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2.4 SmartNail is intended for use in the fixation of fragments of fractured non-load bearing bones, osteotomies and arthrodeses, for example in the fixation of apical fragments, osteochondral fragments and cancellous/non-load bearing fragments.

2.4 SmartNail is not intended for use in and is contraindicated for: 1) Fractures and osteotomies of cortical bone (except cortical bones of the foot and the hand), 2) Fractures and osteotomies in weight bearing cancellous bone, 3) Situations where internal fixation is otherwise contraindicated, e.g., active or potential infection; patient conditions, including blood supply limitations, insufficient quantity or quality of bone; and where patient cooperation cannot be guaranteed, (e.g., alcoholism) 4) Treatment of physeal fractures in children, because the effect of 2.4 SmartNail upon the healing of growth plate has not been tested clinically.

The device description of the 2.4mm SmartNail implant is as follows.

• The implant is composed of poly-96L/4D-lactide copolymer. This is the very same implant raw material with SmartNail (K993074) and 1.5mm Bone Fixation Kit (K012000, K013546)
• Lengths of implant are 16, 25, 35 and 45 mm. The current product selection of SmartNail products contains 16, 20 and 25 mm long implants. The current product selection of 1.5mm Bone Fixation Kit contains 14, 16, 18, 20 and 25mm long implants
• Diameter of implant is 2.4 mm.
• Shelf life is same with SmartNail™ and 1.5mm Bone Fixation Kit (K012000, -K013546), 3 years.
• Our current packaging style of SmartNail is that aluminium pouch is inner and tyvek®-pouch is outer pouch, implant is placed into cardboard holder. This packaging method is identical for 1.5mm and 2.4 SmartNail implants.

The only modifications that were made are:

• Amendment of one new sizes, 2.4mm in diameter and lengths of 16, 25, 35 and 45 mm
• Revision of design accordingly in longer lengths, more rows of barbs than in shorter nails
• Reference numbers for new sizes. These changes are updated in labelling.
• Revision of instrumentation accordingly
• Amendment of optional silicone cover for improvement of arthroscopic surgical technique

The provided text describes a 510(k) premarket notification for a medical device (2.4 SmartNail) and its substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

The document is a regulatory submission for premarket clearance, focusing on demonstrating substantial equivalence to existing devices rather than presenting detailed performance studies against defined acceptance criteria.

Therefore, I cannot provide the requested information. The document focuses on:

• Device Description: Material, dimensions, shelf life, packaging, and modifications compared to predicate devices.
• Intended Use and Contraindications: What the device is designed for and situations where it should not be used.
• Predicate Devices: Identifying similar devices already on the market.
• Substantial Equivalence Claim: Stating that the modifications do not raise new safety or efficacy concerns and do not affect pull-out properties (though no specific data proving this is provided in the excerpt).
• FDA Clearance Letter: Confirming the substantial equivalence determination and allowing marketing.

To answer your questions, a different type of document, such as a detailed technical report, clinical study protocol, or performance testing summary, would be needed.

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The Bionx Duet™ Suture Anchor is intended for use to reattach soft tissue to bone in orthopaedic surgical procedures. The device may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules, to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.

Duet™ Suture Anchor is threaded, bioabsorbable suture anchor, provided as preloaded with two non-absorbable, braided, polyester #2 sutures, one of them is green and another one is white. Diameter of the anchor is 6.0mm and length 16.5mm. It is assembled with sutures with needles into single use, sterile, disposable driver and packaged into blister with a punch. The Duet™ Suture Anchor is made of poly-L/D-lactide copolymer.

The provided text describes a 510(k) premarket notification for a medical device called the Duet™ Suture Anchor. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a standalone study.

Therefore, the requested information elements related to acceptance criteria, device performance, study design (test/training sets, ground truth, expert opinions, MRMC studies) are not explicitly described in the provided text.

Here's a breakdown of what can be extracted and what information is missing:

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

• Not explicitly provided. The document focuses on demonstrating that the Duet™ Suture Anchor has the "same intended use and principles of operation and very similar technological characteristics" as existing predicate devices. It states that "the minor technological differences between the Bionx Implants Inc. Duet™ Suture Anchor and the predicate devices do not raise any new issues of safety or effectiveness." This implies that the device is expected to perform comparably to its predicates, but no specific performance metrics or acceptance criteria are listed for the Duet™ itself.

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

• Not applicable/Not provided. This document is a 510(k) submission, not a clinical study report. It does not describe a test set or data provenance in the context of device performance evaluation.

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/Not provided. Ground truth establishment is not discussed in the context of device performance in this document.

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

• Not applicable/Not provided. Adjudication is not mentioned as no performance study 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 device is a bioabsorbable surgical anchor, not an AI-powered diagnostic tool. Therefore, an MRMC study is irrelevant to its evaluation.

