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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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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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