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1. PINION™ PDO Knotless Sutures are indicated for use in general soft tissue approximation where use of an absorbable suture is appropriate.

2. PINION™ PGA-PCL Knotless Sutures are indicated for use in general soft tissue approximation where use of an absorbable suture is appropriate.

The PINION™ PDO Knotless Suture consists of barbed suture material armed with a surgical needle on each end. Barbs allow for tissue approximation without the need to tie surgical knots. PINION™ PDO Knotless Suture is a sterile, synthetic, absorbable monofilament suture comprised of Poly (p- Polydioxanone). The empirical molecular formula of which is (G.HგO3)x. PINION™ PDO Knotless Sutures are available in undyed or dyed with D & C violet No.2 (21 CFR 74. 3602) at a level not exceeding 0.3 % by weight of the suture in sizes USP (EP) 3-0 (2), 2-0 (3) & 0 (3.5). It is supplied with the attached stainless steel surgical needles. Polydioxanone has been found to be nonantigenic, nonpyrogenic and to elicit only a slight tissue reaction during absorption. The PINION™ PDO Knotless Suture is designed with small unidirectional and bidirectional barbs along the length of the device. It consists of an absorbable thread with unidirectional anchors, equipped with a surgical needle at one end and a fixation tab at the other while the bidirectional anchors equipped with a surgical needle at both end. The anchors and fixation tab design allows for tissue approximation without the need to tie surgical knots.

The PINION™ PGA-PCL Knotless Suture consists of barbed suture material armed with a surgical needle on each end. Barbs allow for tissue approximation without the need to tie surgical knots. PINION™ PGA-PCL Knotless Suture is a sterile, synthetic, absorbable monofilament suture comprised of poly (glycolide-co-caprolactone). PINION™ PGA-PCL Knotless Suture is provided undyed or dyed with D & C violet No.2 (21 CFR 74. 3602) at a level not exceeding 0.25 % by weight of the suture in sizes USP (EP) 4-0 (1.5), 3-0 (2) & 2-0 (3). It is supplied with the attached stainless steel surgical needles. The polymer has been found to be nonantigenic, nonpyrogenic and eliciting only a slight tissue reaction during absorption. The PINION™ PGA-PCL Knotless Suture is designed with small unidirectional and bidirectional barbs along the length of the device. It consists of an absorbable thread with unidirectional anchors, equipped with a surgical needle at one end and a fixation tab at the other while the bidirectional anchors equipped with a surgical needle at both end. The anchors and fixation tab design allows for tissue approximation without the need to tie surgical knots.

The provided text describes the acceptance criteria and the studies performed for two medical devices: PINION™ PDO Knotless Suture and PINION™ PGA-PCL Knotless Suture.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The main acceptance criteria are based on comparison to predicate devices and adherence to USP (United States Pharmacopoeia) and ISO standards. The "Reported Device Performance" column reflects whether the subject device meets these criteria. Since the document states "No change," "Identical," or indicates the subject device provides "more safety" than the predicate device, it implies successful meeting of the criteria.

PINION™ PDO Knotless Suture

PINION™ PGA-PCL Knotless Suture

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

The document details performance testing for both sutures, including:

• Diameter USP
• Tensile strength USP
• Needle attachment USP
• Suture Length
• Number of barbs per linear length of suture
• Barb size (length)
• Barb size Direction
• Barb Angle
• Barb holding strength
• Sterility USP
• Biocompatibility as per ISO 10993-1

However, the specific sample sizes used for each of these performance tests are not explicitly stated in the provided document.

The document mentions "implantation studies in animals" for the predicate devices to establish in-vivo tensile strength retention and absorption profiles. For the subject devices, it explicitly mentions "The results of in vitro study using PINION™ PDO Knotless Suture" and "PINION™ PGA-PCL Knotless Suture retains approximately 62 % of its original strength 7 days post implantation," implying similar in-vitro or animal studies were conducted for the subject devices to demonstrate equivalent performance.

The data provenance is related to the manufacturing country, which is India (M/s. Meril Endo Surgery Private Limited, Gujarat, India). The studies would therefore likely align with standard regulatory practices and be conducted to meet FDA requirements for prospective testing to demonstrate device performance and safety. The document does not specify if any retrospective data was used for direct performance comparison of the subject device, beyond referencing predicate device characteristics.

