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The CP Medical nonabsorbable C-PTFETM Surgical Suture is a removable, nonabsorbable surgical suture intended for use in general soft tissue approximation and/or ligation, including dental surgical procedures. CP Medical C-PTFETM sutures are contra indicated for use in microsurgery, ophthalmic procedures, or peripheral neural tissue.

The CP Medical C-PTFETM Surgical Sutures are Nonabsorbable, Polytetraflouroethylene, single use, sterile, disposable, monofilament sutures and are provided with or without needles. Individual sutures are available in a "racetrack" configuration, attached around a HDPE delivery system, and/or in a figure 8 in a Tyvek/film pouch. The CP Medical C-PTFETM Surgical Sutures are sterilized via EO in accordance with EN ISO-11135:2014

This document is primarily a 510(k) premarket notification letter and summary for a surgical suture and does not describe a study involving an AI/Machine Learning device or a diagnostic device. Therefore, most of the requested information regarding AI/ML acceptance criteria and study design (e.g., sample sizes for test and training sets, expert ground truth, adjudication methods, MRMC studies, standalone performance) is not applicable to this document.

The document discusses the substantial equivalence of the C-PTFE™ Surgical Suture to a predicate device based on non-clinical performance testing and biocompatibility.

Here's a breakdown of what can be extracted from the provided text, and what cannot:

Information that can be extracted:

1. A table of acceptance criteria and the reported device performance (Non-Clinical Performance Testing):

The document mentions that the C-PTFE™ Surgical Suture was tested against recognized standards to demonstrate substantial equivalence to the predicate device. While specific quantitative "acceptance criteria" and "reported performance" values are not provided in a detailed table format within this summary, the document states that the new device's performance was compared to the predicate device and found to be "substantially equivalent" or "comparable."

• USP-40-NF35:2017, Nonabsorbable Surgical Suture (6-393)
• USP-40-NF35:2017, Tensile Strength () (6-394)
• USP-40-NF35:2017, Diameter () (6-395)
• USP-40-NF35:2017, Sutures – Needle Attachment () (6-396)

Conclusion: "Based on the technological characteristics and non-clinical performance testing, the CP Medical C-PTFE™ Surgical Suture performs comparably [to] the predicate device, MonoTex K140415." "Test report 17-033 confirmed equivalency." |
| Sterility | Yes | Sterilized via EO in accordance with EN ISO-11135:2014. Confirmed as "Yes" (Sterile) and "EO" (Sterilization method) in comparison table. |
| Electrical Safety and EMC | Not Applicable | No electrical components, no electrical safety information required. |
| Software Verification and Validation | Not Applicable | No software in the device, no software required to function. |
| Mechanical and Acoustical Testing | Not Applicable | This section does not apply to this device. |

2. Sample sizes used for the test set and the data provenance:

• Test Set Sample Size: Not explicitly stated as a number of devices or units. The testing refers to conformance with USP standards and biocompatibility tests, where sample sizes are typically defined by the standards themselves, but not detailed here.
• Data Provenance: Not specified beyond the general nature of lab-based/bench testing and animal studies (for biocompatibility). No mention of country of origin or retrospective/prospective clinical data for performance assessment, as this is a non-clinical submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. This submission is for a medical device (suture) and relies on objective, standardized physical and material testing, and animal biocompatibility studies, not on human expert interpretation of images or clinical outcomes that would require "ground truth" establishment by multiple human experts.

4. Adjudication method for the test set:

• Not Applicable. As above, there's no "adjudication" in the context of expert consensus for a test set, as this is not a diagnostic or AI device study.

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 a study for an AI/ML device.

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

• Not Applicable. This is not an AI/ML device.

7. The type of ground truth used:

• Objective Test Standards and Biocompatibility Endpoints: The "ground truth" or reference for this device's performance is established by conformance to recognized industry standards (USP, ISO) for physical properties (e.g., tensile strength, diameter) and biological responses (e.g., tissue reaction in animal models for biocompatibility). There is no "pathology" or "outcomes data" in the typical diagnostic sense.