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

• Not applicable. This is a physical implant, not an algorithm.

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

• Not applicable/Not provided. Ground truth is not discussed.

8. The sample size for the training set

• Not applicable/Not provided. Training sets are relevant for AI/machine learning models, which this device is not.

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

• Not applicable/Not provided. Ground truth for a training set is not discussed.

Summary of what the document does provide:

• Intended Use: Reattachment of soft tissue to bone by arthroscopy or direct visualization.
• Predicate Devices: A long list of existing bioabsorbable suture anchors with similar intended uses and principles of operation.
• Material: Self-Reinforced (96/4D) PLA Copolymer, with the material provenance being previously cleared Bionx Implants Inc. devices.
• Mechanism of action: Retains 90% strength through 20 weeks and completely resorbs over several years, allowing gradual strength loss as collagen fibers heal.
• Conclusion: The FDA determined the device is "substantially equivalent" to legally marketed predicate devices, meaning it does not raise new issues of safety or effectiveness. This is the primary "proof" of meeting regulatory requirements for this type of submission.

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1.5mm Bone Fixation Kit is intended for use in the fixation of fragments of fractured non-load bearing bones, osteotomies and arthrodeses, for example in the fixation of apical fragments, osteochondral fragments and cancellous/non-load bearing fragments.

1.5mm Bone Fixation Kit is not intended for use in and is contraindicated for: 1) Fractures and osteotomies of cortical bone (except cortical bones of the foot and the hand), 2) Fractures and osteotomies in weight bearing cancellous bone, 3) Situations where internal fixation is otherwise contraindicated, e.g., active or potential infection and where patient co-operation cannot be guaranteed (e.g. alcoholism), 4) Treatment of physeal fractures in children, because the effect of the implant upon the healing of growth plate has not been tested clinically.

The implants are composed of poly-L/D-lactide copolymer. This is the very same raw material with SmartNail (K993074) and 1.5mm Bone Fixation Kit (K012000)
Lengths of implants are 14, 16, 18, 20 and 25 mm. -
Diameter of implants is 1.5mm. This is identical with SmartNail (K993074) and -1.5mm Bone Fixation Kit (K012000)
Shelf life is same with SmartNail™ and 1.5mm Bone Fixation Kit (K012000). -
Implants and single use, sterile, disposable instruments are packed into blister, which is sealed with the Tyvek® lid. Blister with Tyvek® lid is packed into aluminium foil pouch and sealed.

The modifications are:

Amendment of new length, 14mm implant, into product line. -
Modified design accordingly. -

The provided 510(k) summary does not contain the detailed information typically associated with acceptance criteria and a study that proves a device meets those criteria, especially for a software-based medical device.

This submission is for a physical medical device: the 1.5mm Bone Fixation Kit, an absorbable bone fixation nail. For such devices, "acceptance criteria" and "study" would typically refer to mechanical and material testing, and possibly pre-clinical (animal) or limited clinical trials (human) demonstrating safety and performance. However, this submission focuses on demonstrating substantial equivalence to existing predicate devices rather than providing detailed study results.

Here's a breakdown based on the provided text, highlighting what is present and what is absent:

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

The submission does not provide a table of acceptance criteria or reported device performance in the way a software or AI device submission would. Instead, it relies on demonstrating that the revised device (with a new length and minor design modification) is substantially equivalent to existing cleared devices.

The key performance aspect mentioned is:

• "This modification has no effect on pull-out properties of the device."
  • This is a critical mechanical property for bone fixation devices, implying that testing was conducted to ensure the pull-out strength of the modified device remained comparable to the predicate. However, no specific values, criteria, or test results are provided in this summary.

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

• Sample Size: Not mentioned. It's likely that mechanical and material testing involved a certain number of implants, but this detail is not in the summary.
• Data Provenance: Not mentioned.

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

• This is not applicable to a physical bone fixation device. "Ground truth" in this context would be established through engineering and material testing standards.

4. Adjudication method for the test set

• This is not applicable to
  a physical bone fixation 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

• This question is not applicable as the device is a physical bone fixation implant, not a diagnostic or AI-assisted device for human interpretation.

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

• This question is not applicable as the device is a physical bone fixation implant.

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

• For this device, "ground truth" would be established through recognized engineering standards for mechanical strength (e.g., pull-out strength, bending strength), material biocompatibility, and degradation rates. The submission states the device uses the "very same raw material" as predicates, implying material properties are consistent. Specific details of these tests and their results are not included in the summary.

8. The sample size for the training set

• This question is not applicable as the device is a physical bone fixation implant. There is no AI or machine learning component requiring a training set.

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

• This question is not applicable as the device is a physical bone fixation implant.

