamma radiation at a dose of 25–40 kGy, achieving a sterility assurance level (SAL) of 10⁻⁶". |
| Packaging & Shelf-life | Maintenance of sterility and device integrity throughout shelf-life. | "packed in a transparent polymer pouch, enclosed in an aluminized pouch... consistent with both predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The verification testing would involve a sufficient number of device samples to demonstrate consistency in manufacturing and material properties.
- Data Provenance: The data are from non-clinical bench testing. No geographical or temporal provenance is specified, as the tests are against material and mechanical standards for the device itself rather than patient data. The tests are prospective in the sense that they are performed on newly manufactured devices to demonstrate compliance.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- This concept is not applicable. "Ground truth" for this device relates to established engineering and material science standards for physical device properties (e.g., material composition confirmed by analytical chemistry, mechanical properties confirmed by engineering tests). It does not involve expert consensus on medical image interpretation or clinical outcomes.
4. Adjudication Method for the Test Set
- Not applicable. Adjudication methods are typically used in clinical studies or AI evaluations to resolve discrepancies among human readers or algorithm outputs. For physical device testing, the results are objective measurements against predefined specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation (often with AI assistance). The submission explicitly states: "No clinical tests were performed; determination of substantial equivalence was not based on an evaluation of clinical performance data."
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
- Not applicable. This device is not an algorithm or software. It is a physical wound dressing.
7. The Type of Ground Truth Used
- The "ground truth" for this device's acceptance is based on established engineering specifications, material science standards, and performance characteristics of the predicate devices. This includes:
- Chemical composition (e.g., polyurethane).
- Physical properties (e.g., density, porosity, pore size).
- Mechanical properties (e.g., strength, durability).
- Sterility assurance level (SAL).
- Packaging integrity.
8. The Sample Size for the Training Set
- Not applicable. This device is not an AI model, and therefore, there is no "training set."
9. How the Ground Truth for the Training Set was Established
- Not applicable. As there is no AI model or training set, the concept of establishing ground truth for it does not apply.
In summary, the FDA 510(k) for NovoSorb BTM is a clearance based on substantial equivalence to existing predicate devices, supported by non-clinical bench testing that confirms the modified device maintains the same physical, material, and performance characteristics. The detailed questions about AI study methodologies are not relevant to this specific device submission.
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(225 days)
NovoSorb® MTX is indicated for the management of wounds including: partial and full thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic and vascular ulcers, tunneled/ undermined wounds, surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, second-degree burns, and skin tears) and draining wounds. The device is intended for single use only.
NovoSorb® MTX is a fully synthetic biodegradable device that is composed of a single foam layer. The foam is a 2-6 mm thick, white, open cell degradable foam with a high degree of porosity (>90%) providing a scaffold for dermal tissue integration. NovoSorb® MTX will be supplied in sizes ranging from 4 cm2 to 800 cm2 with a maximum volume of 160 cm³.
NovoSorb® MTX is a terminally sterilized, single use device intended for deep partial and full thickness wounds. It is intended for use by qualified healthcare professionals in a hospital/clinical environment and is not intended for use at home.
Each NovoSorb® MTX is packed in a transparent polymer pouch, enclosed in an aluminized pouch. A product label is placed on the pouch. The aluminized pouch together with an instruction for use is individually packaged in a cardboard envelope and a product label is placed on the envelope.
The provided FDA 510(k) summary for NovoSorb® MTX (K242149) does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria in the context of an AI/algorithm-driven device.
This submission is for a medical device that is a wound dressing, not an AI or algorithm-based diagnostic or prognostic tool. Therefore, the concepts of "acceptance criteria" related to algorithm performance (like sensitivity, specificity, AUC), sample sizes for test sets, data provenance, expert ground truth establishment, MRMC studies, or standalone performance studies, and training set details are not applicable as described in your request.
The submission focuses on demonstrating substantial equivalence to a predicate wound dressing based on material properties, physical characteristics, mechanical strength, durability, and biocompatibility.
Here's a breakdown of why your specific questions cannot be answered from this document:
- 1. A table of acceptance criteria and the reported device performance: This document discusses performance in terms of physical characteristics, mechanical strength, durability, and a hydrolytic degradation study, as well as biocompatibility. These are typical for a physical medical product, not for an algorithm's diagnostic performance. There are no explicit "acceptance criteria" listed in a tabular format for algorithm performance.
- 2. Sample size used for the test set and the data provenance: Not applicable. There is no "test set" in the context of an AI algorithm evaluation. The document mentions testing of the device itself (e.g., hydrolytic degradation, mechanical properties) but not a dataset for an AI.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no AI test set requiring expert-established ground truth.