8. The sample size for the training set:

• Not Applicable. This is not a study for an AI/ML device, so there is no concept of a "training set."

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

• Not Applicable. As above, no training set.

In summary, this document pertains to the regulatory submission for a surgical suture, demonstrating its substantial equivalence to a predicate device through non-clinical laboratory testing and biocompatibility assessments, rather than an AI/ML or diagnostic device that would require comprehensive clinical performance studies with expert-adjudicated ground truth.

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CP-Fiber is indicated for use in soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, neurological, and orthopedic surgeries.

CP-Fiber is a synthetic non-absorbable suture composed of a braided polyblend. As with all surgical sutures, CP-Fiber is a single-use device. This submission expands the indications for use to include orthopedic surgeries.

The provided document is a 510(k) summary for a medical device (CP-Fiber suture). While it describes the device's intended use and substantial equivalence to predicate devices, it does not contain the specific information requested about acceptance criteria and a study proving the device meets those criteria.

This document focuses on regulatory approval based on demonstrating equivalence to existing products rather than presenting a performance study with detailed acceptance criteria and results.

Therefore, I cannot extract the requested information from the provided text.

Specifically, the document does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for a test set, nor its data provenance.
3. Number of experts or their qualifications for establishing ground truth.
4. Adjudication method.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
6. Results of a standalone algorithm performance study.
7. The type of ground truth used.
8. Sample size for a training set.
9. How ground truth for a training set was established.

The document states: "Testing activities demonstrate that the product complies with USP requirements for nonabsorbable sutures." This is a general statement about compliance with a standard, but it doesn't provide the detailed acceptance criteria or study results that you're asking for.

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Monoswift™ is a monofilament, synthetic absorbable suture indicated for use in soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological surgery, microsurgery, or ophthalmic surgery.

Monoswift™ is a monofilament, synthetic absorbable suture indicated for use in soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological surgery, microsurgery, or ophthalmic surgery.

This looks like a 510(k) summary for a medical device (Monoswift™ Synthetic Absorbable Suture), which is a premarket submission made to the FDA to demonstrate that the device is at least as safe and effective as a legally marketed predicate device.

The provided document does not contain the kind of detailed study information (like sample sizes, expert qualifications, adjudication methods, or MRMC studies) that would be present for evaluating a diagnostic AI/ML device. The document primarily focuses on demonstrating substantial equivalence to predicate devices based on design verification and USP requirements for needle attachment tensile strength.

Therefore, for this specific input, the requested information cannot be fully provided because it pertains to a different type of device evaluation (e.g., for AI/ML diagnostic software) than what is presented here.

However, I can extract the relevant information that is present in the document.

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

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

• Sample Size for Test Set: Not specified in the provided document.
• Data Provenance: Not specified in the provided document. The manufacturer is CP Medical, Portland, OR, USA. The testing was likely conducted in the US.
• Retrospective or Prospective: Not specified.

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 and not present for this type of device (surgical suture). Ground truth in the context of diagnostic AI/ML refers to diagnoses or classifications established by human experts or definitive tests. For a surgical suture, the "ground truth" relates to its physical and biological performance characteristics, measured through various laboratory and potentially in-vivo tests, rather than expert interpretation of data.

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

• Not applicable and not present for this type of device. Adjudication methods are relevant for resolving discrepancies in expert interpretations in diagnostic 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. MRMC studies are used to evaluate the performance of diagnostic imaging devices (often with AI assistance). This device is a surgical suture.

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

• Not applicable. This is not an algorithm-only device.

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

• For this device, the "ground truth" or reference standard for verification is based on USP (United States Pharmacopeia) requirements for needle attachment tensile strength and comparison of breaking strength retention with predicate devices. This involves laboratory testing and performance metrics of the suture material itself, rather than expert interpretation of patient data or outcomes in the traditional sense of diagnostic devices.

8. The sample size for the training set:

• Not applicable. This device does not use a training set in the context of machine learning.