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 section is not applicable to this type of medical device submission. The devices are surgical sutures, and their performance is evaluated through measurable physical and biological properties against established standards (USP, ISO) and comparison to predicate devices, not through expert-reviewed interpretations of images or clinical outcomes that require "ground truth" established by human experts in the same way an AI diagnostic device would.

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

This section is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving human readers and AI for diagnostic or screening tasks to establish a consensus "ground truth." For surgical sutures, the assessments are based on objective physical measurements and biological tests, not subjective interpretations requiring adjudication.

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 section is not applicable. MRMC studies are relevant for diagnostic or screening devices, particularly those involving AI assistance for human readers. These sutures are physical medical devices, not diagnostic software.

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

This section is not applicable. This question pertains to AI/software device performance, which is not relevant to surgical sutures.

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

For these surgical sutures, the "ground truth" or reference standards are:

• United States Pharmacopoeia (USP) standards for properties like diameter, tensile strength, and needle attachment.
• ISO 10993-1 standards for biocompatibility.
• Established performance profiles of the legally marketed predicate devices (e.g., STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device and STRATAFIX™ Spiral MONOCRYL™ Knotless Tissue Control Device) for characteristics like tensile strength retention and absorption rates.

These are objective, quantitative and scientifically established benchmarks or comparisons.

8. The sample size for the training set

This section is not applicable. "Training set" refers to data used to train machine learning models. Surgical sutures are physical devices, not AI/ML systems, and therefore do not have training sets.

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

This section is not applicable for the same reason as above.

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MEGASORB Absorbable Polyglycolic Acid Surgical Sutures are indicated for use in soft tissue approximation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological procedures.

MITSU suture is intended for use in general soft tissue approximation including use in ophthalmic procedures, but not for use in cardiovascular or neurological tissues.

MITSU FST suture is indicated only for use in superficial general soft tissue approximation of the skin and mucosa, where only short term wound support (7-10 days) is required. MITSU FST suture is not intended for use in ligation, ophthalmic, cardiovascular or neurological procedures.

FILAXYN sutures are indicated for use in soft tissue approximation, including use in ophthalmic procedures, but not for use in cardio vascular and neurological procedures.

FILAPRON dyed / undyed sutures are intended for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.

MEGASORB™ suture is a synthetic absorbable sterile surgical suture composed of Polyglycolic Acid. Braided MEGASORB™ sutures are coated with polycaprolactone and calcium stearate.

MITSUTM is a braided coated synthetic absorbable sterile poly(glycolide/llactide) surgical suture. It is composed of a copolymer made of glycolide and L-lactide. MITSUTM sutures are coated with a mixture containing equal parts of copolymer of glycolide and lactide and calcium stearate.

MITSU FST™ is a braided coated synthetic absorbable sterile poly(glycolide/llactide) surgical suture. It is composed of a copolymer made from glycolide and L-lactide. MITSU FST™ sutures are coated with a mixture containing equal parts of copolymer of glycolide and calcium stearate. The rapid loss of strength is achieved by using polymer material with lower molecular weight than that of regular MITSUTM suture.

FILAXYN™ is a sterile synthetic absorbable monofilament suture composed of Poly (p-dioxanone).

FILAPRON™ is a sterile synthetic absorbable monofilament suture is composed of poly(glycolide-co-caprolactone).

All sutures are available in a range of gauge sizes and lengths, attached to standard stainless steel needles of varying types and sizes.

This document is a 510(k) premarket notification for several types of absorbable surgical sutures (MEGASORB, MITSU, MITSU FST, FILAXYN, FILAPRON). It focuses on demonstrating substantial equivalence to previously marketed predicate devices rather than proving novel effectiveness through a new clinical effectiveness study.

Therefore, the typical acceptance criteria and study design for new AI/Medical Device effectiveness, as requested in your prompt (which often includes human reader studies, ground truth establishment by experts, and analysis of effect sizes), are not applicable to this type of regulatory submission.

Instead, the "acceptance criteria" here refer to meeting the performance specifications of the predicate devices and relevant USP standards, and the "study" is a series of laboratory and biocompatibility tests designed to show that the new devices perform equivalently to the predicates.

Here's a breakdown based on the provided document, addressing the closest analogues to your requested points:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical "acceptance criteria" but refers to compliance with USP (United States Pharmacopeia) standards and equivalence to predicate devices. The "reported device performance" is implicitly that the devices met these standards and demonstrated substantial equivalence.