- 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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 not an AI-assisted device.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- 8. The sample size for the training set: Not applicable. There is no AI training set.
- 9. How the ground truth for the training set was established: Not applicable.
In summary, the provided document is a 510(k) summary for a physical medical device (a wound dressing) and does not contain any information about an AI or algorithm-based component.
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(116 days)
Indications for Use: NovoFine® Plus needles are intended for use with pen injector devices for the subcutaneous injection of drugs.
NovoFine® Plus is a sterile single use needle for subcutaneous injection of drugs with a pen injector device.
I am sorry, but the provided text from the FDA 510(k) summary for the NovoFine® Plus does not contain the specific information required to answer your request regarding acceptance criteria and a study proving a digital health device meets acceptance criteria.
The document is for a hypodermic single lumen needle (NovoFine® Plus), which is a physical medical device, not a digital health device or an AI/software as a medical device (SaMD). Therefore, the concepts of "acceptance criteria" and "study types" as you've described them (e.g., sample sizes for test sets, data provenance, expert adjudication, MRMC studies, standalone algorithm performance, training set details) are not applicable or detailed in this submission.
The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device based on:
- Intended Use, Indications for Use, and Basic Design: Stating they are the same as the predicate.
- Technological Characteristics: Primarily noting the difference in needle gauge size (29G vs. 32G) and asserting that this difference does not introduce new risks.
- Performance Testing: Mentioning compliance with ISO standards (ISO 9626 for material/dimensions and ISO 11608-2 for performance) to verify the design against established requirements for such physical devices.
- Biocompatibility: Confirmation that the new needle meets the same biocompatibility standards as the predicate.
There is no mention of AI, algorithms, or any form of digital health technology that would necessitate the kind of performance studies or ground truth establishment you are asking about.
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(472 days)
NovoGen Wound Matrix is indicated for the management of wounds including:
· Partial and full-thickness wounds
- Pressure ulcers
- Venous ulcers
- · Diabetic ulcers
- · Chronic vascular ulcers
- · Tunneled/undermined wounds
- · Surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence)
- · Trauma wounds (abrasions, lacerations, partial thickness burns, and skin tears)
- · Draining wounds
NovoGen Wound Matrix is a an absorbable, non-pyrogenic, sterile, single use device intended for use in local management of cutaneous wounds. It is manufactured from bovine type I collagen and 45S5 bioactive glass. When hydrated with wound exudate or sterile water, this product transforms into a soft conforming layer which is naturally incorporated into the wound over time.
The provided text describes the NovoGen Wound Matrix, a medical device, and its substantial equivalence determination by the FDA. However, it does not contain a study that proves the device meets specific acceptance criteria in the way described in the prompt (e.g., performance metrics, sample sizes, expert adjudication, MRMC studies, or standalone algorithm performance).
Instead, it outlines the device's characteristics, its comparison to a predicate device, and a summary of non-clinical performance testing. The "acceptance criteria" here are implicitly related to demonstrating substantial equivalence to a predicate device based on similar intended use, technological characteristics, and safety and performance testing.
Here's a breakdown of the information provided, formatted to address your request as much as possible, with explicit notes where the requested information is not present:
1. Table of Acceptance Criteria and Reported Device Performance
Since there are no explicitly stated numerical acceptance criteria or thresholds in the document, this table will reflect the types of performance tests conducted and their qualitative results as stated in the submission.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Absorption Capacity (demonstrates appropriate fluid handling) | Testing performed. (Specific values or ranges not provided, but implies satisfactory performance given the conclusion of substantial equivalence). |
| Compression Recovery (demonstrates material integrity/shape retention) | Testing performed. (Specific values or ranges not provided). |
| Degradation Potential via Collagenase (demonstrates appropriate bio-resorption) | Testing performed. (Specific values or rates not provided). |
| Hydration Time (demonstrates proper hydration characteristics) | Testing performed. (Specific values or ranges not provided). |
| Tensile Strength (demonstrates mechanical integrity) | Testing performed. (Specific values or ranges not provided). |
| Viral Inactivation (demonstrates safety from viral contaminants) | Testing performed. (Specific methods or quantitative reduction not provided, but implies successful inactivation). |
| Wound Healing Performance (demonstrates effectiveness in promoting wound healing) | A full-thickness porcine wound healing study found equivalent wound healing performance for the NovoGen Wound Matrix when compared to the primary predicate device and untreated control sites. |
| Biocompatibility (demonstrates non-toxic, non-irritating, non-sensitizing properties) | Found to be biocompatible for its intended use when tested in compliance with ISO 10993-1. Cytotoxicity, sensitization, acute systemic toxicity, material mediated pyrogenicity, subacute systemic toxicity, implantation, genotoxicity, and endotoxin endpoints were addressed via testing. Chronic toxicity and carcinogenicity were addressed via a toxicological risk assessment. The Human Repeat Insult Patch Test (HRIPT) found no potential for eliciting dermal irritation or inducing sensitization. |
| Sterilization (demonstrates sterility assurance) | Gamma, 10^-6 SAL. (Implies successful sterilization). |
| Non-Pyrogenic (demonstrates absence of fever-inducing substances) | Yes. (Implies successful testing). |
2. Sample size used for the test set and the data provenance
- Porcine Wound Healing Study: "A full thickness porcine wound healing study" - Sample size (number of animals or wounds) is not specified. Data provenance is animal study (porcine).