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

• Not applicable. This device does not use a training set.

In summary, the provided document outlines a 510(k) submission for a surgical suture, where "acceptance criteria" are related to physical and performance characteristics of the material (e.g., tensile strength, absorbability) as measured against established standards (like USP) and comparison to predicate devices, rather than the diagnostic performance metrics typically associated with AI/ML devices.

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The needles are used for interstitial placement of gold seed markers. Once implanted, the gold markers serve as localization devices for the purpose of radiation therapy.

The CP Medical Pre-waxed Needles with Gold Fiduciary Markers are designed for use in conjunction with conventional radiation therapy methods. The product consists of one (1) solid gold seed marker, loaded into a standard 17 or 18 gauge brachytherapy needle that has been preplugged with bone wax (CP Medical, K024372). The loaded needles are packaged individually or in groups of three. The packaged needles are sterilized via ethylene oxide.

The provided document K071550 describes the CP Medical Pre-waxed Needles with Gold Fiduciary Markers. This 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria through a clinical trial or extensive standalone performance evaluation.

Therefore, much of the requested information regarding acceptance criteria, sample sizes for test/training sets, expert contributions, adjudication methods, and MRMC studies, which are typical for AI/CAD device submissions, is not applicable or available in this document. The submission relies on design verification and a comparison of materials and packaging to a predicate device.

Here's a breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Not explicitly defined in terms of specific performance metrics with acceptance criteria. The submission focuses on substantial equivalence to the predicate device (Best Radiopaque Marker, K043117) rather than setting and meeting de novo performance targets. The "acceptance criteria" here implicitly relate to demonstrating equivalent materials, packaging, and the intended function through design verification.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable in the context of a typical AI/CAD performance study. The submission for this type of device (implantable marker/needle) focuses on engineering design verification rather than clinical test set performance. No "test set" of patient data (images, pathology, etc.) was used for evaluating algorithm performance. The "testing and verification activities" refer to engineering and manufacturing tests (sterilization, packaging, product integrity).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not applicable. There was no test set requiring expert ground truth establishment for this device submission.

4. Adjudication Method for the Test Set

Not applicable. There was no test set requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This type of study is not relevant for an implantable radiographic marker and needle device, which does not involve human readers interpreting imaging with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No. This device is a physical medical instrument, not an algorithm, so standalone performance in the context of AI is not applicable.

7. The Type of Ground Truth Used

Not applicable in the context of AI/CAD ground truth. The "ground truth" for this submission is whether the physical device meets engineering specifications and is equivalent to the predicate device in materials, packaging, and intended use. This is established through design verification rather than expert consensus on clinical data or pathology reports.

8. The Sample Size for the Training Set

Not applicable. This device submission does not involve a "training set" as it's not an AI/CAD system.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There was no training set for this device.

Summary of Approach:

The K071550 submission for the CP Medical Pre-waxed Needles with Gold Fiduciary Markers followed a substantial equivalence pathway to a legally marketed predicate device (Best Radiopaque Marker, K043117). The primary evidence presented involved:

• Comparison of materials and packaging: Stating that they are equivalent to the predicate device.
• Design Verification: Confirming that engineering design inputs were achieved through activities like sterilization validation and package validation. Product integrity for the needle component was referenced as previously performed (K024372).

This type of submission does not involve the detailed performance studies or data sets typically associated with AI/CAD devices, as the product is a conventional medical instrument.

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The Oscera7™ Synthetic Absorbable Bone Wax is indicated in the control of bleeding from cut or damaged bones by acting as a pressure tamponade, or mechanical barrier .

The Oscera7™ Synthetic Absorbable Bone Wax is a kneadable, biocompatible, synthetic absorbable material indicated for control of bleeding from bone surfaces. Hemostasis is accomplished by the physical mechanism of tamponade as it is pressed into the pores of the cut or damaged bone surface.