2. Sample Size for Test Set and Data Provenance

• Sample Size: The document does not specify the exact sample sizes used for each individual performance test (e.g., number of sutures tested for tensile strength, number of animals for biocompatibility). It generally states that the "Surgical Suture was subjected to the performance testing as per USP requirements." USP standards often outline minimum sample sizes for specific tests.
• Data Provenance: The tests were conducted by the submitter, Meril Endo Surgery Private Limited, based in India. The studies are prospective in the sense that they were conducted specifically to demonstrate the performance of these new devices for the 510(k) submission.

3. Number of Experts and Qualifications for Ground Truth

• Not Applicable: This type of submission (510(k) for surgical sutures) does not involve medical image interpretation or clinical diagnostic tasks that require experts to establish "ground truth" in the way an AI diagnostic device would. Performance is measured against physical and biological standards, not against expert medical consensus on a particular condition.

4. Adjudication Method for Test Set

• Not Applicable: There is no "adjudication method" in the sense of resolving conflicting interpretations by multiple human readers. Lab tests follow standardized protocols. Biocompatibility studies involve expert animal pathologists and toxicologists interpreting results, but this is standard scientific interpretation rather than "adjudication" of a ground truth label in an AI context.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Not Applicable: No MRMC study was done. This device is a surgical suture, not a diagnostic imaging device or an AI-assisted tool meant to improve human reader performance.

6. Standalone Performance Study (Algorithm Only)

• Not Applicable: This is not an algorithm or AI device. Its performance is measured directly through physical and biological testing.

7. Type of Ground Truth Used

• For physical properties (diameter, tensile strength, needle attachment, suture length): The "ground truth" is established by objective measurements against predefined scientific standards (USP specifications).
• For resorption profile: The "ground truth" or reference is the resorption profile of the legally marketed predicate device.
• For biocompatibility: The "ground truth" is established by standardized laboratory tests and expert interpretation of biological responses, adhering to recognized toxicology and biocompatibility guidelines (e.g., ISO 10993 series, though not explicitly cited in the summary, is standard practice). There isn't a single "ground truth" label; rather, it's a demonstration that the device's biological interactions fall within acceptable safety limits.

8. Sample Size for Training Set

• Not Applicable: There is no "training set" as this is not a machine learning or AI device.

9. How Ground Truth for Training Set was Established

• Not Applicable: As above, no training set or its associated ground truth.

In summary: The K172659 submission demonstrates substantial equivalence for absorbable surgical sutures by showing that these new devices meet established performance standards (primarily USP) and exhibit similar material compositions, designs, and intended uses to existing predicate devices. The evaluation focuses on laboratory testing and biocompatibility assessments rather than clinical performance studies that would involve human readers or AI algorithms.

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TRUGLYDE Absorbable Polyglycolic Acid Surgical Suture is indicated for use in soft tissue approximation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological procedures

Absorbable Surgical Suture,Synthetic (Polyglycolic Acid)

The provided text is related to a 510(k) premarket notification for a medical device: "TRUGLYDE Absorbable Polyglycolic Acid Surgical Suture."

This document is a regulatory approval letter from the FDA, a 510(k) summary, and an indications for use statement. It does NOT contain information about acceptance criteria, a specific study proving device performance against acceptance criteria, or any details regarding sample sizes, ground truth, expert qualifications, or MRMC studies.

The document states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices based on the information provided in the 510(k) submission. This substantial equivalence is typically established by demonstrating that the new device has the same intended use, technological characteristics, and performance as a predicate device, or that any differences do not raise new questions of safety or effectiveness.

Therefore, I cannot fulfill your request for the specific details of acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text. The document focuses on regulatory approval based on equivalence, not on a detailed clinical or performance study with defined acceptance criteria in the way you've described.

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Atramat ® Polyglycolic Acid Sutures are indicated for use as absorbable sutures in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures.

sorb-FAST ® Polyglycolic Acid Sutures are indicated only for use in superficial general soft tissue approximation of the skin and mucosa, where only short term wound support (7-10 days) is required. These sutures are not intended for use in ligation, ophthalmic, cardiovascular or neurological procedures.

Atramat® Polyglycolic Acid and sorb-FAST® Polyglycolic Acid are synthetic absorbable sterile surgical sutures composed of a synthetic polyglycolic acid polymer.