- Biocompatibility (ISO 10993-1): Sample size not specified. Provenance is in vitro and in vivo (e.g., animal tests for systemic toxicity, implantation).
- Human Repeat Insult Patch Test (HRIPT): "Based on the test population who completed the study" - Sample size (number of human subjects) is not specified. Provenance is prospective human study. Specific country of origin is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This type of information is not provided in the document. The studies performed (animal, biocompatibility, HRIPT) would typically involve trained personnel, but the specific number and qualifications of "experts" to establish a ground truth in the sense of clinical interpretation are not mentioned, as these are primarily laboratory and animal studies.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable/not provided. The studies described are not of a diagnostic nature 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
An MRMC study was not done. This device is a wound matrix, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical wound matrix, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Porcine Wound Healing Study: The "ground truth" for wound healing would be based on direct observation and measurement of wound closure, tissue regeneration, and potentially histopathology in the porcine model. It's compared to a predicate device and untreated controls for equivalence.
- Biocompatibility Studies: Ground truth is established by standardized laboratory test results against established safety thresholds (e.g., cell viability in cytotoxicity, immune response in sensitization, absence of fever in pyrogenicity).
- HRIPT: Ground truth is clinical observation of skin reactions (irritation/sensitization) in human subjects.
8. The sample size for the training set
This is not applicable as the device is not an AI/machine learning algorithm requiring a training set.
9. How the ground truth for the training set was established
This is not applicable as the device is not an AI/machine learning algorithm.
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(97 days)
NovoSorb® Matrix is indicated for use in the management of wounds including: partial and full thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic and vascular ulcers, surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, partial thickness burns, and skin tears) and draining wounds.
Not Found
I am sorry, but the provided text from the FDA 510(k) clearance letters for the NovoSorb® Matrix does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria.
The letters primarily address the administrative aspects of the 510(k) submission, confirming the device's substantial equivalence to a legally marketed predicate device and detailing regulatory guidelines for its marketing. They do not include details about:
- A table of acceptance criteria or reported device performance metrics.
- Sample sizes, data provenance, or details about test and training sets.
- Information on expert panels, ground truth establishment, or adjudication methods.
- Any multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
Therefore, I cannot fulfill your request for this information based on the provided document. The 510(k) clearance process focuses on substantial equivalence, which often relies on comparison to existing devices rather than new performance studies demonstrating specific numerical acceptance criteria in the way described for an AI/ML medical device.
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(377 days)
Novo is a software only device intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review, interpret, and manage digital images of these slides for primary diagnosis. Novo is not intended for use with frozen sections, cytology, or non- FFPE hematopathology specimens.
It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the quality of the images obtained and, where necessary, use conventional light microscopy review when making a diagnostic decision. Novo is intended for use with the Philips Ultra Fast Scanner and the Barco PP27QHD or Philips PS27QHDCR display.
The PathAI Novo device is a web-based software-only device that is intended to aid pathology professionals in the viewing, interpretation, and management of digital whole slide images (WSIs) of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue using the Philips IntelliSite Pathology Solution (PIPS) Ultra Fast Scanner (UFS).
The proposed device is typically operated as follows:
-
- A user prepares and scans slides and reviews the slide quality in accordance with the PIPS UFS IFU and standard lab procedures. The Novo device workflow is initiated when a user uploads WSIs from the local file system to the cloud storage using Novo.
-
- After uploading WSIs to cloud storage using Novo, a user builds a patient accession using the patient's medical record number (MRN), date of birth (DOB) and accession ID to support linkage of one or more slides from a single procedure using patient identifiers in Novo.
-
- A pathologist uses the slide viewer to perform their primary diagnosis workflow including zooming and panning images.