Post-application, the component materials, which include a fatty acid salt, isopropyl hexadecanoate, an alkylene oxide copolymer and ß-tricalcium phosphate, are dispersed and absorbed within the body.

The provided text describes a 510(k) submission for the Oscera7TM Synthetic Absorbable Bone Wax. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and studies in the format requested for AI/software devices.

Therefore, many of the requested fields cannot be directly extracted or are not applicable to this type of medical device submission. However, I can infer some information based on the context of a 510(k) and the provided text.

Here's a breakdown of the available and inferred information:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of Inference:

• Acceptance Criteria: These are inferred from the "Intended Use," "Device Description," and "Design Verification" sections. For a 510(k), compliance with these functional requirements and demonstrating substantial equivalence to legally marketed predicate devices are the primary "acceptance criteria."
• Reported Device Performance: The document states that "Verification testing of Oscera7™ included both bench and animal testing. The testing demonstrated the hemostatic capability, bioresorbability, and biocompatibility, thereby establishing compliance to the functional requirements of the device." It also concludes that "the cumulative test results demonstrated the functionality, safety and effectiveness of Oscera7™, as well as its substantial equivalence to the predicate devices."

2. Sample Size Used for the Test Set and the Data Provenance

This information is not provided in the document. The text only mentions "bench and animal testing" but does not specify sample sizes or data provenance (e.g., country, retrospective/prospective). This level of detail is typically not included in a 510(k) summary.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not provided and is not applicable to a non-AI/software medical device like bone wax. "Ground truth" in this context would likely refer to direct measurements or observations from animal models or bench tests, not expert interpretation of data.

4. Adjudication Method for the Test Set

This information is not provided and is not applicable to this type of device. Adjudication methods (like 2+1, 3+1) are typically used in studies involving human interpretation, especially for diagnostic or screening devices.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable as the Oscera7TM Synthetic Absorbable Bone Wax is a physical medical device, not an AI or software device.

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

This is not applicable as the Oscera7TM Synthetic Absorbable Bone Wax is a physical medical device, not an AI or software device.

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

Based on the type of device and testing mentioned ("bench and animal testing"), the "ground truth" would likely be established through:

• Direct measurement/observation in bench tests: For properties like mechanical integrity, absorption rates, or material composition.
• Histopathology or physiological measurements in animal models: To assess hemostasis, bioresorption, and biocompatibility (e.g., inflammation, tissue integration, presence/absence of material).
• Clinical observation in animal models: For immediate hemostatic effect.

The document does not explicitly state the specific ground truth methods but implies these through the types of tests mentioned.

8. The Sample Size for the Training Set

This information is not provided and is not applicable to this type of device. "Training set" is a term used in machine learning; this device undergoes traditional design verification and validation testing.

9. How the Ground Truth for the Training Set was Established

This information is not provided and is not applicable to this type of device for the same reasons as #8.

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General soft tissue approximation including use in cardiovascular, ophthalmic, and neurological procedures.

The polyblend surgical suture meets USP requirements as described in the USP monograph for nonabsorbable surgical sutures. CP Medical non-absorbable polyblend surgical sutures made with a braided, twisted core of polyethylene terephthalate and a polyethylene cover, are available in sterile form to an SAL of 106. Sterilization is performed by either Ethylene Oxide or Gamma Irradiation.

The provided text describes a 510(k) premarket notification for a medical device called "CP Fiber, Non-Absorbable Polyblend Surgical Suture." This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria as you might see for novel devices.

Therefore, the information you're requesting regarding acceptance criteria, study details, sample sizes, and expert ground truth is not applicable to this document. This submission primarily relies on comparing the new device's characteristics and performance to already approved predicate devices.