Atramat® Polyglycolic acid and sorb-FAST® Polyglycolic Acid meet all requirements as described in the United States Pharmacopeia (USP) monograph for Absorbables Surgical Sutures. These products are offered as monofilament or multifilament and it is offered uncoated or coated with polycaprolactone and calcium sterarate, it could also be undyed or dyed with D&C Violet No. 2.

Sizes offered are U.S.P. 8-0 through 2 ( metric equivalent 0.4 through 5).

Materials: Polyglycolic acid. USP & Polycaprolactone and Calcium Stearate

The provided text describes a 510(k) summary for Atramat® Polyglycolic Acid and sorb-FAST® Polyglycolic Acid surgical sutures. This submission is for a medical device and therefore the acceptance criteria and study information provided are related to demonstrating substantial equivalence to a predicate device, rather than the performance of a diagnostic or AI-driven device. As such, the typical structure for reporting on acceptance criteria for diagnostic devices (like those involving AI) does not directly apply here.

However, I can extract the information relevant to device performance and the "study" conducted to demonstrate equivalence, framed within the context of a 510(k) submission for a non-AI surgical suture.

Acceptance Criteria and Reported Device Performance

For both Atramat® Polyglycolic Acid and sorb-FAST® Polyglycolic Acid, the core acceptance criteria revolve around meeting or exceeding the performance requirements of the United States Pharmacopeia (USP). This is the key "performance" standard for these devices.

Study Information (Non-Clinical Testing for Substantial Equivalence)

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

   • The document states "Non-clinical testing was conducted on the subject devices to prove conformance to the requirements of USP standards". It does not specify the exact sample sizes used for each test (e.g., how many sutures were tested for tensile strength or absorption rate).
   • Data Provenance: Not specified, but generally, such non-clinical testing would be performed by the manufacturer (Internacional Farmaceutica S. A. de C.V.) in Mexico, or by a contract testing laboratory. It is retrospective in the sense that the testing was completed before the 510(k) submission.

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

   • This question is not applicable in the context of this 510(k) submission. "Ground truth" established by experts is relevant for diagnostic performance studies, often comparing human interpretation to a definitive answer. For medical devices like surgical sutures, "ground truth" is defined by established engineering and material science standards (e.g., USP monographs) rather than expert consensus on a diagnostic outcome. The "experts" involved would be those performing the standardized physical and chemical tests according to USP guidelines.

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

   • Not applicable. Adjudication methods are used to resolve discrepancies among multiple expert readers in diagnostic studies. Here, the "test results" are objective measurements against defined standards.

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 is a 510(k) submission for a surgical suture, not a diagnostic device or an AI-powered system that assists human readers.

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

   • Not applicable. This is not an algorithm or AI device. The "performance" is the physical and chemical properties of the suture itself.

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

   • The "ground truth" is adherence to United States Pharmacopeia (USP) standards for absorbable surgical sutures. These are objective, quantitative specifications for material composition, physical dimensions, tensile strength, and absorption rates. For Atramat® Polyglycolic Acid, the standard is USP 24, and for sorb-FAST® Polyglycolic Acid, it is USP 26.

7. The sample size for the training set:

   • Not applicable. There is no "training set" as this is not an AI/machine learning device. The product development and manufacturing processes would involve internal testing and quality control, but this is distinct from a "training set" in an algorithm development context.

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

   • Not applicable, as there is no training set. The "ground truth" for the device's performance is established by the well-defined and published USP monographs.

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Sharpoint® Coated FAST ABSORBING™ PolyGlycolic Acid suture is indicated only for use in superficial general soft tissue approximation of the skin and mucosa where only short-term wound support (7-10 days) is required. Coated FAST ABSORBING PolyGlycolic Acid suture is not intended for use in ligation, ophthalmic, cardiovascular or neurological procedures.

Suture is a synthetic absorbable braided, sterile, surgical suture composed of a homopolymer of Glycolic Acid. The suture material is coated with a copolymer of Polycaprolactone and PolyGlycolic Acid. The substances contained in the coating and suture are noncollagenous and nonantigenic.

This document is a 510(k) Summary for a surgical suture, which is a medical device. The information provided heavily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a traditional clinical study with defined acceptance criteria and performance metrics for a diagnostic or AI-driven device.

Therefore, many of the requested categories for AI/diagnostic device studies (like MRMC studies, ground truth establishment for training sets, number of experts for ground truth, adjudication methods) are not applicable or cannot be extracted from this type of regulatory submission. The "study" here is a set of physical and animal tests to show the suture meets performance standards and is biocompatible.