After viewing all images belonging to a particular accession, the pathologist will make a diagnosis.
The provided text describes the regulatory clearance for the "Novo" device, a software-only whole slide imaging system, and references a clinical study conducted to establish its substantial equivalence to a predicate device. However, the document primarily focuses on regulatory approval and does not contain the detailed acceptance criteria table or comprehensive study breakdown as requested in the prompt.
Therefore, the following response will extract what is available and highlight where information is missing based on your request.
Acceptance Criteria and Device Performance for Novo (as described by available information)
Based on the provided FDA 510(k) summary, details regarding specific quantifiable acceptance criteria and performance beyond a non-inferiority finding are limited. The document focuses on demonstrating substantial equivalence to a predicate device (Philips IntelliSite Pathology Solution - PIPS).
Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Metric (Inferred/Stated) | Acceptance Threshold (Inferred/Stated) | Reported Device Performance |
|---|---|---|---|
| Clinical Equivalence | Major Discordance Rate | Upper limit of 95% CI for difference in major discordance rates < 4%. | -0.1% (95% CI, -2.05, 1.78) for all organs (MD vs. MO compared to GT). Met. |
| Image Loading Speed | Load time for selected images | < 7 seconds | "Images load in less than 7 seconds when selected for viewing." Met. |
| Image Panning/Zooming Speed | Load time during panning/zooming | < 10 seconds | "Images load in less than 10 seconds when panning or zooming." Met. |
| Image Reproduction (Pixel-wise) | Color differences ($\Delta$E00) | Implicitly, not significantly different from PIPS/IMS with JPEG compression. | "Color differences ($\Delta$E00) between Novo and PIPS/IMS are not zero." "Novo-generated images are similar to PIPS/IMS-generated images that had been JPEG-compressed at quality 95." |
| Human Factors | Safety and Effectiveness | Implicitly, found safe and effective for intended users, uses, and environments. | "Novo has been found to be safe and effective for the intended users, uses, and use environments." Met. |
Missing Information (Not Available in the Provided Text):
- Explicit, pre-specified quantitative acceptance criteria beyond the non-inferiority margin for major discordance.
- Detailed quantitative performance for features like color differences beyond a statement of similarity to JPEG-compressed images.
Study Details (Extracted from the provided text):
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated. The text mentions "WSIs of H&E stained FFPE tissue slides."
- Data Provenance: Not specified for the test set. (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The reference diagnosis (ground truth) was the "original sign-out pathologic diagnosis using MO [manual optical] rendered at the institution," implying involvement of qualified pathologists for routine diagnosis, but specific qualifications for ground truth establishment are not given.
4. Adjudication method for the test set:
- Adjudication Method: Not specified. The study compared "major discordance rates between MD [manual digital read, using Novo] and MO [manual optical] when compared to the reference (main) diagnosis, which was the original sign-out pathologic diagnosis using MO [ground truth, (GT)] rendered at the institution." This suggests a comparison against an existing diagnosis, not necessarily a separate adjudication process for the test set.
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:
- MRMC Study: Yes, a clinical study was conducted. It involved human pathologists making diagnoses using both the Novo device (MD) and conventional microscopy (MO).
- Effect Size of Improvement: The study focused on non-inferiority of the manual digital read (MD) using Novo compared to manual optical (MO) read. It did not measure "how much human readers improve with AI vs without AI assistance" because Novo is described as a "viewing and management" tool, not an AI-assisted diagnostic tool. Its purpose is to present the image for the pathologist's primary diagnosis, making it a replacement for conventional microscopy, not an enhancement tool for human readers in the context of an AI-assisted workflow. The primary outcome was maintaining diagnostic accuracy (non-inferiority) when switching from MO to MD.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: No, this device is a "viewer and management" software for human pathologists. It does not perform diagnostic algorithms independently. The performance data presented (non-inferiority) is explicitly human-in-the-loop (MD: "manual digital read").
7. The type of ground truth used:
- Ground Truth Type: "The original sign-out pathologic diagnosis using MO [manual optical] rendered at the institution." This can be categorized as expert consensus/clinical outcomes data based on standard practice.
8. The sample size for the training set:
- Training Set Sample Size: Not applicable/Not specified. Novo is a viewing and management system, not described as an AI/machine learning algorithm that requires a "training set" in the conventional sense for a diagnostic prediction model. The "pixel-wise comparison" tests were likely technical assessments, not dependent on a "training set."
9. How the ground truth for the training set was established:
- Ground Truth Establishment for Training Set: Not applicable, as there is no mention of an algorithm requiring a "training set" with ground truth in the provided information.