However, I can extract information related to the device and its equivalence to the predicate:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: The primary acceptance criterion for this 510(k) submission is substantial equivalence to the predicate devices. This means the new device must meet the same performance standards as the predicate devices and be suitable for the same indications for use. Specifically, it must meet USP requirements for nonabsorbable sutures.
• Reported Device Performance (from text):
  • Device Type: Non-absorbable polyblend surgical suture.
  • Composition: Braided, twisted core of polyethylene terephthalate and a polyethylene cover.
  • Sterility: Available in sterile form to an SAL of 10^-6 (Sterility Assurance Level). Sterilization by Ethylene Oxide or Gamma Irradiation.
  • USP Compliance: Meets USP requirements as described in the USP monograph for nonabsorbable surgical sutures.
  • Predicate Device Compliance: Both predicate and proposed devices are indicated for use in soft tissue approximation; both meet USP for nonabsorbable sutures, may be silicone-coated or uncoated, and may be dyed or undyed with an appropriate FDA listed color additive. The sutures may also be provided with or without a standard needle attached.

2. Sample size used for the test set and the data provenance:

• Not applicable. This 510(k) submission does not describe a test set or clinical study in the manner implied by these questions. Equivalence is primarily demonstrated through material properties, manufacturing processes, and adherence to recognized standards (like USP) that are common to the predicate device.

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 mention of a "test set" requiring expert-established ground truth in this submission.

4. Adjudication method for the test set:

• Not applicable. No test set requiring adjudication is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable. This is a surgical suture, not an imaging or diagnostic device that would typically involve human readers or AI assistance.

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

• Not applicable. This is a physical medical device (suture), not an algorithm or AI system.

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

• Not applicable. The "ground truth" here is the established performance and safety profile of the predicate devices and the universally accepted standards for surgical sutures (e.g., USP monograph).

8. The sample size for the training set:

• Not applicable. No "training set" in the context of machine learning or clinical trials is mentioned.

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

• Not applicable. As above, no training set.

In summary: The provided document is a 510(k) premarket notification. These submissions demonstrate "substantial equivalence" of a new device to a legally marketed predicate device, rather than proving safety and effectiveness through new clinical studies with specific acceptance criteria that require extensive clinical data, sample sizes, and expert input as you might expect for a PMA or a novel device. The "study" here is primarily a comparison of the new device's characteristics and performance to established standards and the predicate device.

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CP Medical's synthetic, absorbable placement sleeve accessory is intended to be used with absorbable seeding spacers to facilitate the introduction of radionuclide seeds and spacers into the body during Brachytherapy procedures. It is used to orient, hold, carry and maintain spacing of the radionuclide seeds and the spacer component.

The Carrier Sleeve is indicated for use in soft tissues or organ tissue but should not be used during cardiovascular or neurological procedures.

The CP Medical CARRIER SLEEVE consists of synthetic absorbable polymer or copolymer material, braided and non-braided, which is used with absorbable seeding spacers to facilitate the introduction of radionuclide seeds and spacers into the body during Brachytherapy procedures.

This document is a 510(k) premarket notification for a medical device called the "Carrier-Sleeve," an accessory for brachytherapy procedures. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a formal study. Therefore, most of the requested information regarding acceptance criteria, sample sizes, expert involvement, and ground truth generation is not applicable or not present in this type of submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. This 510(k) submission does not present a table of acceptance criteria or reported device performance in the manner of a formal performance study with quantitative metrics. The basis for clearance is demonstrating substantial equivalence to a predicate device.

2. Sample size used for the test set and the data provenance

Not applicable. There is no mention of a "test set" for performance evaluation in this 510(k). The submission relies on a comparison of technological characteristics to predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Ground truth establishment for a test set is not part of this 510(k) submission.

4. Adjudication method for the test set

Not applicable. There is no "test set" or adjudication method described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an accessory for brachytherapy procedures (a "sleeve"), not an AI-powered diagnostic or interpretive tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and not performed.

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

Not applicable. This is a physical accessory and does not involve an algorithm or standalone performance in the context of AI.

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

Not applicable. There is no mention of establishing ground truth for a performance study. The ground for substantial equivalence is based on comparing the intended use and technological characteristics to predicate devices.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" as it is not an AI or machine learning algorithm.

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

Not applicable. As above, there is no training set mentioned or implied.