Summary of Device Performance (Based only on the provided text):

The device performance is inferred from its substantial equivalence claim, specifically:

• The material (poly-L/D-lactide copolymer) is identical to predicate devices.
• The diameter (1.5mm) is identical to predicate devices.
• The shelf life is identical to predicate devices.
• Crucially, the submission explicitly states: "This modification has no effect on pull-out properties of the device." This implies that testing was conducted to confirm this, and the device performs equivalently to the predicates in terms of its ability to fix bone fragments without prematurely dislodging.

Missing Information:

The 510(k) summary provided here is a high-level overview focused on substantial equivalence. It lacks the specific details of mechanical testing methodologies, quantitative acceptance criteria (e.g., minimum pull-out strength in Newtons), and the actual test results that would typically be reviewed by the FDA as part of the full submission for a physical device. These details are generally found in the comprehensive testing reports within the complete 510(k) submission, not typically in the public-facing summary document.

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1.5mm Bone Fixation Kit is intended for use in the fixation of fragments of fractured non-load bearing bones, osteotomies and arthrodeses, for example in the fixation of apical fragments, osteochondral fragments and cancellous/non-load bearing fragments.

1.5mm Bone Fixation Kit is not intended for use in and is contraindicated for: 1) Fractures and osteotomies of cortical bone (except cortical bones of the foot and the I ractures and osteotomies in weight bearing cancellous bone, 3) Situations where internal fixation is otherwise contraindicated, e.g., active or potential infection where patient co-operation cannot be guaranteed (e.g. alcoholism), 4) Treatment and where pation of operation vecause the effect of the implant upon the healing of growth plate has not been tested clinically.

The implants are composed of poly-L/D-lactide copolymer. This is the very same raw material with SmartNail (K993074)

• Lengths of implants are 16, 18, 20 and 25 mm. -
• Diameter of implants is 1.5mm. This is identical with SmartNail (K993074) 1
• Design of the implant of 1.5mm Bone Fixation Kit is identical with SmartNail -(K993074).
• Shelf life is same with SmartNail™ -
• Implants and single use, sterile, disposable instruments are packed into blister, which is sealed with the Tyvek® lid. Blister with Tyvek® lid is packed into aluminium foil pouch and sealed.

The provided document is a 510(k) summary for the "Bionx Implants Inc. 1.5mm Bone Fixation Kit." This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance metrics typically associated with a new device's efficacy or safety study.

Therefore, many of the requested sections (e.g., acceptance criteria table, sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set details) are not applicable or not present in this type of regulatory submission. The document aims to show that the new device is functionally the same as an already-approved device, thus not requiring new clinical performance studies.

Here's an analysis based on the available information:

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

• Not applicable / Not explicitly stated. This document is a 510(k) submission aiming for substantial equivalence. It does not present a de novo study with specific performance acceptance criteria or a "reported device performance" against those criteria in the way new drug or novel medical device clinical trials would. The "acceptance criteria" here implicitly relate to demonstrating similarity to the predicate device.

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

• Not applicable. There is no "test set" or clinical data presented from a study to prove performance. The submission relies on technological characteristics and intended use equivalence to the predicate device.

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. No clinical test set data or ground truth establishment by experts is described as this is a substantial equivalence claim.

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

• Not applicable. No clinical test set data requiring adjudication is presented.

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 bone fixation kit (a physical implant), not an AI-powered diagnostic or assistive tool for human readers.

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

• Not applicable. This device is a physical bone implant, not an algorithm.

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

• Not applicable. The "ground truth" for this submission is the predicate device's pre-established safety and effectiveness. The new device aims to be substantially equivalent to that.

8. The sample size for the training set

• Not applicable. No training set for an algorithm is relevant to this physical medical device submission.

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

• Not applicable.

Summary of Device Acceptance & Study Information from the Document:

The acceptance of the "1.5mm Bone Fixation Kit" into the market is based on its substantial equivalence to a predicate device, the "Bionx Implants Inc. SmartNail (K993074)." The "study" in this context is the detailed comparison of the new device's characteristics against the predicate device to support the claim of substantial equivalence.

Table of Acceptance Criteria and Reported Device Performance (as implied by Substantial Equivalence):

Data Provenance and Ground Truth:

• Data Provenance: The "data" proving equivalence comes from the specifications and characteristics of the new device and the known specifications and regulatory clearance of the predicate device (K993074). This is a descriptive comparison, not a clinical data collection.
• Ground Truth: The "ground truth" for the new device's safety and effectiveness is inferred from the established safety and effectiveness of the legally marketed predicate device.

Conclusion:

This 510(k) summary is a regulatory submission focused on demonstrating substantial equivalence, not a clinical trial report. As such, the concept of "acceptance criteria" and "study results" pertains to meeting the requirements for substantial equivalence by comparing the device features and intended use to a legally marketed predicate device, rather than presenting de novo clinical performance data.

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