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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

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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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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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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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.

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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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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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:

• 1. 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.
• 2. 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.
• 3. 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

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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:

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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:

1. A table of acceptance criteria and the reported device performance (in terms of clinical outcomes or diagnostic metrics).
2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and their qualifications.
4. Adjudication method for the test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc).
8. The sample size for the training set.
9. 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.

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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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:

1. 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.

2. 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.

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. 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.

4. 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.

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 device for drug delivery, not a diagnostic or AI-assisted interpretation device, so MRMC studies are not relevant.

6. 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.

7. 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.

8. The sample size for the training set

   • Not Applicable. This is a physical device, not an AI model, so there is no "training set."

9. 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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Ready-to-Use Format

For in vitro diagnostic use.

BOND Ready-to-Use Primary Antibody Progesterone Receptor (16) is a monoclonal antibody intended to the qualitative identification by light microscopy of human progesterone receptor in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND-III systems. Progesterone Receptor Clone (16) specifically binds to the progesterone receptor antigen located in the nucleus of progesterone receptor positive normal and neoplastic cells.

Progesterone Receptor Clone (16) is indicated as an aid in the management, prognosis and prediction of therapy outcome of breast cancer. The clinical interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist.

Progesterone Receptor Clone (16) is optimized for use on the Leica Biosystems automated BOND-MAX or BOND-III systems using the BOND Polymer Refine Detection kit.

Concentrated Liquid Antibody Format

For in vitro diagnostic use.

Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone (16) (Concentrated Liquid Antibody Format) is intended to be used for the qualitative identification by light microscopy of human progesterone receptor in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining. Progesterone Receptor Clone (10) specifically binds to the progesterone receptor antigen located in the nucleus of progesterone receptor positive normal and neoplastic cells.

Progesterone Receptor Clone (16) Monoclonal Antibody (Concentrated Liquid Antibody Format) is indicated as an aid in the management, prognosis and prediction of therapy outcome of breast cancer. The clinical interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist.

Progesterone Receptor (16) is a mouse anti-human monoclonal antibody produced as a tissue culture supernatant. This antibody is utilized to perform a qualitative immunohistochemical (IHC) assay to identify Progesterone Receptor expression in human breast cancer tissue routinely processed and paraffin-embedded for histological examination.

Progesterone Receptor (PGR) Clone 16 Primary Antibody is provided in a Ready-to-Use (RTU) and a concentrated liquid format. The RTU format is supplied in Tris buffered saline with carrier protein, containing 0.35% ProClin™ 950 as a preservative and is provided in two volumes (7 mL and 30 mL). The total protein concentration is approximately 10 mg/mL and the total antibody concentration is greater than or equal to 1 mg/L as determined by ELISA. The RTU format is optimally diluted for use on the automated BOND-MAX and BOND-III instrument staining platforms in combination with BOND Polymer Refine Detection (DS9800). The concentrated liquid format is provided so that customers may utilize manual staining protocols. The concentrated liquid format is a liquid tissue culture supernatant containing 15 mM sodium azide as a preservative. The total protein concentration is determined on a per batch basis and is described on the vial label, and the antibody concentration is greater than or equal to 324.0 mg/L as determined by ELISA.

The BOND-MAX and BOND-III instruments are fully automated slide stainers that perform automated deparaffinization (dewaxing), antigen retrieval, immunohistochemistry (IHC) staining/in situ hybridization (ISH) staining, and counterstaining. The major components of the BOND staining platforms are the processing module, computer (BOND controller), handheld ID scanner, and slide label printer. The BOND staining platforms are composed of a number of discrete software components including the BOND application software, BOND instrument/processing module software, BOND service software, and Laboratory interface system - integration package (LIS-IP).

Here's a breakdown of the acceptance criteria and study details based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state numerical acceptance criteria for immunoreactivity or stability beyond "met acceptance criteria". However, the repeatability and reproducibility sections do provide numerical agreements and state that they met criteria. The method comparison also provides numerical agreements and states it met acceptance criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Intra-run Repeatability: 6 unique breast tumor tissue cases.
• Inter-day, Inter-instrument, Inter-lot Repeatability: 27 unique breast tumor tissue cases.
• Reproducibility (Inter-laboratory & Inter-pathologist): 135 unique FFPE breast tumor tissue cases.
• Method Comparison: A total of 455 cases (implied from the table total).
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It only mentions "human progesterone receptor in formalin-fixed, paraffin-embedded tissue" and "breast tumor tissue cases."

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)

• Reproducibility (Inter-laboratory & Inter-pathologist): 3 pathologists were involved in scoring the slides, one per site. Their qualifications are not specified beyond "pathologist."
• Other studies (Repeatability, Method Comparison): The document does not explicitly state the number of experts used for establishing ground truth or their qualifications for these studies. The scoring for repeatability likely involved expert assessment, and method comparison relied on comparing the subject device to a predicate device, which would also implicitly rely on established expert assessment standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not describe an explicit adjudication method (like 2+1 or 3+1) for resolving discrepancies. For the reproducibility studies, agreements are calculated between observers, suggesting individual pathologist assessments were compared rather than being subjected to a specific adjudication process to establish a single "ground truth" per case.

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 document describes the performance of an immunohistochemistry reagent/antibody, not an AI-assisted diagnostic device. Therefore, an MRMC comparative effectiveness study involving human readers improving with AI assistance is not applicable and was not performed. The studies focus on the analytical performance and reproducibility of the staining process and the antibody's interpretation by pathologists.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is an immunohistochemistry reagent, not an algorithm. Therefore, a standalone algorithm-only performance study is not applicable and was not performed. The performance is intrinsically linked to its use in a laboratory setting by human interpretation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the evaluations appears to be based on pathology assessments by qualified pathologists, specifically following ASCO/CAP guidelines (≥1% cut-off) for determining PR status in breast cancer tissue. This is indicated by phrases like "scored according to ASCO/CAP guidelines" and "clinical interpretation of any staining or its absence should be complemented by morphological studies... by a qualified pathologist."

8. The sample size for the training set

The document describes performance studies, not the development or training of an AI model. Therefore, there is no mention of a "training set" or its sample size.

9. How the ground truth for the training set was established

As this is not an AI model, there is no training set and thus no ground truth establishment process described for one. The "training" of the antibody is inherent to its development and optimization for specific antigen binding, which is evaluated through immunoreactivity and analytical performance studies.

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