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(140 days)
The NovoFlow Reinforced ureteral stents are intended for patients 12 years of age (40 kg) and over for drainage of the upper urinary tract over fistulas or ureteral obstacles and/or for healing of the ureter. These stents may remain implanted for up to 6 months.
NovoFlow Reinforced Ureteral Stents are implantable ureteral stents used to maintain urine drainage and allow healing of the ureter. They are inserted into the ureter during a surgical procedure using mainly a retrograde technique, although an antegrade approach is also possible. The stents are supplied in 7 Fr or 8 Fr diameters and lengths from 26 cm through 30 cm, with both tips open (O/O). NovoFlow Reinforced Ureteral Stents are supplied in kits which contain the following components: - A double loop ureteral stent - A steerable pusher, packed separately Also contained in some kits: - -An Orchestra® Hydrophilic guidewire, packed separately The NovoFlow Reinforced Ureteral Stents and accessories included in the kits are supplied sterile via ethylene oxide. The ureteral stent and each accessory are packaged and sterilized separately prior to being combined in the kit.
The document provided is a 510(k) summary for the NovoFlow™ Reinforced Ureteral Stent, which is a medical device. This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.
The 510(k) summary does not include information about AI/ML device performance, ground truth, or human reader studies. The "study" mentioned refers to non-clinical bench testing to demonstrate physical properties and biocompatibility.
Here's a breakdown based on the information provided, and where information is not provided:
1. A table of acceptance criteria and the reported device performance
The document lists mechanical tests that were performed, but does not provide a table with specific acceptance criteria (e.g., minimum flow rate, tensile strength) or the reported values for the NovoFlow™ Reinforced Ureteral Stent for each test. It states that "Mechanical testing was completed using the FDA guidance document 'Guidance for the content of premarket notifications for ureteral stents' for reference." This implies that the tests and criteria were based on FDA recommendations for ureteral stents in general. The document also mentions "Biocompatibility testing was conducted based upon ISO 10993-1 (2018)" and sterilization and packaging tests.
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. The "test set" in this context would refer to the physical devices tested for mechanical properties, biocompatibility, etc. The document does not specify the number of stents or accessories tested for each category. Data provenance (country of origin, retrospective/prospective) is not applicable or provided for physical device testing.
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. The device is a physical ureteral stent, not an AI/ML algorithm that requires expert ground truth for classification or diagnosis. The "ground truth" for the performance of this device would be its adherence to established engineering and biocompatibility standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable, as it pertains to AI/ML performance evaluation through expert review, which is not relevant for this device.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No such study was done. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No such study was done. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this medical device's performance is compliance with established physical, mechanical, chemical (biocompatibility), and sterility standards derived from FDA guidance documents and international standards (like ISO 10993-1). No expert consensus, pathology, or outcomes data were used to establish "ground truth" for the performance tests conducted for this 510(k). The document explicitly states: "No animal studies or clinical testing were provided to support substantial equivalence between the subject and predicate devices."
8. The sample size for the training set
This information is not applicable. This is not an AI/ML device, so there is no training set in that context.
9. How the ground truth for the training set was established
This information is not applicable. This is not an AI/ML device.
Summary of "Acceptance Criteria" and "Study" for the NovoFlow™ Reinforced Ureteral Stent (based on the provided document):
Study: The substantial equivalence determination for the NovoFlow™ Reinforced Ureteral Stent was supported by non-clinical performance data, including:
- Biocompatibility Testing: Conducted based on ISO 10993-1 (2018) and relevant FDA guidance.
- Mechanical Testing: Based on FDA's "Guidance for the content of premarket notifications for ureteral stents." Specific tests included:
- Visual Inspection
- Dimensional Testing (Diameter, Length)
- Flow Rate
- Elongation/Yield and Tensile Strength
- Loop/Curl strength
- Guidewire compatibility
- Radiopacity
- Magnetic resonance compatibility
- Shelf Life/Expiration Date
- Sterilization Testing: Validated using ethylene oxide to achieve a sterility assurance level of 10-6.
- Packaging and Distribution Testing: To ensure product integrity and sterility throughout its life.