Here's the information that can be extracted and a clear indication of what is not applicable:

Acceptance Criteria and Device Performance

• U.S.P. 24, Sutures - Diameter
• U.S.P. 24, Sutures - Needle Attachment
• U.S.P. 24, Tensile Strength | Physical testing was conducted on the device to USP 24, including Sutures - Diameter, Sutures- Needle Attachment, and Tensile Strength (implies conformance, as this is a 510(k) approval). |
  | Biocompatibility | Conformance to ISO 10993 for biocompatibility. | Animal testing was performed for conformance to ISO 10993 for biocompatibility. |
  | Implant Performance | Demonstration of rates of tensile strength and mass loss (consistent with absorbable suture expectations). | Animal implant studies were performed to demonstrate rates of tensile strength and mass loss. |
  | Substantial Equivalence | Similar in intended use, materials, design, and performance characteristics to the Ethicon VICRYL Rapide Synthetic Absorbable Surgical Suture (K944110). | The FDA concluded the device is substantially equivalent to the Predicate Device. |

Study Details

1. Sample Size Used for the Test Set and Data Provenance:

   • Test Set Sample Size: Not explicitly stated as a number of "samples" in a traditional diagnostic sense. Instead, "physical testing was conducted" and "animal testing was performed." The number of sutures tested or animals used is not specified.
   • Data Provenance: The testing was conducted by the manufacturer, Surgical Specialties Corporation. The location of the animal testing is not specified, but it would have been part of preclinical testing required for regulatory submission. This would be considered prospective testing for the purpose of this submission.

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

   • Not Applicable. For a surgical suture, "ground truth" as typically defined for diagnostic or AI devices (e.g., disease diagnosis) is not relevant. The "truth" is established by adherence to physical standards (USP 24) and biological responses (ISO 10993), which are objectively measured.

3. Adjudication Method for the Test Set:

   • Not Applicable. There was no human adjudication process involved as the "test set" consists of physical and biological measurements against established standards.

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 is a surgical suture, not a diagnostic or AI-assisted device for human readers.

5. 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.

6. The Type of Ground Truth Used:

   • For physical properties (diameter, needle attachment, tensile strength): Established industry standards and monographs (USP 24).
   • For biocompatibility and implant studies: Established international medical device standards (ISO 10993) and biological response measurements (rates of tensile strength and mass loss in animal models).

7. The Sample Size for the Training Set:

   • Not Applicable. There is no "training set" in the context of a physical medical device like a suture, as it does not involve machine learning or pattern recognition.

8. How the Ground Truth for the Training Set was Established:

   • Not Applicable. (See point 7).

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POLYGLYCOLIC ACID is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures.

POLYGLYCOLIC ACID is a synthetic absorbable sterile surgical suture composed of a synthetic polyglycolic acid polymer and is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures. POLYGLYCOLIC ACID meets all requirements as described in the United States Pharmacopeia (U.S.P.) monograph for Absorbable Surgical Suture. Offered as monofilament or multifilament in form, and it is offered uncoated or coated with polycarpolactone and calcium stearate, it could also be undyed or dyed with an FDA listed color additive, D&C Violet No. 2 (21CFR74.3602). POLYGLYCOLIC ACID will be offered with or without standard needles attached.

Here's an analysis of the provided text regarding the acceptance criteria and study for the POLYGLYCOLIC ACID surgical suture:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "Non-Clinical Testing was conducted on the subject device to prove conformance to the requirements of U.S.P. standards." This implies a sample size adequate for the tests required by USP, but the specific number of units tested is not provided.
• Data Provenance: Not explicitly stated regarding country of origin. The study is described as "Non-Clinical Testing," which is typically laboratory-based and not tied to specific patient populations or geographical locations. It is a retrospective study in the sense that the tests were performed and then reported, but it's not a retrospective analysis of patient data.

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

• Not applicable. The ground truth for the non-clinical testing is based on the United States Pharmacopeia (U.S.P.) standards. These are established, widely accepted objective performance metrics for medical devices, particularly sutures. No human experts are described as establishing "ground truth" for these physical and chemical tests.

4. Adjudication Method for the Test Set

• Not applicable. The evaluation relies on objective measurements against pre-defined U.S.P. standards. There is no human adjudication process described for interpreting the results of these standardized tests.