Summary of the Study that Proves the Device Meets Acceptance Criteria (as presented in this 510(k)):

The "study" or justification for the device meeting acceptance criteria (in this context, being suitable for market) is a comparison of technological characteristics and intended use to legally marketed predicate devices, demonstrating substantial equivalence.

• Predicate Device(s):

  • CP Medical, K013975, Placement Sleeve for Brachytherapy Procedures
  • RIVER Medical Absorbable Seeding PDO Spacer component (K021311)

• Comparison: The submission states, "The proposed device, the CP Medical CARRIER SLEEVE is comprised of a synthetic absorbable material and is intended to facilitate the loading, delivery and implantation of radioactive seeds and spacers. Similarly, the predicate devices are composed of synthetic absorbable material intended to facilitate the loading, delivery and implantation of radioactive seeds and spacers."

• Conclusion (from FDA letter): The FDA reviewed the 510(k) and "determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." This determination is the "proof" that the device meets the relevant regulatory acceptance criteria for market clearance via the 510(k) pathway.

In essence, the "acceptance criteria" for a 510(k) are met by demonstrating that the new device is as safe and effective as a legally marketed predicate device, primarily through a comparison of design, materials, intended use, and other relevant characteristics. This document does not describe a traditional clinical or performance study with quantitative acceptance metrics.

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The CP Medical Bone Wax is indicated for use in the control of bleeding from bone surfaces.

The proposed device is composed of a beeswax and paraffin formulation.
The proposed device is manufactured in compliance with cGMP and ISO quality standards.

This submission K024372 is for a medical device (Bone Wax) and does not contain information related to AI/ML software. Therefore, none of the requested information (acceptance criteria, study details, sample sizes, ground truth, expert qualifications, etc.) is applicable or available in the provided text. The submission focuses on substantial equivalence to predicate devices based on composition and manufacturing standards, not on performance metrics of an AI algorithm.

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CP Medical's synthetic absorbable monofilament is indicated for use in soft tissue approximation and/or ligation but not for use in cardiovascular or neurological surgery, microsurgery or ophthalmic surgery.
MonoSwift™ is intended to be used for surgical wound closure.

The proposed device is a synthetic absorbable monofilament surgical suture comprised of polydioxanone, trimethylene-carbonate and caprolactone copolymers. These polymers, individually, and as co-formulated herein, are substantially equivalent to other synthetic absorbable monofilament sutures in commercial distribution today.

The provided text is a 510(k) premarket notification summary for a medical device (surgical suture). It primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and the comprehensive study that proves the device meets those criteria in a typical "AI/software device" context.

Therefore, many of the requested sections below cannot be fully answered with the information provided because this document is for a physical surgical suture, not an AI or software-based medical device. The "study" mentioned is conformity to recognized consensus standards for surgical sutures, which is different from a performance study for AI.

Here's an analysis based on the available information:

1. Table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance

• Sample Size: Not specified in the provided text.
• Data Provenance: Not specified, but given it's a physical product, the testing would likely be performed in a lab setting rather than using "data provenance" in the sense of patient data from specific countries.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This information is not applicable and not provided. "Ground truth" in the context of material science and biocompatibility testing for a surgical suture refers to established scientific/medical standards (USP, ISO) rather than expert consensus on interpretive data as in AI.

4. Adjudication method for the test set

• Not applicable and not provided. Adjudication methods like 2+1 or 3+1 are typically for human interpretation tasks, not physical material testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This device is a surgical suture, not an AI or imaging diagnostic device that would involve human readers or AI assistance.

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

• Not applicable. This device is a surgical suture, not an algorithm.

7. The type of ground truth used

• The "ground truth" for evaluating this device's safety and effectiveness relies on adherence to recognized consensus standards, specifically:
  • United States Pharmacopoeia (USP) for surgical suture specifications.
  • ISO 10993 for biocompatibility.
• The primary "proof" for this 510(k) submission is also substantial equivalence to an existing legally marketed predicate device (CP Medical's polydioxanone surgical suture) based on its chemistry, material, and composition.