Acceptance Criteria & Reported Performance:
| Acceptance Criteria Category | Reported Device Performance (Summary from Document) |
|---|---|
| Biocompatibility | Compliant with ISO 10993-1 (2018) and FDA Guidance. (Specific test results and acceptance limits not provided, but the statement implies successful completion based on established standards for medical devices with prolonged tissue contact.) |
| Mechanical Performance | Tests were completed for Visual Inspection, Dimensional (Diameter, Length), Flow Rate, Elongation/Yield and Tensile Strength, Loop/Curl strength, Guidewire compatibility, Radiopacity, Magnetic Resonance Compatibility, and Shelf Life/Expiration Date as referenced in FDA guidance. (Specific numerical acceptance criteria and results are not detailed in this summary, but the conclusion states "substantial equivalence... based on the non-clinical data provided," implying the device met the criteria set forth in the referenced FDA guidance and standards.) |
| Sterilization | Validated ethylene oxide cycle achieved a sterility assurance level (SAL) of 10-6. (Acceptance criterion: SAL of 10-6 achieved.) |
| Packaging & Distribution | Subjected to distribution and verification testing to demonstrate product and package remain undamaged and maintain device sterility throughout product life. (Acceptance criterion: Product and package integrity maintained, sterility maintained. Specific tests and results not detailed, but implied successful completion.) |
| Overall Conclusion | The document concludes that "The NovoFlow Reinforced Ureteral Stents and related accessories have been demonstrated to be substantially equivalent to the predicate device... based on the non-clinical data provided, similar intended use, patient population, materials, biocompatibility, kit composition, and technological characteristics. The differences in technological characteristics do not raise new questions of safety or effectiveness." This implies all performed tests met their respective acceptance criteria to support the substantial equivalence claim. |
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(142 days)
NovoFine® needles are intended for use with pen injector devices for the subcutaneous injection of drugs.
NovoFine® is a sterile single use needle for subcutaneous injection of drugs with a pen injector device. Prior to giving an injection, the protective tab is removed from the outer needle cap of the single-use disposable needle. With the disposable needle remaining in the outer needle cap, it is then carefully screwed onto the injection delivery device until tight and then the needle outer and inner caps are removed. Use the needles as described in the instructions for use that comes with the pen-injector device and as instructed by the healthcare professional. After the injection, the needle is removed from the skin. The needle is detached from the injection device and disposed of in accordance with national/local regulations. For each subsequent injection, a new disposable needle must be used.
This document is a 510(k) premarket notification for the NovoFine® hypodermic single lumen needle, seeking to expand its indications for use. It primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device (K173479).
Based on the provided text, there is no information regarding acceptance criteria for a device's performance that would typically be measured through sensitivity, specificity, accuracy, or other similar metrics. This document is for a medical device (hypodermic needle), and the "performance" discussed relates to its mechanical and material properties, rather than diagnostic accuracy or algorithmic performance.
Therefore, the following information cannot be extracted from the provided text, as it describes a different type of evaluation:
- A table of acceptance criteria and the reported device performance (in terms of clinical outcomes or diagnostic metrics).
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and their qualifications.
- Adjudication method for the test set.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc).
- The sample size for the training set.
- How the ground truth for the training set was established.
Instead, the document details non-clinical performance testing to demonstrate the device's physical and material properties meet established standards, thereby supporting its substantial equivalence to a predicate device.
Here's the relevant information that can be extracted concerning the device's characteristics and testing:
Device Acceptance Criteria and Performance (Non-Clinical/Engineering):
The document describes material and mechanical specifications that the device must meet, demonstrating its substantial equivalence to the predicate device. These are more akin to engineering specifications rather than clinical performance metrics.
| Acceptance Criteria (Specification) | Reported Device Performance (Subject Device) |
|---|---|
| Outer diameter, cylindrical part | 0.25-0.27 mm for 31G and 32G |
| 0.298-0.32 mm for 30G | |
| Inner diameter | Minimum 0.146 mm for 31G and 32G |
| Minimum 0.165 mm for 30G | |
| Length from hub | 4 mm for 32G |
| 6 mm for 31G and 32G | |
| 8 mm for 30G | |
| Gauge | 30G, 31G, 32G |
| Tip configuration | 1st and 2nd grinding and glass blasting |
| Hub/needle bond strength | Fmin = 22 N |
| Shelf life | 5 years from production date |
| Biocompatibility | Complies with ISO 10993-1 |
| Performance testing | Complies with ISO 11608-2: 2012, ISO 9626: 2016 |
| Reuse | Single use |
| Sterilization | Ethylene Oxide |
| Package integrity | Protection of product and sterility maintenance after environmental conditioning and simulated transportation |
| Compatibility | Functional compatibility with all leading pen injectors on the market, maintaining dose accuracy |
Study Information (Non-Clinical/Engineering):
- Non-Clinical Tests Performed: The device underwent non-clinical performance testing to support the determination of substantial equivalence.