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 (e.g., radiologists reading images) and assessing the impact of AI assistance on their performance. The device in question is a surgical suture, which is a physical product, and its evaluation relies on non-clinical performance characteristics.

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 or AI system. The concept of "standalone performance" for an algorithm does not apply here. The evaluation is of the physical product's performance against established standards.

7. The Type of Ground Truth Used

• U.S.P. Standards: The ground truth for the device's performance is objective compliance with the United States Pharmacopeia (U.S.P.) monograph for Absorbable Surgical Suture. These standards define the acceptable range for physical properties like diameter, tensile strength, length, and absorption characteristics.

8. The Sample Size for the Training Set

• Not applicable. The device is a surgical suture, not an AI or machine learning model. Therefore, there is no "training set" of data in the context of AI development.

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

• Not applicable. As there is no training set for an AI model, the question of establishing its ground truth is not relevant here.

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Bondek Plus Synthetic Absorbable Surgical Suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures.

Bondek Plus Synthetic Absorbable Surgical Suture is a sterile, absorbable, braided multifilament suture composed of a homopolymer of glycolic acid. The suture material is coated with a copolymer of polycaprolactone and polyglycolic acid.

This document describes the marketing authorization for the BONDEK® PLUS Synthetic Absorbable Surgical Suture. It is a 510(k) Summary of Substantial Equivalence, which means the manufacturer demonstrated that their device is as safe and effective as a legally marketed predicate device.

Key takeaway: This device is a surgical suture, and the acceptance criteria and supporting studies will revolve around its physical properties, biocompatibility, and performance in comparison to existing sutures, rather than accuracy metrics for a diagnostic device.

Here's the breakdown of the information requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not contain a specific table detailing "acceptance criteria" and "reported device performance" in the context of typical diagnostic or AI device studies (e.g., sensitivity, specificity, accuracy). Instead, substantial equivalence for this surgical suture is based on its similarity in intended use, materials, design, and performance characteristics to predicate devices, and conformance with voluntary performance standards.

Therefore, the "acceptance criteria" are implied to be meeting the requirements of these standards and being comparable to the predicate devices. The "reported device performance" refers to the demonstration of this conformance and comparability.

• Bondek Synthetic Absorbable Surgical Suture (#K905482, #K930378 and #K991191(pending))
• Sherwood-Davis & Geck Dexon® PGA Suture (#K972566, #K951352, #K900198)
• Lukens Medical Corp. Lukens® PGA suture (#K965162) |

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

The provided document does not mention a specific "test set" in the way one would for diagnostic device studies involving data samples. The evaluation of a surgical suture primarily involves bench testing (to meet physical standards) and biocompatibility testing (often in vitro and in vivo animal studies, or reliance on established material safety).

• Sample Size: Not specified in terms of clinical or data samples. The "data" here refers to the results of bench and biocompatibility testing required by the aforementioned standards.
• Data Provenance: Not specified. This would typically be from laboratory testing conducted by the manufacturer or accredited labs, and potentially animal studies for biocompatibility, rather than human patient data.

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 applicable to this 510(k) submission for a surgical suture. "Ground truth" established by experts (e.g., radiologists) is relevant for diagnostic devices that interpret medical images or data. For a physical device like a suture, the "ground truth" is established by adherence to recognized engineering, material science, and biological standards through objective testing.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This is not applicable. Adjudication methods are used in studies where multiple human readers or algorithms provide interpretations that need to be reconciled for a definitive "ground truth." This is not how a surgical suture's performance or equivalence is evaluated. Its performance is measured against objective standards.

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. MRMC studies and the concept of "human readers improving with AI assistance" are relevant for diagnostic AI devices, not for a synthetic absorbable surgical suture.

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

This is not applicable. This question pertains to AI algorithms, which are not part of this medical device (a surgical suture).

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For this surgical suture, the "ground truth" is defined by:

• Voluntary Performance Standards: Such as ISO 10993-1 (biocompatibility) and U.S.P. Section 1475 (physical properties of sutures).
• Material Science and Engineering Principles: Ensuring the suture material meets specifications for strength, degradation, and handling characteristics.
• Comparability to Predicate Devices: Demonstrating that the new device performs equivalently to existing, legally marketed sutures based on their established performance profiles.