8. The sample size for the training set

• Not applicable. This device is a physical product the subject of material science and manufacturing standards, not an AI model that requires a "training set."

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

• Not applicable. See point 8.

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Stainless Steel Surgical Suture is indicated for use in abdominal wound closure, hernia repair, sternal closure and certain orthopedic procedures including cerclage and tendon repair.

The CP Medical Stainless Steel Surgical Suture, monofilament, manufactured by C.P. Medical is equivalent to Nonabsorbable Surgical Sutures, Monofilament Stainless Steel manufactured by: Davis-Geck US Surgical Danbury, CT 06810 and Ethicon, Inc. P O BOX 151 Somerville. NJ 08876-0151. C.P. Medical's proposed device is packaged as four (4) individual sutures inside one suture card. The four-unit suture card is placed into Tyvek and twelve Tyvek packs are inserted into a suture box. The suture may also be supplied in bulk on an OEM basis as requested via customer specifications. The suture is supplied sterile or non-sterile and is either Gamma Irradiated or EtO sterilized to the SAL of 10°. The shelf life/expiration date is validated to five years from date of manufacture. USP Size 5 (metric 7.0), 6 and 7 (length 18") are primarily intended to be used for sternal closures. Additional sizes and lengths may be available in the future. All product is tested to USP standards prior to market release. The proposed device meets the requirements of ASTM F138-00 Gr.2 (Reg. Melt).

This summarization is for a 510(k) Premarket Notification for a Class II medical device, specifically a Stainless Steel Surgical Suture. These submissions primarily focus on demonstrating substantial equivalence to already legally marketed devices, rather than establishing de novo performance criteria against clinical outcomes.

Therefore, the requested information on acceptance criteria and a study proving the device meets them will be interpreted within the context of a 510(k) submission, meaning the "acceptance criteria" are typically USP standards and equivalence to predicate devices, and the "study" is often bench testing to confirm these standards are met.

Here's the breakdown:

Acceptance Criteria and Device Performance

Study Details to Prove Acceptance Criteria (Substantial Equivalence)

1. Sample sizes used for the test set and the data provenance:

   • Test Set Description: The provided text indicates "Physical testing was performed on the predicate and proposed surgical sutures." While specific sample sizes for each test (suture diameter, length, tensile strength, needle attachment strength) are not explicitly stated, the implication is that sufficient samples were tested to demonstrate compliance with USP standards for each.
   • Data Provenance: The testing was performed internally by CP Medical, Inc. or by a certified laboratory on their behalf, demonstrating compliance with USP standards. It appears to be prospective testing conducted for the purpose of this 510(k) submission. No country of origin for patient data is relevant as this is bench testing, not clinical data.

2. 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. For a stainless steel surgical suture, "ground truth" is established by adherence to recognized regulatory standards (e.g., USP, ASTM) and physical test methods. There are no human experts "adjudicating" diagnostic or clinical "ground truth" in this context. The "truth" is whether the physical properties of the suture meet the predefined specifications.

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

   • Not Applicable. As this involves physical bench testing against objective standards, there is no need for expert adjudication methods like 2+1 or 3+1, which are common in clinical image interpretation studies. The results are quantitative measurements compared against a numerical threshold set by the USP.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • Not Applicable. This device is a surgical suture, not a diagnostic imaging AI algorithm. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is entirely irrelevant to this submission.

5. 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.

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

   • The "ground truth" for this device's performance is objective, quantitative data obtained from physical and mechanical bench testing (e.g., measuring diameter, length, tensile strength, needle attachment strength) against established industry standards, specifically United States Pharmacopeia (USP) standards and ASTM F138-00 Gr.2.

7. The sample size for the training set:

   • Not Applicable. This device is a physical product and does not involve AI or machine learning algorithms that require a "training set."

8. How the ground truth for the training set was established:

   • Not Applicable. Since there is no training set, this question is not relevant.

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