- Testing Standards:
- ISO 10993-1: 2018 (Biological evaluation of medical devices)
- DS EN/ISO 11607-2:2019 (Packaging for terminally sterilized medical devices)
- ISO 11608-2: 2012 (Needle-based injection systems for medical use)
- ISO 9626: 2016 (Stainless steel needle tubing for the manufacture of medical devices)
- Particulates per ISO 11040-4:2015 (Prefilled syringes)
- ASTM F1980-16 (Accelerated Aging of Sterile Barrier Systems for Medical Devices for shelf-life validation)
- Biocompatibility Tests: In vitro cytotoxicity, intracutaneous reactivity, skin sensitisation, acute systemic toxicity, and haemocompatibility (haemolysis).
- Functional Compatibility: Tested with a list of pen injectors (e.g., Autopen® 24, FlexPen®, Ozempic®, etc.) to demonstrate connectivity and maintenance of dose accuracy.
- Package Integrity Testing: Conducted after environmental conditioning and simulated transportation in accordance with ISTA 3A, on final, packaged, and sterile devices.
The document does not describe a clinical study measuring diagnostic performance or AI algorithm effectiveness, as it pertains to a physical medical device.
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(151 days)
Indications for Use: NovoFine® Plus 32 G 4 mm needles are intended for use with pen injector devices for the subcutaneous injection of drugs.
NovoFine® Plus 32 G 4 mm needle is a sterile single use needle for subcutaneous injection of drugs with a pen injector device. Prior to giving an injection, the protective tab is removed from the outer needle cap of the single-use disposable needle. With the disposable needle remaining in the outer needle cap, it is then carefully screwed onto the injection delivery device until tight and then the needle outer and inner caps are removed. Use the needles as described in the instructions for use that comes with the pen-injector device and as instructed by the healthcare professional.
After the injection, the needle is removed from the skin. The needle is detached from the injection device and disposed of in accordance with national/local regulations. For each subsequent injection, a new disposable needle must be used.
The provided document is a 510(k) premarket notification for a medical device, the NovoFine® Plus 32G 4 mm needle, and details why it is substantially equivalent to a previously cleared predicate device (NovoFine® Plus 32G 4 mm ETW cleared under K133738). This type of submission focuses on demonstrating equivalence rather than establishing new performance criteria for novel devices.
Therefore, the document does not contain information about acceptance criteria for a novel device, nor a study proving a device meets such criteria. Instead, it focuses on demonstrating that minor changes to an existing, already cleared device do not introduce new safety or effectiveness concerns, and that the updated device performs similarly to the predicate.
Here's an analysis of the provided text in relation to your request:
-
A table of acceptance criteria and the reported device performance
- Not Applicable. The document provides a "Side by side comparison of the subject device and predicate device" (Table 1 on page 7). This table compares specifications like outer diameter, inner diameter, length, gauge, and material composition between the current device (K202005) and the predicate device (K133738). It also lists existing standards that apply to both. However, these are device specifications and standards compliance for an equivalent product, not new acceptance criteria established for a novel device and corresponding performance data from a specific study against those criteria.
- For example, it states "Inner diameter: Minimum 0.146 mm" for the subject device and "0.145-0.16 mm" for the predicate. This is a specified parameter, not an acceptance criterion with a calculated performance output from a study.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. The document states "Biocompatibility and performance tests have been performed and the results are in compliance with existing domestic and international standards" (page 8). It also mentions "functional compatibility according to ISO 11608-2:2012 with all leading pen injectors available on the market." However, it does not detail sample sizes, data provenance, or whether the testing was retrospective or prospective.
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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)
- Not Applicable. This question typically pertains to studies involving expert review for diagnostic or screening devices where a "ground truth" is established by human experts (e.g., in medical image analysis). The NovoFine® Plus is a hypodermic needle; its performance is assessed through engineering and biocompatibility testing against established standards, not expert-adjudicated clinical outcomes.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. As explained above, this device and its clearance process do not involve expert adjudication methods typically seen in AI/diagnostic device studies.
-
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 device for drug delivery, not a diagnostic or AI-assisted interpretation device, so MRMC studies are not relevant.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device, not an algorithm, so "standalone algorithm performance" is not relevant.
-
The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not Applicable. The "ground truth" for this device's performance would be compliance with manufacturing specifications, established engineering standards (like ISO 11608-2:2012 for needle-based injection systems, and ISO 10993-1 for biocompatibility), and functionality testing (e.g., flow rate, bond strength, sterility). This is not typically referred to as "ground truth" in the context of clinical outcomes or expert consensus.
-
The sample size for the training set
- Not Applicable. This is a physical device, not an AI model, so there is no "training set."