There is no "expert consensus" or "pathology" in the typical sense for establishing performance of the suture itself, although expert surgeons would evaluate its handling characteristics in practice. Outcomes data might be collected in a larger clinical trial for novel claims, but for a 510(k) for a well-understood device type, it's primarily bench and biocompatibility data.

8. The Sample Size for the Training Set

This is not applicable. The concept of a "training set" refers to data used to train machine learning algorithms. This device is a physical surgical suture, not an AI or software device.

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

This is not applicable for the same reasons as point 8.

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Bondek Synthetic Absorbable Surgical Suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures.

Bondek Synthetic Absorbable Surgical Suture is a sterile, absorbable, braided multifilament suture composed of a homopolymer of glycolic acid, polyglycolic acid. The suture material is coated with a polycaprolactone-glycerol monostearate solution.

This document is a 510(k) summary for the Bondek® Synthetic Absorbable Surgical Suture. It establishes substantial equivalence to previously marketed devices and outlines the indications for use and device description. It does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of device performance metrics like sensitivity, specificity, or reader improvement with AI.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and the reported device performance
• Sample sized used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts
• Adjudication method for the test set
• If a multi reader multi case (MRMC) comparative effectiveness study was done, and the 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

This type of information is typically found in submissions for devices that involve diagnostic or AI components, where performance is measured against a ground truth. For sutures, the "performance" is generally related to material properties, biological compatibility, and mechanical strength, which are assessed through conformance to standards (e.g., USP, ISO 10993-1) as mentioned in the document. The document states:

"The determination of substantial equivalence for this device was based on a detailed device description, performance testing and conformance with voluntary performance standards, e.g. ISO 10993-1 Biological Evaluation of Medical Deices, U.S.P. Section 1475 - Absorbable Surgical Sutures, and the FDA Guidance Document "Alternate Suture Labeling Resulting from January 11, 1993 Meeting with HIMA"."

This indicates that the "acceptance criteria" were compliance with these established standards, and the "study" was the performance testing conducted to demonstrate this compliance. However, the specific data from these tests is not provided in this summary.

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The intended use of the device is in general soft tissue approximation and/or ligation including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures.

Lukens® · PGA (polyglycolic acid), synthetic absorbable surgical sutures, coated, braided USP manufactured by Lukens Medical Corporation are equivalent to Dexon II polyglycolic acid, synthetic, absorbable surgical sutures USP with polycaprolate coating system manufactured by Davis & Geck. Lukens - PGA (polyglycolic acid), synthetic absorbable surgical sutures USP are dyed with D&C Violet No. 2 and are coated with E-Caprolactone.

Here's an analysis of the provided text regarding device acceptance criteria and studies:

The document describes the Lukens® - PGA (Polyglycolic Acid) Synthetic Absorbable Surgical Suture, Coated, Braided U.S.P. and its equivalence to a predicate device, Dexon II. The studies presented are for regulatory clearance (510(k) submission), not for AI/ML device performance. Therefore, many of the requested AI/ML specific details (like AI effect size, training data, ground truth establishment for AI, etc.) are not applicable or present in this document.

However, I can extract the relevant acceptance criteria and study information provided.

Acceptance Criteria and Reported Device Performance

Study Details (Based on Provided Text)

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

   • Sample Size: Not specified in the document. The text mentions "Testing...demonstrates," but no specific number of samples or batches is provided for the physical tests.
   • Data Provenance: Not specified, but generally for medical device testing like this, it would be internal lab testing by the manufacturer or a certified contract lab. The implantation studies were in "animals," implying pre-clinical, non-human data.

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

   • Not Applicable. This is not a study involving human experts establishing ground truth for perception/diagnostic tasks, but rather laboratory and animal testing of a physical medical device. The "ground truth" for the physical and biocompatibility properties are standards set by USP and observed biological responses.

3. Adjudication method for the test set:

   • Not Applicable. See point 2.

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:

   • No. This is a conventional medical device (suture) and the studies describe its physical properties and biocompatibility, not an AI/ML system.

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):

   • For physical properties (diameter, length, tensile strength, needle attachment): USP XXIII standards are the ground truth/reference.
   • For biocompatibility: Observed biological response (absence of toxicity) from standard in-vitro or in-vivo tests.
   • For absorption and tensile strength retention: Observed in-vivo biological response in animals.

7. The sample size for the training set:

   • Not Applicable. There is no "training set" as this is not an AI/ML device.

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

   • Not Applicable. See point 7.

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