(65 days)
The Hemorrhage Occluder Pin is indicated for the control of localized severe presacral hemorrhage during pelvic surgery. When other techniques (cautery, suture, clamping, etc.) are judged ineffective.
The Hemorrhage Occluder Pin is a 7 mm long pin capped with an 8 mm diameter, 1.5 mm thick truncated conc-shaped head. The 1.25 mm diameter pin section has four tissue and bone retaining ridges formed by machining four equally spaced truncated conical sections. It is made of medical grade titanium suitable for implantation.
The provided text describes a medical device called the "Hemorrhage Occluder Pin" and its submission for 510(k) clearance. The submission aims to demonstrate substantial equivalence to a predicate device, rather than proving the device meets specific performance criteria through a study.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the traditional sense of numerical thresholds or performance targets for a device. Instead, it focuses on demonstrating substantial equivalence to a predicate device. The acceptance is based on the new device being "as safe and effective as the predicate device." The "reported device performance" in this context is that its characteristics and function are materially identical to the predicate.
| Characteristic | Acceptance Basis (from text) | Reported Device Performance (from text) |
|---|---|---|
| Intended Use | Substantially equivalent to predicate device. | "For the control of localized severe hemorrhage from the presacral area during surgery." (Exactly the same as predicate) |
| Indications for Use | Substantially equivalent to predicate device. | "When other techniques (cautery, suture, clamping, etc.) are judged ineffective." (Exactly the same as predicate) |
| Target Population | Substantially equivalent to predicate device. | "All males or females with the above indication for use." (Exactly the same as predicate) |
| Design | Substantially equivalent to predicate device. | "Developed by reverse engineering the predicate device." (Exactly the same as predicate) |
| Materials | Substantially equivalent to predicate device. | "Machined from medical grade 6AL4V titanium." (Exactly the same as predicate) |
| Performance | Substantially equivalent to predicate device. | "Sterile single use device is pressed thru the tissue and imbedded in the bone... until the head is seated and the bleeding controlled. The pin... remains implanted in the bone. Clinical experience of the product device validates the performance." (Exactly the same as predicate) |
| Biocompatibility | Substantially equivalent to predicate device. | "Titanium is known to be completely inert and immune to corrosion... prior clinical experience with the predicate pins of the same material... validates the biocompatibility." (Exactly the same as predicate) |
| Mechanical Safety | Substantially equivalent to predicate device. | "Supported by materials high strength, corrosion resistance, ability to withstand repeated sterilizations... and by its identical design to the predicate device with its long successful clinical usage." (Exactly the same as predicate) |
| Chemical Safety | Substantially equivalent to predicate device. | "Supported by safe usage of much larger volume of identical material in imbedded prostheses and the materials biocompatibility." (Exactly the same as predicate) |
| Anatomical Sites | Substantially equivalent to predicate device. | "Only site indicated for usage is in the sacral area during pelvic surgery." (Exactly the same as predicate) |
| Human Factors | Substantially equivalent to predicate device. | "Not an issue. Only finger pressure required..." (Exactly the same as predicate) |
| Energy Used or Delivered | Substantially equivalent to predicate device. | "None." (Exactly the same as predicate) |
| Compatibility with environmental and other devices | Substantially equivalent to predicate device. | "Material is highly inert, chemically safe and non-magnetic..." (Exactly the same as predicate) |
| Standards Met | Substantially equivalent to predicate device. | "MIL-T9047 6AL4V EL1 ASTM F136." (Exactly the same as predicate) |
| Electrical Safety | Substantially equivalent to predicate device. | "Device is passive. No electrical input, output or generated power." (Exactly the same as predicate) |
| Thermal Safety | Substantially equivalent to predicate device. | "Device is passive, not heat generating..." (Exactly the same as predicate) |
| Radiation Safety | Substantially equivalent to predicate device. | "Device is immune to damage by any level of radiation exposure..." (Exactly the same as predicate) |
| Sterility | Substantially equivalent to predicate device. | "To be marketed both as 'unsterilized' and as 'sterilized'. The latter will be ETO sterilized and validated in accordance with ANSI/AAMI 11135-1994 and EN550. Sterilization validated per method 'c', half cycle method." (Predicate used radiation sterilization; packaging is "exactly the same"). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not describe a "test set" in the context of a performance study with a specific sample size. The claim for performance is based on "clinical experience of the product device validates the performance" and "prior clinical experience with the predicate pins." This suggests reliance on existing clinical data and the historical performance of the predicate device, rather than a new prospective study with a defined sample size. The provenance of this "clinical experience" or "prior clinical experience" is not specified (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
No information is provided about experts used to establish ground truth. This type of detail is typical for studies involving diagnostic or analytical devices, not typically for mechanical implants demonstrating substantial equivalence where the primary evidence is material equivalence and historical safety data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
No test set or adjudication method 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
This is not applicable. The device is a physical implant, not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study or AI assistance effect size would be relevant or performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. The device is a physical implant, and there is no algorithm or standalone performance being evaluated.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the device's safety and effectiveness relies on the demonstrated substantial equivalence to a legally marketed predicate device. This includes:
- Material equivalence: Medical grade titanium identical to the predicate.
- Design equivalence: Reverse engineered from the predicate.
- Intended use and indications for use equivalence: Identical to the predicate.
- Historical clinical experience/outcomes data from the predicate device: The document mentions "prior clinical experience with the predicate pins" and "long successful clinical usage" of the predicate. This historical data serves as the "ground truth" for the safety and effectiveness of the device by proxy of its substantial equivalence.
8. The sample size for the training set
This is not applicable. There is no mention of a "training set" as this is not a machine learning or AI-based device.
9. How the ground truth for the training set was established
This is not applicable. There is no training set.
§ 878.4750 Implantable staple.
(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.