-
How the ground truth for the training set was established
- Not Applicable. As above, there is no "training set" or corresponding ground truth establishment process for this type of device.
In summary, the provided document is a 510(k) submission for substantial equivalence of a hypodermic needle. It describes product specifications and compliance with established ISO standards, but it is not a study that establishes new acceptance criteria for a novel device or provides detailed performance data against such criteria in the way your request outlines for AI or diagnostic devices. The closest information available is the comparison table of specifications between the subject device and the predicate device, implying that the acceptance criteria are met by conforming to these specifications and relevant ISO standards.
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(104 days)
The NovoPen Echo® is a re-useable pen injector designed for single patient use by diabetics for the self-injection of a desired dose of insulin. The pen injector uses PenFill® 3 mL cartridge of NovoLog®, 100 units/mL (U-100) [insulin aspart injection], Fiasp® 100 units/mL (U-100) [insulin aspart injection], and a single use detachable and disposable pen needle (supplied separately). The pen injector allows the user to dial the desired dose from 0.5 to 30 units in 0.5 unit increments.
The NovoPen Echo® is a reusable mechanical pen-injector capable of injecting a dose of up to 30 units of insulin, in 0.5 unit increments, from a NovoLog 3 mL PenFill® cartridge. The memory function enables the user of the device to see the quantity of last given dose and hours that have passed since last dose. The operation of the pen-injection of insulin is entirely independent of the operation of the memory function. The intended dose is mechanically set by rotating a dose button. The insulin is injected by depressing the dose button which via mechanical coupling causes the piston in the insulin cartridge to move forward thereby expelling the intended dose. The device has a memory function and liquid crystal display that allows the user to review the units of the last dose and the number of hours that have elapsed since the last dose was taken. Rotation of the dose button during dose setting causes a sensor to rotate within a coded cylinder. The movement detected by this sensor is stored for later display on the liquid crystal display in the dosage selector module as the number of units injected.
The provided text describes a 510(k) premarket notification for the NovoPen Echo®, specifically to expand its approved use to include Fiasp® (insulin aspart injection) 3mL PenFill® cartridges. It primarily focuses on demonstrating substantial equivalence to a previously cleared device (K162602) rather than presenting a standalone study of the device's diagnostic or therapeutic performance in a clinical setting.
Therefore, many of the requested categories for acceptance criteria and study details are not directly applicable or available in this regulatory document. This document is about a device's safety and performance in delivering a drug, not about its diagnostic accuracy or establishing a new therapeutic effect.
Here's the information that can be extracted or reasonably inferred from the document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Performance Requirement) | Reported Device Performance |
|---|---|
| Meets requirements of ISO11608-1:2014 (Needle-based injection systems for medical use - Requirement and test methods - Part 1: Needle based injection systems) for dose accuracy with Fiasp® 3mL PenFill® cartridges. | "Dose accuracy performance test of the Fiasp® (insulin aspart injection) 3 mL PenFill® cartridges with NovoPen Echo® was performed which meets the requirements of ISO11608-1:2014." |
| Device in-use lifetime | 5 years, provided pen is taken into use within two years of production date. (Device informs user when end of life is reached via memory display). |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated for the dose accuracy performance test. ISO11608-1:2014 would specify the number of individual tests (e.g., number of pens tested, number of doses per pen) required for compliance. This document only states that the testing was performed and met the standard.
- Data Provenance: Not specified, but generally, such performance tests are conducted by the manufacturer (Novo Nordisk) in a controlled laboratory environment. It is not clinical data, so terms like "retrospective or prospective" or "country of origin of the data" are not applicable in this context.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable. The "ground truth" for a mechanical device's dose accuracy is typically established by precision measurement equipment (e.g., gravimetric or volumetric methods) in an engineering or metrology lab, not by human experts, and certainly not by medical experts for diagnostic purposes.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. This concept applies to human interpretation of diagnostic data where a consensus among experts is needed. For mechanical performance testing, the results are objectively measured.
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 for insulin delivery, not an AI-assisted diagnostic tool or a system involving human readers/interpreters in a diagnostic context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable in the sense of an algorithm for diagnosis or interpretation. The device itself operates mechanically. The "standalone" performance here refers to the device's ability to accurately deliver insulin doses, which was tested.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for device performance (dose accuracy) would be the precisely measured volume or weight of liquid dispensed, determined using calibrated laboratory equipment according to the methods outlined in ISO11608-1:2014.
8. The sample size for the training set
- Not applicable. The NovoPen Echo® is a mechanical device, not an AI/ML algorithm that requires training data.
9. How the ground truth for the training set was established
- Not applicable for the reason above.
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